WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

PubMed Central

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Schornstein, Katrin; Vernooij-Dassen, Myrra; Olde-Rikkert, Marcel; Huell, Michael

2009-01-01

Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion. Discussion The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment. The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform. PMID:19799779

Timing of intervention in high-risk non-ST-elevation acute coronary syndromes in PCI versus non-PCI centres : Sub-group analysis of the ELISA-3 trial.

PubMed

Badings, E A; Remkes, W S; Dambrink, J-H E; The, S H K; Van Wijngaarden, J; Tjeerdsma, G; Rasoul, S; Timmer, J R; van der Wielen, M L J; Lok, D J A; van 't Hof, A W J

2016-03-01

To compare the effect of timing of intervention in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) in percutaneous coronary intervention (PCI) versus non-PCI centres. A post-hoc sub-analysis was performed of the ELISA III trial, a randomised multicentre trial investigating outcome of early (< 12 h) versus late (> 48 h) angiography and revascularisation in 542 patients with high-risk NSTE-ACS. 90 patients were randomised in non-PCI centres and tended to benefit more from an early invasive strategy than patients included in the PCI centre (relative risk 0.23 vs. 0.85 [p for interaction = 0.089] for incidence of the combined primary endpoint of death, reinfarction and recurrent ischaemia after 30 days of follow-up). This was largely driven by reduction in recurrent ischaemia. In non-PCI centres, patients randomised to the late group had a 4 and 7 day longer period until PCI or coronary artery bypass grafting, respectively. This difference was less pronounced in the PCI centre. This post-hoc analysis from the ELISA-3 trial suggests that NSTE-ACS patients initially hospitalised in non-PCI centres show the largest benefit from early angiography and revascularisation, associated with a shorter waiting time to revascularisation. Improved patient logistics and transfer between non-PCI and PCI centres might therefore result in better clinical outcome.

Assessing value-based health care delivery for haemodialysis.

PubMed

Parra, Eduardo; Arenas, María Dolores; Alonso, Manuel; Martínez, María Fernanda; Gamen, Ángel; Aguarón, Juan; Escobar, María Teresa; Moreno-Jiménez, José María; Alvarez-Ude, Fernando

2017-06-01

Disparities in haemodialysis outcomes among centres have been well-documented. Besides, attempts to assess haemodialysis results have been based on non-comprehensive methodologies. This study aimed to develop a comprehensive methodology for assessing haemodialysis centres, based on the value of health care. The value of health care is defined as the patient benefit from a specific medical intervention per monetary unit invested (Value = Patient Benefit/Cost). This study assessed the value of health care and ranked different haemodialysis centres. A nephrology quality management group identified the criteria for the assessment. An expert group composed of stakeholders (patients, clinicians and managers) agreed on the weighting of each variable, considering values and preferences. Multi-criteria methodology was used to analyse the data. Four criteria and their weights were identified: evidence-based clinical performance measures = 43 points; yearly mortality = 27 points; patient satisfaction = 13 points; and health-related quality of life = 17 points (100-point scale). Evidence-based clinical performance measures included five sub-criteria, with respective weights, including: dialysis adequacy; haemoglobin concentration; mineral and bone disorders; type of vascular access; and hospitalization rate. The patient benefit was determined from co-morbidity-adjusted results and corresponding weights. The cost of each centre was calculated as the average amount expended per patient per year. The study was conducted in five centres (1-5). After adjusting for co-morbidity, value of health care was calculated, and the centres were ranked. A multi-way sensitivity analysis that considered different weights (10-60% changes) and costs (changes of 10% in direct and 30% in allocated costs) showed that the methodology was robust. The rankings: 4-5-3-2-1 and 4-3-5-2-1 were observed in 62.21% and 21.55%, respectively, of simulations, when weights were varied by 60%. Value assessments may integrate divergent stakeholder perceptions, create a context for improvement and aid in policy-making decisions. © 2015 John Wiley & Sons, Ltd.

Interventions to improve hand hygiene compliance in patient care.

PubMed

Gould, Dinah J; Moralejo, Donna; Drey, Nicholas; Chudleigh, Jane H; Taljaard, Monica

2017-09-01

Health care-associated infection is a major cause of morbidity and mortality. Hand hygiene is regarded as an effective preventive measure. This is an update of a previously published review. To assess the short- and long-term success of strategies to improve compliance to recommendations for hand hygiene, and to determine whether an increase in hand hygiene compliance can reduce rates of health care-associated infection. We conducted electronic searches of the Cochrane Register of Controlled Trials, PubMed, Embase, and CINAHL. We conducted the searches from November 2009 to October 2016. We included randomised trials, non-randomised trials, controlled before-after studies, and interrupted time series analyses (ITS) that evaluated any intervention to improve compliance with hand hygiene using soap and water or alcohol-based hand rub (ABHR), or both. Two review authors independently screened citations for inclusion, extracted data, and assessed risks of bias for each included study. Meta-analysis was not possible, as there was substantial heterogeneity across studies. We assessed the certainty of evidence using the GRADE approach and present the results narratively in a 'Summary of findings' table. This review includes 26 studies: 14 randomised trials, two non-randomised trials and 10 ITS studies. Most studies were conducted in hospitals or long-term care facilities in different countries, and collected data from a variety of healthcare workers. Fourteen studies assessed the success of different combinations of strategies recommended by the World Health Organization (WHO) to improve hand hygiene compliance. Strategies consisted of the following: increasing the availability of ABHR, different types of education for staff, reminders (written and verbal), different types of performance feedback, administrative support, and staff involvement. Six studies assessed different types of performance feedback, two studies evaluated education, three studies evaluated cues such as signs or scent, and one study assessed placement of ABHR. Observed hand hygiene compliance was measured in all but three studies which reported product usage. Eight studies also reported either infection or colonisation rates. All studies had two or more sources of high or unclear risks of bias, most often associated with blinding or independence of the intervention.Multimodal interventions that include some but not all strategies recommended in the WHO guidelines may slightly improve hand hygiene compliance (five studies; 56 centres) and may slightly reduce infection rates (three studies; 34 centres), low certainty of evidence for both outcomes.Multimodal interventions that include all strategies recommended in the WHO guidelines may slightly reduce colonisation rates (one study; 167 centres; low certainty of evidence). It is unclear whether the intervention improves hand hygiene compliance (five studies; 184 centres) or reduces infection (two studies; 16 centres) because the certainty of this evidence is very low.Multimodal interventions that contain all strategies recommended in the WHO guidelines plus additional strategies may slightly improve hand hygiene compliance (six studies; 15 centres; low certainty of evidence). It is unclear whether this intervention reduces infection rates (one study; one centre; very low certainty of evidence).Performance feedback may improve hand hygiene compliance (six studies; 21 centres; low certainty of evidence). This intervention probably slightly reduces infection (one study; one centre) and colonisation rates (one study; one centre) based on moderate certainty of evidence.Education may improve hand hygiene compliance (two studies; two centres), low certainty of evidence.Cues such as signs or scent may slightly improve hand hygiene compliance (three studies; three centres), low certainty of evidence.Placement of ABHR close to point of use probably slightly improves hand hygiene compliance (one study; one centre), moderate certainty of evidence. With the identified variability in certainty of evidence, interventions, and methods, there remains an urgent need to undertake methodologically robust research to explore the effectiveness of multimodal versus simpler interventions to increase hand hygiene compliance, and to identify which components of multimodal interventions or combinations of strategies are most effective in a particular context.

Community embedded reproductive health interventions for adolescents in Latin America: development and evaluation of a complex multi-centre intervention

PubMed Central

2013-01-01

Background Adolescents in Latin America are at high risk for unwanted and unplanned pregnancies, which often result in unsafe abortions or poor maternal health outcomes. Both young men and women in the region face an increased risk of sexually transmitted infections due to inadequate sexual and reproductive health information, services and counselling. To date, many adolescent health programmes have targeted a single determinant of sexual and reproductive health. However, recent evidence suggests that the complexity of sexual and reproductive health issues demands an equally multi-layered and comprehensive approach. Methods This article describes the development, implementation and evaluation design of the community-embedded reproductive health care for adolescents (CERCA) study in three Latin American cities: Cochabamba (Bolivia), Cuenca (Ecuador) and Managua (Nicaragua). Project CERCA’s research methodology builds on existing methodological frameworks, namely: action research, community based participatory research and intervention-mapping. The interventions in each country address distinct target groups (adolescents, parents, local authorities and health providers) and seek improvement of the following sexual health behaviours: communication about sexuality, sexual and reproductive health information-seeking, access to sexual and reproductive health care and safe sexual relationships. In Managua, we implemented a randomised controlled study, and in Cochabamba and Cuenca we adopted a non-randomised controlled study to evaluate the effectiveness of Project CERCA interventions, in addition to a process evaluation. Discussion This research will result in a methodological framework that will contribute to the improved design and implementation of future adolescent sexual and reproductive health interventions. Trial registration ClinicalTrials.gov (NCT01722084) PMID:23311647

Cost effectiveness of interpersonal community psychiatric treatment for people with long-term severe non-psychotic mental disorders: protocol of a multi-centre randomized controlled trial.

PubMed

van Veen, Mark; Koekkoek, Bauke; Mulder, Niels; Postulart, Debby; Adang, Eddy; Teerenstra, Steven; Schoonhoven, Lisette; van Achterberg, Theo

2015-05-02

This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders. Present care for this population has a limited evidence base, is often open ended, little effective, and expensive. Recent epidemiological data shows that 43.5% of the Dutch are affected by mental illness during their life. About 80% of all patients receiving mental health services (MHS) have one or more non-psychotic disorders. Particularly for this group, long-term treatment and care is poorly developed. Care As Usual (CAU) currently is a form of low-structured treatment/care. Interpersonal Community Psychiatric Treatment (ICPT) is a structured treatment for people with long-term, non-psychotic disorders, developed together with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study. Multi-centre cluster-randomized clinical trial: 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months. 180 Patients between 18-65 years of age will be included, who have been diagnosed with a non-psychotic psychiatric disorder (depressive, anxiety, personality or substance abuse disorder), have long-term (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year), and who receive treatment in a specialized mental health care setting. The primary outcome variable is quality of life; secondary outcomes are costs, recovery, general mental health, therapeutic alliance, professional-perceived difficulty of patient, care needs and social contacts. No RCT, nor cost-effectiveness study, has been conducted on ICPT so far. The empirical base for current CAU is weak, if not absent. This study will fill this void, and generate data needed to improve daily mental health care. Netherlands Trial Register (NTR): 3988 . Registered 13th of May 2013.

Structuring Communication Relationships for Interprofessional Teamwork (SCRIPT): a cluster randomized controlled trial.

PubMed

Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

2007-09-18

Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs) in general internal medicine (GIM) divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS); adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Pre-intervention qualitative analysis revealed that a substantial amount of interprofessional interaction lacks key core elements of collaborative communication such as self-introduction, description of professional role, and solicitation of other professional perspectives. Incorporating these findings, a four-component intervention was designed with a goal of creating a culture of communication in which the fundamentals of collaboration become a routine part of interprofessional interactions during unstructured work periods on GIM wards. Registered with National Institutes of Health as NCT00466297.

A Randomised Controlled Trial of Two Early Intervention Programs for Young Children with Autism: Centre-Based with Parent Program and Home-Based

ERIC Educational Resources Information Center

Roberts, Jacqueline; Williams, Katrina; Carter, Mark; Evans, David; Parmenter, Trevor; Silove, Natalie; Clark, Trevor; Warren, Anthony

2011-01-01

This study compares outcomes of early intervention programs for young children with autism; an individualised home-based program (HB), a small group centre-based program for children combined with a parent training and support group (CB) and a non-treatment comparison group (WL). Outcome measures of interest include social and communication skill…

Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early-onset sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study.

PubMed

Stocker, Martin; Hop, Wim C J; van Rossum, Annemarie M C

2010-12-08

Early diagnosis and treatment of the newborn infant with suspected sepsis are essential to prevent severe and life threatening complications. Diagnosis of neonatal sepsis is difficult because of the variable and nonspecific clinical presentation. Therefore, many newborns with nonspecific symptoms are started on antibiotic treatment before the presence of sepsis has been proven. With our recently published single-centre intervention study we were able to show that Procalcitonin determinations allowed to shorten the duration of antibiotic therapy in newborns with suspected early-onset sepsis. The study is designed as randomized controlled international multicenter intervention trial on the efficacy and safety of Procalcitonin guided treatment. Term and near-term infants (gestational age ≥ 34 0/7 weeks) with suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy will be included. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the likelihood of infection (infection unlikely, possible, probable or proven). In the Procalcitonin group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive Procalcitonin values are within the normal range. Co-primary outcome measures are the duration of antibiotic therapy (superiority aspect of the trial) and the proportion of infants with a recurrence of infection requiring additional courses of antibiotic therapy and/or death in the first month of life (safety of study intervention, non-inferiority aspect of the trial). The number of infants to be included equals 800 per arm. With these numbers the power of the study to demonstrate superiority for duration of antibiotic therapy as well as non-inferiority regarding safety, i.e. excluding a disadvantage difference larger than 2% for the experimental arm, will both be greater than 80%. Benefit of the study is a possible limitation of unnecessary use of antibiotics. The results of our first study suggest that there is a low risk on discontinuing antibiotic treatment too early, resulting in the development of a neonatal infection with its morbidity and mortality. This trial is registered in the U.S. National Institutes of Health's register, located at http://www.clinicaltrials.gov. (NCT00854932).

Improving access to medicines for non-communicable diseases in rural India: a mixed methods study protocol using quasi-experimental design.

PubMed

Prashanth, N S; Elias, Maya Annie; Pati, Manoj Kumar; Aivalli, Praveenkumar; Munegowda, C M; Bhanuprakash, Srinath; Sadhana, S M; Criel, Bart; Bigdeli, Maryam; Devadasan, Narayanan

2016-08-22

India has the distinction of financing its healthcare mainly through out-of-pocket expenses by individual families contributing to catastrophic health expenditure and impoverishment. Nearly 70 % of the expenditure is on medicines purchased at private pharmacies. Patients with chronic ailments are especially affected, as they often need lifelong medicines. Over the past years in India, there have been several efforts to improve drug availability at government primary health centres. In this study, we aim to understand health system factors that affect utilisation and access to generic medicines for people with non-communicable diseases. This study aims to understand if (and how) a package of interventions targeting primary health centres and community participation platforms affect utilisation and access to generic medicines for people with non-communicable diseases in the current district context in India. This study will employ a quasi-experimental design and a qualitative theory-driven approach. PHCs will be randomly assigned to one of three arms of the intervention. In one arm, PHCs will receive inputs to optimise service delivery for non-communicable diseases, while the second arm will receive an additional package of interventions to strengthen community participation platforms for improving non-communicable disease care. The third arm will be the control. We will conduct household and facility surveys, before and after the intervention and will estimate the effect of the intervention by difference-in-difference analysis. Sample size for measuring effects was calculated based on obtaining at least 30 households for each primary health centre spread across three distance-based clusters. Primary outcomes include availability and utilisation of medicines at primary health centres and out-of-pocket expenditure for medicines by non-communicable disease households. Focus group discussions with patients and in-depth interviews with health workers will also be conducted. Qualitative and process documentation data will be used to explain how the intervention could have worked. By taking into consideration several health system building blocks and trying to understand how they interact, our study aims to generate evidence for health planners on how to optimise health services to improve access to medicines. Protocol registered on Clinical Trials Registry of India with registration identifier number CTRI/2015/03/005640 on 17(th) March 2015.

Health Facility Utilisation Changes during the Introduction of Community Case Management of Malaria in South Western Uganda: An Interrupted Time Series Approach.

PubMed

Lal, Sham; Ndyomugenyi, Richard; Alexander, Neal D; Lagarde, Mylene; Paintain, Lucy; Magnussen, Pascal; Chandramohan, Daniel; Clarke, Siân E

2015-01-01

Malaria endemic countries have scaled-up community health worker (CHW) interventions, to diagnose and treat malaria in communities with limited access to public health systems. The evaluations of these programmes have centred on CHW's compliance to guidelines, but the broader changes at public health centres including utilisation and diagnoses made, has received limited attention. This analysis was conducted during a CHW-intervention for malaria in Rukungiri District, Western Uganda. Outpatient department (OPD) visit data were collected for children under-5 attending three health centres one year before the CHW-intervention started (pre-intervention period) and for 20 months during the intervention (intervention-period). An interrupted time series analysis with segmented regression models was used to compare the trends in malaria, non-malaria and overall OPD visits during the pre-intervention and intervention-period. The introduction of a CHW-intervention suggested the frequency of diagnoses of diarrhoeal diseases, pneumonia and helminths increased, whilst the frequency of malaria diagnoses declined at health centres. In May 2010 when the intervention began, overall health centre utilisation decreased by 63% compared to the pre-intervention period and the health centres saw 32 fewer overall visits per month compared to the pre-intervention period (p<0.001). Malaria visits also declined shortly after the intervention began and there were 27 fewer visits per month during the intervention-period compared with the pre-intervention period (p<0.05). The declines in overall and malaria visits were sustained for the entire intervention-period. In contrast, there were no observable changes in trends of non-malarial visits between the pre-intervention and intervention-period. This analysis suggests introducing a CHW-intervention can reduce the number of child malaria visits and change the profile of cases presenting at health centres. The reduction in workload of health workers may allow them to spend more time with patients or undertake additional curative or preventative roles.

Centre-based day care for children younger than five years of age in low- and middle-income countries.

PubMed

Brown, Taylor W; van Urk, Felix C; Waller, Rebecca; Mayo-Wilson, Evan

2014-09-25

Because of poverty, children and families in low- and middle-income countries often face significant impediments to health and well-being. Centre-based day care services may influence the development of children and the economic situation of parents by providing good quality early childhood care and by freeing parents to participate in the labour force. To assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development, health and well-being of children and families in low- and middle-income countries (as defined by the World Bank 2011). In April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, ERIC and 16 other sources, including several World Health Organization (WHO) regional databases. We also searched two trials registers, websites of government and non-government agencies and reference lists of relevant studies. We included randomised and quasi-randomised controlled trials and prospective non-randomised studies with contemporaneous control groups and assessments both before and after intervention. We considered non-randomised controlled trials, as centre-based care in low- and middle-income countries is unlikely to be studied using randomised controlled trials (Higgins 2011). We included the following outcomes: child intellectual development, child psychosocial development, maternal and family outcomes and incidence of infectious diseases. Two review authors independently assessed risk of bias and extracted data from the single included study. Only one trial, involving 256 children, met the inclusion criteria for this review. This study was assessed as having high risk of bias because of non-random allocation, incomplete outcome data and insufficient control of confounding factors. Results from this study suggest that centre-based day care may have a positive effect on child cognitive ability compared with no treatment (care at home) (assessed using a modified version of the British Ability Scale-II (BAS-II) (standardised mean difference (SMD) 0.74, 95% confidence interval (CI) 0.48 to 1.00, 256 participants, 1 study, very low-quality evidence). This study did not measure other variables relevant to this review. The single study included in this review provides limited evidence on the effects of centre-based day care for children younger than five years of age in low- and middle-income countries. This study was at high risk of bias and may have limited generalisability to other low- and middle-income countries. Many of the studies excluded from this review paired day care attendance with co-interventions that are unlikely to be provided in normal day care centres. Effectiveness studies on centre-based day care without these co-interventions are few, and the need for such studies is significant. In future studies, comparisons might include home visits or alternative day care arrangements.

The Stamp-in-Safety programme, an intervention to promote better supervision of children on childcare centre playgrounds: an evaluation in an urban setting.

PubMed

Chelvakumar, Gayathri; Sheehan, Karen; Hill, Amy L; Lowe, Danita; Mandich, Nicole; Schwebel, David C

2010-10-01

Using a non-equivalent control group design, this report evaluated a previously studied behavioural intervention, the Stamp-in-Safety programme, which is designed to reduce the injury risk for young children on playgrounds at childcare centres by increasing the quality of adult supervision and rewarding children for safe play. In an urban, commercial childcare centre, 71 children aged 3-5 years and 15 teachers participated. Primary outcome measures were teacher verbalisations (warnings, explanations, redirects), teacher location (core, outskirt, or fringe of playground), child risk-taking behaviours (using equipment appropriately) and the number of injuries on the playground. Analyses revealed that the intervention had a modest positive effect in promoting safer teacher and child playground behaviours. This study reaffirms previous results that the Stamp-in-Safety programme is an effective method to decrease the risk of playground injuries at childcare centres.

Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

PubMed

van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

2016-07-26

Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

Family-centred approaches to healthcare interventions in chronic diseases in adults: a quantitative systematic review.

PubMed

Deek, Hiba; Hamilton, Sandra; Brown, Nicola; Inglis, Sally C; Digiacomo, Michelle; Newton, Phillip J; Noureddine, Samar; MacDonald, Peter S; Davidson, Patricia M

2016-05-01

Increasingly there is a focus on self-care strategies for both malignant and non-malignant conditions. Models of self-care interventions have focussed on the individual and less on the broader context of family and society. In many societies, decision-making and health seeking behaviours, involve family members. To identify elements of effective family-centred self-care interventions that are likely to improve outcomes of adults living with chronic conditions. Review paper. MEDLINE (Ovid), CINAHL, Academic Search Complete, PsychInfo and Scopus between 2000-2014. Quantitative studies targeting patient outcomes through family-centred interventions in adults were retrieved using systematic methods in January, 2015. Search terms used were: 'family', 'spouse', 'carer', 'caregiver', 'chronic', 'chronic disease', 'self-care', 'self-management' and 'self-efficacy'. Reference lists were reviewed. Risk of bias assessment was performed using the Cochrane Collaboration's tool. Data were reported using a narrative summary approach. Ten studies were identified. Improvements were noted in readmission rates, emergency department presentations, and anxiety levels using family-centred interventions compared with controls. Elements of effective interventions used were a family-centred approach, active learning strategy and transitional care with appropriate follow-up. Involving the family in self-care has shown some positive results for patients with chronic conditions. The benefits of family-centred care may be more likely in specific socio-cultural contexts. The review has year limits and further research needs to identify support for both the patients and family caregivers. © 2016 John Wiley & Sons Ltd.

Exploration of dynamics in a complex person-centred intervention process based on health professionals' perspectives.

PubMed

Friberg, Febe; Wallengren, Catarina; Håkanson, Cecilia; Carlsson, Eva; Smith, Frida; Pettersson, Monica; Kenne Sarenmalm, Elisabeth; Sawatzky, Richard; Öhlén, Joakim

2018-06-13

The assessment and evaluation of practical and sustainable development of health care has become a major focus of investigation in health services research. A key challenge for researchers as well as decision-makers in health care is to understand mechanisms influencing how complex interventions work and become embedded in practice, which is significant for both evaluation and later implementation. In this study, we explored nurses' and surgeons' perspectives on performing and participating in a complex multi-centre person-centred intervention process that aimed to support patients diagnosed with colorectal cancer to feel prepared for surgery, discharge and recovery. Data consisted of retrospective interviews with 20 professionals after the intervention, supplemented with prospective conversational data and field notes from workshops and follow-up meetings (n = 51). The data were analysed to construct patterns in line with interpretive description. Although the participants highly valued components of the intervention, the results reveal influencing mechanisms underlying the functioning of the intervention, including multiple objectives, unclear mandates and competing professional logics. The results also reveal variations in processing the intervention focused on differences in using and talking about intervention components. The study indicates there are significant areas of ambiguity in understanding how theory-based complex clinical interventions work and in how interventions are socially constructed and co-created by professionals' experiences, assumptions about own professional practice, contextual conditions and the researchers' intentions. This process evaluation reveals insights into reasons for success or failure and contextual aspects associated with variations in outcomes. Thus, there is a need for further interpretive inquiry, and not only descriptive studies, of the multifaceted characters of complex clinical interventions and how the intervention components are actually shaped in constantly shifting contexts.

Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial.

PubMed

Bölenius, Karin; Lämås, Kristina; Sandman, Per-Olof; Edvardsson, David

2017-02-16

The literature indicates that current home care service are largely task oriented with limited focus on the involvement of the older people themselves, and studies show that lack of involvement might reduce older people's quality of life. Person-centred care has been shown to improve the satisfaction with care and quality of life in older people cared for in hospitals and nursing homes, with limited published evidence about the effects and meanings of person-centred interventions in home care services for older people. This study protocol outlines a study aiming to evaluate such effects and meanings of a person-centred and health-promoting intervention in home aged care services. The study will take the form of a non-randomised controlled trial with a before/after approach. It will include 270 older people >65 years receiving home care services, 270 relatives and 65 staff, as well as a matched control group of equal size. All participants will be recruited from a municipality in northern Sweden. The intervention is based on the theoretical concepts of person-centredness and health-promotion, and builds on the four pedagogical phases of: theory apprehension, experimental learning, operationalization, and clinical supervision. Outcome assessments will focus on: a) health and quality of life (primary outcomes), thriving and satisfaction with care for older people; b) caregiver strain, informal caregiving engagement and relatives' satisfaction with care: c) job satisfaction and stress of conscience among care staff (secondary outcomes). Evaluation will be conducted by means of self-reported questionnaires and qualitative research interviews. Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services, and the results can point the way to establishing a more person-centred and health-promoting model for home care services for older people. NCT02846246 .

Multi-faceted case management: reducing compensation costs of musculoskeletal work injuries in Australia.

PubMed

Iles, Ross Anthony; Wyatt, M; Pransky, G

2012-12-01

This study aimed to determine whether a multi-faceted model of management of work related musculoskeletal disorders reduced compensation claim costs and days of compensation for injured workers. An intervention including early reporting, employee centred case management and removal of barriers to return to work was instituted in 16 selected companies with a combined remuneration over $337 million. Outcomes were evaluated by an administrative dataset from the Victorian WorkCover Authority database. A 'quasi experimental' pre-post design was employed with 492 matched companies without the intervention used as a control group and an average of 21 months of post-intervention follow-up. Primary outcomes were average number of days of compensation and average cost of claims. Secondary outcomes were total medical costs and weekly benefits paid. Information on 3,312 claims was analysed. In companies where the intervention was introduced the average cost of claims was reduced from $6,019 to $3,913 (estimated difference $2,329, 95 % CI $1,318-$3,340) and the number of days of compensation decreased from 33.5 to 14.1 (HR 0.77, 95 % CI 0.67-0.88). Medical costs and weekly benefits costs were also lower after the intervention (p < 0.05). Reduction in claims costs were noted across industry types, injury location and most employer sizes. The model of claims management investigated was effective in reducing the number of days of compensation, total claim costs, total medical costs and the amount paid in weekly benefits. Further research should investigate whether the intervention improves non-financial outcomes in the return to work process.

Structuring communication relationships for interprofessional teamwork (SCRIPT): a cluster randomized controlled trial

PubMed Central

Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

2007-01-01

Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs) in general internal medicine (GIM) divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS); adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a substantial amount of interprofessional interaction lacks key core elements of collaborative communication such as self-introduction, description of professional role, and solicitation of other professional perspectives. Incorporating these findings, a four-component intervention was designed with a goal of creating a culture of communication in which the fundamentals of collaboration become a routine part of interprofessional interactions during unstructured work periods on GIM wards. Trial registration Registered with National Institutes of Health as NCT00466297. PMID:17877830

[R]MIT Research Centre at Delft University of Technology: A Bridge between Research, Education, Society and Profession

ERIC Educational Resources Information Center

Zijlstra, Hielkje

2009-01-01

In 2006, we launched the [R]MIT Research Centre (Modification, Intervention Transformation) at the Faculty of Architecture at Delft University of Technology. [R]MIT was founded to respond to the need for an integrated, multi-disciplinary approach to the transformation of the built environment. [R]MIT aims to bring momentum to the renewal of…

Effectiveness of contact-based education for reducing mental illness-related stigma in pharmacy students.

PubMed

Patten, Scott B; Remillard, Alfred; Phillips, Leslie; Modgill, Geeta; Szeto, Andrew Ch; Kassam, Aliya; Gardner, David M

2012-12-05

A strategy for reducing mental illness-related stigma in health-profession students is to include contact-based sessions in their educational curricula. In such sessions students are able to interact socially with a person that has a mental illness. We sought to evaluate the effectiveness of this strategy in a multi-centre study of pharmacy students. The study was a randomized controlled trial conducted at three sites. Because it was necessary that all students receive the contact-based sessions, the students were randomized either to an early or late intervention, with the late intervention group not having participated in the contact-based education at the time when the primary outcome was assessed. The primary outcome, stigma, was assessed using an attitudes scale called the Opening Minds Survey for Health Care Providers (OMS-HC). We initially confirmed that outcomes were homogeneous across study centres, centre by group interaction, p = 0.76. The results were pooled across the three study centres. A significant reduction in stigma was observed in association with the contact-based sessions (mean change 4.3 versus 1.5, t=2.1, p=0.04). The effect size (Cohen's d) was 0.45. A similar reduction was seen in the control group when they later received the intervention. Contact-based education is an effective method of reducing stigma during pharmacy education. These results add to a growing literature confirming the effectiveness of contact-based strategies for stigma reduction in health profession trainees.

Effects and feasibility of a multi-disciplinary orientation program for newly registered cancer patients: design of a randomised controlled trial.

PubMed

Chan, Raymond; Webster, Joan; Bennett, Linda

2009-11-11

Diagnosis and treatment of cancer can contribute to psychological distress and anxiety amongst patients. Evidence indicates that information giving can be beneficial in reducing patient anxiety, so oncology specific information may have a major impact on this patient group. This study investigates the effects of an orientation program on levels of anxiety and self-efficacy amongst newly registered cancer patients who are about to undergo chemotherapy and/or radiation therapy in the cancer care centre of a large tertiary Australian hospital. The concept of interventions for orienting new cancer patients needs revisiting due to the dynamic health care system. Historically, most orientation programs at this cancer centre were conducted by one nurse. A randomised controlled trial has been designed to test the effectiveness of an orientation program with bundled interventions; a face-to-face program which includes introduction to the hospital facilities, introduction to the multi-disciplinary team and an overview of treatment side effects and self care strategies. The aim is to orientate patients to the cancer centre and to meet the health care team. We hypothesize that patients who receive this orientation will experience lower levels of anxiety and distress, and a higher level of self-efficacy. An orientation program is a common health care service provided by cancer care centres for new cancer patients. Such programs aim to give information to patients at the beginning of their encounter at a cancer care centre. It is clear in the literature that interventions that aim to improve self-efficacy in patients may demonstrate potential improvement in health outcomes. Yet, evidence on the effects of orientation programs for cancer patients on self-efficacy remains scarce, particularly with respect to the use of multidisciplinary team members. This paper presents the design of a randomised controlled trial that will evaluate the effects and feasibility of a multidisciplinary orientation program for new cancer patients. Current Controlled Trials ACTRN12609000018213.

Using a smartphone-based self-management platform to support medication adherence and clinical consultation in Parkinson's disease.

PubMed

Lakshminarayana, Rashmi; Wang, Duolao; Burn, David; Chaudhuri, K Ray; Galtrey, Clare; Guzman, Natalie Valle; Hellman, Bruce; Ben James; Pal, Suvankar; Stamford, Jon; Steiger, Malcolm; Stott, R W; Teo, James; Barker, Roger A; Wang, Emma; Bloem, Bastiaan R; van der Eijk, Martijn; Rochester, Lynn; Williams, Adrian

2017-01-01

The progressive nature of Parkinson's disease, its complex treatment regimens and the high rates of comorbid conditions make self-management and treatment adherence a challenge. Clinicians have limited face-to-face consultation time with Parkinson's disease patients, making it difficult to comprehensively address non-adherence. Here we share the results from a multi-centre (seven centres) randomised controlled trial conducted in England and Scotland to assess the impact of using a smartphone-based Parkinson's tracker app to promote patient self-management, enhance treatment adherence and quality of clinical consultation. Eligible Parkinson's disease patients were randomised using a 1:1 ratio according to a computer-generated random sequence, stratified by centre and using blocks of variable size, to intervention Parkinson's Tracker App or control (Treatment as Usual). Primary outcome was the self-reported score of adherence to treatment (Morisky medication adherence scale -8) at 16 weeks. Secondary outcomes were Quality of Life (Parkinson's disease questionnaire -39), quality of consultation for Parkinson's disease patients ( Patient-centred questionnaire for Parkinson's disease ), impact on non-motor symptoms (Non-motor symptoms questionnaire), depression and anxiety (Hospital anxiety and depression scale) and beliefs about medication (Beliefs about Medication Questionnaire) at 16 weeks. Primary and secondary endpoints were analysed using a generalised linear model with treatment as the fixed effect and baseline measurement as the covariate. 158 patients completed the study (Parkinson's tracker app = 68 and TAU = 90). At 16 weeks Parkinson's tracker app significantly improved adherence, compared to treatment as usual (mean difference: 0.39, 95%CI 0.04-0.74; p  = 0.0304) with no confounding effects of gender, number of comorbidities and age. Among secondary outcomes, Parkinson's tracker app significantly improved patients' perception of quality of consultation (0.15, 95% CI 0.03 to 0.27; p  = 0.0110). The change in non-motor symptoms was -0.82 (95% CI -1.75 to 0.10; p  = 0.0822). 72% of participants in the Parkinson's tracker app group continued to use and engage with the application throughout the 16-week trial period. The Parkinson's tracker app can be an effective and novel way of enhancing self-reported medication adherence and quality of clinical consultation by supporting self-management in Parkinson's disease in patients owning smartphones. Further work is recommended to determine whether the benefits of the intervention are maintained beyond the 16 week study period.

Factors affecting adherence to appointment system in the clinic for non-communicable diseases in UNRWA's Khan Younis Health Centre and the role of mobile phone text messages to improve adherence: a descriptive cross-sectional study.

PubMed

Al Najjar, Sanaa; Al Shaer, Tamer

2018-02-21

To meet the emerging needs of the increasing numbers of patients with non-communicable diseases and to provide optimum care with optimum contact time and minimum waiting time, as stated in UNRWA guidelines, the mobile phone text messaging system was implemented in UNRWA centres to remind patients of upcoming appointments and to thereby improve the quality of care for vulnerable patients and regulate the work load in the clinics for non-communicable diseases. The aim of this study was to assess the causes for lack of adherence to the appointment system at UNRWA centres. This descriptive cross-sectional study was done in the UNRWA's Khan Younis Health Centre (KYHC), which serves the same refugee population as other UNRWA health centres and follows the same guidelines with minimal variation. Data were collected through interviewer-administered questionnaires, with ten medical staff members involved in the appointment process and 50 patients with non-communicable diseases selected randomly from patients attending the KYHC. The text-message reminder intervention targeted 1000 patients with non-communicable diseases and consisted of an electronic message technique that was developed to remind patients about the day and time of upcoming appointments. Administrative approval was obtained from the chief of UNRWA health programme. Verbal consent was obtained from participants. We followed the Modified International Code of Ethics Principles (1975), known as the Declaration of Helsinki. The main barrier to adherence to appointments in the clinic for non-communicable diseases was forgetting the appointment. Other factors were lack of awareness, clinic overcrowding, appointments that do not match the patient's preference, availability of other service providers, and financial issues. In March, 2016, after the completion of the intervention, the proportion of patients that adhered to their appointment by date and time was 76%, compared with about 45% in January and February, 2016 (p=0·013). The text messaging reminder is a successful way of improving patient's adherence to appointments in UNRWA clinics for non-communicable diseases. The intervention should be continued and integrated in daily work. More financial resources are needed to support the text messaging reminder system. None. Copyright © 2018 Elsevier Ltd. All rights reserved.

Is an opportunistic primary care-based intervention for non-responders to bowel screening feasible and acceptable? A mixed-methods feasibility study in Scotland

PubMed Central

Calanzani, Natalia; Cavers, Debbie; Vojt, Gabriele; Orbell, Sheina; Steele, Robert J C; Brownlee, Linda; Smith, Steve; Patnick, Julietta; Weller, David; Campbell, Christine

2017-01-01

Objectives We aimed to test whether a brief, opportunistic intervention in general practice was a feasible and acceptable way to engage with bowel screening non-responders. Design This was a feasibility study testing an intervention which comprised a brief conversation during routine consultation, provision of a patient leaflet and instructions to request a replacement faecal occult blood test kit. A mixed-methods approach to evaluation was adopted. Data were collected from proformas completed after each intervention, from the Bowel Screening Centre database and from questionnaires. Semi-structured interviews were carried out. We used descriptive statistics, content and framework analysis to determine intervention feasibility and acceptability. Participants Bowel screening non-responders (as defined by the Scottish Bowel Screening Centre) and primary care professionals working in five general practices in Lothian, Scotland. Primary and secondary outcome measures Several predefined feasibility parameters were assessed, including numbers of patients engaging in conversation, requesting a replacement kit and returning it, and willingness of primary care professionals to deliver the intervention. Results The intervention was offered to 258 patients in five general practices: 220 (87.0%) engaged with the intervention, 60 (23.3%) requested a new kit, 22 (8.5%) kits were completed and returned. Interviews and questionnaires suggest that the intervention was feasible, acceptable and consistent with an existing health prevention agenda. Reported challenges referred to work-related pressures, time constraints and practice priorities. Conclusions This intervention was acceptable and resulted in a modest increase in non-responders participating in bowel screening, although outlined challenges may affect sustained implementation. The strategy is also aligned with the increasing role of primary care in promoting bowel screening. PMID:29025829

Foetal Antiepileptic Drug Exposure and Verbal versus Non-Verbal Abilities at Three Years of Age

ERIC Educational Resources Information Center

Meador, Kimford J.; Baker, Gus A.; Browning, Nancy; Cohen, Morris J.; Clayton-Smith, Jill; Kalayjian, Laura A.; Kanner, Andres; Liporace, Joyce D.; Pennell, Page B.; Privitera, Michael; Loring, David W.

2011-01-01

We previously reported that foetal valproate exposure impairs intelligence quotient. In this follow-up investigation, we examined dose-related effects of foetal antiepileptic drug exposure on verbal and non-verbal cognitive measures. This investigation is an ongoing prospective observational multi-centre study in the USA and UK, which has enrolled…

Using drama to improve person-centred dementia care.

PubMed

Kontos, Pia C; Mitchell, Gail J; Mistry, Bhavnita; Ballon, Bruce

2010-06-01

We implemented a 12-week drama-based educational intervention to introduce to dementia practitioners person-centred care that emphasizes the notion of embodied selfhood (defined as non-verbal self-expression). Person-centred dementia care guidelines emphasize the assessment of individual needs, and where appropriate, the use of non-pharmacological interventions before resorting to pharmacological management. However, dementia care is not consistent with these guidelines suggesting conceptual limitations and reliance on passive knowledge translation strategies. Focus groups and semi-structured interviews with practitioners (n = 24) in two nursing homes in central Canada were undertaken to assess the effectiveness of the drama-based components of the intervention. Our findings suggest that drama was effective as an educational modality, and helped implement the person-centred approach into practice. Significant practice outcomes included: new awareness that residents' body movements and dispositions can convey meaning; seeking biographical information from families; increased time efficiency; and supporting residents' independence. Our findings make an important contribution to person-centred dementia care by broadening the notion of personhood, and by facilitating implementation using drama. As an enhancement of person-centred care, the support of embodied selfhood may significantly improve residents' quality of life, quality of care, and practitioners' care-giving experience. © 2010 Blackwell Publishing Ltd.

Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial

PubMed Central

2010-01-01

Background Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. Discussion We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres. Trial Registration ISRCTN21392091 PMID:20067619

An Investigation of the Effectiveness of Family-Centred Positive Behaviour Support of Young Children with Disabilities

ERIC Educational Resources Information Center

Chu, Szu-Yin

2015-01-01

Positive Behaviour Intervention and Support (PBIS) is an evidence-based approach that has been proven to be effective in remediating problem behaviours in children. The purpose of this study was to evaluate the effectiveness of the family-centred PBIS approach when involving Taiwanese families in the treatment of off-task and non-compliant…

Using Multi-Component Consultation to Increase the Integrity with Which Teachers Implement Behavioral Classroom Interventions: A Pilot Study

ERIC Educational Resources Information Center

Owens, Julie Sarno; Coles, Erika K.; Evans, Steven W.; Himawan, Lina K.; Girio-Herrera, Erin; Holdaway, Alex S.; Zoromski, Allison K.; Schamberg, Terah; Schulte, Ann

2017-01-01

The goal of this pilot study was to evaluate the effectiveness of a multi-component consultation package in improving teachers' classroom management skills, particularly among teachers with lower baseline levels of knowledge, skills, and intervention-supportive beliefs. Participants were 58 elementary school teachers (93% female; 50% Non-Hispanic…

Protocol of a multi-centre randomised controlled trial of a web-based information intervention with nurse-delivered telephone support for haematological cancer patients and their support persons.

PubMed

Bryant, Jamie; Sanson-Fisher, Rob; Stevenson, William; Smits, Rochelle; Henskens, Frans; Wei, Andrew; Tzelepis, Flora; D'Este, Catherine; Paul, Christine; Carey, Mariko

2015-04-17

High rates of anxiety, depression and unmet needs are evident amongst haematological cancer patients undergoing treatment and their Support Persons. Psychosocial distress may be minimised by ensuring that patients are sufficiently involved in decision making, provided with tailored information and adequate preparation for potentially threatening procedures. To date, there are no published studies evaluating interventions designed to reduce psychosocial distress and unmet needs specifically in patients with haematological cancers and their Support Persons. This study will examine whether access to a web-based information tool and nurse-delivered telephone support reduces depression, anxiety and unmet information needs for haematological cancer patients and their Support Persons. A non-blinded, parallel-group, multi-centre randomised controlled trial will be conducted to compare the effectiveness of a web-based information tool and nurse-delivered telephone support with usual care. Participants will be recruited from the haematology inpatient wards of five hospitals in New South Wales, Australia. Patients diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt's lymphoma, Lymphoblastic lymphoma (B or T cell), or Diffuse Large B-Cell lymphoma and their Support Persons will be eligible to participate. Patients and their Support Persons will be randomised as dyads. Participants allocated to the intervention will receive access to a tailored web-based tool that provides accurate, up-to-date and personalised information about: cancer and its causes; treatment options including treatment procedures information; complementary and alternative medicine; and available support. Patients and Support Persons will complete self-report measures of anxiety, depression and unmet needs at 2, 4, 8 and 12 weeks post-recruitment. Patient and Support Person outcomes will be assessed independently. This study will assess whether providing information and support using web-based and telephone support address the major psychosocial challenges faced by haematological patients and their Support Persons. The approach, if found to be effective, has potential to improve psychosocial outcomes for haematological and other cancer patients, reduce the complexity and burden of meeting patients' psychosocial needs for health care providers with high potential for translation into clinical practice. ACTRN12612000720819.

Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial

PubMed Central

2011-01-01

Background Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term). Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration ISRCTN: ISRCTN58719694 PMID:21859489

Impact of a population based intervention to increase the adoption of multiple physical activity practices in centre based childcare services: a quasi experimental, effectiveness study

PubMed Central

2012-01-01

Background There is considerable scope to improve the delivery of practices that increase the physical activity of children in centre based childcare services. Few studies have reported the effectiveness of interventions to address this, particularly at a population level. The primary aim of this study was to describe the impact of an intervention to increase the adoption of multiple policies and practices to promote physical activity in centre based childcare services. Methods A quasi experimental study was conducted in centre based childcare services (n =228) in New South Wales (NSW), Australia and involved a three month intervention to increase the adoption of eight practices within childcare services that have been suggested to promote child physical activity. Intervention strategies to support the adoption of practices included staff training, resources, incentives, follow-up support and performance monitoring and feedback. Randomly selected childcare services in the remainder of NSW acted as a comparison group (n = 164) and did not receive the intervention but may have been exposed to a concurrent NSW government healthy eating and physical activity initiative. Self reported information on physical activity policies, fundamental movement skills sessions, structured physical activity opportunities, staff involvement in active play and provision of verbal prompts to encourage physical activity, small screen recreation opportunities, sedentary time, and staff trained in physical activity were collected by telephone survey with childcare service managers at baseline and 18 months later. Results Compared with the comparison area, the study found significantly greater increases in the prevalence of intervention services with a written physical activity policy, with policy referring to placing limits on small screen recreation, and with staff trained in physical activity. In addition, non-significant trends towards a greater increase in the proportion of intervention services conducting daily fundamental movement skill sessions, and such services having a physical activity policy supporting physical activity training for staff were also evident. Conclusion The intervention was effective in improving a number of centre based childcare service policies and practices associated with promoting child physical activity. Adoption of a broader range of practices may require more intensive and prolonged intervention support. PMID:22929434

Maintenance Cognitive Stimulation Therapy (CST) for dementia: A single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia

PubMed Central

2010-01-01

Background Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period. Methods/Design This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks. The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective. Discussion A pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive evidence of the potential efficacy of maintenance CST and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors. Trial Registration ISRCTN26286067 PMID:20426866

Maintenance Cognitive Stimulation Therapy (CST) for dementia: a single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia.

PubMed

Aguirre, Elisa; Spector, Aimee; Hoe, Juanita; Russell, Ian T; Knapp, Martin; Woods, Robert T; Orrell, Martin

2010-04-28

Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period. This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks.The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective. A pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive evidence of the potential efficacy of maintenance CST and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors.

Phenotypic factors influencing the variation in response of circulating cholesterol level to personalised dietary advice in the Food4Me study.

PubMed

Kirwan, Laura; Walsh, Marianne C; Celis-Morales, Carlos; Marsaux, Cyril F M; Livingstone, Katherine M; Navas-Carretero, Santiago; Fallaize, Rosalind; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Kolossa, Silvia; Daniel, Hannelore; Moschonis, George; Manios, Yannis; Surwillo, Agnieszka; Godlewska, Magdalena; Traczyk, Iwona; Drevon, Christian A; Gibney, Mike J; Lovegrove, Julie A; Martinez, J Alfredo; Saris, Wim H M; Mathers, John C; Gibney, Eileen R; Brennan, Lorraine

2016-12-01

Individual response to dietary interventions can be highly variable. The phenotypic characteristics of those who will respond positively to personalised dietary advice are largely unknown. The objective of this study was to compare the phenotypic profiles of differential responders to personalised dietary intervention, with a focus on total circulating cholesterol. Subjects from the Food4Me multi-centre study were classified as responders or non-responders to dietary advice on the basis of the change in cholesterol level from baseline to month 6, with lower and upper quartiles defined as responder and non-responder groups, respectively. There were no significant differences between demographic and anthropometric profiles of the groups. Furthermore, with the exception of alcohol, there was no significant difference in reported dietary intake, at baseline. However, there were marked differences in baseline fatty acid profiles. The responder group had significantly higher levels of stearic acid (18 : 0, P=0·034) and lower levels of palmitic acid (16 : 0, P=0·009). Total MUFA (P=0·016) and total PUFA (P=0·008) also differed between the groups. In a step-wise logistic regression model, age, baseline total cholesterol, glucose, five fatty acids and alcohol intakes were selected as factors that successfully discriminated responders from non-responders, with sensitivity of 82 % and specificity of 83 %. The successful delivery of personalised dietary advice may depend on our ability to identify phenotypes that are responsive. The results demonstrate the potential use of metabolic profiles in identifying response to an intervention and could play an important role in the development of precision nutrition.

Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care

PubMed Central

2012-01-01

Background Communication impairment is a frequent consequence of stroke. Patients who cannot articulate their needs respond with frustration and agitation, resulting in poor optimization of post-stroke functions. A key component of patient-centred care is the ability of staff to communicate in a way that allows them to understand the patient’s needs. We developed a patient-centred communication intervention targeting registered and unregulated nursing staff caring for complex continuing care patients with communication impairments post stroke. Research objectives include 1) examining the effects of the intervention on patients’ quality of life, depression, satisfaction with care, and agitation; and (2) examining the extent to which the intervention improves staff’s attitudes and knowledge in caring for patients with communication impairments. The intervention builds on a previous pilot study. Methods/design A quasi-experimental repeated measures non-equivalent control group design in a complex continuing care facility is being used. Patients with a communication impairment post-stroke admitted to the facility are eligible to participate. All staff nurses are eligible. Baseline data are collected from staff and patients. Follow-up will occur at 1 and 3 months post-intervention. Subject recruitment and data collection from 60 patients and 30 staff will take approximately 36 months. The Patient-Centred Communication Intervention consists of three components: (1) development of an individualized patient communication care plan; (2) a one-day workshop focused on communication and behavioural management strategies for nursing staff; and (3) a staff support system. The intervention takes comprehensive patient assessments into account to inform the development of communication and behavioural strategies specifically tailored to each patient. Discussion The Patient-Centred Communication Intervention will provide staff with strategies to facilitate interactions with patients and to minimize agitation associated with considerable stress. The improvement of these interactions will lead to a reduction of agitation, which has the additional significance of increasing patients’ well-being, quality of life, and satisfaction with care. Trial registration ClinicalTrials.gov Identifier NCT01654029 PMID:23050517

A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented. Discussion This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012. Trial registration ISRCTN58683841 PMID:22721452

Seniors centre-based health intervention programmes in the United States and South Korea: A systematic review.

PubMed

Song, Misoon; Seo, Kyoungsan; Choi, Suyoung; Choi, Jeongshil; Ko, Hana; Lee, Soo Jin

2017-10-01

Despite the great need for health interventions among seniors centre participants, this matter has received little attention. This systematic review aimed to identify what types of health interventions are effective and feasible for seniors centre participants. MEDLINE, Ovid, CINAHL, Google Scholar, EMBASE, and RISS were searched. We searched for health intervention studies conducted in seniors centres published in English and Korean between 1990 and 2014. Of 907 screened articles, 22 studies of all types of experimental designs were selected. Selected studies were grouped by intervention domain: health promotion (n = 8), safety (n = 5), chronic disease management (n = 6), and comprehensive wellness (n = 3). Overall, 59.1% of the interventions were provided by nurses. The health interventions resulted in positive effects on seniors centre participants' knowledge, health behaviours, clinical indices, and hospitalization rates. Few studies reported on feasibility outcomes such as satisfaction and cost-effectiveness. Considering the impact and ease of access to older people at seniors centres, health interventions and services within seniors centres should be strengthened. There is potential for nursing to spearhead seniors centre health intervention programmes to enhance active ageing for participants. © 2017 John Wiley & Sons Australia, Ltd.

Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease.

PubMed

Hussain, Shazia T; Paul, Matthias; Plein, Sven; McCann, Gerry P; Shah, Ajay M; Marber, Michael S; Chiribiri, Amedeo; Morton, Geraint; Redwood, Simon; MacCarthy, Philip; Schuster, Andreas; Ishida, Masaki; Westwood, Mark A; Perera, Divaka; Nagel, Eike

2012-09-19

In patients with stable coronary artery disease (CAD), decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR) have shown improved event free survival. Cardiovascular magnetic resonance (CMR) perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation. The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1) The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2) The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at one year. Clinical trials.gov identifier NCT01236807. MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR) would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.

Integrating care for frequent users of emergency departments: implementation evaluation of a brief multi-organizational intensive case management intervention.

PubMed

Kahan, Deborah; Leszcz, Molyn; O'Campo, Patricia; Hwang, Stephen W; Wasylenki, Donald A; Kurdyak, Paul; Wise Harris, Deborah; Gozdzik, Agnes; Stergiopoulos, Vicky

2016-04-27

Addressing the needs of frequent users of emergency departments (EDs) is a health system priority in many jurisdictions. This study describes stakeholder perspectives on the implementation of a multi-organizational brief intervention designed to support integration and continuity of care for frequent ED users with mental health and addictions problems, focusing on perceived barriers and facilitators to early implementation in a large urban centre. Coordinating Access to Care from Hospital Emergency Departments (CATCH-ED) is a brief case management intervention bridging hospital, primary and community care for frequent ED users experiencing mental illness and addictions. To examine barriers and facilitators to early implementation of this multi-organizational intervention, between July and October 2012, 47 stakeholders, including direct service providers, managers and administrators participated in 32 semi-structured qualitative interviews and one focus group exploring their experience with the intervention and factors that helped or hindered successful early implementation. Qualitative data were analyzed using thematic analysis. Stakeholders valued the intervention and its potential to support continuity of care for this population. Service delivery system factors, including organizational capacity and a history of collaborative relationships across the healthcare continuum, and support system factors, such as training and supervision, emerged as key facilitators of program implementation. Operational challenges included early low program referral rates, management of a multi-organizational initiative, variable adherence to the model among participating organizations, and scant access to specialty psychiatric resources. Factors contributing to these challenges included lack of dedicated staff in the ED and limited local system capacity to support this population, and insufficient training and technical assistance available to participating organizations. A multi-organizational brief intervention is an acceptable model to support integration of hospital, primary and community care for frequent ED users. The study highlights the importance of early implementation evaluation to identify potential solutions to implementation barriers that may be applicable to many jurisdictions.

Is an opportunistic primary care-based intervention for non-responders to bowel screening feasible and acceptable? A mixed-methods feasibility study in Scotland.

PubMed

Calanzani, Natalia; Cavers, Debbie; Vojt, Gabriele; Orbell, Sheina; Steele, Robert J C; Brownlee, Linda; Smith, Steve; Patnick, Julietta; Weller, David; Campbell, Christine

2017-10-11

We aimed to test whether a brief, opportunistic intervention in general practice was a feasible and acceptable way to engage with bowel screening non-responders. This was a feasibility study testing an intervention which comprised a brief conversation during routine consultation, provision of a patient leaflet and instructions to request a replacement faecal occult blood test kit. A mixed-methods approach to evaluation was adopted. Data were collected from proformas completed after each intervention, from the Bowel Screening Centre database and from questionnaires. Semi-structured interviews were carried out. We used descriptive statistics, content and framework analysis to determine intervention feasibility and acceptability. Bowel screening non-responders (as defined by the Scottish Bowel Screening Centre) and primary care professionals working in five general practices in Lothian, Scotland. Several predefined feasibility parameters were assessed, including numbers of patients engaging in conversation, requesting a replacement kit and returning it, and willingness of primary care professionals to deliver the intervention. The intervention was offered to 258 patients in five general practices: 220 (87.0%) engaged with the intervention, 60 (23.3%) requested a new kit, 22 (8.5%) kits were completed and returned. Interviews and questionnaires suggest that the intervention was feasible, acceptable and consistent with an existing health prevention agenda. Reported challenges referred to work-related pressures, time constraints and practice priorities. This intervention was acceptable and resulted in a modest increase in non-responders participating in bowel screening, although outlined challenges may affect sustained implementation. The strategy is also aligned with the increasing role of primary care in promoting bowel screening. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Design of the Quality of Life in Motion (QLIM) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer.

PubMed

Braam, Katja I; van Dijk, Elisabeth M; Veening, Margreet A; Bierings, Marc B; Merks, Johannes H M; Grootenhuis, Martha A; Chinapaw, Mai J M; Sinnema, Gerben; Takken, Tim; Huisman, Jaap; Kaspers, Gertjan J L; van Dulmen-den Broeder, Eline

2010-11-11

Childhood cancer and its treatment have considerable impact on a child's physical and mental wellbeing. Especially long-term administration of chemotherapy and/or radiotherapy impairs physical fitness both during and after therapy, when children often present with muscle weakness and/or low cardiorespiratory fitness. Physical exercise can improve these two elements of physical fitness, but the positive effects of physical exercise might be further increased when a child's wellbeing is simultaneously enhanced by psychosocial training. Feeling better may increase the willingness and motivation to engage in sports activities. Therefore, this multi-centre study evaluates the short and long-term changes in physical fitness of a child with a childhood malignancy, using a combined physical exercise and psychosocial intervention program, implemented during or shortly after treatment. Also examined is whether positive effects on physical fitness reduce inactivity-related adverse health problems, improve quality of life, and are cost-effective. This multi-centre randomized controlled trial compares a combined physical and psychosocial intervention program for children with cancer, with care as usual (controls). Children with cancer (aged 8-18 years) treated with chemotherapy and/or radiotherapy, and who are no longer than 1 year post-treatment, are eligible for participation. A total of 100 children are being recruited from the paediatric oncology/haematology departments of three Dutch university medical centres. Patients are stratified according to pubertal stage (girls: age ≤10 or >10 years; boys: ≤11 or >11 years), type of malignancy (haematological or solid tumour), and moment of inclusion into the study (during or after treatment), and are randomly assigned to the intervention or control group. Childhood cancer patients undergoing long-term cancer therapy may benefit from a combined physical exercise and psychosocial intervention program since it may maintain or enhance their physical fitness and increase their quality of life. However, the feasibility, patient need, and effectiveness of such a program should be established before the program can be implemented as part of standard care. NTR1531 (The Netherlands National Trial Register).

Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

PubMed

Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

2015-07-10

Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol.

PubMed

Serra-Paya, Noemi; Ensenyat, Assumpta; Real, Jordi; Castro-Viñuales, Iván; Zapata, Amalia; Galindo, Gisela; Solé-Mir, Eduard; Bosch-Muñoz, Jordi; Mur, Jose Maria; Teixidó, Concepció

2013-10-23

Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children's obesity. The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups. This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres. ClinicalTrials.gov, NCT01878994.

Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

PubMed Central

2013-01-01

Background Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing. The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity. Methods/Design The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups. Discussion This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres. Trial registration ClinicalTrials.gov, NCT01878994 PMID:24153001

Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

PubMed

Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

2017-09-26

Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and 12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis. The findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA. Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015 (retrospectively registered).

Characteristics of Effective Interventions Promoting Healthy Eating for Pre-Schoolers in Childcare Settings: An Umbrella Review

PubMed Central

Coveney, John

2018-01-01

Early Childhood Education and Care (ECEC) settings have a pivotal role in shaping children’s dietary food habits by providing the contextual environment within which they develop these behaviours. This study examines systematic reviews for (1) the effectiveness of interventions to promote healthy eating in children aged 2–5 years attending centre-based childcare; (2) intervention characteristics which are associated with promoting healthy eating and; (3) recommendations for child-health policies and practices. An Umbrella review of systematic reviews was undertaken using a standardized search strategy in ten databases. Twelve systematic reviews were examined using validated critical appraisal and data extraction tools. Children’s dietary food intake and food choices were significantly influenced. Interventions to prevent obesity did not significantly change children’s anthropometric measures or had mixed results. Evidence was more convincing if interventions were multi-component, addressed physical activity and diet, targeted individual-level and environmental-level determinants and engaged parents. Positive outcomes were mostly facilitated by researchers/external experts and these results were not replicated when implemented in centres by ECEC providers without this support. The translation of expert-led interventions into practice warrants further exploration of implementation drivers and barriers. Based on the evidence reviewed, recommendations are made to inform child-health directed practices and policies. PMID:29494537

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

PubMed

Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p < 0.001; p < 0.004). This pilot study suggests that the CoDuSe exercise improved balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) - study protocol of a cluster-randomised controlled trial.

PubMed

Behrndt, Elisa-Marie; Straubmeier, Melanie; Seidl, Hildegard; Book, Stephanie; Graessel, Elmar; Luttenberger, Katharina

2017-07-17

It is the wish of both people with cognitive impairment and their informal caregivers for the impaired person to live at home for as long as possible. This is also in line with economic arguments about health. The existing structure of day-care services for the elderly can be used to achieve this. Due to the current lack of empirical evidence in this field, most day-care centres do not offer a scientifically evaluated, structured intervention, but instead offer a mixture of individual activities whose efficacy has not yet been established. Informal caregivers of people with dementia use day-care centres primarily to relieve themselves of their care tasks and as a support service. The present study therefore investigates the effectiveness of a combination of a multicomponent activation therapy for people with mild cognitive impairment (MCI) or mild to moderate dementia at day-care centres and a brief telephone intervention for their informal caregivers. The study is conducted as a cluster-randomised intervention trial at 34 day-care centres in Germany with a 6-month treatment phase. The centres in the waitlist control group provide "care as usual". A power analysis indicated that 346 people should initially be included in the study. The primary endpoints of the study include the ability to perform activities of daily living (ADL) and cognitive capacities on the side of the day-care centre users and the subjectively perceived burden and well-being of the informal caregivers. The total duration of the study is 3 years, during which data are collected both by the psychometric testing of the people with cognitive impairment and by telephone interviews with informal caregivers. The project has three distinctive quality features. First, it is embedded in real care situations since the day-care services have already been established for this target group. Second, due to the large number of cases and the fact that the participating day-care centres are spread across the entire country, the results can be expected to be generalisable. Third, the interventions can be assumed to be implementable as they required only a one-day training event for the staff already working at the centres. ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

Special Issue: Using Drama to Improve Person-Centred Dementia Care

PubMed Central

Mitchell, Gail J.; Mistry, Bhavnita; Ballon, Bruce

2013-01-01

Background Person-centred dementia care guidelines emphasize the assessment of individual needs, and, where appropriate, the use of non-pharmacological interventions before resorting to pharmacological management. Yet dementia care is not consistent with these guidelines suggesting conceptual limitations and reliance on passive knowledge translation strategies. Aims and Objectives We implemented a 12-week drama-based educational intervention to introduce to dementia practitioners person-centred care that emphasizes the notion of embodied selfhood (defined as non-verbal self-expression). Design and Methods Focus groups and semi-structured interviews with practitioners (n=24) in two nursing homes in central Canada were undertaken to assess the effectiveness of the drama-based components of the intervention. Results Our findings suggest that drama was effective as an educational modality, and helped implement the person-centred approach into practice. Significant practice outcomes included: new awareness that residents’ body movements and dispositions convey meaning; seeking biographical information from families; increased time efficiency; and supporting residents’ independence. Conclusions Our findings make an important contribution to person-centred dementia care by broadening the notion of personhood, and by facilitating implementation using drama. Implications for Practice As an enhancement of person-centered care, the support of embodied selfhood may significantly improve residents’ quality of life, quality of care, and practitioners’ caregiving experience. PMID:20925717

Quality assurance in non-interventional studies.

PubMed

Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

2009-11-09

Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres - in between 2% and 5% of the centres depending on the number of participating centres. Before start of statistical analysis a statistical analysis plan (SAP) should be created. The use of standardized tables and figures is highly recommended. The basis of the report writing should be the STROBE-statement "Strengthening the Reporting of Observational studies in Epidemiology Initiative" containing a checklist of 22 points to be covered in the report. The development of own standard operating procedures (SOP) describing the processes during planning, conduct and evaluation of a non-interventional study as well as the quality management and the regular training of all involved people is also highly recommended. All accompanying measures to improve or to keep the quality of the NIS should not violate the concept of non-intervention.

Quality assurance in non-interventional studies

PubMed Central

Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

2009-01-01

Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres. Before start of statistical analysis a statistical analysis plan (SAP) should be created. The use of standardized tables and figures is highly recommended. The basis of the report writing should be the STROBE-statement “Strengthening the Reporting of Observational studies in Epidemiology Initiative” containing a checklist of 22 points to be covered in the report. The development of own standard operating procedures (SOP) describing the processes during planning, conduct and evaluation of a non-interventional study as well as the quality management and the regular training of all involved people is also highly recommended. All accompanying measures to improve or to keep the quality of the NIS should not violate the concept of non-intervention. PMID:19949447

The effects of policy actions to improve population dietary patterns and prevent diet-related non-communicable diseases: scoping review

PubMed Central

Hyseni, L; Atkinson, M; Bromley, H; Orton, L; Lloyd-Williams, F; McGill, R; Capewell, S

2017-01-01

Poor diet generates a bigger non-communicable disease (NCD) burden than tobacco, alcohol and physical inactivity combined. We reviewed the potential effectiveness of policy actions to improve healthy food consumption and thus prevent NCDs. This scoping review focused on systematic and non-systematic reviews and categorised data using a seven-part framework: price, promotion, provision, composition, labelling, supply chain, trade/investment and multi-component interventions. We screened 1805 candidate publications and included 58 systematic and non-systematic reviews. Multi-component and price interventions appeared consistently powerful in improving healthy eating. Reformulation to reduce industrial trans fat intake also seemed very effective. Evidence on food supply chain, trade and investment studies was limited and merits further research. Food labelling and restrictions on provision or marketing of unhealthy foods were generally less effective with uncertain sustainability. Increasingly strong evidence is highlighting potentially powerful policies to improve diet and thus prevent NCDs, notably multi-component interventions, taxes, subsidies, elimination and perhaps trade agreements. The implications for policy makers are becoming clearer. PMID:27901036

The effects of policy actions to improve population dietary patterns and prevent diet-related non-communicable diseases: scoping review.

PubMed

Hyseni, L; Atkinson, M; Bromley, H; Orton, L; Lloyd-Williams, F; McGill, R; Capewell, S

2017-06-01

Poor diet generates a bigger non-communicable disease (NCD) burden than tobacco, alcohol and physical inactivity combined. We reviewed the potential effectiveness of policy actions to improve healthy food consumption and thus prevent NCDs. This scoping review focused on systematic and non-systematic reviews and categorised data using a seven-part framework: price, promotion, provision, composition, labelling, supply chain, trade/investment and multi-component interventions. We screened 1805 candidate publications and included 58 systematic and non-systematic reviews. Multi-component and price interventions appeared consistently powerful in improving healthy eating. Reformulation to reduce industrial trans fat intake also seemed very effective. Evidence on food supply chain, trade and investment studies was limited and merits further research. Food labelling and restrictions on provision or marketing of unhealthy foods were generally less effective with uncertain sustainability. Increasingly strong evidence is highlighting potentially powerful policies to improve diet and thus prevent NCDs, notably multi-component interventions, taxes, subsidies, elimination and perhaps trade agreements. The implications for policy makers are becoming clearer.

SLA-based optimisation of virtualised resource for multi-tier web applications in cloud data centres

NASA Astrophysics Data System (ADS)

Bi, Jing; Yuan, Haitao; Tie, Ming; Tan, Wei

2015-10-01

Dynamic virtualised resource allocation is the key to quality of service assurance for multi-tier web application services in cloud data centre. In this paper, we develop a self-management architecture of cloud data centres with virtualisation mechanism for multi-tier web application services. Based on this architecture, we establish a flexible hybrid queueing model to determine the amount of virtual machines for each tier of virtualised application service environments. Besides, we propose a non-linear constrained optimisation problem with restrictions defined in service level agreement. Furthermore, we develop a heuristic mixed optimisation algorithm to maximise the profit of cloud infrastructure providers, and to meet performance requirements from different clients as well. Finally, we compare the effectiveness of our dynamic allocation strategy with two other allocation strategies. The simulation results show that the proposed resource allocation method is efficient in improving the overall performance and reducing the resource energy cost.

The challenges of implementing a multi-centre audit of end-of-life care in care homes.

PubMed

Levy, Jean; Kinley, Julie; Conway, Frances

2016-11-02

This article aims to share the experience of a hospice in facilitating a multi-centre audit of end-of-life care in care homes, particularly noting the challenges and enablers of carrying out the audit. The audit was a retrospective multi-centre survey of bereaved relatives/next of kin of residents who died in the care home, using an anonymous, validated questionnaire: the Family Perception of Care Scale. Questionnaires were sent 3-months after bereavement. Returned questionnaires were analysed using SPSS and Excel. The care homes were in areas encompassing outer and inner city populations. The team identified eight challenges to the audit process, in particular, embedding procedures within the care homes, non-responses and developing action plans for improvement. Overall, the audit provided an indication of where improvements could be made and where care was already excellent, built confidence and increased expertise in the care-home staff.

Optimizing lay counsellor services for chronic care in South Africa: a qualitative systematic review.

PubMed

Petersen, Inge; Fairall, Lara; Egbe, Catherine O; Bhana, Arvin

2014-05-01

To conduct a qualitative systematic review on the use of lay counsellors in South Africa to provide lessons on optimizing their use for psychological and behavioural change counselling for chronic long-term care in scare-resource contexts. A qualitative systematic review of the literature on lay counsellor services in South Africa. Twenty-nine studies met the inclusion criteria. Five randomized control trials and two cohort studies reported that lay counsellors can provide behaviour change counselling with good outcomes. One multi-centre cohort study provided promising evidence of improved anti-retroviral treatment adherence and one non-randomized controlled study provided promising results for counselling for depression. Six studies found low fidelity of lay counsellor-delivered interventions in routine care. Reasons for low fidelity include poor role definition, inconsistent remuneration, lack of standardized training, and poor supervision and logistical support. Within resource-constrained settings, adjunct behaviour change and psychological services provided by lay counsellors can be harnessed to promote chronic care at primary health care level. Optimizing lay counsellor services requires interventions at an organizational level that provide a clear role definition and scope of practice; in-service training and formal supervision; and sensitization of health managers to the importance and logistical requirements of counselling. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Dealing with Actors and Compliance in Intervention Operations in a Non-permissive Hybrid Environment

DTIC Science & Technology

2009-12-01

Patton, (2002). Qualitative research & evaluation methods (Vol. Third). California, London, New Delhi: Sage publications, Inc. 59 See these themes...non-compliant actors … … the study follows a question based approach with a general research question in the centre of interest:12 Which...1 Version 1.0 December 2009 Study authors: Col Dieter Muhr (AUT) Hon. Assoc. Prof. Dr. Andrea Riemer, Ph.D. (AUT) Objective

Community wide interventions for increasing physical activity.

PubMed

Baker, Philip Ra; Francis, Daniel P; Soares, Jesus; Weightman, Alison L; Foster, Charles

2011-04-13

Multi-strategic community wide interventions for physical activity are increasingly popular but their ability to achieve population level improvements is unknown. To evaluate the effects of community wide, multi-strategic interventions upon population levels of physical activity. We searched the Cochrane Public Health Group Specialised Register, The Cochrane Library, MEDLINE, MEDLINE in Process, EMBASE, CINAHL, LILACS, PsycINFO, ASSIA, The British Nursing Index, Chinese CNKI databases, EPPI Centre (DoPHER, TRoPHI), ERIC, HMIC, Sociological Abstracts, SPORTDiscus, Transport Database and Web of Science (Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index). We also scanned websites of the EU Platform on Diet, Physical Activity and Health; Health-Evidence.ca; the International Union for Health Promotion and Education; the NIHR Coordinating Centre for Health Technology (NCCHTA) and NICE and SIGN guidelines. Reference lists of all relevant systematic reviews, guidelines and primary studies were followed up. We contacted experts in the field from the National Obesity Observatory Oxford, Oxford University; Queensland Health, Queensland University of Technology, the University of Central Queensland; the University of Tennessee and Washington University; and handsearched six relevant journals. The searches were last updated to the end of November 2009 and were not restricted by language or publication status. Cluster randomised controlled trials, randomised controlled trials (RCT), quasi-experimental designs which used a control population for comparison, interrupted time-series (ITS) studies, and prospective controlled cohort studies (PCCS) were included. Only studies with a minimum six-month follow up from the start of the intervention to measurement of outcomes were included. Community wide interventions had to comprise at least two broad strategies aimed at physical activity for the whole population. Studies which randomised individuals from the same community were excluded. At least two review authors independently extracted the data and assessed the risk of bias of each included study. Non-English language papers were reviewed with the assistance of an epidemiologist interpreter. Each study was assessed for the setting, the number of included components and their intensity. Outcome measures were grouped according to whether they were dichotomous (physically active, physically active during leisure time and sedentary or physically inactive) or continuous (leisure time physical activity, walking, energy expenditure). For dichotomous measures we calculated the unadjusted and adjusted risk difference, and the unadjusted and adjusted relative risk. For continuous measures we calculated net percentage change from baseline, unadjusted and adjusted risk difference, and the unadjusted and adjusted relative risk. After the selection process had been completed 25 studies were included in the review. Of the included studies, 19 were set in high income countries, using the World Bank economic classification, and the remaining six were in low income countries. The interventions varied by the number of strategies included and their intensity. Almost all of the interventions included a component of building partnerships with local governments or non-governmental organisations (NGOs) (22 studies). None of the studies provided results by socio-economic disadvantage or other markers of equity consideration. However of those included studies undertaken in high income countries, 11 studies were described by the authors as being provided to deprived, disadvantaged, or low socio-economic communities.Fifteen studies were identified as having a high risk of bias, 10 studies were unclear, and no studies had a low risk of bias. Selection bias was a major concern with these studies, with only one study using randomisation to allocate communities (Simon 2008). No studies were judged as being at low risk of selection bias although 16 studies were considered to have an unclear risk of bias. Eleven studies had a high risk of detection bias, 10 with an unclear risk and four with no risk. Assessment of detection bias included an assessment of the validity of the measurement tools and quality of outcome measures. The effects reported were inconsistent across the studies and the measures. Some of the better designed studies showed no improvement in measures of physical activity. Publication bias was evident. Although numerous studies have been undertaken, there is a noticeable inconsistency of the findings of the available studies and this is confounded by serious methodological issues within the included studies. The body of evidence in this review does not support the hypothesis that multi-component community wide interventions effectively increase population levels of physical activity. There is a clear need for well-designed intervention studies and such studies should focus on the quality of the measurement of physical activity, the frequency of measurement and the allocation to intervention and control communities.

Preventing work-related stress among staff working in children's cancer Principal Treatment Centres in the UK: a brief survey of staff support systems and practices.

PubMed

Beresford, B; Gibson, F; Bayliss, J; Mukherjee, S

2018-03-01

Growing evidence of the association between health professionals' well-being and patient and organisational outcomes points to the need for effective staff support. This paper reports a brief survey of the UK's children's cancer Principal Treatment Centres (PTCs) regarding staff support systems and practices. A short on-line questionnaire, administered in 2012-2013, collected information about the availability of staff support interventions which seek to prevent work-related stress among different members of the multi-disciplinary team (MDT). It was completed by a member of staff with, where required, assistance from colleagues. All PTCs (n = 19) participated. Debriefs following a patient death was the most frequently reported staff support practice. Support groups were infrequently mentioned. There was wide variability between PTCs, and between professional groups, regarding the number and type of interventions available. Doctors appear to be least likely to have access to support. A few Centres routinely addressed work-related stress in wider staff management strategies. Two Centres had developed a bespoke intervention. Very few Centres were reported to actively raise awareness of support available from their hospital's Occupational Health department. A minority of PTCs had expert input regarding staff support from clinical psychology/liaison psychiatry. © 2016 The Authors. European Journal of Cancer Care Published by John Wiley & Sons Ltd.

Effectiveness of a Hospital-Based Work Support Intervention for Female Cancer Patients – A Multi-Centre Randomised Controlled Trial

PubMed Central

Tamminga, Sietske J.; Verbeek, Jos H. A. M.; Bos, Monique M. E. M.; Fons, Guus; Kitzen, Jos J. E. M.; Plaisier, Peter W.; Frings-Dresen, Monique H. W.; de Boer, Angela G. E. M.

2013-01-01

Objective One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. Methods Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65) or control group (n = 68). The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial), quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. Results Return-to-work rates were 86% and 83% (p = 0.6) for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14–435) versus 192 days (range 82–465) (p = 0.90) with a hazard ratio of 1.03 (95% CI 0.64–1.6). Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. Conclusion The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which aspects of the intervention are useful and which elements need improvement. Trial Registration Nederlands Trial Register (NTR) 1658 PMID:23717406

A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease.

PubMed

Johnson, Miriam J; Kanaan, Mona; Richardson, Gerry; Nabb, Samantha; Torgerson, David; English, Anne; Barton, Rachael; Booth, Sara

2015-09-07

About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population. This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat. Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %. There was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden. Registry: ISRCTN; ISRCTN49387307; http://www.isrctn.com/ISRCTN49387307 ; registration date: 25/01/2011.

The gap between policy and practice: a systematic review of patient-centred care interventions in chronic heart failure.

PubMed

Kane, P M; Murtagh, F E M; Ryan, K; Mahon, N G; McAdam, B; McQuillan, R; Ellis-Smith, C; Tracey, C; Howley, C; Raleigh, C; O'Gara, G; Higginson, I J; Daveson, B A

2015-11-01

Patient-centred care (PCC) is recommended in policy documents for chronic heart failure (CHF) service provision, yet it lacks an agreed definition. A systematic review was conducted to identify PCC interventions in CHF and to describe the PCC domains and outcomes. Medline, Embase, CINAHL, PsycINFO, ASSIA, the Cochrane database, clinicaltrials.gov, key journals and citations were searched for original studies on patients with CHF staged II-IV using the New York Heart Association (NYHA) classification. Included interventions actively supported patients to play informed, active roles in decision-making about their goals of care. Search terms included 'patient-centred care', 'quality of life' and 'shared decision making'. Of 13,944 screened citations, 15 articles regarding 10 studies were included involving 2540 CHF patients. Three studies were randomised controlled trials, and seven were non-randomised studies. PCC interventions focused on collaborative goal setting between patients and healthcare professionals regarding immediate clinical choices and future care. Core domains included healthcare professional-patient collaboration, identification of patient preferences, patient-identified goals and patient motivation. While the strength of evidence is poor, PCC has been shown to reduce symptom burden, improve health-related quality of life, reduce readmission rates and enhance patient engagement for patients with CHF. There is a small but growing body of evidence, which demonstrates the benefits of a PCC approach to care for CHF patients. Research is needed to identify the key components of effective PCC interventions before being able to deliver on policy recommendations.

Study protocol: a multi-professional team intervention of physical activity referrals in primary care patients with cardiovascular risk factors—the Dalby lifestyle intervention cohort (DALICO) study

PubMed Central

2012-01-01

Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than physical activity prescription in usual care. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes. Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, 2) Control group A (CA): physical activity prescription in usual care and 3) Control group B: treatment as usual (retrospective data collection). The intervention is based on self-determination theory and follows the principles of motivational interviewing. The primary outcome, physical activity, is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides feed-back to the health-care providers on the patients’ health status. Cost-effectiveness of the intervention is evaluated continuously and the intermediate outcomes of the intervention are extrapolated by economic modelling. Discussions By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication. PMID:22726659

A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

PubMed

Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

2018-03-01

To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

The non-specific effects of vaccines and other childhood interventions: the contribution of INDEPTH Health and Demographic Surveillance Systems

PubMed Central

Sankoh, Osman; Welaga, Paul; Debpuur, Cornelius; Zandoh, Charles; Gyaase, Stephney; Poma, Mary Atta; Mutua, Martin Kavao; Hanifi, SM Manzoor Ahmed; Martins, Cesario; Nebie, Eric; Kagoné, Moubassira; Emina, Jacques BO; Aaby, Peter

2014-01-01

Most childhood interventions (vaccines, micronutrients) in low-income countries are justified by their assumed effect on child survival. However, usually the interventions have only been studied with respect to their disease/deficiency-specific effects and not for their overall effects on morbidity and mortality. In many situations, the population-based effects have been very different from the anticipated effects; for example, the measles-preventive high-titre measles vaccine was associated with 2-fold increased female mortality; BCG reduces neonatal mortality although children do not die of tuberculosis in the neonatal period; vitamin A may be associated with increased or reduced child mortality in different situations; effects of interventions may differ for boys and girls. The reasons for these and other contrasts between expectations and observations are likely to be that the immune system learns more than specific prevention from an intervention; such training may enhance or reduce susceptibility to unrelated infections. INDEPTH member centres have been in an ideal position to document such additional non-specific effects of interventions because they follow the total population long term. It is proposed that more INDEPTH member centres extend their routine data collection platform to better measure the use and effects of childhood interventions. In a longer perspective, INDEPTH may come to play a stronger role in defining health research issues of relevance to low-income countries. PMID:24920644

A multi-center prospective cohort study to evaluate the effect of differential pricing and health systems strengthening on access to medicines and management of hypertension and diabetes in Ghana: A study protocol.

PubMed

Mobula, Linda Meta; Sarfo, Stephen; Arthur, Lynda; Burnham, Gilbert; Plange-Rhule, Jacob; Ansong, Daniel; Gavor, Edith; Ofori-Adjei, David

2018-02-07

Background: There is evidence to suggest that the prevalence of non-communicable diseases (NCDs), in particular cardiovascular diseases and diabetes, are being recognized as forming a substantial proportion of the burden of disease among populations in Low- and Middle-Income Countries (LMICs).  Access to treatment is likely a key barrier to the control and prevention of NCD outcomes.  Differential pricing, an approach used to price drugs based on the purchasing power of patients in different socioeconomic segments, has been shown to be beneficial and leads to improved access and affordability. Methods: This is a quasi-experimental study, with a pragmatic trial design, to be conducted over the course of three years. A mixed methods design will be used to evaluate the effects of health systems strengthening and differential pricing on the management of diabetes, hypertension and selected cancers in Ghana. A public private partnership was established between all sites that will receive multi-level interventions, including health systems strengthening  and access to medicines interventions. Study populations and sites: Study participants will include individuals with new or recently diagnosed hypertension and diabetes (n=3,300), who present to two major referral hospitals, Komfo Anokye Teaching Hospital and Tamale Teaching Hospital, as well as three district hospitals, namely Kings Medical Centre, Agogo Presbyterian District Hospital, and Atua Government Hospital. Discussion: The objective of this study aims to test approaches intended to improve access to drugs for the treatment of hypertension and diabetes, and improve disease control. Patients with these conditions will benefit from health systems strengthening interventions (education, counseling, improved management of disease), and increased access to innovative medicines via differential pricing. Pilot programs also will facilitate health system strengthening at the participating institutions, which includes training of clinicians and updating of guidelines and production of protocols for the treatment of diabetes, hypertension and cancer.

Non-invasive biomarkers of fetal brain development reflecting prenatal stress: An integrative multi-scale multi-species perspective on data collection and analysis.

PubMed

Frasch, Martin G; Lobmaier, Silvia M; Stampalija, Tamara; Desplats, Paula; Pallarés, María Eugenia; Pastor, Verónica; Brocco, Marcela A; Wu, Hau-Tieng; Schulkin, Jay; Herry, Christophe L; Seely, Andrew J E; Metz, Gerlinde A S; Louzoun, Yoram; Antonelli, Marta C

2018-05-30

Prenatal stress (PS) impacts early postnatal behavioural and cognitive development. This process of 'fetal programming' is mediated by the effects of the prenatal experience on the developing hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system (ANS). We derive a multi-scale multi-species approach to devising preclinical and clinical studies to identify early non-invasively available pre- and postnatal biomarkers of PS. The multiple scales include brain epigenome, metabolome, microbiome and the ANS activity gauged via an array of advanced non-invasively obtainable properties of fetal heart rate fluctuations. The proposed framework has the potential to reveal mechanistic links between maternal stress during pregnancy and changes across these physiological scales. Such biomarkers may hence be useful as early and non-invasive predictors of neurodevelopmental trajectories influenced by the PS as well as follow-up indicators of success of therapeutic interventions to correct such altered neurodevelopmental trajectories. PS studies must be conducted on multiple scales derived from concerted observations in multiple animal models and human cohorts performed in an interactive and iterative manner and deploying machine learning for data synthesis, identification and validation of the best non-invasive detection and follow-up biomarkers, a prerequisite for designing effective therapeutic interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Health providers' opinions on provider-client relations: results of a multi-country study to test Health Workers for Change.

PubMed

Fonn, S; Mtonga, A S; Nkoloma, H C; Bantebya Kyomuhendo, G; daSilva, L; Kazilimani, E; Davis, S; Dia, R

2001-09-01

A multi-centre study in four African countries was undertaken to test the acceptability and effectiveness of Health Workers for Change, a methodology to explore provider-client relations within a gender-sensitive context. This intervention addresses the interpersonal component of quality of care. The methodology, consisting of six workshops, was implemented by research teams in Zambia, Senegal, Mozambique and Uganda. It was found to be acceptable within in a range of cultural and primary health care settings. The workshops allowed difficult issues such as prejudice and bribery to be discussed openly, fostered problem solving and the development of practical plans to address problems that could strengthen district health systems.

"Staying safe" - a narrative review of falls prevention in people with Parkinson's - "PDSAFE".

PubMed

Hulbert, Sophia; Rochester, Lynn; Nieuwboer, Alice; Goodwin, Vicki; Fitton, Carolyn; Chivers-Seymour, Kim; Ashburn, Ann

2018-05-18

Parkinson's disease demonstrates a spectrum of motor and non-motor symptoms. Falling is common and disabling. Current medical management shows minimal impact to reduce falls or fall-related risk factors, such as deficits in gait, strength, and postural instability. Despite evidence supporting rehabilitation in reducing fall risk factors, the most appropriate intervention to reduce overall fall rate remains inconclusive. This article aims to 1) synthesise current evidence and conceptual models of falls rehabilitation in Parkinson's in a narrative review; and based on this evidence, 2) introduce the treatment protocol used in the falls prevention and multi-centre clinical trial "PDSAFE". Search of four bibliographic databases using the terms "Parkinson*" and "Fall*" combined with each of the following; "Rehab*, Balanc*, Strength*, Strateg*and Exercis*" and a framework for narrative review was followed. A total of 3557 papers were identified, 416 were selected for review. The majority report the impact of rehabilitation on isolated fall risk factors. Twelve directly measure the impact on overall fall rate. Results were used to construct a narrative review with conceptual discussion based on the "International Classification of Functioning", leading to presentation of the "PDSAFE" intervention protocol. Evidence suggests training single, fall risk factors may not affect overall fall rate. Combining with behavioural and strategy training in a functional, personalised multi-dimensional model, addressing all components of the "International Classification of Functioning" is likely to provide a greater influence on falls reduction. "PDSAFE" is a multi-dimensional, physiotherapist delivered, individually tailored, progressive, home-based programme. It is designed with a strong evidence-based approach and illustrates a model for the clinical delivery of the conceptual theory discussed. Implications for Rehabilitation Parkinson's disease demonstrates a spectrum of motor and non-motor symptoms, where falling is common and disabling. Current medical and surgical management have minimal impact on falls, rehabilitation of falls risk factors has strong evidence but the most appropriate intervention to reduce overall fall rate remains inconclusive. Addressing all components of the International Classification of Function in a multifactorial model when designing falls rehabilitation interventions may be more effective at reducing fall rates in people with Parkinson's than treating isolated risk factors. The clinical model for falls rehabilitation in people with Parkinson's should be multi-dimensional.

The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial.

PubMed

Vanova, Martina; Irazoki, Eider; García-Casal, J Antonio; Martínez-Abad, Fernando; Botella, Cristina; Shiells, Kate R; Franco-Martín, Manuel A

2018-02-12

Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms. In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year. The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments. Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome: a multicentre, cluster randomised controlled trial.

PubMed

Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

2017-03-01

To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. Multicentre, open, cluster randomised controlled trial. Obstetric units in the Netherlands. Women with a singleton pregnancy beyond 24 weeks of gestation. Random allocation of obstetric units to a 1-day, multi-professional, simulation-based team training focusing on crew resource management (CRM) in a simulation centre or to no such team training. Intention-to-treat analyses were performed at the cluster level, including a measurement 1 year prior to the intervention. Primary outcome was a composite outcome of obstetric complications during the first year post-intervention, including low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischaemic encephalopathy. Maternal and perinatal mortality were also registered. Each study group included 12 units with a median unit size of 1224 women, combining for a total of 28 657 women. In total, 471 medical professionals received the training course. The composite outcome of obstetric complications did not differ between study groups [odds ratio (OR) 1.0, 95% confidence interval (CI) 0.80-1.3]. Team training reduced trauma due to shoulder dystocia (OR 0.50, 95% CI 0.25-0.99) and increased invasive treatment for severe postpartum haemorrhage (OR 2.2, 95% CI 1.2-3.9) compared with no intervention. Other outcomes did not differ between study groups. A 1-day, off-site, simulation-based team training, focusing on teamwork skills, did not reduce a composite of obstetric complications. 1-day, off-site, simulation-based team training did not reduce a composite of obstetric complications. © 2016 Royal College of Obstetricians and Gynaecologists.

Conducting a paediatric multi-centre RCT with an industry partner: challenges and lessons learned.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2012-11-01

There are many benefits of multi-centred research including large sample sizes, statistical power, timely recruitment and generalisability of results. However, there are numerous considerations when planning and implementing a multi-centred study. This article reviews the challenges and successes of planning and implementing a multi-centred prospective randomised control trial involving an industry partner. The research investigated the impact on psychosocial functioning of a cosmetic camouflage product for children and adolescents with burn scarring. Multi-centred studies commonly have many stakeholders. Within this study, six Australian and New Zealand paediatric burn units as well as an industry partner were involved. The inclusion of an industry partner added complexities as they brought different priorities and expectations to the research. Further, multifaceted ethical and institutional approval processes needed to be negotiated. The challenges, successes, lessons learned and recommendations from this study regarding Australian and New Zealand ethics and research governance approval processes, collaboration with industry partners and the management of differing expectations will be outlined. Recommendations for future multi-centred research with industry partners include provision of regular written reports for the industry partner; continual monitoring and prompt resolution of concerns; basic research practices education for industry partners; minimisation of industry partner contact with participants; clear roles and responsibilities of all stakeholders and utilisation of single ethical review if available. © 2012 The Authors. Journal of Paediatrics and Child Health © 2012 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Influence of magnetic field strength and image registration strategy on voxel-based morphometry in a study of Alzheimer's disease.

PubMed

Marchewka, Artur; Kherif, Ferath; Krueger, Gunnar; Grabowska, Anna; Frackowiak, Richard; Draganski, Bogdan

2014-05-01

Multi-centre data repositories like the Alzheimer's Disease Neuroimaging Initiative (ADNI) offer a unique research platform, but pose questions concerning comparability of results when using a range of imaging protocols and data processing algorithms. The variability is mainly due to the non-quantitative character of the widely used structural T1-weighted magnetic resonance (MR) images. Although the stability of the main effect of Alzheimer's disease (AD) on brain structure across platforms and field strength has been addressed in previous studies using multi-site MR images, there are only sparse empirically-based recommendations for processing and analysis of pooled multi-centre structural MR data acquired at different magnetic field strengths (MFS). Aiming to minimise potential systematic bias when using ADNI data we investigate the specific contributions of spatial registration strategies and the impact of MFS on voxel-based morphometry in AD. We perform a whole-brain analysis within the framework of Statistical Parametric Mapping, testing for main effects of various diffeomorphic spatial registration strategies, of MFS and their interaction with disease status. Beyond the confirmation of medial temporal lobe volume loss in AD, we detect a significant impact of spatial registration strategy on estimation of AD related atrophy. Additionally, we report a significant effect of MFS on the assessment of brain anatomy (i) in the cerebellum, (ii) the precentral gyrus and (iii) the thalamus bilaterally, showing no interaction with the disease status. We provide empirical evidence in support of pooling data in multi-centre VBM studies irrespective of disease status or MFS. Copyright © 2013 Wiley Periodicals, Inc.

Patient or treatment centre? Where are efforts invested to improve cancer patients' psychosocial outcomes?

PubMed Central

Carey, ML; Clinton-McHarg, T; Sanson-Fisher, RW; Campbell, S; Douglas, HE

2011-01-01

The psychosocial outcomes of cancer patients may be influenced by individual-level, social and treatment centre predictors. This paper aimed to examine the extent to which individual, social and treatment centre variables have been examined as predictors or targets of intervention for psychosocial outcomes of cancer patients. Medline was searched to find studies in which the psychological outcomes of cancer patient were primary variables. Papers published in English between 1999 and 2009 that reported primary data relevant to psychosocial outcomes for cancer patients were included, with 20% randomly selected for further coding. Descriptive studies were coded for inclusion of individual, social or treatment centre variables. Intervention studies were coded to determine if the unit of intervention was the individual patient, social unit or treatment centre. After random sampling, 412 publications meeting the inclusion criteria were identified, 169 were descriptive and 243 interventions. Of the descriptive papers 95.0% included individual predictors, and 5.0% social predictors. None of the descriptive papers examined treatment centre variables as predictors of psychosocial outcomes. Similarly, none of the interventions evaluated the effectiveness of treatment centre interventions for improving psychosocial outcomes. Potential reasons for the overwhelming dominance of individual predictors and individual-focused interventions in psychosocial literature are discussed. PMID:20646035

Psychiatric intervention and repeated admission to emergency centres due to drug overdose.

PubMed

Kanehara, Akiko; Yamana, Hayato; Yasunaga, Hideo; Matsui, Hiroki; Ando, Shuntaro; Okamura, Tsuyoshi; Kumakura, Yousuke; Fushimi, Kiyohide; Kasai, Kiyoto

2015-10-01

Repeated drug overdose is a major risk factor for suicide. Data are lacking on the effect of psychiatric intervention on preventing repeated drug overdose. To investigate whether psychiatric intervention was associated with reduced readmission to emergency centres due to drug overdose. Using a Japanese national in-patient database, we identified patients who were first admitted to emergency centres for drug overdose in 2010-2012. We used propensity score matching for patient and hospital factors to compare readmission rates between intervention (patients undergoing psychosocial assessment) and unexposed groups. Of 29 564 eligible patients, 13 035 underwent psychiatric intervention. In the propensity-matched 7938 pairs, 1304 patients were readmitted because of drug overdose. Readmission rate was lower in the intervention than in the unexposed group (7.3% v . 9.1% respectively, P <0.001). Psychiatric intervention was associated with reduced readmission in patients who had taken a drug overdose. None. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Short video interventions to reduce mental health stigma: a multi-centre randomised controlled trial in nursing high schools.

PubMed

Winkler, Petr; Janoušková, Miroslava; Kožený, Jiří; Pasz, Jiří; Mladá, Karolína; Weissová, Aneta; Tušková, Eva; Evans-Lacko, Sara

2017-12-01

We aimed to assess whether short video interventions could reduce stigma among nursing students. A multi-centre, randomised controlled trial was conducted. Participating schools were randomly selected and randomly assigned to receive: (1) an informational leaflet, (2) a short video intervention or (3) a seminar involving direct contact with a service user. The Community Attitudes towards Mental Illness (CAMI) and Reported and Intended Behaviour Scale (RIBS) were selected as primary outcome measures. SPANOVA models were built and Cohen's d calculated to assess the overall effects in each of the trial arms. Compared to the baseline, effect sizes immediately after the intervention were small in the flyer arm (CAMI: d = 0.25; RIBS: d = 0.07), medium in the seminar arm (CAMI: d = 0.61; RIBS: d = 0.58), and medium in the video arm (CAMI: d = 0.49 RIBS: d = 0.26; n = 237). Effect sizes at the follow-up were vanishing in the flyer arm (CAMI: d = 0.05; RIBS: d = 0.04), medium in the seminar arm (CAMI: d = 0.43; RIBS: d = 0.26; n = 254), and small in the video arm (CAMI: d = 0.22 RIBS: d = 0.21; n = 237). Seminar had the strongest and relatively stable effect on students' attitudes and intended behaviour, but the effect of short video interventions was also considerable and stable over time. Since short effective video interventions are relatively cheap, conveniently accessible and easy to disseminate globally, we recommend them for further research and development.

Smoking, awareness of smoking-associated health risks, and knowledge of national tobacco legislation in Gaza, Palestine.

PubMed

Abu Shomar, Reem T; Lubbad, Ihab K; El Ansari, Walid; Al-Khatib, Issam A; Alharazin, Hatem J

2014-06-01

To assess university students' extent of smoking, knowledge of smoking health risks, and awareness of existing national anti-smoking laws. Self-administered questionnaire was employed across 7 universities (1,104 students, equal proportions of males and females) located in Gaza Strip, Palestine. About 55% of participants reported ever smoking, 31% were current cigarette smokers, and 36% were 'strictly' (only) narghile (water pipe) smokers. Mean age of smoking initiation was 17 +/- 3.15 years. Smokers had less knowledge of smoking associated health risks than nonsmokers. Students' knowledge of existing anti-smoking laws was generally low (11.3-25.5%), and significantly more smokers had knowledge about existing laws (ban of advertisement of smoking, ban of smoking in public places, and ban of selling cigarettes to minors) than non-smokers. About 81% of current smokers tried to quit smoking at least once during their life, 53% felt ready to quit smoking if cessation assistance was provided, 17% were not ready to quit, and 30% were reluctant/felt unsure if they were ready to quit. Most students (94.3%) reported that there were no smoking cessation centres in Palestine, or did not know if such centres existed. Males were associated with almost all categories of smoking (e.g. smoking both cigarettes and narghile, or smoking narghile only). There is a lack of knowledge about the existing national anti-smoking legislation among university students in Gaza, Palestine. Smoking cessation centres also seem non-existent in Gaza. Multi-level interventions and actions are required by policy makers, educators and non-governmental agencies to prevent smoking among university students in Gaza, and to educate them on tobacco cessation counselling, on the dangers of tobacco use, and about effective stress management strategies to help them to cope with stressors. Smoking cessation interventions are required to address both cigarette and narghile use. Efforts need to be invested in ensuring compliance with legislation and for follow-up activities to enforce the anti-smoking laws through coordinated actions across ministries and departments.

New directions for patient-centred care in scleroderma: the Scleroderma Patient-centred Intervention Network (SPIN)

PubMed Central

Thombs, Brett D.; Jewett, Lisa R.; Assassi, Shervin; Baron, Murray; Bartlett, Susan J.; Costa Maia, Angela; El-Baalbaki, Ghassan; Furst, Daniel E.; Gottesman, Karen; Haythornthwaite, Jennifer A.; Hudson, Marie; Ann Impens, PhD; Korner, Annett; Leite, Catarina; Mayes, Maureen D.; Malcarne, Vanessa L.; Motivala, Sarosh J.; Mouthon, Luc; Nielson, Warren R.; Plante, Diane; Poiraudeau, Serge; Poole, Janet L.; Pope, Janet; Sauve, Maureen; Steele, Russell J.; Suarez-Almazor, Maria E.; Taillefer, Suzanne; van den Ende, Cornelia H.; Erin Arthurs, BSc; Bassel, Marielle; Delisle, Vanessa; Milette, Katherine; Leavens, Allison; Razykov, Ilya; Khanna, Dinesh

2014-01-01

Systemic sclerosis (SSc), or scleroderma, is a chronic multisystem autoimmune disorder characterised by thickening and fibrosis of the skin and by the involvement of internal organs such as the lungs, kidneys, gastrointestinal tract, and heart. Because there is no cure, feasibly-implemented and easily accessible evidence-based interventions to improve health-related quality of life (HRQoL) are needed. Due to a lack of evidence, however, specific recommendations have not been made regarding non-pharmacological interventions (e.g. behavioural/psychological, educational, physical/occupational therapy) to improve HRQoL in SSc. The Scleroderma Patient-centred Intervention Network (SPIN) was recently organised to address this gap. SPIN is comprised of patient representatives, clinicians, and researchers from Canada, the USA, and Europe. The goal of SPIN, as described in this article, is to develop, test, and disseminate a set of accessible interventions designed to complement standard care in order to improve HRQoL outcomes in SSc. PMID:22244687

Person-centred web-based support--development through a Swedish multi-case study.

PubMed

Josefsson, Ulrika; Berg, Marie; Koinberg, Ingalill; Hellström, Anna-Lena; Nolbris, Margaretha Jenholt; Ranerup, Agneta; Lundin, Carina Sparud; Skärsäter, Ingela

2013-10-19

Departing from the widespread use of the internet in modern society and the emerging use of web applications in healthcare this project captures persons' needs and expectations in order to develop highly usable web recourses. The purpose of this paper is to outline a multi-case research project focused on the development and evaluation of person-centred web-based support for people with long-term illness. To support the underlying idea to move beyond the illness, we approach the development of web support from the perspective of the emergent area of person-centred care. The project aims to contribute to the ongoing development of web-based supports in health care and to the emerging field of person-centred care. The research design uses a meta-analytical approach through its focus on synthesizing experiences from four Swedish regional and national cases of design and use of web-based support in long-term illness. The cases include children (bladder dysfunction and urogenital malformation), young adults (living close to persons with mental illness), and two different cases of adults (women with breast cancer and childbearing women with type 1 diabetes). All of the cases are ongoing, though in different stages of design, implementation, and analysis. This, we argue, will lead to a synthesis of results on a meta-level not yet described. To allow valid comparisons between the four cases we explore and problematize them in relation to four main aspects: 1) The use of people's experiences and needs; 2) The role of use of theories in the design of person-centred web-based supports; 3) The evaluation of the effects of health outcomes for the informants involved and 4) The development of a generic person-centred model for learning and social support for people with long-term illness and their significant others. Person-centred web-based support is a new area and few studies focus on how web-based interventions can contribute to the development of person-centred care. In summary, the main intention of the project outlined here is to contribute with both a synthesis of results on meta-level from four cases and a substantial contribution to the field person-centred care.

Ecological, biological and social dimensions of dengue vector breeding in five urban settings of Latin America: a multi-country study.

PubMed

Quintero, Juliana; Brochero, Helena; Manrique-Saide, Pablo; Barrera-Pérez, Mario; Basso, César; Romero, Sonnia; Caprara, Andrea; De Lima Cunha, Jane Cris; Beltrán-Ayala, Efraín; Mitchell-Foster, Kendra; Kroeger, Axel; Sommerfeld, Johannnes; Petzold, Max

2014-01-21

Dengue is an increasingly important public health problem in most Latin American countries and more cost-effective ways of reducing dengue vector densities to prevent transmission are in demand by vector control programs. This multi-centre study attempted to identify key factors associated with vector breeding and development as a basis for improving targeted intervention strategies. In each of 5 participant cities in Mexico, Colombia, Ecuador, Brazil and Uruguay, 20 clusters were randomly selected by grid sampling to incorporate 100 contiguous households, non-residential private buildings (businesses) and public spaces. Standardized household surveys, cluster background surveys and entomological surveys specifically targeted to obtain pupal indices for Aedes aegypti, were conducted in the dry and wet seasons. The study clusters included mainly urban low-middle class populations with satisfactory infrastructure and -except for Uruguay- favourable climatic conditions for dengue vector development. Household knowledge about dengue and "dengue mosquitoes" was widespread, mainly through mass media, but there was less awareness around interventions to reduce vector densities. Vector production (measured through pupal indices) was favoured when water containers were outdoor, uncovered, unused (even in Colombia and Ecuador where the large tanks used for household water storage and washing were predominantly productive) and -particularly during the dry season- rainwater filled. Larval infestation did not reflect productive container types. All productive container types, including those important in the dry season, were identified by pupal surveys executed during the rainy season. A number of findings are relevant for improving vector control: 1) there is a need for complementing larval surveys with occasional pupal surveys (to be conducted during the wet season) for identifying and subsequently targeting productive container types; 2) the need to raise public awareness about useful and effective interventions in productive container types specific to their area; and 3) the motivation for control services that-according to this and similar studies in Asia- dedicated, targeted vector management can make a difference in terms of reducing vector abundance.

Effect of comprehensive cardiac telerehabilitation on one-year cardiovascular rehospitalization rate, medical costs and quality of life: A cost-effectiveness analysis.

PubMed

Frederix, Ines; Hansen, Dominique; Coninx, Karin; Vandervoort, Pieter; Vandijck, Dominique; Hens, Niel; Van Craenenbroeck, Emeline; Van Driessche, Niels; Dendale, Paul

2016-05-01

Notwithstanding the cardiovascular disease epidemic, current budgetary constraints do not allow for budget expansion of conventional cardiac rehabilitation programmes. Consequently, there is an increasing need for cost-effectiveness studies of alternative strategies such as telerehabilitation. The present study evaluated the cost-effectiveness of a comprehensive cardiac telerehabilitation programme. This multi-centre randomized controlled trial comprised 140 cardiac rehabilitation patients, randomized (1:1) to a 24-week telerehabilitation programme in addition to conventional cardiac rehabilitation (intervention group) or to conventional cardiac rehabilitation alone (control group). The incremental cost-effectiveness ratio was calculated based on intervention and health care costs (incremental cost), and the differential incremental quality adjusted life years (QALYs) gained. The total average cost per patient was significantly lower in the intervention group (€2156 ± €126) than in the control group (€2720 ± €276) (p = 0.01) with an overall incremental cost of €-564.40. Dividing this incremental cost by the baseline adjusted differential incremental QALYs (0.026 QALYs) yielded an incremental cost-effectiveness ratio of €-21,707/QALY. The number of days lost due to cardiovascular rehospitalizations in the intervention group (0.33 ± 0.15) was significantly lower than in the control group (0.79 ± 0.20) (p = 0.037). This paper shows the addition of cardiac telerehabilitation to conventional centre-based cardiac rehabilitation to be more effective and efficient than centre-based cardiac rehabilitation alone. These results are useful for policy makers charged with deciding how limited health care resources should best be allocated in the era of exploding need. © The European Society of Cardiology 2015.

Effectiveness of multi-component non-pharmacologic delirium interventions: A Meta-analysis

PubMed Central

Hshieh, Tammy T.; Yue, Jirong; Oh, Esther; Puelle, Margaret; Dowal, Sarah; Travison, Thomas; Inouye, Sharon K.

2015-01-01

Importance Delirium, an acute disorder with high morbidity and mortality, is often preventable through multi-component non-pharmacologic strategies. The efficacy of these strategies for preventing subsequent adverse outcomes has been limited to small studies. Objective Evaluate available evidence on multi-component non-pharmacologic delirium interventions in reducing incident delirium and preventing poor outcomes associated with delirium. Data Sources PubMed, Google Scholar, ScienceDirect and Cochrane Database of Systematic Reviews from January 1, 1999–December 31, 2013. Study Selection Studies examining the following outcomes were included: delirium incidence, falls, length of stay, rate of discharge to a long-term care institution, change in functional or cognitive status. Data Extraction and Synthesis Two experienced physician reviewers independently and blindly abstracted data on outcome measures using a standardized approach. The reviewers conducted quality ratings based on the Cochrane Risk of Bias criteria for each study. Main Outcomes and Measures We identified 14 interventional studies. Results for outcomes of delirium, falls, length of stay and institutionalization data were pooled for meta-analysis but heterogeneity limited meta-analysis of results for outcomes of functional and cognitive decline. Overall, eleven studies demonstrated significant reductions in delirium incidence (Odds Ratio 0.47, 95% Confidence Interval 0.38–0.58). The four randomized or matched (RMT) studies reduced delirium incidence by 44% (95% CI 0.42–0.76). Rate of falls decreased significantly among intervention patients in four studies (OR 0.38, 95% CI 0.25–0.60); in the two RMTs, the fall rate was reduced by 64% (95% CI 0.22–0.61). Lengths of stay and institutionalization rates also trended towards decreases in the intervention groups, mean difference −0.16 days shorter (95% CI −0.97–0.64) and odds of institutionalization 5% lower (OR 0.95, 95% CI 0.71–1.26) respectively. Among the higher quality RMTs, length of stay trended −0.33 days shorter (95% CI −1.38–0.72) and odds of institutionalization trended 6% lower (95% CI 0.69–1.30). Conclusions and Relevance Multi-component non-pharmacologic delirium prevention interventions are effective in reducing delirium incidence and preventing falls, with trend towards decreasing length of stay and avoiding institutionalization. Given the current focus on prevention of hospital-based complications and improved cost-effectiveness of care, this meta-analysis supports the use of these interventions to advance acute care for older persons. PMID:25643002

Effectiveness of a multi-strategy intervention in increasing the implementation of vegetable and fruit breaks by Australian primary schools: a non-randomized controlled trial

PubMed Central

2012-01-01

Background Limited evidence exists describing the effectiveness of strategies in facilitating the implementation of vegetable and fruit programs by schools on a population wide basis. The aim of this study was to examine the effectiveness of a multi-strategy intervention in increasing the population-wide implementation of vegetable and fruit breaks by primary schools and to determine if intervention effectiveness varied by school characteristics. Methods A quasi-experimental study was conducted in primary schools in the state of New South Wales, Australia. All primary schools in one region of the state (n = 422) received a multi-strategy intervention. A random sample of schools (n = 406) in the remainder of the state served as comparison schools. The multi-strategy intervention to increase vegetable and fruit breaks involved the development and provision of: program consensus and leadership; staff training; program materials; incentives; follow-up support; and implementation feedback. Comparison schools had access to routine information-based Government support. Data to assess the prevalence of vegetable and fruit breaks were collected by telephone from Principals of the intervention and comparison schools at baseline (2006–2007) and 11 to 15 months following the commencement of the intervention (2009–2010). GEE analysis was used to examine the change in the prevalence of vegetable and fruit breaks in intervention schools compared to comparison schools. Results At follow-up, prevalence of vegetable and fruit breaks increased significantly in both intervention (50.3 % to 82.0 %, p < 0.001) and comparison (45.4 % to 60.9 % p < 0.001) schools. The increase in prevalence in intervention schools was significantly larger than among comparison schools (OR 2.36; 95 % CI 1.60-3.49, p <0.001). The effect size was similar between schools regardless of the rurality or socioeconomic status of school location, school size or government or non-government school type. Conclusion The findings suggest that a multi-strategy intervention can significantly increase the implementation of vegetable and fruit breaks by a large number of Australian primary schools. PMID:22889085

Effectiveness of a multi-strategy intervention in increasing the implementation of vegetable and fruit breaks by Australian primary schools: a non-randomized controlled trial.

PubMed

Nathan, Nicole; Wolfenden, Luke; Bell, Andrew C; Wyse, Rebecca; Morgan, Philip J; Butler, Michelle; Sutherland, Rachel; Milat, Andrew J; Hector, Debra; Wiggers, John

2012-08-13

Limited evidence exists describing the effectiveness of strategies in facilitating the implementation of vegetable and fruit programs by schools on a population wide basis. The aim of this study was to examine the effectiveness of a multi-strategy intervention in increasing the population-wide implementation of vegetable and fruit breaks by primary schools and to determine if intervention effectiveness varied by school characteristics. A quasi-experimental study was conducted in primary schools in the state of New South Wales, Australia. All primary schools in one region of the state (n = 422) received a multi-strategy intervention. A random sample of schools (n = 406) in the remainder of the state served as comparison schools. The multi-strategy intervention to increase vegetable and fruit breaks involved the development and provision of: program consensus and leadership; staff training; program materials; incentives; follow-up support; and implementation feedback. Comparison schools had access to routine information-based Government support. Data to assess the prevalence of vegetable and fruit breaks were collected by telephone from Principals of the intervention and comparison schools at baseline (2006-2007) and 11 to 15 months following the commencement of the intervention (2009-2010). GEE analysis was used to examine the change in the prevalence of vegetable and fruit breaks in intervention schools compared to comparison schools. At follow-up, prevalence of vegetable and fruit breaks increased significantly in both intervention (50.3% to 82.0%, p < 0.001) and comparison (45.4% to 60.9% p < 0.001) schools. The increase in prevalence in intervention schools was significantly larger than among comparison schools (OR 2.36; 95% CI 1.60-3.49, p <0.001). The effect size was similar between schools regardless of the rurality or socioeconomic status of school location, school size or government or non-government school type. The findings suggest that a multi-strategy intervention can significantly increase the implementation of vegetable and fruit breaks by a large number of Australian primary schools.

PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial

PubMed Central

Fogelholm, Mikael; Larsen, Thomas Meinert; Westerterp-Plantenga, Margriet; Macdonald, Ian; Martinez, J. Alfredo; Boyadjieva, Nadka; Poppitt, Sally; Schlicht, Wolfgang; Stratton, Gareth; Sundvall, Jouko; Lam, Tony; Jalo, Elli; Christensen, Pia; Drummen, Mathijs; Simpson, Elizabeth; Navas-Carretero, Santiago; Handjieva-Darlenska, Teodora; Muirhead, Roslyn; Silvestre, Marta P.; Kahlert, Daniela; Pastor-Sanz, Laura; Brand-Miller, Jennie; Raben, Anne

2017-01-01

Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand). Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6) years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018. PMID:28632180

PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial.

PubMed

Fogelholm, Mikael; Larsen, Thomas Meinert; Westerterp-Plantenga, Margriet; Macdonald, Ian; Martinez, J Alfredo; Boyadjieva, Nadka; Poppitt, Sally; Schlicht, Wolfgang; Stratton, Gareth; Sundvall, Jouko; Lam, Tony; Jalo, Elli; Christensen, Pia; Drummen, Mathijs; Simpson, Elizabeth; Navas-Carretero, Santiago; Handjieva-Darlenska, Teodora; Muirhead, Roslyn; Silvestre, Marta P; Kahlert, Daniela; Pastor-Sanz, Laura; Brand-Miller, Jennie; Raben, Anne

2017-06-20

Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand). Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6) years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.

Effectiveness of Exercise Interventions to Improve Postural Control in Older Adults: A Systematic Review and Meta-Analyses of Centre of Pressure Measurements.

PubMed

Low, Daniel C; Walsh, Gregory S; Arkesteijn, Marco

2017-01-01

Previous reviews have shown balance in older adults to be improved with exercise. However, it is currently unclear whether postural control, indicated by centre of pressure (COP) measurement, can be improved in older adults and thus whether postural control could be a mechanism to improve balance. The purpose of this systematic review was to assess the effectiveness of force platform COP variables to identify changes in postural control following exercise interventions in older adults. In addition, a secondary purpose was to determine whether the exercise types (balance, resistance or multi-component exercise interventions) are equally effective to improve postural control. Randomised controlled trials were identified using searches of databases and reference lists (PROSPERO registration number CRD42014010617). Trials performing exercise interventions, reporting force platform COP measurements, in participants with a mean age of ≥60 years were included. Risk of bias assessments were performed following the Cochrane guidelines. Data were pooled in meta-analyses, and standardised mean differences (SMDs) with 95 % confidence intervals (CIs) were calculated. Twenty-three trials met the inclusion criteria for the systematic review. Twenty-two trials could be defined as either utilising a balance, resistance or multi-component exercise intervention. These 22 trials were used in the meta-analyses. All trials reported measurements of double leg stance; eight trials reported additional stance conditions. The meta-analyses of double leg stance showed that balance exercise interventions significantly decreased total sway path length/velocity [SMD -1.13, 95 % CI -1.75 to -0.51 (eyes open); SMD -0.79, 95 % CI -1.33 to -0.26 (eyes closed)] and anterior-posterior sway path length/velocity [SMD -1.02, 95 % CI -2.01 to -0.02 (eyes open); SMD -0.82, 95 % CI -1.46 to -0.17 (eyes closed)] in both eyes open and eyes closed conditions. Balance exercise interventions also decreased sway area in eyes closed conditions (SMD -0.57, 95 % CI -1.01 to -0.13) and medio-lateral sway path length/velocity in eyes open conditions (SMD -0.8, 95 % CI -1.48 to -0.12). In contrast, neither resistance nor multi-component exercise interventions affected any of the included COP measurements. Postural control is improved by balance exercise interventions. In contrast, strength or multi-component exercise interventions did not influence postural control measurements in older adults. In addition, a lack of standardisation in collection protocol and COP variables calculated across trials was identified.

Who defaults from colposcopy? A multi-centre, population-based, prospective cohort study of predictors of non-attendance for follow-up among women with low-grade abnormal cervical cytology.

PubMed

Sharp, Linda; Cotton, Seonaidh; Thornton, Alison; Gray, Nicola; Cruickshank, Margaret; Whynes, David; Duncan, Ian; Hammond, Robert; Smart, Louise; Little, Julian

2012-12-01

The success of cervical screening relies on women with abnormal cervical cytology attending for follow-up by colposcopy and related procedures. Failure to attend for colposcopy, however, is a common problem in many countries. The objective of this study was to identify factors associated with non-attendance at an initial colposcopy examination among women with low-grade abnormal cervical cytology. A cohort study was conducted within one arm of a multi-centre population-based randomised controlled trial nested within the UK NHS Cervical Screening Programmes. The trial recruited women aged 20-59 years with recent low-grade cervical cytology; women randomised to immediate referral for colposcopy were included in the current analysis (n=2213). At trial recruitment, women completed a socio-demographic and lifestyle questionnaire; 1693 women in the colposcopy arm were also invited to complete a psychosocial questionnaire, including the Hospital Anxiety and Depression Scale. Women were sent up to two colposcopy appointments. A telephone number was provided to reschedule if necessary. Defaulters were defined as those who failed to attend after two appointments. Logistic regression methods were used to compute multivariate odds ratios (OR) to identify variables significantly associated with default. 148 women defaulted (6.7%, 95%CI 5.7-7.8%). In multivariate analysis, risk of default was significantly raised in those not in paid employment (OR=2.70, 95%CI 1.64-4.43) and current smokers (OR=1.62, 95%CI 1.12-2.34). Default risk deceased with increasing age and level of post-school education/training and was lower in women with children (OR=0.59, 95%CI 0.35-0.98). Among the sub-group invited to complete psychosocial questionnaires, women who were not worried about having cervical cancer were significantly more likely to default (multivariate OR=1.56, 95%CI 1.04-2.35). Anxiety and depression were not significantly associated with default. Women at highest risk of default from colposcopy are younger, not in paid employment, smoke, lack post-school education, have not had children and are not worried about having cervical cancer. Findings such as these could inform the development of tools to predict the likelihood that an individual woman will default from follow-up. Interventions to minimise default also deserve consideration, but a better understanding of reasons for default is needed to inform intervention development. Copyright © 2012. Published by Elsevier Ireland Ltd.

Experience of using mHealth to link village doctors with physicians: lessons from Chakaria, Bangladesh.

PubMed

Khan, Nazib Uz Zaman; Rasheed, Sabrina; Sharmin, Tamanna; Ahmed, Tanvir; Mahmood, Shehrin Shaila; Khatun, Fatema; Hanifi, Sma; Hoque, Shahidul; Iqbal, Mohammad; Bhuiya, Abbas

2015-08-05

Bangladesh is facing serious shortage of trained health professionals. In the pluralistic healthcare system of Bangladesh, formal health care providers constitute only 5 % of the total workforce; the rest are informal health care providers. Information Communication Technologies (ICTs) are increasingly seen as a powerful tool for linking the community with formal healthcare providers. Our study assesses an intervention that linked village doctors (a cadre of informal health care providers practising modern medicine) to formal doctors through call centres from the perspective of the village doctors who participated in the intervention. The study was conducted in Chakaria, a remote rural area in south-eastern Bangladesh during April-May 2013. Twelve village doctors were selected purposively from a pool of 55 village doctors who participated in the mobile health (mHealth) intervention. In depth interviews were conducted to collect data. The data were manually analysed using themes that emerged. The village doctors talked about both business benefits (access to formal doctors, getting support for decision making, and being entitled to call trained doctors) and personal benefits (both financial and non-financial). Some of the major barriers mentioned were technical problems related to accessing the call centre, charging consultation fees, and unfamiliarity with the call centre physicians. Village doctors saw many benefits to having a business relationship with the trained doctors that the mHealth intervention provided. mHealth through call centres has the potential to ensure consultation services to populations through existing informal healthcare providers in settings with a shortage of qualified healthcare providers.

The non-specific effects of vaccines and other childhood interventions: the contribution of INDEPTH Health and Demographic Surveillance Systems.

PubMed

Sankoh, Osman; Welaga, Paul; Debpuur, Cornelius; Zandoh, Charles; Gyaase, Stephney; Poma, Mary Atta; Mutua, Martin Kavao; Hanifi, S M Manzoor Ahmed; Martins, Cesario; Nebie, Eric; Kagoné, Moubassira; Emina, Jacques B O; Aaby, Peter

2014-06-01

Most childhood interventions (vaccines, micronutrients) in low-income countries are justified by their assumed effect on child survival. However, usually the interventions have only been studied with respect to their disease/deficiency-specific effects and not for their overall effects on morbidity and mortality. In many situations, the population-based effects have been very different from the anticipated effects; for example, the measles-preventive high-titre measles vaccine was associated with 2-fold increased female mortality; BCG reduces neonatal mortality although children do not die of tuberculosis in the neonatal period; vitamin A may be associated with increased or reduced child mortality in different situations; effects of interventions may differ for boys and girls. The reasons for these and other contrasts between expectations and observations are likely to be that the immune system learns more than specific prevention from an intervention; such training may enhance or reduce susceptibility to unrelated infections. INDEPTH member centres have been in an ideal position to document such additional non-specific effects of interventions because they follow the total population long term. It is proposed that more INDEPTH member centres extend their routine data collection platform to better measure the use and effects of childhood interventions. In a longer perspective, INDEPTH may come to play a stronger role in defining health research issues of relevance to low-income countries. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: insights from the Japan multi-centre post-marketing surveillance registry.

PubMed

Otsuka, Yoritaka; Ishiwata, Sugao; Inada, Tsukasa; Kanno, Hiroyuki; Kyo, Eisho; Hayashi, Yasuhiko; Fujita, Hiroshi; Michishita, Ichiro

2011-04-01

Long-term outcomes after sirolimus-eluting stent (SES) implantation in haemodialysis (HD) patients have remained controversial. We investigated the impact of HD on outcomes after SES implantation. We analysed the data on 2050 patients who underwent SES implantation in a multi-centre prospective registry in Japan. Three-year clinical outcomes were compared between the HD group (n = 106) and the non-haemodialysis (NH) group (n = 1944). At the 3-year clinical follow-up, the rates of unadjusted cardiac mortality (HD: 16.3 vs. NH: 2.3%) and target-lesion revascularization (TLR) (HD: 19.4 vs. NH: 6.6%) were significantly higher in the HD group than the NH group (P < 0.001). Although HD group had a numerically higher stent thrombosis rate, the difference in stent thrombosis between the two groups (HD: 2.0 vs. NH: 0.7%) did not reach statistical significance. Using Cox's proportional-hazard models with propensity score adjustment for baseline differences, the HD group had higher risks of TLR [HD: 16.3 vs. NH: 6.1%; hazard ratio, 2.83; 95% confidence interval (CI): 1.62-4.93, P = 0.0003] and cardiac death (HD: 12.3 vs. NH: 2.3%; hazard ratio, 5.51; 95% CI: 2.58-11.78, P < 0.0001). The consistent results of analyses, whether unadjusted or adjusted for other baseline clinical and procedural differences, identify HD as an independent risk factor for cardiac death and TLR. Percutaneous coronary intervention with SES in HD patients has a higher incidence of repeat revascularization and mortality compared with those in NH patients. Haemodialysis appears to be strongly associated with mortality and repeat revascularization even after SES implantation.

Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2014-02-01

Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Pilot evaluation of the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) Food-O-Meter, a computer-tailored nutrition advice for adolescents: a study in six European cities.

PubMed

Maes, Lea; Cook, Tina Louisa; Ottovaere, Charlene; Matthijs, Christophe; Moreno, Luis A; Kersting, Mathilde; Papadaki, Alina; Manios, Yannis; Dietrich, Sabine; Hallström, Lena; Haerens, Leen; De Bourdeaudhuij, Ilse; Vereecken, Carine

2011-07-01

To investigate the feasibility and impact of the Food-O-Meter, an Internet-based computer-tailored nutrition intervention in adolescents. Participants in the intervention condition received the computer-tailored advice at baseline and at 1 month, those in the control condition received standardised advice. Effects were evaluated at 1 month (n 621) and at 3 months (n 558) using multi-level modelling. Secondary schools in six European cities. Adolescents accessed the intervention in the school computer room under the supervision of teachers. Classes with students aged 12-17 years in the schools participating in the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) cross-sectional study were randomised into intervention and control schools. In most participating centres the intervention was feasible and generally well appreciated, especially by girls. Technical problems and lack of motivation of the teachers hindered implementation in some centres. Overweight adolescents had higher scores for reading and using the advice than normal weight adolescents. After 1 month adolescents receiving the standardised advice reported an increase in fat intake, while fat intake in the intervention condition was stable (F = 4·82, P < 0·05). After 3 months, there was a trend in the total group for an intervention effect of the tailored advice on fat intake (F = 2·80, P < 0·10). In the overweight group there was a clear positive effect (F = 5·76, P < 0·05). The Food-O-Meter should be developed further. The results were modest but clear for percentage energy from fat, specifically in the overweight group. Adaptations based on new research are needed to enhance the reliability and effectiveness of the intervention.

The making of indigenous vascular prosthesis

PubMed Central

Unnikrishnan, Madathipat; Viswanathan, Sidharth; Balasubramaniam, K.; Muraleedharan, C.V.; Lal, Arthur Vijayan; Mohanan, P.V.; Mohanty, Meera; Kapilamoorthy, Tirur Raman

2016-01-01

Background & objectives: Vascular illnesses are on the rise in India, due to increase in lifestyle diseases and demographic transition, requiring intervention to save life, organ or limbs using vascular prosthesis. The aim of this study was to develop indigenous large diameter vascular graft for treatment of patients with vascular pathologies. Methods: The South India Textile Research Association, at Coimbatore, Tamil Nadu, India, developed seamless woven polyester (Polyethylene terephthalate) graft at its research wing. Further characterization and testing followed by clinical trials were conducted at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India. Fifteen in vivo experiments were carried out in 1992-1994 in pigs as animal model. Controlled (phase I) clinical trial in ten patients was performed along with control graft. Thereafter, phase II trial involved 22 patients who underwent multi-centre clinical trial in four centres across India. Results: Laboratory testing showed that polyester graft was non-toxic, non-leeching and non-haemolytic with preserved long-term quality, further confirming in pigs by implanting in thoracic aorta, comparable to control Dacron grafts. Perigraft incorporation and smooth neointima formation which are prime features of excellent healing characteristics, were noted at explantation at planned intervals. Subsequently in the phase I and II clinical trials, all patients had excellent recovery without mortality or device-related adverse events. Patients receiving the test graft were followed up for 10 and 5 years, respectively. Serial clinical, duplex scans and CT angiograms performed periodically confirmed excellent graft performance. Interpretation & conclusions: Indigenously developed Chitra vascular graft was comparable to commercially available Dacron graft, ready for clinical use at affordable cost to patients as against costly imported grafts. PMID:27748302

Evaluating a Dutch cardiology primary care plus intervention on the Triple Aim outcomes: study design of a practice-based quantitative and qualitative research.

PubMed

Quanjel, Tessa C C; Spreeuwenberg, Marieke D; Struijs, Jeroen N; Baan, Caroline A; Ruwaard, Dirk

2017-09-06

In an attempt to deal with the pressures on the health-care system and to guarantee sustainability, changes are needed. This study focuses on a cardiology primary care plus intervention. Primary care plus (PC+) is a new health-care delivery model focused on substitution of specialist care in the hospital setting with specialist care in the primary care setting. The intervention consists of a cardiology PC+ centre in which cardiologists, supported by other health-care professionals, provide consultations in a primary care setting. The PC+ centre aims to improve the health of the population and quality of care as experienced by patients, and reduce the number of referrals to hospital-based outpatient specialist care in order to reduce health-care costs. These aims reflect the Triple Aim principle. Hence, the objectives of the study are to evaluate the cardiology PC+ centre in terms of the Triple Aim outcomes and to evaluate the process of the introduction of PC+. The study is a practice-based, quantitative study with a longitudinal observational design, and an additional qualitative study to supplement, interpret and improve the quantitative study. The study population of the quantitative part will consist of adult patients (≥18 years) with non-acute and low-complexity cardiology-related health complaints, who will be referred to the cardiology PC+ centre (intervention group) or hospital-based outpatient cardiology care (control group). All eligible patients will be asked to complete questionnaires at three different time points consisting of questions about their demographics, health status and experience of care. Additionally, quantitative data will be collected about health-care utilization and related health-care costs at the PC+ centre and the hospital. The qualitative part, consisting of semi-structured interviews, focus groups, and observations, is designed to evaluate the process as well as to amplify, clarify and explain quantitative results. This study will evaluate a cardiology PC+ centre using quantitative and supplementary qualitative methods. The findings of both sub-studies will fill a gap in knowledge about the effects of PC+ and in particular whether PC+ is able to pursue the Triple Aim outcomes. NTR6629 (Data registered: 25-08-2017) (registered retrospectively).

Drug and poison information centres: An emergent need for health care professionals in Pakistan.

PubMed

Khaliq, Asif; Sayed, Sayeeda Amber

2016-06-01

To determine the need of drug and poison information centres in public and private hospitals of Karachi. The cross-sectional study was conducted at 3 public and 3 private tertiary care hospitals of Karachi, from July 2013 to April 2014, using a self-administered, multi-item questionnaire. Non-probability convenient sampling was used to select the participants. SPSS 18 was used to analyse data. Of the 307 physicians, 282(92%) highlighted the need for a 24/7 drug and poison information centre and 206(67%) suggested opening a drug information centre at the hospital. Besides, 215(70%) respondents said they took at least 15 minutes for searching information about the drug while managing a case. Regarding the poisoning case management, 160(52%) physicians complained about the unavailability of medicines in hospitals. Provision of 24 /7 drug information centres with specialised staff are necessary to reduce treatment delays and to ensure provision of quality healthcare.

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial.

PubMed

Reiss, Kate; Andersen, Kathryn; Barnard, Sharmani; Ngo, Thoai D; Biswas, Kamal; Smith, Christopher; Carpenter, James; Church, Kathryn; Nuremowla, Sadid; Pearson, Erin

2017-10-03

Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and experience of violence during the 12 month study period. Mobile phones offer a low-cost mechanism for providing individualised support to women with contraception outside of the clinic setting. This study will provide information on the effects of such an intervention among MR clients in Bangladesh. Trial registered with clinicaltrials.gov Registration number: NCT02579785 Date of registration: 16th October 2015.

Healthy urban environments for children and young people: A systematic review of intervention studies.

PubMed

Audrey, Suzanne; Batista-Ferrer, Harriet

2015-11-01

This systematic review collates, and presents as a narrative synthesis, evidence from interventions which included changes to the urban environment and reported at least one health behaviour or outcome for children and young people. Following a comprehensive search of six databases, 33 primary studies relating to 27 urban environment interventions were included. The majority of interventions related to active travel. Others included park and playground renovations, road traffic safety, and multi-component community-based initiatives. Public health evidence for effectiveness of such interventions is often weak because study designs tend to be opportunistic, non-randomised, use subjective outcome measures, and do not incorporate follow-up of study participants. However, there is some evidence of potential health benefits to children and young people from urban environment interventions relating to road safety and active travel, with evidence of promise for a multi-component obesity prevention initiative. Future research requires more robust study designs incorporating objective outcome measures. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Venous Thromboembolism Risk and Adequacy of Prophylaxis in High Risk Pregnancy in the Arabian Gulf

PubMed Central

Alsayegh, Faisal; Al-Jassar, Waleed; Wani, Salima; Tahlak, Muna; Al-Bahar, Awatef; Al-Kharusi, Lamya; Al-Tamimi, Halima; El-Taher, Faten; Mahmood, Naeema; Al-Zakwani, Ibrahim

2016-01-01

Objectives: To estimate the prevalence of venous thromboembolism (VTE) risk factors in pregnancy and the proportion of pregnancies at risk of VTE that received the recommended prophylaxis according to the American College of Chest Physicians (ACCP) 2012 published guidelines in antenatal clinics in the Arabian Gulf. Methods: The evaluation of venous thromboembolism (EVE)-Risk project was a non-interventional, cross-sectional, multi-centre, multi-national study of all eligible pregnant women (≥17 years) screened during antenatal clinics from 7 centres in the Arabian Gulf countries (United Arab Emirates, Kuwait, Bahrain, Qatar and Oman). Pregnant women were recruited during a 3-month period between September and December 2012. Results: Of 4,131 screened pregnant women, 32% (n=1,337) had ≥1 risk factors for VTE. Common VTE risk factors included obesity (76%), multiparity (33%), recurrent miscarriages (9.1%), varicose veins (6.9%), thrombophilia (2.6%), immobilization (2.0%), sickle cell disease (2.8%) and previous VTE (1.6%). Only 8.3% (n=111) of the high risk patients were on the recommended VTE prophylaxis. Enoxaparin was used in 80% (n=89) of the cases followed by tinzaparin (4%; n=4). Antiplatelet agents were prescribed in 11% (n=149) of pregnant women. Of those on anticoagulants (n=111), 59% (n=66) were also co-prescribed antiplatelet agents. Side effects (mainly local bruising at the injection site) were reported in 12% (n=13) of the cases. Conclusion: A large proportion of pregnant women in the Arabian Gulf countries have ≥1 VTE risk factor with even a smaller fraction on prophylaxis. VTE risk assessment must be adopted to identify those at risk who would need VTE prophylaxis. PMID:26517701

Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)

PubMed Central

2013-01-01

Background Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers. Methods/design In this multi-centre, single-blind randomised controlled trial, 480 people with early-stage dementia, each with a carer, will be randomised to receive either treatment as usual or cognitive rehabilitation (10 therapy sessions over 3 months, followed by 4 maintenance sessions over 6 months). We will compare the effectiveness of cognitive rehabilitation with that of treatment as usual with regard to improving self-reported and carer-rated goal performance in areas identified as causing concern by people with early-stage dementia; improving quality of life, self-efficacy, mood and cognition of people with early-stage dementia; and reducing stress levels and ameliorating quality of life for carers of participants with early-stage dementia. The incremental cost-effectiveness of goal-oriented cognitive rehabilitation compared to treatment as usual will also be examined. Discussion If the study confirms the benefits and cost-effectiveness of cognitive rehabilitation, it will be important to examine how the goal-oriented cognitive rehabilitation approach can most effectively be integrated into routine health-care provision. Our aim is to provide training and develop materials to support the implementation of this approach following trial completion. Trial registration Current Controlled Trials ISRCTN21027481 PMID:23710796

Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

PubMed Central

2010-01-01

Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, appropriately targeted population-based approaches. Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from randomised intervention trials in screen-detected T2DM cases. UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM. To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care. Here we describe the rationale and methods of a systematic community screening programme and randomised controlled trial of cardiovascular risk management within a UK multiethnic setting (ADDITION-Leicester). Design A single-blind cluster randomised, parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care. Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practices coordinated from a single academic research centre. Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40-75 years (25-75 years South Asian). Volunteers also provide detailed medical and family histories; complete health questionnaires, undergo anthropometric measures, lipid profiling and a proteinuria assessment. Primary outcome is reduction in modelled Coronary Heart Disease (UKPDS CHD) risk at five years. Seven thousand (30% of South Asian ethnic origin) volunteers over three years will be recruited to identify a screen-detected T2DM cohort (n = 285) powered to detected a 6% relative difference (80% power, alpha 0.05) between treatment groups at one year. Randomisation will occur at practice-level with newly diagnosed T2DM cases receiving either conventional (according to current national guidelines) or intensive (algorithmic target-driven multi-factorial cardiovascular risk intervention) treatments. Discussion ADDITION-Leicester is the largest multiethnic (targeting >30% South Asian recruitment) community T2DM and vascular risk screening programme in the UK. By assessing feasibility and efficacy of T2DM screening, it will inform national disease prevention policy and contribute significantly to our understanding of the health care needs of UK South Asians. Trial registration Clinicaltrial.gov (NCT00318032). PMID:20170482

Development of a Multi-Disciplinary Intervention for the Treatment of Childhood Obesity Based on Cognitive Behavioral Therapy

ERIC Educational Resources Information Center

Bathrellou, Eirini; Yannakoulia, Mary; Papanikolaou, Katerina; Pehlivanidis, Artemios; Pervanidou, Panagiota; Kanaka-Gantenbein, Christina; Tsiantis, John; Chrousos, George P.; Sidossis, Labros S.

2010-01-01

Along the lines of the evidence-based recommendations, we developed a multi-disciplinary intervention for overweight children 7- to 12-years-old, primarily aiming at helping children to adopt healthier eating habits and a physically active lifestyle. The program combined nutrition intervention, based on a non-dieting approach, with physical…

Impact of an antimicrobial stewardship intervention on appropriateness of prescribing for community-acquired pneumonia in an Australian regional hospital.

PubMed

Bond, Stuart E; Boutlis, Craig S; Yeo, Wilfred W; Miyakis, Spiros

2017-05-01

Community-acquired pneumonia (CAP) is the second commonest indication for antibiotic use in Australian hospitals and is therefore a frequent target for antimicrobial stewardship. A single-centre prospective study was conducted in a regional referral hospital comparing management of adult patients with CAP before and after an educational intervention. We demonstrated a reduction in duration of therapy and reduced inappropriate use of ceftriaxone-based regimens for non-severe CAP. © 2017 Royal Australasian College of Physicians.

Adoption of workplaces and reach of employees for a multi-faceted intervention targeting low back pain among nurses' aides.

PubMed

Rasmussen, Charlotte Diana Nørregaard; Larsen, Anne Konring; Holtermann, Andreas; Søgaard, Karen; Jørgensen, Marie Birk

2014-05-01

Workplace adoption and reach of health promotion are important, but generally poorly reported. The aim of this study is therefore to evaluate the adoption of workplaces (organizational level) and reach of employees (individual level) of a multi-faceted workplace health promotion and work environment intervention targeting low back pain among nurses' aides in elderly care. Percentage of adopters was calculated among eligible workplaces and differences between adopters and non-adopters were evaluated through workplace registrations and manager questionnaires from all eligible workplaces. From the adopted workplaces reach was calculated among eligible employees as the percentage who responded on a questionnaire. Responders were compared with non-responders using data from company registrations. Among responders, comparisons based on questionnaire data were performed between those consenting to participate in the intervention (consenters) and those not consenting to participate in the intervention (non-consenters). Comparisons were done using Student's t-test for the continuous variables, Fisher's exact test for dichotomous variables and the Pearson's chi(2) for categorical variables. Moreover odds ratios for non-responding and non-consenting were investigated with binary logistic regression analyses. The project was adopted by 44% of the offered workplaces. The main differences between adopters and non-adopters were that workplaces adopting the intervention had a more stable organization as well as a management with positive beliefs of the intervention's potential benefits. Of eligible employees, 71% responded on the questionnaire and 57% consented to participate. Non-responders and non-consenters did not differ from the responders and consenters on demographic factors and health. However, more non-responders and non-consenters were low skilled, worked less than 30 hours pr. week, and worked evening and nightshift compared to responders and consenters, respectively. Consenters had more musculoskeletal pain and reduced self-rated health, as well as higher physical exertion during work compared to non-consenters. Our recruitment effort yielded a population of consenters that was representative of the target population of nurses' aides with respect to demographic factors, and health. Moreover more consenters had problems like pain and high physical exertion during work, which fitted the scope of the intervention. The study is registered as ISRCTN78113519.

Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar

PubMed Central

Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-01-01

Objectives To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. Methods A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Findings Pupae per person index (PPI) decreased at the last evaluation by 5.7% (0.35–0.33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63.6% (0.33–0.12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18.6% in evaluation 2 and 44.1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. Conclusions The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment. PMID:23318238

Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar.

PubMed

Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-12-01

To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description: The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Pupae per person index (PPI) decreased at the last evaluation by 5·7% (0·35-0·33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63·6% (0·33-0·12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18·6% in evaluation 2 and 44·1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment.

Cost-effectiveness of ward-based pharmacy care in surgical patients: protocol of the SUREPILL (Surgery & Pharmacy In Liaison) study.

PubMed

de Boer, Monica; Ramrattan, Maya A; Kiewiet, Jordy J S; Boeker, Eveline B; Gombert-Handoko, Kim B; van Lent-Evers, Nicolette A E M; Kuks, Paul F; Dijkgraaf, Marcel G W; Boermeester, Marja A; Lie-A-Huen, Loraine

2011-03-07

Preventable adverse drug events (pADEs) are widely known to be a health care issue for hospitalized patients. Surgical patients are especially at risk, but prevention of pADEs in this population is not demonstrated before. Ward-based pharmacy interventions seem effective in reducing pADEs in medical patients. The cost-effectiveness of these preventive efforts still needs to be assessed in a comparative study of high methodological standard and also in the surgical population. For these aims the SUREPILL (Surgery & Pharmacy in Liaison) study is initiated. A multi-centre controlled trial, with randomisation at ward-level and preceding baseline assessments is designed. Patients admitted to the surgical study wards for elective surgery with an expected length of stay of more than 48 hours will be included. Patients admitted to the intervention ward, will receive ward-based pharmacy care from the clinical pharmacy team, i.e. pharmacy practitioners and hospital pharmacists. This ward-based pharmacy intervention includes medication reconciliation in consultation with the patient at admission, daily medication review with face-to-face contact with the ward doctor, and patient counselling at discharge. Patients admitted in the control ward, will receive standard pharmaceutical care.The primary clinical outcome measure is the number of pADEs per 100 elective admissions. These pADEs will be measured by systematic patient record evaluation using a trigger tool. Patient records positive for a trigger will be evaluated on causality, severity and preventability by an independent expert panel. In addition, an economic evaluation will be performed from a societal perspective with the costs per preventable ADE as the primary economic outcome. Other outcomes of this study are: severity of pADEs, number of patients with pADEs per total number of admissions, direct (non-)medical costs and indirect non-medical costs, extra costs per prevented ADE, number and type of pharmacy interventions, length of hospital stay, complications registered in a national complication registration system for surgery, number of readmissions within three months after initial admission (follow-up), quality of life and number of non-institutionalized days during follow-up. This study will assess the cost-effectiveness of ward-based pharmacy care on preventable adverse drug events in surgical patients from a societal perspective, using a comparative study design. Netherlands Trial Register (NTR): NTR2258.

Non-pharmacological approaches to alleviate distress in dementia care.

PubMed

Mitchell, Gary; Agnelli, Joanne

2015-11-25

Distress is one of the most common clinical manifestations associated with dementia. Pharmacological intervention may be appropriate in managing distress in some people. However, best practice guidelines advocate non-pharmacological interventions as the preferred first-line treatment. The use of non-pharmacological interventions encourages healthcare professionals to be more person-centred in their approach, while considering the causes of distress. This article provides healthcare professionals with an overview of some of the non-pharmacological approaches that can assist in alleviating distress for people living with dementia including: reminiscence therapy, reality orientation, validation therapy, music therapy, horticultural therapy, doll therapy and pet therapy. It provides a summary of their use in clinical practice and links to the relevant literature.

Improving treatment for obese women with early stage cancer of the uterus: rationale and design of the levonorgestrel intrauterine device ± metformin ± weight loss in endometrial cancer (feMME) trial.

PubMed

Hawkes, A L; Quinn, M; Gebski, V; Armes, J; Brennan, D; Janda, M; Obermair, A

2014-09-01

Endometrial adenocarcinoma (EC) is the most common gynaecologic cancer. Up to 90% of EC patients are obese which poses a health threat to patients post-treatment. Standard treatment for EC includes hysterectomy, although this has significant side effects for obese women at high risk of surgical complications and for women of childbearing age. This trial investigates the effectiveness of non-surgical or conservative treatment options for obese women with early stage EC. The primary aim is to determine the efficacy of: levonorgestrel intrauterine device (LNG-IUD); with or without metformin (an antidiabetic drug); and with or without a weight loss intervention to achieve a pathological complete response (pCR) in EC at six months from study treatment initiation. The secondary aim is to enhance understanding of the molecular processes and to predict a treatment response by investigating EC biomarkers. An open label, three-armed, randomised, phase-II, multi-centre trial of LNG-IUD ± metformin ± weight loss intervention. 165 participants from 28 centres are randomly assigned in a 3:3:5 ratio to the treatment arms. Clinical, quality of life and health behavioural data will be collected at baseline, six weeks, three and six months. EC biomarkers will be assessed at baseline, three and six months. There is limited prospective evidence for conservative treatment for EC. Trial results could benefit patients and reduce health system costs through a reduction in hospitalisations and through lower incidence of adverse events currently observed with standard treatment. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Person-centred web-based support - development through a Swedish multi-case study

PubMed Central

2013-01-01

Background Departing from the widespread use of the internet in modern society and the emerging use of web applications in healthcare this project captures persons’ needs and expectations in order to develop highly usable web recourses. The purpose of this paper is to outline a multi-case research project focused on the development and evaluation of person-centred web-based support for people with long-term illness. To support the underlying idea to move beyond the illness, we approach the development of web support from the perspective of the emergent area of person-centred care. The project aims to contribute to the ongoing development of web-based supports in health care and to the emerging field of person-centred care. Methods/Design The research design uses a meta-analytical approach through its focus on synthesizing experiences from four Swedish regional and national cases of design and use of web-based support in long-term illness. The cases include children (bladder dysfunction and urogenital malformation), young adults (living close to persons with mental illness), and two different cases of adults (women with breast cancer and childbearing women with type 1 diabetes). All of the cases are ongoing, though in different stages of design, implementation, and analysis. This, we argue, will lead to a synthesis of results on a meta-level not yet described. Discussion To allow valid comparisons between the four cases we explore and problematize them in relation to four main aspects: 1) The use of people’s experiences and needs; 2) The role of use of theories in the design of person-centred web-based supports; 3) The evaluation of the effects of health outcomes for the informants involved and 4) The development of a generic person-centred model for learning and social support for people with long-term illness and their significant others. Person-centred web-based support is a new area and few studies focus on how web-based interventions can contribute to the development of person-centred care. In summary, the main intention of the project outlined here is to contribute with both a synthesis of results on meta-level from four cases and a substantial contribution to the field person-centred care. PMID:24139057

Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels.

PubMed

Brach, Michael; Nieder, Frank; Nieder, Ulrike; Mechling, Heinz

2009-11-24

There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL), the organisational-institutional level (OIL) and the political-cultural level (PCL). Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. The intervention consisted of (a) two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL), (b) a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL), (c) informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL). Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL), number of groups continued without external financial support (at the end of the project, and after one year) (OIL). Secondary outcome was measured by sensorimotor tests and care-related assessments in the beginning and every 16 weeks (ISL), by qualitative outcome descriptions 12 months after group implementation (OIL) and by analysis of media response and structured interviews with stakeholders, also after 12 months (PCL). Exemplarily, preventive exercise has been established for a neglected target population. The multi-level approach used here seems to be helpful to overcome institutional and individual (attitude) barriers. Current Controlled Trials ISRCTN55213782.

Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

PubMed

Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike

2017-01-06

This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice. ISRCTN34805606 (Retrospectively registered 16.3.16).

Self-referral psychological treatment centre for young adults: a 2-year observational evaluation of routine practice before and after treatment

PubMed Central

Halje, Karin; Timpka, Toomas; Tylestedt, Petra; Adler, Anna-Karin; Fröberg, Lena; Schyman, Tommy; Johansson, Kristoffer; Dahl, Katarina

2015-01-01

Objectives To examine a self-referral psychological service provided to young adults with regard to effects on anxiety, depression and psychological distress and to explore client factors predicting non-adherence and non-response. Design Observational study over a 2-year period. Setting Young Adults Centre providing psychological services by self-referral (preprimary care) to Linköping, Åtvidaberg, and Kinda municipalities (combined population 145 000) in Östergötland county, Sweden. Participants 607 young adults (16–25 years of age); 71% females (n=429). Intervention Individually scheduled cognitive behavioural therapy delivered in up to six 45 min sessions structured according to an assessment of the client's mental health problems: anxiety, depression, anxiety and depression combined, or decreased distress without specific anxiety or depression. Primary outcome measures Pre–post intervention changes in psychological distress (General Health Questionnaire-12, GHQ-12), Hospital Anxiety and Depression Scale Anxiety/Depression (HADS-A/D). Results 192 clients (32.5%) discontinued the intervention on their own initiative and 39 clients (6.6%) were referred to a psychiatric clinic during the course of the intervention. Intention-to-treat analyses including all clients showed a medium treatment effect size (d=0.64) with regard to psychological distress, and small effect sizes were observed with regard to anxiety (d=0.58) and depression (d=0.57). Restricting the analyses to clients who adhered to the agreed programme, a large effect size (d=1.26) was observed with regard to psychological distress, and medium effect sizes were observed with regard to anxiety (d=1.18) and depression (d=1.19). Lower age and a high initial HADS-A score were the strongest risk factors for non-adherence, and inability to concentrate and thinking of oneself as a worthless person increased the risk for discontinuation. Conclusions We conclude that provision of psychological services to young people through a self-referral centre has potential to improve long-term mental health in communities, but management of non-adherence remains a central challenge. PMID:26283666

Advanced Nursing Process quality: Comparing the International Classification for Nursing Practice (ICNP) with the NANDA-International (NANDA-I) and Nursing Interventions Classification (NIC).

PubMed

Rabelo-Silva, Eneida Rejane; Dantas Cavalcanti, Ana Carla; Ramos Goulart Caldas, Maria Cristina; Lucena, Amália de Fátima; Almeida, Miriam de Abreu; Linch, Graciele Fernanda da Costa; da Silva, Marcos Barragan; Müller-Staub, Maria

2017-02-01

To assess the quality of the advanced nursing process in nursing documentation in two hospitals. Various standardised terminologies are employed by nurses worldwide, whether for teaching, research or patient care. These systems can improve the quality of nursing records, enable care continuity, consistency in written communication and enhance safety for patients and providers alike. Cross-sectional study. A total of 138 records from two facilities (69 records from each facility) were analysed, one using the NANDA-International and Nursing Interventions Classification terminology (Centre 1) and one the International Classification for Nursing Practice (Centre 2), by means of the Quality of Diagnoses, Interventions, and Outcomes instrument. Quality of Diagnoses, Interventions, and Outcomes scores range from 0-58 points. Nursing records were dated 2012-2013 for Centre 1 and 2010-2011 for Centre 2. Centre 1 had a Quality of Diagnoses, Interventions, and Outcomes score of 35·46 (±6·45), whereas Centre 2 had a Quality of Diagnoses, Interventions, and Outcomes score of 31·72 (±4·62) (p < 0·001). Centre 2 had higher scores in the 'Nursing Diagnoses as Process' dimension, whereas in the 'Nursing Diagnoses as Product', 'Nursing Interventions' and 'Nursing Outcomes' dimensions, Centre 1 exhibited superior performance; acceptable reliability values were obtained for both centres, except for the 'Nursing Interventions' domain in Centre 1 and the 'Nursing Diagnoses as Process' and 'Nursing Diagnoses as Product' domains in Centre 2. The quality of nursing documentation was superior at Centre 1, although both facilities demonstrated moderate scores considering the maximum potential score of 58 points. Reliability analyses showed satisfactory results for both standardised terminologies. Nursing leaders should use a validated instrument to investigate the quality of nursing records after implementation of standardised terminologies. © 2016 John Wiley & Sons Ltd.

Centre-based day care for children younger than five years of age in high-income countries.

PubMed

van Urk, Felix C; Brown, Taylor W; Waller, Rebecca; Mayo-Wilson, Evan

2014-09-23

A large proportion of children younger than five years of age in high-income countries experience significant non-parental care. Centre-based day care services may influence the development of children and the economic situation of parents. To assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development and well-being of children and families in high-income countries (as defined by the World Bank 2011). In April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, the Education Resources Information Center (ERIC) and eight other databases. We also searched two trials registers and the reference lists of relevant studies. We included randomised and quasi-randomised controlled trials of centre-based day care for children younger than five years of age. We excluded studies that involved co-interventions not directed toward children (e.g. parent programmes, home visits, teacher training). We included the following outcomes: child cognitive development (primary outcome), child psychosocial development, maternal and family outcomes and child long-term outcomes. Two review authors independently assessed the risk of bias and extracted data from the single included study. We contacted investigators to obtain missing information. We included in the review one trial, involving 120 families and 143 children. Risk of bias was high because of contamination between groups, as 63% of control group participants accessed day care services separate from those offered within the intervention. No evidence suggested that centre-based day care, rather than no treatment (care at home), improved or worsened children's cognitive ability (Griffiths Mental Development Scale, standardised mean difference (SMD) 0.34, 95% confidence interval (CI) -0.01 to 0.69, 127 participants, 1 study, very low-quality evidence) or psychosocial development (parental report of abnormal development, risk ratio (RR) 1.21, 95% CI 0.25 to 5.78, 137 participants, 1 study, very low-quality evidence). No other measures of child intellectual or psychosocial development were reported in the included study. Moreover, no evidence indicated that centre-based day care, rather than no treatment (care at home), improved or worsened employment of parents, as measured by the number of mothers in full-time or part-time employment (RR 1.12, 95% CI 0.85 to 1.48, 114 participants, 1 study, very low-quality evidence) and maternal hours per week in paid employment (SMD 0.20, 95% -0.15 to 0.55, 127 participants, 1 study, very low-quality evidence) or household income above £200 per week (RR 0.86, 95% CI 0.57 to 1.29, 113 participants, 1 study, very low-quality evidence). This study did not report on long-term outcomes for children (high-school completion or income). This review includes one trial that provides inconclusive evidence as regards the effects of centre-based day care for children younger than five years of age and their families in high-income countries. Robust guidance for parents, policymakers and other stakeholders on the effects of day care cannot currently be offered on the basis of evidence from randomised controlled trials. Some trials included co-interventions that are unlikely to be found in normal day care centres. Effectiveness studies of centre-based day care without these co-interventions are few, and the need for such studies is significant. Comparisons might include home visits or alternative day care arrangements that provide special attention to children from low-income families while exploring possible mechanisms of effect.

Community wide interventions for increasing physical activity.

PubMed

Baker, Philip R A; Francis, Daniel P; Soares, Jesus; Weightman, Alison L; Foster, Charles

2015-01-05

Multi-strategic community wide interventions for physical activity are increasingly popular but their ability to achieve population level improvements is unknown. To evaluate the effects of community wide, multi-strategic interventions upon population levels of physical activity. We searched the Cochrane Public Health Group Segment of the Cochrane Register of Studies,The Cochrane Library, MEDLINE, MEDLINE in Process, EMBASE, CINAHL, LILACS, PsycINFO, ASSIA, the British Nursing Index, Chinese CNKI databases, EPPI Centre (DoPHER, TRoPHI), ERIC, HMIC, Sociological Abstracts, SPORT Discus, Transport Database and Web of Science (Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index). We also scanned websites of the EU Platform on Diet, Physical Activity and Health; Health-Evidence.org; the International Union for Health Promotion and Education; the NIHR Coordinating Centre for Health Technology (NCCHTA); the US Centre for Disease Control and Prevention (CDC) and NICE and SIGN guidelines. Reference lists of all relevant systematic reviews, guidelines and primary studies were searched and we contacted experts in the field. The searches were updated to 16 January 2014, unrestricted by language or publication status. Cluster randomised controlled trials, randomised controlled trials, quasi-experimental designs which used a control population for comparison, interrupted time-series studies, and prospective controlled cohort studies were included. Only studies with a minimum six-month follow up from the start of the intervention to measurement of outcomes were included. Community wide interventions had to comprise at least two broad strategies aimed at physical activity for the whole population. Studies which randomised individuals from the same community were excluded. At least two review authors independently extracted the data and assessed the risk of bias. Each study was assessed for the setting, the number of included components and their intensity. The primary outcome measures were grouped according to whether they were dichotomous (per cent physically active, per cent physically active during leisure time, and per cent physically inactive) or continuous (leisure time physical activity time (time spent)), walking (time spent), energy expenditure (as metabolic equivalents or METS)). For dichotomous measures we calculated the unadjusted and adjusted risk difference, and the unadjusted and adjusted relative risk. For continuous measures we calculated percentage change from baseline, unadjusted and adjusted. After the selection process had been completed, 33 studies were included. A total of 267 communities were included in the review (populations between 500 and 1.9 million). Of the included studies, 25 were set in high income countries and eight were in low income countries. The interventions varied by the number of strategies included and their intensity. Almost all of the interventions included a component of building partnerships with local governments or non-governmental organisations (NGOs) (29 studies). None of the studies provided results by socio-economic disadvantage or other markers of equity. However, of those included studies undertaken in high income countries, 14 studies were described as being provided to deprived, disadvantaged or low socio-economic communities. Nineteen studies were identified as having a high risk of bias, 10 studies were unclear, and four studies had a low risk of bias. Selection bias was a major concern with these studies, with only five studies using randomisation to allocate communities. Four studies were judged as being at low risk of selection bias although 19 studies were considered to have an unclear risk of bias. Twelve studies had a high risk of detection bias, 13 an unclear risk and four a low risk of bias. Generally, the better designed studies showed no improvement in the primary outcome measure of physical activity at a population level.All four of the newly included, and judged to be at low risk of bias, studies (conducted in Japan, United Kingdom and USA) used randomisation to allocate the intervention to the communities. Three studies used a cluster randomised design and one study used a stepped wedge design. The approach to measuring the primary outcome of physical activity was better in these four studies than in many of the earlier studies. One study obtained objective population representative measurements of physical activity by accelerometers, while the remaining three low-risk studies used validated self-reported measures. The study using accelerometry, conducted in low income, high crime communities of USA, emphasised social marketing, partnership with police and environmental improvements. No change in the seven-day average daily minutes of moderate to vigorous physical activity was observed during the two years of operation. Some program level effect was observed with more people walking in the intervention community, however this result was not evident in the whole community. Similarly, the two studies conducted in the United Kingdom (one in rural villages and the other in urban London; both using communication, partnership and environmental strategies) found no improvement in the mean levels of energy expenditure per person per week, measured from one to four years from baseline. None of the three low risk studies reporting a dichotomous outcome of physical activity found improvements associated with the intervention.Overall, there was a noticeable absence of reporting of benefit in physical activity for community wide interventions in the included studies. However, as a group, the interventions undertaken in China appeared to have the greatest possibility of success with high participation rates reported. Reporting bias was evident with two studies failing to report physical activity measured at follow up. No adverse events were reported.The data pertaining to cost and sustainability of the interventions were limited and varied. Although numerous studies have been undertaken, there is a noticeable inconsistency of the findings in the available studies and this is confounded by serious methodological issues within the included studies. The body of evidence in this review does not support the hypothesis that the multi-component community wide interventions studied effectively increased physical activity for the population, although some studies with environmental components observed more people walking.

[What is the attitude of doctors to the current model of primary care?].

PubMed

Llor Esteban, B; Saturno Hernández, P J; Gascón Canovas, J J; Sáez Navarro, C; Sánchez Ortuño, M

2001-11-30

To determine the attitude of doctors towards the current model of primary care and to calculate its relationship with social and demographic and/or work variables. Multi-centre cross-sectional study. Health centres in Area II of the Murcia region. Participants. All general practitioners, family doctors and paediatricians in the health centres mentioned (54 in all). The "Scale of attitudes towards the contents of primary health care" by Ballesteros et al. was used as the tool of evaluation. This scale provides both a total score and a specific score for each of its 7 dimensions. In general, doctors' attitudes were favourable (4.1 points average out of 5). We found a less favourable attitude in the dimension "Inclusion of second-level professionals in primary care", with family doctors most in agreement. The professionals working in centres on the periphery and those without tenure had a more positive attitude towards the current model, for the remaining variables. Understanding professionals' attitudes and the variables related to them may serve as a basis for designing intervention strategies aimed at improving the quality of primary care and for the positive evolution of professionals working in PC.

Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer-the SiP study protocol.

PubMed

Wells, Mary; King, Emma; Toft, Kate; MacAulay, Fiona; Patterson, Joanne; Dougall, Nadine; Hulbert-Williams, Nick; Boa, Sally; Slaven, Eleanor; Cowie, Julie; McGarva, John; Niblock, Patricia Gail; Philp, Julie; Roe, Justin

2016-01-01

Head and neck cancer (HNC) is the sixth most common cancer worldwide, and the functional, psychological and social consequences of HNC cancer and its treatment can be severe and chronic. Dysphagia (swallowing problems) affects up to two thirds of patients undergoing combined chemoradiotherapy. Recent reviews suggest that prophylactic swallowing exercises may improve a range of short- and long-term outcomes; however, the importance of psychological and behavioural factors on adherence to swallowing exercises has not been adequately studied. This study aims to develop and test the feasibility of a Swallowing intervention Package (SiP) designed in partnership with patients, speech and language therapists (SLTs) and other members of the head and neck multi-disciplinary team (MDT), for patients undergoing chemoradiotherapy (CRT) or radiotherapy (RT) for head and neck cancer. This feasibility study uses quantitative and qualitative research methods, within a quasi-experimental design, to assess whether patients will tolerate and adhere to the SiP intervention, which aspects of the intervention can be implemented and which cannot, whether treatment fidelity can be achieved across different contexts, whether study processes and outcome measures will be feasible and acceptable and to what extent the intervention is likely to have an impact on swallowing dysfunction and quality of life. Patients are being recruited from five sites in Scotland and England (three interventions and two usual care). The SLT based in the relevant intervention centre teaches the exercise programme and provides supporting materials. A combination of patient-reported outcome measures (PROMs), adherence measures and clinical swallowing assessments are used prior to intervention (baseline), at the end of treatment, 3 and 6 months post-treatment. This collaborative study has taken a unique approach to the development of a patient-centred and evidence-based swallowing intervention. The introduction of an e-SiP app provides an exploration of the use of technology in delivering this intervention. The study provides an opportunity to examine the feasibility of delivering and participating in a supported swallowing intervention across several different NHS sites and will provide the evidence needed to refine intervention and study processes for a future trial. NCRI portfolio, 18192 & 20259.

AHEAD. Advate in HaEmophilia A outcome Database.

PubMed

Oldenburg, J; Kurnik, K; Huth-Kühne, A; Zimmermann, R; Abraham, I; Klamroth, R

2010-11-01

The clinical picture of haemophilia A patients is often characterised by recurrent bleedings, in particular joint bleeds. Thus far, long-term data on the outcome of haemophilia A patients are scarce as regards the development of target joints, joint replacement, lost days from school or work due to bleedings, and the quality of life, as most previous studies were limited to the aspects of safety and efficacy. The Baxter-initiated AHEAD (Advate in HaEmophilia A outcome Database) study is a multi-centre, prospective, non-interventional observational study of haemophilia A patients. All patients with a residual FVIII activity of £5% who are being treated with ADVATE are eligible. There are no limitations in terms of patient age or treatment regimen. AHEAD is scientifically supported by a renowned interdisciplinary steering board and is intended to yield data on 500 patients in up to 30 haemophilia centres, collected during a period of four years. The large patient population has been chosen in order to ensure a valid database. The objective of the study is to record haemophilia-related arthropathies, which will be defined based on imaging techniques (e. g. MRI, X-ray, ultrasound) and the judgment of the attending physician. In addition, extensive data will be collected on joint replacement surgeries, pseudotumour development, bleeding-related pain, quality of life (age-related questionnaires: Haem-A-QoL, Haemo-QoL, SF10, SF12v2), risk factors (diabetes mellitus, arterial hypertension, nicotine abuse), blood group, gene mutation, physical activity, and on the efficacy and safety of Advate. The patient data will be entered into an electronic CRF system at the centres. Plausibility checks during data entry, regular monitoring visits, and the option of auditing all serve to ensure a high data quality for AHEAD. The first patient was enrolled in the study in early June 2010; recruitment is planned to continue until the end of 2011. The Ethics Committee of the University of Bonn has given its favorable opinion.

Development, Implementation and Evaluation of an Educational Intervention to Prevent Low Speed Vehicle Run-Over Events: Lessons Learned.

PubMed

Griffin, Bronwyn; Watt, Kerrianne; Kimble, Roy; Shields, Linda

2018-04-05

There is a growing body of literature regarding low speed vehicle runover (LSVRO) events among children. To date, no literature exists on evaluation of interventions to address this serious childhood injury. Knowledge, attitudes, and behaviour regarding LSVROs were assessed via survey at a shopping centre (pre-intervention), then five months later (post-intervention), to investigate the effect of a population level educational intervention in Queensland, Australia. Participants' knowledge regarding frequency of LSVRO events was poor. No participant demonstrated 'adequate behaviour' in relation to four safe driveway behaviours pre-intervention; this increased at post-intervention ( p < 0.05). Most of the sample perceived other's driveway behaviour as inadequate, and this reduced significantly (<0.05). Perceived effectiveness of LSVRO prevention strategies increased from pre- to post-intervention, but not significantly. TV was the greatest source of knowledge regarding LSVROs pre- and post-intervention. This study provides some evidence that the educational campaign and opportunistic media engagement were successful in increasing awareness and improving behaviour regarding LSVROs. While there are several limitations to this study, our experience reflects the 'real-world' challenges associated with implementing prevention strategies. We suggest a multi-faceted approach involving media (including social media), legislative changes, subsidies (for reversing cameras), and education to prevent LSVROs.

MP-AzeFlu provides rapid and effective allergic rhinitis control: results of a non-interventional study in Romania.

PubMed

Agache, I; Doros, I C; Leru, P M; Bucur, I; Poenaru, M; Sarafoleanu, C

2018-03-01

Allergic Rhinitis and its Impact on Asthma (ARIA) and the European Union (EU) recommend a shift to guide allergic rhinitis (AR) treatment decisions from symptom severity to disease control, using a simple visual analogue scale (VAS). Using this VAS we assessed, in a real-life study in Romania, the effectiveness of MP-AzeFlu nasal spray. In this multi-centre, prospective, non-interventional study, 253 patients (over 11 years old) with moderate-to-severe AR were prescribed MP-AzeFlu and assessed their symptoms on a VAS (0 (not at all bothersome) to 100 mm (very bothersome)) on Days 0, 1, 3, 7 and 14. The proportion of patients who achieved a defined VAS score cut-off for well-controlled (38 mm) AR were also calculated. Patients perception of disease control was assessed on Day 3. MP-AzeFlu use was associated with a mean (standard deviation) VAS score reduction from 78.4 (15.1) mm at baseline to 14.7 (15.1) mm on the last day. Effectiveness was consistent irrespective of disease severity, phenotype or patient age. 83.4% of patients achieved the smaller than 39 mm well-controlled VAS score cut-off by last day and 95.2% considered their symptoms to be well- or partly controlled at Day 3. MP-AzeFlu provided rapid, effective and sustained AR symptom control in a real-life setting in Romania, irrespective of severity, phenotype or patient age, aligning with ARIA and EU recommendations and supporting the position of MP-AzeFlu as the drug of choice for the treatment of moderate-to-severe AR.

[Team Development in Medical Rehabilitation: Concept and Evaluation of a Team Intervention].

PubMed

Körner, M; Luzay, L; Becker, S; Rundel, M; Müller, C; Zimmermann, L

2016-04-01

Interprofessional collaboration is a main precondition of successful treatment in rehabilitation. In order to improve interprofessional collaboration, a clinic-specific, goal- and solution-oriented and systemic team development approach was designed. The aim of the study is the evaluation of this approach. A multi-centre cluster-randomized controlled study with staff questionnaires. The team development could be implemented successfully in 4 of 5 clinics and led to significant improvements in team organisation, willingness to accept responsibility and knowledge integration. The effects are small and are caused by the opposed development of intervention and control group. The team development approach can be recommended for rehabilitation practice. A train-the-trainer approach will be developed and further studies are planned in order to disseminate the approach and to investigate the conditions of implementation. © Georg Thieme Verlag KG Stuttgart · New York.

Psoriatic arthritis treatment regimens, therapy duration and reasons for cessation in the biologics era: a multi-centre Australian study.

PubMed

Tymms, Kathleen; Kelly, Ayano; Bird, Paul; Griffiths, Hedley; de Jager, Julien; Littlejohn, Geoff; Louw, Sandra; Roberts, Lynden; Youssef, Peter; Zochling, Jane; Nichols, Dave

2018-02-01

To describe the treatment regimens, duration of therapy and reasons for disease-modifying antirheumatic drug (DMARD) cessation in a large psoriatic arthritis (PsA) cohort. A retrospective non-interventional multi-centre study using Audit4 electronic medical records, with de-identified, routinely collected clinical data from rheumatology practices in the OPAL consortium (Optimising Patient outcomes in Australian rheumatoLogy) during November 2015. Baseline characteristics, type and duration of conventional and biologic DMARDs (cDMARD and bDMARD, respectively), disease activity (Disease Activity Score of 28 joints C-reactive protein [DAS28-CRP]), and reasons for treatment cessation were recorded. A total of 3422 rheumatologist-diagnosed PsA patients were included: 60% female, mean age 54 years and disease duration 10 years. Of patients with treatment recorded (n = 2948), 46% were on cDMARD monotherapy, 19% bDMARD monotherapy, 13% combination bDMARD and cDMARDs, 11% combination cDMARDs and 10% no DMARDs. Of those with DAS28-CRP results (n = 494), the highest mean DAS28-CRP was 3.32 on combination cDMARDs, and the lowest was 2.19 on bDMARD monotherapy. Median duration on cDMARD monotherapy was 33.5 months (n = 2232), on bDMARD monotherapy 110.1 months (n = 751), on combination bDMARD and cDMARDs 68.5 months (n = 559). The most common reasons for cessation of cDMARD monotherapy was adverse reactions (41%), for bDMARD monotherapy lack of efficacy (26%), and for combination bDMARD and cDMARDs treatment completed or no longer required (37%). Most PsA patients were prescribed DMARD therapies with a large proportion receiving cDMARDs. Patients on combination cDMARD therapies had the highest DAS28-CRP results. Adverse reactions were the most common reason for cessation of cDMARD monotherapy, whereas for bDMARD monotherapy it was lack of efficacy. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Mediterranean Diet and Multi-Ingredient-Based Interventions for the Management of Non-Alcoholic Fatty Liver Disease

PubMed Central

Suárez, Manuel; Boqué, Noemí; del Bas, Josep M.; Arola, Lluís; Caimari, Antoni

2017-01-01

Non-alcoholic fatty liver disease (NAFLD) comprises a wide spectrum of hepatic disorders, from simple steatosis to hepatic necro-inflammation leading to non-alcoholic steatohepatitis (NASH). Although the prevalence of these multifactorial pathologies is continuously increasing in the population, there is still not an established methodology for their treatment other than weight loss and a change in lifestyle habits, such as a hypocaloric diet and physical exercise. In this framework, there is increasing evidence that several food bioactives and dietary patterns are effective for reversing and preventing the onset of these pathologies. Some studies have claimed that better responses are obtained when treatments are performed under a multifaceted approach, using different bioactive compounds that act against complementary targets. Thus, in this work, current strategies for treating NAFLD and NASH based on multi-ingredient-based supplements or the Mediterranean diet, a dietary pattern rich in bioactive compounds, are reviewed. Furthermore, the usefulness of omics techniques to design effective multi-ingredient nutritional interventions and to predict and monitor their response against these disorders is also discussed. PMID:28937599

Healthy Start - Départ Santé: A pilot study of a multilevel intervention to increase physical activity, fundamental movement skills and healthy eating in rural childcare centres.

PubMed

Froehlich Chow, Amanda; Leis, Anne; Humbert, Louise; Muhajarine, Nazeem; Engler-Stringer, Rachel

2016-10-20

In order to improve healthy behaviours among rural children in their early years, a physical activity and healthy eating intervention (Healthy Start - Départ Santé) was implemented in rural childcare centres throughout Saskatchewan. The objective of the current study was to evaluate the impact of a multimodal physical activity and healthy eating intervention on educators' provision of opportunities for children to improve their physical activity levels, fundamental movement skills and healthy eating behaviours. Six childcare centres (three Francophone and three Anglophone) located in five different rural and semi-rural communities in Saskatchewan participated in this intervention. A total of 69 children with a mean age of 4 years 9 months, and 19 female early childhood educators. Guided by an ecological framework, we implemented a population health controlled intervention, using a wait list control design (48 weeks delayed intervention), and evaluated its impact in rural childcare centres. Mixed methods were employed to determine the effectiveness of the intervention. Overall, educators felt that the intervention supported the provision of physical activity and healthy eating opportunities for children. Increases in children's physical activity levels were reported following the intervention. The lessons learned in this study can be used to improve the Healthy Start - Départ Santé intervention so that its implementation can be effectively expanded to childcare centres within and outside Saskatchewan, in turn, supporting the healthy development of early years (0-5) children in the province and beyond.

Constraints, synergies and avenues for scaling up breastfeeding, antibiotics for pneumonia and IMCI interventions in the Cusco region, Peru

PubMed Central

Gericke, Christian A

2012-01-01

Objective: The purpose of this qualitative case study was to assess the feasibility of scaling up exclusive breastfeeding for 6 months, antibiotics for pneumonia and integrated management of childhood illness (IMCI) child interventions in three districts of the Cusco region, Peru. Methods: During field visits, constraints, synergies and solutions to the implementation of the selected interventions were collected through observational recording and interviews of mothers, health workers, and health managers/decision makers. Results are presented for each intervention according to the health system level where they occurred: mother/community, health worker, health centre, and political/managerial levels. Findings: This case study demonstrates that it is feasible to scale up exclusive breastfeeding, antibiotics for pneumonia and IMCI interventions in poverty-stricken rural areas of a low-income country. Factors that helped and hindered the implementation were identified for each intervention. Conclusions: The need for a coherent multi-sector approach that includes regulation, implementation and monitoring of health policies and education of all involved stakeholders was apparent. This study also demonstrates that global health interventions need to undergo local adaptation. Identifying local constraints and facilitating factors in a systematic way as proposed in this study is a useful step to increase their effectiveness and reach at the local level and to identify areas for improvement in the original intervention policies. PMID:24358831

Ecological, biological and social dimensions of dengue vector breeding in five urban settings of Latin America: a multi-country study

PubMed Central

2014-01-01

Background Dengue is an increasingly important public health problem in most Latin American countries and more cost-effective ways of reducing dengue vector densities to prevent transmission are in demand by vector control programs. This multi-centre study attempted to identify key factors associated with vector breeding and development as a basis for improving targeted intervention strategies. Methods In each of 5 participant cities in Mexico, Colombia, Ecuador, Brazil and Uruguay, 20 clusters were randomly selected by grid sampling to incorporate 100 contiguous households, non-residential private buildings (businesses) and public spaces. Standardized household surveys, cluster background surveys and entomological surveys specifically targeted to obtain pupal indices for Aedes aegypti, were conducted in the dry and wet seasons. Results The study clusters included mainly urban low-middle class populations with satisfactory infrastructure and –except for Uruguay- favourable climatic conditions for dengue vector development. Household knowledge about dengue and “dengue mosquitoes” was widespread, mainly through mass media, but there was less awareness around interventions to reduce vector densities. Vector production (measured through pupal indices) was favoured when water containers were outdoor, uncovered, unused (even in Colombia and Ecuador where the large tanks used for household water storage and washing were predominantly productive) and –particularly during the dry season- rainwater filled. Larval infestation did not reflect productive container types. All productive container types, including those important in the dry season, were identified by pupal surveys executed during the rainy season. Conclusions A number of findings are relevant for improving vector control: 1) there is a need for complementing larval surveys with occasional pupal surveys (to be conducted during the wet season) for identifying and subsequently targeting productive container types; 2) the need to raise public awareness about useful and effective interventions in productive container types specific to their area; and 3) the motivation for control services that-according to this and similar studies in Asia- dedicated, targeted vector management can make a difference in terms of reducing vector abundance. PMID:24447796

Behavioural intervention to reduce resistance in those attending adult day care centres: PROCENDIAS study protocol for a randomized clinical trial.

PubMed

Rodriguez-Sánchez, Emiliano; Tamayo-Morales, Olaya; González-Sanchez, Jesús; Mora-Simón, Sara; Losada-Baltar, Andrés; Unzueta-Arce, Jaime; Patino-Alonso, María C; De Dios-Rodríguez, Elena; Gómez-Marcos, Manuel A; García-Ortiz, Luis

2018-06-01

This study evaluates the effectiveness of a behavioural intervention programme aimed at reducing the reluctance of dependent people to attend Adult Day Care Centres. We hope that reducing resistance will have a positive influence on the mental health of caregivers. Care centres offer important relief and rest services for family caregivers. Some caregivers report being affected by behavioural and psychological symptoms of dementia when they prepare dependents for the Care Centres, especially when these have dementia. Caregivers often report the need for information about how to manage the behaviour of the sick. Nurses in community healthcare units can investigate cases of patients who present resistance when attending care centres and can promote the use of interventions aimed at reducing this problem. Randomised controlled clinical trial. The reference population will be care centre users in Salamanca (Spain) to select 120 family members responsible for the preparation and transfer of the care-recipient. Each participant will be randomised to an intervention group or control group (standard care). A baseline assessment and 6 months follow-up assessment will be performed (study approved in September 2016). The intervention group will consist of 8 sessions, one per week, each lasting 90 min. Each session will be run by a psychologist trained in behaviour analysis and will be tailored to the specific behavioural problems reported by the caregivers. The results of a previously published pilot study allow us to be optimistic about the possibilities of a brief intervention. © 2018 John Wiley & Sons Ltd.

[Analysis of the refusal of the flu vaccination (REGRIVI study)].

PubMed

Méijome-Blanco, S; González-Cristobo, G; Regueiro-Martínez, A Á

2018-02-10

The objective of this study is to determine the reasons for refusing the flu vaccination in the Primary Care Health Centre of Vilanova de Arousa, Spain, as well as to evaluate the flu vaccination coverage after an educational intervention. A quasi-experimental before and after study was conducted after an educational intervention on a total of 73 people that included those Primary Care Health Centre patients from Vilanova de Arousa who had refused the flu vaccination in 2014, and who did not meet the exclusion criteria (death during 2014 and 2015 campaigns, non-acceptance of participation, vaccine registration mistakes, contraindication or no indication for the vaccine, inability to contact). After a brief educational intervention, vaccination data from those patients in the 2015 and 2016 campaigns were checked. A descriptive analysis of the variables under study was then carried out. Of the 73 patients initially included, 72 completed the study. The main reasons for refusing a vaccination were the concerns about the adverse effects and patient perception of good health. Vaccination coverage was 50.7% in 2015, and 48.6% in 2016. The reasons for refusing vaccination are approachable with a brief intervention since the refusal decreases by half in the long-term. Copyright © 2018 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

Dual-process cognitive interventions to enhance diagnostic reasoning: a systematic review.

PubMed

Lambe, Kathryn Ann; O'Reilly, Gary; Kelly, Brendan D; Curristan, Sarah

2016-10-01

Diagnostic error incurs enormous human and economic costs. The dual-process model reasoning provides a framework for understanding the diagnostic process and attributes certain errors to faulty cognitive shortcuts (heuristics). The literature contains many suggestions to counteract these and to enhance analytical and non-analytical modes of reasoning. To identify, describe and appraise studies that have empirically investigated interventions to enhance analytical and non-analytical reasoning among medical trainees and doctors, and to assess their effectiveness. Systematic searches of five databases were carried out (Medline, PsycInfo, Embase, Education Resource Information Centre (ERIC) and Cochrane Database of Controlled Trials), supplemented with searches of bibliographies and relevant journals. Included studies evaluated an intervention to enhance analytical and/or non-analytical reasoning among medical trainees or doctors. Twenty-eight studies were included under five categories: educational interventions, checklists, cognitive forcing strategies, guided reflection, instructions at test and other interventions. While many of the studies found some effect of interventions, guided reflection interventions emerged as the most consistently successful across five studies, and cognitive forcing strategies improved accuracy and confidence judgements. Significant heterogeneity of measurement approaches was observed, and existing studies are largely limited to early-career doctors. Results to date are promising and this relatively young field is now close to a point where these kinds of cognitive interventions can be recommended to educators. Further research with refined methodology and more diverse samples is required before firm recommendations may be made for medical education and policy; however, these results suggest that such interventions hold promise, with much current enthusiasm for new research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cognition and bimanual performance in children with unilateral cerebral palsy: protocol for a multicentre, cross-sectional study.

PubMed

Hoare, Brian; Ditchfield, Michael; Thorley, Megan; Wallen, Margaret; Bracken, Jenny; Harvey, Adrienne; Elliott, Catherine; Novak, Iona; Crichton, Ali

2018-05-08

Motor outcomes of children with unilateral cerebral palsy are clearly documented and well understood, yet few studies describe the cognitive functioning in this population, and the associations between the two is poorly understood. Using two hands together in daily life involves complex motor and cognitive processes. Impairment in either domain may contribute to difficulties with bimanual performance. Research is yet to derive whether, and how, cognition affects a child's ability to use their two hands to perform bimanual tasks. This study will use a prospective, cross-sectional multi-centre observational design. Children (aged 6-12 years) with unilateral cerebral palsy will be recruited from one of five Australian treatment centres. We will examine associations between cognition, bimanual performance and brain neuropathology (lesion type and severity) in a sample of 131 children. The primary outcomes are: Motor - the Assisting Hand Assessment; Cognitive - Executive Function; and Brain - lesion location on structural MRI. Secondary data collected will include: Motor - Box and Blocks, ABILHAND- Kids, Sword Test; Cognitive - standard neuropsychological measures of intelligence. We will use generalized linear modelling and structural equation modelling techniques to investigate relationships between bimanual performance, executive function and brain lesion location. This large multi-centre study will examine how cognition affects bimanual performance in children with unilateral cerebral palsy. First, it is anticipated that distinct relationships between bimanual performance and cognition (executive function) will be identified. Second, it is anticipated that interrelationships between bimanual performance and cognition will be associated with common underlying neuropathology. Findings have the potential to improve the specificity of existing upper limb interventions by providing more targeted treatments and influence the development of novel methods to improve both cognitive and motor outcomes in children with unilateral cerebral palsy. ACTRN12614000631606 ; Date of retrospective registration 29/05/2014.

QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali.

PubMed

Dumont, Alexandre; Fournier, Pierre; Fraser, William; Haddad, Slim; Traore, Mamadou; Diop, Idrissa; Gueye, Mouhamadou; Gaye, Alioune; Couturier, François; Pasquier, Jean-Charles; Beaudoin, François; Lalonde, André; Hatem, Marie; Abrahamowicz, Michal

2009-09-18

Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been evaluated, in this context, using rigorous methods for analyzing effectiveness in terms of health outcomes. The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1) Educational outreach visits; and 2) the implementation of facility-based maternal death reviews. The unit of intervention is the public health facility equipped with a functional operating room. On the basis of consent provided by hospital authorities, 46 centres out of 49 eligible were selected in Mali and Senegal. Using randomization stratified by country and by level of care, 23 centres will be allocated to the intervention group and 23 to the control group. The intervention will last two years. It will be preceded by a pre-intervention one-year period for baseline data collection. A continuous clinical data collection system has been set up in all participating centres. This, along with the inventory of resources and the satisfaction surveys administered to the health personnel, will allow us to measure results before, during, and after the intervention. The overall rate of maternal mortality measured in hospitals during the post-intervention period (Year 4) is the primary outcome. The evaluation will also include cost-effectiveness.

Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series

PubMed Central

Rimland, Joseph M; Trotta, Fabiana Mirella; Dell'Aquila, Giuseppina; Cruz-Jentoft, Alfonso; Petrovic, Mirko; Gudmundsson, Adalsteinn; Soiza, Roy; O'Mahony, Denis; Guaita, Antonio; Cherubini, Antonio

2017-01-01

Objective To provide an overview of non-pharmacological interventions for behavioural and psychological symptoms in dementia (BPSD). Design Systematic overview of reviews. Data sources PubMed, EMBASE, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO (2009–March 2015). Eligibility criteria Systematic reviews (SRs) that included at least one comparative study evaluating any non-pharmacological intervention, to treat BPSD. Data extraction Eligible studies were selected and data extracted independently by 2 reviewers. The AMSTAR checklist was used to assess the quality of the SRs. Data analysis Extracted data were synthesised using a narrative approach. Results 38 SRs and 142 primary studies were identified, comprising the following categories of non-pharmacological interventions: (1) sensory stimulation interventions (12 SRs, 27 primary studies) that encompassed: acupressure, aromatherapy, massage/touch therapy, light therapy and sensory garden; (2) cognitive/emotion-oriented interventions (33 SRs; 70 primary studies) that included cognitive stimulation, music/dance therapy, dance therapy, snoezelen, transcutaneous electrical nerve stimulation, reminiscence therapy, validation therapy, simulated presence therapy; (3) behaviour management techniques (6 SRs; 32 primary studies) and (4) other therapies (5 SRs, 12 primary studies) comprising exercise therapy, animal-assisted therapy, special care unit and dining room environment-based interventions. Music therapy was effective in reducing agitation (SMD, −0.49; 95% CI −0.82 to −0.17; p=0.003), and anxiety (SMD, −0.64; 95% CI −1.05 to −0.24; p=0.002). Home-based behavioural management techniques, caregiver-based interventions or staff training in communication skills, person-centred care or dementia care mapping with supervision during implementation were found to be effective for symptomatic and severe agitation. Conclusions A large number of non-pharmacological interventions for BPSD were identified. The majority of the studies had great variation in how the same type of intervention was defined and applied, the follow-up duration, the type of outcome measured, usually with modest sample size. Overall, music therapy and behavioural management techniques were effective for reducing BPSD. PMID:28302633

Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial.

PubMed

van Bloemendaal, Maijke; Bus, Sicco A; de Boer, Charlotte E; Nollet, Frans; Geurts, Alexander C H; Beelen, Anita

2016-10-01

Many stroke survivors suffer from paresis of lower limb muscles, resulting in compensatory gait patterns characterised by asymmetries in spatial and temporal parameters and reduced walking capacity. Functional electrical stimulation has been used to improve walking capacity, but evidence is mostly limited to the orthotic effects of peroneal functional electrical stimulation in the chronic phase after stroke. The aim of this study is to investigate the therapeutic effects of up to 10 weeks of multi-channel functional electrical stimulation (MFES)-assisted gait training on the restoration of spatiotemporal gait symmetry and walking capacity in subacute stroke patients. In a proof-of-principle study with a randomised controlled design, 40 adult patients with walking deficits who are admitted for inpatient rehabilitation within 31 days since the onset of stroke are randomised to either MFES-assisted gait training or conventional gait training. Gait training is delivered in 30-minute sessions each workday for up to 10 weeks. The step length symmetry ratio is the primary outcome. Blinded assessors conduct outcome assessments at baseline, every 2 weeks during the intervention period, immediately post intervention and at 3-month follow-up. This study aims to provide preliminary evidence for the feasibility and effectiveness of MFES-assisted gait rehabilitation early after stroke. Results will inform the design of a larger multi-centre trial. This trial is registered at the Netherlands Trial Register (number NTR4762 , registered 28 August 2014).

A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.

PubMed

Bowrey, David J; Baker, Melanie; Halliday, Vanessa; Thomas, Anne L; Pulikottil-Jacob, Ruth; Smith, Karen; Morris, Tom; Ring, Arne

2015-11-21

Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients. Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences. Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking part, and 3) uncertainty of the study process. This study demonstrated that home enteral feeding by jejunostomy was feasible, safe and acceptable to patients and their carers. Whether home enteral feeding as 'usual practice' is a cost-effective therapy would require confirmation in an appropriately powered, multi-centre study. UK Clinical Research Network ID 12447 (main trial, first registered 30 May 2012); UK Clinical Research Network ID 13361 (qualitative substudy, first registered 30 May 2012); ClinicalTrials.gov NCT01870817 (first registered 28 May 2013).

Implementing primary health care-based PMTCT interventions: operational perspectives from Muhima cohort analysis (Rwanda)

PubMed Central

Bucagu, Maurice; Muganda, John

2014-01-01

Introduction In countries with high burden of HIV, major programmatic challenges have been identified to preventing new infections among children and scaling up of treatment for pregnant mothers. We initiated this study to examine operational approaches that were used to enhance implementation of PMTCT interventions in Muhima health Centre (Kigali/Rwanda) from 2007 to 2010. Methods The prospective cohort study was conducted at Muhima health centre. A sample size of 656 was the minimum number required for the study. The main outcome was cumulative incidence of mother - to - child transmission of HIV-1 measured at 6 weeks of life among live born children. Results Among the 679 live born babies and followed up in this study, the overall cumulative rate of HIV-1 mother - to - child transmission observed was 3.2% at 6 weeks of age after birth. Disclosure of HIV status to partner was significantly associated with HIV-1 status of infants at 6 weeks of age (non-disclosure of HIV status adjusted odds ratio [AOR] 4.68, CI 1.39 to 15.77, p. Conclusion The Muhima type of decentralized health facility offered an appropriate platform for implementation of PMTCT interventions, with the following operational features: family - centered approach; integrated service delivery for PMTCT/MCH interventions, task shifting; subsidized membership fees for people living with HIV, allowing for access to the community-based health insurance benefits. PMID:26113893

Community interventions for preventing smoking in young people.

PubMed

Sowden, A; Arblaster, L

2000-01-01

Decisions to smoke are made within a broad social context. Community interventions use co-ordinated, widespread, multi-component programmes to try and influence behaviour. To determine the effectiveness of community interventions in preventing the uptake of smoking in young people. The Tobacco Addiction group specialised register, Medline and 21 other health, psychology and public policy electronic databases were searched, the bibliographies of identified studies were checked and contact was made with content area specialists. Randomised and non randomised controlled trials that assessed the effectiveness of multi-component community interventions compared to no intervention or to single component or school-based programmes only. Reported outcomes had to include smoking behaviour in young people under the age of 25 years. Information relating to the characteristics and the content of community interventions, participants, outcomes and methods of the study was extracted by one reviewer and checked by a second. Studies were combined using qualitative narrative synthesis. Thirteen studies were included in the review, 44 studies did not meet all of the inclusion criteria. All studies used a controlled trial design, with four using random allocation of schools or communities. Of nine studies which compared community interventions to no intervention controls, two, which were part of cardiovascular disease prevention programmes, reported lower smoking prevalence. Of three studies comparing community interventions to school-based programmes only, one found differences in reported smoking prevalence. One study reported a lower rate of increase in prevalence in a community receiving a multi-component intervention compared to a community exposed to a mass media campaign alone. One study reported a significant difference in smoking prevalence between a group receiving a media, school and homework intervention compared to a group receiving the media component only There is some limited support for the effectiveness of community interventions in helping prevent the uptake of smoking in young people.

Community interventions for preventing smoking in young people.

PubMed

Sowden, A; Arblaster, L; Stead, L

2003-01-01

Decisions to smoke are made within a broad social context. Community interventions use co-ordinated, widespread, multi-component programmes to try and influence behaviour. To determine the effectiveness of community interventions in preventing the uptake of smoking in young people. The Tobacco Addiction group specialised register, Medline and other health, psychology and public policy electronic databases were searched, the bibliographies of identified studies were checked and contact was made with content area specialists. Searches were updated in September 2002. Randomised and non randomised controlled trials that assessed the effectiveness of multi-component community interventions compared to no intervention or to single component or school-based programmes only. Reported outcomes had to include smoking behaviour in young people under the age of 25 years. Information relating to the characteristics and the content of community interventions, participants, outcomes and methods of the study was extracted by one reviewer and checked by a second. Studies were combined using qualitative narrative synthesis. Seventeen studies were included in the review, 46 studies did not meet all of the inclusion criteria. All studies used a controlled trial design, with six using random allocation of schools or communities. Of thirteen studies which compared community interventions to no intervention controls, two, which were part of cardiovascular disease prevention programmes, reported lower smoking prevalence. Of three studies comparing community interventions to school-based programmes only, one found differences in reported smoking prevalence. One study reported a lower rate of increase in prevalence in a community receiving a multi-component intervention compared to a community exposed to a mass media campaign alone. One study reported a significant difference in smoking prevalence between a group receiving a media, school and homework intervention compared to a group receiving the media component only. There is some limited support for the effectiveness of community interventions in helping prevent the uptake of smoking in young people.

Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT. PMID:22998983

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

PubMed Central

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence.

PubMed

Müller, Ueli C; Asherson, Philip; Banaschewski, Tobias; Buitelaar, Jan K; Ebstein, Richard P; Eisenberg, Jaques; Gill, Michael; Manor, Iris; Miranda, Ana; Oades, Robert D; Roeyers, Herbert; Rothenberger, Aribert; Sergeant, Joseph A; Sonuga-Barke, Edmund Js; Thompson, Margaret; Faraone, Stephen V; Steinhausen, Hans-Christoph

2011-04-07

The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling), informant, and centres on sample homogeneity in psychopathological measures. Conners' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are used. These possible sources of variance should be counteracted in genetic analyses either by using age and gender adjusted diagnostic procedures and regional normative data or by adjusting for design artefacts by use of covariate statistics, by eliminating outliers, or by other methods suitable for reducing heterogeneity.

Accounting for the cost of scaling-up health interventions.

PubMed

Johns, Benjamin; Baltussen, Rob

2004-11-01

Recent studies such as the Commission on Macroeconomics and Health have highlighted the need for expanding the coverage of services for HIV/AIDS, malaria, tuberculosis, immunisations and other diseases. In order for policy makers to plan for these changes, they need to analyse the change in costs when interventions are 'scaled-up' to cover greater percentages of the population. Previous studies suggest that applying current unit costs to an entire population can misconstrue the true costs of an intervention. This study presents the methodology used in WHO-CHOICE's generalised cost effectiveness analysis, which includes non-linear cost functions for health centres, transportation and supervision costs, as well as the presence of fixed costs of establishing a health infrastructure. Results show changing marginal costs as predicted by economic theory. 2004 John Wiley & Sons, Ltd.

A guide to multi-centre ethics for surgical research in Australia and New Zealand.

PubMed

Boult, Maggi; Fitzpatrick, Kate; Maddern, Guy; Fitridge, Robert

2011-03-01

This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial. The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial. Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules. Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol

PubMed Central

Coulton, Simon; Perryman, Katherine; Bland, Martin; Cassidy, Paul; Crawford, Mike; Deluca, Paolo; Drummond, Colin; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; Kaner, Eileen; Myles, Judy; Newbury-Birch, Dorothy; Oyefeso, Adenekan; Parrott, Steve; Phillips, Tom; Shenker, Don; Shepherd, Jonathan

2009-01-01

Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption on the physical, psychological and social health of the population. There also exists a substantial evidence base for the efficacy of brief interventions aimed at reducing alcohol consumption across a range of healthcare settings. Primary research conducted in emergency departments has reinforced the current evidence regarding the potential effectiveness and cost-effectiveness. Within this body of evidence there is marked variation in the intensity of brief intervention delivered, from very minimal interventions to more intensive behavioural or lifestyle counselling approaches. Further the majority of primary research has been conducted in single centre and there is little evidence of the wider issues of generalisability and implementation of brief interventions across emergency departments. Methods/design The study design is a prospective pragmatic factorial cluster randomised controlled trial. Individual Emergency Departments (ED) (n = 9) are randomised with equal probability to a combination of screening tool (M-SASQ vs FAST vs SIPS-PAT) and an intervention (Minimal intervention vs Brief advice vs Brief lifestyle counselling). The primary hypothesis is that brief lifestyle counselling delivered by an Alcohol Health Worker (AHW) is more effective than Brief Advice or a minimal intervention delivered by ED staff. Secondary hypotheses address whether short screening instruments are more acceptable and as efficient as longer screening instruments and the cost-effectiveness of screening and brief interventions in ED. Individual participants will be followed up at 6 and 12 months after consent. The primary outcome measure is performance using a gold-standard screening test (AUDIT). Secondary outcomes include; quantity and frequency of alcohol consumed, alcohol-related problems, motivation to change, health related quality of life and service utilisation. Discussion This paper presents a protocol for a large multi-centre pragmatic factorial cluster randomised trial to evaluate the effectiveness and cost-effectiveness of screening and brief interventions for hazardous alcohol users attending emergency departments. Trial Registration ISRCTN 93681536 PMID:19575791

Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial

PubMed Central

Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

2017-01-01

Background Many developed countries have high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children’s services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. Methods We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children’s centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children’s centre. Results 1112 parents at 36 children’s centres participated. There was no significant effect of the intervention on families’ possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in the intervention arms reported more behaviours for escaping from house fires (AOR IPB only vs. usual care: 2.56, 95%CI 01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95%CI 1.01, 3.15). Conclusion Our study demonstrated that children’s centres can deliver an injury prevention intervention to families in disadvantaged communities and achieve changes in home safety behaviours. PMID:28339460

Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

PubMed

Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

2017-01-01

Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre. 1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in the intervention arms reported more behaviours for escaping from house fires (AOR IPB only vs. usual care: 2.56, 95%CI 01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95%CI 1.01, 3.15). Our study demonstrated that children's centres can deliver an injury prevention intervention to families in disadvantaged communities and achieve changes in home safety behaviours.

Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

PubMed

Radford, Kathryn A; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O'Connor, Rory; Forshaw, Denise; Shakespeare, David

2015-01-01

Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a larger trial. To our knowledge, this is the first feasibility randomised controlled trial of a vocational rehabilitation health intervention specific to traumatic brain injury. The results will inform the design of a definitive trial. The trial is registered ISRCTN Number 38581822.

The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

PubMed Central

2011-01-01

Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit/hyperactivity disorder (ADHD-CT) and 1446 'unselected' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive/impulsive symptoms. Conclusions Despite a symptom-based standardized inclusion procedure according to DSM-IV criteria with defined symptom thresholds, centres may differ markedly in probands' ADHD symptom frequencies. Both the diagnostic procedure and the multi-centre design influence the behavioural characteristics of a sample and, thus, may bias statistical analyses, particularly in genetic or neurobehavioral studies. PMID:21473745

Effectiveness of Nutrition Education vs. Non-Nutrition Education Intervention in Improving Awareness Pertaining Iron Deficiency among Anemic Adolescents.

PubMed

Yusoff, Hafzan; Wan Daud, Wan Nudri; Ahmad, Zulkifli

2013-01-01

This study was carried out to compare the effect between nutrition education intervention and non-nutrition education intervention on awareness regarding iron deficiency among schooling adolescents in Tanah Merah, one of rural district in Kelantan, Malaysia. This study which was started in year 2010 involved 280 respondents (223 girls, 57 boys, age: 16 yr) from schools in Tanah Merah. The selection criteria were based on hemoglobin level (Hb = 7 - 11.9 g/dL for girls; Hb = 7 - 12.9 g/dL for boys). They were divided into 2 groups. The first group received nutrition education package (Nutrition education, NE), whereas another group was entitled to receive non-nutrition education intervention (Non-Nutrition Education, NNE) (supplement only). Both interventions were implemented for 3 months. The changes in awareness among respondents of both groups were evaluated using multi-choices questionnaire. Nutrition education receiver group (NE) demonstrated improvement in awareness at post-intervention. No substantial improvement was demonstrated by the counterpart group (NNE). Multimedia nutrition education program conducted at school setting was in fact practical and effective in improving awareness on iron deficiency among anemic adolescents.

Protocol of a mixed method, randomized controlled study to assess the efficacy of a psychosocial intervention to reduce fatigue in patients with End-Stage Renal Disease (ESRD).

PubMed

van der Borg, Wieke E; Schipper, Karen; Abma, Tineke A

2016-07-08

Patients with end-stage renal disease (ESRD) commonly suffer from severe fatigue, which strongly impacts their quality of life (QoL). Although fatigue is often attributed to disease- and treatment characteristics, research also shows that behavioural, psychological and social factors affect perceived fatigue in dialysis patients. Whereas studies on fatigue in other chronic patient groups suggest that psychological or psychosocial interventions are effective in reducing fatigue, such interventions are not yet available for ESRD patients on dialysis treatment. The objective of this study is to examine the efficacy of a psychosocial intervention for dialysis patients aimed at reducing fatigue (primary outcome) and improving QoL (secondary outcome). The intervention consists of counselling sessions led by a social worker. The implementation process and patients' and social workers' expectations and experiences with the intervention will also be evaluated. This study follows a mixed-methods design in which both quantitative and qualitative data will be collected. A multi-centre, randomised controlled trial (RCT) with repeated measures will be conducted to quantitatively assess the efficacy of the psychosocial intervention in reducing fatigue and improving QoL in ESRD patients. Additional secondary outcomes and medical parameters will be assessed. Outcomes will be compared to patients receiving usual care. A sample of 74 severely fatigued dialysis patients will be recruited from 10 dialysis centres. Patients will be randomly assigned to the intervention or control group. Outcomes will be assessed at baseline, post intervention/16 weeks, and at three and six-month follow-ups. A qualitative process evaluation will be conducted parallel to/following the effectiveness RCT. Interviews and focus groups will be conducted to gain insight into patients' and social workers' perspectives on outcomes and implementation procedures. Implementation fidelity will be assessed by audio-taped and written registrations. Participatory methods ensure the continuous input of experiential knowledge, improving the quality of study procedures and the applicability of outcomes. This is the first mixed method study (including an RCT and qualitative process evaluation) to examine the effect and implementation process of a psychosocial intervention on reducing fatigue and improving QoL in ESRD patients on dialysis treatment. NTR5366 , The Netherlands National Trial Register (NTR), registered August 26, 2015.

Methods for a longitudinal quantitative outcome with a multivariate Gaussian distribution multi-dimensionally censored by therapeutic intervention.

PubMed

Sun, Wanjie; Larsen, Michael D; Lachin, John M

2014-04-15

In longitudinal studies, a quantitative outcome (such as blood pressure) may be altered during follow-up by the administration of a non-randomized, non-trial intervention (such as anti-hypertensive medication) that may seriously bias the study results. Current methods mainly address this issue for cross-sectional studies. For longitudinal data, the current methods are either restricted to a specific longitudinal data structure or are valid only under special circumstances. We propose two new methods for estimation of covariate effects on the underlying (untreated) general longitudinal outcomes: a single imputation method employing a modified expectation-maximization (EM)-type algorithm and a multiple imputation (MI) method utilizing a modified Monte Carlo EM-MI algorithm. Each method can be implemented as one-step, two-step, and full-iteration algorithms. They combine the advantages of the current statistical methods while reducing their restrictive assumptions and generalizing them to realistic scenarios. The proposed methods replace intractable numerical integration of a multi-dimensionally censored MVN posterior distribution with a simplified, sufficiently accurate approximation. It is particularly attractive when outcomes reach a plateau after intervention due to various reasons. Methods are studied via simulation and applied to data from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study of treatment for type 1 diabetes. Methods proved to be robust to high dimensions, large amounts of censored data, low within-subject correlation, and when subjects receive non-trial intervention to treat the underlying condition only (with high Y), or for treatment in the majority of subjects (with high Y) in combination with prevention for a small fraction of subjects (with normal Y). Copyright © 2013 John Wiley & Sons, Ltd.

Improving access to interventions among mothers screened positive for post-partum depression (PPD) at National Programme on Immunization (NPI) clinics in south-western and south-eastern Nigeria - A service development report.

PubMed

Bakare, Muideen O; Bello-Mojeed, Mashudat A; Munir, Kerim M; Duduyemi, Olaniyi O; Orovwigho, Andrew O; Odetunde, Odutola I; Taiwo, Olufemi G; Olofinlade, Jushua A; Omotoso, Olakunle N; Famurewa, Olayinka H; Omolabi, Oladipupo O; Jejeloye, Adebayo O

2017-01-01

We investigate the possibility of improving access to interventions among mothers screened positive for post-partum depression (PPD) at National Programme on Immunization (NPI) clinics randomly selected from Lagos and Enugu States in south-western and south-eastern Nigeria respectively. The principle of human centred design was employed by engaging the mothers screened positive for PPD to be part of the decision making regarding their further assessment and intervention services. The study brought intervention services to primary healthcare centre at the NPI clinics. Improvement in willingness to seek interventions was observed among the mothers screened positive for PPD in this study when compared to our observation in a previous report, where mothers diagnosed with PPD were referred and requested to visit a mental health facility closer to their NPI clinics for further assessment and interventions (95.2% versus 33.7%). Interventional services for the mothers diagnosed with PPD also impact positively on the growth parameters of their infants on follow-up. Principle of human centred design improved access to intervention services among the mothers and infants studied. NPI clinics at primary healthcare level would provide appropriate forum for early screening of mothers for PPD and interventions in low-resource setting like Nigeria. There would be improvement in maternal and child health coverage if the Nigerian Government can adapt human centred design principles employed in this study nationwide.

Implementing an Injury Prevention Briefing to aid delivery of key fire safety messages in UK children's centres: qualitative study nested within a multi-centre randomised controlled trial.

PubMed

Beckett, Kate; Goodenough, Trudy; Deave, Toity; Jaeckle, Sally; McDaid, Lisa; Benford, Penny; Hayes, Mike; Towner, Elizabeth; Kendrick, Denise

2014-12-10

To improve the translation of public health evidence into practice, there is a need to increase practitioner involvement in initiative development, to place greater emphasis on contextual knowledge, and to address intervention processes and outcomes. Evidence that demonstrates the need to reduce childhood fire-related injuries is compelling but its translation into practice is inconsistent and limited. With this knowledge the Keeping Children Safe programme developed an "Injury Prevention Briefing (IPB)" using a 7 step process to combine scientific evidence with practitioner contextual knowledge. The IPB was designed specifically for children's centres (CCs) to support delivery of key fire safety messages to parents. This paper reports the findings of a nested qualitative study within a clustered randomised controlled trial of the IPB, in which staff described their experiences of IPB implementation to aid understanding of why or how the intervention worked. Interviews were conducted with key staff at 24 CCs participating in the two intervention arms: 1) IPB supplemented by initial training and regular facilitation; 2) IPB sent by post with no facilitation. Framework Analysis was applied to these interview data to explore intervention adherence including; exposure or dose; quality of delivery; participant responsiveness; programme differentiation; and staff experience of IPB implementation. This included barriers, facilitators and suggested improvements. 83% of CCs regarded the IPB as a simple, accessible tool which raised awareness, and stimulated discussion and behaviour change. 15 CCs suggested minor modifications to format and content. Four levels of implementation were identified according to content, frequency, duration and coverage. Most CCs (75%) achieved 'extended' or 'essential' IPB implementation. Three universal factors affected all CCs: organisational change and resourcing; working with hard to engage groups; additional demands of participating in a research study. Six specific factors were associated with the implementation level achieved: staff engagement and training; staff continuity; adaptability and flexibility; other agency support; conflicting priorities; facilitation. CCs achieving high implementation levels increased from 58% (no facilitation) to 92% with facilitation. Incorporating service provider perspectives and scientific evidence into health education initiatives enhances potential for successful implementation, particularly when supplemented by ongoing training and facilitation.

Diagnosis of neglected tropical diseases among patients with persistent digestive disorders (diarrhoea and/or abdominal pain ≥14 days): Pierrea multi-country, prospective, non-experimental case-control study.

PubMed

Polman, Katja; Becker, Sören L; Alirol, Emilie; Bhatta, Nisha K; Bhattarai, Narayan R; Bottieau, Emmanuel; Bratschi, Martin W; Burza, Sakib; Coulibaly, Jean T; Doumbia, Mama N; Horié, Ninon S; Jacobs, Jan; Khanal, Basudha; Landouré, Aly; Mahendradhata, Yodi; Meheus, Filip; Mertens, Pascal; Meyanti, Fransiska; Murhandarwati, Elsa H; N'Goran, Eliézer K; Peeling, Rosanna W; Ravinetto, Raffaella; Rijal, Suman; Sacko, Moussa; Saye, Rénion; Schneeberger, Pierre H H; Schurmans, Céline; Silué, Kigbafori D; Thobari, Jarir A; Traoré, Mamadou S; van Lieshout, Lisette; van Loen, Harry; Verdonck, Kristien; von Müller, Lutz; Yansouni, Cédric P; Yao, Joel A; Yao, Patrick K; Yap, Peiling; Boelaert, Marleen; Chappuis, François; Utzinger, Jürg

2015-08-18

Diarrhoea still accounts for considerable mortality and morbidity worldwide. The highest burden is concentrated in tropical areas where populations lack access to clean water, adequate sanitation and hygiene. In contrast to acute diarrhoea (<14 days), the spectrum of pathogens that may give rise to persistent diarrhoea (≥14 days) and persistent abdominal pain is poorly understood. It is conceivable that pathogens causing neglected tropical diseases play a major role, but few studies investigated this issue. Clinical management and diagnostic work-up of persistent digestive disorders in the tropics therefore remain inadequate. Hence, important aspects regarding the pathogenesis, epidemiology, clinical symptomatology and treatment options for patients presenting with persistent diarrhoea and persistent abdominal pain should be investigated in multi-centric clinical studies. This multi-country, prospective, non-experimental case-control study will assess persistent diarrhoea (≥14 days; in individuals aged ≥1 year) and persistent abdominal pain (≥14 days; in children/adolescents aged 1-18 years) in up to 2000 symptomatic patients and 2000 matched controls. Subjects from Côte d'Ivoire, Indonesia, Mali and Nepal will be clinically examined and interviewed using a detailed case report form. Additionally, each participant will provide a stool sample that will be examined using a suite of diagnostic methods (i.e., microscopic techniques, rapid diagnostic tests, stool culture and polymerase chain reaction) for the presence of bacterial and parasitic pathogens. Treatment will be offered to all infected participants and the clinical treatment response will be recorded. Data obtained will be utilised to develop patient-centred clinical algorithms that will be validated in primary health care centres in the four study countries in subsequent studies. Our research will deepen the understanding of the importance of persistent diarrhoea and related digestive disorders in the tropics. A diversity of intestinal pathogens will be assessed for potential associations with persistent diarrhoea and persistent abdominal pain. Different diagnostic methods will be compared, clinical symptoms investigated and diagnosis-treatment algorithms developed for validation in selected primary health care centres. The findings from this study will improve differential diagnosis and evidence-based clinical management of digestive syndromes in the tropics. ClinicalTrials.gov; identifier: NCT02105714 .

WebBioBank: a new platform for integrating clinical forms and shared neurosignal analyses to support multi-centre studies in Parkinson's Disease.

PubMed

Rossi, Elena; Rosa, Manuela; Rossi, Lorenzo; Priori, Alberto; Marceglia, Sara

2014-12-01

The web-based systems available for multi-centre clinical trials do not combine clinical data collection (Electronic Health Records, EHRs) with signal processing storage and analysis tools. However, in pathophysiological research, the correlation between clinical data and signals is crucial for uncovering the underlying neurophysiological mechanisms. A specific example is the investigation of the mechanisms of action for Deep Brain Stimulation (DBS) used for Parkinson's Disease (PD); the neurosignals recorded from the DBS target structure and clinical data must be investigated. The aim of this study is the development and testing of a new system dedicated to a multi-centre study of Parkinson's Disease that integrates biosignal analysis tools and data collection in a shared and secure environment. We designed a web-based platform (WebBioBank) for managing the clinical data and biosignals of PD patients treated with DBS in different clinical research centres. Homogeneous data collection was ensured in the different centres (Operative Units, OUs). The anonymity of the data was preserved using unique identifiers associated with patients (ID BAC). The patients' personal details and their equivalent ID BACs were archived inside the corresponding OU and were not uploaded on the web-based platform; data sharing occurred using the ID BACs. The system allowed researchers to upload different signal processing functions (in a .dll extension) onto the web-based platform and to combine them to define dedicated algorithms. Four clinical research centres used WebBioBank for 1year. The clinical data from 58 patients treated using DBS were managed, and 186 biosignals were uploaded and classified into 4 categories based on the treatment (pharmacological and/or electrical). The user's satisfaction mean score exceeded the satisfaction threshold. WebBioBank enabled anonymous data sharing for a clinical study conducted at multiple centres and demonstrated the capabilities of the signal processing chain configuration as well as its effectiveness and efficiency for integrating the neurophysiological results with clinical data in multi-centre studies, which will allow the future collection of homogeneous data in large cohorts of patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Adoption of workplaces and reach of employees for a multi-faceted intervention targeting low back pain among nurses’ aides

PubMed Central

2014-01-01

Background Workplace adoption and reach of health promotion are important, but generally poorly reported. The aim of this study is therefore to evaluate the adoption of workplaces (organizational level) and reach of employees (individual level) of a multi-faceted workplace health promotion and work environment intervention targeting low back pain among nurses’ aides in elderly care. Methods Percentage of adopters was calculated among eligible workplaces and differences between adopters and non-adopters were evaluated through workplace registrations and manager questionnaires from all eligible workplaces. From the adopted workplaces reach was calculated among eligible employees as the percentage who responded on a questionnaire. Responders were compared with non-responders using data from company registrations. Among responders, comparisons based on questionnaire data were performed between those consenting to participate in the intervention (consenters) and those not consenting to participate in the intervention (non-consenters). Comparisons were done using Student's t-test for the continuous variables, Fisher's exact test for dichotomous variables and the Pearson’s chi2 for categorical variables. Moreover odds ratios for non-responding and non-consenting were investigated with binary logistic regression analyses. Results The project was adopted by 44% of the offered workplaces. The main differences between adopters and non-adopters were that workplaces adopting the intervention had a more stable organization as well as a management with positive beliefs of the intervention’s potential benefits. Of eligible employees, 71% responded on the questionnaire and 57% consented to participate. Non-responders and non-consenters did not differ from the responders and consenters on demographic factors and health. However, more non-responders and non-consenters were low skilled, worked less than 30 hours pr. week, and worked evening and nightshift compared to responders and consenters, respectively. Consenters had more musculoskeletal pain and reduced self-rated health, as well as higher physical exertion during work compared to non-consenters. Conclusions Our recruitment effort yielded a population of consenters that was representative of the target population of nurses’ aides with respect to demographic factors, and health. Moreover more consenters had problems like pain and high physical exertion during work, which fitted the scope of the intervention. Trial registration The study is registered as ISRCTN78113519. PMID:24885476

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

Malaria epidemiology in Lihir Island, Papua New Guinea.

PubMed

Mitjà, Oriol; Paru, Raymond; Selve, Billy; Betuela, Inoni; Siba, Peter; De Lazzari, Elisa; Bassat, Quique

2013-03-15

Plasmodium vivax and Plasmodium falciparum malaria remain highly endemic in the Pacific Islands including Lihir Island, Papua New Guinea. Lihir Gold Limited is conducting mining activities and funded an integrated vector control intervention within the villages surrounding the mine. The aim of this study was to assess the impact of such programme by comparing the epidemiological trends of malaria in different parts of the island. Two cross-sectional surveys were conducted before and after the intervention (2006-2010) to determine malaria prevalence in mine-impact (MI) and non-MI areas. Incidence of malaria was estimated for the Lihir Medical Centre catchment area using island population denominators and a health-centre passive case detection ongoing from 2006-2011. A total of 2,264 and 1,653 children < 15 were surveyed in the cross-sectional studies. The prevalence of any malaria parasitaemia initially was 31.5% in MI areas and, 34.9% in non-MI (POR 1.17; 95 CI 0.97 - 1.39). After four years there was a significant reduction in prevalence in the MI areas (5.8%; POR 0.13, 95 CI 0.09-0.20), but reduction was less marked in non-MI areas (26.9%; POR 0.69, 95 CI 0.58-0.81).28,747 patients were included in the evaluation of incidence trends and overall malaria in local Lihirian population in MI areas declined over time, while it remained at similar high levels among migrants. The age-incidence analysis showed that for each higher age range the malaria incidence declines compared to that of the previous stratum. There was a substantial reduction in prevalence and incidence rates of both P. vivax and P. falciparum in the mining area following implementation of a malaria control intervention, which was not seen in the area outside the mining activities.

Does cataract surgery alleviate poverty? Evidence from a multi-centre intervention study conducted in Kenya, the Philippines and Bangladesh.

PubMed

Kuper, Hannah; Polack, Sarah; Mathenge, Wanjiku; Eusebio, Cristina; Wadud, Zakia; Rashid, Mamunur; Foster, Allen

2010-11-09

Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh). Poverty data (household per capita expenditure--PCE, asset ownership and self-rated wealth) were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye) and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls), of which 263 cases had undergone cataract surgery ("operated cases"). At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007), assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68). There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate poverty and achieve the Millennium Development Goals.

[Health education in schools for adults: by a teacher or health education lecture?].

PubMed

Tormo Molina, J; Rodríguez Fernández, M J; Hernán García, M; Fernández Ajuria, A; García-Marcos, A

2000-03-15

To compare the results of two ways of teaching the rational use of medicines to students of centres of permanent education of adults (CPEA): one taught by the normal teachers (after training by health personnel) and one through a lecture given by the health staff. Intervention study without randomised distribution and with a control group. Five CPEA in an urban centre. 385 students and 15 CPEA teachers. Three groups: a) "teachers" group: consisting of students who received education on medicines in the class-room through their teachers, who had been previously trained by health personnel; b) "lecture" group: students who had received a health education lecture on medicines given by health staff; c) non-intervention group. All three groups were administered a questionnaire before and after the intervention. Both questionnaires were paired. 248 people completed the first questionnaire and 149 the second. Significant gains in knowledge were only found in the teachers intervention group (p < 0.01; 7.8% increase in score). Dividing the students into terciles made these gains significantly greater (11.7%) in the students of the teachers group who in the first questionnaire had intermediate scores than in the students in the other groups who had intermediate scores. Intervention with teachers seems more effective than either a health education lecture or no intervention, especially in the improvement in knowledge of students who already had beforehand intermediate knowledge.

Effects of person-centred care on health outcomes-A randomized controlled trial in patients with acute coronary syndrome.

PubMed

Pirhonen, Laura; Olofsson, Elisabeth Hansson; Fors, Andreas; Ekman, Inger; Bolin, Kristian

2017-02-01

To study the effects of person-centred care provided to patients with acute coronary syndrome, using four different health-related outcome measures. Also, to examine the performance of these outcomes when measuring person-centred care. The data used in this study consists of primary data from a multicentre randomized parallel group, controlled intervention study for patients with acute coronary syndrome at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention and control group consisted of 94 and 105 patients, respectively. The effect of the intervention on health-related outcomes was estimated, controlling for socio-economic and disease-related variables. Patients in the intervention group reported significantly higher general self-efficacy than those in the control group six months after intervention start-up. Moreover, the intervention group returned to work in a greater extent than controls; their physical activity level had increased more and they had a higher EQ-5D score, meaning higher health-related quality of life. These latter effects are not significant but are all pointing towards the beneficial effects of person-centred care. All the effects were estimated while controlling for important socio-economic and disease-related variables. The effectiveness of person-centred care varies between different outcomes considered. A statistically significant beneficial effect was found for one of the four outcome measures (self-efficacy). The other measures all captured beneficial, but not significant, effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Short term (14 days) consumption of insoluble wheat bran fibre-containing breakfast cereals improves subjective digestive feelings, general wellbeing and bowel function in a dose dependent manner.

PubMed

Lawton, Clare L; Walton, Jenny; Hoyland, Alexa; Howarth, Elaine; Allan, Peter; Chesters, David; Dye, Louise

2013-04-22

This study investigated whether increasing insoluble (predominantly wheat bran) fibre over 14 days improves subjective digestive feelings, general wellbeing and bowel function. A single centre, multi-site, open, within subjects design with a 14 day non-intervention (baseline) monitoring period followed by a 14 day fibre consumption (intervention) period was performed. 153 low fibre consumers (<15 g/day AOAC 985.29) completed a daily symptom diary for 14 days after which they consumed one bowl of ready-to-eat breakfast cereal containing at least 5.4 g fibre (3.5 g from wheat bran) for 14 days and completed a daily symptom diary. Significant improvements were demonstrated in subjective perception of bowel function (e.g., ease of defecation) and digestive feelings (bloating, constipation, feeling sluggish and digestive discomfort). Significant improvements were also found in subjective perception of general wellbeing (feeling less fat, more mentally alert, slim, happy and energetic whilst experiencing less stress, mental and physical tiredness, difficulty concentrating and fewer headaches). In general, improvements in study outcomes increased with increasing cereal/fibre consumption. However, consuming an additional minimum 5.4 g of fibre (3.5 g wheat bran) per day was shown to deliver measurable and significant benefits for digestive health, comfort and wellbeing. Encouraging consumption of relatively small amounts of wheat bran could also provide an effective method of increasing overall fibre consumption.

Mobile populations and HIV/AIDS in Central America and Mexico: research for action.

PubMed

Bronfman, Mario N; Leyva, Rene; Negroni, Mirka J; Rueda, Celina M

2002-12-01

To present a multi-centre study that analyses the socioeconomic, cultural and political contexts that give rise to population mobility, and its relationship to vulnerability to sexually transmitted infections (STI)/HIV/AIDS, in order to provide information that can be used to design appropriate and focused interventions. In each of 11 transit stations (border towns, port cities, areas where mobile populations congregate) in Central America and Mexico, a household survey of the local population was conducted to analyse demographic, socioeconomic characteristics, and information known and opinions held about HIV/AIDS and mobile populations. In-depth interviews with key informants, community members and mobile populations were held to ascertain knowledge about prevention and transmission of STI/HIV/AIDS. Likewise, an ethnographic study was undertaken to identify interactions between local and mobile populations. The transit stations share low educational levels among the local population, few public services, repeated human rights violations, violence, poverty and corrupt authorities. Within this social context, transactional sex, sex for survival, rape and non-professional commercial sex happen in conditions that increase the risk of the transmission of STI/HIV, such as infrequent condom use. Migrant women and sex workers are particularly vulnerable in this context. A wide gap exists between information about STI/HIV transmission and reported prevention practices. Given the conditions that exist in these transit stations, interventions should be multisectoral, sustainable, and should defend the human rights of various groups, including women and people living with HIV/AIDS.

Short Term (14 Days) Consumption of Insoluble Wheat Bran Fibre-Containing Breakfast Cereals Improves Subjective Digestive Feelings, General Wellbeing and Bowel Function in a Dose Dependent Manner

PubMed Central

Lawton, Clare L.; Walton, Jenny; Hoyland, Alexa; Howarth, Elaine; Allan, Peter; Chesters, David; Dye, Louise

2013-01-01

This study investigated whether increasing insoluble (predominantly wheat bran) fibre over 14 days improves subjective digestive feelings, general wellbeing and bowel function. A single centre, multi-site, open, within subjects design with a 14 day non-intervention (baseline) monitoring period followed by a 14 day fibre consumption (intervention) period was performed. 153 low fibre consumers (<15 g/day AOAC 985.29) completed a daily symptom diary for 14 days after which they consumed one bowl of ready-to-eat breakfast cereal containing at least 5.4 g fibre (3.5 g from wheat bran) for 14 days and completed a daily symptom diary. Significant improvements were demonstrated in subjective perception of bowel function (e.g., ease of defecation) and digestive feelings (bloating, constipation, feeling sluggish and digestive discomfort). Significant improvements were also found in subjective perception of general wellbeing (feeling less fat, more mentally alert, slim, happy and energetic whilst experiencing less stress, mental and physical tiredness, difficulty concentrating and fewer headaches). In general, improvements in study outcomes increased with increasing cereal/fibre consumption. However, consuming an additional minimum 5.4 g of fibre (3.5 g wheat bran) per day was shown to deliver measurable and significant benefits for digestive health, comfort and wellbeing. Encouraging consumption of relatively small amounts of wheat bran could also provide an effective method of increasing overall fibre consumption. PMID:23609776

Analysis of multi lobe journal bearings with surface roughness using finite difference method

NASA Astrophysics Data System (ADS)

PhaniRaja Kumar, K.; Bhaskar, SUdaya; Manzoor Hussain, M.

2018-04-01

Multi lobe journal bearings are used for high operating speeds and high loads in machines. In this paper symmetrical multi lobe journal bearings are analyzed to find out the effect of surface roughnessduring non linear loading. Using the fourth order RungeKutta method, time transient analysis was performed to calculate and plot the journal centre trajectories. Flow factor method is used to evaluate the roughness and the finite difference method (FDM) is used to predict the pressure distribution over the bearing surface. The Transient analysis is done on the multi lobe journal bearings for threedifferent surface roughness orientations. Longitudinal surface roughness is more effective when compared with isotopic and traverse surface roughness.

Knowledge, Attitudes and Practice Relating to Hazardous Alcohol Use across the Continuum of Care in a Community Healthcare Centre

ERIC Educational Resources Information Center

Kishore, Vimal; Lynch, Sara; Pichon, Jamilia; Theall, Katherine; Johnson, Sandy; Roberson, Emily; Hinton, Susan

2011-01-01

Alcohol screening and intervention in community health settings places a great time demand on practitioners. Thus, implementation of practitioner-delivered intervention is challenging. Aims: The aim of this study was to assess the feasibility of incorporating a brief alcohol intervention into daily practices of a community health care centre by…

Staff and patient accounts of PRN medication administration and non-pharmacological interventions for anxiety.

PubMed

Martin, Krystle; Ham, Elke; Hilton, N Zoe

2018-05-31

Most psychiatric inpatients will receive psychotropic PRN medication during their hospital stay for agitation, anxiety, and/or insomnia. While helpful in some cases, caution is warranted with regard to PRN use due to inherent risks of additional medication; therefore, experts advise that non-pharmacological interventions should be attempted first where indicated. However, research to date highlights that, in practice, non-pharmaceutical approaches are attempted in a minority of cases. While some information is known about the practice of PRN administration and the use of and barriers to implementing non-pharmacological interventions for treating acute psychiatric symptoms, full understanding of this practice is hampered by poor or altogether missing documentation of the process. This study used interviews with patients and staff from two psychiatric hospitals to collect first-person accounts of administering PRN medication for anxiety, thereby addressing the limitations of relying on documented notation found in previous research. Our results indicate that nurses are engaging in non-pharmacological interventions more often than had previously been captured in research. However, the types of strategies suggested are not typically evidence based and further, only happening approximately half the time. The barriers to providing such care are centred on two main beliefs about client choice and efficacy of these non-medical strategies. Implications for research and practice are discussed. © 2018 Australian College of Mental Health Nurses Inc.

Decrease social inequalities return-to-work: development and design of a randomised controlled trial among women with breast cancer.

PubMed

Vidor, Clémence; Leroyer, Ariane; Christophe, Véronique; Seillier, Mélanie; Foncel, Jérome; Van de Maële, Justine; Bonneterre, Jacques; Fantoni, Sophie

2014-04-17

Despite the improvement in the care management, women cancer patients who are still in employment find themselves for the most part obliged to stop working while they are having treatment. Their return-to-work probability is impacted by numerous psychosocial factors. The objective is to describe the development and the content of an intervention aimed to facilitate the return to work of female breast cancer patients and in particular the women in the most precarious situations through early active individualised psychosocial support (APAPI). The intervention proposed is made up of 4 interviews with a psychologist at the hospital, distributed over the year according to the diagnosis and conducted on the same day as a conventional follow-up consultation, then a consultation with a specialist job retention physician. We expect, in the first instance, that this intervention will reduce the social inequalities of the return-to-work rate at 12 months. The EPICES score will enable the population to be broken down according to the level of social precariousness. The other expected results are the reduction of the social inequalities in the quality of the return to work at 18 and 24 months and the disparities between the individual and collective resources of the patients. This intervention is assessed in the context of a controlled and randomised multi-centre study. The patients eligible are women aged between 18 and 55 years with a unilateral breast cancer with local extension exclusively, having received surgery followed by adjuvant chemotherapy, in employment at the time of the diagnosis and dealt with by one of the 2 investigating centres. It is essential to assess this type of intervention before envisaging its generalisation. The study set in place will enable us to measure the impact of this intervention aiming to facilitate the return to work of breast cancer patients, in particular for those who suffer from social fragility, compared with the standard care.

The Dutch Birth Centre Study: study design of a programmatic evaluation of the effect of birth centre care in the Netherlands.

PubMed

Hermus, Marieke A A; Wiegers, Therese A; Hitzert, Marit F; Boesveld, Inge C; van den Akker-van Marle, M Elske; Akkermans, Henk A; Bruijnzeels, Marc A; Franx, Arie; de Graaf, Johanna P; Rijnders, Marlies E B; Steegers, Eric A P; van der Pal-de Bruin, Karin M

2015-07-16

Birth centres are regarded as settings where women with uncomplicated pregnancies can give birth, assisted by a midwife and a maternity care assistant. In case of (threatening) complications referral to a maternity unit of a hospital is necessary. In the last decade up to 20 different birth centres have been instituted in the Netherlands. This increase in birth centres is attributed to various reasons such as a safe and easy accessible place of birth, organizational efficiency in integration of care and direct access to obstetric hospital care if needed, and better use of maternity care assistance. Birth centres are assumed to offer increased integration and quality of care and thus to contribute to better perinatal and maternal outcomes. So far there is no evidence for this assumption as no previous studies of birth centres have been carried out in the Netherlands. The aims are 1) Identification of birth centres and measuring integration of organization and care 2) Measuring the quality of birth centre care 3) Effects of introducing a birth centre on regional quality and provision of care 4) Cost-effectiveness analysis 5) In depth longitudinal analysis of the organization and processes in birth centres. Different qualitative and quantitative methods will be used in the different sub studies. The design is a multi-centre, multi-method study, including surveys, interviews, observations, and analysis of registration data and documents. The results of this study will enable users of maternity care, professionals, policy makers and health care financers to make an informed choice about the kind of birth location that is appropriate for their needs and wishes.

A systematic review of the clinical effectiveness and cost-effectiveness of sensory, psychological and behavioural interventions for managing agitation in older adults with dementia.

PubMed

Livingston, Gill; Kelly, Lynsey; Lewis-Holmes, Elanor; Baio, Gianluca; Morris, Stephen; Patel, Nishma; Omar, Rumana Z; Katona, Cornelius; Cooper, Claudia

2014-06-01

Agitation is common, persistent and distressing in dementia and is linked with care breakdown. Psychotropic medication is often ineffective or harmful, but the evidence regarding non-pharmacological interventions is unclear. We systematically reviewed and synthesised the evidence for clinical effectiveness and cost-effectiveness of non-pharmacological interventions for reducing agitation in dementia, considering dementia severity, the setting, the person with whom the intervention is implemented, whether the effects are immediate or longer term, and cost-effectiveness. We searched twice using relevant search terms (9 August 2011 and 12 June 2012) in Web of Knowledge (incorporating MEDLINE); EMBASE; British Nursing Index; the Health Technology Assessment programme database; PsycINFO; NHS Evidence; System for Information on Grey Literature; The Stationery Office Official Documents website; The Stationery National Technical Information Service; Cumulative Index to Nursing and Allied Health Literature; and The Cochrane Library. We also searched Cochrane reviews of interventions for behaviour in dementia, included papers' references, and contacted authors about 'missed' studies. We included quantitative studies, evaluating non-pharmacological interventions for agitation in dementia, in all settings. We rated quality, prioritising higher-quality studies. We separated results by intervention type and agitation level. As we were unable to meta-analyse results except for light therapy, we present a qualitative evidence synthesis. In addition, we calculated standardised effect sizes (SESs) with available data, to compare heterogeneous interventions. In the health economic analysis, we reviewed economic studies, calculated the cost of effective interventions from the effectiveness review, calculated the incremental cost per unit improvement in agitation, used data from a cohort study to evaluate the relationship between health and social care costs and health-related quality of life (DEMQOL-Proxy-U scores) and developed a new cost-effectiveness model. We included 160 out of 1916 papers screened. Supervised person-centred care, communication skills (SES = -1.8 to -0.3) or modified dementia care mapping (DCM) with implementing plans (SES = -1.4 to -0.6) were all efficacious at reducing clinically significant agitation in care home residents, both immediately and up to 6 months afterwards. In care home residents, during interventions but not at follow-up, activities (SES = -0.8 to -0.6) and music therapy (SES = -0.8 to -0.5) by protocol reduced mean levels of agitation; sensory intervention (SES = -1.3 to -0.6) reduced mean and clinically significant symptoms. Advantages were not demonstrated with 'therapeutic touch' or individualised activity. Aromatherapy and light therapy did not show clinical effectiveness. Training family carers in behavioural or cognitive interventions did not decrease severe agitation. The few studies reporting activities of daily living or quality-of-life outcomes found no improvement, even when agitation had improved. We identified two health economic studies. Costs of interventions which significantly impacted on agitation were activities, £80-696; music therapy, £13-27; sensory interventions, £3-527; and training paid caregivers in person-centred care or communication skills with or without behavioural management training and DCM, £31-339. Among the 11 interventions that were evaluated using the Cohen-Mansfield Agitation Inventory (CMAI), the incremental cost per unit reduction in CMAI score ranged from £162 to £3480 for activities, £4 for music therapy, £24 to £143 for sensory interventions, and £6 to £62 for training paid caregivers in person-centred care or communication skills with or without behavioural management training and DCM. Health and social care costs ranged from around £7000 over 3 months in people without clinically significant agitation symptoms to around £15,000 at the most severe agitation levels. There is some evidence that DEMQOL-Proxy-U scores decline with Neuropsychiatric Inventory agitation scores. A multicomponent intervention in participants with mild to moderate dementia had a positive monetary net benefit and a 82.2% probability of being cost-effective at a maximum willingness to pay for a quality-adjusted life-year of £20,000 and a 83.18% probability at a value of £30,000. Although there were some high-quality studies, there were only 33 reasonably sized (> 45 participants) randomised controlled trials, and lack of evidence means that we cannot comment on many interventions' effectiveness. There were no hospital studies and few studies in people's homes. More health economic data are needed. Person-centred care, communication skills and DCM (all with supervision), sensory therapy activities, and structured music therapies reduce agitation in care-home dementia residents. Future interventions should change care home culture through staff training and permanently implement evidence-based treatments and evaluate health economics. There is a need for further work on interventions for agitation in people with dementia living in their own homes. The study was registered as PROSPERO no. CRD42011001370. The National Institute for Health Research Health Technology Assessment programme.

A comparison of patient characteristics and survival in two trauma centres located in different countries.

PubMed

Templeton, J; Oakley, P A; MacKenzie, G; Cook, A L; Brand, D; Mullins, R J; Trunkey, D D

2000-09-01

The aim of the study was to compare patient characteristics and mortality in severely injured patients in two trauma centres located in different countries, allowing for differences in case-mix. It represents a direct bench-marking exercise between the trauma centres at the North Staffordshire Hospital (NSH), Stoke-on-Trent, UK and the Oregon Health Sciences University (OHSU) Hospital, Portland, Oregon, USA. Patients of all ages admitted to the two hospitals during 1995 and 1996 with an Injury Severity Score >15 were included, except for those who died in the emergency departments. Twenty-three factors were studied, including the Injury Severity Score, Glasgow Coma Score, mechanism of injury and anatomical site of injury. Outcome analysis was based on mortality at discharge. The pattern of trauma differed significantly between Stoke and Portland. Patients from Stoke tended to be older, presented with a lower conscious level and a lower systolic blood pressure and were intubated less frequently before arriving at hospital. Mortality depended on similar factors in both centres, especially age, highest AIS score, systolic blood pressure and Glasgow Coma Score.The crude analysis of mortality showed a highly significant odds-ratio of 1.64 in Stoke compared with Portland. Single-factor adjustments were made for the above four factors, which had a similar influence on mortality in both centres. Adjusting for the first three factors individually did not alter the odds-ratio, which stayed in the range 1.53-1.59 and remained highly significant. Adjusting for the Glasgow Coma Score reduced the odds-ratio to 0.82 and rendered it non-significant. In a multi-factor logistic regression model incorporating all of the factors shown to influence mortality in either centre, the odds-ratio was 1.7 but was not significant. The analysis illustrates the limitations and pitfalls of making crude outcome comparisons between centres. Highly significant differences in crude mortality were rendered non-significant by case-mix adjustments, supporting the null hypothesis that the two centres were equally effective in terms of this short-term indicator of outcome. To achieve a meaningful comparison between centres, adjustments must be made for the factors which affect mortality.

Follow-up study of female delinquent adolescents in a detention centre: effectiveness of psychiatric intervention as a mental health service.

PubMed

Ariga, Michio; Uehara, Toru; Takeuchi, Kazuo; Ishige, Yoko; Nakano, Reiko; Mikuni, Masahiko

2010-01-01

of previous studies suggest that many female offenders have co-morbid psychiatric disorders, which require mental health services. However, few longitudinal studies examined subjects during incarceration or detention. This study compares depressive symptoms, abnormal eating behaviour and impulsivity before release from a detention centre and after incarceration, thereby indicating the effectiveness of psychiatric intervention in a Japanese detention centre. Of 64 young women, 36 were followed up. Self-report measures were used to assess depression, eating behaviour and impulsivity after incarceration and one month before release. s: Of the 36 participants, nine were diagnosed using the MINI-kids as needing mental health services. Those who received psychiatric intervention were diagnosed as having major depression and/or post-traumatic stress disorder. Significant main effects of intervention and effects of time were shown in the DSD. The EAT-26 score demonstrated the significance of the effects of time and interaction. In the BIS-11 scores, neither intervention nor time showed significant effects. Results of this study showed that the time course and psychiatric intervention contributed to recovery of depression and therapeutic intervention. The time course might reduce eating problems. Psychiatric intervention might be necessary for female juvenile detainees, which presents an important issue for future studies.

A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial.

PubMed

Stathi, Afroditi; Withall, Janet; Greaves, Colin J; Thompson, Janice L; Taylor, Gordon; Medina-Lara, Antonieta; Green, Colin; Bilzon, James; Gray, Selena; Johansen-Berg, Heidi; Sexton, Claire E; Western, Max J; de Koning, Jolanthe L; Bollen, Jessica C; Moorlock, Sarah J; Demnitz, Naiara; Seager, Poppy; Guralnik, Jack M; Jack Rejeski, W; Fox, Ken R

2018-04-17

The REtirement in ACTion (REACT) study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial (RCT) with an internal pilot phase. It aims to test the effectiveness and cost-effectiveness of a community, group-based physical activity intervention for reducing, or reversing, the progression of functional limitations in older people who are at high risk of mobility-related disability. A sample of 768 sedentary, community-dwelling, older people aged 65 years and over with functional limitations, but who are still ambulatory (scores between 4 and 9 out of 12 in the Short Physical Performance Battery test (SPPB)) will be randomised to receive either the REACT intervention, delivered over a period of 12 months by trained facilitators, or a minimal control intervention. The REACT study incorporates comprehensive process and economic evaluation and a nested sub-study which will test the hypothesis that the REACT intervention will slow the rate of brain atrophy and of decline in cognitive function assessed using magnetic resonance imaging (MRI). Outcome data will be collected at baseline, 6, 12 and 24 months for the main study, with MRI sub-study data collected at baseline, 6 and 12 months. The primary outcome analysis (SPPB score at 24 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. REACT represents the first large-scale, pragmatic, community-based trial in the UK to target the non-disabled but high-risk segment of the older population with an intervention to reduce mobility-related disability. A programme that can successfully engage this population in sufficient activity to improve strength, aerobic capacity, coordination and balance would have a major impact on sustaining health and independence. REACT is also the first study of its kind to conduct a full economic and comprehensive process evaluation alongside the RCT. If effective and cost-effective, the REACT intervention has strong potential to be implemented widely in the UK and elsewhere. ISRCTN, ID: ISRCTN45627165 . Retrospectively registered on 13 June 2016. Trial sponsor: University of Bath. Protocol Version 1.5.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

PubMed

Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

2017-07-01

To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

The Influence of Cognitive Training on Older Adults’ Recall for Short Stories

PubMed Central

Sisco, S. M.; Marsiske, M; Gross, A. L.; Rebok, G. W.

2013-01-01

Objectives This paper investigated how a multi-component memory intervention affected memory for prose. We compared verbatim and paraphrased recall for short stories immediately and 1-, 2-, 3- and 5-years post-intervention in the ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly) sample. Methods We studied 1,912 ACTIVE participants aged 65–91. Participants were randomized into one of three training arms (Memory, Reasoning, Speed of Processing) or a no-contact Control group; about half of the trained participants received additional booster training 1 and 3 years post-intervention. Results Memory-trained participants showed higher verbatim recall than non-memory-trained participants. Booster memory training led to higher verbatim recall. Memory training effects were evident immediately following training and not after one year following training. Discussion Results suggest that multi-factorial memory training can improve verbatim recall for prose, but the effect does not last without continued intervention. PMID:24385636

Teaching handwashing with soap for schoolchildren in a multi-ethnic population in northern rural Vietnam

PubMed Central

Xuan, Le Thi Thanh; Rheinländer, Thilde; Hoat, Luu Ngoc; Dalsgaard, Anders; Konradsen, Flemming

2013-01-01

Background In Vietnam, initiatives have been started aimed at increasing the practice of handwashing with soap (HWWS) among primary schoolchildren. However, compliance remains low. Objective This study aims to investigate responses to a teacher-centred participatory HWWS intervention in a multi-ethnic population of primary schoolchildren in northern rural Vietnam. Design This study was implemented in two phases: a formative research project over 5 months (July–November 2008) and an action research project with a school-based HWWS intervention study in two rural communes during 5 months (May, September–December 2010). Based upon knowledge from the formative research in 2008, schoolteachers from four selected schools in the study communes actively participated in designing and implementing a HWWS intervention. Qualitative data was collected during the intervention to evaluate the responses and reaction to the intervention of teachers, children and parents. This included semi-structured interviews with children (15), and their parents (15), focus group discussions (FGDs) with schoolchildren (32) and school staff (20) and observations during 15 HWWS involving children. Results Observations and interview data from children demonstrated that children were visibly excited and pleased with HWWS sessions where teachers applied active teaching methods including rewards, games and HWWS demonstrations. All children, schoolteachers and parents also viewed the HWWS intervention as positive and feasible, irrespective of ethnicity, gender of schoolchildren and background of schoolteachers. However, some important barriers were indicated for sustaining and transferring the HWWS practice to the home setting including limited emphasis on hygiene in the standard curriculum of schools, low priority and lack of time given to practical teaching methods and lack of guidance and reminding HWWS on a regular basis at home, in particular by highland parents, who spend most of their time working away from home in the fields. Access to soap and water at the household level did not seem a barrier for the uptake of HWWS but continuous access to these might be a challenge at schools. Conclusions This study demonstrated that it is feasible to engage teachers and implement active teaching methods for behaviour change of HWWS in a group of multi-ethnic primary schoolchildren without the need for major investments in water and hygiene infrastructures. However, in those areas there was limited transfer of practice from school promotion to home. Continuous access to soaps at schools needs to be invested. PMID:23618342

Teaching handwashing with soap for schoolchildren in a multi-ethnic population in northern rural Vietnam.

PubMed

Xuan, Le Thi Thanh; Rheinländer, Thilde; Hoat, Luu Ngoc; Dalsgaard, Anders; Konradsen, Flemming

2013-04-24

In Vietnam, initiatives have been started aimed at increasing the practice of handwashing with soap (HWWS) among primary schoolchildren. However, compliance remains low. This study aims to investigate responses to a teacher-centred participatory HWWS intervention in a multi-ethnic population of primary schoolchildren in northern rural Vietnam. This study was implemented in two phases: a formative research project over 5 months (July-November 2008) and an action research project with a school-based HWWS intervention study in two rural communes during 5 months (May, September-December 2010). Based upon knowledge from the formative research in 2008, schoolteachers from four selected schools in the study communes actively participated in designing and implementing a HWWS intervention. Qualitative data was collected during the intervention to evaluate the responses and reaction to the intervention of teachers, children and parents. This included semi-structured interviews with children (15), and their parents (15), focus group discussions (FGDs) with schoolchildren (32) and school staff (20) and observations during 15 HWWS involving children. Observations and interview data from children demonstrated that children were visibly excited and pleased with HWWS sessions where teachers applied active teaching methods including rewards, games and HWWS demonstrations. All children, schoolteachers and parents also viewed the HWWS intervention as positive and feasible, irrespective of ethnicity, gender of schoolchildren and background of schoolteachers. However, some important barriers were indicated for sustaining and transferring the HWWS practice to the home setting including limited emphasis on hygiene in the standard curriculum of schools, low priority and lack of time given to practical teaching methods and lack of guidance and reminding HWWS on a regular basis at home, in particular by highland parents, who spend most of their time working away from home in the fields. Access to soap and water at the household level did not seem a barrier for the uptake of HWWS but continuous access to these might be a challenge at schools. This study demonstrated that it is feasible to engage teachers and implement active teaching methods for behaviour change of HWWS in a group of multi-ethnic primary schoolchildren without the need for major investments in water and hygiene infrastructures. However, in those areas there was limited transfer of practice from school promotion to home. Continuous access to soaps at schools needs to be invested.

Does implementing a development plan for user participation in a mental hospital change patients' experience? A non-randomized controlled study.

PubMed

Rise, Marit B; Steinsbekk, Aslak

2015-10-01

Governments in several countries attempt to strengthen user participation through instructing health-care organizations to implement user participation initiatives. There is, however, little knowledge on the effect on patients' experience from comprehensive plans for enhancing user participation in whole health service organizations. To investigate whether implementing a development plan intending to enhance user participation in a mental hospital had any effect on the patients' experience of user participation. A non-randomized controlled study including patients in three mental hospitals in Central Norway, one intervention hospital and two control hospitals. A development plan intended to enhance user participation was implemented in the intervention hospital as a part of a larger reorganizational process. The plan included establishment of a patient education centre and a user office, purchase of user expertise, appointment of contact professionals for next of kin and improvement of the centre's information and the professional culture. Perceptions of Care, Inpatient Treatment Alliance Scale and questions made for this study. A total of 1651 patients participated. Implementing a development plan in a mental hospital intending to enhance user participation had no significant effect on the patients' experience of user participation. The lack of effect can be due to inappropriate initiatives or challenges in implementation processes. Further research should ensure that initiatives and implementation processes are appropriate to impact the patients' experience. © 2013 John Wiley & Sons Ltd.

A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan.

PubMed

Lo, Jessica W; Bunce, Catey; Charteris, David; Banerjee, Philip; Phillips, Rachel; Cornelius, Victoria R

2016-08-02

Open globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report. ASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20-25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon's. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity). ISRCTN30012492 . Registered on 5 September 2014. EudraCT2014-002193-37 . Registered on 5 September 2014.

Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years.

PubMed

Willett, Keith; Keene, David J; Morgan, Lesley; Gray, Bridget; Handley, Robert; Chesser, Tim; Pallister, Ian; Tutton, Elizabeth; Knox, Christopher; Lall, Ranjit; Briggs, Andrew; Lamb, Sarah E

2014-03-12

Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery. This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment. This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013. Current Controlled Trials ISRCTN04180738.

Together We STRIDE: A quasi-experimental trial testing the effectiveness of a multi-level obesity intervention for Hispanic children in rural communities.

PubMed

Ko, Linda K; Rillamas-Sun, Eileen; Bishop, Sonia; Cisneros, Oralia; Holte, Sarah; Thompson, Beti

2018-04-01

Hispanic children are disproportionally overweight and obese compared to their non-Hispanic white counterparts in the US. Community-wide, multi-level interventions have been successful to promote healthier nutrition, increased physical activity (PA), and weight loss. Using community-based participatory approach (CBPR) that engages community members in rural Hispanic communities is a promising way to promote behavior change, and ultimately weight loss among Hispanic children. Led by a community-academic partnership, the Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise) aims to test the effectiveness of a community-wide, multi-level intervention to promote healthier diets, increased PA, and weight loss among Hispanic children. The Together We STRIDE is a parallel quasi-experimental trial with a goal of recruiting 900 children aged 8-12 years nested within two communities (one intervention and one comparison). Children will be recruited from their respective elementary schools. Components of the 2-year multi-level intervention include comic books (individual-level), multi-generational nutrition and PA classes (family-level), teacher-led PA breaks and media literacy education (school-level), family nights, a farmer's market and a community PA event (known as ciclovia) at the community-level. Children from the comparison community will receive two newsletters. Height and weight measures will be collected from children in both communities at three time points (baseline, 6-months, and 18-months). The Together We STRIDE study aims to promote healthier diet and increased PA to produce healthy weight among Hispanic children. The use of CBPR approach and the engagement of the community will springboard strategies for intervention' sustainability. Clinical Trials Registration Number: NCT02982759 Retrospectively registered. Copyright © 2018 Elsevier Inc. All rights reserved.

Prevention of violence against women and girls: what does the evidence say?

PubMed

Ellsberg, Mary; Arango, Diana J; Morton, Matthew; Gennari, Floriza; Kiplesund, Sveinung; Contreras, Manuel; Watts, Charlotte

2015-04-18

In this Series paper, we review evidence for interventions to reduce the prevalence and incidence of violence against women and girls. Our reviewed studies cover a broad range of intervention models, and many forms of violence--ie, intimate partner violence, non-partner sexual assault, female genital mutilation, and child marriage. Evidence is highly skewed towards that from studies from high-income countries, with these evaluations mainly focusing on responses to violence. This evidence suggests that women-centred, advocacy, and home-visitation programmes can reduce a woman's risk of further victimisation, with less conclusive evidence for the preventive effect of programmes for perpetrators. In low-income and middle-income countries, there is a greater research focus on violence prevention, with promising evidence on the effect of group training for women and men, community mobilisation interventions, and combined livelihood and training interventions for women. Despite shortcomings in the evidence base, several studies show large effects in programmatic timeframes. Across different forms of violence, effective programmes are commonly participatory, engage multiple stakeholders, support critical discussion about gender relationships and the acceptability of violence, and support greater communication and shared decision making among family members, as well as non-violent behaviour. Further investment in intervention design and assessment is needed to address evidence gaps. Copyright © 2015 Elsevier Ltd. All rights reserved.

Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

PubMed

Halder, Marlies; Depraetere, Hilde; Delannois, Frédérique; Akkermans, Arnoud; Behr-Gross, Marie-Emmanuelle; Bruysters, Martijn; Dierick, Jean-François; Jungbäck, Carmen; Kross, Imke; Metz, Bernard; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina

2018-03-01

Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants. Copyright © 2018.

['Third day intervention': an analysis of the factors associated with following the recommendations on the prescribing of antibiotics].

PubMed

García-San Miguel, Lucía; Cobo, Javier; Martínez, José Antonio; Arnau, Josep Maria; Murillas, Javier; Peña, Carmen; Segura, Ferran; Gurguí, Montserrat; Gálvez, Juan; Giménez, Montserrat; Gudiol, Francesc

2014-12-01

Stewardship programs on the use of antibiotics usually include interventions based on non-compulsory recommendations for the prescribers. Factors related to the adherence to expert recommendations, and the implementation of these programmes in daily practice, are of interest. A randomized, controlled, multicentre intervention study was performed in 32 hospitalization units. Antibiotic prescriptions were evaluated by an infectious disease specialist on the third day. We describe the implementation of the intervention, the factors associated with adherence to recommendations, and the impact of the intervention. A total of 3,192 interventions were carried out. Information sources used to prepare the recommendations varied significantly between centres. A modification was recommended in 65% of cases: withdrawal (47%), change in administration route (26%), change of drugs or number of antibiotics (27%), and change in dose (5%). Simplification of treatment accounted for 75% of all recommendations. Adherence was 68%, with significant differences between hospitals, and higher when the recommendations consisted of a dose adjustment or change of route, during the first intervention period, and also when recommendations were personally commented on, in addition to writing a note in the clinical chart. We did not find any reduction in antibiotic consumption or variation in the incidence of resistant pathogens. An important proportion of antibiotic prescriptions may be susceptible to improvement, most of them towards simplification. The adherence to the intervention was high, but significant variations at different centres were observed, depending on the type of recommendation, and the study period. Those recommendations that were personally commented on were more followed more than those only written. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol

PubMed Central

López-Pelayo, Hugo; Wallace, Paul; Segura, Lidia; Miquel, Laia; Díaz, Estela; Teixidó, Lidia; Baena, Begoña; Struzzo, Pierliugio; Palacio-Vieira, Jorge; Casajuana, Cristina; Colom, Joan; Gual, Antoni

2014-01-01

Introduction Early identification (EI) and brief interventions (BIs) for risky drinkers are effective tools in primary care. Lack of time in daily practice has been identified as one of the main barriers to implementation of BI. There is growing evidence that facilitated access by primary healthcare professionals (PHCPs) to a web-based BI can be a time-saving alternative to standard face-to-face BIs, but there is as yet no evidence about the effectiveness of this approach relative to conventional BI. The main aim of this study is to test non-inferiority of facilitation to a web-based BI for risky drinkers delivered by PHCP against face-to-face BI. Method and analysis A randomised controlled non-inferiority trial comparing both interventions will be performed in primary care health centres in Catalonia, Spain. Unselected adult patients attending participating centres will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test (AUDIT-C) alcohol screening questionnaire. Participants with positive results will be requested online to complete a trial module including consent, baseline assessment and randomisation to either face-to-face BI by the practitioner or BI via the alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 3 months and 1 year using the full AUDIT and D5-EQD5 scale. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis. Ethics and dissemination The protocol was approved by the Ethics Commmittee of IDIAP Jordi Gol i Gurina P14/028. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations. Trial registration number ClinicalTrials.gov NCT02082990. PMID:25552616

Faecal consistency and risk factors for diarrhoea and constipation in cats in UK rehoming shelters.

PubMed

German, Allison C; Cunliffe, Nigel A; Morgan, Kenton L

2017-01-01

Objectives The aim of the study was to describe faecal consistency, prevalence and risk factors for diarrhoea and constipation in a rescue cat population. Methods Faecal samples in litter trays from a stratified random sample of cats in pens at 25 UK rehoming centres were scored for consistency in two discrete time periods, summer and winter. A six-point scale was used, with diarrhoea ⩽3, severe diarrhoea ⩽2 and constipation as 6. The effect on faecal consistency of age, number of cats per pen and season was investigated using multivariable hierarchical logistic regression with centre and pen as random effects. Intraclass correlation coefficients were used to estimate the effect of pen and centre. Results Overall, 11.9% (95% confidence interval [CI]:10.4-13.7) of cats had diarrhoea, 2.4% (95% CI 1.6-3.7) had severe diarrhoea and 5.6% (95% CI 4.2-7.5) were constipated. The prevalence of diarrhoea (median 11.0%, interquartile range [IQR] 5.0-14.5%) and constipation (median 4.2%, IQR 1.8-5.9) varied at the centre level. Diarrhoea was associated with being a kitten (odds ratio [OR] 2.54, 95% CI 1.45-4.46; P = 0.001) and being in a multi-cat pen (OR 1.24, 95% CI 1.04-1.48; P = 0.02) but not with season (OR 0.99, 95% CI 0.55-1.77; P = 0.96). Severe diarrhoea was associated with senior cats (OR 4.66, 95% CI 1.25-17.44; P = 0.02). Constipation was associated with increasing age (OR 1.01; 95% CI 1.00-1.01; P = 0.02) and winter (OR 0.43, 95% CI 0.21-0.89; P = 0.02). Both diarrhoea and constipation showed moderate correlation with pens within a centre. Conclusions and relevance From IQRs, we suggest acceptable levels for diarrhoea and constipation of 11% and 4%, respectively, targets of 5% and 2%, and intervention at 15% and 6%. Increasing age was associated with decreased risk of diarrhoea and increased risk of constipation. However, severe diarrhoea was associated with being a senior cat. Season (winter) was a risk factor for constipation; multi-cat pens were a risk factor for diarrhoea. Describing the prevalence and risk factors for diarrhoea and constipation in cats will assist their management in this population. Understanding and managing constipation may be more important than interventions to reduce severe diarrhoea.

Efficacy of nursing interventions in reducing social and occupational disabilities among patients with neurosis.

PubMed

Nagarajaiah; Jothimani, G; Parthasarathi, R; Reddemma, K; Giri, A T S

2012-01-01

Individuals suffering from neurosis suffer from social and occupational disabilities similar to that of psychoses. Though understanding of disabilities in neurosis is essential in management of the clients, the relevant interventional studies are very limited. The present study attempted to evaluate the effect of nursing interventions in reducing social and occupational disabilities in neurotic patients. Sixty neurotic patients diagnosed as per ICD 9 criteria were randomly assigned to experimental and control groups followed by pre-assessment by Groningen social disability schedule. Of the 10 sessions of nursing intervention, 3 were individual sessions with clients, 5 with clients and family members and 2 with small group of clients with similar problems; nursing intervention group and non-nursing intervention group received the routine drug treatment at rural community mental health centre, NIMHANS, Bengaluru. The post-assessment was carried out first, second, and the third month followed by the nursing intervention. The findings revealed statistically significant reduction in social and occupational disabilities. A community-based psychosocial intervention led by community health nurses catering to the needs of neurotic patients is indicated by the results.

Managing multicentre clinical trials with open source.

PubMed

Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan

2014-03-01

Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.

Project Based Learning in Multi-Grade Class

ERIC Educational Resources Information Center

Ciftci, Sabahattin; Baykan, Ayse Aysun

2013-01-01

The purpose of this study is to evaluate project based learning in multi-grade classes. This study, based on a student-centered learning approach, aims to analyze students' and parents' interpretations. The study was done in a primary village school belonging to the Centre of Batman, already adapting multi-grade classes in their education system,…

Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial.

PubMed

Hwang, Rita; Bruning, Jared; Morris, Norman R; Mandrusiak, Allison; Russell, Trevor

2017-04-01

Is a 12-week, home-based telerehabilitation program conducted in small groups non-inferior to a traditional centre-based program in terms of the change in 6-minute walk distance? Is the telerehabilitation program also non-inferior to a centre-based program in terms of functional capacity, muscle strength, quality of life, urinary incontinence, patient satisfaction, attendance rates, and adverse events? Randomised, parallel, non-inferiority trial with concealed allocation, intention-to-treat analysis and assessor blinding. Patients with stable chronic heart failure (including heart failure with reduced or preserved ejection fraction) were recruited from two tertiary hospitals in Brisbane, Australia. The experimental group received a 12-week, real-time exercise and education intervention delivered into the participant's home twice weekly, using online videoconferencing software. The control group received a traditional hospital outpatient-based program of the same duration and frequency. Both groups received similar exercise prescription. Participants were assessed by independent assessors at baseline (Week 0), at the end of the intervention (Week 12) and at follow-up (Week 24). The primary outcome was a between-group comparison of the change in 6-minute walk distance, with a non-inferiority margin of 28m. Secondary outcomes included other functional measures, quality of life, patient satisfaction, program attendance rates and adverse events. In 53 participants (mean age 67 years, 75% males), there were no significant between-group differences on 6-minute walk distance gains, with a mean difference of 15m (95% CI -28 to 59) at Week 12. The confidence intervals were within the predetermined non-inferiority range. The secondary outcomes indicated that the experimental intervention was at least as effective as traditional rehabilitation. Significantly higher attendance rates were observed in the telerehabilitation group. Telerehabilitation was not inferior to a hospital outpatient-based rehabilitation program in patients with chronic heart failure. Telerehabilitation appears to be an appropriate alternative because it promotes greater attendance at the rehabilitation sessions. ACTRN12613000390785. [Hwang R, Bruning J, Morris NR, Mandrusiak A, Russell T (2017) Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial. Journal of Physiotherapy 63: 101-107]. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

PubMed

Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

2015-11-06

'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The effect of high correlated colour temperature office lighting on employee wellbeing and work performance.

PubMed

Mills, Peter R; Tomkins, Susannah C; Schlangen, Luc J M

2007-01-11

The effects of lighting on the human circadian system are well-established. The recent discovery of 'non-visual' retinal receptors has confirmed an anatomical basis for the non-image forming, biological effects of light and has stimulated interest in the use of light to enhance wellbeing in the corporate setting. A prospective controlled intervention study was conducted within a shift-working call centre to investigate the effect of newly developed fluorescent light sources with a high correlated colour temperature (17000 K) upon the wellbeing, functioning and work performance of employees. Five items of the SF-36 questionnaire and a modification of the Columbia Jet Lag scale, were used to evaluate employees on two different floors of the call centre between February and May 2005. Questionnaire completion occurred at baseline and after a three month intervention period, during which time one floor was exposed to new high correlated colour temperature lighting and the other remained exposed to usual office lighting. Two sided t-tests with Bonferroni correction for type I errors were used to compare the characteristics of the two groups at baseline and to evaluate changes in the intervention and control groups over the period of the study. Individuals in the intervention arm of the study showed a significant improvement in self-reported ability to concentrate at study end as compared to those within the control arm (p < 0.05). The mean individual score on a 5 point Likert scale improved by 36.8% in the intervention group, compared with only 1.7% in the control group. The majority of this improvement occurred within the first 7 weeks of the 14 week study. Substantial within group improvements were observed in the intervention group in the areas of fatigue (26.9%), alertness (28.2%), daytime sleepiness (31%) and work performance (19.4%), as assessed by the modified Columbia Scale, and in the areas of vitality (28.4%) and mental health (13.9%), as assessed by the SF-36 over the study period. High correlated colour temperature fluorescent lights could provide a useful intervention to improve wellbeing and productivity in the corporate setting, although further work is necessary in quantifying the magnitude of likely benefits.

Study Protocol--Improving Access to Kidney Transplants (IMPAKT): a detailed account of a qualitative study investigating barriers to transplant for Australian Indigenous people with end-stage kidney disease.

PubMed

Devitt, Jeannie; Cass, Alan; Cunningham, Joan; Preece, Cilla; Anderson, Kate; Snelling, Paul

2008-02-04

Indigenous Australians are slightly more than 2% of the total Australian population however, in recent years they have comprised between 6 and 10% of new patients beginning treatment for end-stage kidney disease (ESKD). Although transplant is considered the optimal form of treatment for many ESKD patients there is a pronounced disparity between the rates at which Indigenous ESKD patients receive transplants compared with their non-Indigenous counterparts. The IMPAKT (Improving Access to Kidney Transplants) Interview study investigated reasons for this disparity through a large scale, in-depth interview study involving patients, nephrologists and key decision-making staff at selected Australian transplant and dialysis sites. The design and conduct of the study reflected the multi-disciplinary membership of the core IMPAKT team. Promoting a participatory ethos, IMPAKT established partnerships with a network of hospital transplant units and hospital dialysis treatment centres that provide treatment to the vast majority of Indigenous patients across Australia. Under their auspices, the IMPAKT team conducted in-depth interviews in 26 treatment/service centres located in metropolitan, regional and remote Australia. Peer interviewing supported the engagement of Indigenous patients (146), and nephrologists (19). In total IMPAKT spoke with Indigenous and non-Indigenous patients (241), key renal nursing and other (non-specialist) staff (95) and a small number of relevant others (28). Data analysis was supported by QSR software. At each site, IMPAKT also documented educational programs and resources, mapped an hypothetical 'patient journey' to transplant through the local system and observed patient care and treatment routines. The national scope, inter-disciplinary approach and use of qualitative methods in an investigation of a significant health inequality affecting Indigenous people is, we believe, an Australian first. An exceptionally large cohort of Indigenous participants provided evaluative comment on their health services in relation to dialysis and transplant. Additionally, the data includes extensive parallel commentary from a cohort of specialists, nurses and other staff. The study considers a 'patient journey' to transplant within a diverse range of Australian treatment centre/workplace settings. The IMPAKT Interview study protocol may contribute to improvements in multi-disciplinary, flexible design health services research with hard to reach or vulnerable populations in Australia and elsewhere.

Study Protocol – Improving Access to Kidney Transplants (IMPAKT): A detailed account of a qualitative study investigating barriers to transplant for Australian Indigenous people with end-stage kidney disease

PubMed Central

Devitt, Jeannie; Cass, Alan; Cunningham, Joan; Preece, Cilla; Anderson, Kate; Snelling, Paul

2008-01-01

Background Indigenous Australians are slightly more than 2% of the total Australian population however, in recent years they have comprised between 6 and 10% of new patients beginning treatment for end-stage kidney disease (ESKD). Although transplant is considered the optimal form of treatment for many ESKD patients there is a pronounced disparity between the rates at which Indigenous ESKD patients receive transplants compared with their non-Indigenous counterparts. The IMPAKT (Improving Access to Kidney Transplants) Interview study investigated reasons for this disparity through a large scale, in-depth interview study involving patients, nephrologists and key decision-making staff at selected Australian transplant and dialysis sites. Methods The design and conduct of the study reflected the multi-disciplinary membership of the core IMPAKT team. Promoting a participatory ethos, IMPAKT established partnerships with a network of hospital transplant units and hospital dialysis treatment centres that provide treatment to the vast majority of Indigenous patients across Australia. Under their auspices, the IMPAKT team conducted in-depth interviews in 26 treatment/service centres located in metropolitan, regional and remote Australia. Peer interviewing supported the engagement of Indigenous patients (146), and nephrologists (19). In total IMPAKT spoke with Indigenous and non-Indigenous patients (241), key renal nursing and other (non-specialist) staff (95) and a small number of relevant others (28). Data analysis was supported by QSR software. At each site, IMPAKT also documented educational programs and resources, mapped an hypothetical ‘patient journey’ to transplant through the local system and observed patient care and treatment routines. Discussion The national scope, inter-disciplinary approach and use of qualitative methods in an investigation of a significant health inequality affecting Indigenous people is, we believe, an Australian first. An exceptionally large cohort of Indigenous participants provided evaluative comment on their health services in relation to dialysis and transplant. Additionally, the data includes extensive parallel commentary from a cohort of specialists, nurses and other staff. The study considers a ‘patient journey’ to transplant within a diverse range of Australian treatment centre/workplace settings. The IMPAKT Interview study protocol may contribute to improvements in multi-disciplinary, flexible design health services research with hard to reach or vulnerable populations in Australia and elsewhere. PMID:18248667

Findings from Encontros: a multi-level STI/HIV intervention to increase condom use, reduce STI, and change the social environment among sex workers in Brazil

PubMed Central

Lippman, Sheri A.; Chinaglia, Magda; Donini, Angela A.; Diaz, Juan; Reingold, Arthur; Kerrigan, Deanna L.

2012-01-01

Background Sexually transmitted infection (STI)/HIV prevention programs which do not modify social-structural contexts that contribute to risk of STI/HIV may fail to bring about improvements in health, particularly among groups who experience discrimination and exclusion from public life. We conducted a multi-level intervention with sex workers, including improved clinical care and community mobilizing strategies to modify social-structural factors that shape sexual behavior, in order to improve condom use and reduce incident STI. Methods We followed 420 sex workers participating in the Encontros intervention in Corumbá, Brazil from 2003-2005. We estimated the effect of the intervention on incident chlamydia and gonorrhea infections and condom use using generalized estimating equations and inverse probability weighting by comparing those who actively engaged in the intervention activities (exposed) to those who were less engaged (unexposed). We also determined the association of participation on reported social cohesion and participation in networks. Results Exposed participants had significantly higher odds of reporting consistent condom use with regular clients (OR:1.9, 95%CI:1.1-3.3) and non-significantly increased odds with both new clients (OR:1.6, 0.9-2.8) and nonpaying partners (OR:1.5, 0.9-1.5). The odds of an incident STI were non-significantly reduced for exposed participants compared to unexposed (OR:0.46, 0.2-1.3). Participation was significantly associated with increased perceived cohesion and participation in networks. Conclusion This prospective study provides evidence that multi-level interventions with mobilizing strategies to modify aspects of the social environment can improve condom use, reduce STIs, and increase social cohesion and participation in networks among sex workers. PMID:22337108

Parental Concerns Regarding a Centre-Based Early Intervention Programme for Down Syndrome in Malaysia: A Case Study

ERIC Educational Resources Information Center

Kunagaratnam, Nagasangari; Loh, Sau Cheong

2010-01-01

This qualitative study provides information on the concerns faced by parents having children with Down syndrome in a centre-based Early Intervention Programme in Malaysia and how they coped with these concerns. Semi-structured interviews were conducted with a total of five parents and two special educators. The interview and observation findings…

Dietary patterns, insulin sensitivity and adiposity in the multi-ethnic Insulin Resistance Atherosclerosis Study population.

PubMed

Liese, Angela D; Schulz, Mandy; Moore, Charity G; Mayer-Davis, Elizabeth J

2004-12-01

Epidemiological investigations increasingly employ dietary-pattern techniques to fully integrate dietary data. The present study evaluated the relationship of dietary patterns identified by cluster analysis with measures of insulin sensitivity (SI) and adiposity in the multi-ethnic, multi-centre Insulin Resistance Atherosclerosis Study (IRAS, 1992-94). Cross-sectional data from 980 middle-aged adults, of whom 67 % had normal and 33 % had impaired glucose tolerance, were analysed. Usual dietary intake was obtained by an interviewer-administered, validated food-frequency questionnaire. Outcomes included SI, fasting insulin (FI), BMI and waist circumference. The relationship of dietary patterns to log(SI+1), log(FI), BMI and waist circumference was modelled with multivariable linear regressions. Cluster analysis identified six distinct diet patterns--'dark bread', 'wine', 'fruits', 'low-frequency eaters', 'fries' and 'white bread'. The 'white bread' and the 'fries' patterns over-represented the Hispanic IRAS population predominantly from two centres, while the 'wine' and 'dark bread' groups were dominated by non-Hispanic whites. The dietary patterns were associated significantly with each of the outcomes first at the crude, clinical level (P<0.001). Furthermore, they were significantly associated with FI, BMI and waist circumference independent of age, sex, race or ethnicity, clinic, family history of diabetes, smoking and activity (P<0.004), whereas significance was lost for SI. Studying the total dietary behaviour via a pattern approach allowed us to focus both on the qualitative and quantitative dimensions of diet. The present study identified highly consistent associations of distinct dietary patterns with measures of insulin resistance and adiposity, which are risk factors for diabetes and heart disease.

Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study.

PubMed

Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

2015-02-01

This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS) and DNA sequence analysis. Susceptibility testing was performed using the European Committee for Antimicrobial Susceptibility Testing (EUCAST) method and breakpoints. The yeasts originated from superficial infections (SUP, 51.5 %), bloodstream infections (BSI, 31.6 %) and deep-seated infections (DEEP, 16.9 %), from patients of all ages. Nine genera and 30 species were identified. The 20 Candida species accounted for 94.6 % of all isolates. C. albicans was the overall leading pathogen (50.5 %). Lodderomyces elongisporus is reported for the first time as a fungaemia cause in Europe. C. glabrata and Saccharomyces cerevisiae, as well as the non-Candida spp. and non-albicans Candida spp. groups, showed decreased fluconazole susceptibility (<75 %). The overall fluconazole resistance was 10.2 %. C. krusei accounted for 27 of the 56 fluconazole-resistant isolates. The overall voriconazole resistance was 2.5 % and was due mainly to C. glabrata and C. tropicalis isolates. Fluconazole resistance rates for the three categories of infection were similar to the overall value; voriconazole resistance rates differed: 4 % for BSI, 3.2 % for DEEP and 1.4 % for SUP. The antifungal activity of MXP-4509 was superior to voriconazole against C. glabrata and many fluconazole-resistant isolates. There was a large percentage of non-albicans Candida isolates. A large part of the high fluconazole resistance was not acquired but intrinsic, resulting from the high percentage of C. krusei.

The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence. A systematic review.

PubMed

Weiss, H-R; Goodall, D

2008-06-01

Traditionally, the treatment options for adolescent idiopathic scoliosis (AIS), the most common form of scoliosis, are exercises; in-patient rehabilitation; braces and surgery. The outcomes of treatments are usually compared with the natural history or observation (non-intervention). The aim of this paper was to provide a synopsis of all treatment options in the light of evidence based practice (EBP). A systematic review was carried out using the most encompassing databases available. Literature has been searched for the outcome parameter ''rate of progression'' and only prospective controlled studies that have considered the treatment versus the natural history have been included. The search strategy included the following terms: ''adolescent idiopathic scoliosis''; ''idiopathic scoliosis''; ''natural history''; ''observation''; ''physiotherapy''; ''physical therapy''; ''rehabilitation''; ''bracing''; ''orthotics'' and ''surgery''. Prospective short-term studies have been found to support outpatient physiotherapy. One prospective controlled study was found to support scoliosis in-patient rehabilitation (SIR). One prospective multi-centre study, a long-term prospective controlled study and a meta-analysis have been found to support bracing. No controlled study, neither short, mid nor long-term, was found to reveal any substantial evidence to support surgery as a treatment for this condition. There is some evidence supporting the conservative treatment for AIS. No substantial evidence has been found in terms of prospective controlled studies to support surgical intervention. In light of the unknown long-term effects of surgery, a randomised controlled trial (RCT) seems necessary. Due to the presence of evidence to support conservative treatments, a plan to compose a RCT for conservative treatment options seems unethical. But it is also important to conclude that the evidence for conservative treatments is weak in number and length.

Capacity assessment of selected health care facilities for the pilot implementation of Package for Essential Non-communicable Diseases (PEN) intervention in Ghana.

PubMed

Nyarko, Kofi Mensah; Ameme, Donne Kofi; Ocansey, Dennis; Commeh, Efua; Markwei, Mehitabel Tori; Ohene, Sally-Ann

2016-01-01

Non-communicable diseases (NCDs) continue to pose threats to human health and development worldwide. Though preventable, NCDs kill more people annually than all other diseases combined. The four major NCDs namely cardiovascular diseases, chronic respiratory diseases, diabetes and cancers share common modifiable risk factors. In order to prevent and control NCDs, Ghana has adopted the World Health Organisation Package for Essential NCD (WHO-PEN) intervention, to be piloted in selected districts before a nationwide scale-up. We assessed the capacity of these facilities for the implementation of the WHO-PEN pilot. We conducted a cross-sectional health facility-based survey using a multistage sampling technique. We collected data on human resource, equipment, service utilization, medicines availability and health financing through interviews and observation. Descriptive data analysis was performed and expressed in frequencies and relative frequencies. In all, 23 health facilities comprising two regional hospitals, three district hospitals, nine health centres and nine Community-based Health Planning and Services (CHPS) compounds from three regions were surveyed. All the hospitals had medical officers whilst 4 (44.4%) of the health centres had physician assistants. Health financing is mainly by the National Health Insurance Scheme (NHIS). None of the health facilities had spacers and only one health centre had oxygen cylinder, glucometer and nebulizer. Gaps exist in the human resource capacity and service delivery at the primary care levels, the focus of WHO-PEN intervention. Adequately equipping the primary health care level with trained health workers, basic equipment, medications and diagnostics will optimize the performance of WHO-PEN intervention when implemented.

Capacity assessment of selected health care facilities for the pilot implementation of Package for Essential Non-communicable Diseases (PEN) intervention in Ghana

PubMed Central

Nyarko, Kofi Mensah; Ameme, Donne Kofi; Ocansey, Dennis; Commeh, Efua; Markwei, Mehitabel Tori; Ohene, Sally-Ann

2016-01-01

Introduction Non-communicable diseases (NCDs) continue to pose threats to human health and development worldwide. Though preventable, NCDs kill more people annually than all other diseases combined. The four major NCDs namely cardiovascular diseases, chronic respiratory diseases, diabetes and cancers share common modifiable risk factors. In order to prevent and control NCDs, Ghana has adopted the World Health Organisation Package for Essential NCD (WHO-PEN) intervention, to be piloted in selected districts before a nationwide scale-up. We assessed the capacity of these facilities for the implementation of the WHO-PEN pilot. Methods We conducted a cross-sectional health facility-based survey using a multistage sampling technique. We collected data on human resource, equipment, service utilization, medicines availability and health financing through interviews and observation. Descriptive data analysis was performed and expressed in frequencies and relative frequencies. Results In all, 23 health facilities comprising two regional hospitals, three district hospitals, nine health centres and nine Community-based Health Planning and Services (CHPS) compounds from three regions were surveyed. All the hospitals had medical officers whilst 4 (44.4%) of the health centres had physician assistants. Health financing is mainly by the National Health Insurance Scheme (NHIS). None of the health facilities had spacers and only one health centre had oxygen cylinder, glucometer and nebulizer. Conclusion Gaps exist in the human resource capacity and service delivery at the primary care levels, the focus of WHO-PEN intervention. Adequately equipping the primary health care level with trained health workers, basic equipment, medications and diagnostics will optimize the performance of WHO-PEN intervention when implemented. PMID:28149441

Rationale and design for SHAREHD: a quality improvement collaborative to scale up Shared Haemodialysis Care for patients on centre based haemodialysis.

PubMed

Fotheringham, James; Barnes, Tania; Dunn, Louese; Lee, Sonia; Ariss, Steven; Young, Tracey; Walters, Stephen J; Laboi, Paul; Henwood, Andy; Gair, Rachel; Wilkie, Martin

2017-11-24

The study objective is to assess the effectiveness and economic impact of a structured programme to support patient involvement in centre-based haemodialysis and to understand what works for whom in what circumstances and why. It implements a program of Shared Haemodialysis Care (SHC) that aims to improve experience and outcomes for those who are treated with centre-based haemodialysis, and give more patients the confidence to dialyse independently both at centres and at home. The 24 month mixed methods cohort evaluation of 600 prevalent centre based HD patients is nested within a 30 month quality improvement program that aims to scale up SHC at 12 dialysis centres across England. SHC describes an intervention where patients who receive centre-based haemodialysis are given the opportunity to learn, engage with and undertake tasks associated with their treatment. Following a 6-month set up period, a phased implementation programme is initiated across 12 dialysis units using a randomised stepped wedge design with 6 centres participating in each of 2 steps, each lasting 6 months. The intervention utilises quality improvement methodologies involving rapid tests of change to determine the most appropriate mechanisms for implementation in the context of a learning collaborative. Running parallel with the stepped wedge intervention is a mixed methods cohort evaluation that employs patient questionnaires and interviews, and will link with routinely collected data at the end of the study period. The primary outcome measure is the number of patients performing at least 5 dialysis-related tasks collected using 3 monthly questionnaires. Secondary outcomes measures include: the number of people choosing to perform home haemodialysis or dialyse independently in-centre by the end of the study period; end-user recommendation; home dialysis establishment delay; staff impact and confidence; hospitalisation; infection and health economics. The results from this study will provide evidence of impact of SHC, barriers to patient and centre level adoption and inform development of future interventions to support its implementation. ISRCTN Number: 93999549 , (retrospectively registered 1 st May 2017); NIHR Research Portfolio: 31566.

Nurse-led empowerment strategies for patients with hypertension: a questionnaire survey.

PubMed

Rasjö Wrååk, G; Törnkvist, L; Hasselström, J; Wändell, P E; Josefsson, K

2015-06-01

Hypertension is common and may lead to cerebrovascular and cardiovascular events and mortality. District nurses frequently encounter patients requiring blood pressure monitoring, lifestyle counsel and support. Empowerment as a method enables patients to both increase their control over their health and improve it. This study aims to describe the effects of the counsel and support from district nurses to patients with hypertension. A randomized controlled intervention trial. Questionnaires were answered by patients with hypertension before and after the intervention comprising district nurses' counsel and support based upon empowerment. A specially developed card for blood pressure monitoring was also used. Blood pressure decreased in intervention and the control groups. The intervention group experienced significantly improved health, with better emotional and physical health, and reduced stress. Living habits did not change significantly in either group. Satisfaction with knowledge of hypertension increased significantly in both groups. The intervention group reported that their care was based upon their health needs. Conducting large multi-centre studies with long follow-ups is complicated and results sometimes have a tendency to decline with time. A shorter follow-up might have shown a greater difference between the groups. Nursing interventions through district nurses' counsel and support with empowerment improved patients' health. More research is needed to evaluate nursing interventions' effect on hypertension. This study highlighted that district nurses' counsel and support increased patients' health and decreased stress by focusing on empowerment. © 2015 International Council of Nurses.

A multi-phase telepsychiatry programme in Michigan: organizational factors affecting utilization and user perceptions.

PubMed

Whitten, Pamela; Kuwahara, Emily

2004-01-01

Over the last few years, telepsychiatry services in Michigan have been developed by LifeWays, a Medicaid-managed behavioural health-care organization. The project had four phases, involving the introduction of telepsychiatry services between a rural and an urban clinic, to a crisis intervention centre, to a youth detention centre and to patients' homes. The role of organizational issues in the success of the programme was examined through patient interviews, provider interviews, patient and provider pre- and post-project focus groups, and service documents. Utilization data were obtained from activity logs and patient charts. During the study, 297 clients received 578 teleconsultations. Almost 97% of the telepsychiatry visits were scheduled. Telemedicine usage varied between the four project phases. The reasons for its variation in use included provider roles, existing organizational strategic goals and resources, the inherent organizational culture and quirks, and leadership and managerial factors. The major difficulties stemmed from the providers and the organization itself. There is tremendous potential for telepsychiatry and the ways in which organizational variables can be managed to influence the success of telepsychiatry programmes deserve further study.

A comparison of the clinical effectiveness and cost of specialised individually delivered parent training for preschool attention-deficit/hyperactivity disorder and a generic, group-based programme: a multi-centre, randomised controlled trial of the New Forest Parenting Programme versus Incredible Years.

PubMed

Sonuga-Barke, Edmund J S; Barton, Joanne; Daley, David; Hutchings, Judy; Maishman, Tom; Raftery, James; Stanton, Louise; Laver-Bradbury, Cathy; Chorozoglou, Maria; Coghill, David; Little, Louisa; Ruddock, Martin; Radford, Mike; Yao, Guiqing Lily; Lee, Louise; Gould, Lisa; Shipway, Lisa; Markomichali, Pavlina; McGuirk, James; Lowe, Michelle; Perez, Elvira; Lockwood, Joanna; Thompson, Margaret J J

2018-06-01

The objective of this study is to compare the efficacy and cost of specialised individually delivered parent training (PT) for preschool children with attention-deficit/hyperactivity disorder (ADHD) against generic group-based PT and treatment as usual (TAU). This is a multi-centre three-arm, parallel group randomised controlled trial conducted in National Health Service Trusts. The participants included in this study were preschool children (33-54 months) fulfilling ADHD research diagnostic criteria. New Forest Parenting Programme (NFPP)-12-week individual, home-delivered ADHD PT programme; Incredible Years (IY)-12-week group-based, PT programme initially designed for children with behaviour problems were the interventions. Primary outcome-Parent ratings of child's ADHD symptoms (Swanson, Nolan & Pelham Questionnaire-SNAP-IV). Secondary outcomes-teacher ratings (SNAP-IV) and direct observations of ADHD symptoms and parent/teacher ratings of conduct problems. NFPP, IY and TAU outcomes were measured at baseline (T1) and post treatment (T2). NFPP and IY outcomes only were measured 6 months post treatment (T3). Researchers, but not therapists or parents, were blind to treatment allocation. Analysis employed mixed effect regression models (multiple imputations). Intervention and other costs were estimated using standardized approaches. NFPP and IY did not differ on parent-rated SNAP-IV, ADHD combined symptoms [mean difference - 0.009 95% CI (- 0.191, 0.173), p = 0.921] or any other measure. Small, non-significant, benefits of NFPP over TAU were seen for parent-rated SNAP-IV, ADHD combined symptoms [- 0.189 95% CI (- 0.380, 0.003), p = 0.053]. NFPP significantly reduced parent-rated conduct problems compared to TAU across scales (p values < 0.05). No significant benefits of IY over TAU were seen for parent-rated SNAP, ADHD symptoms [- 0.16 95% CI (- 0.37, 0.04), p = 0.121] or parent-rated conduct problems (p > 0.05). The cost per family of providing NFPP in the trial was significantly lower than IY (£1591 versus £2103). Although, there were no differences between NFPP and IY with regards clinical effectiveness, individually delivered NFPP cost less. However, this difference may be reduced when implemented in routine clinical practice. Clinical decisions should take into account parental preferences between delivery approaches.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

PubMed

Carmona-Terés, Victoria; Lumillo-Gutiérrez, Iris; Jodar-Fernández, Lina; Rodriguez-Blanco, Teresa; Moix-Queraltó, Joanna; Pujol-Ribera, Enriqueta; Mas, Xavier; Batlle-Gualda, Enrique; Gobbo-Montoya, Milena; Berenguera, Anna

2015-02-25

The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. will receive standard care. quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. ISRCTN57405925. Registred 20 June 2014.

Telephonic screening and brief intervention for alcohol misuse among workers contacting the employee assistance program: A feasibility study.

PubMed

McPherson, Tracy L; Goplerud, Eric; Derr, Dennis; Mickenberg, Judy; Courtemanche, Sherry

2010-11-01

Substantial empirical support exists for alcohol screening, brief intervention, and referral to treatment (SBIRT) in medical, but not non-medical settings such as the workplace. Workplace settings remain underutilised for delivering evidenced-based health services. This research aims to translate medical research into behavioural health-care practice in a telephonic call centre acting as a point of entry into an Employee Assistance Program (EAP). The goal of the study is to examine the feasibility of implementing routine telephonic alcohol SBIRT in an EAP call centre and assess whether routine SBIRT results in increased identification of workers who misuse alcohol. The design was pretest-posttest, one-group, pre-experimental. An alcohol SBIRT program developed based on World Health Organization recommendations was implemented in one EAP call centre serving one large employer. Workers were offered screening using the Alcohol Use Disorder Identification Test (AUDIT) during intake, brief counselling using motivational interviewing, referral to counselling, and follow-up. At 5 months, 93% of workers contacting the EAP completed the AUDIT-C: 40% prescreened positive and 52% went on to screen at moderate or high risk for an alcohol problem. Overall identification rate (18%) approached general US population estimates. Most agreed to follow-up and three-quarters set an appointment for face-to-face counselling. Integration of routine alcohol SBIRT into EAP practice is feasible in telephonic delivery systems and increases identification and opportunity for brief motivational counselling. When SBIRT is seamlessly integrated workers are willing to answer questions about alcohol and participate in follow-up.[McPherson TL, Goplerud E, Derr D, Mickenberg J, Courtemanche S. Telephonic screening and brief intervention for alcohol misuse among workers contacting the employee assistance program: A feasibility study. © 2010 Australasian Professional Society on Alcohol and other Drugs.

Hypoxia and hypotension in patients intubated by physician staffed helicopter emergency medical services - a prospective observational multi-centre study.

PubMed

Sunde, Geir Arne; Sandberg, Mårten; Lyon, Richard; Fredriksen, Knut; Burns, Brian; Hufthammer, Karl Ove; Røislien, Jo; Soti, Akos; Jäntti, Helena; Lockey, David; Heltne, Jon-Kenneth; Sollid, Stephen J M

2017-07-11

The effective treatment of airway compromise in trauma and non-trauma patients is important. Hypoxia and hypotension are predictors of negative patient outcomes and increased mortality, and may be important quality indicators of care provided by emergency medical services. Excluding cardiac arrests, critical trauma and non-trauma patients remain the two major groups to which helicopter emergency medical services (HEMS) are dispatched. Several studies describe the impact of pre-hospital hypoxia or hypotension on trauma patients, but few studies compare this in trauma and non-trauma patients. The primary aim was to describe the incidence of pre-hospital hypoxia and hypotension in the two groups receiving pre-hospital tracheal intubation (TI) by physician-staffed HEMS. Data were collected prospectively over a 12-month period, using a uniform Utstein-style airway template. Twenty-one physician-staffed HEMS in Europe and Australia participated. We compared peripheral oxygen saturation and systolic blood pressure before and after definitive airway management. Data were analysed using Cochran-Mantel-Haenszel methods and mixed-effects models. Eight hundred forty three trauma patients and 422 non-trauma patients receiving pre-hospital TI were included. Non-trauma patients had significantly lower predicted mean pre-intervention SpO 2 compared to trauma patients. Post-intervention and admission SpO 2 for the two groups were comparable. However, 3% in both groups were still hypoxic at admission. For hypotension, the differences between the groups were less prominent. However, 9% of trauma and 10% of non-trauma patients were still hypotensive at admission. There was no difference in short-term survival between trauma (97%) and non-trauma patients (95%). Decreased level of consciousness was the most frequent indication for TI, and was associated with increased survival to hospital (cOR 2.8; 95% CI: 1.4-5.4). Our results showed that non-trauma patients had a higher incidence of hypoxia before TI than trauma patients, but few were hypoxic at admission. The difference for hypotension was less prominent, but one in ten patients were still hypotensive at admission. Further investigations are needed to identify reversible causes that may be corrected to improve haemodynamics in the pre-hospital setting. We found high survival rates to hospital in both groups, suggesting that physician-staffed HEMS provide high-quality emergency airway management in trauma and non-trauma patients. Clinicaltrials.gov Identifier: NCT01502111 . Registered 22 Desember 2011.

Genetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets

PubMed Central

Sørensen, Thorkild I. A; Boutin, Philippe; Taylor, Moira A; Larsen, Lesli H; Verdich, Camilla; Petersen, Liselotte; Holst, Claus; Echwald, Søren M; Dina, Christian; Toubro, Søren; Petersen, Martin; Polak, Jan; Clément, Karine; Martínez, J. Alfredo; Langin, Dominique; Oppert, Jean-Michel; Stich, Vladimir; Macdonald, Ian; Arner, Peter; Saris, Wim H. M; Pedersen, Oluf; Astrup, Arne; Froguel, Philippe

2006-01-01

Objectives: To study if genes with common single nucleotide polymorphisms (SNPs) associated with obesity-related phenotypes influence weight loss (WL) in obese individuals treated by a hypo-energetic low-fat or high-fat diet. Design: Randomised, parallel, two-arm, open-label multi-centre trial. Setting: Eight clinical centres in seven European countries. Participants: 771 obese adult individuals. Interventions: 10-wk dietary intervention to hypo-energetic (−600 kcal/d) diets with a targeted fat energy of 20%–25% or 40%–45%, completed in 648 participants. Outcome Measures: WL during the 10 wk in relation to genotypes of 42 SNPs in 26 candidate genes, probably associated with hypothalamic regulation of appetite, efficiency of energy expenditure, regulation of adipocyte differentiation and function, lipid and glucose metabolism, or production of adipocytokines, determined in 642 participants. Results: Compared with the noncarriers of each of the SNPs, and after adjusting for gender, age, baseline weight and centre, heterozygotes showed WL differences that ranged from −0.6 to 0.8 kg, and homozygotes, from −0.7 to 3.1 kg. Genotype-dependent additional WL on low-fat diet ranged from 1.9 to −1.6 kg in heterozygotes, and from 3.8 kg to −2.1 kg in homozygotes relative to the noncarriers. Considering the multiple testing conducted, none of the associations was statistically significant. Conclusions: Polymorphisms in a panel of obesity-related candidate genes play a minor role, if any, in modulating weight changes induced by a moderate hypo-energetic low-fat or high-fat diet. PMID:16871334

Effect of urban closed circuit television on assault injury and violence detection

PubMed Central

Sivarajasingam, V; Shepherd, J; Matthews, K

2003-01-01

Objective: To evaluate the effect of closed circuit television (CCTV) surveillance on levels of assault injury and violence detection. Design: Intervention versus control study design. Setting: Five town/cities with CCTV surveillance and five, matched control centres without CCTV surveillance in England. Intervention: CCTV installation and surveillance. Methods: Assault related emergency department attendances and violent offences recorded by the police in CCTV and control centres in the four years, 1995–99, two years before and two years after CCTV installation, were compared. Results: Assault related emergency department attendances decreased in intervention centres (3% decrease, ratio 0.96; 95% confidence interval (CI) 0.93 to 0.99) and increased in control centres (11% increase, ratio 1.11; 95% CI 1.08 to 1.14). Overall, changes in emergency department assault attendance in CCTV and control centres were significantly different (t test, p<0.05). Police recorded violence increased in CCTV (11% increase, ratio 1.16; 95% CI 1.08 to 1.24) and control centres (5% increase, ratio 1.06; 95% CI 0.99 to 1.13). Overall, changes in police recording in CCTV and control centres were not significantly different (t test, p>0.05). In CCTV centres, decreases in assault related emergency department attendances and increases in police violence detection were not uniform. Conclusion: CCTV surveillance was associated with increased police detection of violence and reductions in injury or severity of injury. CCTV centre variation deserves further study. PMID:14693891

Improving the implementation of nutrition guidelines in childcare centres improves child dietary intake: findings of a randomised trial of an implementation intervention.

PubMed

Seward, Kirsty; Wolfenden, Luke; Finch, Meghan; Wiggers, John; Wyse, Rebecca; Jones, Jannah; Yoong, Sze Lin

2018-02-01

Evidence suggests that improvements to the childcare nutrition environment can have a positive impact on child dietary intake. The primary aim of the present study was to assess, relative to usual care, the effectiveness of a multi-strategy implementation intervention in improving childcare compliance with nutrition guidelines. As a secondary aim, the impact on child dietary intake was assessed. Parallel-group, randomised controlled trial design. The 6-month intervention was designed to overcome barriers to implementation of the nutrition guidelines that had been identified by applying the theoretical domains framework. Hunter New England region, New South Wales, Australia. Forty-five centre-based childcare services. There were no differences between groups in the proportion of services providing food servings (per child) compliant with nutrition guideline recommendations for all five (5/5) food groups at follow-up (i.e. full compliance). Relative to control services, intervention services were more likely to be compliant with guidelines (OR; 95 % CI) in provision of fruit (10·84; 1·19, 551·20; P=0·0024), meat and meat alternatives (8·83; 1·55, -; P=0·023), dairy (8·41; 1·60, 63·62; P=0·006) and discretionary foods (17·83; 2·15, 853·73; P=0·002). Children in intervention services consumed greater servings (adjusted difference; 95 % CI) of fruit (0·41; 0·09, 0·73; P=0·014) and vegetables (0·70; 0·33, 1·08; P<0·001). Findings indicate that service-level changes to menus in line with dietary guidelines can result in improvements to children's dietary intake. The study provides evidence to advance implementation research in the setting as a means of enhancing child public health nutrition.

Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial.

PubMed

Wenborn, Jennifer; Hynes, Sinéad; Moniz-Cook, Esme; Mountain, Gail; Poland, Fiona; King, Michael; Omar, Rumana; Morris, Steven; Vernooij-Dassen, Myrra; Challis, David; Michie, Susan; Russell, Ian; Sackley, Catherine; Graff, Maud; O'Keeffe, Aidan; Crellin, Nadia; Orrell, Martin

2016-02-03

A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual. This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists. COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK. Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.

Natural disaster management: experience of an academic institution after a 7.8 magnitude earthquake in Ecuador.

PubMed

Cordero-Reyes, A M; Palacios, I; Ramia, D; West, R; Valencia, M; Ramia, N; Egas, D; Rodas, P; Bahamonde, M; Grunauer, M

2017-03-01

This case study describes the implementation of an academic institution's disaster management plan. Case study. USFQ's Medical School developed a six-phase disaster relief plan consisting of: induction, establishing a base camp, crisis management and mental health aid, creation of multidisciplinary teams and multi-agency teams, and reconstruction. Each phase uses a community-oriented approach to foster survivor autonomy and recovery. Our methodology facilitated the successful implementation of multidisciplinary interventions to manage the earthquake's aftermath on the personal, community and regional levels, treated and prevented psychological and physical morbidity among survivors and promoted healthy living conditions and independence. A multidisciplinary response team that addresses medical needs, mental health, education, food, nutrition and sanitation is highly effective in contributing to timely, effective relief efforts. The short- and long-term solutions we describe could be applicable to other academic centres' interventions in future disaster scenarios around the world. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Non-pharmacological interventions for caregivers of stroke survivors.

PubMed

Legg, Lynn A; Quinn, Terry J; Mahmood, Fahd; Weir, Christopher J; Tierney, Jayne; Stott, David J; Smith, Lorraine N; Langhorne, Peter

2011-10-05

A substantial component of care is provided to stroke survivors by informal caregivers. However, providing such care is often a new and challenging experience and has been linked to a number of adverse outcomes. A range of interventions targeted towards stroke survivors and their family or other informal caregivers have been tested in randomised controlled trials (RCTs).  To evaluate the effect of interventions targeted towards informal caregivers of stroke survivors or targeted towards informal caregivers and the care recipient (the stroke survivor). We searched the Cochrane Stroke Group Trials Register (March 2011), CENTRAL (The Cochrane Library Issue 2010, Issue 4), MEDLINE (1950 to August 2010), EMBASE (1980 to December 2010), CINAHL (1982 to August 2010), AMED (1985 to August 2010), PsycINFO (1967 to August 2010) and 11 additional databases. In an effort to identify further published, unpublished and ongoing studies, we searched conference proceedings and trials registers, scanned reference lists of relevant articles and contacted authors and researchers. There were no language restrictions. We included RCTs if they evaluated the effect of non-pharmacological interventions (compared with no care or routine care) on informal caregivers of stroke survivors. We included trials of interventions delivered to stroke survivors and informal caregivers only if the stroke survivor and informal caregiver were randomised as a dyad. We excluded studies which included stroke survivors and caregivers if the stroke survivors were the primary target of the intervention. Two review authors selected studies for inclusion, independently extracted data and assessed methodological quality. We sought original data from trialists. We categorised interventions into three groups: support and information, teaching procedural knowledge/vocational training type interventions, and psycho-educational type interventions. The primary outcome was caregivers' stress or strain. We resolved disagreements by consensus. Eight studies, including a total of 1007 participants, met our inclusion criteria. We did not pool the results of all the studies because of substantial methodological, statistical and clinical heterogeneity. For caregivers' stress or strain we found no significant results within categories of intervention, with the exception of one single-centre study examining the effects of a 'vocational training' type intervention which found a mean difference between the intervention and comparator group at the end of scheduled follow-up of -8.67 (95% confidence interval -11.30 to -6.04, P < 0.001) in favour of the 'teaching procedural knowledge' type intervention group. It was not possible to carry out a meta-analysis of the evidence from RCTs because of methodological, clinical and statistical heterogeneity. One limitation across all studies was the lack of a description of important characteristics that define the informal caregiver population. However, 'vocational educational' type interventions delivered to caregivers prior to the stroke survivor's discharge from hospital appear to be the most promising intervention. However, this is based on the results from one, small, single-centre study.  

The cost effectiveness of integrated care for people living with HIV including antiretroviral treatment in a primary health care centre in Bujumbura, Burundi.

PubMed

Renaud, A; Basenya, O; de Borman, N; Greindl, I; Meyer-Rath, G

2009-11-01

The incremental cost effectiveness of an integrated care package (i.e., medical care including antiretroviral therapy (ART) and other services such as psychological and social support) for people living with HIV/AIDS was calculated in a not-for-profit primary health care centre in Bujumbura run by Society of Women against AIDS-Burundi (SWAA-Burundi), an African non-governmental organisation (NGO). Results are expressed as cost-effectiveness ratio 2007, constant US$ per disability-adjusted life year (DALY) averted. Unit costs are estimated from the NGO's accounting data and activity reports, healthcare utilisation is estimated from the medical records of a cohort of 149 patients. Effectiveness is modelled on the survival of this cohort, using standard calculation methods. The incremental cost of integrated care for people living with HIV/AIDS in the Bujumbura health centre of SWAA-Burundi is 258 USD per DALY averted. The package of care provided by SWAA-Burundi is therefore a very cost-effective intervention in comparison with other interventions against HIV/AIDS that include ART. It is however, less cost effective than other types of interventions against HIV/AIDS, such as preventive activities.

Using geographic methods to inform cancer screening interventions for South Asians in Ontario, Canada.

PubMed

Lofters, Aisha K; Gozdyra, Piotr; Lobb, Rebecca

2013-04-26

Literature suggests that South Asians in Ontario, Canada are under-screened for breast, cervical and colorectal cancer. Accordingly, we are involved in a community-engaged multi-phase study aimed at increasing cancer screening for this vulnerable group. In the work described in this manuscript, we aimed to use visual displays of spatial analyses to identify the most appropriate small geographic areas in which to pilot targeted cancer screening interventions for Ontario's South Asian community. We used Geographic Information Systems (GIS), including Local Indicators of Spatial Association (LISA) using GeoDa software, and population-level administrative data to create multi-layered maps of: i) rates of appropriate cancer screening, ii) the percentage of residents of South Asian ethnicity, and iii) the locations of primary care practices and community health centres by census tract in the Peel Region of Ontario (population: 1.2 million). The maps were shared with partner health service and community service organizations at an intervention development workgroup meeting to examine face validity. The lowest rates of appropriate cancer screening for census tracts across the region were 51.1% for cervical cancer, 48.5% for breast cancer, and 42.5% for colorectal cancer. We found marked variation both in screening rates and in the proportion of South Asians residents by census tract but lower screening rates in the region were consistently associated with larger South Asian populations. The LISA analysis identified a high-risk area consisting of multiple neighbouring census tracts with relatively low screening rates for all three cancer types and with a relatively large South Asian population. Partner organizations recognized and validated the geographic location highlighted by the LISA analysis. Many primary care practices are located in this high-risk area, with one community health centre located very nearby. In this populous region of Ontario, South Asians are more likely to reside in areas with lower rates of appropriate breast, cervical and colorectal cancer screening. We have identified a high-risk area appropriate for both patient- and provider-focused interventions. Geographic Information Systems, in particular LISA analyses, can be invaluable when working with health service and community organizations to define areas with the greatest need for interventions to reduce health inequities.

The burden of healthcare-associated Clostridium difficile infection in a non-metropolitan setting.

PubMed

Bond, S E; Boutlis, C S; Yeo, W W; Pratt, W A B; Orr, M E; Miyakis, S

2017-04-01

Healthcare-associated Clostridium difficile infection (HCA-CDI) remains a major cause of morbidity and mortality in industrialized countries. However, few data exist on the burden of HCA-CDI in multi-site non-metropolitan settings. This study examined the introduction of an antimicrobial stewardship programme (ASP) in relation to HCA-CDI rates, and the effect of HCA-CDI on length of stay (LOS) and hospital costs. A comparative before-and-after intervention study of patients aged ≥16 years with HCA-CDI from December 2010 to April 2016 across the nine hospitals of a non-metropolitan health district in New South Wales, Australia was undertaken. The intervention comprised a multi-site ASP supported by a clinical decision support system, with subsequent introduction of email feedback of HCA-CDI cases to admitting medical officers. HCA-CDI rates, comparative LOS and hospital costs, prior use of antimicrobials and proton pump inhibitors, and appropriateness of CDI treatment. HCA-CDI rates rose from 3.07 to 4.60 cases per 10,000 occupied bed-days pre-intervention, and remained stable at 4 cases per 10,000 occupied bed-days post-intervention (P=0.24). Median LOS (17 vs six days; P<0.01) and hospital costs (AU$19,222 vs $7861; P<0.01) were significantly greater for HCA-CDI cases (N=91) than for matched controls (N=172). Half of the patients with severe HCA-CDI (4/8) did not receive initial appropriate treatment (oral vancomycin). HCA-CDI placed a significant burden on the regional and rural health service through increased LOS and hospital costs. Interventions targeting HCA-CDI could be employed to consolidate the effects of ASPs. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review.

PubMed

Parker, Deborah; Mills, Sandra; Abbey, Jennifer

The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Types of participants Adult caregivers who provide support for people with dementia living in the community (non-institutional care).Types of interventions Interventions designed to support caregivers in their role such as skills training, education to assist in caring for a person living with dementia and support groups/programs. Interventions of formal approaches to care designed to support caregivers in their role, care planning, case management and specially designated members of the healthcare team - for example dementia nurse specialist or volunteers trained in caring for someone with dementia.Types of studies This review considered any meta-analyses, systematic reviews, randomised control trials, quasi-experimental studies, cohort studies, case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. The search sought to identify published studies from 2000 to 2005 through the use of electronic databases. Only studies in English were considered for inclusion. The initial search was conducted of the databases, CINAHL, MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group. A second more extensive search was then conducted using the appropriate Medical Subject Headings (MeSH) and keywords for other available databases. Finally, hand searching of reference lists of articles retrieved and of core dementia, geriatric and psycho geriatric journals was undertaken. Methodological quality of each of the articles was assessed by two independent reviewers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Reviews and Dissemination. Standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each included study reported in the meta-analysis. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software from the Cochrane Collaboration. Heterogeneity between combined studies was tested using standard chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. A comprehensive search of relevant databases, hand searching and cross referencing found 685 articles that were assessed for relevance to the review. Eighty-five papers appeared to meet the inclusion criteria based on title and abstract, and the full paper was retrieved. Of the 85 full papers reviewed, 40 were accepted for inclusion, three were systematic reviews, three were meta-analysis, and the remaining 34 were randomised controlled trials. For the randomised controlled trials that were able to be included in a meta-analysis, standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form.The results are discussed in two main sections. Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression, health, subjective well-being, self-efficacy and burden. Secondly, results are reported by main outcome category. For each of these sections, meta-analysis was conducted where it was possible; otherwise, a narrative summary describes the findings. Four categories of intervention were included in the review - psycho-educational, support, multi-component and other.Psycho-educational Thirteen studies used psycho-educational interventions, and all but one showed positive results across a range of outcomes. Eight studies were entered in a meta-analysis. No significant impact of psycho-educational interventions was found for the outcome categories of subjective well-being, self-efficacy or health. However, small but significant results were found for the categories of depression and burden.Support Seven studies discussed support only interventions and two of these showed significant results. These two studies were suitable for meta-analysis and demonstrated a small but significant improvement on caregiver burden.Multi-component Twelve of the studies report multi-component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self-efficacy, depression, subjective well-being and burden. Unfortunately because of the heterogeneity of study designs and outcome measures, no meta-analysis was possible.Other interventions Other interventions included the use of exercise or nutrition which resulted in improvements in psychological distress and health benefits. Case management and a computer aided support intervention provided mixed results. One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour. In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies. In particular the impact of interventions on caregiver depression was available for meta-analysis from eight studies. This indicated that multi-component and psycho-educational interventions showed a small but significant positive effect on caregiver depression.Five studies using the outcome category of caregiver burden were entered into a meta-analysis and findings indicated that there were no significant effects of any of interventions. No meta-analysis was possible for the outcome categories of health, self-efficacy or subjective well-being. From this review there is evidence to support the use of well-designed psycho-educational or multi-component interventions for caregivers of people with dementia who live in the community. Factors that appear to positively contribute to effective interventions are those which:Factors which do not appear to have benefit in interventions are those which.

Patient-centred screening for primary immunodeficiency, a multi-stage diagnostic protocol designed for non-immunologists: 2011 update

PubMed Central

de Vries, E

2012-01-01

Members of the European Society for Immunodeficiencies (ESID) and other colleagues have updated the multi-stage expert-opinion-based diagnostic protocol for non-immunologists incorporating newly defined primary immunodeficiency diseases (PIDs). The protocol presented here aims to increase the awareness of PIDs among doctors working in different fields. Prompt identification of PID is important for prognosis, but this may not be an easy task. The protocol therefore starts from the clinical presentation of the patient. Because PIDs may present at all ages, this protocol is aimed at both adult and paediatric physicians. The multi-stage design allows cost-effective screening for PID of the large number of potential cases in the early phases, with more expensive tests reserved for definitive classification in collaboration with a specialist in the field of immunodeficiency at a later stage. PMID:22132890

Generalisation and extension of a web-based data collection system for clinical studies using Java and CORBA.

PubMed

Eich, H P; Ohmann, C

1999-01-01

Inadequate informatical support of multi-centre clinical trials lead to pure quality. In order to support a multi-centre clinical trial a data collection via WWW and Internet based on Java has been developed. In this study a generalization and extension of this prototype has been performed. The prototype has been applied to another clinical trial and a knowledge server based on C+t has been integrated via CORBA. The investigation and implementation of security aspects of web-based data collection is now under evaluation.

Development of an optimised 1:1 physiotherapy intervention post first-time lumbar discectomy: a mixed-methods study

PubMed Central

Rushton, A; White, L; Heap, A; Heneghan, N; Goodwin, P

2016-01-01

Objectives To develop an optimised 1:1 physiotherapy intervention that reflects best practice, with flexibility to tailor management to individual patients, thereby ensuring patient-centred practice. Design Mixed-methods combining evidence synthesis, expert review and focus groups. Setting Secondary care involving 5 UK specialist spinal centres. Participants A purposive panel of clinical experts from the 5 spinal centres, comprising spinal surgeons, inpatient and outpatient physiotherapists, provided expert review of the draft intervention. Purposive samples of patients (n=10) and physiotherapists (n=10) (inpatient/outpatient physiotherapists managing patients with lumbar discectomy) were invited to participate in the focus groups at 1 spinal centre. Methods A draft intervention developed from 2 systematic reviews; a survey of current practice and research related to stratified care was circulated to the panel of clinical experts. Lead physiotherapists collaborated with physiotherapy and surgeon colleagues to provide feedback that informed the intervention presented at 2 focus groups investigating acceptability to patients and physiotherapists. The focus groups were facilitated by an experienced facilitator, recorded in written and tape-recorded forms by an observer. Tape recordings were transcribed verbatim. Data analysis, conducted by 2 independent researchers, employed an iterative and constant comparative process of (1) initial descriptive coding to identify categories and subsequent themes, and (2) deeper, interpretive coding and thematic analysis enabling concepts to emerge and overarching pattern codes to be identified. Results The intervention reflected best available evidence and provided flexibility to ensure patient-centred care. The intervention comprised up to 8 sessions of 1:1 physiotherapy over 8 weeks, starting 4 weeks postsurgery. The intervention was acceptable to patients and physiotherapists. Conclusions A rigorous process informed an optimised 1:1 physiotherapy intervention post-lumbar discectomy that reflects best practice. The developed intervention was agreed on by the 5 spinal centres for implementation in a randomised controlled trial to evaluate its effectiveness. PMID:26916690

Effects of a co-financed interdisciplinary collaboration model in primary health care on service utilisation among patients with musculoskeletal disorders.

PubMed

Hultberg, Eva-Lisa; Lönnroth, Knut; Allebeck, Peter

2007-01-01

In 1994 Sweden introduced a trial legislation allowing co-financing between authorities. The legislation aimed to stimulate new ways of collaboration between health and social care providers. One of the specific objectives was to make management of patients with conditions requiring multidisciplinary care more efficient and reduce costs. This study aims to assess if there were any differences in management of patients with musculoskeletal disorders at health centres applying the trial legislation compared to health centre with conventional care with regards to health services utilisation, health care interventions received, and costs. A comparative prospective study was conducted. Consecutive patients aged 16-64 with musculoskeletal disorders attending the health care centres with (n=107) and without (n=31) co-financing model were interviewed at inclusion and after 6 and 12 months. Number of contacts with professionals and interventions received were registered. Patients at the intervention centres had significantly more contact with physiotherapists and physicians than the controls. Contacts with other services such as social insurance office, social services office or hospitals did not differ significantly between the groups. Costs were higher for the interventions centres. The findings do not suggest that the trial legislation reduced health care utilisation or costs for patients with musculoskeletal disorders.

Impact of financial incentives on alcohol intervention delivery in primary care: a mixed-methods study.

PubMed

O'Donnell, Amy; Haighton, Catherine; Chappel, David; Shevills, Colin; Kaner, Eileen

2016-11-25

Local and national financial incentives were introduced in England between 2008 and 2015 to encourage screening and brief alcohol intervention delivery in primary care. We used routine Read Code data and interviews with General Practitioners (GPs) to assess their impact. A sequential explanatory mixed-methods study was conducted in 16 general practices representing 106,700 patients and 99 GPs across two areas in Northern England. Data were extracted on screening and brief alcohol intervention delivery for 2010-11 and rates were calculated by practice incentive status. Semi-structured interviews with 14 GPs explored which factors influence intervention delivery and recording in routine consultations. Screening and brief alcohol intervention rates were higher in financially incentivised compared to non-incentivised practices. However absolute rates were low across all practices. Rates of short screening test administration ranged from 0.05% (95% CI: 0.03-0.08) in non-incentivised practices to 3.92% (95% CI: 3.70-4.14) in nationally incentivised practices. For the full AUDIT, rates were also highest in nationally incentivised practices (3.68%, 95% CI: 3.47-3.90) and lowest in non-incentivised practices (0.17%, 95% CI: 0.13-0.22). Delivery of alcohol interventions was highest in practices signed up to the national incentive scheme (9.23%, 95% CI: 8.91-9.57) and lowest in non-incentivised practices (4.73%, 95% CI: 4.50-4.96). GP Interviews highlighted a range of influences on alcohol intervention delivery and subsequent recording including: the hierarchy of different financial incentive schemes; mixed belief in the efficacy of alcohol interventions; the difficulty of codifying complex conditions; and GPs' beliefs about patient-centred practice. Financial incentives have had some success in encouraging screening and brief alcohol interventions in England, but levels of recorded activity remain low. To improve performance, future policies must prioritise alcohol prevention work within the quality and outcomes framework, and address the values, attitudes and beliefs that shape how GPs' provide care.

Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER).

PubMed

Richmond, Helen; Lait, Clare; Srikesavan, Cynthia; Williamson, Esther; Moser, Jane; Newman, Meredith; Betteley, Lauren; Fordham, Beth; Rees, Sophie; Lamb, Sarah E; Bruce, Julie

2018-06-18

Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER). A pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres. The PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions. International Standard Randomised Controlled Trial Number: ISRCTN 35358984 .

Effectiveness of Workplace Interventions in Return-to-Work for Musculoskeletal, Pain-Related and Mental Health Conditions: An Update of the Evidence and Messages for Practitioners.

PubMed

Cullen, K L; Irvin, E; Collie, A; Clay, F; Gensby, U; Jennings, P A; Hogg-Johnson, S; Kristman, V; Laberge, M; McKenzie, D; Newnam, S; Palagyi, A; Ruseckaite, R; Sheppard, D M; Shourie, S; Steenstra, I; Van Eerd, D; Amick, B C

2018-03-01

Purpose The objective of this systematic review was to synthesize evidence on the effectiveness of workplace-based return-to-work (RTW) interventions and work disability management (DM) interventions that assist workers with musculoskeletal (MSK) and pain-related conditions and mental health (MH) conditions with RTW. Methods We followed a systematic review process developed by the Institute for Work & Health and an adapted best evidence synthesis that ranked evidence as strong, moderate, limited, or insufficient. Results Seven electronic databases were searched from January 1990 until April 2015, yielding 8898 non-duplicate references. Evidence from 36 medium and high quality studies were synthesized on 12 different intervention categories across three broad domains: health-focused, service coordination, and work modification interventions. There was strong evidence that duration away from work from both MSK or pain-related conditions and MH conditions were significantly reduced by multi-domain interventions encompassing at least two of the three domains. There was moderate evidence that these multi-domain interventions had a positive impact on cost outcomes. There was strong evidence that cognitive behavioural therapy interventions that do not also include workplace modifications or service coordination components are not effective in helping workers with MH conditions in RTW. Evidence for the effectiveness of other single-domain interventions was mixed, with some studies reporting positive effects and others reporting no effects on lost time and work functioning. Conclusions While there is substantial research literature focused on RTW, there are only a small number of quality workplace-based RTW intervention studies that involve workers with MSK or pain-related conditions and MH conditions. We recommend implementing multi-domain interventions (i.e. with healthcare provision, service coordination, and work accommodation components) to help reduce lost time for MSK or pain-related conditions and MH conditions. Practitioners should also consider implementing these programs to help improve work functioning and reduce costs associated with work disability.

Tackling alcohol related violence in city centres: effect of emergency medicine and police intervention

PubMed Central

Warburton, A L; Shepherd, J P

2006-01-01

Objectives To identify correlates of alcohol related assault injury in the city centre of a European capital city, with particular reference to emergency department (ED) and police interventions, and number and capacity of licensed premises. Methods Assaults resulting in ED treatment were studied using a longitudinal controlled intervention, a three stage design during a three year period of rapid expansion in the night‐time economy, when ED initiated targeted police interventions were delivered. A controlled ED intervention targeted at high risk night‐clubs was carried out. Main outcome measure was ED treatment after assault in licensed premises and the street. Results Targeted police intervention was associated with substantial reductions in assaults in licensed premises but unexpected increases in street assault were also observed (34% overall: 105% in the principal entertainment thoroughfare). Combined police/ED intervention was associated with a significantly greater reduction compared with police intervention alone (OR = 0.61, 95% CI 0.40 to 0.91). Street assault correlated significantly with numbers and capacity of premises. Risk of assault was 50% greater in and around licensed premises in the city centre compared with those in the suburbs, although dispersion of violence to more licensed premises was not observed. Conclusions Marked decreases in licensed premises assaults resulting from targeted policing were enhanced by the intervention of ED and maxillofacial consultants. Capacity of licensed premises was a major predictor of assaults in the city centre street in which they are clustered. City centre assault injury prevention can be achieved through police/ED interventions targeted at high risk licensed premises, which should also target the streets around which these premises are clustered. PMID:16373796

Talent Development Gamification in Talent Selection Assessment Centres

ERIC Educational Resources Information Center

Tansley, Carole; Hafermalz, Ella; Dery, Kristine

2016-01-01

Purpose: The purpose of this paper is to examine the relationship between the use of sophisticated talent selection processes such as gamification and training and development interventions designed to ensure that candidates can successfully navigate the talent assessment process. Gamification is the application of game elements to non-game…

The effectiveness of interventions to increase physical activity among young girls: a meta-analysis.

PubMed

Biddle, Stuart J H; Braithwaite, Rock; Pearson, Natalie

2014-05-01

Pre-adolescent girls are an important target population for physical activity behaviour change as it may enhance tracking into the crucial period of adolescence. The quantification of intervention effectiveness for this age group of girls has not been previously reported. Studies published in English up to and including August 2013 were located from computerised (MedLine, PsychInfo, Science Direct, Web of Science, EPPI centre databases, and Cochrane Library database) and manual searches. Intervention studies aimed at promoting physical activity, which included pre-adolescent girls aged 5-11 years, and a non-physical activity control/comparison group were included. A random effects meta-analysis was conducted. The average treatment effect for pre-adolescent girls involved in physical activity interventions was significant but small (g=0.314, p<.001). Moderator analyses showed larger effects for interventions that catered for girls only and used educational and multicomponent strategies. Interventions to increase physical activity in pre-adolescent girls show small but significant effects, suggesting that behaviour change may be challenging, but results suggest some strategies that could be successful. Copyright © 2014 Elsevier Inc. All rights reserved.

Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

PubMed

Lundström, Erik; Isaksson, Eva; Wester, Per; Laska, Ann-Charlotte; Näsman, Per

2018-01-08

Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke. The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.

Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial.

PubMed

das Nair, Roshan; Lincoln, Nadina B; Ftizsimmons, Deborah; Brain, Nicola; Montgomery, Alan; Bradshaw, Lucy; Drummond, Avril; Sackley, Catherine; Newby, Gavin; Thornton, Jim; Stapleton, Sandip; Pink, Anthony

2015-01-06

Impairments of memory are commonly reported by people with traumatic brain injuries (TBI). Such deficits are persistent, debilitating, and can severely impact quality of life. Currently, many do not routinely receive follow-up appointments for residual memory problems following discharge. This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme. Three hundred and twelve people with a traumatic brain injury will be randomised from four centres. Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment, have memory problems, are 18 to 69 years of age, are able to travel to one of our centres and attend group sessions, and are able to give informed consent. Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care. Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme, which has been developed in previous pilot studies. The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems. All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation. The primary outcome is the Everyday Memory Questionnaire at 6 months. Secondary outcomes include the Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, health related quality of life, cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire, individual goal attainment, European Brain Injury Questionnaire (patient and relative versions), and the Everyday Memory Questionnaire-relative version. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme. The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI. We discuss our decision-making regarding choice of outcome measures and control group, and the unique challenges to recruiting people with memory problems to trials. ISRCTN65792154; Date: 18 October 2012.

[Spanish opinions on tobacco smoke-free areas].

PubMed

Clemente Jiménez, María Lourdes; Bartolomé Moreno, Cruz; Rubio Aranda, Encarnación; Martín Cantera, Carlos; Puente, Diana; Sobradiel Sierra, Natalia

2012-03-01

To determine the number of passive smokers, the environments where exposure to second-hand smoke (SHS) is higher, the opinion of smokers and non-smokers with regard to these spaces and their influence on smoking. Descriptive and cross-sectional observational study of a convenience sample. Multi-centre, Spanish Health-care Centres. A total of 9733 people older than 16 years who were seen or were working in Spanish Health-care Centres in April 2008. Smoker condition, gender, profession and their opinion with regard to second-hand smoke (SHS) exposure. A total of 42.4% of participants considered themselves second-hand (passive) smokers in public places and 96.8% in indoor areas. Almost all of them (91.8%) considered SHS exposure harmful for non-smokers, Smoke-free environments were considered to be good for discouraging people from starting to smoke (70.3%), and for quitting smoking (71.8%). Smoke-free environments were preferred by 81.1%. They felt more exposed SHS inside a car (79.8%) and in cafes (34.7%). Non-smokers, both men and women, shared these opinions significantly (P<.05). Altogether, those surveyed considered themselves as second-hand smokers and think that smoke-free environments reduce the impact of smoking and help in quitting smoking. Besides, they prefer living in those environments. Considering the preferences of most of the population, this stresses the need to urge governments to establish legislative measures promoting smoke-free environments. Copyright © 2010 Elsevier España, S.L. All rights reserved.

Implementing people-centred health systems governance in 3 provinces and 11 districts of Afghanistan: a case study.

PubMed

Anwari, Zelaikha; Shukla, Mahesh; Maseed, Basir Ahmad; Wardak, Ghulam Farooq Mukhlis; Sardar, Sakhi; Matin, Javid; Rashed, Ghulam Sayed; Hamedi, Sayed Amin; Sahak, Hedayatullah; Aziz, Abdul Hakim; Boyd-Boffa, Mariah; Trasi, Reshma

2015-01-01

Previous studies show that health systems governance influences health system performance and health outcomes. However, there are few examples of how to implement and monitor good governing practices in fragile and conflict affected environments. Good governance has the potential to make the health system people-centered. More research is needed on implementing a people-centered governance approach in these environments. We piloted an intervention that placed a people-centred health systems governance approach in the hands of multi-stakeholder committees that govern provincial and district health systems. We report the results of this intervention from three provinces and eleven districts in Afghanistan over a six month period. This mixed-methods exploratory case study uses analysis of governance self-assessment scores, health management information system data on health system performance, and focus group discussions. The outcomes of interest are governance scores and health system performance indicators. We document the application of a people-centred health systems governance conceptual model based on applying four effective governing practices: cultivating accountability, engaging with stakeholders, setting a shared strategic direction, and stewarding resources responsibly. We present a participatory approach where health system leaders identify and act on opportunities for making themselves and their health systems more accountable and responsive to the needs of the communities they serve. We found that health systems governance can be improved in fragile and conflict affected environments, and that consistent application of the effective governing practices is key to improving governance. Intervention was associated with a 20% increase in antenatal care visit rate in pilot provinces. Focus group discussions showed improvements across the four governing practices, including: establishment of new sub-committees that oversee financial transparency and governance, collaboration with diverse stakeholders, sharper focus on community health needs, more frequent presentation of service delivery data, and increased use of data for decision making. Our findings have implications for policy and practice within and beyond Afghanistan. Governance is central to making health systems responsive to the needs of people who access and provide services. We provide a practical approach to improving health systems governance in fragile and conflict affected environments.

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

PubMed

Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

2013-11-15

Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention. Current Controlled Trials ISRCTN35911035.

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

PubMed Central

2013-01-01

Background Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Methods Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Results Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Conclusions Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention. Trial registration Current Controlled Trials ISRCTN35911035 PMID:24228935

Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study

PubMed Central

Kjærgaard, Hanne; Olsen, Jørn; Ottesen, Bent; Nyberg, Per; Dykes, Anna-Karin

2008-01-01

Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix < 4 cm (1.63, 1.38–1.92), tense cervix (1.31, 1.04–1.65), thick lower segment (1.32, 1.09–1.61), fetal head above the inter-spinal diameter (2.29, 1.80–2.92) and poor fetal head-to-cervix contact (1.83, 1.31–2.56). The use of epidural analgesia (5.65, 4.33–7.38) was also associated with dystocia. Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern. PMID:18837972

Preventive medical care in remote Aboriginal communities in the Northern Territory: a follow-up study of the impact of clinical guidelines, computerised recall and reminder systems, and audit and feedback.

PubMed

Bailie, Ross S; Togni, Samantha J; Si, Damin; Robinson, Gary; d'Abbs, Peter H N

2003-07-30

Interventions to improve delivery of preventive medical services have been shown to be effective in North America and the UK. However, there are few studies of the extent to which the impact of such interventions has been sustained, or of the impact of such interventions in disadvantaged populations or remote settings. This paper describes the trends in delivery of preventive medical services following a multifaceted intervention in remote community health centres in the Northern Territory of Australia. The intervention comprised the development and dissemination of best practice guidelines supported by an electronic client register, recall and reminder systems and associated staff training, and audit and feedback. Clinical records in seven community health centres were audited at regular intervals against best practice guidelines over a period of three years, with feedback of audit findings to health centre staff and management. Levels of service delivery varied between services and between communities. There was an initial improvement in service levels for most services following the intervention, but improvements were in general not fully sustained over the three year period. Improvements in service delivery are consistent with the international experience, although baseline and follow-up levels are in many cases higher than reported for comparable studies in North America and the UK. Sustainability of improvements may be achieved by institutionalisation of relevant work practices and enhanced health centre capacity.

Patient-centred performance monitoring systems and multi-agency care provision: a case study using a stakeholder participative approach.

PubMed

Connell, N A; Goddard, A R; Philp, I; Bray, J

1998-05-01

We describe the processes involved in the development of an information system which can assess how care given by a number of agencies could be monitored by those agencies. In particular, it addresses the problem of sharing information as the boundaries of each agency are crossed. It focuses on the care of one specific patient group--the rehabilitation of elderly patients in the community, which provided an ideal multi-agency setting. It also describes: how a stakeholder participative approach to information system development was undertaken, based in part on the Soft Systems Methodology (SSM) approach (Checkland, 1981, 1990); some of the difficulties encountered in using such an approach; and the ways in which these were addressed. The paper goes on to describe an assessment tool called SCARS (the Southampton Community Ability Rating Scale). It concludes by reflecting on the management lessons arising from this project. It also observes, inter alia, how stakeholders have a strong preference for simpler, non-IT based systems, and comments on the difficulties encountered by stakeholders in attempting to reconcile their perceptions of the needs of their discipline or specialty with a more patient-centred approach of an integrated system.

Comparison of pharmacological and non-pharmacological interventions to prevent delirium in critically ill patients: a protocol for a systematic review incorporating network meta-analyses.

PubMed

Burry, L D; Hutton, B; Guenette, M; Williamson, D; Mehta, S; Egerod, I; Kanji, S; Adhikari, N K; Moher, D; Martin, C M; Rose, L

2016-09-08

Delirium is characterized by acute changes in mental status including inattention, disorganized thinking, and altered level of consciousness, and is highly prevalent in critically ill adults. Delirium has adverse consequences for both patients and the healthcare system; however, at this time, no effective treatment exists. The identification of effective prevention strategies is therefore a clinical and research imperative. An important limitation of previous reviews of delirium prevention is that interventions were considered in isolation and only direct evidence was used. Our systematic review will synthesize all existing data using network meta-analysis, a powerful statistical approach that enables synthesis of both direct and indirect evidence. We will search Ovid MEDLINE, CINAHL, Embase, PsycINFO, and Web of Science from 1980 to March 2016. We will search the PROSPERO registry for protocols and the Cochrane Library for published systematic reviews. We will examine reference lists of pertinent reviews and search grey literature and the International Clinical Trials Registry Platform for unpublished studies and ongoing trials. We will include randomized and quasi-randomized trials of critically ill adults evaluating any pharmacological, non-pharmacological, or multi-component intervention for delirium prevention, administered in or prior to (i.e., peri-operatively) transfer to the ICU. Two authors will independently screen search results and extract data from eligible studies. Risk of bias assessments will be completed on all included studies. To inform our network meta-analysis, we will first conduct conventional pair-wise meta-analyses for primary and secondary outcomes using random-effects models. We will generate our network meta-analysis using a Bayesian framework, assuming a common heterogeneity parameter across all comparisons, and accounting for correlations in multi-arm studies. We will perform analyses using WinBUGS software. This systematic review will address the existing knowledge gap regarding best practices for delirium prevention in critically ill adults by synthesizing evidence from trials of pharmacological, non-pharmacological, and multi-component interventions administered in or prior to transfer to the ICU. Use of network meta-analysis will clarify which delirium prevention strategies are most effective in improving clinical outcomes while causing least harm. The network meta-analysis is a novel approach and will provide knowledge users and decision makers with comparisons of multiple interventions of delirium prevention strategies. PROSPERO CRD42016036313.

EUDOR-A multi-centre research program: A naturalistic, European Multi-centre Clinical study of EDOR Test in adult patients with primary depression.

PubMed

Sarchiapone, Marco; Iosue, Miriam; Carli, Vladimir; Amore, Mario; Baca-Garcia, Enrique; Batra, Anil; Cosman, Doina; Courtet, Philippe; Di Sciascio, Guido; Gusmao, Ricardo; Parnowski, Tadeusz; Pestality, Peter; Saiz, Pilar; Thome, Johannes; Tingström, Anders; Wojnar, Marcin; Zeppegno, Patrizia; Thorell, Lars-Håkan

2017-03-23

Electrodermal reactivity has been successfully used as indicator of interest, curiosity as well as depressive states. The measured reactivity depends on the quantity of sweat secreted by those eccrine sweat glands that are located in the hypodermis of palmar and plantar regions. Electrodermal hyporeactive individuals are those who show an unusual rapid habituation to identical non-significant stimuli. Previous findings suggested that electrodermal hyporeactivity has a high sensitivity and a high specificity for suicide. The aims of the present study are to test the effectiveness and the usefulness of the EDOR (ElectroDermal Orienting Reactivity) Test as a support in the suicide risk assessment of depressed patients and to assess the predictive value of electrodermal hyporeactivity, measured through the EDOR Test, for suicide and suicide attempt in adult patients with a primary diagnosis of depression. 1573 patients with a primary diagnosis of depression, whether currently depressed or in remission, have been recruited at 15 centres in 9 different European countries. Depressive symptomatology was evaluated through the Montgomery-Asberg Depression Scale. Previous suicide attempts were registered and the suicide intent of the worst attempt was rated according to the first eight items of the Beck Suicide Intent Scale. The suicide risk was also assessed according to rules and traditions at the centre. The EDOR Test was finally performed. During the EDOR Test, two fingers are put on gold electrodes and direct current of 0.5 V is passed through the epidermis of the fingers according to standards. A moderately strong tone is presented through headphones now and then during the test. The electrodermal responses to the stimuli represent an increase in the conductance due to the increased number of filled sweat ducts that act as conductors through the electrically highly resistant epidermis. Each patient is followed up for one year in order to assess the occurrence of intentional self-harm. Based on previous studies, expected results would be that patients realizing a suicide attempt with a strong intent or committing suicide should be electrodermally hyporeactive in most cases and non-hyporeactive patients should show only few indications of death intent or suicides. The German Clinical Trials Register, DRKS00010082 . Registered May 31 st , 2016. Retrospectively registered.

The ‘Hothaps’ programme for assessing climate change impacts on occupational health and productivity: an invitation to carry out field studies

PubMed Central

Kjellstrom, Tord; Gabrysch, Sabine; Lemke, Bruno; Dear, Keith

2009-01-01

The ‘high occupational temperature health and productivity suppression’ programme (Hothaps) is a multi-centre health research and prevention programme aimed at quantifying the extent to which working people are affected by, or adapt to, heat exposure while working, and how global heating during climate change may increase such effects. The programme will produce essential new evidence for local, national and global assessment of negative impacts of climate change that have largely been overlooked. It will also identify and evaluate preventive interventions in different social and economic settings. Hothaps includes studies in any part of the world where hourly heat exposure exceeds physiological stress limits that may affect workers. This usually happens at temperatures above 25°C, depending on humidity, wind movement and heat radiation. Working people in low and middle-income tropical countries are particularly vulnerable, because many of them are involved in heavy physical work, either outdoors in strong sunlight or indoors without effective cooling. If high work intensity is maintained in workplaces with high heat exposure, serious health effects can occur, including heat stroke and death. Depending on the type of occupation, the required work intensity, and the level of heat stress, working people have to slow down their work in order to reduce internal body heat production and the risk of heat stroke. Thus, unless preventive interventions are used to reduce the heat stress on workers, their individual health and productivity will be affected and economic output per work hour will be reduced. Heat also influences other daily physical activities, unrelated to work, in all age groups. Poorer people without access to household or workplace cooling devices are most likely to be affected. The Hothaps programme includes a pilot study, heat monitoring of selected workplaces, qualitative studies of perceived heat impacts and preventative interventions, quantitative studies of impacts on health and productivity, and assessments of local impacts of climate change taking into account different applications of preventative interventions. Fundraising for the global programme is in progress and has enabled local field studies to start in 2009. Local funding support is also of great value and is being sought by several interested scientific partners. The Hothaps team welcomes independent use of the study protocols, but would be grateful for information about any planned, ongoing or completed studies of this type. Coordinated implementation of the protocols in multi-centre studies is also welcome. Eventually, the results of the Hothaps field studies will be used in global assessments of climate change-induced heat exposure increase in workplaces and its impacts on occupational health and productivity. These results will also be of value for the next assessment by the Intergovernmental Panel on Climate Change (IPCC) in 2013. PMID:20052425

The 'Hothaps' programme for assessing climate change impacts on occupational health and productivity: an invitation to carry out field studies.

PubMed

Kjellstrom, Tord; Gabrysch, Sabine; Lemke, Bruno; Dear, Keith

2009-11-11

The 'high occupational temperature health and productivity suppression' programme (Hothaps) is a multi-centre health research and prevention programme aimed at quantifying the extent to which working people are affected by, or adapt to, heat exposure while working, and how global heating during climate change may increase such effects. The programme will produce essential new evidence for local, national and global assessment of negative impacts of climate change that have largely been overlooked. It will also identify and evaluate preventive interventions in different social and economic settings.Hothaps includes studies in any part of the world where hourly heat exposure exceeds physiological stress limits that may affect workers. This usually happens at temperatures above 25 degrees C, depending on humidity, wind movement and heat radiation. Working people in low and middle-income tropical countries are particularly vulnerable, because many of them are involved in heavy physical work, either outdoors in strong sunlight or indoors without effective cooling. If high work intensity is maintained in workplaces with high heat exposure, serious health effects can occur, including heat stroke and death.Depending on the type of occupation, the required work intensity, and the level of heat stress, working people have to slow down their work in order to reduce internal body heat production and the risk of heat stroke. Thus, unless preventive interventions are used to reduce the heat stress on workers, their individual health and productivity will be affected and economic output per work hour will be reduced. Heat also influences other daily physical activities, unrelated to work, in all age groups. Poorer people without access to household or workplace cooling devices are most likely to be affected.The Hothaps programme includes a pilot study, heat monitoring of selected workplaces, qualitative studies of perceived heat impacts and preventative interventions, quantitative studies of impacts on health and productivity, and assessments of local impacts of climate change taking into account different applications of preventative interventions.Fundraising for the global programme is in progress and has enabled local field studies to start in 2009. Local funding support is also of great value and is being sought by several interested scientific partners. The Hothaps team welcomes independent use of the study protocols, but would be grateful for information about any planned, ongoing or completed studies of this type. Coordinated implementation of the protocols in multi-centre studies is also welcome. Eventually, the results of the Hothaps field studies will be used in global assessments of climate change-induced heat exposure increase in workplaces and its impacts on occupational health and productivity. These results will also be of value for the next assessment by the Intergovernmental Panel on Climate Change (IPCC) in 2013.

Multicentre cluster randomised controlled trial evaluating implementation of a fire prevention Injury Prevention Briefing in children's centres: study protocol.

PubMed

Deave, Toity; Towner, Elizabeth; McColl, Elaine; Reading, Richard; Sutton, Alex; Coupland, Carol; Cooper, Nicola; Stewart, Jane; Hayes, Mike; Pitchforth, Emma; Watson, Michael; Kendrick, Denise

2014-01-22

The UK has one of the highest fatality rates for deaths from fire-related injuries in children aged 0-14 years; these injuries have the steepest social gradient of all injuries in the UK. Children's centres provide children under five years old and their families with a range of services and information, including home safety, but their effectiveness in promoting injury prevention has yet to be evaluated. We developed a fire prevention intervention for use in children's centres comprising an Injury Prevention Briefing (IPB) which provides evidence on what works and best practice from those running injury prevention programmes, and a facilitation package to support implementation of the IPB. This protocol describes the design and methods of a trial evaluating the effectiveness and cost-effectiveness of the IPB and facilitation package in promoting fire prevention. Pragmatic, multicentre cluster randomised controlled trial, with a nested qualitative study, in four study centres in England. Children's centres in the most disadvantaged areas will be eligible to participate and will be randomised to one of three treatment arms comprising: IPB with facilitation package; IPB with no facilitation package; usual care (control). The primary outcome measure will be the proportion of families who have a fire escape plan at follow-up. Eleven children's centres per arm are required to detect an absolute difference in the percentage of families with a fire escape plan of 20% in either of the two intervention arms compared with the control arm, with 80% power and a 5% significance level (2-sided), an intraclass correlation coefficient of 0.05 and assuming outcomes are assessed on 20 families per children's centre. Secondary outcomes include the assessment of the cost-effectiveness of the intervention, other fire safety behaviours and factors associated with degree of implementation of the IPB. This will be the first trial to develop and evaluate a fire prevention intervention for use in children's centres in the UK. Its findings will be generalisable to children's centres in the most disadvantaged areas of the UK and may also be generalisable to similar interventions to prevent other types of injury. http://NCT01452191 (date of registration: 13/10/2011).

Multicentre cluster randomised controlled trial evaluating implementation of a fire prevention Injury Prevention Briefing in children’s centres: study protocol

PubMed Central

2014-01-01

Background The UK has one of the highest fatality rates for deaths from fire-related injuries in children aged 0–14 years; these injuries have the steepest social gradient of all injuries in the UK. Children’s centres provide children under five years old and their families with a range of services and information, including home safety, but their effectiveness in promoting injury prevention has yet to be evaluated. We developed a fire prevention intervention for use in children’s centres comprising an Injury Prevention Briefing (IPB) which provides evidence on what works and best practice from those running injury prevention programmes, and a facilitation package to support implementation of the IPB. This protocol describes the design and methods of a trial evaluating the effectiveness and cost-effectiveness of the IPB and facilitation package in promoting fire prevention. Methods/Design Pragmatic, multicentre cluster randomised controlled trial, with a nested qualitative study, in four study centres in England. Children’s centres in the most disadvantaged areas will be eligible to participate and will be randomised to one of three treatment arms comprising: IPB with facilitation package; IPB with no facilitation package; usual care (control). The primary outcome measure will be the proportion of families who have a fire escape plan at follow-up. Eleven children’s centres per arm are required to detect an absolute difference in the percentage of families with a fire escape plan of 20% in either of the two intervention arms compared with the control arm, with 80% power and a 5% significance level (2-sided), an intraclass correlation coefficient of 0.05 and assuming outcomes are assessed on 20 families per children’s centre. Secondary outcomes include the assessment of the cost-effectiveness of the intervention, other fire safety behaviours and factors associated with degree of implementation of the IPB. Discussion This will be the first trial to develop and evaluate a fire prevention intervention for use in children’s centres in the UK. Its findings will be generalisable to children’s centres in the most disadvantaged areas of the UK and may also be generalisable to similar interventions to prevent other types of injury. Trial registration http://NCT01452191 (date of registration: 13/10/2011). PMID:24450931

The impact of distance and duration of travel on participation rates and participants’ satisfaction: results from a pilot study at one study centre in Pretest 2 of the German National Cohort

PubMed Central

Schweitzer, Aparna; Akmatov, Manas K; Kindler, Florentina; Kemmling, Yvonne; Kreienbrock, Lothar; Krause, Gérard; Pessler, Frank

2015-01-01

Objectives In this pilot study within the Pretest 2 phase of the German National Cohort, we aimed to (1) test the hypothesis that distance and duration of travel to a study centre may affect participation rates and participants’ satisfaction and (2) to obtain data that would help to select recruitment areas around the study centre Hannover with the greatest projected participation rate for the main study. Setting Mixed urban/suburban environment in Northern Germany with approximately 600 000 inhabitants. 4 recruitment areas with divergent estimated mean distances (range, 7–40 km) and duration of travel to the study centre Hannover were selected. Participants 1050 men and women (ratio, 1:1), aged 20–69 years, were randomly selected from the population registries of the 4 recruitment areas and invited by mail to participate in the Pretest 2 study programme at the study centre Hannover, covering a variety of questionnaire-based and physical assessments. 166 individuals participated (16%). Interventions All 166 participants completed a travel questionnaire containing 5 items relating to travel duration and satisfaction, amounting to a participation rate of 100% in the questionnaire-based part of the study. Results Participation rates in the Pretest 2 programme at the study centre Hannover by area ranged from 11% (area farthest from the study centre, estimated median distance 38 km) to 18% (nearest area, 2 km). The odds of non-participation were highest in the area farthest from the study centre (adjusted OR 2.06; p=0.01; CI 1.28 to 3.32). Nonetheless, 97% of participants were satisfied with travel duration. Conclusions Increasing distance was associated with a lower participation rate. However, acceptance of duration of travel was high, irrespective of distance or duration. Thus, recruiting in farther away locations may select individuals with a greater frustration tolerance for travel to the study centre, perhaps due to a greater interest in participating in health-oriented studies and thus different health-related behaviour. PMID:26297358

Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial.

PubMed

Holland, Anne E; Mahal, Ajay; Hill, Catherine J; Lee, Annemarie L; Burge, Angela T; Moore, Rosemary; Nicolson, Caroline; O'Halloran, Paul; Cox, Narelle S; Lahham, Aroub; Ndongo, Rebecca; Bell, Emily; McDonald, Christine F

2013-09-08

Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease (COPD) to improve exercise capacity, symptoms and quality of life, however only a minority of individuals with COPD are able to participate. Travel and transport are frequently cited as barriers to uptake of centre-based programs. Other models of pulmonary rehabilitation, including home-based programs, have been proposed in order to improve access to this important treatment. Previous studies of home-based pulmonary rehabilitation in COPD have demonstrated improvement in exercise capacity and quality of life, but not all elements of the program were conducted in the home environment. It is uncertain whether a pulmonary rehabilitation program delivered in its entirety at home is cost effective and equally capable of producing benefits in exercise capacity, symptoms and quality of life as a hospital-based program. The aim of this study is to compare the costs and benefits of home-based and hospital-based pulmonary rehabilitation for people with COPD. This randomised, controlled, equivalence trial conducted at two centres will recruit 166 individuals with spirometrically confirmed COPD. Participants will be randomly allocated to hospital-based or home-based pulmonary rehabilitation. Hospital programs will follow the traditional outpatient model consisting of twice weekly supervised exercise training and education for eight weeks. Home-based programs will involve one home visit followed by seven weekly telephone calls, using a motivational interviewing approach to enhance exercise participation and facilitate self management. The primary outcome is change in 6-minute walk distance immediately following intervention. Measurements of exercise capacity, physical activity, symptoms and quality of life will be taken at baseline, immediately following the intervention and at 12 months, by a blinded assessor. Completion rates will be compared between programs. Direct healthcare costs and indirect (patient-related) costs will be measured to compare the cost-effectiveness of each program. This trial will identify whether home-based pulmonary rehabilitation can deliver equivalent benefits to centre-based pulmonary rehabilitation in a cost effective manner. The results of this study will contribute new knowledge regarding alternative models of pulmonary rehabilitation and will inform pulmonary rehabilitation guidelines for COPD.

Information and professional support: key factors in the provision of family-centred early childhood intervention services.

PubMed

Fordham, L; Gibson, F; Bowes, J

2012-09-01

Much has been written on the principles of family-centred practice and on the service delivery methods and skills required of its practitioners. Far less has been written from the perspective of families whose children have a disability. The aims of this study were twofold: firstly to understand families' experiences of family-centred early childhood intervention services and secondly to explore other factors that might impact on these experiences. One hundred and thirty families attending two established early childhood intervention services in New South Wales, Australia completed a survey incorporating the Measure of Processes of Care-56, the Family Empowerment Scale, the Family Support Scale and the Parenting Daily Hassles Scale. Consistent with previous research using the Measure of Processes of Care-56, 'respectful and supportive care' was the domain of care families rated to occur most and 'provision of general information' was the domain they rated to occur least. Significant positive relationships existed between families' ratings of family-centred care and feelings of empowerment. Being provided with general information was strongly correlated with family empowerment. Families' social support networks played an important role but support from professionals was most strongly correlated with families' experiences of family-centred care. Finally, families whose children's early intervention services were co-ordinated by a professional experienced significantly better care. The provision of general information and professional support are key components of family-centred early childhood intervention services. © 2011 Blackwell Publishing Ltd.

Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III)

PubMed Central

Turner-Stokes, Lynne; Ashford, Stephen; Jacinto, Jorge; Maisonobe, Pascal; Balcaitiene, Jovita; Fheodoroff, Klemens

2016-01-01

Objectives Describe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection cycles and concomitant therapies, on patient-centred goal attainment. Outline novel outcome assessment methods for ULIS-III and report initial evaluation data from goal setting in early stages of the study. Design Large international longitudinal cohort study of integrated upper limb spasticity management, including BoNT-A. Participants and setting ULIS-III is a 2-year study expected to enrol >1000 participants at 58 study centres across 14 countries. Interventions The study design is non-interventional and intended to reflect real-life clinical practice. It will describe injection practices and additional treatment strategies, and record clinical decision-making in a serial approach to long-term spasticity management. Outcome measures ULIS-III will use a goal-directed approach to selection of targeted standardised measures to capture the diversity of presentation, goals and outcomes. ULIS-III will implement the Upper Limb Spasticity Index, a battery of assessments including a structured approach to goal attainment scaling (Goal Attainment Scaling—Evaluation of Outcomes for Upper Limb Spasticity tool), alongside a limited set of standardised measures, chosen according to patients' selected goal areas. Concomitant therapy inputs, patient satisfaction with engagement in goal setting, health economic end points and health-related quality of life data will also be captured. Results of initial evaluation of goal quality Recruitment started in January 2015. By June 2015, 58 sites had been identified and initial data collected for 79 patients across 13 sites in 3 countries. Goal setting data were quality-checked and centres rated on the basis of function-related and Specific, Measurable, Achievable, Realistic, Timed (SMART) characteristics of goal statements. Overall, 11/13 centres achieved the highest rating (A++). Conclusions ULIS-III will provide valuable information regarding treatment of and outcomes from real-life upper limb spasticity management worldwide. Trial registration number NCT02454803; Pre-results. PMID:27315835

A review of patient-centred post-fracture interventions in the context of theories of health behaviour change.

PubMed

Sujic, R; Gignac, M A; Cockerill, R; Beaton, D E

2011-08-01

The purpose of this literature review is to determine whether and to what extent current post-fracture osteoporosis interventions utilize theories of health behaviour change and whether those that are theory-based are more successful in producing desired behaviour changes. Studies were identified by applying additional criteria to the final selection stage of a systematic review of non-surgical osteoporosis interventions in the orthopaedic environment. We identified 42 primary studies targeted at patients and improving post-fracture osteoporosis care. As well as describing the studies (in terms of design, population, interventions, outcomes), we focused on theoretical framework and elements of behaviour change models. The 42 studies included in this review utilized a variety of post-fracture interventions; however, none of them reported using an underlying theoretical base. Only three studies drew on what we felt to be elements of a theoretical framework. The lack of theoretically based studies points to a currently under-utilized area of behaviour change research that could be applied to post-fracture interventions in order to make them more effective. Despite an abundance of literature supporting theories of behaviour change, post-fracture osteoporosis interventions do not report utilizing these theories. Theories of behaviour change could be applied to post-fracture osteoporosis interventions to explain why patients initiate osteoporosis management. Future research should explore the application of theories of health behaviour change to post-fracture interventions.

Malaria epidemiology in Lihir Island, Papua New Guinea

PubMed Central

2013-01-01

Background Plasmodium vivax and Plasmodium falciparum malaria remain highly endemic in the Pacific Islands including Lihir Island, Papua New Guinea. Lihir Gold Limited is conducting mining activities and funded an integrated vector control intervention within the villages surrounding the mine. The aim of this study was to assess the impact of such programme by comparing the epidemiological trends of malaria in different parts of the island. Methods Two cross-sectional surveys were conducted before and after the intervention (2006–2010) to determine malaria prevalence in mine-impact (MI) and non-MI areas. Incidence of malaria was estimated for the Lihir Medical Centre catchment area using island population denominators and a health-centre passive case detection ongoing from 2006–2011. Results A total of 2,264 and 1,653 children < 15 were surveyed in the cross-sectional studies. The prevalence of any malaria parasitaemia initially was 31.5% in MI areas and, 34.9% in non-MI (POR 1.17; 95 CI 0.97 – 1.39). After four years there was a significant reduction in prevalence in the MI areas (5.8%; POR 0.13, 95 CI 0.09–0.20), but reduction was less marked in non-MI areas (26.9%; POR 0.69, 95 CI 0.58-0.81). 28,747 patients were included in the evaluation of incidence trends and overall malaria in local Lihirian population in MI areas declined over time, while it remained at similar high levels among migrants. The age-incidence analysis showed that for each higher age range the malaria incidence declines compared to that of the previous stratum. Conclusions There was a substantial reduction in prevalence and incidence rates of both P. vivax and P. falciparum in the mining area following implementation of a malaria control intervention, which was not seen in the area outside the mining activities. PMID:23497296

Application of dried blood spots to determine vitamin D status in a large nutritional study with unsupervised sampling: the Food4Me project.

PubMed

Hoeller, Ulrich; Baur, Manuela; Roos, Franz F; Brennan, Lorraine; Daniel, Hannelore; Fallaize, Rosalind; Forster, Hannah; Gibney, Eileen R; Gibney, Mike; Godlewska, Magdalena; Hartwig, Kai; Kolossa, Silvia; Lambrinou, Christina P; Livingstone, Katherine M; Lovegrove, Julie A; Macready, Anna L; Manios, Yannis; Marsaux, Cyril F M; Martinez, J Alfredo; Celis-Morales, Carlos; Moschonis, George; Navas-Carretero, Santiago; O'Donovan, Clare B; San-Cristobal, Rodrigo; Saris, Wim H M; Surwiłło, Agnieszka; Traczyk, Iwona; Tsirigoti, Lydia; Walsh, Marianne C; Woolhead, Clara; Mathers, John C; Weber, Peter

2016-01-28

An efficient and robust method to measure vitamin D (25-hydroxy vitamin D3 (25(OH)D3) and 25-hydroxy vitamin D2 in dried blood spots (DBS) has been developed and applied in the pan-European multi-centre, internet-based, personalised nutrition intervention study Food4Me. The method includes calibration with blood containing endogenous 25(OH)D3, spotted as DBS and corrected for haematocrit content. The methodology was validated following international standards. The performance characteristics did not reach those of the current gold standard liquid chromatography-MS/MS in plasma for all parameters, but were found to be very suitable for status-level determination under field conditions. DBS sample quality was very high, and 3778 measurements of 25(OH)D3 were obtained from 1465 participants. The study centre and the season within the study centre were very good predictors of 25(OH)D3 levels (P<0·001 for each case). Seasonal effects were modelled by fitting a sine function with a minimum 25(OH)D3 level on 20 January and a maximum on 21 July. The seasonal amplitude varied from centre to centre. The largest difference between winter and summer levels was found in Germany and the smallest in Poland. The model was cross-validated to determine the consistency of the predictions and the performance of the DBS method. The Pearson's correlation between the measured values and the predicted values was r 0·65, and the sd of their differences was 21·2 nmol/l. This includes the analytical variation and the biological variation within subjects. Overall, DBS obtained by unsupervised sampling of the participants at home was a viable methodology for obtaining vitamin D status information in a large nutritional study.

Three-dimensional printing in cardiac surgery and interventional cardiology: a single-centre experience.

PubMed

Schmauss, Daniel; Haeberle, Sandra; Hagl, Christian; Sodian, Ralf

2015-06-01

In individual cases, routine preoperative imaging might not be sufficient for optimal planning of cardiovascular procedures. Three-dimensional printing (3D), a widely used technique to build life-like replicas of anatomical structures that has proven value in different medical disciplines, might overcome these shortcomings. However, data on 3D printing in cardiovascular medicine are limited to single reports. This stimulated us to present our single-centre experience with 3D printing models in cardiac surgery and interventional cardiology. Between the years 2006 and 2013, we fabricated 3D printing models using preoperative computed tomography or magnetic resonance imaging data in paediatric and adult cardiac surgery, as well as interventional cardiology. We present the 8 most representative cases. The models were very helpful for perioperative planning and orientation, as well as simulation of procedures due to the exact and life-like illustration of the cardiovascular anatomy. The fabrication of 3D printing models is feasible for perioperative planning and simulation in a variety of complex cases in paediatric and adult cardiac surgery, as well as in interventional cardiology. Further studies including more patients and providing more data are expected to demonstrate that the use of 3D printing may decrease morbidity and mortality of complex, non-routine procedures in cardiovascular medicine. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program.

PubMed

Butel, Jean; Braun, Kathryn L; Novotny, Rachel; Acosta, Mark; Castro, Rose; Fleming, Travis; Powers, Julianne; Nigg, Claudio R

2015-12-01

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children's Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p < 0.001), and intervention improvement opportunities were identified through data review and group discussion. Fidelity for the multi-level, multi-component, multi-site CHL intervention was successfully assessed, identifying adaptations as well as ways to improve intervention delivery prior to the end of the intervention.

A hermeneutic phenomenological study of Belgian midwives' views on ideal and actual maternity care.

PubMed

Van Kelst, Liesbeth; Spitz, Bernard; Sermeus, Walter; Thomson, Ann M

2013-01-01

to explore midwives' views on ideal and actual maternity care. a qualitative hermeneutic phenomenological study based on the method of van Manen (1997) using individual in-depth interviews to gather data. Flanders, Belgium. 12 purposively sampled midwives, of whom nine from three different non-university hospitals and three independent midwives conducting home births. five major themes were identified: 'woman-centred care', 'cultural change', 'support', 'midwife and obstetrician as equal partners' and 'inter-collegial harmony'. In this paper 'woman-centred care', 'cultural change' and 'support' are discussed along with their subthemes. Midwives thought ideal maternity care should be woman-centred in which there were no unnecessary interventions, women were able to make an informed choice and there was continuity of care. Furthermore, ideal maternity care should be supported by midwifery education and an adequate staffing level. Also, a cultural change was wanted as actual maternity care was perceived to be highly medicalised. Barriers to achieving woman-centred care and possible strategies to overcome these were described. findings from this study were consistent with those of other studies on midwives' experience with obstetric-led care. Despite the medicalised care, midwives still held a woman-centred ideology. In order to be able to work according to their ideology, different barriers need to be addressed. Although midwives suggested strategies to overcome these barriers, some were considered to be very difficult to overcome. Copyright © 2011 Elsevier Ltd. All rights reserved.

Assessment of the quality of harms reporting in non-randomised studies and randomised controlled studies of topiramate for the treatment of epilepsy using CONSORT criteria.

PubMed

Carmichael, Katie; Nolan, Sarah J; Weston, Jennifer; Tudur Smith, Catrin; Marson, Anthony G

2015-08-01

Treatment decisions should be informed by high quality evidence of both the potential benefit and harms of treatment alternatives. Randomised controlled trials (RCTs) provide the best evidence regarding benefits; however information relating to serious, rare and long-term harms is usually available only from non-randomised studies (NRSs). The aim of this study was to use a checklist based on the CONSORT (Consolidating Standards for Reporting Trials) extension for harms recommendations to assess the quality of reporting of harms data in both NRSs and RCTs of antiepileptic drugs, using studies of topiramate as an example. Seventy-eight studies were included from an online search of seven databases. Harms data was extracted from each study using a 25-point checklist. The mean number of items met was 11.5 (SD 2.96) per study. Commercially funded studies met on average 12.7 items and non-commercially funded studies met 10.08 (p value < 0.001). RCTs met on average 13.0 items and NRSs met 10.8 (p = 0.001). Multi-centre studies and commercially funded studies met significantly more items than single centre and non-commercially funded studies respectively. There was no significant difference in the mean number of items met by studies that had included adult vs. child participants, or studies published pre- vs. post-CONSORT extension for harms in 2004. Reporting of harms is significantly better in RCTs than in NRSs of TPM, but is suboptimal overall and has not improved since the publication of CONSORT extension for harms in 2004. There is a need to improve the reporting of harms in order to better inform treatment decisions. Copyright © 2015 Elsevier B.V. All rights reserved.

PubMed Central

CICIRIELLO, E.

2016-01-01

SUMMARY Non-uniform, late, or inappropriate care of childhood with permanent hearing impairment (PHI) predisposes many children to develop communicative- behaviour problems and impaired psychosocial adjustment that can persist in adolescence and adulthood.In March 2014, the CCM (Centro Controllo Malattie or Disease Control Centre) of the Italian Ministry of Health funded a project entitled " Preventing Communication Disorders: a Regional Program for Early Identification, Intervention and Care of Hearing Impaired Children". The project involved 5 tertiary centres with UNHS programs formally approved by the Region. The main purpose of the project is to define and launch an integrated regionally-based public health model for identification, diagnosis and intervention of childhood PHI. The first phase of the project investigated the state of art and produced recommendations for positive changes in identification, diagnosis, therapy and care of childhood PHI in Italy, taking into account diagnostic and treatment innovations, family empowerment, treatment alliance and an interdisciplinary approach. Recommendations drawn from this initial phase will represent the basis for a regional system for early intervention that is validated, integrated and shared between the five regions. PMID:27054384

Prevalence of maternal anaemia and its predictors: a multi-centre study.

PubMed

Barroso, Filipa; Allard, Shubha; Kahan, Brennan C; Connolly, Catriona; Smethurst, Heather; Choo, Louise; Khan, Khalid; Stanworth, Simon

2011-11-01

To investigate the prevalence, predictors, and management of anaemia in pregnancy. A multi centre study across 11 maternity units in the UK. Data were collected over a two week study period in 2008 on maternal history, haemoglobin (Hb) and ferritin concentrations, iron therapy during pregnancy and in the postpartum period. Logistic regression models were used to explore factors associated with anaemia during pregnancy. Main outcomes included anaemia, defined as Hb<11 g/dl at booking, Hb<10.5 g/dl in subsequent antenatal visits, and Hb<10 g/dl postnatally. Completed data were received on 2103 of 2155 women (97% completion rate). Of these, 24.4% (502) (95% CI 22.5-26.2%) were anaemic at some stage during the antenatal period. Predictors for having anaemia by 32 weeks gestation included young maternal age (odds ratio 1.96, 95% CI 1.38-2.79), non-white ethnic origin (odds ratios varied 1.37-2.89 depending on ethnic origin) and increasing parity (odds ratio 1.24, 95% CI 1.08-1.41). Of women who had postnatal Hb levels checked, 30% (309/1031) were anaemic and, depending on centre, 16% to 86% of these received iron therapy. Anaemia was reported in nearly one in four women in the antenatal period, and nearly one in three of the women who had a postpartum Hb checked. Despite national guidelines, there was considerable variation in administration of iron including low utilisation of parenteral iron therapy. Future research needs to focus on the consequences of iron deficiency anaemia for maternal and infant health outcomes and effectiveness of implementation strategies to reduce anaemia. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Interventions to improve care coordination between primary healthcare and oncology care providers: a systematic review.

PubMed

Tomasone, Jennifer R; Brouwers, Melissa C; Vukmirovic, Marija; Grunfeld, Eva; O'Brien, Mary Ann; Urquhart, Robin; Walker, Melanie; Webster, Fiona; Fitch, Margaret

2016-01-01

Coordination of patient care between primary care and oncology care providers is vital to care quality and outcomes across the cancer continuum, yet it is known to be challenging. We conducted a systematic review to evaluate current or new models of care and/or interventions aimed at improving coordination between primary care and oncology care providers for patients with adult breast and/or colorectal cancer. MEDLINE, EMBASE, CINAHL, Cochrane Library Database of Systematic Reviews, and the Centre for Reviews and Dissemination were searched for existing English language studies published between January 2000 and 15 May 2015. Systematic reviews, meta-analyses, randomised controlled trials (RCTs) and non-randomised studies were included if they evaluated a specific model/intervention that was designed to improve care coordination between primary care and oncology care providers, for any stage of the cancer continuum, for patients with adult breast and/or colorectal cancer. Two reviewers extracted data and assessed risk of bias. Twenty-two studies (5 systematic reviews, 6 RCTs and 11 non-randomised studies) were included and varied with respect to the targeted phase of the cancer continuum, type of model or intervention tested, and outcome measures. The majority of studies showed no statistically significant changes in any patient, provider or system outcomes. Owing to conceptual and methodological limitations in this field, the review is unable to provide specific conclusions about the most effective or preferred model/intervention to improve care coordination. Imprecise results that lack generalisability and definitiveness provide limited evidence to base the development of future interventions and policies. CRD42015025006.

Claims for fertility interventions: a systematic assessment of statements on UK fertility centre websites

PubMed Central

Spencer, E A; Mahtani, K R; Goldacre, B; Heneghan, C

2016-01-01

Objectives Fertility services in the UK are offered by over 200 Human Fertilisation and Embryology Authority (HFEA)-registered NHS and private clinics. While in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) form part of the National Institute for Health and Care Excellence (NICE) guidance, many further interventions are offered. We aimed to record claims of benefit for interventions offered by fertility centres via information on the centres' websites and record what evidence was cited for these claims. Methods We obtained from HFEA a list of all UK centres providing fertility treatments and examined their websites. We listed fertility interventions offered in addition to standard IVF and ICSI and recorded statements about interventions that claimed or implied improvements in fertility in healthy women. We recorded which claims were quantified, and the evidence cited in support of the claims. Two reviewers extracted data from websites. We accessed websites from 21 December 2015 to 31 March 2016. Results We found 233 websites for HFEA-registered fertility treatment centres, of which 152 (65%) were excluded as duplicates or satellite centres, 2 were andrology clinics and 5 were unavailable or under construction websites. In total, 74 fertility centre websites, incorporating 1401 web pages, were examined for claims. We found 276 claims of benefit relating to 41 different fertility interventions made by 60 of the 74 centres (median 3 per website; range 0 to 10). Quantification was given for 79 (29%) of the claims. 16 published references were cited 21 times on 13 of the 74 websites. Conclusions Many fertility centres in the UK offer a range of treatments in addition to standard IVF procedures, and for many of these interventions claims of benefit are made. In most cases, the claims are not quantified and evidence is not cited to support the claims. There is a need for more information on interventions to be made available by fertility centres, to support well-informed treatment decisions. PMID:27890866

Making physiological birth possible: birth at a free-standing birth centre in Berlin.

PubMed

Stone, Nancy I

2012-10-01

the practical training in midwifery education in Germany takes place predominantly in hospital delivery wards, where high rates of intervention and caesarean section prevail. When midwives practice birth assistance at free-standing birth centres, they have to make adjustments to what they learned in the clinic to support women without the interventions common to hospital birth. the primary aim of this study was to investigate and describe the approach of midwives practicing birth assistance at a free-standing birth centre. a qualitative approach to data collection and analysis with grounded theory was used which included semi-structured expert interviews and participant observation. Five midwives were interviewed and nine births observed in the research period. The setting was a free-standing birth centre in a large German city with approximately 115 births per year. the midwives all had to re-learn birth assistance when commencing work outside of the hospital. However, having been trained predominantly in hospital maternity wards, they have retained many aspects characteristic of their training. The midwives use technology, although minimal, and medical discourse in combination with 1:1, woman-centred care. The birthing woman and midwife share authority at birth. The fetus is treated as an ally of the mother, suited for birth and cooperative. Through use of objective and subjective criteria, the midwives have their own approach to making physiological birth possible. to prepare midwives to support low-intervention birth, it is necessary to include training in birth assistance with women who birth physiologically, without interventions common to hospital birth. The results of this study would also suggest that the rate of interventions in hospital could be reduced if midwives gain more experience with women birthing without the above-mentioned interventions. Copyright © 2012 Elsevier Ltd. All rights reserved.

Communication training for centre-based carers of children with severe or profound disabilities in the Western Cape, South Africa.

PubMed

Geiger, Martha

2012-01-01

The purpose of this paper is to provide a preliminary, qualitative review of an approach to training centre-based carers in supporting basic communication development and providing communication opportunities for the children with severe and profound disabilities in their care. In South Africa, these children are often the most neglected in terms of planning and providing appropriate interventions. For those with severe communication disabilities, an additional lack is in the area of the basic human right to meaningful interactions and communication. Sustainable strategies to provide opportunities for basic communication development of these children are urgently sought. Several effective international and local parent training programmes have been developed, but the urgent need remains to train centre-based carers who are taking care of groups of diversely disabled children in severely under-resourced settings . Non-profit organisations (NPOs) have been exploring practical centre-based approaches to skills sharing in physical rehabilitation, activities for daily living, feeding and support for basic communication development. As a freelance speech therapist contracted by four NPOs to implement hands-on training in basic communication for centre-based carers of non-verbal children, the author describes a training approach that evolved over three years, in collaboration with the carers and centre managements. Implications for training (for speech therapists and for community-based rehabilitation workers) and for further research are identified.

Decrease social inequalities return-to-work: development and design of a randomised controlled trial among women with breast cancer

PubMed Central

2014-01-01

Background Despite the improvement in the care management, women cancer patients who are still in employment find themselves for the most part obliged to stop working while they are having treatment. Their return-to-work probability is impacted by numerous psychosocial factors. The objective is to describe the development and the content of an intervention aimed to facilitate the return to work of female breast cancer patients and in particular the women in the most precarious situations through early active individualised psychosocial support (APAPI). Methods The intervention proposed is made up of 4 interviews with a psychologist at the hospital, distributed over the year according to the diagnosis and conducted on the same day as a conventional follow-up consultation, then a consultation with a specialist job retention physician. We expect, in the first instance, that this intervention will reduce the social inequalities of the return-to-work rate at 12 months. The EPICES score will enable the population to be broken down according to the level of social precariousness. The other expected results are the reduction of the social inequalities in the quality of the return to work at 18 and 24 months and the disparities between the individual and collective resources of the patients. This intervention is assessed in the context of a controlled and randomised multi-centre study. The patients eligible are women aged between 18 and 55 years with a unilateral breast cancer with local extension exclusively, having received surgery followed by adjuvant chemotherapy, in employment at the time of the diagnosis and dealt with by one of the 2 investigating centres. Discussion It is essential to assess this type of intervention before envisaging its generalisation. The study set in place will enable us to measure the impact of this intervention aiming to facilitate the return to work of breast cancer patients, in particular for those who suffer from social fragility, compared with the standard care. PMID:24742314

Typology of birth centres in the Netherlands using the Rainbow model of integrated care: results of the Dutch Birth Centre Study.

PubMed

Boesveld, Inge C; Bruijnzeels, Marc A; Hitzert, Marit; Hermus, Marieke A A; van der Pal-de Bruin, Karin M; van den Akker-van Marle, M E; Steegers, Eric A P; Franx, Arie; de Vries, Raymond G; Wiegers, Therese A

2017-06-21

The goal of integrated care is to offer a continuum of care that crosses the boundaries of public health, primary, secondary, and tertiary care. Integrated care is increasingly promoted for people with complex needs and has also recently been promoted in maternity care systems to improve the quality of care. Especially when located near an obstetric unit, birth centres are considered to be ideal settings for the realization of integrated care. At present, however, we know very little about the degree of integration in these centres and we do not know if increased levels of integration improve the quality of the care delivered. The Dutch Birth Centre Study is designed to evaluate birth centres and their contribution to the Dutch maternity care system. The aim of this particular sub-study is to classify birth centres in clusters with similar characteristics based on integration profiles, to support the evaluation of birth centre care. This study is based on the Rainbow Model of Integrated Care. We used a survey followed by qualitative interviews in 23 birth centres in the Netherlands to determine which integration profiles can be distinguished and to describe their discriminating characteristics. Cluster analysis was used to classify the birth centres. Birth centres were classified into three clusters: 1)"Mono-disciplinary-oriented birth centres" (n = 10): which are mainly owned by primary care organizations and established as physical facilities to provide an alternative birthplace for low risk births; 2) "Multi-disciplinary-oriented birth centres" (n = 6): which are mainly multi-disciplinary oriented and can be regarded as facilities to give birth, with a focus on integrated birth care; 3) "Mixed Cluster of birth centres" (n = 7): which have a range of organizational forms that differentiate them from centres in the other clusters. We identified a recognizable classification, with similar characteristics between birth centres in the clusters. The results of this study can be used to relate integration profiles of birth centres to quality of care, costs, and perinatal outcomes. This assessment makes it possible to develop recommendations with regard to the type and degree of integration of Dutch birth centres in the future.

The effects of a multi-component higher-functioning autism anti-stigma program on adolescent boys.

PubMed

Staniland, Jessica J; Byrne, Mitchell K

2013-12-01

A six-session higher-functioning autism anti-stigma program incorporating descriptive, explanatory and directive information was delivered to adolescent boys and the impact upon knowledge, attitudes and behavioural intentions towards peers with autism was evaluated. Participants were seventh-, eighth- and ninth-grade students (N = 395) from regular classes in a mainstream school. Two-eighth-grade classes were randomly allocated to the intervention condition and all remaining students were either allocated to the no-intervention peer or no-intervention non-peer condition. The anti-stigma program improved the knowledge and attitudes, but not the behavioural intentions of participants towards their peers with autism. Knowledge and attitudinal changes were maintained at follow-up. There were no spill-over effects of the program to non-targeted students. These results provide some preliminary evidence for the effectiveness of multi-session anti-stigma programs incorporating combined information for adolescent students in inclusive educational environments.

Interventions for disorder and severe intoxication in and around licensed premises, 1989-2009.

PubMed

Brennan, Iain; Moore, Simon C; Byrne, Ellie; Murphy, Simon

2011-04-01

To systematically review rigorous evaluation studies into the effectiveness of interventions in and around licensed premises that aimed to reduce severe intoxication and disorder. A systematic search was conducted. Papers that rigorously evaluated interventions based in and around licensed premises to reduce disorder or intoxication were included. Fifteen studies were identified, three randomized controlled trials and 12 non-randomized quasi-experimental evaluations. Outcome measures were intoxication (n = 6), disorder (n = 6) and intoxication and disorder (n = 3). Interventions included responsible beverage service training (n = 5), server violence prevention training (n = 1), enhanced enforcement of licensing regulations (n = 1), multi-level interventions (n = 5), licensee accords (n = 2) and a risk-focused consultation (n = 1). Intervention effects varied, even across studies using similar interventions. Server training courses that are designed to reduce disorder have some potential, although there is a lack of evidence to support their use to reduce intoxication and the evidence base is weak. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Outdoor Experiential Environmental Education: An Adult-Centred Intervention for the Affective Domain

ERIC Educational Resources Information Center

Okur-Berberoglu, Emel

2017-01-01

The aim of this research is to evaluate the impact of an outdoor experiential environmental education (OEEE) programme on the affective domain of adult participants--namely, in-service teachers from Turkey. Data collection methods such as; psychodrama, non-participant observation, open-ended questions and content analysis were used within a…

Barriers and facilitators to the implementation of person-centred care in different healthcare contexts.

PubMed

Moore, Lucy; Britten, Nicky; Lydahl, Doris; Naldemirci, Öncel; Elam, Mark; Wolf, Axel

2017-12-01

To empower patients and improve the quality of care, policy-makers increasingly adopt systems to enhance person-centred care. Although models of person-centredness and patient-centredness vary, respecting the needs and preferences of individuals receiving care is paramount. In Sweden, as in other countries, healthcare providers seek to improve person-centred principles and address gaps in practice. Consequently, researchers at the University of Gothenburg Centre for Person-Centred Care are currently delivering person-centred interventions employing a framework that incorporates three routines. These include eliciting the patient's narrative, agreeing a partnership with shared goals between patient and professional, and safeguarding this through documentation. To explore the barriers and facilitators to the delivery of person-centred care interventions, in different contexts. Qualitative interviews were conducted with a purposeful sample of 18 researchers from seven research studies across contrasting healthcare settings. Interviews were transcribed, translated and thematically analysed, adopting some basic features of grounded theory. The ethical code of conduct was followed and conformed to the ethical guidelines adopted by the Swedish Research Council. Barriers to the implementation of person-centred care covered three themes: traditional practices and structures; sceptical, stereotypical attitudes from professionals; and factors related to the development of person-centred interventions. Facilitators included organisational factors, leadership and training and an enabling attitude and approach by professionals. Trained project managers, patients taking an active role in research and adaptive strategies by researchers all helped person-centred care delivery. At the University of Gothenburg, a model of person-centred care is being initiated and integrated into practice through research. Knowledgeable, well-trained professionals facilitate the routines of narrative elicitation and partnership. Strong leadership and adaptive strategies are important for overcoming existing practices, routines and methods of documentation. This study provides guidance for practitioners when delivering and adapting person-centred care in different contexts. © 2016 The Authors. Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.

Research on treating neuropsychiatric symptoms of advanced dementia with non-pharmacological strategies, 1998–2008: a systematic literature review

PubMed Central

Kverno, Karan S.; Black, Betty S.; Nolan, Marie T.; Rabins, Peter V.

2011-01-01

Background Advanced dementia is characterized by severe cognitive and functional impairments that lead to almost total dependency in self-care. Neuropsychiatric symptoms (NPS) are common in advanced dementia, diminishing quality of life and increasing the care burden. The challenge for health care providers is to find safe and effective treatments. Non-pharmacological interventions offer the potential for safer alternatives to pharmacotherapy, but little is known about their efficacy. This review evaluates the published literature on non-pharmacological interventions for treating NPS in advanced dementia. Methods A literature search was undertaken to find non-pharmacological intervention studies published between 1998 and 2008 that measured NPS outcomes in individuals diagnosed with advanced dementia. Strict inclusion criteria initially required that all study participants have severe or very severe dementia, but this range was later broadened to include moderately severe to very severe stages. Results Out of 215 intervention studies, 21 (9.8%) specifically focused on treatments for individuals with moderately severe to very severe dementia. The studies provide limited moderate to high quality evidence for the use of sensory-focused strategies, including aroma, preferred or live music, and multi-sensory stimulation. Emotion-oriented approaches, such as simulated presence may be more effective for individuals with preserved verbal interactive capacity. Conclusions Most studies of interventions for dementia-related NPS have focused on individuals with mild to moderate cognitive impairment. Individuals with severe cognitive impairment do not necessarily respond to NPS treatments in the same manner. Future studies should be specifically designed to further explore the stage-specific efficacy of non-pharmacological therapies for patients with advanced dementia. Areas of particular need for further research include movement-based therapies, hands-on (touch) therapies, and interventions that can be provided during personal care routines. Interventions appear to work best when they are tailored to balance individual arousal patterns. PMID:19586562

Research on treating neuropsychiatric symptoms of advanced dementia with non-pharmacological strategies, 1998-2008: a systematic literature review.

PubMed

Kverno, Karan S; Black, Betty S; Nolan, Marie T; Rabins, Peter V

2009-10-01

Advanced dementia is characterized by severe cognitive and functional impairments that lead to almost total dependency in self-care. Neuropsychiatric symptoms (NPS) are common in advanced dementia, diminishing quality of life and increasing the care burden. The challenge for health care providers is to find safe and effective treatments. Non-pharmacological interventions offer the potential for safer alternatives to pharmacotherapy, but little is known about their efficacy. This review evaluates the published literature on non-pharmacological interventions for treating NPS in advanced dementia. A literature search was undertaken to find non-pharmacological intervention studies published between 1998 and 2008 that measured NPS outcomes in individuals diagnosed with advanced dementia. Strict inclusion criteria initially required that all study participants have severe or very severe dementia, but this range was later broadened to include moderately severe to very severe stages. Out of 215 intervention studies, 21 (9.8%) specifically focused on treatments for individuals with moderately severe to very severe dementia. The studies provide limited moderate to high quality evidence for the use of sensory-focused strategies, including aroma, preferred or live music, and multi-sensory stimulation. Emotion-oriented approaches, such as simulated presence may be more effective for individuals with preserved verbal interactive capacity. Most studies of interventions for dementia-related NPS have focused on individuals with mild to moderate cognitive impairment. Individuals with severe cognitive impairment do not necessarily respond to NPS treatments in the same manner. Future studies should be specifically designed to further explore the stage-specific efficacy of non-pharmacological therapies for patients with advanced dementia. Areas of particular need for further research include movement-based therapies, hands-on (touch) therapies, and interventions that can be provided during personal care routines. Interventions appear to work best when they are tailored to balance individual arousal patterns.

Optimum random and age replacement policies for customer-demand multi-state system reliability under imperfect maintenance

NASA Astrophysics Data System (ADS)

Chen, Yen-Luan; Chang, Chin-Chih; Sheu, Dwan-Fang

2016-04-01

This paper proposes the generalised random and age replacement policies for a multi-state system composed of multi-state elements. The degradation of the multi-state element is assumed to follow the non-homogeneous continuous time Markov process which is a continuous time and discrete state process. A recursive approach is presented to efficiently compute the time-dependent state probability distribution of the multi-state element. The state and performance distribution of the entire multi-state system is evaluated via the combination of the stochastic process and the Lz-transform method. The concept of customer-centred reliability measure is developed based on the system performance and the customer demand. We develop the random and age replacement policies for an aging multi-state system subject to imperfect maintenance in a failure (or unacceptable) state. For each policy, the optimum replacement schedule which minimises the mean cost rate is derived analytically and discussed numerically.

Interventions to improve fundamental motor skills in pre-school aged children: A systematic review and meta-analysis.

PubMed

Van Capelle, Abbey; Broderick, Carolyn R; van Doorn, Nancy; E Ward, Rachel; Parmenter, Belinda J

2017-07-01

Mastery in -fundamental motor skills (FMS) is associated with increased physical activity (PA) in school-aged children; however, there is limited research on pre-schoolers (3-5 years). We aimed to evaluate interventions for improving FMS as well as PA. A search of electronic databases was conducted for controlled trials using PA interventions with FMS as outcomes in healthy pre-schoolers. Standardised mean difference (SMD), 95% confidence intervals and publication bias were calculated for each outcome using Revman 5.3. Twenty trials met inclusion criteria. In total, 4255 pre-schoolers were analysed with 854 completing a FMS intervention. Studies were categorised into three groups (i) Teacher-Led (TL)(n=13); (ii) Child-Centred (CC)(n=6) and (iii) Parent-Led (PL)(n=1). Mean age was 4.3±0.4 years, with equal gender distribution. Interventions ran for 21±17 weeks, 3±1 times per week for 35±17 minutes. TL interventions significantly improved overall FMS (SMD=0.14[0.06, 0.21]; p=0.0003), object control (SMD=0.47[0.15, 0.80]; p= 0.004), and locomotor skills (SMD=0.44[0.16, 0.73]; p=0.002), whereas CC interventions were not significant. There was a small, non-significant reduction in sedentary time (SMD=-0.35[-0.80, 0.10]; p= 0.12), and a large non-significant increase in PA (SMD=0.79[-0.83, 2.41]; p=0.34). PA interventions improve FMS in pre-schoolers; however, due to limited research, more study is needed on CC interventions. Targeting FMS development in pre-schoolers may promote higher PA levels and reduce sedentary time, however more study is needed. Copyright © 2017 Sports Medicine Australia. All rights reserved.

A person-centred intervention for providing information to parents of children with cancer. Experiences and effects.

PubMed

Ringnér, Anders; Karlsson, Stig; Hällgren Graneheim, Ulla

2015-06-01

The aim of this paper is to describe the experiences of participating in a person-centred information intervention aimed at parents of children with cancer. Eight parents participated in the intervention, beginning two months after their child's diagnosis. The intervention was based upon the representational approach to patient education and a mixed method approach was employed in the study. The experiences of parents and intervention nurses were captured via qualitative interviews and the effects of the intervention on parental psychosocial measures, primarily perceived stress, were evaluated using a single-case design with web-based questionnaires. Parents expressed high satisfaction with the intervention, as reported in the follow-up interviews and on the scale measuring satisfaction. However, no changes were seen in the quantitative measures of psychosocial distress. The nurses performing the intervention felt it was useful and feasible. A representational approach to providing person-centred information to parents of children with cancer was appreciated and considered feasible by both the parents and the intervention nurses. However, further research is needed considering the lack of effect on the parents' perceived stress. Copyright © 2014 Elsevier Ltd. All rights reserved.

Development of an optimised 1:1 physiotherapy intervention post first-time lumbar discectomy: a mixed-methods study.

PubMed

Rushton, A; White, L; Heap, A; Calvert, M; Heneghan, N; Goodwin, P

2016-02-25

To develop an optimised 1:1 physiotherapy intervention that reflects best practice, with flexibility to tailor management to individual patients, thereby ensuring patient-centred practice. Mixed-methods combining evidence synthesis, expert review and focus groups. Secondary care involving 5 UK specialist spinal centres. A purposive panel of clinical experts from the 5 spinal centres, comprising spinal surgeons, inpatient and outpatient physiotherapists, provided expert review of the draft intervention. Purposive samples of patients (n=10) and physiotherapists (n=10) (inpatient/outpatient physiotherapists managing patients with lumbar discectomy) were invited to participate in the focus groups at 1 spinal centre. A draft intervention developed from 2 systematic reviews; a survey of current practice and research related to stratified care was circulated to the panel of clinical experts. Lead physiotherapists collaborated with physiotherapy and surgeon colleagues to provide feedback that informed the intervention presented at 2 focus groups investigating acceptability to patients and physiotherapists. The focus groups were facilitated by an experienced facilitator, recorded in written and tape-recorded forms by an observer. Tape recordings were transcribed verbatim. Data analysis, conducted by 2 independent researchers, employed an iterative and constant comparative process of (1) initial descriptive coding to identify categories and subsequent themes, and (2) deeper, interpretive coding and thematic analysis enabling concepts to emerge and overarching pattern codes to be identified. The intervention reflected best available evidence and provided flexibility to ensure patient-centred care. The intervention comprised up to 8 sessions of 1:1 physiotherapy over 8 weeks, starting 4 weeks postsurgery. The intervention was acceptable to patients and physiotherapists. A rigorous process informed an optimised 1:1 physiotherapy intervention post-lumbar discectomy that reflects best practice. The developed intervention was agreed on by the 5 spinal centres for implementation in a randomised controlled trial to evaluate its effectiveness. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

PubMed Central

Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

2010-01-01

Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

Study participant reported outcomes of mental health interventions: results from a randomized controlled trial among survivors of systematic violence in southern Iraq.

PubMed

Mahmooth, Z; Weiss, W M; Zangana, G A S; Bolton, P

2018-01-01

Common mental health problems experienced by survivors of systematic violence include trauma, depression, and anxiety. A trial of mental health interventions by community mental health workers for survivors of systematic violence in southern Iraq showed benefits from two psychotherapies on trauma, depression, anxiety, and function: Common Elements Treatment Approach (CETA) and cognitive processing therapy (CPT). This study assessed whether other non-predetermined changes reported by intervention participants were more common than in the control group. The trial involved 342 participants (CETA: 99 intervention, 50 control; CPT: 129 intervention, 64 control). Sixteen intervention-related changes since enrollment were identified from free-listing interviews of 15 early therapy completers. The changes were then added as a new quantitative module to the follow-up questionnaire. The changes were organized into eight groupings by thematic analysis - family, social standing, anger management, interest in regular activities, optimism, feeling close to God, avoiding smoking and drugs, and physical health. All participants were interviewed with this module and responses were compared between intervention and control participants. Multi-level, multi-variate regression models showed CETA intervention subjects with significant, positive changes relative to CETA controls on most themes. CPT intervention subjects showed little to no change compared with CPT controls in most themes. Participants receiving CETA reported more positive changes from therapy compared with controls than did participants receiving CPT. This study suggests differential effects of psychotherapy beyond the predetermined clinical outcome measures and that identification of these effects should be part of intervention evaluations.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study

PubMed Central

2011-01-01

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596. PMID:22078490

Multi-centre parallel arm randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based cognitive behavioural approach to managing fatigue in people with multiple sclerosis.

PubMed

Thomas, Peter W; Thomas, Sarah; Kersten, Paula; Jones, Rosemary; Nock, Alison; Slingsby, Vicky; Green, Colin; Baker, Roger; Galvin, Kate; Hillier, Charles

2010-06-16

Fatigue is one of the most commonly reported and debilitating symptoms of multiple sclerosis (MS); approximately two-thirds of people with MS consider it to be one of their three most troubling symptoms. It may limit or prevent participation in everyday activities, work, leisure, and social pursuits, reduce psychological well-being and is one of the key precipitants of early retirement. Energy effectiveness approaches have been shown to be effective in reducing MS-fatigue, increasing self-efficacy and improving quality of life. Cognitive behavioural approaches have been found to be effective for managing fatigue in other conditions, such as chronic fatigue syndrome, and more recently, in MS. The aim of this pragmatic trial is to evaluate the clinical and cost-effectiveness of a recently developed group-based fatigue management intervention (that blends cognitive behavioural and energy effectiveness approaches) compared with current local practice. This is a multi-centre parallel arm block-randomised controlled trial (RCT) of a six session group-based fatigue management intervention, delivered by health professionals, compared with current local practice. 180 consenting adults with a confirmed diagnosis of MS and significant fatigue levels, recruited via secondary/primary care or newsletters/websites, will be randomised to receive the fatigue management intervention or current local practice. An economic evaluation will be undertaken alongside the trial. Primary outcomes are fatigue severity, self-efficacy and disease-specific quality of life. Secondary outcomes include fatigue impact, general quality of life, mood, activity patterns, and cost-effectiveness. Outcomes in those receiving the fatigue management intervention will be measured 1 week prior to, and 1, 4, and 12 months after the intervention (and at equivalent times in those receiving current local practice). A qualitative component will examine what aspects of the fatigue management intervention participants found helpful/unhelpful and barriers to change. This trial is the fourth stage of a research programme that has followed the Medical Research Council guidance for developing and evaluating complex interventions. What makes the intervention unique is that it blends cognitive behavioural and energy effectiveness approaches. A potential strength of the intervention is that it could be integrated into existing service delivery models as it has been designed to be delivered by staff already working with people with MS. Service users will be involved throughout this research. Current Controlled Trials ISRCTN76517470.

Methodological idiosyncracies, frameworks and challenges of non-pharmaceutical and non-technical treatment interventions.

PubMed

Schünemann, Holger J

2013-01-01

In this brief article which summarises a presentation given at the "6. Diskussionsforum zur Nutzenbewertung im Gesundheitswesen" of the German Ministry of Education and Research "Gesundheitsforschungsrat (GFR)" and the Institute for Quality and Efficiency in Healthcare (IQWiG) I will analyse some methodological idiosyncrasies of studies evaluating non-pharmacological non-technical interventions (NPNTI). I will focus on how the methodological framework of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group may support design and appraisal of NPNTI. Specific design features that may be of particular value in NPNTI research, such as expertise-based randomised controlled trials, will be briefly described. Finally, based on an example, I will argue that - despite the methodological idiosyncrasies - there is neither a sufficient reason to accept different standards for the assessment of the confidence in the evidence from NPNTI nor for using study designs that are less rigorous compared to "simpler" interventions but that special measures have to be taken to reduce the risk of bias. The example that will be used in this article will primarily come from the field of respiratory rehabilitation, a typical multi-component or complex intervention and by definition a complex NPNTI, which has been evaluated in many randomised controlled trials. (As supplied by publisher). Copyright © 2013. Published by Elsevier GmbH.

Maximising value from a United Kingdom Biomedical Research Centre: study protocol.

PubMed

Greenhalgh, Trisha; Ovseiko, Pavel V; Fahy, Nick; Shaw, Sara; Kerr, Polly; Rushforth, Alexander D; Channon, Keith M; Kiparoglou, Vasiliki

2017-08-14

Biomedical Research Centres (BRCs) are partnerships between healthcare organisations and universities in England. Their mission is to generate novel treatments, technologies, diagnostics and other interventions that increase the country's international competitiveness, to rapidly translate these innovations into benefits for patients, and to improve efficiency and reduce waste in healthcare. As NIHR Oxford BRC (Oxford BRC) enters its third 5-year funding period, we seek to (1) apply the evidence base on how best to support the various partnerships in this large, multi-stakeholder research system and (2) research how these partnerships play out in a new, ambitious programme of translational research. Organisational case study, informed by the principles of action research. A cross-cutting theme, 'Partnerships for Health, Wealth and Innovation' has been established with multiple sub-themes (drug development, device development, business support and commercialisation, research methodology and statistics, health economics, bioethics, patient and public involvement and engagement, knowledge translation, and education and training) to support individual BRC research themes and generate cross-theme learning. The 'Partnerships' theme will support the BRC's goals by facilitating six types of partnership (with patients and citizens, clinical services, industry, across the NIHR infrastructure, across academic disciplines, and with policymakers and payers) through a range of engagement platforms and activities. We will develop a longitudinal progress narrative centred around exemplar case studies, and apply theoretical models from innovation studies (Triple Helix), sociology of science (Mode 2 knowledge production) and business studies (Value Co-creation). Data sources will be the empirical research studies within individual BRC research themes (who will apply separately for NHS ethics approval), plus documentary analysis and interviews and ethnography with research stakeholders. This study has received ethics clearance through the University of Oxford Central University Research Ethics Committee. We anticipate that this work will add significant value to Oxford BRC. We predict accelerated knowledge translation; closer alignment of the innovation process with patient priorities and the principles of responsible, ethical research; reduction in research waste; new knowledge about the governance and activities of multi-stakeholder research partnerships and the contexts in which they operate; and capacity-building that reflects the future needs of a rapidly-evolving health research system.

Computerized detection of breast lesions in multi-centre and multi-instrument DCE-MR data using 3D principal component maps and template matching

NASA Astrophysics Data System (ADS)

Ertas, Gokhan; Doran, Simon; Leach, Martin O.

2011-12-01

In this study, we introduce a novel, robust and accurate computerized algorithm based on volumetric principal component maps and template matching that facilitates lesion detection on dynamic contrast-enhanced MR. The study dataset comprises 24 204 contrast-enhanced breast MR images corresponding to 4034 axial slices from 47 women in the UK multi-centre study of MRI screening for breast cancer and categorized as high risk. The scans analysed here were performed on six different models of scanner from three commercial vendors, sited in 13 clinics around the UK. 1952 slices from this dataset, containing 15 benign and 13 malignant lesions, were used for training. The remaining 2082 slices, with 14 benign and 12 malignant lesions, were used for test purposes. To prevent false positives being detected from other tissues and regions of the body, breast volumes are segmented from pre-contrast images using a fast semi-automated algorithm. Principal component analysis is applied to the centred intensity vectors formed from the dynamic contrast-enhanced T1-weighted images of the segmented breasts, followed by automatic thresholding to eliminate fatty tissues and slowly enhancing normal parenchyma and a convolution and filtering process to minimize artefacts from moderately enhanced normal parenchyma and blood vessels. Finally, suspicious lesions are identified through a volumetric sixfold neighbourhood connectivity search and calculation of two morphological features: volume and volumetric eccentricity, to exclude highly enhanced blood vessels, nipples and normal parenchyma and to localize lesions. This provides satisfactory lesion localization. For a detection sensitivity of 100%, the overall false-positive detection rate of the system is 1.02/lesion, 1.17/case and 0.08/slice, comparing favourably with previous studies. This approach may facilitate detection of lesions in multi-centre and multi-instrument dynamic contrast-enhanced breast MR data.

Four years of experience with the Australian kidney paired donation programme.

PubMed

Cantwell, Linda; Woodroffe, Claudia; Holdsworth, Rhonda; Ferrari, Paolo

2015-03-01

New approaches to increase kidney transplantation rates through expansion of live donor kidney transplantation have become necessary due to ongoing shortage of deceased donor organs. These strategies include desensitization in antibody-incompatible transplants to overcome the barrier of blood group incompatibility or human leucocyte antigen antibodies between recipient and donor and kidney paired donation (KPD) programmes. In KPD, a kidney transplant candidate with an incompatible live donor joins a registry of other incompatible pairs in order to find potentially compatible transplant solutions. To match the largest possible number of donor-recipient pairs while minimizing immunologic risk, KPD programmes use sophisticated algorithms to identify suitable matches with simultaneous two-way or more complex multi-way exchanges as well as including non-directed anonymous donors to start a chain of compatible transplantations. Because of the significant immunologic barriers when fewer donor options are available, the optimal solution for difficult-to-match, highly sensitized patients is access to more potential donors using large multi-centre or national KPD registries. This review focuses on the first 4 years of experience with the Australian multi-centre KPD programme that was established in October 2010. © 2014 Asian Pacific Society of Nephrology.

Serological markers of hepatitis B in patients with alcoholic liver disease: a multi-centre survey

PubMed Central

Hislop, WS; Follett, EAC; Bouchier, IAD; MacSween, RNM

1981-01-01

In a study of 195 patients derived from five centres in northern Britain and with histologically confirmed alcoholic liver disease we have found an increased prevalence of serological markers of hepatitis B. This increased prevalence was found in each of the five centres; the overall frequency ranged from 11% sero-positivity in fatty liver, 12% in alcoholic hepatitis and 27% in cirrhosis. PMID:7276216

Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial

PubMed Central

Worthley, Stephen G.; Tsioufis, Costas P.; Worthley, Matthew I.; Sinhal, Ajay; Chew, Derek P.; Meredith, Ian T.; Malaiapan, Yuvi; Papademetriou, Vasilios

2013-01-01

Aims Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN™ multi-electrode system. Methods and results We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN™ system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by −28/10, −27/10 and −26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Conclusion Renal sympathetic denervation, using the EnligHTN™ multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN™ system delivers a promising therapy for the treatment of drug-resistant hypertension. PMID:23782649

Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial.

PubMed

Worthley, Stephen G; Tsioufis, Costas P; Worthley, Matthew I; Sinhal, Ajay; Chew, Derek P; Meredith, Ian T; Malaiapan, Yuvi; Papademetriou, Vasilios

2013-07-01

Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN(™) multi-electrode system. We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by -28/10, -27/10 and -26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Renal sympathetic denervation, using the EnligHTN multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN system delivers a promising therapy for the treatment of drug-resistant hypertension.

Identification of innovation in public health.

PubMed

Fung, Matthew; Simpson, Sue; Packer, Claire

2011-03-01

The National Horizon Scanning Centre provides national policy-makers in England with forewarning about emerging and new health technologies. This includes public health interventions (PHIs) but identification of these interventions is not always easy. The aim of this study was to explore the meaning and define innovation in public health. We used a quasi-Delphi method with questionnaire 1 sent to 106 public health and horizon scanning professionals and decision-makers in June 2008. Questionnaire 2 was developed based on answers to questionnaire 1 and sent to all respondents. A definition of innovative PHIs was developed: 'Innovative PHIs are generally new and different to established interventions. They should be equitable, applicable to all in a population, cost-effective and may address health determinants in the non-health sector of society. A good evidence base is ideal, but sometimes it may be necessary to consider PHIs lacking evidence'. Sources suggested for identifying innovative PHIs were similar to those used for other types of health technologies. Our findings should help early awareness and alert systems distinguish innovative from non-innovative PHIs, although its application in practice needs trialling.

Neurogenic bowel management after spinal cord injury: A systematic review of the evidence

PubMed Central

Krassioukov, Andrei; Eng, Janice J.; Claxton, Geri; Sakakibara, Brodie M.; Shum, Serena

2011-01-01

OBJECTIVE To systematically review evidence for the management of neurogenic bowel in individuals with spinal cord injuries (SCI). DATA SOURCES Literature searches were conducted for relevant articles, as well as practice guidelines, using numerous electronic databases. Manual searches of retrieved articles from 1950 to July 2009 were also conducted to identify literature. STUDY SELECTION Randomized controlled trials, prospective cohort, case-control, and pre-post studies, and case reports that assessed pharmacological and non-pharmacological intervention for the management of the neurogenic bowel in SCI were included. DATA EXTRACTION Two independent reviewers evaluated each study’s quality, using the PEDro scale for RCTs and the Downs & Black scale for all other studies. Results were tabulated and levels of evidence assigned. DATA SYNTHESIS 2956 studies were found as a result of the literature search. Upon review of the titles and abstracts, 52 studies met the inclusion criteria. Multi-faceted programs are the first approach to neurogenic bowel and are supported by lower levels of evidence. Of the non-pharmacological (conservative and non-surgical) interventions, transanal irrigation is a promising treatment to reduce constipation and fecal incontinence. When conservative management is not effective, pharmacological interventions (e.g., prokinetic agents) are supported by strong evidence for the treatment of chronic constipation. When conservative and pharmacological treatments are not effective, surgical interventions may be considered and are supported by lower levels of evidence in reducing complications. CONCLUSIONS Often, more than one procedure is necessary to develop an effective bowel routine. Evidence is low for non-pharmacological approaches and high for pharmacological interventions. PMID:20212501

Enabling physical activity participation for children and youth with disabilities following a goal-directed, family-centred intervention.

PubMed

Willis, Claire; Nyquist, Astrid; Jahnsen, Reidun; Elliott, Catherine; Ullenhag, Anna

2018-06-01

There is a paucity of research demonstrating the optimisation and maintenance of participation outcomes following physical activity interventions for children and youth with disabilities. To evaluate changes in physical activity participation in children with disabilities following a goal-directed, family-centred intervention at a healthsports centre, and to identify factors influencing participation following the intervention. A mixed methods pre-test post-test cohort design was applied. Recruitment occurred over a 12 month period during standard clinical service provision. The Canadian Occupational Performance Measure (COPM) was administered to children and parents pre (T1) and post-intervention (T2), and at 12 weeks follow-up (T3). Goal Attainment Scaling (GAS) was applied to assess outcomes at 12 weeks follow-up (T2-T3). Qualitative inquiry described barriers to goal attainment at T3. Ninety two children with a range of disabilities (mean age 11.1yr; 49 males) were included in the study. Statistically significant and clinically meaningful improvements in parent ratings of COPM performance and satisfaction of participation goals were observed following intervention. Ratings at 12 weeks follow-up remained significantly higher than baseline, and 32% of children attained their COPM-derived GAS goal. Environmental factors were the most frequent barrier to goal attainment following intervention. These results provide preliminary evidence for goal-directed, family-centred interventions to optimise physical activity participation outcomes for children with disabilities. Copyright © 2018 Elsevier Ltd. All rights reserved.

Transitional and Transformational Spaces: Mentoring Young Academics through Writing Centres

ERIC Educational Resources Information Center

Archer, Arlene; Parker, Shabnam

2016-01-01

The effectiveness of writing centre interventions on student writing in higher education has been well-documented in academic literacies studies. This paper changes the focus of investigation from student to consultant and, consequently, explores the way in which an academic writing centre can function as a mentoring environment for young…

The importance of dietary change for men diagnosed with and at risk of prostate cancer: a multi-centre interview study with men, their partners and health professionals.

PubMed

Avery, Kerry N L; Donovan, Jenny L; Horwood, Jeremy; Neal, David E; Hamdy, Freddie C; Parker, Chris; Wade, Julia; Lane, Athene

2014-05-03

The diagnosis of prostate cancer (PC) can provide a trigger for dietary change, and there is evidence that healthier diets may improve quality of life and clinical outcomes. However, men's views about dietary change in PC survivorship are largely unknown. This multi-centre qualitative interview study explored men's views about dietary change in PC survivorship, to better understand motivations for, and barriers to, achieving desired changes. The role of radical and active surveillance treatments on dietary change and the influence of men's partners were examined. Focus groups also evaluated stakeholder opinion, including healthcare professionals, about the provision of dietary advice to PC patients. A multi-centre interview study explored views about diet and motivations for, and barriers to, dietary change in men at elevated risk or diagnosed with PC following prostate specific antigen (PSA) testing. 58 men and 11 partners were interviewed. Interviews and focus groups were undertaken with 11 healthcare professionals, 5 patients and 4 partners to evaluate stakeholders' opinions about the feasibility and acceptability of providing dietary advice to PC patients. Data were analysed using methods of constant comparison and thematic analysis. Over half of diagnosed men reported making dietary changes, primarily to promote general or prostate health or facilitate coping, despite their uncertainty about diet-PC links. Interest in dietary advice was high. Information needs varied depending on treatment received, with men on active surveillance more frequently modifying their diet and regarding this as an adjunct therapy. Men considered their partners integral to implementing changes. Provision of dietary advice to men diagnosed with PC was considered by healthcare professionals and men to be feasible and appropriate in the context of a holistic 'care package'. Many men make positive dietary changes after PC diagnosis, which are perceived by men and their partners to bring psychological and general health benefits and could help future dietary intervention trials. Men and their partners desire more and better dietary information that may support PC survivorship, particularly among those embarking on active surveillance/monitoring programmes. There are opportunities for healthcare professionals to support PC patients both clinically and psychologically by the routine integration of healthy eating advice into survivorship care plans.

EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial.

PubMed

Rammazzo, Laura; Kikidis, Dimitris; Anwer, Amal; Macdonald, Nora; Kyrodimos, Efthymios; Maurer, Christoph; Wuyts, Floris; Luxon, Linda; Bibas, Athanasios; Bamiou, Doris-Eva

2016-09-05

Balance problems are caused by multiple factors and often lead to falls and related fractures, bringing large socio-economic costs. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment contribute to the delayed or incorrect diagnosis and management ofthese patients. Advances in computer science have allowed the development of computer systems that support clinical diagnosis and treatment decisions based on individualised patient data. The aim of the EMBalance decision support system (DSS) is to support doctors facing this clinical challenge, to make a definitive diagnosis and implement an effective management plan. The EMBalance study will determine the accuracy of this supportive tool when used by non-specialist doctors. This study is funded by the European Union's Seventh Framework Programme. EMBalance is a proof-of-concept study designed as a non-commercial, international, multi-centre, single-blind, parallel-group randomised controlled trial to be carried out at four clinical sites in the United Kingdom, Germany, Greece and Belgium. The study is comprised of three stages: internal pilot, phase I (diagnosis) and stage II (management). For this purpose, 200 patients presenting with persistent dizziness (>3 months' duration) to primary care services will be randomised to either the intervention group (diagnostic assessment with the DSS) or a control group (diagnostic assessment without the DSS). Patients allocated to the intervention group will be assessed by a doctor with the support of the EMBalance DSS, while patients allocated to the control group will receive a visit as per standard practice. Ultimately, all patients' diagnoses and management plans will be certified by a consultant in neuro-otology. EMBalance is the first trial to test the accuracy of a DSS in both the diagnosis of and the management plan for vestibular disorders across the healthcare systems of four different countries. The EMBalance study is the result of a combined effort of engineers and physicians to develop an accurate tool to support non-specialist doctors, with no risk for the patient. This trial will provide reliable information about the benefits of implementing DSSs in primary care while supporting the feasibility of testing the EMBalance algorithms in further research. ClinicalTrials.gov NCT02704819 . Registered 29 February 2016.

Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

PubMed

Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

2015-02-01

Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

Ankle Injury Management (AIM): design of a pragmatic multi-centre equivalence randomised controlled trial comparing Close Contact Casting (CCC) to Open surgical Reduction and Internal Fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

PubMed Central

2014-01-01

Background Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery. Methods/Design This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment. Discussion This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013. Trial registration Current Controlled Trials ISRCTN04180738. PMID:24621174

Improving diabetes care among patients with severe mental illness: A systematic review of the effect of interventions.

PubMed

Grøn, A O; Dalsgaard, E-M; Ribe, A R; Seidu, S; Mora, G; Cebrián-Cuenca, A M; Charles, M

2018-04-27

Individuals with severe mental illness (SMI) who suffer from type 2 diabetes (T2DM) are likely to be sub-optimally treated for their physical condition. This study aimed to review the effect of interventions in this population. A systematic search in five databases was conducted in July 2017. Seven studies on multi-faced interventions were included. These comprised nutrition and exercise counselling, behavioural modelling and increased disease awareness aiming to reduce HbA1c, fasting plasma glucose, body mass index and weight. Non-pharmacologic interventions in individuals with SMI and T2DM could possibly improve measures of diabetes care, although with limited clinical impact. Copyright © 2018 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

A multi-centre evaluation of oral cancer in Southern and Western Nigeria: an African oral pathology research consortium initiative.

PubMed

Omitola, Olufemi Gbenga; Soyele, Olujide Oladele; Sigbeku, Opeyemi; Okoh, Dickson; Akinshipo, Abdulwarith Olaitan; Butali, Azeez; Adeola, Henry Ademola

2017-01-01

Oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer registries and under-reporting has inaccurately depicted its magnitude in Nigeria. Development of multi-centre collaborative oral pathology networks such as the African Oral Pathology Research Consortium (AOPRC) facilitates skill and expertise exchange and fosters a robust and systematic investigation of oral diseases across Africa. In this descriptive cross-sectional study, we have leveraged the auspices of the AOPRC to examine the burden of oral cancer in Nigeria, using a multi-centre approach. Data from 4 major tertiary health institutions in Western and Southern Nigeria was generated using a standardized data extraction format and analysed using the SPSS data analysis software (version 20.0; SPSS Inc. Chicago, IL). Of the 162 cases examined across the 4 centres, we observed that oral squamous cell carcinomas (OSCC) occurred mostly in the 6 th and 7 th decades of life and maxillary were more frequent than mandibular OSCC lesions. Regional variations were observed both for location, age group and gender distribution. Significant regional differences was found between poorly, moderately and well differentiated OSCC (p value = 0.0071). A multi-centre collaborative oral pathology research approach is an effective way to achieve better insight into the patterns and distribution of various oral diseases in men of African descent. The wider outlook for AOPRC is to employ similar approaches to drive intensive oral pathology research targeted at addressing the current morbidity and mortality of various oral diseases across Africa.

Patient-centred screening for primary immunodeficiency: a multi-stage diagnostic protocol designed for non-immunologists

PubMed Central

de Vries, E

2006-01-01

Efficient early identification of primary immunodeficiency disease (PID) is important for prognosis, but is not an easy task for non-immunologists. The Clinical Working Party of the European Society for Immunodeficiencies (ESID) has composed a multi-stage diagnostic protocol that is based on expert opinion, in order to increase the awareness of PID among doctors working in different fields. The protocol starts from the clinical presentation of the patient; immunological skills are not needed for its use. The multi-stage design allows cost-effective screening for PID within the large pool of potential cases in all hospitals in the early phases, while more expensive tests are reserved for definitive classification in collaboration with an immunologist at a later stage. Although many PIDs present in childhood, others may present at any age. The protocols presented here are therefore aimed at both adult physicians and paediatricians. While designed for use throughout Europe, there will be national differences which may make modification of this generic algorithm necessary. PMID:16879238

Fasciatherapy and Reflexology compared to Hypnosis and Music Therapy in Daily Stress Management

PubMed Central

Payrau, Bernard; Quere, Nadine; Breton, Elisabeth; Payrau, Christine

2017-01-01

Background Patients suffering from stress symptoms due to every-day life who are looking for a non-pharmacological response to their relief expectation are many. Furthermore, early reckoning of the day-to-day stress which may lead to clinical diagnosis is the best way of preventing the stress-related diseases. Among the many alternative medicinal options, there is little evidence that fasciatherapy (Fs) and reflexology (Rf) are effective in this field. Purpose assess incidence of fasciatherapy Danis Bois Method (DBM) and of reflexology on patients’ stress level in everyday-life, and provide a more informed choice among the numerous mind and body techniques by comparing them with hypnosis (Hp) and music therapy (Mt). Settings Specialized Complementary and Alternative Medicine (CAM) centres for outpatients. Participants 308 individuals (average age = 50.53 SD 14.37, 93 males, 215 females) going to the centres for health care, but free from serious diseases and not heavily medicated respecting the inclusion criteria and providing valid forms. Research Design Four armed, non-randomized observational pragmatic trial with pretest–posttest repeated measures, on separate samples of natural groups. Intervention According to the centre participants where they used to be treated, they were exposed to a single semi-standardized session of a technique of their choice: Fs, Rf, Hp, Mt. Volunteers had a controlled non-intervention resting (Rt) session. Main Outcome Measures Mean STAI-Y assessing anxiety as reflecting the stress level: MANCOVA and ANCOVA performed with Tukey’s HSD. Results MANCOVA indicates a significant reduction of anxiety (p < .01) in each condition, resting included. ANCOVA performance adjusting on stress level in T0 (41.73) and on the mean sumscore of the trait (44.89), Fs (−13.92), Rf (−15.92), and Hp (−15.88) were equally effective on the stress level decrease. Mt (−10.0) and Rt (−6.38) showed the same level of effectiveness. Conclusions The results suggest fasciatherapy DBM, hypnosis, and reflexology could be used as non-pharmacological and safe interventions in stress management. Though showing a lesser efficiency, music therapy could be useful in different circumstances. PMID:28912904

Development of a web-based register for the Dutch national study on biologicals in JIA: www.ABC-register.nl.

PubMed

Prince, F H M; Ferket, I S; Kamphuis, S; Armbrust, W; Ten Cate, R; Hoppenreijs, E P A H; Koopman-Keemink, Y; van Rossum, M A J; van Santen-Hoeufft, M; Twilt, M; van Suijlekom-Smit, L W A

2008-09-01

Most clinical studies use paper case record forms (CRFs) to collect data. In the Dutch multi-centre observational study on biologicals we encountered several disadvantages of using the paper CRFs. These are delay in data collection, lack of overview in collected data and difficulties in obtaining up-to-date interim reports. Therefore, we wanted to create a more effective method of data collection compared with CRFs on paper in a multi-centre study. We designed a web-based register with the intention to make it easy to use for participating physicians and at the same time accurate and up-to-date. Security demands were taken into account to secure the safety of the patient data. The web-based register was tested with data from 161 juvenile idiopathic arthritis patients from nine different centres. Internal validity was obtained and user-friendliness guaranteed. To secure the completeness of the data automatically generated e-mail alerts were implemented into the web-based register. More transparency of data was achieved by including the option to automatically generate interim reports of data in the web-based register. The safety was tested and approved. By digitalizing the CRF we achieved our aim to provide easy, rapid and safe access to the database and contributed to a new way of data collection. Although the web-based register was designed for the current multi-centre observational study, this type of instrument can also be applied to other types of studies. We expect that especially collaborative study groups will find it an efficient tool to collect data.

Investigating the Impact of Working in Multi-Agency Service Delivery Settings in the UK on Early Years Practitioners' Beliefs and Practices

ERIC Educational Resources Information Center

Anning, Angela

2005-01-01

In the UK Centres of Excellence were funded by the DfES to model high quality, multi-agency, early years services for young children and their families. They were precursors to Children's Centres to be established across the UK. Early Excellence Centres were evaluated at national and local levels. This article will draw on data from local…

Ventricular enlargement as a possible measure of Alzheimer's disease progression validated using the Alzheimer's disease neuroimaging initiative database

PubMed Central

Nestor, Sean M.; Rupsingh, Raul; Borrie, Michael; Smith, Matthew; Accomazzi, Vittorio; Wells, Jennie L.; Fogarty, Jennifer

2008-01-01

Ventricular enlargement may be an objective and sensitive measure of neuropathological change associated with mild cognitive impairment (MCI) and Alzheimer's disease (AD), suitable to assess disease progression for multi-centre studies. This study compared (i) ventricular enlargement after six months in subjects with MCI, AD and normal elderly controls (NEC) in a multi-centre study, (ii) volumetric and cognitive changes between Apolipoprotein E genotypes, (iii) ventricular enlargement in subjects who progressed from MCI to AD, and (iv) sample sizes for multi-centre MCI and AD studies based on measures of ventricular enlargement. Three dimensional T1-weighted MRI and cognitive measures were acquired from 504 subjects (NEC n = 152, MCI n = 247 and AD n = 105) participating in the multi-centre Alzheimer's Disease Neuroimaging Initiative. Cerebral ventricular volume was quantified at baseline and after six months using semi-automated software. For the primary analysis of ventricle and neurocognitive measures, between group differences were evaluated using an analysis of covariance, and repeated measures t-tests were used for within group comparisons. For secondary analyses, all groups were dichotomized for Apolipoprotein E genotype based on the presence of an ε4 polymorphism. In addition, the MCI group was dichotomized into those individuals who progressed to a clinical diagnosis of AD, and those subjects that remained stable with MCI after six months. Group differences on neurocognitive and ventricle measures were evaluated by independent t-tests. General sample size calculations were computed for all groups derived from ventricle measurements and neurocognitive scores. The AD group had greater ventricular enlargement compared to both subjects with MCI (P = 0.0004) and NEC (P < 0.0001), and subjects with MCI had a greater rate of ventricular enlargement compared to NEC (P = 0.0001). MCI subjects that progressed to clinical AD after six months had greater ventricular enlargement than stable MCI subjects (P = 0.0270). Ventricular enlargement was different between Apolipoprotein E genotypes within the AD group (P = 0.010). The number of subjects required to demonstrate a 20% change in ventricular enlargement was substantially lower than that required to demonstrate a 20% change in cognitive scores. Ventricular enlargement represents a feasible short-term marker of disease progression in subjects with MCI and subjects with AD for multi-centre studies. PMID:18669512

India-Based Knee Osteoarthritis Evaluation (iKare): A Multi-Centre Cross-Sectional Study on the Management of Knee Pain and Early Osteoarthritis in India.

PubMed

Sancheti, Parag; Shetty, Vijay D; Dhillon, Mandeep S; Sprague, Sheila A; Bhandari, Mohit

2017-09-01

Access to early knee osteoarthritis treatment in low and middle income nations is often believed to be limited. We conducted a cross-sectional study in India to assess prior access to treatment among patients presenting with knee pain to specialist orthopaedic clinics. The multi-centre, cross-sectional study included patients presenting with knee pain at 3 hospitals in India. Patients who met the inclusion criteria and provided informed consent completed a questionnaire designed to assess patient demographics, socioeconomic status, knee pain, treatment method, and patient's knowledge on osteoarthritis (OA). Their orthopaedic surgeons also completed a questionnaire on the severity of patient's OA and their recommended treatments. The impact of demographic characteristics on the prescription of treatment options was analyzed using logistic regression. A total of 714 patients met the eligibility criteria and participated in this study. The majority of patients had been experiencing pain for less than 1 year (64.8%) and had previously been prescribed medications (91.6%), supplements (68.6%), and nonpharmacological (81.9%) treatments to manage their knee OA. Current treatment recommendations included oral medications (83.3%), intra-articular injections (29.8%), and surgical intervention (12.7%). Prescription of oral medications was related to younger age, lack of deformities, and lower Kellgren-Lawrence grades ( p < 0.01). Patients treated in private hospital settings were more likely to have been previously treated with medications (range, 84.3% to 92.6%; p < 0.01) and physical treatments (range, 61.8% to 84.8%; p < 0.01) than patients treated at government hospitals. Contrary to the perception, our findings suggest a similar proportion of early knee OA treatment between India and North America.

Expanding access to non-medicalized community-based rapid testing to men who have sex with men: an urgent HIV prevention intervention (the ANRS-DRAG study).

PubMed

Lorente, Nicolas; Preau, Marie; Vernay-Vaisse, Chantal; Mora, Marion; Blanche, Jerome; Otis, Joanne; Passeron, Alain; Le Gall, Jean-Marie; Dhotte, Philippe; Carrieri, Maria Patrizia; Suzan-Monti, Marie; Spire, Bruno

2013-01-01

Little is known about the public health benefits of community-based, non-medicalized rapid HIV testing offers (CBOffer) specifically targeting men who have sex with men (MSM), compared with the standard medicalized HIV testing offer (SMOffer) in France. This study aimed to verify whether such a CBOffer, implemented in voluntary counselling and testing centres, could improve access to less recently HIV-tested MSM who present a risk behaviour profile similar to or higher than MSM tested with the SMOffer. This multisite study enrolled MSM attending voluntary counselling and testing centres' during opening hours in the SMOffer. CBOffer enrolees voluntarily came to the centres outside of opening hours, following a communication campaign in gay venues. A self-administered questionnaire was used to investigate HIV testing history and sexual behaviours including inconsistent condom use and risk reduction behaviours (in particular, a score of "intentional avoidance" for various at-risk situations was calculated). A mixed logistic regression identified factors associated with access to the CBOffer. Among the 330 participants, 64% attended the CBOffer. Percentages of inconsistent condom use in both offers were similar (51% CBOffer, 50% SMOffer). In multivariate analyses, those attending the CBOffer had only one or no test in the previous two years, had a lower intentional avoidance score, and met more casual partners in saunas and backrooms than SMOffer enrolees. This specific rapid CBOffer attracted MSM less recently HIV-tested, who presented similar inconsistent condom use rates to SMOffer enrolees but who exposed themselves more to HIV-associated risks. Increasing entry points for HIV testing using community and non-medicalized tests is a priority to reach MSM who are still excluded.

Injury and illness among athletes during a multi-day elite cycling road race.

PubMed

Yanturali, Sedat; Canacik, Omer; Karsli, Emre; Suner, Selim

2015-11-01

Although road bicycle races have been held for more than a century, injury and illness patterns during multi-day bicycle events have not been widely studied. The aim of this study was to determine the incidence of injury and illness among riders and describe the medical care interventions provided to participants of cycling road races. A prospective observational study was conducted on the Presidential Cycling Tour of Turkey, which was held between April 26 and May 3, 2015. The race lasted 8 days and covered 1258 km of road. There were 166 elite cycling athletes representing 21 teams from various countries. Data collected pertaining to incidents involving injury or illness included the following: type of injury; anatomical location of injury; details of the medical encounter; location of the intervention; treatment provided; medication administered and disposition of the rider. An injury was defined as a physical complaint or observable damage to the body produced by the transfer of energy of the rider. An illness was defined as a physical complaint or presentation not related to injury. The overall incidence (injury and illness) was 5.83 per 1000 cycling hours. (Injury incidence was 2.82 vs illness incidence of 3.01 per 1000 hours cycling). A total of 31 incidents occurred. Of these, 15 were injuries, while 16 were complaints of a non-traumatic nature. A total of 43 interventions were made in the 15 cases of injury. The most commonly injured body regions were limbs; the majority of injuries involved the skin and soft tissue. The most common medical intervention was wound care (64% of all interventions). Two riders had to withdraw from the race, and one was hospitalized due to a traumatic pneumothorax. None of the non-traumatic cases resulted in withdrawal from the race. A broad spectrum of illness and injury occurs during elite multi-day road races, ranging from simple skin injuries to serious injuries requiring hospital admission. Most injuries and illnesses are minor; however, medical teams must be prepared to treat life-threatening trauma.

Claims for fertility interventions: a systematic assessment of statements on UK fertility centre websites.

PubMed

Spencer, E A; Mahtani, K R; Goldacre, B; Heneghan, C

2016-11-27

Fertility services in the UK are offered by over 200 Human Fertilisation and Embryology Authority (HFEA)-registered NHS and private clinics. While in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) form part of the National Institute for Health and Care Excellence (NICE) guidance, many further interventions are offered. We aimed to record claims of benefit for interventions offered by fertility centres via information on the centres' websites and record what evidence was cited for these claims. We obtained from HFEA a list of all UK centres providing fertility treatments and examined their websites. We listed fertility interventions offered in addition to standard IVF and ICSI and recorded statements about interventions that claimed or implied improvements in fertility in healthy women. We recorded which claims were quantified, and the evidence cited in support of the claims. Two reviewers extracted data from websites. We accessed websites from 21 December 2015 to 31 March 2016. We found 233 websites for HFEA-registered fertility treatment centres, of which 152 (65%) were excluded as duplicates or satellite centres, 2 were andrology clinics and 5 were unavailable or under construction websites. In total, 74 fertility centre websites, incorporating 1401 web pages, were examined for claims. We found 276 claims of benefit relating to 41 different fertility interventions made by 60 of the 74 centres (median 3 per website; range 0 to 10). Quantification was given for 79 (29%) of the claims. 16 published references were cited 21 times on 13 of the 74 websites. Many fertility centres in the UK offer a range of treatments in addition to standard IVF procedures, and for many of these interventions claims of benefit are made. In most cases, the claims are not quantified and evidence is not cited to support the claims. There is a need for more information on interventions to be made available by fertility centres, to support well-informed treatment decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Issues and challenges associated with classifying neoplasms in percutaneous needle biopsies of incidentally found small renal masses.

PubMed

Evans, Andrew J; Delahunt, Brett; Srigley, John R

2015-03-01

Percutaneous needle core biopsy has become acceptable for classifying renal tumours and guiding patient management in the setting of an incidentally-detected small renal mass (SRM), defined as an asymptomatic, non-palpable mass <4cm in maximum dimension. Long-held concerns preventing the incorporation of biopsies into routine patient care, including the perception of poor diagnostic yield and risks of complications such as bleeding or biopsy tract seeding, have largely been disproven. While needle biopsies for SRMs have traditionally been performed in academic centres, pathologists based in non-academic centres can expect to encounter these specimens as urologists and/or interventional radiologist trainees complete their training programs and begin work in non-academic centres. This review covers the rationale for performing these biopsies, the expected diagnostic yield, relevant differential diagnoses and an approach to classifying SRMs based on limited samples as well as the use of immunohistochemical (IHC) staining panels to aid in this process. There is also an undeniable learning curve for pathologists faced with reporting these biopsies and a number of issues and potential pitfalls attributable to sampling must be kept in mind by pathologists and clinicians alike. Copyright © 2015 Elsevier Inc. All rights reserved.

Well-being, health and fitness of children who use wheelchairs: feasibility study protocol to develop child-centred 'keep-fit' exercise interventions.

PubMed

O'Brien, Thomas D; Noyes, Jane; Spencer, Llinos Haf; Kubis, Hans-Peter; Edwards, Rhiannon T; Bray, Nathan; Whitaker, Rhiannon

2015-02-01

To undertake the pre-clinical and modelling phases of the Medical Research Council complex intervention framework to underpin development of child-centred 'keep-fit', exercise and physical activity interventions for children and young people who use wheelchairs. Children who use wheelchairs face many barriers to participation in physical activity, which compromises fitness, obesity, well-being and health. 'Keep-fit' programmes that are child-centred and engaging are urgently required to enhance participation of disabled children and their families as part of a healthy lifestyle. Nurses will likely be important in promoting and monitoring 'keep-fit' intervention(s) when implemented in the community. Mixed-method (including economic analysis) feasibility study to capture child and family preferences and keep-fit needs and to determine outcome measures for a 'keep-fit' intervention. The study comprises three stages. Stage 1 includes a mixed-method systematic review of effectiveness, cost effectiveness and key stakeholder views and experiences of keep-fit interventions, followed by qualitative interviews with children, young people and their parents to explore preferences and motivations for physical activity. Stage 2 will identify standardized outcome measures and test their application with children who use wheelchairs to obtain baseline fitness data. Options for an exercise-based keep-fit intervention will then be designed based on Stage 1 and 2 findings. In stage 3, we will present intervention options for feedback and further refinement to children and parents/carers in focus groups. (Project funded October 2012). At completion, this study will lead to the design of the intervention and a protocol to test its efficacy. © 2014 John Wiley & Sons Ltd.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Cardiovascular safety of vildagliptin in patients with type 2 diabetes: A European multi-database, non-interventional post-authorization safety study.

PubMed

Williams, Rachael; de Vries, Frank; Kothny, Wolfgang; Serban, Carmen; Lopez-Leon, Sandra; Chu, Changan; Schlienger, Raymond

2017-10-01

The aim of this non-interventional, multi-database, analytical cohort study was to assess the cardiovascular (CV) safety of vildagliptin vs other non-insulin antidiabetic drugs (NIADs) using real-world data from 5 European electronic healthcare databases. Patients with type 2 diabetes aged ≥18 years on NIAD treatment were enrolled. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for the outcomes of interest (myocardial infarction [MI], acute coronary syndrome [ACS], stroke, congestive heart failure [CHF], individually and as a composite) were estimated using negative binomial regression. Approximately 2.8% of the enrolled patients (n = 738 054) used vildagliptin at any time during the study, with an average follow-up time of 1.4 years, resulting in a cumulative current vildagliptin exposure of 28 330 person-years. The adjusted IRRs (vildagliptin [±other NIADs] vs other NIADs) were in the range of 0.61 to 0.97 (MI), 0.55 to 1.60 (ACS), 0.02 to 0.77 (stroke), 0.49 to 1.03 (CHF), and 0.22 to 1.02 (composite CV outcomes). The IRRs and their 95% CIs were close to 1, demonstrating no increased risk of adverse CV events, including the risk of CHF, with vildagliptin vs other NIADs in real-world conditions. © 2017 Crown copyright. Diabetes, Obesity and Metabolism © 2017 John Wiley & Sons Ltd.

Designing and delivering facilitated storytelling interventions for chronic disease self-management: a scoping review.

PubMed

Gucciardi, Enza; Jean-Pierre, Nicole; Karam, Grace; Sidani, Souraya

2016-07-11

Little is known about how to develop and deliver storytelling as an intervention to support those managing chronic illnesses. This scoping review aims to describe the core elements of storytelling interventions in order to help facilitate its implementation. A scoping review was conducted in seven databases for articles published up to May 2014 to identify interventions that describe in detail how storytelling was used to support people in disease self-management interventions. Ten articles met all inclusion criteria. Core elements consistently observed across the storytelling interventions were: reflection and interactive meaning-making of experiences; principles of informality and spontaneity; non-directional and non-hierarchical facilitation; development of group norms and conduct to create a community among participants; and both an individual and collective role for participants. Differences were also observed across interventions, such as: the conceptual frameworks that directed the design of the intervention; the type and training of facilitators; intervention duration; and how session topics were selected and stories delivered. Furthermore, evaluation of the intervention and outcome assessment varied greatly across studies. The use of storytelling can be a novel intervention to enhance chronic disease self-management. The core elements identified in the review inform the development of the intervention to be more patient-centred by guiding participants to take ownership of and lead the intervention, which differs significantly from traditional support groups. Storytelling has the potential to provide patients with a more active role in their health care by identifying their specific needs as well as gaps in knowledge and skills, while allowing them to form strong bonds with peers who share similar disease-related experiences. However, measures of impact differed across interventions given the variation in chronic conditions. Our findings can guide future development and implementations of storytelling interventions.

Perspectives on a ‘Sit Less, Move More’ Intervention in Australian Emergency Call Centres

PubMed Central

Chau, Josephine Y; Engelen, Lina; Burks-Young, Sarah; Daley, Michelle; Maxwell, Jen-Kui; Milton, Karen; Bauman, Adrian

2016-01-01

Background Prolonged sitting is associated with increased risk of chronic diseases. Workplace programs that aim to reduce sitting time (sit less) and increase physical activity (move more) have targeted desk-based workers in corporate and university settings with promising results. However, little is known about ‘move more, sit less’ programs for workers in other types of jobs and industries, such as shift workers. This formative research examines the perceptions of a ‘sit less, move more’ program in an Australian Emergency Call Centre that operates 24 hours per day, 7 days per week. Methods Participants were employees (N = 39, 72% female, 50% aged 36–55 years) recruited from Emergency Services control centres located in New South Wales, Australia. The ‘sit less, move more’ intervention, consisting of emails, posters and timer lights, was co-designed with the management team and tailored to the control centre environment and work practices, which already included electronic height-adjustable sit-stand workstations for all call centre staff. Participants reported their perceptions and experiences of the intervention in a self-report online questionnaire, and directly to the research team during regular site visits. Questionnaire topics included barriers and facilitators to standing while working, mental wellbeing, effects on work performance, and workplace satisfaction. Field notes and open-ended response data were analysed in an iterative process during and after data collection to identify the main themes. Results Whilst participants already had sit-stand workstations, use of the desks in the standing position varied and sometimes were contrary to expectations (e.g, less tired standing than sitting; standing when experiencing high call stress). Participants emphasised the “challenging” and “unrelenting” nature of their work. They reported sleep issues (“always tired”), work stress (“non-stop demands”), and feeling mentally and physically drained due to shift work and length of shifts. Overall, participants liked the initiative but acknowledged that their predominantly sitting habits were entrenched and work demands took precedence. Conclusions This study demonstrates the low acceptability of a ‘sit less, move more’ program in shift workers in high stress environments like emergency call centres. Work demands take priority and other health concerns, like poor sleep and high stress, may be more salient than the need to sit less and move more during work shifts. PMID:29546163

Perspectives on a 'Sit Less, Move More' Intervention in Australian Emergency Call Centres.

PubMed

Chau, Josephine Y; Engelen, Lina; Burks-Young, Sarah; Daley, Michelle; Maxwell, Jen-Kui; Milton, Karen; Bauman, Adrian

2016-01-01

Prolonged sitting is associated with increased risk of chronic diseases. Workplace programs that aim to reduce sitting time (sit less) and increase physical activity (move more) have targeted desk-based workers in corporate and university settings with promising results. However, little is known about 'move more, sit less' programs for workers in other types of jobs and industries, such as shift workers. This formative research examines the perceptions of a 'sit less, move more' program in an Australian Emergency Call Centre that operates 24 hours per day, 7 days per week. Participants were employees (N = 39, 72% female, 50% aged 36-55 years) recruited from Emergency Services control centres located in New South Wales, Australia. The 'sit less, move more' intervention, consisting of emails, posters and timer lights, was co-designed with the management team and tailored to the control centre environment and work practices, which already included electronic height-adjustable sit-stand workstations for all call centre staff. Participants reported their perceptions and experiences of the intervention in a self-report online questionnaire, and directly to the research team during regular site visits. Questionnaire topics included barriers and facilitators to standing while working, mental wellbeing, effects on work performance, and workplace satisfaction. Field notes and open-ended response data were analysed in an iterative process during and after data collection to identify the main themes. Whilst participants already had sit-stand workstations, use of the desks in the standing position varied and sometimes were contrary to expectations (e.g, less tired standing than sitting; standing when experiencing high call stress). Participants emphasised the "challenging" and "unrelenting" nature of their work. They reported sleep issues ("always tired"), work stress ("non-stop demands"), and feeling mentally and physically drained due to shift work and length of shifts. Overall, participants liked the initiative but acknowledged that their predominantly sitting habits were entrenched and work demands took precedence. This study demonstrates the low acceptability of a 'sit less, move more' program in shift workers in high stress environments like emergency call centres. Work demands take priority and other health concerns, like poor sleep and high stress, may be more salient than the need to sit less and move more during work shifts.

ATHENA: Remote Sensing Science Center for Cultural Heritage in Cyprus

NASA Astrophysics Data System (ADS)

Hadjimitsis, Diofantos G.; Agapiou, Athos; Lysandrou, Vasiliki; Themistocleous, Kyriakos; Cuca, Branka; Lasaponara, Rosa; Masini, Nicola; Krauss, Thomas; Cerra, Daniele; Gessner, Ursula; Schreier, Gunter

2016-04-01

The Cultural Heritage (CH) sector, especially those of monuments and sites has always been facing a number of challenges from environmental pressure, pollution, human intervention from tourism to destruction by terrorism.Within this context, CH professionals are seeking to improve currently used methodologies, in order to better understand, protect and valorise the common European past and common identity. "ATHENA" H2020-TWINN-2015 project will seek to improve and expand the capabilities of the Cyprus University of Technology, involving professionals dealing with remote sensing technologies for supporting CH sector from the National Research Center of Italy (CNR) and German Aerospace Centre (DLR). The ATHENA centre will be devoted to the development, introduction and systematic use of advanced remote sensing science and technologies in the field of archaeology, built cultural heritage, their multi-temporal analysis and interpretation and the distant monitoring of their natural and anthropogenic environment in the area of Eastern Mediterranean.

Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

PubMed

Vaughan, Geraldine; Pollock, Wendy; Peek, Michael J; Knight, Marian; Ellwood, David; Homer, Caroline S; Pulver, Lisa Jackson; McLintock, Claire; Ho, Maria T; Sullivan, Elizabeth A

2012-04-01

The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. To describe the ethics/governance review pathway undertaken by AMOSS. Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Prevalence and pattern of prescription errors in a Nigerian kidney hospital.

PubMed

Babatunde, Kehinde M; Akinbodewa, Akinwumi A; Akinboye, Ayodele O; Adejumo, Ademola O

2016-12-01

To determine (i) the prevalence and pattern of prescription errors in our Centre and, (ii) appraise pharmacists' intervention and correction of identified prescription errors. A descriptive, single blinded cross-sectional study. Kidney Care Centre is a public Specialist hospital. The monthly patient load averages 60 General Out-patient cases and 17.4 in-patients. A total of 31 medical doctors (comprising of 2 Consultant Nephrologists, 15 Medical Officers, 14 House Officers), 40 nurses and 24 ward assistants participated in the study. One pharmacist runs the daily call schedule. Prescribers were blinded to the study. Prescriptions containing only galenicals were excluded. An error detection mechanism was set up to identify and correct prescription errors. Life-threatening prescriptions were discussed with the Quality Assurance Team of the Centre who conveyed such errors to the prescriber without revealing the on-going study. Prevalence of prescription errors, pattern of prescription errors, pharmacist's intervention. A total of 2,660 (75.0%) combined prescription errors were found to have one form of error or the other; illegitimacy 1,388 (52.18%), omission 1,221(45.90%), wrong dose 51(1.92%) and no error of style was detected. Life-threatening errors were low (1.1-2.2%). Errors were found more commonly among junior doctors and non-medical doctors. Only 56 (1.6%) of the errors were detected and corrected during the process of dispensing. Prescription errors related to illegitimacy and omissions were highly prevalent. There is a need to improve on patient-to-healthcare giver ratio. A medication quality assurance unit is needed in our hospitals. No financial support was received by any of the authors for this study.

Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area.

PubMed

Rodríguez Cristóbal, Juan José; Panisello Royo, Josefa Ma; Alonso-Villaverde Grote, Carlos; Pérez Santos, José Ma; Muñoz Lloret, Anna; Rodríguez Cortés, Francisca; Travé Mercadé, Pere; Benavides Márquez, Francisca; Martí de la Morena, Pilar; González Burgillos, Ma José; Delclós Baulies, Marta; Bleda Fernández, Domingo; Quillama Torres, Elida

2010-03-18

The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study to determine whether a group motivational intervention, together with current clinical practice, is more efficient than the latter alone in the treatment of overweight and obesity, for initial weight loss and essentially to achieve maintenance of the weight achieved; and, secondly, to know if this intervention is more effective for reducing cardiovascular risk factors associated with overweight and obesity. This 26-month follow up multi-centre trial, will include 1200 overweight/obese patients. Random assignment of the intervention by Basic Health Areas (BHA): two geographically separate groups have been created, one of which receives group motivational intervention (group intervention), delivered by a nurse trained by an expert phsychologist, in 32 group sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard program of diet, exercise, and the other (control group), receiving the usual follow up, with regular visits every 3 months. By addressing currently unanswered questions regarding the maintenance in weight loss in obesity/overweight, upon the expected completion of participant follow-up in 2012, the IMOAP trial should document, for the first time, the benefits of a motivational intervention as a treatment tool of weight loss in a primary care setting. ClinicalTrials.gov Identifier: NCT01006213.

Aspirin and clonidine in non-cardiac surgery: acute kidney injury substudy protocol of the Perioperative Ischaemic Evaluation (POISE) 2 randomised controlled trial.

PubMed

Garg, Amit X; Kurz, Andrea; Sessler, Daniel I; Cuerden, Meaghan; Robinson, Andrea; Mrkobrada, Marko; Parikh, Chirag; Mizera, Richard; Jones, Philip M; Tiboni, Maria; Rodriguez, Raul Gonzalez; Popova, Ekaterina; Rojas Gomez, Maria Fernanda; Meyhoff, Christian S; Vanhelder, Tomas; Chan, Matthew T V; Torres, David; Parlow, Joel; de Nadal Clanchet, Miriam; Amir, Mohammed; Bidgoli, Seyed Javad; Pasin, Laura; Martinsen, Kristian; Malaga, German; Myles, Paul; Acedillo, Rey; Roshanov, Pavel; Walsh, Michael; Dresser, George; Kumar, Priya; Fleischmann, Edith; Villar, Juan Carlos; Painter, Tom; Biccard, Bruce; Bergese, Sergio; Srinathan, Sadeesh; Cata, Juan P; Chan, Vincent; Mehra, Bhupendra; Leslie, Kate; Whitlock, Richard; Devereaux, P J

2014-02-25

Perioperative Ischaemic Evaluation-2 (POISE-2) is an international 2×2 factorial randomised controlled trial of low-dose aspirin versus placebo and low-dose clonidine versus placebo in patients who undergo non-cardiac surgery. Perioperative aspirin (and possibly clonidine) may reduce the risk of postoperative acute kidney injury (AKI). After receipt of grant funding, serial postoperative serum creatinine measurements began to be recorded in consecutive patients enrolled at substudy participating centres. With respect to the study schedule, the last of over 6500 substudy patients from 82 centres in 21 countries were randomised in December 2013. The authors will use logistic regression to estimate the adjusted OR of AKI following surgery (compared with the preoperative serum creatinine value, a postoperative increase ≥26.5 μmol/L in the 2 days following surgery or an increase of ≥50% in the 7 days following surgery) comparing each intervention to placebo, and will report the adjusted relative risk reduction. Alternate definitions of AKI will also be considered, as will the outcome of AKI in subgroups defined by the presence of preoperative chronic kidney disease and preoperative chronic aspirin use. At the time of randomisation, a subpopulation agreed to a single measurement of serum creatinine between 3 and 12 months after surgery, and the authors will examine intervention effects on this outcome. The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this POISE-2 AKI substudy. Ethics approval was obtained for additional kidney data collection in consecutive patients enrolled at participating centres, which first began for patients enrolled after January 2011. In patients who provided consent, the remaining longer term serum creatinine data will be collected throughout 2014. The results of this study will be reported no later than 2015. NCT01082874.

[Impact of a multidimensional intervention in elderly patients with community-acquired pneumonia: IMIEPCAP clinical trial].

PubMed

Torres, Olga Herminia; Gil, Eva; Comas, Maria Teresa; Saez, Maria Encarnación; Clotet, Sandra; Ramirez, Hector David; Mateo, Miriam; Ruiz, Domingo

2016-01-01

The main objective of this study is to determine whether a multidimensional intervention applied to elderly patients admitted to hospital due to pneumonia reduces re-admissions and emergency department visits in the year after the intervention. This is a single-centre non-pharmacological randomised clinical trial with a parallel design. Three hundred and fourteen patients will be included (157 in each arm). Eligible patients will be ≥65 years old and with a Barthel index ≥60 that are admitted to hospital due to pneumonia. Participants will be randomised to multidimensional intervention or to control group. Two months after hospital discharge the intervention group will receive a geriatric intervention, carried out by a nurse and a physician. It will include assessment of co-morbidities, nutritional, functional and cognitive status, and immunisation. The control group will receive conventional follow-up. The number of re-admissions, visits to the emergency department, functional status, survival, and institutionalisation will be evaluated one year after intervention. If the intervention shows an improvement in the studied outcomes, it would allow us to improve individual outcomes, and indirectly reduce healthcare costs using a relatively simple, standardised tool. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.

[Health promotion in day-care centres in Reykjavík--intervention and result of actions].

PubMed

Gudmarsdóttir, Agústa; Tómasson, Kristinn

2007-03-01

The purpose of the study was to compare wellbeing, health and work environment before and after intervention among employees of Reykjavík city day-care centre. The study is a prospective interventions study. In the year 2000 employees of 16 day-care centres responded to a questionnaire regarding work environment, health and wellbeing. Work environment evaluation was completed and the centre classified into four groups accordingly. Subsequently, the "equipment was renewed" noise protection improved and the employee received education concerning occupational health. Six months, after interventions, in the year 2002 the same questionnaire was readministered. Response rate in 2002 was 88% (n=267) but 90% in the year 2000. Work environment had improved. More employees had received instruction on good workposture and good work technique than 2 years earlier. Fewer employees used awkward posture than before. Better workspace resulted in reduced number of symptoms, also for the youngest employees. Symptoms were also fewer where unskilled employees were in majority and where the fewest of them had received proper education on work posture. In the year 2002, psychosocial wellbeing was better or equal than two years earlier. This was associated with better education and higher age even despite less workspace. Employees awareness towards noise was greatly improved. It is possible to improve work methods and work environment of employees with goal directed intervention, thus laying the ground for wellbeing at work. The interplay between the factors education and age is complex, though. Thus it is important, that all workplaces, adopt the process of "risk assessment", intervention, and then reassessment of the work environment. By doing so the goals of health promotion and good occupational health can be reached.

Specialist health visitor-led weight management intervention in primary care: exploratory evaluation.

PubMed

Jackson, Cath; Coe, Anne; Cheater, Francine M; Wroe, Stephen

2007-04-01

This paper is a report of an exploratory study to evaluate the effectiveness and acceptability of a specialist health visitor-led weight management clinic in primary care. Tackling obesity is a global health priority. Whilst there is evidence to support a role for primary healthcare professionals in its management, provision in England varies widely. Using designated 'obesity specialists' is an approach warranting further investigation. In 2003-2004, patients with a body mass index of 30 or more received a specialist health visitor-led intervention based on the Jan Felgens 'I2E2' model. Clinical outcome data and self-reported dietary consumption data were collected at weeks 1, 13, 27 and 52. Quantitative and qualitative data on patient acceptability of the clinic were collected at week 26. Eighty-nine patients attended the clinic. Mean body weight and body mass index and systolic and diastolic blood pressure decreased over time by statistically significant amounts. There was a non-significant decrease in fasting blood sugar over time, but approximately one in 10 patients with undiagnosed diabetes were identified. No statistically significant change was evident for cholesterol levels. Mean self-reported weekly consumption of cakes, desserts and snacks decreased and that of fruit and vegetables increased, each by statistically significant amounts. Participants found the clinic highly acceptable and identified the specialist health visitor as fundamental to its success. A partnership approach to weight management through which patients are empowered to make sustainable lifestyle changes now needs to be tested in a multi-centre randomized controlled trial.

Organization of care for persons with HIV-infection: a systematic review.

PubMed

Handford, Curtis D; Tynan, Anne-Marie; Agha, Ayda; Rzeznikiewiz, Damian; Glazier, Richard H

2017-07-01

The objective of this systematic review was to examine the effectiveness of the organization of care: case management, multidisciplinary care, multi-faceted treatment, hours of service, outreach programs and health information systems on medical, immunological, virological, psychosocial and economic outcomes for persons living with HIV/AIDS. We searched PubMed (MEDLINE) and 10 other electronic databases from 1 January 1980 to April, 2012 for both experimental and controlled observational studies. Thirty-three studies met the inclusion criteria. Eleven studies were randomized controlled trials (RCTs), three of which were conducted in low-middle income settings. Patient characteristics, study design, organization measures and outcomes data were abstracted independently by two reviewers from all studies. A risk of bias tool was applied to RCTs and a separate tool was used to assess the quality of observational studies. This review concludes that case management interventions were most consistently associated with improvements in immunological outcomes but case management demonstrates no clear association with other outcome measures. The same mixed results were also identified for multidisciplinary and multi-faceted care interventions. Eight studies with an outreach intervention were identified and demonstrated improvements or non-inferiority with respect to mortality, receipt of antiretroviral medications, immunological outcomes, improvements in healthcare utilization and lower reported healthcare costs when compared to usual care. Of the interventions examined in this review, sustained in-person case management and outreach interventions were most consistently associated with improved medical and economic outcomes, in particular antiretroviral prescribing, immunological outcomes and healthcare utilization. No firm conclusions can be reached about the impact of any one intervention on patient mortality.

Developing the Coach Analysis and Intervention System (CAIS): establishing validity and reliability of a computerised systematic observation instrument.

PubMed

Cushion, Christopher; Harvey, Stephen; Muir, Bob; Nelson, Lee

2012-01-01

We outline the evolution of a computerised systematic observation tool and describe the process for establishing the validity and reliability of this new instrument. The Coach Analysis and Interventions System (CAIS) has 23 primary behaviours related to physical behaviour, feedback/reinforcement, instruction, verbal/non-verbal, questioning and management. The instrument also analyses secondary coach behaviour related to performance states, recipient, timing, content and questioning/silence. The CAIS is a multi-dimensional and multi-level mechanism able to provide detailed and contextualised data about specific coaching behaviours occurring in complex and nuanced coaching interventions and environments that can be applied to both practice sessions and competition.

Prevalence and associations of neuropathic pain in a cohort of multi-ethnic Asian low back pain patients.

PubMed

Kew, Yueting; Tan, Cheng-Yin; Ng, Chong-Jing; Thang, Sue-Sien; Tan, Leong-Hooi; Khoo, Yvonne Khaii; Lim, Jun-Ni; Ng, Jia-Hui; Chan, Chris Yin-Wei; Kwan, Mun-Keong; Goh, Khean-Jin

2017-04-01

The prevalence of neuropathic low back pain differs in different ethnic populations. The aims of the study are to determine its frequency and associations in a multi-ethnic cohort of Asian low back pain patients. This was a cross-sectional study of low back patients seen at the University of Malaya Medical Centre, Kuala Lumpur, Malaysia. Neuropathic low back pain patients were identified using the painDETECT questionnaire and compared with non-neuropathic (unclear or nociceptive) low back pain patients, in terms of socio-demographic and clinical factors, pain severity (numerical pain rating scale, NPRS), disability (Roland Morris Disability Questionnaire, RMDQ), as well as anxiety and depression (Hospital Anxiety and Depression Scale, HADS). Of 210 patients, 26 (12.4%) have neuropathic low back pain. Neuropathic pain is associated with non-Chinese ethnicity, higher body mass index and pain radiation below the knee. Patients with neuropathic pain have significantly higher NPRS and RMDQ scores, and there are more subjects with anxiety on HADS. However, there are no differences between the groups in age, gender, pain duration or underlying diagnosis of low back pain. The prevalence of neuropathic low back pain in a multi-ethnic Malaysian cohort is lower than previously reported in other populations with possible differences between ethnic groups. It is associated with greater pain severity, disability and anxiety.

Development of an intervention program to increase effective behaviours by patients and clinicians in psychiatric services: Intervention Mapping study.

PubMed

Koekkoek, Bauke; van Meijel, Berno; Schene, Aart; Hutschemaekers, Giel

2010-10-25

Health clinicians perceive certain patients as 'difficult' across all settings, including mental health care. In this area, patients with non-psychotic disorders that become long-term care users may be perceived as obstructing their own recovery or seeking secondary gain. This negative perception of patients results in ineffective responses and low-quality care by health clinicians. Using the concept of illness behaviour, this paper describes the development, implementation, and planned evaluation of a structured intervention aimed at prevention and management of ineffective behaviours by long-term non-psychotic patients and their treating clinicians. The principles of Intervention Mapping were applied to guide the development, implementation, and planned evaluation of the intervention. Qualitative (individual and group interviews), quantitative (survey), and mixed methods (Delphi-procedure) research was used to gain a broad perspective of the problem. Empirical findings, theoretical models, and existing evidence were combined to construct a program tailored to the needs of the target groups. A structured program to increase effective illness behaviour in long-term non-psychotic patients and effective professional behaviour in their treating clinicians was developed, consisting of three subsequent stages and four substantial components, that is described in detail. Implementation took place and evaluation of the intervention is being carried out. Intervention Mapping proved to be a suitable method to develop a structured intervention for a multi-faceted problem in mental health care.

Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL – III trial)

PubMed Central

2014-01-01

Background Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. Methods/Design Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. Intervention: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). Discussion This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. Trial registration NTR3492 Dutch Trial Register (http://www.trialregister.nl). PMID:24708702

[Non-randomised trial of an educational intervention based on cognitive-behavioural principles for patients with chronic low back pain attended in Primary Care Physiotherapy].

PubMed

Díaz-Cerrillo, Juan Luis; Rondón-Ramos, Antonio; Pérez-González, Rita; Clavero-Cano, Susana

2016-01-01

To assess the influence of an educational intervention in reducing «fear-avoidance» (FA) and «pain catastrophising» (CAT) in a population with unspecific chronic low back pain (UCLBP), attending physiotherapy in Primary Health Care. A pragmatic quasi-experimental study was conducted in Health Centres of a Costa del Sol Health District. Quasi-experimental study. Primary Health Care physiotherapy Back Schools in Health Centres of a Costa del Sol Health District. The selection criteria were: UCLBP; 18-65years; understanding of the Spanish language; absence of parallel educational interventions; absence of red flags; not showing cognitive impairment or fibromyalgia; absence of thoracic-lumbar surgery, and exercise tolerance. The control group received the usual Back Schools program. The experimental group also received a written document for home reading, plus the subsequent sharing, clarifying doubts, and beliefs and goals restructuring during the development of the sessions. Both interventions lasted about 280minutes (7 sessions×40min). The main variables included FA and CAT. Pain and disability were also assessed. Some «demographic» and «related disorder» variables were considered in the analysis. Statistically significant differences were observed in the experimental group versus control, in the variation of FA -14 (-25.5; 0) vs -4 (-13; 0) (P=.009), and CAT -9 (-18; -4) vs -4,5 (-8.25; 0) (P=.000), were observed. Also differences in disability (P=.046), but not in pain (P=.280). These results should be considered in light of possible limits imposed by the study. Its pragmatic nature would allow a potential transfer to usual care. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

The impact of a home visitation programme on household hazards associated with unintentional childhood injuries: a randomised controlled trial.

PubMed

Odendaal, Willem; van Niekerk, Ashley; Jordaan, Esme; Seedat, Mohamed

2009-01-01

The continued high mortality and morbidity rates for unintentional childhood injuries remain a public health concern. This article reports on the influence of a home visitation programme (HVP) on household hazards associated with unintentional childhood injuries in a South African low-income setting. A randomised controlled trial (n=211 households) was conducted in a South African informal settlement. Community members were recruited and trained as paraprofessional visitors. Four intervention visits were conducted over 3 months, focusing on child development, and the prevention of burn, poison, and fall injuries. The HVP, a multi-component intervention, included educational inputs, provision of safety devices, and an implicit enforcement strategy. The intervention effect (IE) was measured with a standardised risk assessment index that compared post-intervention scores for intervention and control households. A significant reduction was observed in the hazards associated with electrical and paraffin appliances, as well as in hazards related to poisoning. Non-significant changes were observed for burn safety household practices and fall injury hazards. This study confirmed that a multi-component HVP effectively reduced household hazards associated with electrical and paraffin appliances and poisoning among children in a low-income South African setting.

Interacting with… What? Exploring Children's Social and Sensory Practices in a Science Discovery Centre

ERIC Educational Resources Information Center

Dicks, Bella

2013-01-01

This paper presents findings from a qualitative UK study exploring the social practices of schoolchildren visiting an interactive science discovery centre. It is promoted as a place for "learning through doing", but the multi-modal, ethnographic methods adopted suggest that children were primarily engaged in (1) sensory pleasure-taking…

Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

PubMed

Anisimov, Vladimir V

2011-01-01

This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial

PubMed Central

2013-01-01

Background Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation. Methods/design A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff. Trial registration ISRCTN18912042 PMID:24021033

TELEMAM: a cluster randomised trial to assess the use of telemedicine in multi-disciplinary breast cancer decision making.

PubMed

Kunkler, I H; Prescott, R J; Lee, R J; Brebner, J A; Cairns, J A; Fielding, R G; Bowman, A; Neades, G; Walls, A D F; Chetty, U; Dixon, J M; Smith, M E; Gardner, T W; Macnab, M; Swann, S; Maclean, J R

2007-11-01

The TELEMAM trial aimed to assess the clinical effectiveness and costs of telemedicine in conducting breast cancer multi-disciplinary meetings (MDTs). Over 12 months 473 MDT patient discussions in two district general hospitals (DGHs) were cluster randomised (2:1) to the intervention of telemedicine linkage to breast specialists in a cancer centre or to the control group of 'in-person' meetings. Primary endpoints were clinical effectiveness and costs. Economic analysis was based on a cost-minimisation approach. Levels of agreement of MDT members on a scale from 1 to 5 were high and similar in both the telemedicine and standard meetings for decision sharing (4.04 versus 4.17), consensus (4.06 versus 4.20) and confidence in the decision (4.16 versus 4.07). The threshold at which the telemedicine meetings became cheaper than standard MDTs was approximately 40 meetings per year. Telemedicine delivered breast cancer multi-disciplinary meetings have similar clinical effectiveness to standard 'in-person' meetings.

Pre-post evaluation of effects of a titanium dioxide coating on environmental contamination of an intensive care unit: the TITANIC study.

PubMed

de Jong, B; Meeder, A M; Koekkoek, K W A C; Schouten, M A; Westers, P; van Zanten, A R H

2018-07-01

Among patients admitted to European hospitals or intensive care units (ICUs), 5.7% and 19.5% will encounter healthcare-associated infections (HAIs), respectively, and antimicrobial resistance is emerging. As hospital surfaces are contaminated with potentially pathogenic bacteria, environmental cleanliness is an essential aspect to reduce HAIs. To address the efficacy of a titanium dioxide coating in reducing the microbial colonization of environmental surfaces in an ICU. A prospective, controlled, single-centre pilot study was conducted to examine the effect of a titanium dioxide coating on the microbial colonization of surfaces in an ICU. During the pre- and post-intervention periods, surfaces were cultured with agar contact plates (BBL RODAC plates). Factors that were potentially influencing the bacterial colonization of surfaces were recorded. A repeated measurements analysis within a hierarchic multi-level framework was used to analyse the effect of the intervention, controlling for the explanatory variables. The mean ratio for the total number of colony-forming units (cfus) in a room between the pre- and post-intervention periods was 0.86 (standard deviation 0.57). The optimal model included the following explanatory variables: intervention (P=0.065), week (P=0.002), culture surfaces (P<0.001), ICU room (P=0.039), and interaction between intervention and week (P=0.002) and between week and culture surfaces (P=0.031). The effect of the intervention on the number of cfus from all culture plates in Week 4 between the pre- and post-intervention periods was -0.47 (95% confidence interval -0.24 to - 0.70). This study found that a titanium dioxide coating had no effect on the microbial colonization of surfaces in an ICU. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

PROTECTED-UK - Clinical pharmacist interventions in the UK critical care unit: exploration of relationship between intervention, service characteristics and experience level.

PubMed

Rudall, Nicola; McKenzie, Catherine; Landa, June; Bourne, Richard S; Bates, Ian; Shulman, Rob

2017-08-01

Clinical pharmacist (CP) interventions from the PROTECTED-UK cohort, a multi-site critical care interventions study, were further analysed to assess effects of: time on critical care, number of interventions, CP expertise and days of week, on impact of intervention and ultimately contribution to patient care. Intervention data were collected from 21 adult critical care units over 14 days. Interventions could be error, optimisation or consults, and were blind-coded to ensure consistency, prior to bivariate analysis. Pharmacy service demographics were further collated by investigator survey. Of the 20 758 prescriptions reviewed, 3375 interventions were made (intervention rate 16.1%). CPs spent 3.5 h per day (mean, ±SD 1.7) on direct patient care, reviewed 10.3 patients per day (±SD 4.2) and required 22.5 min (±SD 9.5) per review. Intervention rate had a moderate inverse correlation with the time the pharmacist spent on critical care (P = 0.05; r = 0.4). Optimisation rate had a strong inverse association with total number of prescriptions reviewed per day (P = 0.001; r = 0.7). A consultant CP had a moderate inverse correlation with number of errors identified (P = 0.008; r = 0.6). No correlation existed between the presence of electronic prescribing in critical care and any intervention rate. Few centres provided weekend services, although the intervention rate was significantly higher on weekends than weekdays. A CP is essential for safe and optimised patient medication therapy; an extended and developed pharmacy service is expected to reduce errors. CP services should be adequately staffed to enable adequate time for prescription review and maximal therapy optimisation. © 2016 Royal Pharmaceutical Society.

Comparison of symptoms, treatment, and outcomes of coronary artery disease among rheumatoid arthritis and matched subjects undergoing percutaneous coronary intervention.

PubMed

Desai, Sonali P; Januzzi, James L; Pande, Ashvin N; Pomerantsev, Eugene V; Resnic, Frederic S; Fossel, Anne; Chibnik, Lori B; Solomon, Daniel H

2010-12-01

Rheumatoid arthritis (RA) is associated with an increased prevalence of coronary artery disease (CAD). We investigated the presenting symptoms of CAD, coronary anatomy (single versus multi-vessel CAD), and treatment among a group of subjects undergoing percutaneous coronary intervention (PCI) with angioplasty and/or stenting. We evaluated a retrospective cohort of 43 RA subjects and 43 matched non-RA subjects undergoing PCI at 2 academic referral centers. RA subjects were matched to non-RA subjects on age, gender, history of coronary artery bypass grafting, date of PCI, and interventional cardiologist. We compared cardiac risk factors, presentation, treatment, and outcomes. The mean age of the study cohort was 71 ± 10 years, and the distribution of traditional cardiac risk factors was similar in the subjects with RA compared with the matched non-RA subjects (all P values > 0.05). Seventy-four percent of subjects with RA compared with 67% of those without RA presented with an acute coronary syndrome before PCI (P = 0.48). All subjects in this cohort undergoing PCI had at least 1 stenosis in a major epicardial vessel and similar percentages of subjects with RA (44%) and without RA (40%) had multi-vessel CAD (P = 0.66). The administration of cardiac medications both at PCI and at hospital discharge was not different among subjects with RA compared with matched non-RA subjects. Among this cohort with significant CAD undergoing PCI, clinical characteristics, presentation, severity of CAD, treatment modalities, and outcomes were similar in subjects with RA and well-matched non-RA subjects. Copyright © 2010 Elsevier Inc. All rights reserved.

Multi-criteria decision analysis for bioenergy in the Centre Region of Portugal

NASA Astrophysics Data System (ADS)

Esteves, T. C. J.; Cabral, P.; Ferreira, A. J. D.; Teixeira, J. C.

2012-04-01

With the consumption of fossil fuels, the resources essential to Man's survival are being rapidly contaminated. A sustainable future may be achieved by the use of renewable energies, allowing countries without non-renewable energy resources to guarantee energetic sovereignty. Using bioenergy may mean a steep reduction and/or elimination of the external dependency, enhancing the countries' capital and potentially reducing of the negative effects that outcome from the use of fossil fuels, such as loss of biodiversity, air, water, and soil pollution, … This work's main focus is to increase bioenergy use in the centre region of Portugal by allying R&D to facilitate determination of bioenergy availability and distribution throughout the study area.This analysis is essential, given that nowadays this knowledge is still very limited in the study area. Geographic Information Systems (GIS) was the main tool used to asses this study, due to its unseeingly ability to integrate various types of information (such as alphanumerical, statistical, geographical, …) and various sources of biomass (forest, agricultural, husbandry, municipal and industrial residues, shrublands, used vegetable oil and energy crops) to determine the bioenergy potential of the study area, as well as their spatial distribution. By allying GIS with multi-criteria decision analysis, the initial table-like information of difficult comprehension is transformed into tangible and easy to read results: both intermediate and final results of the created models will facilitate the decision making process. General results show that the major contributors for the bioenergy potential in the Centre Region of Portugal are forest residues, which are mostly located in the inner region of the study area. However, a more detailed analysis should be made to analyze the viability to use energy crops. As a main conclusion, we can say that, although this region may not use only this type of energy to be completely independent in terms of energy, it will certainly reduce the amount of consumed fossil fuels, leading to a substantial reduction of the importation of this product.

Motivation is a crucial factor for adherence to a healthy lifestyle among people with coronary heart disease after percutaneous coronary intervention.

PubMed

Kähkönen, Outi; Kankkunen, Päivi; Saaranen, Terhi; Miettinen, Heikki; Kyngäs, Helvi; Lamidi, Marja-Leena

2015-10-01

To test the Theory of Adherence of People with Chronic Disease with regard to adherence to treatment among patients with coronary heart disease after a percutaneous coronary intervention. Increased knowledge of the concept of adherence is needed for the development of nursing interventions and nursing guidelines for patients with coronary heart disease. A cross-sectional, multi-centre study. This study was conducted from February-December 2013 with 416 patients with coronary heart disease 4 months after undergoing a percutaneous coronary intervention. A self-reported questionnaire was used to assess their adherence to treatment. Data were analysed using structural equation modelling. The theory explained 45% of the adherence to a healthy lifestyle and 7% of the adherence to medication. Structural equation modelling confirmed that motivation and results of care had the highest association with adherence to a healthy lifestyle. Responsibility was associated with adherence to medication. Support from next of kin, support from nurses and physicians, and motivation, co-operation, fear of complications and a sense of normality were associated with adherence. Patients who are motivated to perform self-care and consider the results of care to be important were more likely to adhere to a healthy lifestyle. Responsible patients were more likely to adhere to their medication. It is important to account for these elements as a part of secondary prevention strategies among patients with coronary heart disease after a percutaneous coronary intervention. © 2015 John Wiley & Sons Ltd.

The effect of an educational intervention in family phisicians on self-rated quality of life in patients with medically unexplained symptoms.

PubMed

Ivetić, Vojislav; Pašić, Klemen; Selič, Polona

2017-06-01

Medically unexplained symptoms (MUS) are very common in family medicine, despite being a poorly-defined clinical entity. This study aimed to evaluate the effect of an educational intervention (EI) on self-rated quality of life, treatment satisfaction, and the family physician-patient relationship in patients with MUS. In a multi-centre longitudinal intervention study, which was performed between 2012 and 2014, patients were asked to rate their quality of life, assess their depression, anxiety, stress and somatisation, complete the Hypochondriasis Index, the Medical Interview Satisfaction Scale and the Patient Enablement Instrument for assessing the physician-patient relationship, before and after the EI. The mean values before and after the intervention showed that after the EI, patients with MUS gave a lower (total) mean rating of their health issues and a higher rating of their quality of life, and they also had a more positive opinion of their relationship with the physician (p<0.05). However, there were no differences in the (total) rating of treatment satisfaction before and after the EI (p=0.423). Significant differences in the symptoms in patients with MUS before and after the intervention were confirmed for stress, somatisation and hypochondriasis (p<0.05). It could be beneficial to equip family physicians with the knowledge, skills and tools to reduce hypochondriasis and somatisation in MUS patients, which would improve patients' self-rated health status.

Radiological clinical trials: Proposal of a problem-finding questionnaire to improve study success.

PubMed

Valdora, Francesca; Bignotti, Bianca; Calabrese, Massimo; Houssami, Nehmat; Tagliafico, Alberto

2016-12-26

To develop a survey to help define the main problems in radiological clinical trials. Since 2006, we have managed seven different radiological clinical trials recruiting patients in academic and non-academic centres. We developed a preliminary questionnaire using a four-round Delphi approach to identify problems occurring in radiological clinical trials run at our centre. We investigated the recruitment experience, involvement of all multi-disciplinary team members and main obstacles to completing the projects. A final round of Delphi processes elucidated solutions to the identified problems. Among 19/20 (95%) respondents, 10 (53%) were young physicians (under 35 years old), and the respondents included non-faculty members, fellows, residents, and undergraduate students. Ninety-four percent (18/19) of respondents showed interest in conducting clinical trials. On a scale of 1 to 10, the problems with higher/worse scores (8-9) were related to technical or communication problems. The most frequent problems across all studies were technical problems related to clinical trial equipment, insufficient willingness to participate, obstacles to understanding the design of electronic-case report form and extra work. The developed questionnaire identified the main recurring problems in radiological clinical trials as perceived by end-users and helped define possible solutions that are mostly related to having dedicated clinical trial research staff.

Improving availability, promotion and purchase of fruit and vegetable and non sugar-sweetened drink products at community sporting clubs: a randomised trial.

PubMed

Wolfenden, Luke; Kingsland, Melanie; Rowland, Bosco C; Dodds, Pennie; Gillham, Karen; Yoong, Sze Lin; Sidey, Maree; Wiggers, John

2015-03-10

Amateur sporting clubs represent an attractive setting for health promotion. This study assesses the impact of a multi-component intervention on the availability, promotion and purchase of fruit and vegetable and non sugar -sweetened drink products from community sporting club canteens. We also assessed the impact the intervention on sporting club revenue from the sale of food and beverages. A repeat cross-sectional, parallel group, cluster randomized controlled trial was undertaken with amateur community football clubs in New South Wales, Australia. The intervention was conducted over 2.5 winter sporting seasons and sought to improve the availability and promotion of fruit and vegetables and non sugar-sweetened drinks in sporting club canteens. Trial outcomes were assessed via telephone surveys of sporting club representatives and members. Eighty five sporting clubs and 1143 club members participated in the study. Relative to the control group, at follow-up, clubs allocated to the intervention were significantly more likely to have fruit and vegetable products available at the club canteen (OR = 5.13; 95% CI 1.70-15.38), were more likely to promote fruit and vegetable selection using reduced pricing and meal deals (OR = 34.48; 95% CI 4.18-250.00) and members of intervention clubs were more likely to report purchase of fruit and vegetable (OR = 2.58 95% CI; 1.08-6.18) and non sugar -sweetened drink (OR = 1.56; 95% CI 1.09-2.25) products. There was no significant difference between groups in the annual club revenue from food and non-alcoholic beverage sales. The findings demonstrate that the intervention can improve the nutrition environment of sporting clubs and the purchasing behaviour of members. Australian New Zealand Clinical Trials Registry: ACTRN12609000224224 .

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

PubMed

Martin-Lujan, Francisco; Piñol-Moreso, Josep L I; Martin-Vergara, Nuria; Basora-Gallisa, Josep; Pascual-Palacios, Irene; Sagarra-Alamo, Ramon; Llopis, Estefania Aparicio; Basora-Gallisa, Maria T; Pedret-Llaberia, Roser

2011-11-11

There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Multicentre randomized clinical trial with an intervention and a control group. 12 primary care centres in the province of Tarragona (Spain). 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Smoking cessation at 12 months. Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. ClinicalTrial.gov, number NCT01194596.

Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

PubMed

Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

2011-09-01

To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Etiology and mode of presentation of chronic liver diseases in India: A multi centric study.

PubMed

Mukherjee, Partha S; Vishnubhatla, Sreenivas; Amarapurkar, Deepak N; Das, Kausik; Sood, Ajit; Chawla, Yogesh K; Eapen, Chundamannil E; Boddu, Prabhakar; Thomas, Varghese; Varshney, Subodh; Hidangmayum, Diamond Sharma; Bhaumik, Pradip; Thakur, Bhaskar; Acharya, Subrat K; Chowdhury, Abhijit

2017-01-01

There is a paucity of health policy relevant data for chronic liver disease from India, impeding formulation of an interventional strategy to address the issue. A prospective, multicentric study to delineate the etiology and clinical profile of chronic liver disease in India is reported here. A centrally coordinated and monitored web-based data repository was developed (Feb, 2010 to Jan, 2013) and analyzed. Eleven hospitals from different parts of India participated. Data were uploaded into a web based proforma and monitored by a single centre according to a standardized protocol. 1.28% (n = 266621) of all patients (n = 20701383) attending the eleven participating hospitals of India had liver disease. 65807 (24·68%) were diagnosed for the first time (new cases). Of these, 13014 (19·77%, median age 43 years, 73% males) cases of chronic liver disease were finally analyzed. 33.9% presented with decompensated cirrhosis. Alcoholism (34·3% of 4413) was the commonest cause of cirrhosis while Hepatitis B (33·3%) was predominant cause of chronic liver disease in general and non-cirrhotic chronic liver disease (40·8% out of 8163). There was significant interregional differences (hepatitis C in North, hepatitis B in East and South, alcohol in North-east, Non-alcoholic Fatty Liver Disease in West) in the predominant cause of chronic liver disease. Hepatitis B (46·8% of 438 cases) was the commonest cause of hepatocellular Cancer.11·7% had diabetes. Observations of our study will help guide a contextually relevant liver care policy for India and could serve as a framework for similar endeavor in other developing countries as well.

Making free public healthcare attractive: optimizing health equity funds in Cambodia.

PubMed

Jacobs, Bart; Bajracharya, Ashish; Saha, Jyotirmoy; Chhea, Chhorvann; Bellows, Ben; Flessa, Steffen; Fernandes Antunes, Adelio

2018-06-25

Following the introduction of user fees in Cambodia, Health Equity Funds (HEF) were developed to enable poor people access to public health services by paying public health providers on their behalf, including non-medical costs for hospitalised beneficiaries (HEFB). The national scheme covers 3.1 million pre-identified HEFB. Uptake of benefits, however, has been mixed and a substantial proportion of poor people still initiate care at private facilities where they incur considerable out-of-pocket costs. We examine the benefits of additional interventions compared to existing stand-alone HEF scenarios in stimulating care seeking at public health facilities among eligible poor people. We report on three configurations of HEF and their ability to attract HEFB to initiate care at public health facilities and their degree of financial risk protection: HEF covering only hospital services (HoHEF), HEF covering health centre and hospital services (CHEF), and Integrated Social Health Protection Scheme (iSHPS) that allowed non-HEFB community members to enrol in HEF. The iSHPS also used vouchers for selected health services, pay-for-performance for quantity and quality of care, and interventions aimed at increasing health providers' degree of accountability. A cross sectional survey collected information from 1636 matched HEFB households in two health districts with iSHPS and two other health districts without iSHPS. Respondents were stratified according to the three HEF configurations for the descriptive analysis. The findings indicated that the proportion of HEFB who sought care first from public health providers in iSHPS areas was 55.7%, significantly higher than the 39.5% in the areas having HEF with health centres (CHEF) and 13.4% in the areas having HEF with hospital services only (HoHEF). The overall costs (out-of-pocket and transport) associated with the illness episode were lowest for cases residing within iSHPS sites, US$10.4, and highest in areas where health centres were not included in the package (HoHEF), US$20.7. Such costs were US$19.5 at HEF with health centres (CHEF). The findings suggest that HEF encompassing health centre and hospital services and complemented by additional interventions are better than stand-alone HEF in attracting sick HEFB to public health facilities and lowering out-of-pocket expenses associated with healthcare seeking.

Effectiveness of interventions that assist caregivers to support people with dementia living in the community: a systematic review.

PubMed

Parker, Deborah; Mills, Sandra; Abbey, Jennifer

2008-06-01

Objectives  The objective of this review was to assess the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Inclusion criteria  Types of participants  Adult caregivers who provide support for people with dementia living in the community (non-institutional care). Types of interventions  Interventions designed to support caregivers in their role such as skills training, education to assist in caring for a person living with dementia and support groups/programs. Interventions of formal approaches to care designed to support caregivers in their role, care planning, case management and specially designated members of the healthcare team - for example dementia nurse specialist or volunteers trained in caring for someone with dementia. Types of studies  This review considered any meta-analyses, systematic reviews, randomised control trials, quasi-experimental studies, cohort studies, case control studies and observational studies without control groups that addressed the effectiveness of interventions that assist caregivers to provide support for people living with dementia in the community. Search strategy  The search sought to identify published studies from 2000 to 2005 through the use of electronic databases. Only studies in English were considered for inclusion. The initial search was conducted of the databases, CINAHL, MEDLINE and PsychINFO using search strategies adapted from the Cochrane Dementia and Cognitive Improvement Group. A second more extensive search was then conducted using the appropriate Medical Subject Headings (MeSH) and keywords for other available databases. Finally, hand searching of reference lists of articles retrieved and of core dementia, geriatric and psycho geriatric journals was undertaken. Assessment of quality  Methodological quality of each of the articles was assessed by two independent reviewers using appraisal checklist developed by the Joanna Briggs Institute and based on the work of the Cochrane Collaboration and Centre for Reviews and Dissemination. Data collection and analysis  Standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each included study reported in the meta-analysis. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software from the Cochrane Collaboration. Heterogeneity between combined studies was tested using standard chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. Results  A comprehensive search of relevant databases, hand searching and cross referencing found 685 articles that were assessed for relevance to the review. Eighty-five papers appeared to meet the inclusion criteria based on title and abstract, and the full paper was retrieved. Of the 85 full papers reviewed, 40 were accepted for inclusion, three were systematic reviews, three were meta-analysis, and the remaining 34 were randomised controlled trials. For the randomised controlled trials that were able to be included in a meta-analysis, standardised mean differences or weighted mean differences and their 95% confidence intervals were calculated for each. Results from comparable groups of studies were pooled in statistical meta-analysis using Review Manager Software and heterogeneity between combined studies was assessed by using the chi-square test. Where statistical pooling was not appropriate or possible, the findings are summarised in narrative form. The results are discussed in two main sections. Firstly it was possible to assess the effectiveness of different types of caregiver interventions on the outcome categories of depression, health, subjective well-being, self-efficacy and burden. Secondly, results are reported by main outcome category. For each of these sections, meta-analysis was conducted where it was possible; otherwise, a narrative summary describes the findings. Effectiveness of intervention type  Four categories of intervention were included in the review - psycho-educational, support, multi-component and other. Psycho-educational Thirteen studies used psycho-educational interventions, and all but one showed positive results across a range of outcomes. Eight studies were entered in a meta-analysis. No significant impact of psycho-educational interventions was found for the outcome categories of subjective well-being, self-efficacy or health. However, small but significant results were found for the categories of depression and burden. Support Seven studies discussed support only interventions and two of these showed significant results. These two studies were suitable for meta-analysis and demonstrated a small but significant improvement on caregiver burden. Multi-component Twelve of the studies report multi-component interventions and 10 of these report significant outcomes across a broad range of outcome measures including self-efficacy, depression, subjective well-being and burden. Unfortunately because of the heterogeneity of study designs and outcome measures, no meta-analysis was possible. Other interventions Other interventions included the use of exercise or nutrition which resulted in improvements in psychological distress and health benefits. Case management and a computer aided support intervention provided mixed results. One cognitive behavioural therapy study reported a reduction in anxiety and positive impacts on patient behaviour. Effectiveness of interventions using specific outcome categories  In addition to analysis by type of intervention it was possible to analyse results based on some outcome categories that were used across the studies. In particular the impact of interventions on caregiver depression was available for meta-analysis from eight studies. This indicated that multi-component and psycho-educational interventions showed a small but significant positive effect on caregiver depression. Five studies using the outcome category of caregiver burden were entered into a meta-analysis and findings indicated that there were no significant effects of any of interventions. No meta-analysis was possible for the outcome categories of health, self-efficacy or subjective well-being. Implications for practice  From this review there is evidence to support the use of well-designed psycho-educational or multi-component interventions for caregivers of people with dementia who live in the community. Factors that appear to positively contribute to effective interventions are those which: •  Provide opportunities within the intervention for the person with dementia as well as the caregiver to be involved •  Encourage active participation in educational interventions for caregivers •  Offer individualised programs rather than group sessions •  Provide information on an ongoing basis, with specific information about services and coaching regarding their new role •  Target the care recipient particularly by reduction in behaviours Factors which do not appear to have benefit in interventions are those which: •  Simply refer caregivers to support groups •  Only provide self help materials •  Only offer peer support. © 2008 The Authors. Journal Compilation © Blackwell Publishing Asia Pty Ltd.

Assessing the adequacy of pressure ulcer prevention in hospitals: a nationwide prevalence survey.

PubMed

Vanderwee, Katrien; Defloor, Tom; Beeckman, Dimitri; Demarré, Liesbet; Verhaeghe, Sofie; Van Durme, Thérèse; Gobert, Micheline

2011-03-01

The development of a pressure ulcer is an adverse event and is often avoidable if adequate preventive measures are applied. No large-scale data, based on direct patient observations, are available regarding the pressure ulcer preventive interventions used in hospitals. The aim of this study was to obtain insight into the adequacy of interventions used to prevent pressure ulcers in Belgian hospitals. A cross-sectional, multi-centre pressure ulcer prevalence study was performed in Belgian hospitals. The methodology used to measure pressure ulcer prevalence was developed by the European Pressure Ulcer Advisory Panel. The data collection instrument includes five categories of data: general data, patient data, risk assessment, skin observation and prevention. The total sample consisted of 19,968 patients. The overall prevalence of pressure ulcers Category I-IV was 12.1%. Only 10.8% of the patients at risk received fully adequate prevention in bed and while sitting. More than 70% of the patients not at risk received some pressure ulcer prevention while lying or sitting. Generally, there is a limited use of adequate preventive interventions for pressure ulcers in hospitals, which reflects a rather low quality of preventive care. The implementation of pressure ulcer guidelines requires more attention. The pressure ulcer prevention used in practice should be re-evaluated on a regular basis.

Improving human health outcomes with a low-cost intervention to reduce exposures from lead acid battery recycling: Dong Mai, Vietnam.

PubMed

Ericson, Bret; Duong, Thi To; Keith, John; Nguyen, Trong Cuu; Havens, Deborah; Daniell, William; Karr, Catherine J; Ngoc Hai, Doan; Van Tung, Lo; Thi Nhi Ha, Tran; Wilson, Brian; Hanrahan, David; Croteau, Gerry; Patrick Taylor, Mark

2018-02-01

This study details the first comprehensive evaluation of the efficacy of a soil lead mitigation project in Dong Mai village, Vietnam. The village's population had been subject to severe lead poisoning for at least a decade as a result of informal Used Lead Acid Battery (ULAB) recycling. Between July 2013 to February 2015, Pure Earth and the Centre for Environment and Community Development (Hanoi, Vietnam) implemented a multi-faceted environmental and human health intervention. The intervention consisted of a series of institutional and low-cost engineering controls including the capping of lead contaminated surface soils, cleaning of home interiors, an education campaign and the construction of a work-clothes changing and bathing facility. The mitigation project resulted in substantial declines in human and environmental lead levels. Remediated home yard and garden areas decreased from an average surface soil concentration of 3940mg/kg to <100mg/kg. One year after the intervention, blood lead levels in children (<6 years old) were reduced by an average of 67%-from a median of 40.4μg/dL to 13.3μg/dL. The Dong Mai project resulted in significantly decreased environmental and biological lead levels demonstrating that low-cost, rapid and well-coordinated interventions could be readily applied elsewhere to significantly reduce preventable human health harm. Copyright © 2017 Elsevier Inc. All rights reserved.

Non-adherence in children with asthma reviewed: The need for improvement of asthma care and medical education.

PubMed

Klok, Ted; Kaptein, Adrian A; Brand, Paul L P

2015-05-01

Adherence to daily inhaled corticosteroid therapy is a key determinant of asthma control. Therefore, improving adherence to inhaled corticosteroids is the most effective method through which healthcare providers can help children with uncontrolled asthma. However, identifying non-adherent patients is difficult, and electronic monitoring is the only reliable method to assess adherence. (Non-)adherence is a complex behavioural process influenced by many interacting factors. Intentional barriers to adherence are common; driven by illness perceptions and medication beliefs, patients and parents deliberately choose not to follow the doctor's recommendations. Common non-intentional barriers are related to family routines, child-raising issues, and to social issues such as poverty. Effective interventions improving adherence are complex, because they take intentional and non-intentional barriers to adherence into account. There is evidence that comprehensive, guideline-based asthma self-management programmes can be successful, with excellent adherence and good asthma control. Patient-centred care focused on healthcare provider-patient/parent collaboration is the key factor determining the success of guided self-management programmes. Such care should focus on shared decision-making as this has been shown to improve adherence and healthcare outcomes. Current asthma care falls short because many physicians fail to adhere to asthma guidelines in their diagnostic approach and therapeutic prescriptions, and because of the lack of application of patient-centred health care. Increased awareness of the importance of patient-centred communication and increased training in patient-centred communication skills of undergraduates and experienced attending physicians are needed to improve adherence to daily controller therapy and asthma control in children with asthma. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Plan for improving pharmacy indicators in a primary health area of Madrid. Description and results].

PubMed

Izquierdo-Palomares, José Manuel; Carretón, María José Almodóvar; Fernández, Luís Carlos Saiz; Gómez, Raquel Siguín; Gómez, Carlos López; Elustondo, Sofía Garrido

2011-03-01

To evaluate the results of a plan for improving pharmacy indicators in a Primary Care (PC) Health Area. Quasi-experimental study with a control group. The differences between the pre-intervention (Jan-Dec 2007) and post-intervention (Jan-Dec 2008) periods were evaluated. Intervention group: Primary Care doctors from PC Area 7 of the Community of Madrid (n=397). the rest of PC doctors of the Community of Madrid (n=4428). A multi-focus plan in which the main activities were: sessions in the health centres with the worst results, involvement of those responsible for the Rational Use of Drugs, interviews with the doctors with the most improvable indicators, recognition of those with good indicators, and preparing short notes on drugs. Prescription and notification indicators associated with the safety of drugs. In relation to Madrid, the absolute improvements of Area 7 in the accumulated indicators, %Generic drugs, %Statins, %ARAII y %Omeprazole were 0.29; 1.17; 0.61 and 0.37 percentage points, respectively. DHD Osteoporosis equalled the improvement of Madrid. In Area 7, the increase in notifications of suspected serious ADRs was 180% and number of ADR notifications of ADRs was 233%, better than the Madrid data (48% and 21%). The notification of medication errors showed similar increases in both groups (PC Area 7 1567% vs. Madrid PC 1633%). Implementing a multi-focus improvement plan with feasible and specific actions can be a useful tool for improving pharmacy indicators. Copyright © 2009 Elsevier España, S.L. All rights reserved.

The effectiveness of different interventions to promote poison prevention behaviours in households with children: a network meta-analysis.

PubMed

Achana, Felix A; Sutton, Alex J; Kendrick, Denise; Wynn, Persephone; Young, Ben; Jones, David R; Hubbard, Stephanie J; Cooper, Nicola J

2015-01-01

There is evidence from 2 previous meta-analyses that interventions to promote poison prevention behaviours are effective in increasing a range of poison prevention practices in households with children. The published meta-analyses compared any intervention against a "usual care or no intervention" which potentially limits the usefulness of the analysis to decision makers. We aim to use network meta-analysis to simultaneously evaluate the effectiveness of different interventions to increase prevalence of safe storage of i) Medicines only, ii) Other household products only, iii) Poisons (both medicines and non-medicines), iv) Poisonous plants; and v) Possession of poison control centre (PCC) telephone number in households with children. Data on the effectiveness of poison prevention interventions was extracted from primary studies identified in 2 newly-undertaken systematic reviews. Effect estimates were pooled across studies using a random effects network meta-analysis model. 28 of the 47 primary studies identified were included in the analysis. Compared to usual care intervention, the intervention with education and low cost/free equipment elements was most effective in promoting safe storage of medicines (odds ratio 2.51, 95% credible interval 1.01 to 6.00) while interventions with education, low cost/free equipment, home safety inspection and fitting components were most effective in promoting safe storage of other household products (2.52, 1.12 to 7.13), safe storage of poisons (11.10, 1.60 to 141.50) and possession of PCC number (38.82, 2.19 to 687.10). No one intervention package was more effective than the others in promoting safe storage of poisonous plants. The most effective interventions varied by poison prevention practice, but education alone was not the most effective intervention for any poison prevention practice. Commissioners and providers of poison prevention interventions should tailor the interventions they commission or provide to the poison prevention practices they wish to promote. Network meta-analysis is useful for comparing multiple injury-prevention interventions. More intensive poison prevention interventions were more effective than education alone. Education and low cost/free equipment was most effective in promoting safe storage of medicines. Education, low cost/free equipment, home safety inspection and fitting was most effective in promoting safe storage of household products and poisons. Education, low cost/free equipment and home inspection were most effective in promoting possession of a poison control centre number. None of the intervention packages was more effective than the others in promoting safe storage of poisonous plants.

Outcomes from a randomized controlled trial of a multi-component alcohol use preventive intervention for urban youth: project northland Chicago.

PubMed

Komro, Kelli A; Perry, Cheryl L; Veblen-Mortenson, Sara; Farbakhsh, Kian; Toomey, Traci L; Stigler, Melissa H; Jones-Webb, Rhonda; Kugler, Kari C; Pasch, Keryn E; Williams, Carolyn L

2008-04-01

The goal of this group-randomized trial was to test the effectiveness of an adapted alcohol use preventive intervention for urban, low-income and multi-ethnic settings. Sixty-one public schools in Chicago were recruited to participate, were grouped into neighborhood study units and assigned randomly to intervention or 'delayed program' control condition. The study sample (n = 5812 students) was primarily African American, Hispanic and low-income. Students, beginning in sixth grade (age 12 years), received 3 years of intervention strategies (curricula, family interventions, youth-led community service projects, community organizing). Students participated in yearly classroom-based surveys to measure their alcohol use and related risk and protective factors. Additional evaluation components included a parent survey, a community leader survey and alcohol purchase attempts. Overall, the intervention, compared with a control condition receiving 'prevention as usual', was not effective in reducing alcohol use, drug use or any hypothesized mediating variables (i.e. related risk and protective factors). There was a non-significant trend (P = 0.066) that suggested the ability to purchase alcohol by young-appearing buyers was reduced in the intervention communities compared to the control communities, but this could be due to chance. Secondary outcome analyses to assess the effects of each intervention component indicated that the home-based programs were associated with reduced alcohol, marijuana and tobacco use combined (P = 0.01), with alcohol use alone approaching statistical significance (P = 0.06). Study results indicate the importance of conducting evaluations of previously validated programs in contexts that differ from the original study sample. Also, the findings highlight the need for further research with urban, low-income adolescents from different ethnic backgrounds to identify effective methods to prevent and reduce alcohol use.

Interventions aimed at improving the ability to use everyday technology in work after brain injury.

PubMed

Kassberg, Ann-Charlotte; Prellwitz, Maria; Malinowsky, Camilla; Larsson-Lund, Maria

2016-01-01

The aim of this study was to explore and describe how client-centred occupational therapy interventions may support and improve the ability to use everyday technology (ET) in work tasks in people with acquired brain injury (ABI). A qualitative, descriptive multiple-case study was designed, and occupation-based interventions were provided to three working-age participants with ABI. Multiple sources were used to collect data throughout the three intervention processes, including assessments, field notes, and interviews. The Canadian Occupational Performance Measure and the Management of Everyday Technology Assessment were administered before the interventions, after the interventions and at a follow-up session 2-3 months subsequent to the interventions. The three intervention processes initially consisted of similar actions, but subsequently the actions took on a different focus and intensity for each case. All of the goals in each of the three case processes were achieved, and both perceived and observed abilities to use ET in work tasks improved. Client-centred occupational therapy interventions might have the potential to improve the ability to use ET in work tasks in people with ABI.

[Patients' perception on attention received from Health Centres non-sanitary staff].

PubMed

Ruiz Moral, R; Alba Dios, A; Jiménez García, C; González Neubauer, V; García Torres, M; Pérula de Torres, L A; Barrios Blasco, L

2011-01-01

To know patients' perceptions about relational aspects and technical procedures when they are attended by the administrative staff in Health Centres. To assess the utility of two ways for measuring satisfaction. Cross-sectional study carried out in people attending the administrative sections of Health Centres for diverse reasons. Just after the interaction with the administrative they were interviewed using two different questions for assessing their opinions and satisfaction with communicational and technical aspects related with their demands. Descriptive analysis. Significant differences among mean was explored by χ(2) test. Open-ended questions were grouped in categories in a process involving three researchers independently. Over than 90% (360) of the attendees declared to be satisfied or very satisfied with the service received from the staff personal. Nevertheless, among 18-36% gave suggestions for improving the service after their consultation. Independently the domain explored, people suggested the communicational, personal capability, quality and quantity of explanations and waiting time as the main aspects to be improved. Surveys with open-ended questions are more useful to assess the quality of the attention the citizens receive from no-sanitary staff in Health Centres. These type of questions are also more useful for detecting problems and planning new interventions. Relational and informative issues seem to be the most prioritary areas to improve in this section of Health Centres. Copyright © 2010 SECA. Published by Elsevier Espana. All rights reserved.

Cost-consequence analysis of multimodal interventions with environmental components for pediatric asthma in the state of Maryland.

PubMed

Jassal, Mandeep S; Diette, Gregory B; Dowdy, David W

2013-08-01

Applied environmental strategies for asthma control are often expensive, but may save longer-term healthcare costs. Whether these savings outweigh additional costs of implementing these strategies is uncertain. We conducted a systematic review to estimate the expenditures and savings of environmental interventions for asthma in the state of Maryland. Direct costs included hospitalizations, emergency room, and clinic visits. Indirect expenditures included costs of lost work productivity and travel incurred during the usage of healthcare services. We used decision analysis, assuming a hypothetical cohort of the approximated 49,290 pediatric individuals in Maryland with persistent asthma, to compare costs and benefits of environmental asthma interventions against the standard of care (no intervention) from the societal perspective. Three interventions among nine articles met the inclusion criteria for the systematic review: 1) environmental education using medical professionals; 2) education using non-medical personnel; and 3) multi-component strategy involving education with non-medical personnel, allergen-impermeable covers, and pest management. All interventions were found to be cost-saving relative to the standard of care. Home environmental education using non-medical professionals yielded the highest net savings of $14.1 million (95% simulation interval (SI): $-.283 million, $19.4 million), while the multi-component intervention resulted in the lowest net savings of $8.1 million (95% SI: $-4.9 million, $15.9 million). All strategies were most sensitive to the baseline number of hospitalizations in those not receiving targeted interventions for asthma. Limited environmental reduction strategies for asthma are likely to be cost-saving to the healthcare system in Maryland and should be considered for broader scale-up in other economically similar settings.

Antibiotic resistance and population structure of cystic fibrosis Pseudomonas aeruginosa isolates from a Spanish multi-centre study.

PubMed

López-Causapé, Carla; de Dios-Caballero, Juan; Cobo, Marta; Escribano, Amparo; Asensio, Óscar; Oliver, Antonio; Del Campo, Rosa; Cantón, Rafael; Solé, Amparó; Cortell, Isidoro; Asensio, Oscar; García, Gloria; Martínez, María Teresa; Cols, María; Salcedo, Antonio; Vázquez, Carlos; Baranda, Félix; Girón, Rosa; Quintana, Esther; Delgado, Isabel; de Miguel, María Ángeles; García, Marta; Oliva, Concepción; Prados, María Concepción; Barrio, María Isabel; Pastor, María Dolores; Olveira, Casilda; de Gracia, Javier; Álvarez, Antonio; Escribano, Amparo; Castillo, Silvia; Figuerola, Joan; Togores, Bernat; Oliver, Antonio; López, Carla; de Dios Caballero, Juan; Tato, Marta; Máiz, Luis; Suárez, Lucrecia; Cantón, Rafael

2017-09-01

The first Spanish multi-centre study on the microbiology of cystic fibrosis (CF) was conducted from 2013 to 2014. The study involved 24 CF units from 17 hospitals, and recruited 341 patients. The aim of this study was to characterise Pseudomonas aeruginosa isolates, 79 of which were recovered from 75 (22%) patients. The study determined the population structure, antibiotic susceptibility profile and genetic background of the strains. Fifty-five percent of the isolates were multi-drug-resistant, and 16% were extensively-drug-resistant. Defective mutS and mutL genes were observed in mutator isolates (15.2%). Considerable genetic diversity was observed by pulsed-field gel electrophoresis (70 patterns) and multi-locus sequence typing (72 sequence types). International epidemic clones were not detected. Fifty-one new and 14 previously described array tube (AT) genotypes were detected by AT technology. This study found a genetically unrelated and highly diverse CF P. aeruginosa population in Spain, not represented by the epidemic clones widely distributed across Europe, with multiple combinations of virulence factors and high antimicrobial resistance rates (except for colistin). Copyright © 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

Implementation of the SMART MOVE intervention in primary care: a qualitative study using normalisation process theory.

PubMed

Glynn, Liam G; Glynn, Fergus; Casey, Monica; Wilkinson, Louise Gaffney; Hayes, Patrick S; Heaney, David; Murphy, Andrew W M

2018-05-02

Problematic translational gaps continue to exist between demonstrating the positive impact of healthcare interventions in research settings and their implementation into routine daily practice. The aim of this qualitative evaluation of the SMART MOVE trial was to conduct a theoretically informed analysis, using normalisation process theory, of the potential barriers and levers to the implementation of a mhealth intervention to promote physical activity in primary care. The study took place in the West of Ireland with recruitment in the community from the Clare Primary Care Network. SMART MOVE trial participants and the staff from four primary care centres were invited to take part and all agreed to do so. A qualitative methodology with a combination of focus groups (general practitioners, practice nurses and non-clinical staff from four separate primary care centres, n = 14) and individual semi-structured interviews (intervention and control SMART MOVE trial participants, n = 4) with purposeful sampling utilising the principles of Framework Analysis was utilised. The Normalisation Process Theory was used to develop the topic guide for the interviews and also informed the data analysis process. Four themes emerged from the analysis: personal and professional exercise strategies; roles and responsibilities to support active engagement; utilisation challenges; and evaluation, adoption and adherence. It was evident that introducing a new healthcare intervention demands a comprehensive evaluation of the intervention itself and also the environment in which it is to operate. Despite certain obstacles, the opportunity exists for the successful implementation of a novel healthcare intervention that addresses a hitherto unresolved healthcare need, provided that the intervention has strong usability attributes for both disseminators and target users and coheres strongly with the core objectives and culture of the health care environment in which it is to operate. We carried out a theoretical analysis of stakeholder informed barriers and levers to the implementation of a novel exercise promotion tool in the Irish primary care setting. We believe that this process amplifies the implementation potential of such an intervention in primary care. The SMART MOVE trial is registered at Current Controlled Trials (ISRCTN99944116; Date of registration: 1st August 2012).

Ahead of the game protocol: a multi-component, community sport-based program targeting prevention, promotion and early intervention for mental health among adolescent males.

PubMed

Vella, Stewart A; Swann, Christian; Batterham, Marijka; Boydell, Katherine M; Eckermann, Simon; Fogarty, Andrea; Hurley, Diarmuid; Liddle, Sarah K; Lonsdale, Chris; Miller, Andrew; Noetel, Michael; Okely, Anthony D; Sanders, Taren; Telenta, Joanne; Deane, Frank P

2018-03-21

There is a recognised need for targeted community-wide mental health strategies and interventions aimed specifically at prevention and early intervention in promoting mental health. Young males are a high need group who hold particularly negative attitudes towards mental health services, and these views are detrimental for early intervention and help-seeking. Organised sports provide a promising context to deliver community-wide mental health strategies and interventions to adolescent males. The aim of the Ahead of the Game program is to test the effectiveness of a multi-component, community-sport based program targeting prevention, promotion and early intervention for mental health among adolescent males. The Ahead of the Game program will be implemented within a sample drawn from community sporting clubs and evaluated using a sample drawn from a matched control community. Four programs are proposed, including two targeting adolescents, one for parents, and one for sports coaches. One adolescent program aims to increase mental health literacy, intentions to seek and/or provide help for mental health, and to decrease stigmatising attitudes. The second adolescent program aims to increase resilience. The goal of the parent program is to increase parental mental health literacy and confidence to provide help. The coach program is intended to increase coaches' supportive behaviours (e.g., autonomy supportive behaviours), and in turn facilitate high-quality motivation and wellbeing among adolescents. Programs will be complemented by a messaging campaign aimed at adolescents to enhance mental health literacy. The effects of the program on adolescent males' psychological distress and wellbeing will also be explored. Organised sports represent a potentially engaging avenue to promote mental health and prevent the onset of mental health problems among adolescent males. The community-based design, with samples drawn from an intervention and a matched control community, enables evaluation of adolescent males' incremental mental health literacy, help-seeking intentions, stigmatising attitudes, motivation, and resilience impacts from the multi-level, multi-component Ahead of the Game program. Notable risks to the study include self-selection bias, the non-randomised design, and the translational nature of the program. However, strengths include extensive community input, as well as the multi-level and multi-component design. Australian New Zealand Clinical Trials Registry ACTRN12617000709347 . Date registered 17 May 2017. Retrospectively registered.

Effects of the choice of reference on the selectivity of a multi-contact nerve cuff electrode.

PubMed

Koh, Ryan G L; Zariffa, Jose

2016-08-01

Tripolar referencing is typically used in nerve cuff electrode recordings due to its ability to maximize the signal-to-noise ratio of contacts at the centre, but this may not be the optimal choice for a multi-contact nerve cuff consisting of contacts in off-centre rings. We conducted a simulation study to compare the effects of 3 different reference types on the recording selectivity of a multi-contact nerve cuff: the tripolar reference (TPR), common average reference (CAR), and multiple tripolar references based on consecutive groups of 3 rings (cTPR). For this purpose, we introduce a novel measure called the contact information metric (CIM). Selectivity was tested in 2 noise settings, one in which white Gaussian noise was added inside the nerve cuff electrode and the other in which electromyogram (EMG) noise was added outside the nerve cuff electrode. The mean CIMs values calculated for the best 8 contacts were 3.42±6.25, 2.70±3.37, and 3.65±1.90 for the TPR, the CAR and the cTPR, respectively, in the case of EMG noise added outside the nerve cuff electrode. This study shows that the use of cTPR reference is the optimal choice for selectivity when using a multi-contact nerve cuff electrode which contains off-centre rings.

SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375].

PubMed

McCahon, Deborah; Fitzmaurice, David A; Murray, Ellen T; Fuller, Christopher J; Hobbs, Richard F D; Allan, Teresa F; Raftery, James P

2003-09-18

Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

The Effectiveness of Different Interventions to Promote Poison Prevention Behaviours in Households with Children: A Network Meta-Analysis

PubMed Central

Achana, Felix A.; Sutton, Alex J.; Kendrick, Denise; Wynn, Persephone; Young, Ben; Jones, David R.; Hubbard, Stephanie J.; Cooper, Nicola J.

2015-01-01

Background There is evidence from 2 previous meta-analyses that interventions to promote poison prevention behaviours are effective in increasing a range of poison prevention practices in households with children. The published meta-analyses compared any intervention against a “usual care or no intervention” which potentially limits the usefulness of the analysis to decision makers. We aim to use network meta-analysis to simultaneously evaluate the effectiveness of different interventions to increase prevalence of safe storage of i) Medicines only, ii) Other household products only, iii) Poisons (both medicines and non-medicines), iv) Poisonous plants; and v) Possession of poison control centre (PCC) telephone number in households with children. Methods Data on the effectiveness of poison prevention interventions was extracted from primary studies identified in 2 newly-undertaken systematic reviews. Effect estimates were pooled across studies using a random effects network meta-analysis model. Results 28 of the 47 primary studies identified were included in the analysis. Compared to usual care intervention, the intervention with education and low cost/free equipment elements was most effective in promoting safe storage of medicines (odds ratio 2.51, 95% credible interval 1.01 to 6.00) while interventions with education, low cost/free equipment, home safety inspection and fitting components were most effective in promoting safe storage of other household products (2.52, 1.12 to 7.13), safe storage of poisons (11.10, 1.60 to 141.50) and possession of PCC number (38.82, 2.19 to 687.10). No one intervention package was more effective than the others in promoting safe storage of poisonous plants. Conclusion The most effective interventions varied by poison prevention practice, but education alone was not the most effective intervention for any poison prevention practice. Commissioners and providers of poison prevention interventions should tailor the interventions they commission or provide to the poison prevention practices they wish to promote. Highlights Network meta-analysis is useful for comparing multiple injury-prevention interventions. More intensive poison prevention interventions were more effective than education alone. Education and low cost/free equipment was most effective in promoting safe storage of medicines. Education, low cost/free equipment, home safety inspection and fitting was most effective in promoting safe storage of household products and poisons. Education, low cost/free equipment and home inspection were most effective in promoting possession of a poison control centre number. None of the intervention packages was more effective than the others in promoting safe storage of poisonous plants. PMID:25894385

New drugs and patient-centred end-points in old age: setting the wheels in motion.

PubMed

Mangoni, Arduino A; Pilotto, Alberto

2016-01-01

Older patients with various degrees of frailty and disability, a key population target of pharmacological interventions in acute and chronic disease states, are virtually neglected in pre-marketing studies assessing the efficacy and safety of investigational drugs. Moreover, aggressively pursuing established therapeutic targets in old age, e.g. blood pressure, serum glucose or cholesterol concentrations, is not necessarily associated with the beneficial effects, and the acceptable safety, reported in younger patient cohorts. Measures of self-reported health and functional status might represent additional, more meaningful, therapeutic end-points in the older population, particularly in patients with significant frailty and relatively short life expectancy, e.g. in the presence of cancer and/or neurodegenerative disease conditions. Strategies enhancing early knowledge about key pharmacological characteristics of investigational drugs targeting older adults are discussed, together with the rationale for incorporating non-traditional, patient-centred, end-points in this ever-increasing group.

Exploring an Ecological Model of Perceived Usability within a Multi-Tiered Vocabulary Intervention

ERIC Educational Resources Information Center

Neugebauer, Sabina R.; Chafouleas, Sandra M.; Coyne, Michael D.; McCoach, D. Betsy; Briesch, Amy M.

2016-01-01

The present study examines an ecological model for intervention use to explain student vocabulary performance in a multi-tiered intervention setting. A teacher self-report measure composed of factors hypothesized to influence intervention use at multiple levels (i.e., individual, intervention, and system level) was administered to 54 teachers and…

Chemical Evolution in Sersic 159-03 Observed with Xmm-Newton

DOE Office of Scientific and Technical Information (OSTI.GOV)

de Plaa, Jelle; Werner, N.; Bykov, A.M.

2006-03-10

Using a new long X-ray observation of the cluster of galaxies Sersic 159-03 with XMM-Newton, we derive radial temperature and abundance profiles using single- and multi-temperature models. The fits to the EPIC and RGS spectra prefer multi-temperature models especially in the core. The radial profiles of oxygen and iron measured with EPIC/RGS and the line profiles in RGS suggest that there is a dip in the O/Fe ratio in the centre of the cluster compared to its immediate surroundings. A possible explanation for the large scale metallicity distribution is that SNIa and SNII products are released in the ICM throughmore » ram-pressure stripping of in-falling galaxies. This causes a peaked metallicity distribution. In addition, SNIa in the central cD galaxy enrich mainly the centre of the cluster with iron. This excess of SNIa products is consistent with the low O/Fe ratio we detect in the centre of the cluster. We fit the abundances we obtain with yields from SNIa, SNII and Population-III stars to derive the clusters chemical evolution. We find that the measured abundance pattern does not require a Population-III star contribution. The relative contribution of the number of SNIa with respect to the total number of SNe which enrich the ICM is about 25-50%. Furthermore, we discuss the possible presence of a non-thermal component in the EPIC spectra. A potential source of this non-thermal emission can be inverse-Compton scattering between Cosmic Microwave Background (CMB) photons and relativistic electrons, which are accelerated in bow shocks associated with ram-pressure stripping of in-falling galaxies.« less

[Non-Pharmacological Interventions for Pregnancy-Related Sleep Disturbances].

PubMed

Hung, Hsuan-Man; Chiang, Hsiao-Ching

2017-02-01

Most women experience the worse sleep quality of their life during pregnancy and the early postpartum period. Although pregnancy typically accounts for a relatively short part of a woman's life, the related sleep disturbances may have a significant and negative impact on her long-term health. Approximately 78-80% of pregnant women experience sleep disturbances, including interruptions in deep sleep, decreased total sleep time, poor subjective sleep quality, frequent night waking, and reduced sleep efficacy. Sleep disturbances during pregnancy start during the first trimester and become prevalent during the third trimester. Related factors include physiological and psychosocial changes and an unhealthy lifestyle. As non-pharmacological interventions have the potential to improve sleep quality in 70% to 80% of patients with insomnia, this is the main approached that is currently used to treat pregnancy-related sleep disturbances. Examples of these non-pharmacological interventions include music therapy, aerobic exercise, massage, progressive muscle relaxation, multi-modal interventions, and the use of a maternity support belt. The efficacy and safety of other related non-pharmacological interventions such as auricular acupressure, cognitive therapy, tai chi, and aromatherapy remain uncertain, with more empirical research required. Additionally, non-pharmacological interventions do not effectively treat sleep disturbances in all pregnant women.

Art therapy may be benefitial for reducing stress--related behaviours in people with dementia--case report.

PubMed

Mimica, Ninoslav; Kalinić, Dubravka

2011-03-01

Communication with person with dementia (PWD) is becoming worse and worse during the course of illness, and at the end may be totally lost. Non-pharmacological interventions may be beneficial in increasing the behavioural disturbances which appears frequently during the progression of dementia, and combination of non-pharmacological techniques and drugs is usually more efficacy than psychopharmacs alone. Mr. Zvonko, the PWD diagnosed with Alzheimer's disease of moderate stage, is presented in this case report. Although Mr. Zvonko was treated with antidementia drugs, the behavioural disturbances were present. The introduction of low doses of conventional antipsychotic was accompanied with extrapiramidal side-effects, and atypical antipsychotics were not used due to the FDA warning and non-willingness of caregiver and family to take that risk. After his individual and family status was evaluated, he was advised to attend the daily care centre and to start with art therapy. Despite he was never drawing pictures before developing AD, everybody, including his wife who is also a caregiver, was surprised with his talent and creativity. While drawing the pictures he was calm and satisfied and his behaviour in the daily care centre, but also at home, became much more adequate. There was no need to add psychopharmacs for behavioural disturbances. In this case the art therapy was shown to be an excellent add-on non-pharmacological intervention, beneficial for reducing stress-related behaviours in PWD taking antidementia drugs.

Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial.

PubMed

Winter, Michiel M; van der Bom, Teun; de Vries, Leonie C S; Balducci, Anna; Bouma, Berto J; Pieper, Petronella G; van Dijk, Arie P J; van der Plas, Mart N; Picchio, Fernando M; Mulder, Barbara J M

2012-06-01

To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Multi-centre parallel randomized controlled trial. Patients with a systemic RV due to congenitally or surgically corrected transposition of the great arteries. Fifty-four adult patients with a systemic RV, were randomized using unmarked opaque envelopes to an intervention group (n = 28) with three training sessions per week for 10 consecutive weeks, and a control group (n = 26). Randomization was stratified by participating centre. At baseline, and follow-up, we determined maximal exercise capacity (V'O(2peak)), serum NT-proBNP levels, and quality of life by means of the SF-36, and the TAAQOL Congenital Heart Disease questionnaires. The final analysis was performed by linear regression, taking into account the stratified randomization. Forty-six patients were analysed (male 50%, age 32 ± 11 years, intervention group n = 24, control group n = 22). Analysis at 10 weeks showed a significant difference in V'O(2peak) (3.4 mL/kg/min, 95% CI: 0.2 to 6.7; P = 0.04) and resting systolic blood pressure (-7.6 mmHg, 95% CI: -14.0 to -1.3; P = 0.03) in favour of the exercise group. No significant changes were found in serum NT-proBNP levels or quality of life in the intervention group or in the control group nor between groups. None of the patients in the intervention group had to discontinue the training programme due to adverse events. In adult patients with a systemic RV exercise training improve exercise capacity. We recommend to revise restrictive guidelines, and to encourage patients to become physically active. ( The study was registered at http://trialregister.nl. Identifier: NTR1909.).

A non-interventional comparative study of the 20:1 combination of cafedrine/theodrenaline versus ephedrine for the treatment of intra-operative arterial hypotension: the 'HYPOTENS' study design and rationale.

PubMed

Eberhart, Leopold; Geldner, Götz; Huljic, Susanne; Marggraf, Kerstin; Keller, Thomas; Koch, Tilo; Kranke, Peter

2018-06-01

To compare the effectiveness of 20:1 cafedrine/theodrenaline approved for use in Germany to ephedrine in the restoration of arterial blood pressure and on post-operative outcomes in patients with intra-operative arterial hypotension of any origin under standard clinical practice conditions. 'HYPOTENS' is a national, multi-center, prospective, open-label, two-armed, non-interventional study. Effectiveness and post-operative outcome following cafedrine/theodrenaline or ephedrine therapy will be evaluated in two cohorts of hypotensive patients. Cohort A includes patients aged ≥50 years with ASA-classification 2-4 undergoing non-emergency surgical procedures under general anesthesia. Cohort B comprises patients undergoing Cesarean section under spinal anesthesia. Participating surgical departments will be assigned to a treatment arm by routinely used anti-hypotensive agent. To minimize bias, matched department pairs will be compared in a stratified selection process. The composite primary end-point is the lower absolute deviation from individually determined target blood pressure (IDTBP) and the incidence of heart rate ≥100 beats/min in the first 15 min. Secondary end-points include incidence and degree of early post-operative delirium (cohort A), severity of fetal acidosis in the newborn (cohort B), upper absolute deviation from IDTBP, percentage increase in systolic blood pressure, and time to IDTBP. This open-label, non-interventional study design mirrors daily practice in the treatment of patients with intra-operative hypotension and ensures full treatment decision autonomy with respect to each patient's individual condition. Selection of participating sites by a randomization process addresses bias without interfering with the non-interventional nature of the study. First results are expected in 2018. ClinicalTrials.gov identifier: NCT02893241; DRKS identifier: DRKS00010740.

Fasciatherapy and Reflexology compared to Hypnosis and Music Therapy in Daily Stress Management.

PubMed

Payrau, Bernard; Quere, Nadine; Breton, Elisabeth; Payrau, Christine

2017-09-01

Patients suffering from stress symptoms due to every-day life who are looking for a non-pharmacological response to their relief expectation are many. Furthermore, early reckoning of the day-to-day stress which may lead to clinical diagnosis is the best way of preventing the stress-related diseases. Among the many alternative medicinal options, there is little evidence that fasciatherapy (Fs) and reflexology (Rf) are effective in this field. assess incidence of fasciatherapy Danis Bois Method (DBM) and of reflexology on patients' stress level in everyday-life, and provide a more informed choice among the numerous mind and body techniques by comparing them with hypnosis (Hp) and music therapy (Mt). Specialized Complementary and Alternative Medicine (CAM) centres for outpatients. 308 individuals (average age = 50.53 SD 14.37, 93 males, 215 females) going to the centres for health care, but free from serious diseases and not heavily medicated respecting the inclusion criteria and providing valid forms. Four armed, non-randomized observational pragmatic trial with pretest-posttest repeated measures, on separate samples of natural groups. According to the centre participants where they used to be treated, they were exposed to a single semi-standardized session of a technique of their choice: Fs, Rf, Hp, Mt. Volunteers had a controlled non-intervention resting (Rt) session. Mean STAI-Y assessing anxiety as reflecting the stress level: MANCOVA and ANCOVA performed with Tukey's HSD. MANCOVA indicates a significant reduction of anxiety ( p < .01) in each condition, resting included. ANCOVA performance adjusting on stress level in T0 (41.73) and on the mean sumscore of the trait (44.89), Fs (-13.92), Rf (-15.92), and Hp (-15.88) were equally effective on the stress level decrease. Mt (-10.0) and Rt (-6.38) showed the same level of effectiveness. The results suggest fasciatherapy DBM, hypnosis, and reflexology could be used as non-pharmacological and safe interventions in stress management. Though showing a lesser efficiency, music therapy could be useful in different circumstances.

Management of Fatigue in Persons with Multiple Sclerosis

PubMed Central

Khan, Fary; Amatya, Bhasker; Galea, Mary

2014-01-01

Fatigue is one of the most common symptoms of multiple sclerosis. Despite advances in pharmacological and non-pharmacological treatment, fatigue continues to be the disabling symptom in persons with MS (pwMS), affecting almost 80% of pwMS. In current practice, both pharmacological and non-pharmacological interventions are used in combination, encompassing a multi-disciplinary approach. The body of research investigating the effect of these interventions is growing. This review systematically evaluated the existing evidence on the effectiveness and safety of different interventions currently applied for the management of fatigue in person with multiple sclerosis in improving patient outcomes, to guide treating clinicians. PMID:25309504

A protocol for a systematic review of non-randomised evaluations of strategies to improve participant recruitment to randomised controlled trials.

PubMed

Gardner, Heidi R; Fraser, Cynthia; MacLennan, Graeme; Treweek, Shaun

2016-08-02

Randomised controlled trials guard against selection bias and therefore offer the fairest way of evaluating healthcare interventions such as medicinal products, devices and services. Recruitment to trials can be extremely difficult, and poor recruitment can lead to extensions to both time and budget and may result in an underpowered study which does not satisfactorily answer the original research question. In the worst cases, a trial may be abandoned, causing huge waste. The evidence to support the choice of recruitment interventions is currently weak. Non-randomised evaluations of recruitment interventions are currently rejected on grounds of poor methodological quality, but systematic evaluation and assessment of this substantial body of work (using Grading of Recommendations Assessment, Development and Evaluation (GRADE) where possible) may provide useful information to support and inform the recruitment decisions of trialists and the research priorities of methodology researchers. The following databases will be searched for relevant studies: Cochrane Methodology Register, MEDLINE, EMBASE, CINAHL and PsycINFO. Any non-randomised study that includes a comparison of two or more interventions to improve recruitment to randomised controlled trials will be included. We will not apply any restrictions on publication date, language or journal. The primary outcome will be the number of individuals or centres recruited into a randomised controlled trial. The secondary outcome will be cost per recruit. Two reviewers will independently screen abstracts for eligible studies, and then, full texts of potentially relevant records will be reviewed. Disagreements will be resolved through discussion. The methodological quality of studies will be assessed using the Cochrane risk of bias tool for non-randomised studies, and the GRADE system will be used if studies are pooled. This review aims to summarise the evidence on methods used to improve recruitment to randomised controlled trials. Carrying out a systematic review including only data from non-randomised studies is a novel approach, and one which some may argue is futile. However, we believe that the systematic evaluation of what is likely to be a substantial amount of research activity is necessary, worthwhile, and will yield valuable results for the clinical trials community regardless of whether the outcomes find in favour of one or more interventions. Should the results of this review suggest that non-randomised evaluations do have something to offer trialists planning their recruitment strategies, the review may be combined in the future with the Cochrane review of randomised evaluations to produce a full review of recruitment strategies encompassing both randomised and non-randomised evaluation methods. PROSPERO CRD42016037718.

Harmonization Process and Reliability Assessment of Anthropometric Measurements in the Elderly EXERNET Multi-Centre Study

PubMed Central

Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A.; Olivares, Pedro R.; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A.; Ara, Ignacio

2012-01-01

Background The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. Purpose To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. Materials and Methods A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain) participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. Results For height, intra-rater technical errors of measurement (TEMs) were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. Conclusion The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population. PMID:22860013

Virtual patients design and its effect on clinical reasoning and student experience: a protocol for a randomised factorial multi-centre study.

PubMed

Bateman, James; Allen, Maggie E; Kidd, Jane; Parsons, Nick; Davies, David

2012-08-01

Virtual Patients (VPs) are web-based representations of realistic clinical cases. They are proposed as being an optimal method for teaching clinical reasoning skills. International standards exist which define precisely what constitutes a VP. There are multiple design possibilities for VPs, however there is little formal evidence to support individual design features. The purpose of this trial is to explore the effect of two different potentially important design features on clinical reasoning skills and the student experience. These are the branching case pathways (present or absent) and structured clinical reasoning feedback (present or absent). This is a multi-centre randomised 2 x 2 factorial design study evaluating two independent variables of VP design, branching (present or absent), and structured clinical reasoning feedback (present or absent).The study will be carried out in medical student volunteers in one year group from three university medical schools in the United Kingdom, Warwick, Keele and Birmingham. There are four core musculoskeletal topics. Each case can be designed in four different ways, equating to 16 VPs required for the research. Students will be randomised to four groups, completing the four VP topics in the same order, but with each group exposed to a different VP design sequentially. All students will be exposed to the four designs. Primary outcomes are performance for each case design in a standardized fifteen item clinical reasoning assessment, integrated into each VP, which is identical for each topic. Additionally a 15-item self-reported evaluation is completed for each VP, based on a widely used EViP tool. Student patterns of use of the VPs will be recorded.In one centre, formative clinical and examination performance will be recorded, along with a self reported pre and post-intervention reasoning score, the DTI. Our power calculations indicate a sample size of 112 is required for both primary outcomes. This trial will provide robust evidence to support the effectiveness of different designs of virtual patients, based on student performance and evaluation. The cases and all learning materials will be open access and available on a Creative Commons Attribution-Share-Alike license.

Patients' Non-Medical Characteristics Contribute to Collective Medical Decision-Making at Multidisciplinary Oncological Team Meetings.

PubMed

Restivo, Léa; Apostolidis, Thémis; Bouhnik, Anne-Déborah; Garciaz, Sylvain; Aurran, Thérèse; Julian-Reynier, Claire

2016-01-01

The contribution of patients' non-medical characteristics to individual physicians' decision-making has attracted considerable attention, but little information is available on this topic in the context of collective decision-making. Medical decision-making at cancer centres is currently carried out using a collective approach, at MultiDisciplinary Team (MDT) meetings. The aim of this study was to determine how patients' non-medical characteristics are presented at MDT meetings and how this information may affect the team's final medical decisions. Observations were conducted at a French Cancer Centre during MDT meetings at which non-standard cases involving some uncertainty were discussed from March to May 2014. Physicians' verbal statements and predefined contextual parameters were collected with a non-participant observational approach. Non numerical data collected in the form of open notes were then coded for quantitative analysis. Univariate and multivariate statistical analyses were performed. In the final sample of patients' records included and discussed (N = 290), non-medical characteristics were mentioned in 32.8% (n = 95) of the cases. These characteristics corresponded to demographics in 22.8% (n = 66) of the cases, psychological data in 11.7% (n = 34), and relational data in 6.2% (n = 18). The patient's age and his/her "likeability" were the most frequently mentioned characteristics. In 17.9% of the cases discussed, the final decision was deferred: this outcome was positively associated with the patients' non-medical characteristics and with uncertainty about the outcome of the therapeutic options available. The design of the study made it difficult to draw definite cause-and-effect conclusions. The Social Representations approach suggests that patients' non-medical characteristics constitute a kind of tacit professional knowledge that may be frequently mobilised in physicians' everyday professional practice. The links observed between patients' attributes and the medical decisions made at these meetings show that these attributes should be taken into account in order to understand how medical decisions are reached in difficult situations of this kind.

The effect of a behaviour change intervention on the diets and physical activity levels of women attending Sure Start Children’s Centres: results from a complex public health intervention

PubMed Central

Baird, Janis; Jarman, Megan; Lawrence, Wendy; Black, Christina; Davies, Jenny; Tinati, Tannaze; Begum, Rufia; Mortimore, Andrew; Robinson, Sian; Margetts, Barrie; Cooper, Cyrus; Barker, Mary; Inskip, Hazel

2014-01-01

Objectives The UK government's response to the obesity epidemic calls for action in communities to improve people's health behaviour. This study evaluated the effects of a community intervention on dietary quality and levels of physical activity of women from disadvantaged backgrounds. Design Non-randomised controlled evaluation of a complex public health intervention. Participants 527 women attending Sure Start Children's Centres (SSCC) in Southampton (intervention) and 495 women attending SSCCs in Gosport and Havant (control). Intervention Training SSCC staff in behaviour change skills that would empower women to change their health behaviours. Outcomes Main outcomes dietary quality and physical activity. Intermediate outcomes self-efficacy and sense of control. Results 1-year post-training, intervention staff used skills to support behaviour change significantly more than control staff. There were statistically significant reductions of 0.1 SD in the dietary quality of all women between baseline and follow-up and reductions in self-efficacy and sense of control. The decline in self-efficacy and control was significantly smaller in women in the intervention group than in women in the control group (adjusted differences in self-efficacy and control, respectively, 0.26 (95% CI 0.001 to 0.50) and 0.35 (0.05 to 0.65)). A lower decline in control was associated with higher levels of exposure in women in the intervention group. There was a statistically significant improvement in physical activity in the intervention group, with 22.9% of women reporting the highest level of physical activity compared with 12.4% at baseline, and a smaller improvement in the control group. The difference in change in physical activity level between the groups was not statistically significant (adjusted difference 1.02 (0.74 to 1.41)). Conclusions While the intervention did not improve women's diets and physical activity levels, it had a protective effect on intermediate factors—control and self-efficacy—suggesting that a more prolonged exposure to the intervention might improve health behaviour. Further evaluation in a more controlled setting is justified. PMID:25031194

HypoAware: development and pilot study of a brief and partly web-based psychoeducational group intervention for adults with Type 1 and insulin-treated Type 2 diabetes and problematic hypoglycaemia.

PubMed

Rondags, S M P A; de Wit, M; Snoek, F J

2016-02-01

Our aim was to study the feasibility and acceptability of our partly online psychoeducational group intervention HypoAware targeted at adults with insulin-treated diabetes and hypoglycaemia problems in an uncontrolled multi-centre pilot study. We developed a 4-week, party online, group intervention, based on key elements of the evidence-based Blood Glucose Awareness Training (BGAT) and with input from diabetes healthcare professionals and people with diabetes. We recruited adults with Type 1 and insulin-treated Type 2 diabetes with impaired hypoglycaemia awareness, frequent hypoglycaemic episodes and/or fear of hypoglycaemia. Feasibility was assessed by means of self-report questionnaires. Pre-post outcomes included self-reported frequency of mild hypoglycaemia, fear of hypoglycaemia, confidence in diabetes self-care, subjective health status, diabetes-specific and general psychological distress and emotional well-being. Organization, recruitment, delivery of HypoAware, retention and compliance yielded no major problems, and both trainers and participants were very satisfied with the programme. The intervention materials required only minor changes. We obtained pre-post intervention measurements in 37 participants from eight hospitals with three drop-outs. Worries about hypoglycaemia, diabetes distress and confidence in self-care improved significantly (P < 0.05), although frequency of hypoglycaemia and hypoglycaemia awareness did not. HypoAware is a new, feasible and acceptable intervention including online modules aimed to help adults with Type 1 and insulin-treated Type 2 diabetes reduce hypoglycaemia and related problems. A cluster-randomized controlled trial is planned to test effectiveness, combined with an economic evaluation. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

Positive and cost-effectiveness effect of spa therapy on the resumption of occupational and non-occupational activities in women in breast cancer remission: a French multicentre randomised controlled trial.

PubMed

Mourgues, Charline; Gerbaud, Laurent; Leger, Stéphanie; Auclair, Candy; Peyrol, Fleur; Blanquet, Marie; Kwiatkowski, Fabrice; Leger-Enreille, Anne; Bignon, Yves-Jean

2014-10-01

The main aim was to assess the effects of a spa treatment on the resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission. A cost-effectiveness analysis (CEA) was also performed. A multicentre randomised controlled trial was carried out between 2008 and 2010 in the University Hospital of Auvergne and two private hospitals in Clermont-Ferrand, France. Eligible patients were women in complete breast cancer remission without contraindication for physical activities or cognitive disorders and a body mass index between 18.5 and 40 kg/m(2). The intervention group underwent spa treatment combined with consultation with dietician whereas the control underwent consultations with the dietician only. Of the 181 patients randomised, 92 and 89 were included in the intervention and the control groups, respectively. The CEA involved 90 patients, 42 from the intervention group and 48 from the control group. The main results showed a higher rate of resumption of occupational activities in the intervention group (p = 0.0025) and a positive effect of the intervention on the women's ability to perform occupational activities 12 months after the beginning of the study (p = 0.0014), and on their ability to perform family activities (p = 0.033). The stay in a thermal centre was cost-effective at 12 months. Spa treatment is a cost-effective strategy to improve resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission. Copyright © 2014 Elsevier Ltd. All rights reserved.

Cost-effectiveness of simulation-based team training in obstetric emergencies (TOSTI study).

PubMed

van de Ven, J; van Baaren, G J; Fransen, A F; van Runnard Heimel, P J; Mol, B W; Oei, S G

2017-09-01

Team training is frequently applied in obstetrics. We aimed to evaluate the cost-effectiveness of obstetric multi-professional team training in a medical simulation centre. We performed a model-based cost-effectiveness analysis to evaluate four strategies for obstetric team training from a hospital perspective (no training, training without on-site repetition and training with 6 month or 3-6-9 month repetition). Data were retrieved from the TOSTI study, a randomised controlled trial evaluating team training in a medical simulation centre. We calculated the incremental cost-effectiveness ratio (ICER), which represent the costs to prevent the adverse outcome, here (1) the composite outcome of obstetric complications and (2) specifically neonatal trauma due to shoulder dystocia. Mean costs of a one-day multi-professional team training in a medical simulation centre were €25,546 to train all personnel of one hospital. A single training in a medical simulation centre was less effective and more costly compared to strategies that included repetition training. Compared to no training, the ICERs to prevent a composite outcome of obstetric complications were €3432 for a single repetition training course on-site six months after the initial training and €5115 for a three monthly repetition training course on-site after the initial training during one year. When we considered neonatal trauma due to shoulder dystocia, a three monthly repetition training course on-site after the initial training had an ICER of €22,878. Multi-professional team training in a medical simulation centre is cost-effective in a scenario where repetition training sessions are performed on-site. Copyright © 2017 Elsevier B.V. All rights reserved.

A study protocol of the effectiveness of PEGASUS: a multi-centred study comparing an intervention to promote shared decision making about breast reconstruction with treatment as usual.

PubMed

Harcourt, Diana; Paraskeva, Nicole; White, Paul; Powell, Jane; Clarke, Alex

2017-10-02

Increasingly, women elect breast reconstruction after mastectomy. However, their expectations of surgery are often not met, and dissatisfaction with outcome and ongoing psychosocial concerns and distress are common. We developed a patient-centered intervention, PEGASUS:(Patients' Expectations and Goals: Assisting Shared Understanding of Surgery) which supports shared decision making by helping women clarify their own, individual goals about reconstruction so that they can discuss these with their surgeon. Our acceptability/feasibility work has shown it is well received by patients and health professionals alike. We now need to establish whether PEGASUS improves patients' experiences of breast reconstruction decision making and outcomes. The purpose of this study is, therefore, to examine the effectiveness of PEGASUS, an intervention designed to support shared decision making about breast reconstruction. A multi-centered sequential study will compare the impact of PEGASUS with usual care, in terms of patient reported outcomes (self-reported satisfaction with the outcome of surgery, involvement in decision making and in the consultation) and health economics. Initially we will collect data from our comparison (usual care) group (90 women) who will complete standardized measures (Breast-Q, EQ5D -5 L and ICECAP- A) at the time of decision making, 3, 6 and 12 months after surgery. Health professionals will then be trained to use PEGASUS, which will be delivered to the intervention group (another 90 women completing the same measures at the time of decision making, and 3, 6 and 12 months after surgery). Health professionals and a purposefully selected sample of participants will be interviewed about whether their expectations of reconstruction were met, and their experiences of PEGASUS (if appropriate). PEGASUS may have the potential to provide health professionals with an easily accessible tool aiming to support shared decision making and improve patients' satisfaction with breast reconstruction. Results of this study will be available at the end of 2019. ISRCTN 18000391 (DOI 10.1186/ISRCTN18000391) 27/01/2016.

Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

PubMed

Carlson, Linda E; Zelinski, Erin L; Speca, Michael; Balneaves, Lynda G; Jones, Jennifer M; Santa Mina, Daniel; Wayne, Peter M; Campbell, Tavis S; Giese-Davis, Janine; Faris, Peter; Zwicker, Jennifer; Patel, Kamala; Beattie, Tara L; Cole, Steve; Toivonen, Kirsti; Nation, Jill; Peng, Philip; Thong, Bruce; Wong, Raimond; Vohra, Sunita

2017-08-01

A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system. Copyright © 2017 Elsevier Inc. All rights reserved.

Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area

PubMed Central

2010-01-01

Background The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study to determine whether a group motivational intervention, together with current clinical practice, is more efficient than the latter alone in the treatment of overweight and obesity, for initial weight loss and essentially to achieve maintenance of the weight achieved; and, secondly, to know if this intervention is more effective for reducing cardiovascular risk factors associated with overweight and obesity. Methods This 26-month follow up multi-centre trial, will include 1200 overweight/obese patients. Random assignment of the intervention by Basic Health Areas (BHA): two geographically separate groups have been created, one of which receives group motivational intervention (group intervention), delivered by a nurse trained by an expert phsychologist, in 32 group sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard program of diet, exercise, and the other (control group), receiving the usual follow up, with regular visits every 3 months. Discussion By addressing currently unanswered questions regarding the maintenance in weight loss in obesity/overweight, upon the expected completion of participant follow-up in 2012, the IMOAP trial should document, for the first time, the benefits of a motivational intervention as a treatment tool of weight loss in a primary care setting. Trial Registration ClinicalTrials.gov Identifier: NCT01006213 PMID:20298557

Specific Stimuli Induce Specific Adaptations: Sensorimotor Training vs. Reactive Balance Training

PubMed Central

Freyler, Kathrin; Krause, Anne; Gollhofer, Albert; Ritzmann, Ramona

2016-01-01

Typically, balance training has been used as an intervention paradigm either as static or as reactive balance training. Possible differences in functional outcomes between the two modalities have not been profoundly studied. The objective of the study was to investigate the specificity of neuromuscular adaptations in response to two balance intervention modalities within test and intervention paradigms containing characteristics of both profiles: classical sensorimotor training (SMT) referring to a static ledger pivoting around the ankle joint vs. reactive balance training (RBT) using externally applied perturbations to deteriorate body equilibrium. Thirty-eight subjects were assigned to either SMT or RBT. Before and after four weeks of intervention training, postural sway and electromyographic activities of shank and thigh muscles were recorded and co-contraction indices (CCI) were calculated. We argue that specificity of training interventions could be transferred into corresponding test settings containing properties of SMT and RBT, respectively. The results revealed that i) postural sway was reduced in both intervention groups in all test paradigms; magnitude of changes and effect sizes differed dependent on the paradigm: when training and paradigm coincided most, effects were augmented (P<0.05). ii) These specificities were accompanied by segmental modulations in the amount of CCI, with a greater reduction within the CCI of thigh muscles after RBT compared to the shank muscles after SMT (P<0.05). The results clearly indicate the relationship between test and intervention specificity in balance performance. Hence, specific training modalities of postural control cause multi-segmental and context-specific adaptations, depending upon the characteristics of the trained postural strategy. In relation to fall prevention, perturbation training could serve as an extension to SMT to include the proximal segment, and thus the control of structures near to the body’s centre of mass, into training. PMID:27911944

Implementing training and support, financial reimbursement, and referral to an internet-based brief advice program to improve the early identification of hazardous and harmful alcohol consumption in primary care (ODHIN): study protocol for a cluster randomized factorial trial.

PubMed

Keurhorst, Myrna N; Anderson, Peter; Spak, Fredrik; Bendtsen, Preben; Segura, Lidia; Colom, Joan; Reynolds, Jillian; Drummond, Colin; Deluca, Paolo; van Steenkiste, Ben; Mierzecki, Artur; Kłoda, Karolina; Wallace, Paul; Newbury-Birch, Dorothy; Kaner, Eileen; Gual, Toni; Laurant, Miranda G H

2013-01-24

The European level of alcohol consumption, and the subsequent burden of disease, is high compared to the rest of the world. While screening and brief interventions in primary healthcare are cost-effective, in most countries they have hardly been implemented in routine primary healthcare. In this study, we aim to examine the effectiveness and efficiency of three implementation interventions that have been chosen to address key barriers for improvement: training and support to address lack of knowledge and motivation in healthcare providers; financial reimbursement to compensate the time investment; and internet-based counselling to reduce workload for primary care providers. In a cluster randomized factorial trial, data from Catalan, English, Netherlands, Polish, and Swedish primary healthcare units will be collected on screening and brief advice rates for hazardous and harmful alcohol consumption. The three implementation strategies will be provided separately and in combination in a total of seven intervention groups and compared with a treatment as usual control group. Screening and brief intervention activities will be measured at baseline, during 12 weeks and after six months. Process measures include health professionals' role security and therapeutic commitment of the participating providers (SAAPPQ questionnaire). A total of 120 primary healthcare units will be included, equally distributed over the five countries. Both intention to treat and per protocol analyses are planned to determine intervention effectiveness, using random coefficient regression modelling. Effective interventions to implement screening and brief interventions for hazardous alcohol use are urgently required. This international multi-centre trial will provide evidence to guide decision makers.

Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial.

PubMed

Hester, Katy L M; Newton, Julia; Rapley, Tim; De Soyza, Anthony

2016-04-23

There is currently little patient information on bronchiectasis, a chronic lung disease with rising prevalence. Previous work shows that patients and their families want more information, which could potentially improve their understanding and self-management. Using interviews and focus groups, we have co-developed a novel patient and carer information resource, aiming to meet their identified needs. The aims and objectives are: 1. To assess the potential impact of the information resource 2. To evaluate and refine the intervention 3. To establish the feasibility of carrying out a multi-centre randomised controlled trial to determine its effect on understanding, self-management and health outcomes This is a feasibility study, with a single-centre, randomised controlled trial design, comparing use of a novel patient information resource to usual care in bronchiectasis. Additionally, patients and carers will be invited to focus groups to discuss their views on both the intervention itself and the trial process. The study duration for each participant will be 3 months from the study entry date. A total of 70 patients will be recruited to the study, and a minimum of 30 will be randomised to each arm. Ten participants (and their carers if applicable) will be invited to attend focus groups on completion of the study visits. Participants will be adults with bronchiectasis diagnosed as per national bronchiectasis guidelines. Once consented, participants will be randomised to the intervention or control arm using random permuted blocks to ensure treatment group numbers are evenly balanced. Randomisation will be web-based. Those randomised to the intervention will receive the information resource (website and booklet) and instructions on its use. Outcome measures (resource satisfaction, resource use and alternative information seeking, quality of life questionnaires, unscheduled healthcare visits, exacerbation frequency, bronchiectasis knowledge questionnaire and lung function tests) will be recorded at baseline, 2 weeks and 3 months. All outcome measures will be used in assessing feasibility and acceptability of a future definitive trial. Feasibility outcomes include recruitment, retention and study scale form completion rates. Focus groups will strengthen qualitative data for resource refinement and to identify participant views on the trial process, which will also inform feasibility assessments. Questionnaires will also be used to evaluate and refine the resource. ISRCTN84229105.

A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

PubMed

Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

2015-02-03

Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

A public health framework to translate risk factors related to political violence and war into multi-level preventive interventions.

PubMed

De Jong, Joop T V M

2010-01-01

Political violence, armed conflicts and human rights violations are produced by a variety of political, economic and socio-cultural factors. Conflicts can be analyzed with an interdisciplinary approach to obtain a global understanding of the relative contribution of risk and protective factors. A public health framework was designed to address these risk factors and protective factors. The framework resulted in a matrix that combined primary, secondary and tertiary interventions with their implementation on the levels of the society-at-large, the community, and the family and individual. Subsequently, the risk and protective factors were translated into multi-sectoral, multi-modal and multi-level preventive interventions involving the economy, governance, diplomacy, the military, human rights, agriculture, health, and education. Then the interventions were slotted in their appropriate place in the matrix. The interventions can be applied in an integrative form by international agencies, governments and non-governmental organizations, and molded to meet the requirements of the historic, political-economic and socio-cultural context. The framework maps the complementary fit among the different actors while engaging themselves in preventive, rehabilitative and reconstructive interventions. The framework shows how the economic, diplomatic, political, criminal justice, human rights, military, health and rural development sectors can collaborate to promote peace or prevent the aggravation or continuation of violence. A deeper understanding of the association between risk and protective factors and the developmental pathways of generic, country-specific and culture-specific factors leading to political violence is needed.

Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

PubMed

Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

2014-01-01

Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

The Green Card Clinic: overview of a brief patient-centred intervention following deliberate self-harm.

PubMed

Wilhelm, Kay; Finch, Adam; Kotze, Beth; Arnold, Karen; McDonald, Geoff; Sternhell, Peter; Hudson, Beaver

2007-02-01

The aim of this study was to present an overview of the Green Card Clinic, a novel brief intervention service for patients presenting to the emergency department following deliberate self-harm (DSH) or with suicidal ideation, to examine its effectiveness in terms of service utilization, and patient and clinician feedback, and to explore the correlates of repeated DSH. The aims and structure of the Green Card Clinic are described. We highlight our patient-centred approach involving self-identification of difficulties from a list of problem areas, coupled with tailored intervention strategies. Relevant data are presented and characteristics of repeat DSH patients are compared to the first-episode group. Between 1998 and 2005, 456 DSH patients were referred to the clinic. Of these, 75% (n = 344) attended the first session, 43% (n = 197) the second session, 26% (n = 117) the third session, and 16% (n = 73) completed a 3-15 month follow-up. Clinic attenders (mean age 31.6 years, 57% female) reported a diverse range of self-identified problems and repeat DSH patients reported worse depression, poorer health-related behaviours, and a greater number of problems than those presenting after first-episode DSH. The clinic achieved high rates of first session attendance. This may have been attributable to the use of a few specific strategies aimed at increasing compliance, such as the green card, next-day appointments and assertive follow-up of non-attenders. For repeat self-harmers, we advocate an approach aimed at 'lifestyle change' rather than based on current psychological stressors. The Green Card Clinic service, involving a range of interventions tailored to meet the multitude of presenting needs, appears to be an acceptable and flexible approach to brief intervention for DSH.

The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults.

PubMed

Abildsnes, Eirik; Meland, Eivind; Mildestvedt, Thomas; Stea, Tonje H; Berntsen, Sveinung; Samdal, Gro Beate

2017-01-05

The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short- and long-term effects. The present study will combine a 6-month RCT with a longitudinal cohort study (24 months from baseline) conducted at six HLCs from June 2014 to Sept 2017. Participants are randomized to behavioural change interventions or a 6-month waiting list control group. A randomized trial of interventions in HLCs has the potential to influence the development of policy and practice for behaviour change interventions and patient education programmes in Norway. We discuss some of the important preconditions for obtaining valid results from a complex intervention and outline some of the characteristics of ecological approaches in health care research that can enable a pragmatic intervention study. The study was retrospectively registered on September 19, 2014 and is available online at ClinicalTrials.gov (ID: NCT02247219 ).

Efficacy of simulation-based trauma team training of non-technical skills. A systematic review.

PubMed

Gjeraa, K; Møller, T P; Østergaard, D

2014-08-01

Trauma resuscitation is a complex situation, and most organisations have multi-professional trauma teams. Non-technical skills are challenged during trauma resuscitation, and they play an important role in the prevention of critical incidents. Simulation-based training of these is recommended. Our research question was: Does simulation-based trauma team training of non-technical skills have effect on reaction, learning, behaviour or patient outcome? The authors searched PubMed, EMBASE and the Cochrane Library and found 13 studies eligible for analysis. We described and compared the educational interventions and the evaluations of effect according to the four Kirkpatrick levels: reaction, learning (knowledge, skills, attitudes), behaviour (in a clinical setting) and patient outcome. No studies were randomised, controlled and blinded, resulting in a moderate to high risk of bias. The multi-professional trauma teams had positive reactions to simulation-based training of non-technical skills. Knowledge and skills improved in all studies evaluating the effect on learning. Three studies found improvements in team performance (behaviour) in the clinical setting. One of these found difficulties in maintaining these skills. Two studies evaluated on patient outcome, of which none showed improvements in mortality, complication rate or duration of hospitalisation. A significant effect on learning was found after simulation-based training of the multi-professional trauma team in non-technical skills. Three studies demonstrated significantly increased clinical team performance. No effect on patient outcome was found. All studies had a moderate to high risk of bias. More comprehensive randomised studies are needed to evaluate the effect on patient outcome. © 2014 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

PubMed

Arezzo, Alberto; Passera, Roberto; Bullano, Alberto; Mintz, Yoav; Kedar, Asaf; Boni, Luigi; Cassinotti, Elisa; Rosati, Riccardo; Fumagalli Romario, Uberto; Sorrentino, Mario; Brizzolari, Marco; Di Lorenzo, Nicola; Gaspari, Achille Lucio; Andreone, Dario; De Stefani, Elena; Navarra, Giuseppe; Lazzara, Salvatore; Degiuli, Maurizio; Shishin, Kirill; Khatkov, Igor; Kazakov, Ivan; Schrittwieser, Rudolf; Carus, Thomas; Corradi, Alessio; Sitzman, Guenther; Lacy, Antonio; Uranues, Selman; Szold, Amir; Morino, Mario

2017-07-01

Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups. In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

Lower Genital Tract Trauma in A Tertiary Care Centre in Mid-Western Nepal.

PubMed

Adhikari, A K; Dutta, M; Das, C R

2017-01-01

The study of lower genital tract trauma has become important in gynaecological practice. There is paucity of reports on this clinical entity from our settings. The main aim of this study is to document injuries in female lower genital tract in Mid-Western Nepal. Sixty female patients admitted to the hospital with genital tract injuries caused by coitus or accidents were included in the study. Details of the causes of trauma clinical presentations and management were recorded. These injuries were grouped according to etiological factors. This study included 33 (55%) coital injuries and 27 (45%) non- coital injuries. Out of coital injury, 12 cases were criminal assault (rape) in age group of 4 to 18 years. Four unmarried girls had consensual sex. Non-coital injuries were due to fall from height, cattle horn injuries, straddle type of trauma, vulvar haematoma and anorectal injuries. Appropriate surgical intervention can avert morbidity and mortality.

A trial of the use of pedobarography in the assessment of the effectiveness of rehabilitation in patients with coxarthrosis.

PubMed

Rongies, Witold; Bak, Agata; Lazar, Andrzej; Dolecki, Włodzimierz; Kolanowska-Kenczew, Tomira; Sierdziński, Janusz; Spychała, Andrzej; Krakowiecki, Arkadiusz

2009-01-01

Pedobarography is an evidence-based diagnostic method that allows quantitative, qualitative and repeatable measurement of pressures on every square centimetre of the sole area of the foot as well as centre of gravity sway, with graphic and numerical recording of results. The aim of the study was to assess the progress of a selected model of rehabilitation on the basis of subpedal pressure distribution and centre of gravity sway in pedobarographic examination as well as to evaluate changes in pain intensity in patients with a history of coxarthrosis. The study included 21 patients with Altman grade 2 coxarthrosis. A postural pedobarographic examination was performed immediately before and after a 15-day course of rehabilitation with a PEL 38 electronic pedobarograph and computer image analyser with TWINN 99 software, version 2.08. Following the rehabilitation, the study group displayed a statistically significant reduction in pain intensity, improved balance between the average and maximum subpedal pressures of both feet as well as a decrease in the velocity of centre of gravity sway. 1. A correlation between reduced pain intensity and improved balance of loads on both feet, as well as decreased velocity of centre of gravity sway were observed in the study group after the rehabilitation. 2. The pedobarographic examination may become a new method of diagnosis and follow-up in rehabilitation. 3. Pedobarography, owing to its ease of repeatability and non-invasiveness, may constitute a valuable attempt at objective monitoring of the progress of rehabilitation and its results. 4. The study results encourage further research based on a larger cohort of patients and a control group with a multi-stage prospective design.

Study design and protocol for a culturally adapted cognitive behavioral stress and self-management intervention for localized prostate cancer: The Encuentros de Salud study.

PubMed

Penedo, Frank J; Antoni, Michael H; Moreno, Patricia I; Traeger, Lara; Perdomo, Dolores; Dahn, Jason; Miller, Gregory E; Cole, Steve; Orjuela, Julian; Pizarro, Edgar; Yanez, Betina

2018-06-14

Almost 2.8 million men in the U.S. are living with prostate cancer (PC), accounting for 40% of all male cancer survivors. Men diagnosed with prostate cancer may experience chronic and debilitating treatment side effects, including sexual and urinary dysfunction, pain and fatigue. Side effects can be stressful and can also lead to poor psychosocial functioning. Prior trials reveal that group-based cognitive behavioral stress and self-management (CBSM) is effective in reducing stress and mitigating some of these symptoms, yet little is known about the effects of culturally-translated CBSM among Spanish-speaking men with PC. This manuscript describes the rationale and study design of a multi-site, randomized controlled trial to determine whether participation in a culturally adapted cognitive behavioral stress management (C-CBSM) intervention leads to significantly greater reductions in symptom burden and improvements in health-related quality of life relative to participation in a non-culturally adapted cognitive behavioral stress management (CBSM) intervention. Participants (N = 260) will be Spanish-speaking Hispanic/Latino men randomized to the standard, non-culturally adapted CBSM intervention (e.g., cognitive behavioral strategies, stress management, and health maintenance) or the culturally adapted C-CBSM intervention (e.g., content adapted to be compatible with Hispanic/Latino cultural patterns and belief systems, meanings, values and social context) for 10 weeks. Primary outcomes (i.e., disease-specific symptom burden and health-related quality of life) will be assessed across time. We hypothesize that a culturally adapted C-CBSM intervention will be more efficacious in reducing symptom burden and improving health-related quality of life among Hispanic/Latino men when compared to a non-culturally adapted CBSM intervention. Copyright © 2017. Published by Elsevier Inc.

A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial.

PubMed

Mitchell, Marion L; Kean, Susanne; Rattray, Janice E; Hull, Alastair M; Davis, Chelsea; Murfield, Jenny E; Aitken, Leanne M

2017-06-01

Family members could play an important role in preventing and reducing the development of delirium in Intensive Care Units (ICU) patients. This study sought to assess the feasibility of design and recruitment, and acceptability for family members and nurses of a family delivered intervention to reduce delirium in ICU patients. A single centre randomised controlled trial in an Australian medical/surgical ICU was conducted. Sixty-one family members were randomised (29 in intervention and 32 in non-intervention group). Following instructions, the intervention comprised the family members providing orientation or memory clues (family photographs, orientation to surroundings) to their relative each day. In addition, family members conducted sensory checks (vision and hearing with glasses and hearing aids); and therapeutic or cognitive stimulation (discussing family life, reminiscing) daily. Eleven ICU nurses were interviewed to gain insight into the feasibility and acceptability of implementing the intervention from their perspective. Recruitment rate was 28% of eligible patients (recruited n=90, attrition n=1). Following instruction by the research nurse the family member delivered the intervention which was assessed to be feasible and acceptable by family members and nurses. Protocol adherence could be improved with alternative data collection methods. Nurses considered the activities acceptable. The study was able to recruit, randomise and retain family member participants. Further strategies are required to assess intervention fidelity and improve data collection. Copyright © 2017 Elsevier Ltd. All rights reserved.

Costs associated with implementation of computer-assisted clinical decision support system for antenatal and delivery care: case study of Kassena-Nankana district of northern Ghana.

PubMed

Dalaba, Maxwell Ayindenaba; Akweongo, Patricia; Williams, John; Saronga, Happiness Pius; Tonchev, Pencho; Sauerborn, Rainer; Mensah, Nathan; Blank, Antje; Kaltschmidt, Jens; Loukanova, Svetla

2014-01-01

This study analyzed cost of implementing computer-assisted Clinical Decision Support System (CDSS) in selected health care centres in Ghana. A descriptive cross sectional study was conducted in the Kassena-Nankana district (KND). CDSS was deployed in selected health centres in KND as an intervention to manage patients attending antenatal clinics and the labour ward. The CDSS users were mainly nurses who were trained. Activities and associated costs involved in the implementation of CDSS (pre-intervention and intervention) were collected for the period between 2009-2013 from the provider perspective. The ingredients approach was used for the cost analysis. Costs were grouped into personnel, trainings, overheads (recurrent costs) and equipment costs (capital cost). We calculated cost without annualizing capital cost to represent financial cost and cost with annualizing capital costs to represent economic cost. Twenty-two trained CDSS users (at least 2 users per health centre) participated in the study. Between April 2012 and March 2013, users managed 5,595 antenatal clients and 872 labour clients using the CDSS. We observed a decrease in the proportion of complications during delivery (pre-intervention 10.74% versus post-intervention 9.64%) and a reduction in the number of maternal deaths (pre-intervention 4 deaths versus post-intervention 1 death). The overall financial cost of CDSS implementation was US$23,316, approximately US$1,060 per CDSS user trained. Of the total cost of implementation, 48% (US$11,272) was pre-intervention cost and intervention cost was 52% (US$12,044). Equipment costs accounted for the largest proportion of financial cost: 34% (US$7,917). When economic cost was considered, total cost of implementation was US$17,128-lower than the financial cost by 26.5%. The study provides useful information in the implementation of CDSS at health facilities to enhance health workers' adherence to practice guidelines and taking accurate decisions to improve maternal health care.

Comparing Quality of Childcare and Kindergarten Centres: The Need for a Strong and Equal Partnership in the Greek Early Childhood Education System

ERIC Educational Resources Information Center

Gregoriadis, A.; Tsigilis, N.; Grammatikopoulos, V.; Kouli, O.

2016-01-01

The purpose of this study was to examine whether kindergartens and childcare centres differ in terms of educational and caregiving components. More specifically, two aspects of the process quality of the early childhood education and care were examined regarding the "Activities" and the "Programme Structure." A multi-stage…

Measurement equivalence: A non-technical primer on categorical multi-group confirmatory factor analysis in school psychology.

PubMed

Pendergast, Laura L; von der Embse, Nathaniel; Kilgus, Stephen P; Eklund, Katie R

2017-02-01

Evidence-based interventions (EBIs) have become a central component of school psychology research and practice, but EBIs are dependent upon the availability and use of evidence-based assessments (EBAs) with diverse student populations. Multi-group confirmatory factor analysis (MG-CFA) is an analytical tool that can be used to examine the validity and measurement equivalence/invariance of scores across diverse groups. The objective of this article is to provide a conceptual and procedural overview of categorical MG-CFA, as well as an illustrated example based on data from the Social and Academic Behavior Risk Screener (SABRS) - a tool designed for use in school-based interventions. This article serves as a non-technical primer on the topic of MG-CFA with ordinal (rating scale) data and does so through the framework of examining equivalence of measures used for EBIs within multi-tiered models - an understudied topic. To go along with the illustrated example, we have provided supplementary files that include sample data, Mplus input code, and an annotated guide for understanding the input code (http://dx.doi.org/10.1016/j.jsp.2016.11.002). Data needed to reproduce analyses in this article are available as supplemental materials (online only) in the Appendix of this article. Copyright © 2016 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

PubMed

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2013-09-01

Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

PubMed Central

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2016-01-01

Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

Strategies for rehabilitation professionals to move evidence-based knowledge into practice: a systematic review.

PubMed

Menon, Anita; Korner-Bitensky, Nicol; Kastner, Monika; McKibbon, K Ann; Straus, Sharon

2009-11-01

Rehabilitation clinicians need to stay current regarding best practices, especially since adherence to clinical guidelines can significantly improve patient outcomes. However, little is known about the benefits of knowledge translation interventions for these professionals. To examine the effectiveness of single or multi-component knowledge translation interventions for improving knowledge, attitudes, and practice behaviors of rehabilitation clinicians. Systematic review of 7 databases conducted to identify studies evaluating knowledge translation interventions specific to occupational therapists and physical therapists. 12 studies met the eligibility criteria. For physical therapists, participation in an active multi-component knowledge translation intervention resulted in improved evidence-based knowledge and practice behaviors compared with passive dissemination strategies. These gains did not translate into change in clinicians' attitudes towards best practices. For occupational therapists, no studies have examined the use of multi-component interventions; studies of single interventions suggest limited evidence of effectiveness for all outcomes measured. While this review suggests the use of active, multi-component knowledge translation interventions to enhance knowledge and practice behaviors of physical therapists, additional research is needed to understand the impact of these strategies on occupational therapists. Serious research gaps remain regarding which knowledge translation strategies impact positively on patient outcomes.

Realizing the Potential of Adolescence to Prevent Transgenerational Conditioning of Noncommunicable Disease Risk: Multi-Sectoral Design Frameworks

PubMed Central

Bay, Jacquie L.; Morton, Susan M.; Vickers, Mark H.

2016-01-01

Evidence from the field of Developmental Origins of Health and Disease (DOHaD) demonstrates that early life environmental exposures impact later-life risk of non-communicable diseases (NCDs). This has revealed the transgenerational nature of NCD risk, thus demonstrating that interventions to improve environmental exposures during early life offer important potential for primary prevention of DOHaD-related NCDs. Based on this evidence, the prospect of multi-sectoral approaches to enable primary NCD risk reduction has been highlighted in major international reports. It is agreed that pregnancy, lactation and early childhood offer significant intervention opportunities. However, the importance of interventions that establish positive behaviors impacting nutritional and non-nutritional environmental exposures in the pre-conceptual period in both males and females, thus capturing the full potential of DOHaD, must not be overlooked. Adolescence, a period where life-long health-related behaviors are established, is therefore an important life-stage for DOHaD-informed intervention. DOHaD evidence underpinning this potential is well documented. However, there is a gap in the literature with respect to combined application of theoretical evidence from science, education and public health to inform intervention design. This paper addresses this gap, presenting a review of evidence informing theoretical frameworks for adolescent DOHaD interventions that is accessible collectively to all relevant sectors. PMID:27417627

Women, Co-occurring Disorders, and Violence Study: evaluation design and study population.

PubMed

McHugo, G J; Kammerer, N; Jackson, E W; Markoff, L S; Gatz, M; Larson, M J; Mazelis, R; Hennigan, K

2005-03-01

The Women, Co-occurring Disorders, and Violence Study (WCDVS) was a multi-site cooperative study to evaluate new service models for women with co-occurring mental health and substance use disorders and a history of physical and/or sexual abuse. Despite common features in the service interventions and evaluation procedures, diversity across the nine sites plus differences introduced by non-random assignment led to numerous methodological challenges. This article describes the design, measurement, and analysis decisions behind the WCDVS and lays the foundation for understanding participant-level outcomes and service costs. This article also describes the study population, as recruited and following attrition at the 6-month follow-up, in order to address the threat of selection bias to inferences drawn from this multi-site study.

[Planned non-hospital births in industrialized countries: bureaucratic dream vs. professional responsibility].

PubMed

Arabin, B; Chervenak, F A; McCullough, L B

2013-02-01

This article addresses in how far planned non-hospital births should be an alternative to planned hospital births. Advocates of planned non-hospital deliveries have emphasised patient safety, patient satisfaction, cost effectiveness, and respect for women's rights. We provide a critical evaluation of each of these claims and have doubts that the information available for the pregnant women and the public is in accord with professional responsibility. We understand that the increasing rates of interventions and operative deliveries in hospital births demand an answer, but we doubt that planned home birth is the appropriate professional solution. Complications during non-hospital births inevitably demand a transport of mother and child to a perinatal centre. The time delay by itself is an unnecessary risk for both and this cannot be abolished by bureaucratic quality criteria as introduced for non-hospital births in Germany. Evidence-based studies have shown that modern knowledge of the course of delivery including ultrasound as well as intensive care during the delivery all reduce the rate of operative deliveries. Unfortunately, this is not well-known and only rarely considered during any delivery. All these facts, however, are the best arguments to find a cooperative model within perinatal centres to combine the art of midwifery with modern science, reduction of pain and perinatal care of the pregnant women before, during and after birth. We therefore call on obstetricians, midwifes and health-care providers as well as health politicians to carefully analyse the studies from Western countries showing increasing risks if the model of intention-to-treat is considered and accoordingly not to support planned non-hospital births nor to include these models into prospective trials. Alternatively, we recommend the introduction of a home-like climate within hospitals and perinatal centres, to avoid unnecessary invasive measures and to really care for the pregnant mother before, during and after delivery within a cooperative model without the lack of patient safety for both mother and child in case of impending or acute emergencies. © Georg Thieme Verlag KG Stuttgart · New York.

Empirically Examining the Performance of Approaches to Multi-Level Matching to Study the Effect of School-Level Interventions

ERIC Educational Resources Information Center

Hallberg, Kelly; Cook, Thomas D.; Figlio, David

2013-01-01

The goal of this paper is to provide guidance for applied education researchers in using multi-level data to study the effects of interventions implemented at the school level. Two primary approaches are currently employed in observational studies of the effect of school-level interventions. One approach employs intact school matching: matching…

Effects of cardiac telerehabilitation in patients with coronary artery disease using a personalised patient-centred web application: protocol for the SmartCare-CAD randomised controlled trial.

PubMed

Brouwers, Rutger W M; Kraal, Jos J; Traa, Simone C J; Spee, Ruud F; Oostveen, Laurence M L C; Kemps, Hareld M C

2017-01-31

Cardiac rehabilitation has beneficial effects on morbidity and mortality in patients with coronary artery disease, but is vastly underutilised and short-term improvements are often not sustained. Telerehabilitation has the potential to overcome these barriers, but its superiority has not been convincingly demonstrated yet. This may be due to insufficient focus on behavioural change and development of patients' self-management skills. Moreover, potentially beneficial communication methods, such as internet and video consultation, are rarely used. We hypothesise that, when compared to centre-based cardiac rehabilitation, cardiac telerehabilitation using evidence-based behavioural change strategies, modern communication methods and on-demand coaching will result in improved self-management skills and sustainable behavioural change, which translates to higher physical activity levels in a cost-effective way. This randomised controlled trial compares cardiac telerehabilitation with centre-based cardiac rehabilitation in patients with coronary artery disease. We randomise 300 patients entering cardiac rehabilitation to centre-based cardiac rehabilitation (control group) or cardiac telerehabilitation (intervention group). The core component of the intervention is a patient-centred web application, which enables patients to adjust rehabilitation goals, inspect training and physical activity data, share data with other caregivers and to use video consultation. After six supervised training sessions, the intervention group continues exercise training at home, wearing an accelerometer and heart rate monitor. In addition, physical activity levels are assessed by the accelerometer for four days per week. Patients upload training and physical activity data weekly and receive feedback through video consultation once a week. After completion of the rehabilitation programme, on-demand coaching is performed when training adherence or physical activity levels decline with 50% or more. The primary outcome measure is physical activity level, assessed at baseline, three months and twelve months, and is calculated from accelerometer and heart rate data. Secondary outcome measures include physical fitness, quality of life, anxiety and depression, patient empowerment, patient satisfaction and cost-effectiveness. This study is one of the first studies evaluating effects and costs of a cardiac telerehabilitation intervention comprising a combination of modern technology and evidence-based behavioural change strategies including relapse prevention. We hypothesise that this intervention has superior effects on exercise behaviour without exceeding the costs of a traditional centre-based intervention. Netherlands Trial Register NTR5156 . Registered 22 April 2015.

Impact of study design on recruitment of patients to a primary care trial: an observational time series analysis of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study.

PubMed

Fletcher, K; Mant, J; Roalfe, A; Hobbs, F D R

2010-12-01

recruitment targets to randomized controlled trials (RCTs) are often not met. Many interventions are used to improve recruitment but there is little empirical evidence on whether these approaches work. to examine whether changes to the design and conduct of a primary care-based RCT were associated with changes in patient recruitment. an observational time series analysis of recruitment to a primary care-based multi-centre RCT of aspirin versus warfarin for stroke prevention, which involved 330 practices. Several changes to the trial protocol and procedures were made over the 4 years of patient recruitment. For each quarter throughout the recruitment period, the recruitment rate per 1000 total population in active practices was calculated. the recruitment target of 930 patients was exceeded. Fluctuations in recruitment rate occurred during the recruitment period. Following protocol changes aimed to reduce clinical workload, there was a significant increase in recruitment during the final 6 months of the study, during a period when there was not a similarly large increase in the total population available. these findings suggest that the conduct of a trial is an important consideration if studies are to recruit successfully. Expanding the number of centres may not be the most effective way to improve recruitment.

Family-centred interventions by primary healthcare services for Indigenous early childhood wellbeing in Australia, Canada, New Zealand and the United States: a systematic scoping review.

PubMed

McCalman, Janya; Heyeres, Marion; Campbell, Sandra; Bainbridge, Roxanne; Chamberlain, Catherine; Strobel, Natalie; Ruben, Alan

2017-02-21

Primary healthcare services in Australia, Canada, New Zealand and the United States have embraced the concept of family-centred care as a promising approach to supporting and caring for the health of young Indigenous children and their families. This scoping review assesses the quality of the evidence base and identifies the published literature on family- centred interventions for Indigenous early childhood wellbeing. Fourteen electronic databases, grey literature sources and the reference lists of Indigenous maternal and child health reviews were searched to identify relevant publications from 2000 to 2015. Studies were included if the intervention was: 1) focussed on Indigenous children aged from conception to 5 years from the abovementioned countries; 2) led by a primary healthcare service; 3) described or evaluated; and 4) scored greater than 50% against a validated scale for family-centredness. The study characteristics were extracted and quality rated. Reported aims, strategies, enablers and outcomes of family-centredcare were identified using grounded theory methods. Eighteen studies (reported in 25 publications) were included. Three were randomised controlled studies; most were qualitative and exploratory in design. More than half of the publications were published from 2012 to 2015. The overarching aim of interventions was to promote healthy families. Six key strategies were to: support family behaviours and self- care, increase maternal knowledge, strengthen links with the clinic, build the Indigenous workforce, promote cultural/ community connectedness and advocate for social determinants of health. Four enablers were: competent and compassionate program deliverers, flexibility of access, continuity and integration of healthcare, and culturally supportive care. Health outcomes were reported for Indigenous children (nutritional status; emotional/behavioural; and prevention of injury and illness); parents/caregivers (depression and substance abuse; and parenting knowledge, confidence and skills); health services (satisfaction; access, utilization and cost) and community/cultural revitalisation. The evidence for family-centred interventions is in the early stages of development, but suggests promise for generating diverse healthcare outcomes for Indigenous children and their parents/caregivers, as well as satisfaction with and utilisation of healthcare, and community/cultural revitalisation. Further research pertaining to the role of fathers in family-centred care, and the effects and costs of interventions is needed.

a Comparison among Different Optimization Levels in 3d Multi-Sensor Models. a Test Case in Emergency Context: 2016 Italian Earthquake

NASA Astrophysics Data System (ADS)

Chiabrando, F.; Sammartano, G.; Spanò, A.

2017-02-01

In sudden emergency contexts that affect urban centres and built heritage, the latest Geomatics technique solutions must enable the demands of damage documentation, risk assessment, management and data sharing as efficiently as possible, in relation to the danger condition, to the accessibility constraints of areas and to the tight deadlines needs. In recent times, Unmanned Vehicle System (UAV) equipped with cameras are more and more involved in aerial survey and reconnaissance missions, and they are behaving in a very cost-effective way in the direction of 3D documentation and preliminary damage assessment. More and more UAV equipment with low-cost sensors must become, in the future, suitable in every situation of documentation, but above all in damages and uncertainty frameworks. Rapidity in acquisition times and low-cost sensors are challenging marks, and they could be taken into consideration maybe with time spending processing. The paper will analyze and try to classify the information content in 3D aerial and terrestrial models and the importance of metric and non-metric withdrawable information that should be suitable for further uses, as the structural analysis one. The test area is an experience of Team Direct from Politecnico di Torino in centre Italy, where a strong earthquake occurred in August 2016. This study is carried out on a stand-alone damaged building in Pescara del Tronto (AP), with a multi-sensor 3D survey. The aim is to evaluate the contribution of terrestrial and aerial quick documentation by a SLAM based LiDAR and a camera equipped multirotor UAV, for a first reconnaissance inspection and modelling in terms of level of details, metric and non-metric information.

Effects of a breastfeeding empowerment programme on Korean breastfeeding mothers: a quasi-experimental study.

PubMed

Kang, Jung Sun; Choi, So Young; Ryu, Eun Jung

2008-01-01

This quasi-experimental study examined the effects of a new breastfeeding empowerment programme provided to post-partum mothers within 3 days of entering post-partum care centres on their breastfeeding empowerment, problems and practice rate. The study employed a non-equivalent control group non-synchronized design. Participants who conformed with the selection criteria were selected from two post-partum care centres affiliated with hospitals in a city in South Korea. Each of the two study groups included 30 participants. The breastfeeding empowerment programme comprised four 60-minute sessions, and was applied for 4 weeks to mothers in the experimental group. The breastfeeding empowerment scores were higher in the experimental group than in the control group (p=0.007), and there were fewer breastfeeding problems in the former group (p=0.012) and the breastfeeding rates were higher in the former group (p=0.017, 0.002 and 0.002 at 4, 8 and 12 weeks post-partum, respectively). These results indicate that the provision of breastfeeding empowerment programmes to help mothers to identify and solve problems by themselves can improve breastfeeding empowerment, problem and practice rates, and hence should be considered useful as a post-partum nursing intervention in clinical settings. The effectiveness of the various components of the breastfeeding empowerment programme developed in this study should be verified in field trials.

Three years of national hand hygiene campaign in Germany: what are the key conclusions for clinical practice?

PubMed

Reichardt, C; Königer, D; Bunte-Schönberger, K; van der Linden, P; Mönch, N; Schwab, F; Behnke, M; Gastmeier, P

2013-02-01

The World Health Organization (WHO) started the 'Clean Care is Safer Care' campaign in 2005. Since then, more than 120 countries have pledged to improve hand hygiene as a keystone of their national or subnational healthcare-associated infection prevention programmes. Thirty-eight countries have implemented national campaigns. Germany started a national campaign to improve hand hygiene compliance on 1 January 2008. The campaign, 'AKTION Saubere Hände', is funded by the German Ministry of Health and was initiated by the National Reference Centre for the Surveillance of Nosocomial Infections, the Society for Quality Management in Health Care and the German Coalition for Patient Safety. The campaign is designed as a multi-modal campaign based on the WHO implementation strategy. Since the end of 2010, more than 700 healthcare institutions have been actively participating in the campaign, among which are 28 university hospitals. Voluntarily participating hospitals have to implement the following measures: active support by hospital administrators of local campaign implementation, participation in a one-day introductory course, education of healthcare workers at least once a year, measurement of alcohol-based hand-rub consumption (AHC) and feedback on resulting data, implementation of the WHO 'My Five Moments for Hand Hygiene' model, increase in hand-rub availability, participation in national hand hygiene day at least every two years, and participation in national campaign network workshops at least once every two years. Observational studies to measure hand hygiene compliance are optional. Overall, there has been a significant increase of 11% in hand hygiene compliance in 62 hospitals that observed compliance before and after intervention. A total of 129 hospitals provided AHC data for three years and achieved an overall increase of 30.7%. The availability of alcohol-based hand rub increased from 86.8% to > 100% in intensive care units and from 63.6% to 91.3% in non-intensive care units. Overall, the implementation of a national campaign using the WHO multi-modal intervention strategy has led to improved hand hygiene compliance and hand-rub availability in participating settings. Copyright © 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Enhancing Phonological Awareness and Letter Knowledge in Preschool Children with Down Syndrome

ERIC Educational Resources Information Center

van Bysterveldt, Anne K.; Gillon, Gail T.; Moran, Catherine

2006-01-01

This study investigated the effectiveness of a phonological awareness intervention for 4-year-old children with Down syndrome. Seven children with Down syndrome who attended an early intervention centre participated in the intervention. Their performance on measures of phonological awareness (initial phoneme identity), letter name and sound…

Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

PubMed Central

Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

2013-01-01

Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. PMID:24028942

Changing case Order to Optimise patterns of Performance in mammography Screening (CO-OPS): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background X-ray mammography remains the predominant test for screening for breast cancer, with the aim of reducing breast cancer mortality. In the English NHS Breast Screening Programme each woman’s mammograms are examined separately by two expert readers. The two readers read each batch in the same order and each indicates if there should be recall for further tests. This is a highly skilled, pressurised, repetitive and frequently intellectually unchallenging activity where readers examine one or more batches of 30–50 women’s mammograms in each session. A vigilance decrement or performance decrease over time has been observed in similar repetitive visual tasks such as radar operation. Methods/Design The CO-OPS study is a pragmatic, multi-centre, two-arm, double blind cluster randomised controlled trial of a computer software intervention designed to reduce the effects of a vigilance decrement in breast cancer screening. The unit of randomisation is the batch. Intervention batches will be examined in the opposite order by the two readers (one forwards, one backwards). Control batches will be read in the same order as one another, as is current standard practice. The hypothesis is that cancer detection rates will be higher in the intervention group because each readers’ peak performance will occur when examining different women’s mammograms. The trial will take place in 44 English breast screening centres for 1 year and 4 months. The primary outcome is cancer detection rate, which will be extracted from computer records after 1 year of the trial. The secondary outcomes include rate of disagreement between readers (a more statistically powerful surrogate for cancer detection rate), recall rate, positive predictive value, and interval cancer rate (cancers found between screening rounds which will be measured three years after the end of the trial). Discussion This is the first trial of an intervention to ameliorate a vigilance decrement in breast cancer screening. Trial registration ISRCTN46603370 (submitted: 24 October 2012, date of registration: 26 March 2013). PMID:24411004

Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project)

PubMed Central

Acuña Mora, Mariela; Sparud-Lundin, Carina; Bratt, Ewa-Lena; Moons, Philip

2017-01-01

Introduction When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood. Methods/design STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES). Ethics and dissemination The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals. Trial registration number NCT02675361; pre-results. PMID:28420661

Fibre optical spectroscopy and sensing innovation at innoFSPEC Potsdam

NASA Astrophysics Data System (ADS)

Haynes, Roger; Reich, Oliver; Rambold, William; Hass, Roland; Janssen, Katja

2010-07-01

In October 2009, an interdisciplinary centre for fibre spectroscopy and sensing, innoFSPEC Potsdam, has been established as joint initiative of the Astrophysikalisches Institut Potsdam (AIP) and the Physical Chemistry group of Potsdam University (UPPC), Germany. The centre focuses on fundamental research in the two fields of fibre-coupled multi-channel spectroscopy and optical fibre-based sensing. Thanks to its interdisciplinary approach, the complementary methodologies of astrophysics on the one hand, and physical chemistry on the other hand, are expected to spawn synergies that otherwise would not normally become available in more standard research programmes. innoFSPEC Potsdam targets future innovations for next generation astrophysical instrumentation, environmental analysis, manufacturing control and process analysis, medical diagnostics, non-invasive imaging spectroscopy, biopsy, genomics/proteomics, high throughput screening, and related applications.

Multi-Sensory Intervention Observational Research

ERIC Educational Resources Information Center

Thompson, Carla J.

2011-01-01

An observational research study based on sensory integration theory was conducted to examine the observed impact of student selected multi-sensory experiences within a multi-sensory intervention center relative to the sustained focus levels of students with special needs. A stratified random sample of 50 students with severe developmental…

Functions of behavior change interventions when implementing multi-professional teamwork at an emergency department: a comparative case study

PubMed Central

2014-01-01

Background While there is strong support for the benefits of working in multi-professional teams in health care, the implementation of multi-professional teamwork is reported to be complex and challenging. Implementation strategies combining multiple behavior change interventions are recommended, but the understanding of how and why the behavior change interventions influence staff behavior is limited. There is a lack of studies focusing on the functions of different behavior change interventions and the mechanisms driving behavior change. In this study, applied behavior analysis is used to analyze the function and impact of different behavior change interventions when implementing multi-professional teamwork. Methods A comparative case study design was applied. Two sections of an emergency department implemented multi-professional teamwork involving changes in work processes, aimed at increasing inter-professional collaboration. Behavior change interventions and staff behavior change were studied using observations, interviews and document analysis. Using a hybrid thematic analysis, the behavior change interventions were categorized according to the DCOM® model. The functions of the behavior change interventions were then analyzed using applied behavior analysis. Results The two sections used different behavior change interventions, resulting in a large difference in the degree of staff behavior change. The successful section enabled staff performance of teamwork behaviors with a strategy based on ongoing problem-solving and frequent clarification of directions. Managerial feedback initially played an important role in motivating teamwork behaviors. Gradually, as staff started to experience positive outcomes of the intervention, motivation for teamwork behaviors was replaced by positive task-generated feedback. Conclusions The functional perspective of applied behavior analysis offers insight into the behavioral mechanisms that describe how and why behavior change interventions influence staff behavior. The analysis demonstrates how enabling behavior change interventions, managerial feedback and task-related feedback interact in their influence on behavior and have complementary functions during different stages of implementation. PMID:24885212

Multi-frequency bioimpedance in equine muscle assessment.

PubMed

Harrison, Adrian Paul; Elbrønd, Vibeke Sødring; Riis-Olesen, Kiwa; Bartels, Else Marie

2015-03-01

Multi-frequency BIA (mfBIA) equipment has been shown to be a non-invasive and reliable method to assess a muscle as a whole or at fibre level. In the equine world this may be the future method of assessment of training condition or of muscle injury. The aim of this study was to test if mfBIA reliably can be used to assess the condition of a horse's muscles in connection with health assessment, injury and both training and re-training. mfBIA measurements was carried out on 10 'hobby' horses and 5 selected cases with known anamnesis. Impedance, resistance, reactance, phase angle, centre frequency, membrane capacitance and both extracellular and intracellular resistance were measured. Platinum electrodes in connection with a conductance paste were used to accommodate the typical BIA frequencies and to facilitate accurate measurements. Use of mfBIA data to look into the effects of myofascial release treatment was also demonstrated. Our findings indicate that mfBIA provides a non-invasive, easily measurable and very precise assessment of the state of muscles in horses. This study also shows the potential of mfBIA as a diagnostic tool as well as a tool to monitor effects of treatment e.g. myofascial release therapy and metabolic diseases, respectively.

Interventions to improve immigrant health. A scoping review

PubMed Central

Ortiz-Barreda, Gaby; Ben-Shlomo, Yoav; Holdsworth, Michelle; Salami, Bukola; Rammohan, Anu; Chung, Roger Yat-Nork; Padmadas, Sabu S.; Krafft, Thomas

2017-01-01

Abstract Background: Disparities in health between immigrants and their host populations have been described across countries and continents. Hence, interventions for improving health targeting general populations are not necessarily effective for immigrants. Aims: To conduct a systematic search of the literature evaluating health interventions for immigrants; to map the characteristics of identified studies including range of interventions, immigrant populations and their host countries, clinical areas targeted and reported evaluations, challenges and limitations of the interventions identified. Following the results, to develop recommendations for research in the field. Methods: A scoping review approach was chosen to provide an overview of the type, extent and quantity of research available. Studies were included if they empirically evaluated health interventions targeting immigrants and/or their descendants, included a control group, and were published in English (PubMed and Embase from 1990 to 2015). Results: Most of the 83 studies included were conducted in the USA, encompassed few immigrant groups and used a randomized controlled trial (RCT) or cluster RCT design. Most interventions addressed chronic and non-communicable diseases and attendance at cancer screening services, used individual targeted approaches, targeted adult women and recruited participants from health centres. Outcome measures were often subjective, with the exception of interventions for cardiovascular risk and diabetes. Generally, authors claimed that interventions were beneficial, despite a number of reported limitations. Conclusions: Recommendations for enhancing interventions to improve immigrant health are provided to help researchers, funders and health care commissioners when deciding upon the scope, nature and design of future research in this area. PMID:28339883

Psychosocial interventions in perimenopausal and postmenopausal women: a systematic review of randomised and non-randomised trials and non-controlled studies.

PubMed

Vélez Toral, Mercedes; Godoy-Izquierdo, Débora; Padial García, Ana; Lara Moreno, Raquel; Mendoza Ladrón de Guevara, Nicolás; Salamanca Ballesteros, Alberto; de Teresa Galván, Carlos; Godoy García, Juan F

2014-02-01

Women's care during perimenopause and postmenopause is taking new paths to help women cope with both somatic manifestations and changes related to psychological and social factors. An updated, systematic review was conducted on non-pharmacological psychosocial interventions with regard to peri- and postmenopause. Several databases complemented with reference lists and reviews were used to perform a literature search of any relevant article. Studies were selected if they included psychoeducational programmes, health education and promotion and cognitive-behavioural techniques applied to peri- or postmenopausal women, independently of study design, main outcomes and intervention comparators. A total of 33 reports and 3 relevant reviews published between 1987 and 2013 were included. Psychosocial options are promising intervention options for self-management and self-care, as they provide multiple benefits with no side effects. Moreover, these options are recommended for women in clinical, subclinical and asymptomatic groups, as they offer women the agency and skills necessary to manage and relieve menopausal symptoms, as well as provide information and alternatives to prevent menopausal symptoms and to have a more positive experience during these life stages. These options do more than reduce distress and complaints, as they allow women in any condition to enjoy enhanced health, well-being and quality of life. Moreover, these options are accompanied by important cost reductions in pharmaceutical investment and healthcare. Nevertheless, several issues remain controversial or have scarcely been investigated, and additional high-quality research should address these issues properly in the future. Despite these limitations and the weaknesses of the review, the findings of this review are interesting and positive. Thus, we encourage women-focused institutions and policies (e.g., healthcare centres, public organisations and women's associations) to offer psychosocial interventions to peri- and postmenopausal women within a comprehensive healthcare paradigm. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Genetic polymorphisms and weight loss in obesity: a randomised trial of hypo-energetic high- versus low-fat diets.

PubMed

Sørensen, Thorkild I A; Boutin, Philippe; Taylor, Moira A; Larsen, Lesli H; Verdich, Camilla; Petersen, Liselotte; Holst, Claus; Echwald, Søren M; Dina, Christian; Toubro, Søren; Petersen, Martin; Polak, Jan; Clément, Karine; Martínez, J Alfredo; Langin, Dominique; Oppert, Jean-Michel; Stich, Vladimir; Macdonald, Ian; Arner, Peter; Saris, Wim H M; Pedersen, Oluf; Astrup, Arne; Froguel, Philippe

2006-06-01

To study if genes with common single nucleotide polymorphisms (SNPs) associated with obesity-related phenotypes influence weight loss (WL) in obese individuals treated by a hypo-energetic low-fat or high-fat diet. Randomised, parallel, two-arm, open-label multi-centre trial. Eight clinical centres in seven European countries. 771 obese adult individuals. 10-wk dietary intervention to hypo-energetic (-600 kcal/d) diets with a targeted fat energy of 20%-25% or 40%-45%, completed in 648 participants. WL during the 10 wk in relation to genotypes of 42 SNPs in 26 candidate genes, probably associated with hypothalamic regulation of appetite, efficiency of energy expenditure, regulation of adipocyte differentiation and function, lipid and glucose metabolism, or production of adipocytokines, determined in 642 participants. Compared with the noncarriers of each of the SNPs, and after adjusting for gender, age, baseline weight and centre, heterozygotes showed WL differences that ranged from -0.6 to 0.8 kg, and homozygotes, from -0.7 to 3.1 kg. Genotype-dependent additional WL on low-fat diet ranged from 1.9 to -1.6 kg in heterozygotes, and from 3.8 kg to -2.1 kg in homozygotes relative to the noncarriers. Considering the multiple testing conducted, none of the associations was statistically significant. Polymorphisms in a panel of obesity-related candidate genes play a minor role, if any, in modulating weight changes induced by a moderate hypo-energetic low-fat or high-fat diet.

Enhancing person-centred communication in NICU: a comparative thematic analysis.

PubMed

Weis, Janne; Zoffmann, Vibeke; Egerod, Ingrid

2015-11-01

Aims of this article were (a) to explore how parents of premature infants experience guided family-centred care (GFCC), and (b) to compare how parents receiving GFCC versus standard care (SC) describe nurse-parent communication in the neonatal intensive care unit. Family-centred care (FCC) is acknowledged as fundamental to supporting parents of premature infants, and communication is central to this practice. Accordingly, nurses need good communication skills. GFCC is an intervention developed to improve nurse-parent communication in the neonatal intensive care unit. This intervention helps nurses to realize person-centred communication as an approach to optimize contemporary practice. Our qualitative study had a descriptive and comparative design using semi-structured interviews to explore the parent's experience of GFCC. We conducted 10 dyad interviews with parents (n = 20) and two individual interviews with mothers of premature infants (n = 2). Parents in the intervention group versus SC group were 13 versus 9. Thematic analysis was applied. GFCC was generally experienced as supportive. Three interrelated themes were identified that illustrated how the intervention helped parents cope as persons, parents and couples: (a) discovering and expressing emotions, (b) reaching a deeper level of communication, and (c) obtaining mutual understanding. In contrast, SC communication was more superficial and less structured. Factors such as inaccessibility of nurses, inability to ask for assistance and parent popularity impaired successful communication. Our study suggested that compared to SC, GFCC provided structured delivery of supportive communication between nurses and parents of premature infants. The intervention promoted the discovery of the parents' individual preferences and concerns, which enabled more focused communication, and set the stage for better nurse-parent and parent-parent understanding. We recommend GFCC as a method to improve communication in the neonatal intensive care unit. © 2013 British Association of Critical Care Nurses.

Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

PubMed Central

2014-01-01

Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611 PMID:24502414

Effect of diet and physical exercise intervention programmes on coronary heart disease risk in smoking and non-smoking men in Sweden.

PubMed Central

Näslund, G K; Fredrikson, M; Hellénius, M L; de Faire, U

1996-01-01

STUDY OBJECTIVE: To investigate differences between smokers and non-smokers in health behaviour, cardiovascular risk factors, coronary heart disease (CHD) risks, health knowledge, health attitudes, and compliance with a CHD prevention programme. DESIGN: Differences between smokers and non-smokers were studied via medical examinations, questionnaires, physical exercise activity logs, and food record sheets. Data were analysed using univariate and multivariate analyses. The five and 10 year CHD risks were assessed using the Framingham CHD risk estimate. SETTING: The Karolinska Hospital, Stockholm, and Sollentuna Primary Health Centre, Sollentuna, Sweden. PARTICIPANTS: The analyses were based on 158 healthy smoking and non-smoking men aged 35-60 years with raised cardiovascular risk factors who enrolled in controlled, randomised six month diet and exercise programmes. MAIN RESULTS: Discriminant analysis suggested that smokers, compared with non-smokers, were characterised by a higher alcohol energy percent, lower HDL cholesterol concentration, lower systolic blood pressure, and a higher plasminogen activator inhibitor-1 (PAI-1) value. Knowledge of the risk factors for CHD was not a discriminating factor. Both smokers and non-smokers increased the exercise taken, improved their diet, and lowered their CHD risk. Before, as well as after the intervention, smokers had a higher CHD risk than non-smokers. CONCLUSIONS: The best CHD prevention action that could be taken by smokers would of course be to quit smoking. Those who cannot stop should be encouraged to improve their diet and increase the amount of physical exercise they take in order to reduce the health hazards of their smoking behaviour. PMID:8762375

The 'Severe Hypertensive Illness in Pregnancy' (SHIP) audit: promoting quality care using a high risk monitoring chart and eclampsia treatment pack.

PubMed

Baldwin, K Joanne; Leighton, Nicola A; Kilby, M D; Wyldes, M; Churchill, D; Jones, P W; Johanson, R B

2002-07-01

We set out to measure the standards of care in a regional cohort of women with severe hypertensive illness of pregnancy and to subsequently improve the quality of care using a series of interventions. This was a multi centre cyclical criterion audit involving 21 maternity units in the West Midlands Region. Prospective data collection involved named co-ordinators in each unit using customised proformas. Intervention comprised feedback of baseline results to each hospital, a monitoring chart and eclampsia treatment pack. The first audit period (n = 183) was for a 4-month period between 1/9/96 and 31/12/96 and the second audit period (n = 111) was during the same 4-month period 1 year later. Although compliance with the audit standards set increased in all but one standard, there is clearly a need to make further improvements in the quality of care administered.

Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial.

PubMed

Fowler, David; French, Paul; Banerjee, Robin; Barton, Garry; Berry, Clio; Byrne, Rory; Clarke, Timothy; Fraser, Rick; Gee, Brioney; Greenwood, Kathryn; Notley, Caitlin; Parker, Sophie; Shepstone, Lee; Wilson, Jon; Yung, Alison R; Hodgekins, Joanne

2017-07-11

Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social disability and severe and complex non-psychotic mental health problems. The results will have important implications for policy and practice in the detection and early intervention for this group in mental health services. Trial Registry: International Standard Randomised Controlled Trial Number (ISRCTN) Registry. ISRCTN47998710 (registered 29/11/2012).

Distributed multi-sensor particle filter for bearings-only tracking

NASA Astrophysics Data System (ADS)

Zhang, Jungen; Ji, Hongbing

2012-02-01

In this article, the classical bearings-only tracking (BOT) problem for a single target is addressed, which belongs to the general class of non-linear filtering problems. Due to the fact that the radial distance observability of the target is poor, the algorithm-based sequential Monte-Carlo (particle filtering, PF) methods generally show instability and filter divergence. A new stable distributed multi-sensor PF method is proposed for BOT. The sensors process their measurements at their sites using a hierarchical PF approach, which transforms the BOT problem from Cartesian coordinate to the logarithmic polar coordinate and separates the observable components from the unobservable components of the target. In the fusion centre, the target state can be estimated by utilising the multi-sensor optimal information fusion rule. Furthermore, the computation of a theoretical Cramer-Rao lower bound is given for the multi-sensor BOT problem. Simulation results illustrate that the proposed tracking method can provide better performances than the traditional PF method.

Five-year evolution of reperfusion strategies and early mortality in patients with ST-segment elevation myocardial infarction in France.

PubMed

El Khoury, Carlos; Bochaton, Thomas; Flocard, Elodie; Serre, Patrice; Tomasevic, Danka; Mewton, Nathan; Bonnefoy-Cudraz, Eric

2017-10-01

To assess 5-year evolutions in reperfusion strategies and early mortality in patients with ST-segment elevation myocardial infarction. Using data from the French RESCUe network, we studied patients with ST-segment elevation myocardial infarction treated in mobile intensive care units between 2009 and 2013. Among 2418 patients (median age 62 years; 78.5% male), 2119 (87.6%) underwent primary percutaneous coronary intervention and 299 (12.4%) pre-hospital thrombolysis (94.0% of whom went on to undergo percutaneous coronary intervention). Use of primary percutaneous coronary intervention increased from 78.4% in 2009 to 95.9% in 2013 ( P trend <0.001). Median delays included: first medical contact to percutaneous coronary intervention centre 48 minutes; first medical contact to balloon inflation 94 minutes; and percutaneous coronary intervention centre to balloon inflation 43 minutes. Times from symptom onset to first medical contact and first medical contact to thrombolysis remained stable during 2009-2013, but times from symptom onset to first balloon inflation, and first medical contact to percutaneous coronary intervention centre to first balloon inflation decreased ( P<0.001). Among patients with known timings, 2146 (89.2%) had a first medical contact to percutaneous coronary intervention centre delay ⩽90 minutes, while 260 (10.8%) had a longer delay, with no significant variation over time. Primary percutaneous coronary intervention use increased over time in both delay groups, but was consistently higher in the ⩽90 versus >90 minutes delay group (83.0% in 2009 to 97.7% in 2013; P trend <0.001 versus 34.1% in 2009 to 79.2% in 2013; P trend <0.001). In-hospital (4-6%) and 30-day (6-8%) mortalities remained stable from 2009 to 2013. In the RESCUe network, the use of primary percutaneous coronary intervention increased from 2009 to 2013, in line with guidelines, but there was no evolution in early mortality.

Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study.

PubMed

Hodgson, Carol; Bellomo, Rinaldo; Berney, Susan; Bailey, Michael; Buhr, Heidi; Denehy, Linda; Harrold, Megan; Higgins, Alisa; Presneill, Jeff; Saxena, Manoj; Skinner, Elizabeth; Young, Paul; Webb, Steven

2015-02-26

The aim of this study was to investigate current mobilization practice, strength at ICU discharge and functional recovery at 6 months among mechanically ventilated ICU patients. This was a prospective, multi-centre, cohort study conducted in twelve ICUs in Australia and New Zealand. Patients were previously functionally independent and expected to be ventilated for >48 hours. We measured mobilization during invasive ventilation, sedation depth using the Richmond Agitation and Sedation Scale (RASS), co-interventions, duration of mechanical ventilation, ICU-acquired weakness (ICUAW) at ICU discharge, mortality at day 90, and 6-month functional recovery including return to work. We studied 192 patients (mean age 58.1 ± 15.8 years; mean Acute Physiology and Chronic Health Evaluation (APACHE) (IQR) II score, 18.0 (14 to 24)). Mortality at day 90 was 26.6% (51/192). Over 1,351 study days, we collected information during 1,288 planned early mobilization episodes in patients on mechanical ventilation for the first 14 days or until extubation (whichever occurred first). We recorded the highest level of early mobilization. Despite the presence of dedicated physical therapy staff, no mobilization occurred in 1,079 (84%) of these episodes. Where mobilization occurred, the maximum levels of mobilization were exercises in bed (N = 94, 7%), standing at the bed side (N = 11, 0.9%) or walking (N = 26, 2%). On day three, all patients who were mobilized were mechanically ventilated via an endotracheal tube (N = 10), whereas by day five 50% of the patients mobilized were mechanically ventilated via a tracheostomy tube (N = 18). Early mobilization of patients receiving mechanical ventilation was uncommon. More than 50% of patients discharged from the ICU had developed ICU-acquired weakness, which was associated with death between ICU discharge and day-90. ClinicalTrials.gov NCT01674608. Registered 14 August 2012.

The application of Firefly algorithm in an Adaptive Emergency Evacuation Centre Management (AEECM) for dynamic relocation of flood victims

NASA Astrophysics Data System (ADS)

ChePa, Noraziah; Hashim, Nor Laily; Yusof, Yuhanis; Hussain, Azham

2016-08-01

Flood evacuation centre is defined as a temporary location or area of people from disaster particularly flood as a rescue or precautionary measure. Gazetted evacuation centres are normally located at secure places which have small chances from being drowned by flood. However, due to extreme flood several evacuation centres in Kelantan were unexpectedly drowned. Currently, there is no study done on proposing a decision support aid to reallocate victims and resources of the evacuation centre when the situation getting worsens. Therefore, this study proposes a decision aid model to be utilized in realizing an adaptive emergency evacuation centre management system. This study undergoes two main phases; development of algorithm and models, and development of a web-based and mobile app. The proposed model operates using Firefly multi-objective optimization algorithm that creates an optimal schedule for the relocation of victims and resources for an evacuation centre. The proposed decision aid model and the adaptive system can be applied in supporting the National Security Council's respond mechanisms for handling disaster management level II (State level) especially in providing better management of the flood evacuating centres.

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

PubMed

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P < 0.0005), highest in infection (96.1%) and lowest in recurrence (52.3%). For patient recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients <65 years old recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to <2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

The Southampton Initiative for Health: a complex intervention to improve the diets and increase the physical activity levels of women and children from disadvantaged communities

PubMed Central

Barker, Mary; Lawrence, Wendy; Baird, Janis; Jarman, Megan; Black, Christina; Barnard, Katharine; Cradock, Sue; Davies, Jenny; Margetts, Barrie; Inskip, Hazel; Cooper, Cyrus

2013-01-01

The ‘Southampton Initiative for Health’ (SIH) is a training intervention with Sure Start Children’s Centre staff designed to improve the diets and physical activity levels of women of child-bearing age. Training aims to help staff to support women in making changes to their lifestyles by improving three skills: reflection on current practice; asking ‘open discovery’ questions; and goal setting. The impact of the training on staff practice is being assessed. A before and after non-randomised controlled trial is being used to evaluate the effectiveness and cost-effectiveness of the intervention in improving women’s diets and increasing their physical activity levels. PMID:20709878

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

PubMed

Robinson, Thomas N; Matheson, Donna; Desai, Manisha; Wilson, Darrell M; Weintraub, Dana L; Haskell, William L; McClain, Arianna; McClure, Samuel; Banda, Jorge A; Sanders, Lee M; Haydel, K Farish; Killen, Joel D

2013-11-01

To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. © 2013 Elsevier Inc. All rights reserved.

A randomised controlled trial on the Four Pillars Approach in managing pregnant women with anaemia in Yogyakarta–Indonesia: a study protocol

PubMed Central

2014-01-01

Background Anaemia is a common health problem among pregnant women and a contributing factor with a major influence on maternal mortality in Indonesia. The Four Pillars Approach is a new approach to anaemia in pregnancy, combining four strategies to improve antenatal and delivery care. The primary objective of this study is to measure the effectiveness of the Four Pillars Approach. The barriers, the facilitators, and the patients’ as well as the midwives’ satisfaction with the Four Pillars Approach will also be measured. Methods/Design This study will use a cluster randomised controlled trial. This intervention study will be conducted in the Public Health Centres with basic emergency obstetric care in Yogyakarta Special Province and in Central Java Province. We will involve all the Public Health Centres (24) with emergency obstetric care in Yogyakarta Special Province. Another 24 Public Health Centres with emergency obstetric care in Central Java Province which have similarities in their demographic, population characteristics, and facilities will also be involved. Each Public Health Centre will be asked to choose two or three nurse-midwives to participate in this study. For the intervention group, the Public Health Centres in Yogyakarta Special Province, training on the Four Pillars Approach will be held prior to the model’s implementation. Consecutively, we will recruit 360 pregnant women with anaemia to take part in part in the study to measure the effectiveness of the intervention. The outcome measurements are the differences in haemoglobin levels between the intervention and control groups in the third trimester of pregnancy, the frequency of antenatal care attendance, and the presence of a nurse-midwife during labour. Qualitative data will be used to investigate the barriers and facilitating factors, as to nurse-midwives’ satisfaction with the implementation of the Four Pillars Approach. Discussion If the Four Pillars Approach is effective in improving the outcome for pregnant women with anaemia, this approach could be implemented nationwide and be taken into consideration to improve the outcome for other conditions in pregnancy, after further research. Trial registration Current Controlled Trials ISRCTN35822126. PMID:24884497

A randomised controlled trial on the Four Pillars Approach in managing pregnant women with anaemia in Yogyakarta-Indonesia: a study protocol.

PubMed

Widyawati, Widyawati; Jans, Suze; Bor, Hans; Siswishanto, Rukmono; van Dillen, Jeroen; Lagro-Janssen, Antoine L M

2014-05-07

Anaemia is a common health problem among pregnant women and a contributing factor with a major influence on maternal mortality in Indonesia. The Four Pillars Approach is a new approach to anaemia in pregnancy, combining four strategies to improve antenatal and delivery care. The primary objective of this study is to measure the effectiveness of the Four Pillars Approach. The barriers, the facilitators, and the patients' as well as the midwives' satisfaction with the Four Pillars Approach will also be measured. This study will use a cluster randomised controlled trial. This intervention study will be conducted in the Public Health Centres with basic emergency obstetric care in Yogyakarta Special Province and in Central Java Province. We will involve all the Public Health Centres (24) with emergency obstetric care in Yogyakarta Special Province. Another 24 Public Health Centres with emergency obstetric care in Central Java Province which have similarities in their demographic, population characteristics, and facilities will also be involved. Each Public Health Centre will be asked to choose two or three nurse-midwives to participate in this study. For the intervention group, the Public Health Centres in Yogyakarta Special Province, training on the Four Pillars Approach will be held prior to the model's implementation. Consecutively, we will recruit 360 pregnant women with anaemia to take part in part in the study to measure the effectiveness of the intervention. The outcome measurements are the differences in haemoglobin levels between the intervention and control groups in the third trimester of pregnancy, the frequency of antenatal care attendance, and the presence of a nurse-midwife during labour. Qualitative data will be used to investigate the barriers and facilitating factors, as to nurse-midwives' satisfaction with the implementation of the Four Pillars Approach. If the Four Pillars Approach is effective in improving the outcome for pregnant women with anaemia, this approach could be implemented nationwide and be taken into consideration to improve the outcome for other conditions in pregnancy, after further research. Current Controlled Trials ISRCTN35822126.

Endoscopic tri-modal imaging for detection of early neoplasia in Barrett's oesophagus: a multi-centre feasibility study using high-resolution endoscopy, autofluorescence imaging and narrow band imaging incorporated in one endoscopy system.

PubMed

Curvers, W L; Singh, R; Song, L-M Wong-Kee; Wolfsen, H C; Ragunath, K; Wang, K; Wallace, M B; Fockens, P; Bergman, J J G H M

2008-02-01

To investigate the diagnostic potential of endoscopic tri-modal imaging and the relative contribution of each imaging modality (i.e. high-resolution endoscopy (HRE), autofluorescence imaging (AFI) and narrow-band imaging (NBI)) for the detection of early neoplasia in Barrett's oesophagus. Prospective multi-centre study. Tertiary referral centres. 84 Patients with Barrett's oesophagus. The Barrett's oesophagus was inspected with HRE followed by AFI. All lesions detected with HRE and/or AFI were subsequently inspected in detail by NBI for the presence of abnormal mucosal and/or microvascular patterns. Biopsies were obtained from all suspicious lesions for blinded histopathological assessment followed by random biopsies. (1) Number of patients with early neoplasia diagnosed by HRE and AFI; (2) number of lesions with early neoplasia detected with HRE and AFI; and (3) reduction of false positive AFI findings after NBI. Per patient analysis: AFI identified all 16 patients with early neoplasia identified with HRE and detected an additional 11 patients with early neoplasia that were not identified with HRE. In three patients no abnormalities were seen but random biopsies revealed HGIN. After HRE inspection, AFI detected an additional 102 lesions; 19 contained HGIN/EC (false positive rate of AFI after HRE: 81%). Detailed inspection with NBI reduced this false positive rate to 26%. In this international multi-centre study, the addition of AFI to HRE increased the detection of both the number of patients and the number of lesions with early neoplasia in patients with Barrett's oesophagus. The false positive rate of AFI was reduced after detailed inspection with NBI.

Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

PubMed

Rodriguez-Cristobal, Juan Jose; Alonso-Villaverde, Carlos; Panisello, Jose Ma; Travé-Mercade, Pere; Rodriguez-Cortés, Francisca; Marsal, Josep Ramon; Peña, Esther

2017-06-20

Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

The "Balance Intervention" for Promoting Caloric Compensatory Behaviours in Response to Overeating: A Formative Evaluation

ERIC Educational Resources Information Center

Wammes, Birgitte; Breedveld, Boudewijn; Kremers, Stef; Brug, Johannes

2006-01-01

To help people prevent weight gain, the Netherlands Nutrition Centre initiated the "balance intervention", which promotes moderation of food intake and/or increased physical activity in response to occasions of overeating. The aim of this study was to determine whether intervention materials were appreciated, encouraged information…

Mothers' Satisfaction with a Home Based Early Intervention Programme for Children with ASD

ERIC Educational Resources Information Center

Rodger, Sylvia; Keen, Deb; Braithwaite, Michelle; Cook, Shannon

2008-01-01

Background: Early intervention services adopting a family-centred approach are considered important for ensuring parent satisfaction. This study investigated the satisfaction of two mothers with an early intervention programme for young children with autistic spectrum disorder. Materials and Methods: While 16 mother-child dyads participated in a…

Real world data of 1473 patients treated with ulipristal acetate for uterine fibroids: Premya study results.

PubMed

Fernandez, Hervé; Schmidt, Torsten; Powell, Martin; Costa, Ana Patrícia Freitas; Arriagada, Pablo; Thaler, Christian

2017-01-01

To characterize and describe treatment with Ulipristal acetate (UPA) in a pre-operative setting and to evaluate the safety, effectiveness, and Health Related Quality of Life (HRQoL) outcomes in a population treated according to standard clinical practice in the EU. Multi-centre, prospective, non-interventional study (PREMYA) of patients diagnosed with moderate to severe symptoms of uterine fibroids and undergoing a pre-operative treatment with UPA (Esmya ® ) at 73 clinical practice sites within the EU. Patients were followed during UPA treatment and for 12 months after treatment discontinuation for a total of 15 months follow-up. Data was collected every 3 months in accordance with standard care visits. A total of 1568 women were enrolled, of whom 1473 were found to be eligible for data analysis. Only 38.8% of patients underwent surgery, of which the majority were of a conservative/minimally invasive nature. Physicians' assessments of patients' overall symptomatic change, as measured on the Clinical Global Impression-Improvement (CGI-I) scale, indicated that 60% of patients were much improved or very much improved at 3 months. Pain and quality of life after treatment cessation remain lower than baseline during the entire period of follow-up CONCLUSIONS: The majority of patients do not undergo surgery immediately after treatment cessation. Quality of life and pain are highly improved by Esmya ® treatment. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Childhood obesity prevention and control in city recreation centres and family homes: the MOVE/me Muevo Project.

PubMed

Elder, J P; Crespo, N C; Corder, K; Ayala, G X; Slymen, D J; Lopez, N V; Moody, J S; McKenzie, T L

2014-06-01

Interventions to prevent and control childhood obesity have shown mixed results in terms of short- and long-term changes. 'MOVE/me Muevo' was a 2-year family- and recreation centre-based randomized controlled trial to promote healthy eating and physical activity among 5- to 8-year-old children. It was hypothesized that children in the intervention group would demonstrate lower post-intervention body mass index (BMI) values and improved obesity-related behaviours compared with the control group children. Thirty recreation centres in San Diego County, California, were randomized to an intervention or control condition. Five hundred forty-one families were enrolled and children's BMI, diet, physical activity and other health indicators were tracked from baseline to 2 years post-baseline. Analyses followed an intent-to-treat approach using mixed-effects models. No significant intervention effects were observed for the primary outcomes of child's or parent's BMI and child's waist circumference. Moderator analyses, however, showed that girls (but not boys) in the intervention condition reduced their BMI. At the 2-year follow-up, intervention condition parents reported that their children were consuming fewer high-fat foods and sugary beverages. Favourable implementation fidelity and high retention rates support the feasibility of this intervention in a large metropolitan area; however, interventions of greater intensity may be needed to achieve effects on child's BMI. Also, further research is needed to develop gender-specific intervention strategies so that both genders may benefit from such efforts. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

The contribution of dietitians to the primary health care workforce.

PubMed

Howatson, Alexandra; Wall, Clare R; Turner-Benny, Petrina

2015-12-01

Dietetic intervention is effective in the management of nutrition-related conditions and their comorbidities. New Zealand has an increasing need for primary and preventive health care to reduce the burden of non-communicable disease. To review the recent evidence of effectiveness of dietetic intervention in primary health care on health and wider economic outcomes. Health benefits and cost benefits of employing dietitians to perform nutrition intervention in the primary health care setting are evaluated in the areas of obesity in conjunction with diabetes and cardiovascular disease, and malnutrition in older adults. An electronic literature search of four scientific databases, websites of major dietetic associations and high-impact nutrition and dietetic journals was conducted. Randomised controlled trials and non-randomised studies conducted from 2000 to 2014 were included. Dietetic intervention demonstrates statistically and clinically significant impacts on health outcomes in the areas of obesity, cardiovascular disease, diabetes, and malnutrition in older adults, when compared to usual care. Dietitians working in primary health care can also have significant economic benefits, potentially saving the health care system NZ$5.50-$99 for every NZ$1 spent on dietetic intervention. New Zealand must look to new models of health care provision that are not only patient-centred but are also cost-effective. This review demonstrates that dietitians in primary health care can improve patients' health and quality of life. Increasing the number of dietitians working in primary health care has the potential to make quality nutrition care accessible and affordable for more New Zealanders.

Effect of a web-based audit and feedback intervention with outreach visits on the clinical performance of multidisciplinary teams: a cluster-randomized trial in cardiac rehabilitation.

PubMed

Gude, Wouter T; van Engen-Verheul, Mariëtte M; van der Veer, Sabine N; Kemps, Hareld M C; Jaspers, Monique W M; de Keizer, Nicolette F; Peek, Niels

2016-12-09

The objective of this study was to assess the effect of a web-based audit and feedback (A&F) intervention with outreach visits to support decision-making by multidisciplinary teams. We performed a multicentre cluster-randomized trial within the field of comprehensive cardiac rehabilitation (CR) in the Netherlands. Our participants were multidisciplinary teams in Dutch CR centres who were enrolled in the study between July 2012 and December 2013 and received the intervention for at least 1 year. The intervention included web-based A&F with feedback on clinical performance, facilities for goal setting and action planning, and educational outreach visits. Teams were randomized either to receive feedback that was limited to psychosocial rehabilitation (study group A) or to physical rehabilitation (study group B). The main outcome measure was the difference in performance between study groups in 11 care processes and six patient outcomes, measured at patient level. Secondary outcomes included effects on guideline concordance for the four main CR therapies. Data from 18 centres (14,847 patients) were analysed, of which 12 centres (9353 patients) were assigned to group A and six (5494 patients) to group B. During the intervention, a total of 233 quality improvement goals was identified by participating teams, of which 49 (21%) were achieved during the study period. Except for a modest improvement in data completeness (4.5% improvement per year; 95% CI 0.65 to 8.36), we found no effect of our intervention on any of our primary or secondary outcome measures. Within a multidisciplinary setting, our web-based A&F intervention engaged teams to define local performance improvement goals but failed to support them in actually completing the improvement actions that were needed to achieve those goals. Future research should focus on improving the actionability of feedback on clinical performance and on addressing the socio-technical perspective of the implementation process. NTR3251.

Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial.

PubMed

Moore, Helen J; Nixon, Catherine; Tariq, Anisah; Emery, Jon; Hamilton, Willie; Hoare, Zoë; Kershenbaum, Anne; Neal, Richard D; Ukoumunne, Obioha C; Usher-Smith, Juliet; Walter, Fiona M; Whyte, Sophie; Rubin, Greg

2016-04-04

For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. ISRCTN Registry, ISRCTN12595588 .

Childhood intussusception: 17-year experience at a tertiary referral centre in Hong Kong.

PubMed

Wong, Carol W Y; Chan, Ivy H Y; Chung, Patrick H Y; Lan, Lawrence C L; Lam, Wendy W M; Wong, Kenneth K Y; Tam, Paul K H

2015-12-01

To review all paediatric patients with intussusception over the last 17 years. Retrospective case series. A tertiary centre in Hong Kong. Children who presented with intussusception from January 1997 to December 2014 were reviewed. The duration of symptoms, successful treatment modalities, complication rate, and length of hospital stay were studied. A total of 173 children (108 male, 65 female) presented to our hospital with intussusception during the study period. Their median age at presentation was 12.5 months (range, 2 months to 16 years) and the mean duration of symptoms was 2.3 (standard deviation, 1.8) days. Vomiting was the most common symptom (76.3%) followed by abdominal pain (46.2%), per rectal bleeding or red currant jelly stool (40.5%), and a palpable abdominal mass (39.3%). Overall, 160 patients proceeded to pneumatic or hydrostatic reduction, among whom 127 (79.4%) were successful. Three (1.9%) patients had bowel perforation during the procedure. Early recurrence of intussusception occurred in four (3.1%) patients with non-operative reduction. No recurrence was reported in the operative group. The presence of a palpable abdominal mass was a risk factor for operative treatment (relative risk=2.0; 95% confidence interval, 1.8-2.2). Analysis of our results suggested that duration of symptoms did not affect the success rate of non-operative reduction. Non-operative reduction has a high success rate and low complication rate, but the presence of a palpable abdominal mass is a risk factor for failure. Operative intervention should not be delayed in those patients who encounter difficult or doubtful non-operative reduction.

Feasibility of a patient-centred nutrition intervention to improve oral intakes of patients at risk of pressure ulcer: a pilot randomised control trial.

PubMed

Roberts, Shelley; Desbrow, Ben; Chaboyer, Wendy

2016-06-01

Nutrition is important for pressure ulcer prevention. This randomised control pilot study assessed the feasibility of conducting a larger trial to test the effectiveness of a patient-centred intervention for improving the dietary intakes of patients at risk of pressure ulcer in hospital. A 3-day intervention targeting patients at risk of pressure ulcer was developed, based on three main foundations: patient education, patient participation and guided goal setting. The intervention was piloted in three wards in a metropolitan hospital in Queensland, Australia. Participants were randomised into control or intervention groups and had their oral intakes monitored. A subset of intervention patients was interviewed on their perceptions of the intervention. Feasibility was tested against three criteria: ≥75% recruitment; ≥80% retention; and ≥80% intervention fidelity. Secondary outcomes related to effects on energy and protein intakes. Eighty patients participated in the study and 66 were included in final analysis. The recruitment rate was 82%, retention rate was 88%, and 100% of intervention patients received the intervention. Patients viewed the intervention as motivating and met significantly more of their estimated energy and protein requirements over time. This pilot study indicates that the intervention is feasible and acceptable by patients at risk of pressure ulcer. A larger trial is needed to confirm the effectiveness of the intervention in the clinical setting. © 2015 Nordic College of Caring Science.

Community-based interventions for enhancing access to or consumption of fruit and vegetables among five to 18-year olds: a scoping review

PubMed Central

2012-01-01

Background Low fruit and vegetable ( FV) consumption is a key risk factor for morbidity and mortality. Consumption of FV is limited by a lack of access to FV. Enhanced understanding of interventions and their impact on both access to and consumption of FV can provide guidance to public health decision-makers. The purpose of this scoping review is to identify and map literature that has evaluated effects of community-based interventions designed to increase FV access or consumption among five to 18-year olds. Methods The search included 21 electronic bibliographic databases, grey literature, targeted organization websites, and 15 key journals for relevant studies published up to May 2011. Retrieved citations were screened in duplicate for relevance. Data extracted from included studies covered: year, country, study design, target audience, intervention setting, intervention strategies, interventionists, and reported outcomes. Results The search located 19,607 unique citations. Full text relevance screening was conducted on 1,908 studies. The final 289 unique studies included 30 knowledge syntheses, 27 randomized controlled trials, 55 quasi-experimental studies, 113 cluster controlled studies, 60 before-after studies, one mixed method study, and three controlled time series studies. Of these studies, 46 included access outcomes and 278 included consumption outcomes. In terms of target population, 110 studies focused on five to seven year olds, 175 targeted eight to 10 year olds, 192 targeted 11 to 14 year olds, 73 targeted 15 to 18 year olds, 55 targeted parents, and 30 targeted teachers, other service providers, or the general public. The most common intervention locations included schools, communities or community centres, and homes. Most studies implemented multi-faceted intervention strategies to increase FV access or consumption. Conclusions While consumption measures were commonly reported, this review identified a small yet important subset of literature examining access to FV. This is a critically important issue since consumption is contingent upon access. Future research should examine the impact of interventions on direct outcome measures of FV access and a focused systematic review that examines these interventions is also needed. In addition, research on interventions in low- and middle-income countries is warranted based on a limited existing knowledge base. PMID:22931474

[Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study].

PubMed

Blecha, Sebastian; Thomann-Hackner, Kathrin; Brandstetter, Susanne; Dodoo-Schittko, Frank; Seboek, Philipp; Apfelbacher, Christian; Graf, Bernhard M; Bein, Thomas

2015-09-01

Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed. © Georg Thieme Verlag KG Stuttgart · New York.

A RE-AIM evaluation of evidence-based multi-level interventions to improve obesity-related behaviours in adults: a systematic review (the SPOTLIGHT project).

PubMed

Compernolle, Sofie; De Cocker, Katrien; Lakerveld, Jeroen; Mackenbach, Joreintje D; Nijpels, Giel; Oppert, Jean-Michel; Rutter, Harry; Teixeira, Pedro J; Cardon, Greet; De Bourdeaudhuij, Ilse

2014-12-06

This systematic literature review describes the potential public health impact of evidence-based multi-level interventions to improve obesity-related behaviours in adults, using the Reach, Efficacy, Adoption, Implementation and Maintenance (RE-AIM) framework. Electronic databases (PubMed, Embase, and The Cochrane Library) were searched to identify intervention studies published between January 2000 and October 2013. The following inclusion criteria were used: (1) the study included at least one outcome measure assessing obesity-related behaviours (i.e. diet, physical activity or sedentary behaviour), (2) the study collected data over at least one year and (3) the study's intervention targeted adults, was conducted in a specified geographical area or worksite, and was multi-level (i.e. targeting both individual and environmental level). Evidence of RE-AIM of the selected interventions was assessed. Potential public health impact of an intervention was evaluated if information was provided on at least four of the five RE-AIM dimensions. Thirty-five multi-level interventions met the inclusion criteria. RE-AIM evaluation revealed that the included interventions generally had the potential to: reach a large number of people (on average 58% of the target population was aware of the intervention); achieve the assumed goals (89% found positive outcomes); be broadly adopted (the proportion of intervention deliverers varied from 9% to 92%) and be sustained (sixteen interventions were maintained). The highest potential public health impact was found in multi-level interventions that: 1) focused on all levels at the beginning of the planning process, 2) guided the implementation process using diffusion theory, and 3) used a website to disseminate the intervention. Although most studies underreported results within the RE-AIM dimensions, the reported Reach, Effectiveness, Adoption, Implementation and Maintenance were positively evaluated. However, more information on external validity and sustainability is needed in order to take informed decisions on the choice of interventions that should be implemented in real-world settings to accomplish long-term changes in obesity-related behaviours.

Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO).

PubMed

Brandstetter, Susanne; Dodoo-Schittko, Frank; Blecha, Sebastian; Sebök, Philipp; Thomann-Hackner, Kathrin; Quintel, Michael; Weber-Carstens, Steffen; Bein, Thomas; Apfelbacher, Christian

2015-12-17

Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study ("Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life") to investigate the role of QoC and individual patient characteristics on quality of life and return to work. A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors.

Perceived Case Management Needs and Service Preferences of Frequent Emergency Department Users: Lessons Learned in a Large Urban Centre.

PubMed

Kahan, Deborah; Poremski, Daniel; Wise-Harris, Deborah; Pauly, Daniel; Leszcz, Molyn; Wasylenki, Donald; Stergiopoulos, Vicky

2016-01-01

This study aimed to explore the service needs and preferences of frequent emergency department users with mental health and addictions concerns who participated in a brief intensive case management intervention. We conducted semi-structured individual interviews with 20 frequent emergency department users with mental health and addictions challenges, 13 service providers involved in the delivery of a brief case management intervention, and a focus group with intervention case managers. Thematic analysis was used to explore perceived service user profiles, service needs and preferences of care. Service users experienced complex health and social needs and social isolation, while exhibiting resilience and the desire to contribute. They described multiple instances of stigmatization in interactions with healthcare professionals. Components of the brief intensive case management intervention perceived to be helpful included system navigation, advocacy, intermediation, and practical needs assistance. Frequent service users valued relational responsiveness, a non-judgmental stance, and a recovery orientation in case managers. Interventions for frequent service users in mental health may be enhanced by focusing on the engagement of formal and informal social supports, practical needs assistance, system navigation, advocacy and intermediation, and attention to the recovery goals of service users.

The effectiveness of motivational interviewing for health behaviour change in primary care settings: a systematic review.

PubMed

Morton, Katie; Beauchamp, Mark; Prothero, Anna; Joyce, Lauren; Saunders, Laura; Spencer-Bowdage, Sarah; Dancy, Bernadette; Pedlar, Charles

2015-01-01

Motivational interviewing (MI) is a patient-centred approach to behaviour change that was originally developed in the addiction field but has increasingly been applied to public health settings with a focus on health promotion. The purpose of this review was to examine the evidence base for MI interventions in primary care settings with non-clinical populations to achieve behaviour change for physical activity, dietary behaviours and/or alcohol intake. We also sought to explore the specific behaviour change techniques included in MI interventions within primary care. Electronic databases were searched for relevant articles and 33 papers met inclusion criteria and were included. Approximately 50% of the included studies (n = 18) demonstrated positive effects in relation to health behaviour change. The efficacy of MI approaches is unclear given the inconsistency of MI descriptions and intervention components. Furthermore, research designs that do not isolate the effects of MI make it difficult to determine the effectiveness of such approaches. We offer a number of recommendations for researchers and practitioners seeking to include MI within behaviour change interventions to help improve the quality of the research and the effectiveness of MI-based interventions within primary care settings.

The effectiveness and cost effectiveness of the PAtient-Centred Team (PACT) model: study protocol of a prospective matched control before-and-after study.

PubMed

Bergmo, Trine S; Berntsen, Gro K; Dalbakk, Monika; Rumpsfeld, Markus

2015-10-23

The present study protocol describes the evaluation of a comprehensive integrated care model implemented at two hospital sites at the University Hospital of North Norway (UNN). The PAtient Centred Team (PACT) model includes proactive, patient-centred interdisciplinary teams that aim to improve the continuum and quality of care of frail elderly patients and reduce health care costs. The main objectives of the evaluation are to analyse the effectiveness and cost effectiveness of using patient-centred teams as part of routine service provision for this patient group. The evaluation will analyse the effect on patient health and functional status, patient experiences and hospital utilisation, and it will conduct an economic evaluation. This paper describes the PACT model and the rationale for and design of the planned effectiveness and cost-effectiveness study. This is a prospective, non-randomised matched control before-and-after intervention study. Patients in the intervention group will be recruited from the hospital sites that have implemented the PACT model. The controls will be recruited from two hospitals without the model. The control patients and the index patients will be matched according to sex, age and number of long-term conditions. The study aims to include 600 patients in each group, which will provide sufficient power to detect a clinical change in the primary outcome. The primary outcome is the physical dimension of the Short Form Health Survey (SF-36). Secondary outcomes are the Patient Generated Index (PGI), the Patient Activation Measure (PAM), the Patient Assessment of Chronic Illness Care (PACIC), hospitalisation and length of stay. The cost-effectiveness study takes a health provider perspective and calculates the cost per quality-adjusted life-years (QALYs) gained. The data will be collected at baseline, 6 and 12 months. The data will be analysed using techniques and models that recognise the lack of randomisation and the correlation of cost and effect data. The study results will provide knowledge about whether the integrated care model implemented at UNN improves the quality of care for the frail elderly with multiple conditions. The study will establish whether the PAC. T model improves health and functional status and is cost effective compared to the usual care for this patient group. ClinicalTrials.gov: NCT02541474.

Factors influencing subjective perceptions of everyday occupations: comparing day centre attendees with non-attendees.

PubMed

Argentzell, Elisabeth; Leufstadius, Christel; Eklund, Mona

2012-01-01

Subjective perceptions of everyday occupations are important for the well-being of people with psychiatric disabilities (PD) and are likely to vary with factors such as attending a day centre or not, activity level, self-mastery, sociodemographic and clinical factors. To explore differences in subjective perceptions of occupation and activity level between day centre attendees and non-attendees, and to investigate factors of importance for the subjective perceptions of occupations. The study groups comprised 175 participants: 93 day centre attendees and 82 non-attendees. Data were collected with instruments concerning; subjective perceptions of everyday occupations, activity level, self-mastery, and sociodemographic and clinical factors. Day centre attendees perceived higher levels of occupational value and activity level, while the groups perceived a similar level of satisfaction with daily occupations. For the total sample, self-mastery influenced both valued and satisfying everyday occupations while only value was affected by activity level. Satisfaction with daily occupation increased with age and both value and satisfaction increased with lower levels of psychiatric symptoms. Day centres provide perceptions of occupational value and stimulate activity. Non-differences between the groups regarding satisfaction with everyday occupations implied, however, that day centres might not cover all relevant occupational needs.

Increasing Childhood Influenza Vaccination

PubMed Central

Nowalk, Mary Patricia; Lin, Chyongchiou J.; Hannibal, Kristin; Reis, Evelyn C.; Gallik, Gregory; Moehling, Krissy K.; Huang, Hsin-Hui; Allred, Norma J.; Wolfson, David H.; Zimmerman, Richard K.

2014-01-01

Background Since the 2008 inception of universal childhood influenza vaccination, national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent. Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70%. Purpose To evaluate an intervention to increase childhood influenza vaccination across age and racial groups. Methods In 2011–2012, 20 primary care practices treating children were randomly assigned to Intervention and Control arms of a cluster randomized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine, in-service staff meetings, and publicity. Results The average vaccination differences from pre-intervention to the intervention year were significantly larger in the Intervention arm (n=10 practices) than the Control arm (n=10 practices), for children aged 2–8 years (10.2 percentage points (pct pts) Intervention vs 3.6 pct pts Control) and 9–18 years (11.1 pct pts Intervention vs 4.3 pct pts Control, p<0.05), for non-white children (16.7 pct pts Intervention vs 4.6 pct pts Control, p<0.001), and overall (9.9 pct pts Intervention vs 4.2 pct pts Control, p<0.01). In multi-level modeling that accounted for person- and practice-level variables and the interactions among age, race and intervention, the likelihood of vaccination increased with younger age group (6–23 months), white race, commercial insurance, the practice’s pre-intervention vaccination rate, and being in the Intervention arm. Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged 9–18 years. Conclusions A multi-strategy intervention that includes a practice improvement toolkit can significantly improve influenza vaccination uptake across age and racial groups without targeting specific groups, especially in practices with large percentages of minority children. PMID:25113138

Combining a leadership course and multi-source feedback has no effect on leadership skills of leaders in postgraduate medical education. An intervention study with a control group.

PubMed

Malling, Bente; Mortensen, Lene; Bonderup, Thomas; Scherpbier, Albert; Ringsted, Charlotte

2009-12-10

Leadership courses and multi-source feedback are widely used developmental tools for leaders in health care. On this background we aimed to study the additional effect of a leadership course following a multi-source feedback procedure compared to multi-source feedback alone especially regarding development of leadership skills over time. Study participants were consultants responsible for postgraduate medical education at clinical departments. pre-post measures with an intervention and control group. The intervention was participation in a seven-day leadership course. Scores of multi-source feedback from the consultants responsible for education and respondents (heads of department, consultants and doctors in specialist training) were collected before and one year after the intervention and analysed using Mann-Whitney's U-test and Multivariate analysis of variances. There were no differences in multi-source feedback scores at one year follow up compared to baseline measurements, either in the intervention or in the control group (p = 0.149). The study indicates that a leadership course following a MSF procedure compared to MSF alone does not improve leadership skills of consultants responsible for education in clinical departments. Developing leadership skills takes time and the time frame of one year might have been too short to show improvement in leadership skills of consultants responsible for education. Further studies are needed to investigate if other combination of initiatives to develop leadership might have more impact in the clinical setting.

Effect of family nursing therapeutic conversations on health-related quality of life, self-care and depression among outpatients with heart failure: A randomized multi-centre trial.

PubMed

Østergaard, Birte; Mahrer-Imhof, Romy; Wagner, Lis; Barington, Torben; Videbæk, Lars; Lauridsen, Jørgen

2018-03-07

To evaluate the short-term (3 months) effects of family nursing therapeutic conversations (FNTC) on health-related quality of life, self-care and depression in outpatients with Heart failure (HF). A randomised multi-centre trial was conducted in three Danish HF clinics. The control group (n = 167) received usual care, and the intervention group (n = 180) received FNTCs as supplement to usual care. Primary outcome was clinically significant changes (6 points) in Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score between groups. Secondary outcomes were changes in self-care behaviour and depression scores. Data were assessed before first consultation and repeated after three months. No statistically significant difference was found in the change of KCCQ, self-care and depression scores between the groups. KCCQ scores of patients in the FNTC group changed clinically significant in seven domains, compared to one domain in the control group, with the highest improvement in self-efficacy, social limitation and symptom burden. FNTC was not superior to standard care of patients with HF regarding health-related quality of life, self-care and depression. Addressing the impact of the disease on the family, might improve self-efficacy, social limitation and symptom burden in patients with heart failure. Copyright © 2018 Elsevier B.V. All rights reserved.

Spanning maternal, newborn and child health (MNCH) and health systems research boundaries: conducive and limiting health systems factors to improving MNCH outcomes in West Africa.

PubMed

Agyepong, Irene Akua; Kwamie, Aku; Frimpong, Edith; Defor, Selina; Ibrahim, Abdallah; Aryeetey, Genevieve C; Lokossou, Virgil; Sombie, Issiaka

2017-07-12

Despite improvements over time, West Africa lags behind global as well as sub-Saharan averages in its maternal, newborn and child health (MNCH) outcomes. This is despite the availability of an increasing body of knowledge on interventions that improve such outcomes. Beyond our knowledge of what interventions work, insights are needed on others factors that facilitate or inhibit MNCH outcome improvement. This study aimed to explore health system factors conducive or limiting to MNCH policy and programme implementation and outcomes in West Africa, and how and why they work in context. We conducted a mixed methods multi-country case study focusing predominantly, but not exclusively, on the six West African countries (Burkina Faso, Benin, Mali, Senegal, Nigeria and Ghana) of the Innovating for Maternal and Child Health in Africa initiative. Data collection involved non-exhaustive review of grey and published literature, and 48 key informant interviews. We validated our findings and conclusions at two separate multi-stakeholder meetings organised by the West African Health Organization. To guide our data collection and analysis, we developed a unique theoretical framework of the link between health systems and MNCH, in which we conceptualised health systems as the foundations, pillars and roofing of a shelter for MNCH, and context as the ground on which the foundation is laid. A multitude of MNCH policies and interventions were being piloted, researched or implemented at scale in the sub-region, most of which faced multiple interacting conducive and limiting health system factors to effective implementation, as well as contextual challenges. Context acted through its effect on health system factors as well as on the social determinants of health. To accelerate and sustain improvements in MNCH outcomes in West Africa, an integrated approach to research and practice of simultaneously addressing health systems and contextual factors alongside MNCH service delivery interventions is needed. This requires multi-level, multi-sectoral and multi-stakeholder engagement approaches that span current geographical, language, research and practice community boundaries in West Africa, and effectively link the efforts of actors interested in health systems strengthening with those of actors interested in MNCH outcome improvement.

Inverse probability weighting in STI/HIV prevention research: methods for evaluating social and community interventions

PubMed Central

Lippman, Sheri A.; Shade, Starley B.; Hubbard, Alan E.

2011-01-01

Background Intervention effects estimated from non-randomized intervention studies are plagued by biases, yet social or structural intervention studies are rarely randomized. There are underutilized statistical methods available to mitigate biases due to self-selection, missing data, and confounding in longitudinal, observational data permitting estimation of causal effects. We demonstrate the use of Inverse Probability Weighting (IPW) to evaluate the effect of participating in a combined clinical and social STI/HIV prevention intervention on reduction of incident chlamydia and gonorrhea infections among sex workers in Brazil. Methods We demonstrate the step-by-step use of IPW, including presentation of the theoretical background, data set up, model selection for weighting, application of weights, estimation of effects using varied modeling procedures, and discussion of assumptions for use of IPW. Results 420 sex workers contributed data on 840 incident chlamydia and gonorrhea infections. Participators were compared to non-participators following application of inverse probability weights to correct for differences in covariate patterns between exposed and unexposed participants and between those who remained in the intervention and those who were lost-to-follow-up. Estimators using four model selection procedures provided estimates of intervention effect between odds ratio (OR) .43 (95% CI:.22-.85) and .53 (95% CI:.26-1.1). Conclusions After correcting for selection bias, loss-to-follow-up, and confounding, our analysis suggests a protective effect of participating in the Encontros intervention. Evaluations of behavioral, social, and multi-level interventions to prevent STI can benefit by introduction of weighting methods such as IPW. PMID:20375927

The importance of providing counselling and financial support to patients receiving treatment for multi-drug resistant TB: mixed method qualitative and pilot intervention studies.

PubMed

Baral, Sushil C; Aryal, Yeshoda; Bhattrai, Rekha; King, Rebecca; Newell, James N

2014-01-17

People with multi-drug resistant tuberculosis (MDR-TB) in low-income countries face many problems during treatment, and cure rates are low. The purpose of the study was (a) to identify and document the problems experienced by people receiving care for MDR-TB, and how they cope when support is not provided, to inform development of strategies; (b) to estimate the effectiveness of two resultant strategies, counselling alone, and joint counselling and financial support, of increasing DOTS-plus treatment success under routine programme conditions. A mixed-method study comprising a formative qualitative study, pilot intervention study and explanatory qualitative study to better understand barriers to completion of treatment for MDR-TB. Participants were all people starting MDR-TB treatment in seven DOTS-plus centres in the Kathmandu Valley, Nepal during January to December 2008. The primary outcome measure was cure, as internationally defined. MDR-TB treatment caused extreme social, financial and employment hardship. Most patients had to move house and leave their job, and reported major stigmatisation. They were concerned about the long-term effects of their disease, and feared infecting others. In the resultant pilot intervention study, the two strategies appeared to improve treatment outcomes: cure rates for those receiving counselling, combined support and no support were 85%, 76% and 67% respectively. Compared with no support, the (adjusted) risk ratios of cure for those receiving counselling and receiving combined support were 1.2 (95% CI 1.0 to 1.6) and 1.2 (95% CI 0.9 to 1.6) respectively. The explanatory study demonstrated that patients valued both forms of support. MDR-TB patients are extremely vulnerable to stigma and extreme financial hardship. Provision of counselling and financial support may not only reduce their vulnerability, but also increase cure rates. National Tuberculosis Programmes should consider incorporating financial support and counselling into MDR-TB care: costs are low, and benefits high, especially since costs to society of incomplete treatment and potential for incurable TB are extremely high.

Psychiatric epidemiology in India.

PubMed

Math, Suresh Bada; Chandrashekar, C R; Bhugra, Dinesh

2007-09-01

Epidemiological studies report prevalence rates for psychiatric disorders from 9.5 to 370/1000 populations in India. This review critically evaluates the prevalence rate of mental disorders as reported in Indian epidemiological studies. Extensive search of PubMed, NeuroMed and MEDLARS using search terms "psychiatry" and "epidemiology" was done. Manual search of literature was also done. Retrieved articles were systematically selected using inclusion and exclusion criteria. Only sixteen prevalence studies fulfilled the study criteria. Most of the epidemiological studies done in India neglected anxiety disorders, substance dependence disorders, co-morbidity and dual diagnosis. The use of poor sensitive screening instruments, single informant and systematic underreporting has added to the discrepancy in the prevalence rate. The prevalence of mental disorders reported in epidemiological surveys can be considered lower estimates rather than accurate reflections of the true prevalence in the population. Researchers have focused on broad non-specific, non-modifiable risk factors, such as age, gender and social class. Future research focused on the general population, longitudinal (prospective), multi-centre, co-morbid studies, assessment of disability, functioning, family burden and quality of life studies involving a clinical service providing approach, is required.

Acute neurorehabilitation: does a neurosensory and coordinated interdisciplinary programme reduce tracheostomy weaning time and weaning failure?

PubMed

Berney, Loric; Wasserfallen, Jean-Blaise; Grant, Kathleen; Levivier, Marc; Simon, Christian; Faouzi, Mohamed; Paillex, Roland; Schweizer, Valérie; Diserens, Karin

2014-01-01

A new coordinated interdisciplinary unit was created in the acute section of the department of clinical neurosciences, the Acute NeuroRehabilitation (NRA) unit. The objective was to evaluate the impact of the unit and its neurosensory programme on the management of tracheostomy patients in terms of reduction in the average time taken for weaning, weaning success rate and therapeutic efficiency. This 49-month retrospective study compares 2 groups of tracheostomy patients before (n = 34) and after (n = 46) NRA intervention. The outcome measures evaluate the benefits of the NRA unit intervention (time to decannulation, weaning and complication rates) and the benefits of the coordination (time to registration in a rehabilitation centre and rate of non-compliance with standards of care). Weaning failure rate was reduced from 27.3% to 9.1%, no complications or recannulations were observed in the post-intervention group after weaning and time to decannulation following admission to our unit decreased from 19.13 to 12.75 days. The rate of non-compliance with patient standards of care was significantly reduced from 45% to 30% (Mann-Whitney p = 0.003). This interdisciplinary weaning programme helped to reduce weaning time and weaning failure, without increased complications, in the sample studied. Coordination improved the efficiency of the interdisciplinary team in the multiplicity and complexity of the different treatments.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project).

PubMed

Acuña Mora, Mariela; Sparud-Lundin, Carina; Bratt, Ewa-Lena; Moons, Philip

2017-04-17

When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood. STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES). The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals. NCT02675361; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Randomised controlled trial of a brief intervention targeting predominantly non-verbal communication in general practice consultations.

PubMed

Little, Paul; White, Peter; Kelly, Joanne; Everitt, Hazel; Mercer, Stewart

2015-06-01

The impact of changing non-verbal consultation behaviours is unknown. To assess brief physician training on improving predominantly non-verbal communication. Cluster randomised parallel group trial among adults aged ≥16 years attending general practices close to the study coordinating centres in Southampton. Sixteen GPs were randomised to no training, or training consisting of a brief presentation of behaviours identified from a prior study (acronym KEPe Warm: demonstrating Knowledge of the patient; Encouraging [back-channelling by saying 'hmm', for example]; Physically engaging [touch, gestures, slight lean]; Warm-up: cool/professional initially, warming up, avoiding distancing or non-verbal cut-offs at the end of the consultation); and encouragement to reflect on videos of their consultation. Outcomes were the Medical Interview Satisfaction Scale (MISS) mean item score (1-7) and patients' perceptions of other domains of communication. Intervention participants scored higher MISS overall (0.23, 95% confidence interval [CI] = 0.06 to 0.41), with the largest changes in the distress-relief and perceived relationship subscales. Significant improvement occurred in perceived communication/partnership (0.29, 95% CI = 0.09 to 0.49) and health promotion (0.26, 95% CI = 0.05 to 0.46). Non-significant improvements occurred in perceptions of a personal relationship, a positive approach, and understanding the effects of the illness on life. Brief training of GPs in predominantly non-verbal communication in the consultation and reflection on consultation videotapes improves patients' perceptions of satisfaction, distress, a partnership approach, and health promotion. © British Journal of General Practice 2015.

Learning intervention-induced deformations for non-rigid MR-CT registration and electrode localization in epilepsy patients

PubMed Central

Onofrey, John A.; Staib, Lawrence H.; Papademetris, Xenophon

2015-01-01

This paper describes a framework for learning a statistical model of non-rigid deformations induced by interventional procedures. We make use of this learned model to perform constrained non-rigid registration of pre-procedural and post-procedural imaging. We demonstrate results applying this framework to non-rigidly register post-surgical computed tomography (CT) brain images to pre-surgical magnetic resonance images (MRIs) of epilepsy patients who had intra-cranial electroencephalography electrodes surgically implanted. Deformations caused by this surgical procedure, imaging artifacts caused by the electrodes, and the use of multi-modal imaging data make non-rigid registration challenging. Our results show that the use of our proposed framework to constrain the non-rigid registration process results in significantly improved and more robust registration performance compared to using standard rigid and non-rigid registration methods. PMID:26900569

Study protocol: EXERcise and cognition in sedentary adults with early-ONset dementia (EXERCISE-ON).

PubMed

Hooghiemstra, Astrid M; Eggermont, Laura H P; Scheltens, Philip; van der Flier, Wiesje M; Bakker, Jet; de Greef, Mathieu H G; Koppe, Peter A; Scherder, Erik J A

2012-08-16

Although the development of early-onset dementia is a radical and invalidating experience for both patient and family there are hardly any non-pharmacological studies that focus on this group of patients. One type of a non-pharmacological intervention that appears to have a beneficial effect on cognition in older persons without dementia and older persons at risk for dementia is exercise. In view of their younger age early-onset dementia patients may be well able to participate in an exercise program. The main aim of the EXERCISE-ON study is to assess whether exercise slows down the progressive course of the symptoms of dementia. One hundred and fifty patients with early-onset dementia are recruited. After completion of the baseline measurements, participants living within a 50 kilometre radius to one of the rehabilitation centres are randomly assigned to either an aerobic exercise program in a rehabilitation centre or a flexibility and relaxation program in a rehabilitation centre. Both programs are applied three times a week during 3 months. Participants living outside the 50 kilometre radius are included in a feasibility study where participants join in a daily physical activity program set at home making use of pedometers. Measurements take place at baseline (entry of the study), after three months (end of the exercise program) and after six months (follow-up). Primary outcomes are cognitive functioning; psychomotor speed and executive functioning; (instrumental) activities of daily living, and quality of life. Secondary outcomes include physical, neuropsychological, and rest-activity rhythm measures. The EXERCISE-ON study is the first study to offer exercise programs to patients with early-onset dementia. We expect this study to supply evidence regarding the effects of exercise on the symptoms of early-onset dementia, influencing quality of life. The present study is registered within The Netherlands National Trial Register (ref: NTR2124).

Study protocol: EXERcise and Cognition In Sedentary adults with Early-ONset dementia (EXERCISE-ON)

PubMed Central

2012-01-01

Background Although the development of early-onset dementia is a radical and invalidating experience for both patient and family there are hardly any non-pharmacological studies that focus on this group of patients. One type of a non-pharmacological intervention that appears to have a beneficial effect on cognition in older persons without dementia and older persons at risk for dementia is exercise. In view of their younger age early-onset dementia patients may be well able to participate in an exercise program. The main aim of the EXERCISE-ON study is to assess whether exercise slows down the progressive course of the symptoms of dementia. Methods/Design One hundred and fifty patients with early-onset dementia are recruited. After completion of the baseline measurements, participants living within a 50 kilometre radius to one of the rehabilitation centres are randomly assigned to either an aerobic exercise program in a rehabilitation centre or a flexibility and relaxation program in a rehabilitation centre. Both programs are applied three times a week during 3 months. Participants living outside the 50 kilometre radius are included in a feasibility study where participants join in a daily physical activity program set at home making use of pedometers. Measurements take place at baseline (entry of the study), after three months (end of the exercise program) and after six months (follow-up). Primary outcomes are cognitive functioning; psychomotor speed and executive functioning; (instrumental) activities of daily living, and quality of life. Secondary outcomes include physical, neuropsychological, and rest-activity rhythm measures. Discussion The EXERCISE-ON study is the first study to offer exercise programs to patients with early-onset dementia. We expect this study to supply evidence regarding the effects of exercise on the symptoms of early-onset dementia, influencing quality of life. Trial registration The present study is registered within The Netherlands National Trial Register (ref: NTR2124) PMID:22897903

A Food Retail-Based Intervention on Food Security and Consumption

PubMed Central

Sadler, Richard C.; Gilliland, Jason A.; Arku, Godwin

2013-01-01

The effect of the built environment on diet (and ensuing health outcomes) is less understood than the effect of diet on obesity. Natural experiments are increasingly advocated in place of cross-sectional studies unable to suggest causality. The central research question of this paper, therefore, asks whether a neighborhood-level food retail intervention will affect dietary habits or food security. The intervention did not have a significant impact on fruit and vegetable consumption, and the intervention population actually purchased prepared meals more frequently. More problematic, only 8% of respondents overall regularly consumed enough fruits and vegetables, and 34% were food insecure. Further complicating this public health issue, the new grocery store closed after 17 months of operation. Results indicate that geographic access to food is only one element of malnutrition, and that multi-pronged dietary interventions may be more effective. The economic failure of the store also suggests the importance of non-retail interventions to combat malnutrition. PMID:23921626

Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

PubMed Central

2012-01-01

Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013 PMID:23158830

What is the degree of innovation routinely implemented in Dutch radiotherapy centres? A multicentre cross-sectional study.

PubMed

Jacobs, Maria; Boersma, Liesbeth; Dekker, Andre; Bosmans, Geert; van Merode, Frits; Verhaegen, Frank; de Ruysscher, Dirk; Swart, Rachelle; Kengen, Cindy; Lambin, Philippe

2016-11-01

To study the implementation of innovation activities in Dutch radiotherapy (RT) centres in a broad sense (product, technological, market and organizational innovations). A descriptive cross-sectional study was conducted in 15 Dutch RT centres. A list of innovations implemented from 2011 to 2013 was drawn up for each centre using semi-structured interviews. These innovations were classified into innovation categories according to previously defined innovation indicators. Where applicable, each innovation was rated by each centre on the effort required to implement it and on its expected effects, to get an impression of how far reaching and radical the innovations were and to be able to compare the number of innovations between centres. The participating RT centres in the Netherlands implemented 12 innovations per year on average (range 5-25); this number was not significantly different for academic (n = 13) or non-academic centres (n = 10). Several centres were dealing with the same innovations at the same time. The average required effort and expected output did not differ significantly between product, technological and organizational innovation or between academic and non-academic centres. The number of innovations observed per centre varied across a large range, with a large overlap in terms of the type of innovations that were implemented. Registering innovations using the innovation indicators applied in our study would make it possible to improve collaboration between centres, e.g. with common training modules, to avoid duplication of work. Advances in knowledge: This study is the first of its kind investigating innovation implementation in RT in a broad sense.

Enhancing system-wide implementation of opioid prescribing guidelines in primary care: protocol for a stepped-wedge quality improvement project.

PubMed

Zgierska, Aleksandra E; Vidaver, Regina M; Smith, Paul; Ales, Mary W; Nisbet, Kate; Boss, Deanne; Tuan, Wen-Jan; Hahn, David L

2018-06-05

Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

A randomised controlled trial to assess the impact of a package comprising a patient-orientated, evidence-based self-help guidebook and patient-centred consultations on disease management and satisfaction in inflammatory bowel disease.

PubMed

Kennedy, A; Nelson, E; Reeves, D; Richardson, G; Roberts, C; Robinson, A; Rogers, A; Sculpher, M; Thompson, D

2003-01-01

To determine if a whole systems approach to self-management improves clinical outcomes and leads to cost-effective use of NHS services. Nineteen hospitals were randomised to 10 control sites and nine intervention sites. Consultants from intervention sites received training in patient-centred care before recruitment and introduced the intervention to eligible patients. Patients at the control sites were recruited and went on to have an ordinary consultation. Qualitative interviews were undertaken to obtain an in-depth understanding of patients' and consultants' experience of the intervention. Follow-up outpatient clinics at 19 hospitals in the north-west of England. Seven hundred patients (297 at intervention sites and 403 at control sites) with established ulcerative colitis or Crohn's disease, aged 16 years and over, and able to write in English. Consultants were trained to provide a patient-centred approach to care. Guidebooks on ulcerative colitis and Crohn's disease were developed with patients prior to the study. Patients prepared a written self-management plan and self-referred to services based on a self-evaluation of their need for advice. Rates of hospital outpatient consultation, quality of life (QoL) and acceptability to patients. Health service resource use and assessed cost effectiveness using the EQ-5D. After 1 year, the intervention resulted in fewer hospital visits, without change in the number of primary care visits. Patients felt more able to cope with their condition. The intervention produced no reduction in QoL and did not raise anxiety. The intervention group reported fewer symptom relapses; 74% of patients in the intervention group indicated a preference to continue the system. Qualitative results showed the guidebook was effective but organisational limitations constrained patient-centred aspects of the intervention for some. Cost-effectiveness analyses favoured self-management over standard care. Further use of this method in chronic disease management seems likely to improve overall patient satisfaction and reduce health expenditure without evidence of adverse effect on disease control. Further attention needs to be given to self-referral and access arrangements and a re-distribution of control to patients through increased adherence to patient-centred norms on the part of consultants. Future research is recommended to evaluate the operating systems within secondary and primary care that would allow self-managers to self-refer and to keep them informed of new treatments, also to explore models for training health professionals in self-care methods, to study long-term effects of self-management in chronic disease and to transfer this approach to other chronic conditions.

The Effects of a Multi-Component Intervention on Preschool Children's Literacy Skills

ERIC Educational Resources Information Center

Dennis, Lindsay R.

2016-01-01

This study examined the effects of a multi-component intervention program (i.e., extended instruction and iPad app technology) on preschool children's vocabulary. Instruction utilizing the intervention program was provided across 6 storybooks, 4 verbs per book, for a total of 24 verbs. Dependent variables included expressive vocabulary,…

[Prevention of Obesity and Promotion of Healthy Nutrition in Children by a Kindergarten-Based Intervention: An Evaluation Study].

PubMed

Jahn, I; Böttcher, S

2015-09-01

This outcome evaluation study has investigated different diet concepts in day-care centres and their effects on health-related dietary behaviour of children and their families. No advantage of a certain approach to manage food and diet-related activities in day-care centres could be shown. © Georg Thieme Verlag KG Stuttgart · New York.

Local epidemiology and resistance profiles in acute uncomplicated cystitis (AUC) in women: a prospective cohort study in an urban urological ambulatory setting.

PubMed

Seitz, Michael; Stief, Christian; Waidelich, Raphaela

2017-10-16

Acute uncomplicated cystitis (AUC) is a common ailment in the urological setting. Guidelines for urinary tract infections are based on large-scale multi-centre, epidemiological and international studies. The objective of this observational study was to establish whether the results of a multi-centre study on the resistance profile of Escherichia coli (E. coli) in patients with AUC could be directly applied to an urological practice in a major European city or whether there are divergences in the resistance profile. An observational study was applied prospectively to 502 patients with AUC between January 2015 and January 2017). Personal data were anonymised. Exclusion criteria were the patient's age (<18) and treatment with an antibiotic in the week preceding examination. The average age was 32 (range 18-56). The most commonly detected bacteria was E. coli with 86%, followed by Enterococcus faecalis with 10% and Klebsiella pneumoniae with 4%. Resistance tests showed E. coli to be highly sensitive to fosfomycin (99.2%), nitrofurantoin (98.1%) and cefpodoxime (92.9%). E. coli exhibited resistance to ciprofloxacin (CIP) in 15.1%, to trimethoprim/sulfamethoxazole (TRS) in 25.2% and to amoxicillin/clavulanic acid (AMC) in 34% of cases. The comparison between data from this study and data from a multi-centre European (ECO-SENSI, ECO-SENSII and the 2014 update) showed relatively good sensitivity rates for fosfomycin and nitrofurantoin but significant differences in respect of resistance levels to TRS, CIP and AMC. AUC should therefore only be treated with TRS, CIP and AMC after a susceptibility test has been carried out.

Protocol for the "four steps to control your fatigue (4-STEPS)" randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue

PubMed Central

2012-01-01

Background Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent, severe and debilitating medically unexplained fatigue, leading to impaired functioning and lower quality of life. Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients. Based on the self-regulation (SR) theory of behaviour change, we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills, the "4-STEPS to control your fatigue" program. Methods/Design This is a multi-centre, randomised controlled trial (RCT) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association. Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue (ICF) and Chronic Fatigue Syndrome (CFS) will be recruited and randomly allocated to standard care (SC) or standard care plus a self-regulation based physical activity program (4-STEPS). Patients will be assessed at baseline, after the intervention (3 months) and at 12 months follow-up. The primary outcome is fatigue severity. Discussion The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue. If the program proves to be effective, it may be considered as an adjunctive treatment for these patients. Trial Registration ISRCTN: ISRCTN70763996 PMID:22429404

Analysis of friction and instability by the centre manifold theory for a non-linear sprag-slip model

NASA Astrophysics Data System (ADS)

Sinou, J.-J.; Thouverez, F.; Jezequel, L.

2003-08-01

This paper presents the research devoted to the study of instability phenomena in non-linear model with a constant brake friction coefficient. Indeed, the impact of unstable oscillations can be catastrophic. It can cause vehicle control problems and component degradation. Accordingly, complex stability analysis is required. This paper outlines stability analysis and centre manifold approach for studying instability problems. To put it more precisely, one considers brake vibrations and more specifically heavy trucks judder where the dynamic characteristics of the whole front axle assembly is concerned, even if the source of judder is located in the brake system. The modelling introduces the sprag-slip mechanism based on dynamic coupling due to buttressing. The non-linearity is expressed as a polynomial with quadratic and cubic terms. This model does not require the use of brake negative coefficient, in order to predict the instability phenomena. Finally, the centre manifold approach is used to obtain equations for the limit cycle amplitudes. The centre manifold theory allows the reduction of the number of equations of the original system in order to obtain a simplified system, without loosing the dynamics of the original system as well as the contributions of non-linear terms. The goal is the study of the stability analysis and the validation of the centre manifold approach for a complex non-linear model by comparing results obtained by solving the full system and by using the centre manifold approach. The brake friction coefficient is used as an unfolding parameter of the fundamental Hopf bifurcation point.

Costs Associated with Implementation of Computer-Assisted Clinical Decision Support System for Antenatal and Delivery Care: Case Study of Kassena-Nankana District of Northern Ghana

PubMed Central

Dalaba, Maxwell Ayindenaba; Akweongo, Patricia; Williams, John; Saronga, Happiness Pius; Tonchev, Pencho; Sauerborn, Rainer; Mensah, Nathan; Blank, Antje; Kaltschmidt, Jens; Loukanova, Svetla

2014-01-01

Objective This study analyzed cost of implementing computer-assisted Clinical Decision Support System (CDSS) in selected health care centres in Ghana. Methods A descriptive cross sectional study was conducted in the Kassena-Nankana district (KND). CDSS was deployed in selected health centres in KND as an intervention to manage patients attending antenatal clinics and the labour ward. The CDSS users were mainly nurses who were trained. Activities and associated costs involved in the implementation of CDSS (pre-intervention and intervention) were collected for the period between 2009–2013 from the provider perspective. The ingredients approach was used for the cost analysis. Costs were grouped into personnel, trainings, overheads (recurrent costs) and equipment costs (capital cost). We calculated cost without annualizing capital cost to represent financial cost and cost with annualizing capital costs to represent economic cost. Results Twenty-two trained CDSS users (at least 2 users per health centre) participated in the study. Between April 2012 and March 2013, users managed 5,595 antenatal clients and 872 labour clients using the CDSS. We observed a decrease in the proportion of complications during delivery (pre-intervention 10.74% versus post-intervention 9.64%) and a reduction in the number of maternal deaths (pre-intervention 4 deaths versus post-intervention 1 death). The overall financial cost of CDSS implementation was US$23,316, approximately US$1,060 per CDSS user trained. Of the total cost of implementation, 48% (US$11,272) was pre-intervention cost and intervention cost was 52% (US$12,044). Equipment costs accounted for the largest proportion of financial cost: 34% (US$7,917). When economic cost was considered, total cost of implementation was US$17,128–lower than the financial cost by 26.5%. Conclusions The study provides useful information in the implementation of CDSS at health facilities to enhance health workers' adherence to practice guidelines and taking accurate decisions to improve maternal health care. PMID:25180831

The challenges of quantitative evaluation of a multi-setting, multi-strategy community-based childhood obesity prevention programme: lessons learnt from the eat well be active Community Programs in South Australia.

PubMed

Wilson, Annabelle M; Magarey, Anthea M; Dollman, James; Jones, Michelle; Mastersson, Nadia

2010-08-01

To describe the rationale, development and implementation of the quantitative component of evaluation of a multi-setting, multi-strategy, community-based childhood obesity prevention project (the eat well be active (ewba) Community Programs) and the challenges associated with this process and some potential solutions. ewba has a quasi-experimental design with intervention and comparison communities. Baseline data were collected in 2006 and post-intervention measures will be taken from a non-matched cohort in 2009. Schoolchildren aged 10-12 years were chosen as one litmus group for evaluation purposes. Thirty-nine primary schools in two metropolitan and two rural communities in South Australia. A total of 1732 10-12-year-old school students completed a nutrition and/or a physical activity questionnaire and 1637 had anthropometric measures taken; 983 parents, 286 teachers, thirty-six principals, twenty-six canteen and thirteen out-of-school-hours care (OSHC) workers completed Program-specific questionnaires developed for each of these target groups. The overall child response rate for the study was 49 %. Sixty-five per cent, 43 %, 90 %, 90 % and 68 % of parent, teachers, principals, canteen and OSHC workers respectively, completed and returned questionnaires. A number of practical, logistical and methodological challenges were experienced when undertaking this data collection. Learnings from the process of quantitative baseline data collection for the ewba Community Programs can provide insights for other researchers planning similar studies with similar methods, particularly those evaluating multi-strategy programmes across multiple settings.

Combining a leadership course and multi-source feedback has no effect on leadership skills of leaders in postgraduate medical education. An intervention study with a control group

PubMed Central

2009-01-01

Background Leadership courses and multi-source feedback are widely used developmental tools for leaders in health care. On this background we aimed to study the additional effect of a leadership course following a multi-source feedback procedure compared to multi-source feedback alone especially regarding development of leadership skills over time. Methods Study participants were consultants responsible for postgraduate medical education at clinical departments. Study design: pre-post measures with an intervention and control group. The intervention was participation in a seven-day leadership course. Scores of multi-source feedback from the consultants responsible for education and respondents (heads of department, consultants and doctors in specialist training) were collected before and one year after the intervention and analysed using Mann-Whitney's U-test and Multivariate analysis of variances. Results There were no differences in multi-source feedback scores at one year follow up compared to baseline measurements, either in the intervention or in the control group (p = 0.149). Conclusion The study indicates that a leadership course following a MSF procedure compared to MSF alone does not improve leadership skills of consultants responsible for education in clinical departments. Developing leadership skills takes time and the time frame of one year might have been too short to show improvement in leadership skills of consultants responsible for education. Further studies are needed to investigate if other combination of initiatives to develop leadership might have more impact in the clinical setting. PMID:20003311

The impact of human immunodeficiency virus (HIV) service scale-up on mechanisms of accountability in Zambian primary health centres: a case-based health systems analysis.

PubMed

Topp, Stephanie M; Black, Jim; Morrow, Martha; Chipukuma, Julien M; Van Damme, Wim

2015-02-18

Questions about the impact of large donor-funded HIV interventions on low- and middle-income countries' health systems have been the subject of a number of expert commentaries, but comparatively few empirical research studies. Aimed at addressing a particular evidence gap vis-à-vis the influence of HIV service scale-up on micro-level health systems, this article examines the impact of HIV scale-up on mechanisms of accountability in Zambian primary health facilities. Guided by the Mechanisms of Effect framework and Brinkerhoff's work on accountability, we conducted an in-depth multi-case study to examine how HIV services influenced mechanisms of administrative and social accountability in four Zambian primary health centres. Sites were selected for established (over 3 yrs) antiretroviral therapy (ART) services and urban, peri-urban and rural characteristics. Case data included provider interviews (60); patient interviews (180); direct observation of facility operations (2 wks/centre) and key informant interviews (14). Resource-intensive investment in HIV services contributed to some early gains in administrative answerability within the four ART departments, helping to establish the material capabilities necessary to deliver and monitor service delivery. Simultaneous investment in external supervision and professional development helped to promote transparency around individual and team performance and also strengthened positive work norms in the ART departments. In the wider health centres, however, mechanisms of administrative accountability remained weak, hindered by poor data collection and under capacitated leadership. Substantive gains in social accountability were also elusive as HIV scale-up did little to address deeply rooted information and power asymmetries in the wider facilities. Short terms gains in primary-level service accountability may arise from investment in health system hardware. However, sustained improvements in service quality and responsiveness arising from genuine improvements in social and administrative accountability require greater understanding of, and investment in changing, the power relations, work norms, leadership and disciplinary mechanisms that shape these micro-level health systems.