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.

Students Learning from Patients: Let's Get Real in Medical Education

ERIC Educational Resources Information Center

Bleakley, Alan; Bligh, John

2008-01-01

Medical students must be prepared for working in inter-professional and multi-disciplinary clinical teams centred on a patient's care pathway. While there has been a good deal of rhetoric surrounding patient-centred medical education, there has been little attempt to conceptualise such a practice beyond the level of describing education of…

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.

A patient-centred team-coaching concept for medical rehabilitation.

PubMed

Körner, M; Becker, S; Dinius, J; Müller, C; Zimmermann, L; Rundel, M

2018-01-01

Team coaching enhances teamwork and subsequently improves patient-centredness in medical rehabilitation clinics. Even though interprofessional teamwork is regarded as a crucial factor in medical rehabilitation, to date no evaluated team-coaching approaches are available for improving interprofessional teamwork in medical rehabilitation in Germany. Based on a systematic literature search and interviews with staff, managers, and patients of rehabilitation clinics, we developed a team-coaching approach that is standardized in its process but based on the individual needs and requests of each clinic. It takes a systemic perspective and is goal-oriented and solution-focused. The approach mainly serves to provide impulses to make use of resources within the team and to support a self-directed organisational learning process. It is manualized and can, therefore, be used by professionals aiming to improve interprofessional teamwork in their clinic. A multi-centre, cluster-randomized controlled study that was conducted to evaluate the team-coaching approach showed positive results. Team organization, knowledge integration, and responsibility can be improved, and, therefore, the implementation of the patient-centred team-coaching approach in interprofessional rehabilitation teams can be recommended.

Making a Difference. Visual Health Needs of People with a Learning Disability

ERIC Educational Resources Information Center

McGlade, Anne; Bickerstaff, David; Lindsay, Jennifer; McConkey, Roy; Jackson, Jonathan

2010-01-01

This article discusses the findings from a study to assess the impact of corrective eye treatment in adults with a learning disability. The Special Visual Assessment Clinic (SVAC) is an optometry led multi professional service delivered in a Resource Centre in Belfast, Northern Ireland. The study, which included user and carer input in its design,…

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).

The clinical utility of PGD with HLA matching: a collaborative multi-centre ESHRE study.

PubMed

Kakourou, G; Kahraman, S; Ekmekci, G C; Tac, H A; Kourlaba, G; Kourkouni, E; Sanz, A Cervero; Martin, J; Malmgren, H; Giménez, C; Gold, V; Carvalho, F; Billi, C; Chow, J F C; Vendrell, X; Kokkali, G; Liss, J; Steffann, J; Traeger-Synodinos, J

2018-02-08

Has PGD-HLA been successful relative to diagnostic and clinical efficacy? The diagnostic efficacy of PGD-HLA protocols was found lower in this study in comparison to published PGD-HLA protocols and to that reported for general PGD by ESHRE (78.5 vs 94.1% and vs 92.6%, respectively), while the clinical efficacy has proven very difficult to assess due to inadequate follow-up of both the ART/PGD and HSCT procedure outcomes. The first clinical cases for PGD-HLA were reported in 2001. It is now a well-established procedure, with an increasing number of cycles performed every year. However, PGD-HLA is still offered by relatively few PGD centres, the currently available data is fragmented and most reports on PGD-HLA applications are limited in number and scope. Published systematic details on methodology, diagnostic results, overall ART success and haematopoietic stem cell transplantation (HSCT) outcomes are limited, precluding an evaluation of the true clinical utility of PGD-HLA cycles. This retrospective multi-centre cohort study aimed to investigate the diagnostic and clinical efficacy of the PGD-HLA procedure and the aspects of PGD-HLA cycles influencing positive outcomes: birth of genetically suitable donor-baby (or babies) and HSCT. In April 2014, 32 PGD centres (Consortium members and non-members) with published/known PGD-HLA activity were invited to participate. Between February and September 2015, 14 centres submitted their data, through a custom-designed secure database, with unique login access for each centre. Data parameters covered all aspects of PGD-HLA cycles (ART, embryology and genetic diagnosis), donor-babies born and HSCT. From 716 cycles submitted by 14 centres (performed between August 2001 and September 2015), the quality evaluation excluded 12 cycles, leaving 704, from 364 couples. The online database, based on REDCap, a free, secure, web-based data-capture application, was customized by Centre for Clinical Epidemiology and Outcomes Research (CLEO), Athens. Continuous variables are presented using mean, standard deviation, median and interquartile range, and categorical variables are presented as absolute and relative frequencies. The data included 704 HLA-PGD cycles. Mean maternal age was 33.5 years. Most couples (81.3%) requested HLA-typing with concurrent exclusion of a single monogenic disease (58.6% for beta-thalassaemia). In 92.5% couples, both partners were fertile, with an average 1.93 HLA-PGD cycles/couple. Overall, 9751 oocytes were retrieved (13.9/cycle) and 5532 embryos were analysed (7.9/cycle). Most cycles involved fresh oocytes (94.9%) and Day 3 embryo biopsy (85.3%). In 97.5% of cycles, the genotyping method involved PCR only. Of 4343 embryos diagnosed (78.5% of analysed embryos), 677 were genetically suitable (15.4% of those analysed for HLA alone, 11.6% of those analysed for HLA with exclusion of monogenic disease). Of the 364 couples, 56.6% achieved an embryo transfer (ET) and 598 embryos were transferred in 382 cycles, leading to 164 HCG-positive pregnancies (pregnancy rate/ET 41.3%, pregnancy rate/initiated cycle 23.3%) and 136 babies born (live birth rate/ET 34.3%, live birth rate/initiated cycle 19.3%) to 113 couples. Data analysis identified the following limitations to the overall success of the HLA-PGD procedure: the age of the mother undergoing the treatment cycle, the number of oocytes collected per cycle and genetic chance. HSCT was reported for 57 cases, of which 64.9% involved combined umbilical cord-blood and bone marrow transplantation from the HLA-identical sibling donor; 77.3% of transplants reported no complications. The findings of the study may be limited as not all PGD centres with PGD-HLA experience participated. Reporting bias on completion of the online database may be another potential limitation. Furthermore, the study is based on retrospective data collection from centres with variable practices and strategies for ART, embryology and genetic diagnosis. This is the first multi-centre study evaluating the clinical utility of PGD-HLA, indicating variations in practice and outcomes throughout 15 years and between centres. The study highlights parameters important for positive outcomes and provides important information for both scientists and couples interested in initiating a cycle. Above all, the study underlines the need for better collaboration between all specialists involved in the ART-PGD/HLA procedure, as well as the need for comprehensive and prospective long-term data collection, and encourages all specialists to aim to properly evaluate and follow-up all procedures, with the ultimate aim to promote best practice and encourage patient informed decision making. The study wishes to acknowledge ESHRE for funding the customization of the REDCap database. There are no competing interests. N/A. © The Author(s) 2018. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

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.

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

A person-centred and thriving-promoting intervention in nursing homes - study protocol for the U-Age nursing home multi-centre, non-equivalent controlled group before-after trial.

PubMed

Edvardsson, David; Sjögren, Karin; Lood, Qarin; Bergland, Ådel; Kirkevold, Marit; Sandman, Per-Olof

2017-01-17

The literature suggests that person-centred care can contribute to quality of life and wellbeing of nursing home residents, relatives and staff. However, there is sparse research evidence on how person-centred care can be operationalised and implemented in practice, and the extent to which it may promote wellbeing and satisfaction. Therefore, the U-Age nursing home study was initiated to deepen the understanding of how to integrate person-centred care into daily practice and to explore the effects and meanings of this. The study aims to evaluate effects and meanings of a person-centred and thriving-promoting intervention in nursing homes through a multi-centre, non-equivalent controlled group before-after trial design. Three nursing homes across three international sites have been allocated to a person-centred and thriving-promoting intervention group, and three nursing homes have been allocated to an inert control group. Staff at intervention sites will participate in a 12-month interactive educational programme that operationalises thriving-promoting and person-centred care three dimensions: 1) Doing a little extra, 2) Developing a caring environment, and 3) Assessing and meeting highly prioritised psychosocial needs. A pedagogical framework will guide the intervention. The primary study endpoints are; residents' thriving, relatives' satisfaction with care and staff job satisfaction. Secondary endpoints are; resident, relative and staff experiences of the caring environment, relatives' experience of visiting their relative and the nursing home, as well as staff stress of conscience and perceived person-centredness of care. Data on study endpoints will be collected pre-intervention, post-intervention, and at a six-month follow up. Interviews will be conducted with relatives and staff to explore experiences and meanings of the intervention. The study is expected to provide evidence that can inform further research, policy and practice development on if and how person-centred care may improve wellbeing, thriving and satisfaction for people who reside in, visit or work in nursing homes. The combination of quantitative and qualitative data will illuminate the operationalisation, effects and meaning of person-centred and thriving-promoting care. The trial was registered at ClinicalTrials.gov March 19, 2016, identifier NCT02714452 .

The ICCAM platform study: An experimental medicine platform for evaluating new drugs for relapse prevention in addiction. Part B: fMRI description

PubMed Central

McGonigle, John; Murphy, Anna; Paterson, Louise M; Reed, Laurence J; Nestor, Liam; Nash, Jonathan; Elliott, Rebecca; Ersche, Karen D; Flechais, Remy SA; Newbould, Rexford; Orban, Csaba; Smith, Dana G; Taylor, Eleanor M; Waldman, Adam D; Robbins, Trevor W; Deakin, JF William; Nutt, David J; Lingford-Hughes, Anne R; Suckling, John

2016-01-01

Objectives: We aimed to set up a robust multi-centre clinical fMRI and neuropsychological platform to investigate the neuropharmacology of brain processes relevant to addiction – reward, impulsivity and emotional reactivity. Here we provide an overview of the fMRI battery, carried out across three centres, characterizing neuronal response to the tasks, along with exploring inter-centre differences in healthy participants. Experimental design: Three fMRI tasks were used: monetary incentive delay to probe reward sensitivity, go/no-go to probe impulsivity and an evocative images task to probe emotional reactivity. A coordinate-based activation likelihood estimation (ALE) meta-analysis was carried out for the reward and impulsivity tasks to help establish region of interest (ROI) placement. A group of healthy participants was recruited from across three centres (total n=43) to investigate inter-centre differences. Principle observations: The pattern of response observed for each of the three tasks was consistent with previous studies using similar paradigms. At the whole brain level, significant differences were not observed between centres for any task. Conclusions: In developing this platform we successfully integrated neuroimaging data from three centres, adapted validated tasks and applied whole brain and ROI approaches to explore and demonstrate their consistency across centres. PMID:27703042

The ICCAM platform study: An experimental medicine platform for evaluating new drugs for relapse prevention in addiction. Part B: fMRI description.

PubMed

McGonigle, John; Murphy, Anna; Paterson, Louise M; Reed, Laurence J; Nestor, Liam; Nash, Jonathan; Elliott, Rebecca; Ersche, Karen D; Flechais, Remy Sa; Newbould, Rexford; Orban, Csaba; Smith, Dana G; Taylor, Eleanor M; Waldman, Adam D; Robbins, Trevor W; Deakin, Jf William; Nutt, David J; Lingford-Hughes, Anne R; Suckling, John

2017-01-01

We aimed to set up a robust multi-centre clinical fMRI and neuropsychological platform to investigate the neuropharmacology of brain processes relevant to addiction - reward, impulsivity and emotional reactivity. Here we provide an overview of the fMRI battery, carried out across three centres, characterizing neuronal response to the tasks, along with exploring inter-centre differences in healthy participants. Three fMRI tasks were used: monetary incentive delay to probe reward sensitivity, go/no-go to probe impulsivity and an evocative images task to probe emotional reactivity. A coordinate-based activation likelihood estimation (ALE) meta-analysis was carried out for the reward and impulsivity tasks to help establish region of interest (ROI) placement. A group of healthy participants was recruited from across three centres (total n=43) to investigate inter-centre differences. Principle observations: The pattern of response observed for each of the three tasks was consistent with previous studies using similar paradigms. At the whole brain level, significant differences were not observed between centres for any task. In developing this platform we successfully integrated neuroimaging data from three centres, adapted validated tasks and applied whole brain and ROI approaches to explore and demonstrate their consistency across centres.

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.

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

PubMed Central

2013-01-01

Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder. PMID:23289935

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.

CADASIL: Treatment and Management Options.

PubMed

Bersano, Anna; Bedini, Gloria; Oskam, Joshua; Mariotti, Caterina; Taroni, Franco; Baratta, Silvia; Parati, Eugenio Agostino

2017-09-01

CADASIL is a life-threatening and disabling disease. Despite the progress achieved so far, no therapies able to limit the disease progression have been found and only empiric treatments can be employed to relieve the main disease symptoms. Further in vivo studies as well as data aggregation and multi-centre controlled clinical trials are needed to confirm the emerging findings in order to identify evidence-based therapies for CADASIL.

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

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.

Undergraduate nursing students' performance in recognising and responding to sudden patient deterioration in high psychological fidelity simulated environments: an Australian multi-centre study.

PubMed

Bogossian, Fiona; Cooper, Simon; Cant, Robyn; Beauchamp, Alison; Porter, Joanne; Kain, Victoria; Bucknall, Tracey; Phillips, Nicole M

2014-05-01

Early recognition and situation awareness of sudden patient deterioration, a timely appropriate clinical response, and teamwork are critical to patient outcomes. High fidelity simulated environments provide the opportunity for undergraduate nursing students to develop and refine recognition and response skills. This paper reports the quantitative findings of the first phase of a larger program of ongoing research: Feedback Incorporating Review and Simulation Techniques to Act on Clinical Trends (FIRST2ACTTM). It specifically aims to identify the characteristics that may predict primary outcome measures of clinical performance, teamwork and situation awareness in the management of deteriorating patients. Mixed-method multi-centre study. High fidelity simulated acute clinical environment in three Australian universities. A convenience sample of 97 final year nursing students enrolled in an undergraduate Bachelor of Nursing or combined Bachelor of Nursing degree were included in the study. In groups of three, participants proceeded through three phases: (i) pre-briefing and completion of a multi-choice question test, (ii) three video-recorded simulated clinical scenarios where actors substituted real patients with deteriorating conditions, and (iii) post-scenario debriefing. Clinical performance, teamwork and situation awareness were evaluated, using a validated standard checklist (OSCE), Team Emergency Assessment Measure (TEAM) score sheet and Situation Awareness Global Assessment Technique (SAGAT). A Modified Angoff technique was used to establish cut points for clinical performance. Student teams engaged in 97 simulation experiences across the three scenarios and achieved a level of clinical performance consistent with the experts' identified pass level point in only 9 (1%) of the simulation experiences. Knowledge was significantly associated with overall teamwork (p=.034), overall situation awareness (p=.05) and clinical performance in two of the three scenarios (p=.032 cardiac and p=.006 shock). Situation awareness scores of scenario team leaders were low overall, with an average total score of 41%. Final year undergraduate nursing students may have difficulty recognising and responding appropriately to patient deterioration. Improving pre-requisite knowledge, rehearsal of first response and team management strategies need to be a key component of undergraduate nursing students' education and ought to specifically address clinical performance, teamwork and situation awareness. © 2013 Elsevier Ltd. All rights reserved.

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

PubMed

Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

2017-04-21

Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

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

The relationship between effectiveness and costs measured by a risk-adjusted case-mix system: multicentre study of Catalonian population data bases.

PubMed

Sicras-Mainar, Antoni; Navarro-Artieda, Ruth; Blanca-Tamayo, Milagrosa; Velasco-Velasco, Soledad; Escribano-Herranz, Esperanza; Llopart-López, Josep Ramon; Violan-Fors, Concepción; Vilaseca-Llobet, Josep Maria; Sánchez-Fontcuberta, Encarna; Benavent-Areu, Jaume; Flor-Serra, Ferran; Aguado-Jodar, Alba; Rodríguez-López, Daniel; Prados-Torres, Alejandra; Estelrich-Bennasar, Jose

2009-06-25

The main objective of this study is to measure the relationship between morbidity, direct health care costs and the degree of clinical effectiveness (resolution) of health centres and health professionals by the retrospective application of Adjusted Clinical Groups in a Spanish population setting. The secondary objectives are to determine the factors determining inadequate correlations and the opinion of health professionals on these instruments. We will carry out a multi-centre, retrospective study using patient records from 15 primary health care centres and population data bases. The main measurements will be: general variables (age and sex, centre, service [family medicine, paediatrics], and medical unit), dependent variables (mean number of visits, episodes and direct costs), co-morbidity (Johns Hopkins University Adjusted Clinical Groups Case-Mix System) and effectiveness.The totality of centres/patients will be considered as the standard for comparison. The efficiency index for visits, tests (laboratory, radiology, others), referrals, pharmaceutical prescriptions and total will be calculated as the ratio: observed variables/variables expected by indirect standardization.The model of cost/patient/year will differentiate fixed/semi-fixed (visits) costs of the variables for each patient attended/year (N = 350,000 inhabitants). The mean relative weights of the cost of care will be obtained. The effectiveness will be measured using a set of 50 indicators of process, efficiency and/or health results, and an adjusted synthetic index will be constructed (method: percentile 50).The correlation between the efficiency (relative-weights) and synthetic (by centre and physician) indices will be established using the coefficient of determination. The opinion/degree of acceptance of physicians (N = 1,000) will be measured using a structured questionnaire including various dimensions. multiple regression analysis (procedure: enter), ANCOVA (method: Bonferroni's adjustment) and multilevel analysis will be carried out to correct models. The level of statistical significance will be p < 0.05.

A national appraisal of haemodialysis vascular access provision in Scotland.

PubMed

Oliver, Scott W; Campbell, Jacqueline; Kingsmore, David B; Kasthuri, Ram; Metcalfe, Wendy; Traynor, Jamie P; Fischbacher-Smith, Denis; Jardine, Alan G; Thomson, Peter C

2017-03-21

Published registry data demonstrate longstanding variation in the utilisation of different vascular access (VA) modalities between Scottish renal units; this may reflect different clinical processes between centres. A comprehensive appraisal was undertaken to understand the processes underpinning VA creation and maintenance across Scotland. A mixed methods approach was utilised. Fifty-two semi-structured interviews were conducted with patients and clinicians in all ten, adult and paediatric, Scottish renal units. Interview transcripts were subjected to thematic analysis. Clinical activity data were prospectively collected for six weeks, and correlated with registry data. VA accounts for a large clinical workload. There was significant inter-centre variation in the utilisation of different VA modalities, and patients described frustrating, dissatisfying experiences. VA creation and maintenance pathways functioned best when nephrologists, surgeons and radiologists were co-located on the same campus with close multi-disciplinary working, protected clinical time, and proactive VA maintenance. No unit routinely measured or discussed procedure outcomes or strategic aspects of their service. Varied clinical outcomes reflected varied clinical processes. Optimised clinical pathways, staff education and measurement of clinical outcomes may improve VA service quality and facilitate safer, more effective, patient-centred care.

Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation

PubMed Central

Cooney, Rachel M; Warren, Bryan F; Altman, Douglas G; Abreu, Maria T; Travis, Simon PL

2007-01-01

Clinical trials on novel drug therapies require clear criteria for patient selection and agreed definitions of disease remission. This principle has been successfully applied in the field of rheumatology where agreed disease scoring systems have allowed multi-centre collaborations and facilitated audit across treatment centres. Unfortunately in ulcerative colitis this consensus is lacking. Thirteen scoring systems have been developed but none have been properly validated. Most trials choose different endpoints and activity indices, making comparison of results from different trials extremely difficult. International consensus on endoscopic, clinical and histological scoring systems is essential as these are the key components used to determine entry criteria and outcome measurements in clinical trials on ulcerative colitis. With multiple new therapies under development, there is a pressing need for consensus to be reached. PMID:17592647

Drug resistant Skeletal Tuberculosis in a tertiary care centre in South India.

PubMed

Arockiaraj, J; Balaji, G S; Cherian, V M; T S, Jepegnanam; Thomas, B P; Michael, Joy S; Poonnoose, P M

2018-03-01

Drug resistant tuberculosis is alarmingly on the rise especially in developing countries. Skeletal tuberculosis accounts up to 10% of all extra pulmonary tuberculosis. World Health Organisation (WHO) has not formulated guidelines for the management of Multi-drug resistant skeletal tuberculosis. A retrospective analysis of patients treated for musculoskeletal tuberculosis was done, to study drug resistance patterns. The outcome was assessed both clinically and radiologically.898 patients were treated for skeletal tuberculosis during the period of 2006-2013 (96 months). 478 (53.2%) patients were treated for tubercular spondylitis and 420 (46.8%) for extra-spinal skeletal tuberculosis. Ninety two patients (10.2%) had documented resistance to the anti-tubercular drugs. There were 42 mono resistant tuberculosis cases (4.7%), 13 poly resistant cases (1.4%), 33 multi-drug resistant cases (MDR TB) (3.7%) and 4 (0.4%) extremely drug resistant tuberculosis cases (XDR). All the patients were treated medically as per drug susceptibility patterns and protocols. Surgery was performed when indicated in 59 (66%) cases. 85% completed their course of treatment and were successfully healed as per pre-set clinical, biochemical and radiological criteria. The remaining were lost to follow up. One patient died as a result of post op respiratory infection. The prevalence of Multi-drug resistant tuberculosis patients in our centre was 3.7% and that of Extremely drug resistant tuberculosis cases was 0.4%. A Multi-disciplinary approach with drug susceptibility tests, sensitive drugs, and surgery if required is essential. Health education is essential to improve awareness among health care professionals about the danger of drug resistance in tuberculosis.

[Transversal study of breast cancer treatment in Spain].

PubMed

2008-01-01

The study's objectives were to observe and describe chemotherapy treatment (CT) used in breast cancer (BC) patients in Spain and estimate its cost. Multi-centre and transversal study, which included consecutive BC patients treated with chemotherapy between 10 and 15 May 2004 in 110 centres throughout Spain. Information was gathered on the general characteristics of the centres, the patient data and the treatments administered. This information was collected prospectively based on the data available in the pharmacy service and/or the patient's clinical history. The following information was requested: demographic, clinical, CT administered during the week of the study, established guidelines, inclusion in clinical trials and the direct costs of the medication. A total of 2,134 patients were included (99.7% women) from 16 autonomous communities and the average age was 51.5. The majority of the treatments were administered in general hospitals (89.7%), public or public health partnership hospitals (91.5%) and level 3 specialist hospitals (64.5%). Among these patients, 120 (5.6%) received treatment as part of a clinical study. A total of 51% of patients received adjuvant or neoadjuvant treatment, mainly for stage IIA disease (28.7%). A total of 1011 patients presented metastatic disease (MD). The estimated average cost of chemotherapy treatment was euro428.5 per cycle and the group of patients with MD incurred the greatest cost (euro640.4 per cycle). The results show the current situation of CT for BC in Spain and a great deal of variability is observed both in the use of drugs as well as in the associated costs.

The clinical features of angular cheilitis occurring during orthodontic treatment: a multi-centre observational study.

PubMed

Cross, David; Eide, May L; Kotinas, Anastasios

2010-06-01

To report the prevalence and clinical features of angular cheilitis occurring in patients undergoing orthodontic treatment. Cross-sectional, observational study. Three centres were involved; Glasgow Dental Hospital and two specialist orthodontic practices, one in Scotland and one in Greece. Six hundred and sixty consecutive patients undergoing orthodontic treatment were examined over a 9 month period. The presence and absence of angular cheilitis was recorded. A six-point clinical scale was used to describe the clinical features of angular cheilitis when present. Chi-squared tests were used to investigate the association between the presence of angular cheilitis and oral hygiene level/appliance type. Eleven per cent of orthodontic patients in this Western European population, showed signs of angular cheilitis. No correlation was found between the presence of angular cheilitis and gender. Good oral hygiene was associated with a reduced prevalence (P<0.01). Angular cheilitis is a multifactorial condition that can occur in a small percentage of patients during orthodontic treatment. Good oral hygiene may be associated with a reduced risk. A new clinical grade of angular cheilitis is suggested that may help future research. Further studies are required to investigate the microbiological features associated with angular cheilitis occurring in orthodontic patients, as well as associations with medical conditions, such as asthma.

Physiotherapy and occupational therapy interventions for people with benign joint hypermobility syndrome: a systematic review of clinical trials.

PubMed

Smith, Toby O; Bacon, Holly; Jerman, Emma; Easton, Vicky; Armon, Kate; Poland, Fiona; Macgregor, Alex J

2014-01-01

This study assessed the literature to determine the efficacy and effectiveness of physiotherapy and occupational therapy interventions in the treatment of people with benign joint hypermobility syndrome (BJHS). Published literature databases including: AMED, CINAHL, MEDLINE, EMBASE, PubMed and the Cochrane Library, in addition to unpublished databases and trial registries were searched to October 2012. All clinical trials comparing the clinical outcomes of Occupational Therapy and Physiotherapy interventions compared to non-treatment or control intervention for people with BJHS were included. Of the 126 search results, 3 clinical studies satisfied the eligibility criteria. The data provides limited support for the use of wrist/hand splints for school children. While there is some support for exercise-based intervention, there is insufficient research to determine the optimal mode, frequency, dosage or type of exercise which should be delivered. The current evidence-base surrounding Occupational Therapy and Physiotherapy in the management of BJHS is limited in size and quality. There is insufficient research exploring the clinical outcomes of a number of interventions including sensory integration, positioning and posture management and education. Longer term, rigorous multi-centre randomised controlled trials are warranted to begin to assess the clinical and cost-effectiveness of interventions for children and adults with BJHS. Implications for Rehabilitation There is an evidence-base to support clinician's use of proprioceptive-based exercises in adults, and either tailored or generalised physiotherapy regimes for children with BJHS. Clinicians should be cautious when considering the prescription of hand/wrist splints for school age children with BJHS, based on the current research. Until further multi-centre trials are conducted assessing the clinical and cost-effectiveness of interventions for children and adult with BJHS, clinical decision-making should be based on theoretical rather than evidence-based grounds for this population.

Using routine Haemophilia Joint Health Score for international comparisons of haemophilia outcome: standardization is needed.

PubMed

Nijdam, A; Bladen, M; Hubert, N; Pettersson, M; Bartels, B; van der Net, J; Liesner, R; Petrini, P; Kurnik, K; Fischer, K

2016-01-01

Haemophilia Joint Health Score (HJHS) is the most sensitive validated score for physical examination of joint health in haemophilia. HJHS performed at regular intervals can be used for clinical monitoring as well as for comparative outcomes research. To determine whether routinely collected HJHS could be used to compare outcome of three different prophylactic regimens in children with severe haemophilia A (primary) and which parameters caused variability in HJHS (secondary). International retrospective observational multi-centre study comparing routine HJHS in 127 children with severe haemophilia A born from 1995 to 2009, from London, Stockholm and Utrecht centres. Patient and treatment data were collected from the European Paediatric Network for Haemophilia Management registry and patient files. The independent effects of regimens, physiotherapists, age and inhibitor status on HJHS were explored, using multivariable regression analysis. Prophylaxis varied across participating centres, with differences in initial frequency of infusions (1× per week vs. 3× per week), age at reaching infusions ≥3× per week, and dose kg(-1) week(-1) at HJHS assessment. Evaluation at median age of 11 years showed an illogical association of HJHS with treatment regimen: the least intensive regimen had the lowest HJHS. The HJHS increased with age and history of inhibitor, as expected (internal validity). But the comparison of prophylactic regimens was obscured by systematic differences in assessment between physiotherapists, both within and between centres. Inter-physiotherapist discrepancies in routine HJHS hamper comparison of scores between treatment regimens. For multi-centre research, additional inter-observer standardization for HJHS scoring is needed. © 2015 John Wiley & Sons Ltd.

The development of accurate and high quality radiotherapy treatment delivery

NASA Astrophysics Data System (ADS)

Griffiths, Susan E.

Accurate radiotherapy delivery is required for curing cancer. Historical radiotherapy accuracy studies at Leeds (1983-1991) are discussed in context of when radiographers were not involved in practice design. The seminal research was unique in being led by a radiographer practitioner, and in prospectively studying the accuracy of different techniques within one department. The viability of alignment of treatment beams with marks painted on a patient's skin varied daily, and, using film I showed that the alignment of treatment on anatomy varied. I then led 6 sequential studies with collaborating oncologists. Unique outcomes were in identifying the origins of treatment inaccuracies, implementing and evidencing changes in multi-disciplinary practice, thus improving accuracy and reproducibility generally and achieving accuracy for the pelvis to within current norms. Innovations included: discontinuation of painted skin marks and developing whole-body patient positioning using lasers, tattoos, and standardised supports; unification of set-up conditions through planning and treatment; planning normal tissue margins round target tissue to allow for inaccuracies (1985); improved manual shielding methods, changed equipment usage, its quality assurance and design; influenced the development of portal imaging and image analysis. Consequences and current implications. The research, still cited internationally, contributed to clinical management of lymphoma, and critically underpins contemporary practice. It led to my becoming the first radiographer invited into multi-disciplinary collaborative work, to advise in the first multi-centre clinical trials to consider treatment delivery accuracy, contribute to books written from within other disciplines and inform guidelines for good practice so helping to improve practices, with recent publications. I thus led my profession into research activity. Later work included development of a national staffing formula for radiotherapy Centres, and contributing to the evidence-base for improved National radiotherapy resourcing. I recently researched and developed a textbook (second edition) on quality in treatment delivery.

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.

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.

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

A qualitative study of the role of workplace and interpersonal trust in shaping service quality and responsiveness in Zambian primary health centres

PubMed Central

Topp, Stephanie M; Chipukuma, Julien M

2016-01-01

Background: Human decisions, actions and relationships that invoke trust are at the core of functional and productive health systems. Although widely studied in high-income settings, comparatively few studies have explored the influence of trust on health system performance in low- and middle-income countries. This study examines how workplace and inter-personal trust impact service quality and responsiveness in primary health services in Zambia. Methods: This multi-case study included four health centres selected for urban, peri-urban and rural characteristics. Case data included provider interviews (60); patient interviews (180); direct observation of facility operations (two weeks/centre) and key informant interviews (14) that were recorded and transcribed verbatim. Case-based thematic analysis incorporated inductive and deductive coding. Results: Findings demonstrated that providers had weak workplace trust influenced by a combination of poor working conditions, perceptions of low pay and experiences of inequitable or inefficient health centre management. Weak trust in health centre managers’ organizational capacity and fairness contributed to resentment amongst many providers and promoted a culture of blame-shifting and one-upmanship that undermined teamwork and enabled disrespectful treatment of patients. Although patients expressed a high degree of trust in health workers’ clinical capacity, repeated experiences of disrespectful or unresponsive care undermined patients’ trust in health workers’ service values and professionalism. Lack of patient–provider trust prompted some patients to circumvent clinic systems in an attempt to secure better or more timely care. Conclusion: Lack of resourcing and poor leadership were key factors leading to providers’ weak workplace trust and contributed to often-poor quality services, driving a perverse cycle of negative patient–provider relations across the four sites. Findings highlight the importance of investing in both structural factors and organizational management to strengthen providers’ trust in their employer(s) and colleagues, as an entry-point for developing both the capacity and a work culture oriented towards respectful and patient-centred care. PMID:25999586

The organisation of physiotherapy for people with multiple sclerosis across Europe: a multicentre questionnaire survey.

PubMed

Rasova, Kamila; Freeman, Jenny; Martinkova, Patricia; Pavlikova, Marketa; Cattaneo, Davide; Jonsdottir, Johanna; Henze, Thomas; Baert, Ilse; Van Asch, Paul; Santoyo, Carme; Smedal, Tori; Beiske, Antonie Giæver; Stachowiak, Małgorzata; Kovalewski, Mariusz; Nedeljkovic, Una; Bakalidou, Daphne; Guerreiro, José Manuel Alves; Nilsagård, Ylva; Dimitrova, Erieta Nikolikj; Habek, Mario; Armutlu, Kadriye; Donzé, Cécile; Ross, Elaine; Ilie, Ana Maria; Martić, Andrej; Romberg, Anders; Feys, Peter

2016-10-06

Understanding the organisational set-up of physiotherapy services across different countries is increasingly important as clinicians around the world use evidence to improve their practice. This also has to be taken into consideration when multi-centre international clinical trials are conducted. This survey aimed to systematically describe organisational aspects of physiotherapy services for people with multiple sclerosis (MS) across Europe. Representatives from 72 rehabilitation facilities within 23 European countries completed an online web-based questionnaire survey between 2013 and 2014. Countries were categorised according to four European regions (defined by United Nations Statistics). Similarities and differences between regions were examined. Most participating centres specialized in rehabilitation (82 %) and neurology (60 %), with only 38 % specialising in MS. Of these, the Western based Specialist MS centres were predominately based on outpatient services (median MS inpatient ratio 0.14), whilst the Eastern based European services were mostly inpatient in nature (median MS inpatient ratio 0.5). In almost all participating countries, medical doctors - specialists in neurology (60 %) and in rehabilitation (64 %) - were responsible for referral to/prescription of physiotherapy. The most frequent reason for referral to/prescription of physiotherapy was the worsening of symptoms (78 % of centres). Physiotherapists were the most common members of the rehabilitation team; comprising 49 % of the team in Eastern countries compared to approximately 30 % in the rest of Europe. Teamwork was commonly adopted; 86 % of centres based in Western countries utilised the interdisciplinary model, whilst the multidisciplinary model was utilised in Eastern based countries (p = 0.046). This survey is the first to provide data about organisational aspects of physiotherapy for people with MS across Europe. Overall, care in key organisational aspects of service provision is broadly similar across regions, although some variations, for example the models of teamwork utilised, are apparent. Organisational framework specifics should be considered anytime a multi-centre study is conducted and results from such studies are applied.

The predictive validity of selection for entry into postgraduate training in general practice: evidence from three longitudinal studies

PubMed Central

Patterson, Fiona; Lievens, Filip; Kerrin, Máire; Munro, Neil; Irish, Bill

2013-01-01

Background The selection methodology for UK general practice is designed to accommodate several thousand applicants per year and targets six core attributes identified in a multi-method job-analysis study Aim To evaluate the predictive validity of selection methods for entry into postgraduate training, comprising a clinical problem-solving test, a situational judgement test, and a selection centre. Design and setting A three-part longitudinal predictive validity study of selection into training for UK general practice. Method In sample 1, participants were junior doctors applying for training in general practice (n = 6824). In sample 2, participants were GP registrars 1 year into training (n = 196). In sample 3, participants were GP registrars sitting the licensing examination after 3 years, at the end of training (n = 2292). The outcome measures include: assessor ratings of performance in a selection centre comprising job simulation exercises (sample 1); supervisor ratings of trainee job performance 1 year into training (sample 2); and licensing examination results, including an applied knowledge examination and a 12-station clinical skills objective structured clinical examination (OSCE; sample 3). Results Performance ratings at selection predicted subsequent supervisor ratings of job performance 1 year later. Selection results also significantly predicted performance on both the clinical skills OSCE and applied knowledge examination for licensing at the end of training. Conclusion In combination, these longitudinal findings provide good evidence of the predictive validity of the selection methods, and are the first reported for entry into postgraduate training. Results show that the best predictor of work performance and training outcomes is a combination of a clinical problem-solving test, a situational judgement test, and a selection centre. Implications for selection methods for all postgraduate specialties are considered. PMID:24267856

The predictive validity of selection for entry into postgraduate training in general practice: evidence from three longitudinal studies.

PubMed

Patterson, Fiona; Lievens, Filip; Kerrin, Máire; Munro, Neil; Irish, Bill

2013-11-01

The selection methodology for UK general practice is designed to accommodate several thousand applicants per year and targets six core attributes identified in a multi-method job-analysis study To evaluate the predictive validity of selection methods for entry into postgraduate training, comprising a clinical problem-solving test, a situational judgement test, and a selection centre. A three-part longitudinal predictive validity study of selection into training for UK general practice. In sample 1, participants were junior doctors applying for training in general practice (n = 6824). In sample 2, participants were GP registrars 1 year into training (n = 196). In sample 3, participants were GP registrars sitting the licensing examination after 3 years, at the end of training (n = 2292). The outcome measures include: assessor ratings of performance in a selection centre comprising job simulation exercises (sample 1); supervisor ratings of trainee job performance 1 year into training (sample 2); and licensing examination results, including an applied knowledge examination and a 12-station clinical skills objective structured clinical examination (OSCE; sample 3). Performance ratings at selection predicted subsequent supervisor ratings of job performance 1 year later. Selection results also significantly predicted performance on both the clinical skills OSCE and applied knowledge examination for licensing at the end of training. In combination, these longitudinal findings provide good evidence of the predictive validity of the selection methods, and are the first reported for entry into postgraduate training. Results show that the best predictor of work performance and training outcomes is a combination of a clinical problem-solving test, a situational judgement test, and a selection centre. Implications for selection methods for all postgraduate specialties are considered.

The role and potential contribution of clinical research nurses to clinical trials.

PubMed

Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

2008-02-01

This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

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 predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion.

PubMed

Spiegelhalter, D J; Freedman, L S

1986-01-01

The 'textbook' approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi-centre trial of superficial bladder cancer.

The clinical and cost-benefits of investing in neurobehavioural rehabilitation: a multi-centre study.

PubMed

Oddy, Michael; da Silva Ramos, Sara

2013-01-01

The aim of this study was to investigate the cost-benefits of a residential post-acute neurobehavioural rehabilitation programme and its effects on care needs and social participation of adults with acquired brain injury. Retrospective multi-centre design. Data on occupation, adaptability and level of support required were collected at admission, discharge and 6-months follow-up. Cost analysis was performed on cost estimates based on level of support. Significant gains were observed in all areas of functioning, with individuals progressing towards higher levels of independence and more participation in society upon discharge. Cost-benefits of up to £1.13 million were demonstrated for individuals admitted to rehabilitation within a year of sustaining a brain injury and of up to £0.86 million for those admitted more than 1 year after injury. Functional gains and reductions in levels of care required upon discharge were maintained 6 months later. These results demonstrate that post-acute neurobehavioural rehabilitation can have a positive impact on the lives of individuals with brain injury and that the associated costs are off-set by significant savings in the longer-term.

The clinical and cost-benefits of investing in neurobehavioural rehabilitation: A multi-centre study

PubMed Central

Oddy, Michael

2013-01-01

Primary objective The aim of this study was to investigate the cost-benefits of a residential post-acute neurobehavioural rehabilitation programme and its effects on care needs and social participation of adults with acquired brain injury. Research design Retrospective multi-centre design. Methods and procedures Data on occupation, adaptability and level of support required were collected at admission, discharge and 6-months follow-up. Cost analysis was performed on cost estimates based on level of support. Main outcomes and results Significant gains were observed in all areas of functioning, with individuals progressing towards higher levels of independence and more participation in society upon discharge. Conclusions Cost-benefits of up to £1.13 million were demonstrated for individuals admitted to rehabilitation within a year of sustaining a brain injury and of up to £0.86 million for those admitted more than 1 year after injury. Functional gains and reductions in levels of care required upon discharge were maintained 6 months later. These results demonstrate that post-acute neurobehavioural rehabilitation can have a positive impact on the lives of individuals with brain injury and that the associated costs are off-set by significant savings in the longer-term. PMID:24087973

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.

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,…

Summary Protocol for a Multi-Centre Randomised Controlled Trial of Enteral Lactoferrin Supplementation in Newborn Very Preterm Infants (ELFIN).

PubMed

2018-06-11

In a multi-centre randomised controlled trial (RCT), we are assessing whether giving very preterm (i.e., born at < 32 weeks' gestation) infants prophylactic enteral bovine lactoferrin supplementation (150 mg/kg/day) from shortly after birth until 34 weeks' post-menstrual age reduces the incidence of late-onset invasive infection (primary outcome), all-cause mortality, bronchopulmonary dysplasia, necrotising enterocolitis, retinopathy of prematurity, and the duration of antibiotic exposure, intensive care, and hospital admission. The trial is recruiting 2,200 participants from 37 neonatal care centres in the UK over 4 years. We will undertake an economic evaluation within the RCT to evaluate cost-effectiveness and provide an estimate of incremental costs for differences in the pre-specified outcomes in primary and subgroup analyses. If a statistically significant and clinically important effect on the primary outcome is detected, we will seek further funding and approval to assess the impact of enteral lactoferrin supplementation on rates of adverse neuro-developmental outcomes in the participating infants when they are 5 years old. © 2018 S. Karger AG, Basel.

'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.

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

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

PubMed

Foster, J D; Ewings, P; Falk, S; Cooper, E J; Roach, H; West, N P; Williams-Yesson, B A; Hanna, G B; Francis, N K

2016-10-01

The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

Polish forensic medicine A.D. 2016 - report of the National Consultant.

PubMed

Teresiński, Grzegorz

2016-01-01

The aim of the study was to present the current state and basis of functioning of an academic model of forensic expert activities in Poland and perspectives of their further development. The study material included information obtained from a preliminary survey among regional consultants within the ongoing activities of the national consultant team. The recently completed period of research infrastructure support within the policy of coherence of the European Union contributed to significant advances in scientific-educational potential of the majority of university forensic medicine centres. However, the improved educational base and purchases of new diagnostic devices were not associated with a considerable increase in staff resources of individual units, which finally decides about the renown of the entire discipline. It is necessary to undertake initiatives to highlight the importance of forensic medicine as a separate medical field and to increase the number of physicians starting specialist trainings. A highly profiled nature of the speciality necessitates cooperation with other centres and receptiveness to clinical fields. The establishment of various forms of cooperation is a measure of optimal use of equipment and stimulation of multi-centre research.

Inter-observer agreement for Crohn's disease sub-phenotypes using the Montreal Classification: How good are we? A multi-centre Australasian study.

PubMed

Krishnaprasad, Krupa; Andrews, Jane M; Lawrance, Ian C; Florin, Timothy; Gearry, Richard B; Leong, Rupert W L; Mahy, Gillian; Bampton, Peter; Prosser, Ruth; Leach, Peta; Chitti, Laurie; Cock, Charles; Grafton, Rachel; Croft, Anthony R; Cooke, Sharon; Doecke, James D; Radford-Smith, Graham L

2012-04-01

Crohn's disease (CD) exhibits significant clinical heterogeneity. Classification systems attempt to describe this; however, their utility and reliability depends on inter-observer agreement (IOA). We therefore sought to evaluate IOA using the Montreal Classification (MC). De-identified clinical records of 35 CD patients from 6 Australian IBD centres were presented to 13 expert practitioners from 8 Australia and New Zealand Inflammatory Bowel Disease Consortium (ANZIBDC) centres. Practitioners classified the cases using MC and forwarded data for central blinded analysis. IOA on smoking and medications was also tested. Kappa statistics, with pre-specified outcomes of κ>0.8 excellent; 0.61-0.8 good; 0.41-0.6 moderate and ≤0.4 poor, were used. 97% of study cases had colonoscopy reports, however, only 31% had undergone a complete set of diagnostic investigations (colonoscopy, histology, SB imaging). At diagnosis, IOA was excellent for age, κ=0.84; good for disease location, κ=0.73; only moderate for upper GI disease (κ=0.57) and disease behaviour, κ=0.54; and good for the presence of perianal disease, κ=0.6. At last follow-up, IOA was good for location, κ=0.68; only moderate for upper GI disease (κ=0.43) and disease behaviour, κ=0.46; but excellent for the presence/absence of perianal disease, κ=0.88. IOA for immunosuppressant use ever and presence of stricture were both good (κ=0.79 and 0.64 respectively). IOA using MC is generally good; however some areas are less consistent than others. Omissions and inaccuracies reduce the value of clinical data when comparing cohorts across different centres, and may impair the ability to translate genetic discoveries into clinical practice. Crown Copyright © 2011. Published by Elsevier B.V. All rights reserved.

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.

Developing a social media platform for nurses.

PubMed

Jackson, Jennifer; Kennedy, Maggie

2015-11-18

Social media tools provide opportunities for nurses to connect with colleagues and patients and to advance personally and professionally. This article describes the process of developing an innovative social media platform at a large, multi-centre teaching hospital, The Ottawa Hospital, Canada, and its benefits for nurses. The platform, TOH Nurses, was developed using a nursing process approach, involving assessment, planning, implementation and evaluation. The aim of this initiative was to address the barriers to communication inherent in the large number of nurses employed by the organisation, the physical size of the multi-centre hospital and the shift-work nature of nursing. The platform was used to provide educational materials for clinical nurses, and to share information about professional practice. The implications of using a social media platform in a healthcare setting were considered carefully during its development and implementation, including concerns regarding privacy and confidentiality.

Multi-centre evaluation of mass spectrometric identification of anaerobic bacteria using the VITEK® MS system.

PubMed

Garner, O; Mochon, A; Branda, J; Burnham, C-A; Bythrow, M; Ferraro, M; Ginocchio, C; Jennemann, R; Manji, R; Procop, G W; Richter, S; Rychert, J; Sercia, L; Westblade, L; Lewinski, M

2014-04-01

Accurate and timely identification of anaerobic bacteria is critical to successful treatment. Classic phenotypic methods for identification require long turnaround times and can exhibit poor species level identification. Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is an identification method that can provide rapid identification of anaerobes. We present a multi-centre study assessing the clinical performance of the VITEK(®) MS in the identification of anaerobic bacteria. Five different test sites analysed a collection of 651 unique anaerobic isolates comprising 11 different genera. Multiple species were included for several of the genera. Briefly, anaerobic isolates were applied directly to a well of a target plate. Matrix solution (α-cyano-4-hydroxycinnamic acid) was added and allowed to dry. Mass spectra results were generated with the VITEK(®) MS, and the comparative spectral analysis and organism identification were determined using the VITEK(®) MS database 2.0. Results were confirmed by 16S rRNA gene sequencing. Of the 651 isolates analysed, 91.2% (594/651) exhibited the correct species identification. An additional eight isolates were correctly identified to genus level, raising the rate of identification to 92.5%. Genus-level identification consisted of Actinomyces, Bacteroides and Prevotella species. Fusobacterium nucleatum, Actinomyces neuii and Bacteroides uniformis were notable for an increased percentage of no-identification results compared with the other anaerobes tested. VITEK(®) MS identification of clinically relevant anaerobes is highly accurate and represents a dramatic improvement over other phenotypic methods in accuracy and turnaround time. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

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

Systemic sclerosis in Sarawak: a profile of patients treated in the Sarawak General Hospital.

PubMed

Teh, C L; Kuan, Y C; Wong, J S

2009-08-01

We performed a cross-sectional study of the demography, clinical and laboratory features of patients with systemic sclerosis patients followed up in our centre from 1984 to 2007. There were 23 cases with the majority of them (96%) being female. They have a mean age of 50.3 years and a mean disease duration of 6.02 (SD 5.82) years. Our patients comprised of multi-ethnic groups with predominantly Chinese (52%), Sarawak natives (35%) and Malays (13%). They have a mean lag time to diagnosis of 24.8 (SD 34.8) months. All the patients have sclerodermatous skin changes with 16(70%) having diffuse scleroderma and 7(30%) having limited scleroderma. The common clinical manifestations found in our patients were Raynaud's phenomenon (91%), sclerodactyly (65%), digital ulcers (52%) and pulmonary fibrosis (52%). There was low incidence of pulmonary hypertension (13%) and renal involvement (4%). The majority of our patients (67%) have positive ANA with 33% positive Scl-70. The majority received calcium channel blockers (87%), aspirin (48%) and low-dose prednisolone (48%). One patient developed adenocarcinoma of the lung on follow-up. This study demonstrated the rarity of systemic sclerosis in our centre with considerable lag time to diagnosis in our patients. Diffuse cutaneous systemic scleroderma is more common in our centre with rare pulmonary hypertension and renal involvement.

A qualitative study of the role of workplace and interpersonal trust in shaping service quality and responsiveness in Zambian primary health centres.

PubMed

Topp, Stephanie M; Chipukuma, Julien M

2016-03-01

Human decisions, actions and relationships that invoke trust are at the core of functional and productive health systems. Although widely studied in high-income settings, comparatively few studies have explored the influence of trust on health system performance in low- and middle-income countries. This study examines how workplace and inter-personal trust impact service quality and responsiveness in primary health services in Zambia. This multi-case study included four health centres selected for urban, peri-urban and rural characteristics. Case data included provider interviews (60); patient interviews (180); direct observation of facility operations (two weeks/centre) and key informant interviews (14) that were recorded and transcribed verbatim. Case-based thematic analysis incorporated inductive and deductive coding. Findings demonstrated that providers had weak workplace trust influenced by a combination of poor working conditions, perceptions of low pay and experiences of inequitable or inefficient health centre management. Weak trust in health centre managers' organizational capacity and fairness contributed to resentment amongst many providers and promoted a culture of blame-shifting and one-upmanship that undermined teamwork and enabled disrespectful treatment of patients. Although patients expressed a high degree of trust in health workers' clinical capacity, repeated experiences of disrespectful or unresponsive care undermined patients' trust in health workers' service values and professionalism. Lack of patient-provider trust prompted some patients to circumvent clinic systems in an attempt to secure better or more timely care. Lack of resourcing and poor leadership were key factors leading to providers' weak workplace trust and contributed to often-poor quality services, driving a perverse cycle of negative patient-provider relations across the four sites. Findings highlight the importance of investing in both structural factors and organizational management to strengthen providers' trust in their employer(s) and colleagues, as an entry-point for developing both the capacity and a work culture oriented towards respectful and patient-centred care. © The Author 2015. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids.

PubMed

Tiernan, Jim; Hind, Daniel; Watson, Angus; Wailoo, Allan J; Bradburn, Michael; Shephard, Neil; Biggs, Katie; Brown, Steven

2012-10-25

Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option for treatment depends upon persistence and severity of the symptoms. Minor symptoms often respond to conservative treatment such as dietary fibre and reassurance. For more severe symptoms treatment such as rubber band ligation may be therapeutic and is a very commonly performed procedure in the surgical outpatient setting. Surgery is usually reserved for those who have more severe symptoms, as well as those who do not respond to non-operative therapy; surgical techniques include haemorrhoidectomy and haemorrhoidopexy. More recently, haemorrhoidal artery ligation has been introduced as a minimally invasive, non destructive surgical option.There are substantial data in the literature concerning efficacy and safety of 'rubber band ligation including multiple comparisons with other interventions, though there are no studies comparing it to haemorrhoidal artery ligation. A recent overview has been carried out by the National Institute for Health and Clinical Excellence which concludes that current evidence shows haemorrhoidal artery ligation to be a safe alternative to haemorrhoidectomy and haemorrhoidopexy though it also highlights the lack of good quality data as evidence for the advantages of the technique. The aim of this study is to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic second or third degree (Grade II or Grade III) haemorrhoids. A multi-centre, parallel group randomised controlled trial. The primary outcome is patient-reported symptom recurrence twelve months following the intervention. Secondary outcome measures relate to symptoms, complications, health resource use, health related quality of life and cost effectiveness following the intervention. 350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals. A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group. The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids. ISRCTN41394716.

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.

What contributes to driving ability in Parkinson's disease.

PubMed

Cubo, Esther; Martinez Martin, Pablo; Gonzalez, Miguel; Bergareche, Alberto; Campos, Victor; Fernández, José Manuel; Alvárez, María; Bayes, Angels

2010-01-01

To determine the most significant clinical predictors that influence driving ability in Parkinson disease (PD). National-multi-centre, cross-sectional study covering PD outpatients. Clinical assessment was based on the following questionnaires: cognition (SCOPA-Cog); motor impairment and disabilities (SCOPA motor); depression/anxiety; sleep (SCOPA-Sleep); psychosis and severity/global impairment (HY and CISI-PD). Driving status data was obtained using a standardized questionnaire. Comparisons between drivers and ex-drivers were calculated using chi(2) and Student t-tests as appropriate. Multi-variate logistic regression analysis was performed to identify independent driving ability clinical predictors. Compared with the drivers, the ex-drivers were older (p = 0.00005), had longer disease duration (p = 0.03), had more overall cognitive dysfunction (p = 0.004) and had greater motor impairment, as measured by the CISI (p = 0.02), HY stage (p = 0.034) and by the SCOPA-motor scale (p = 0.002) and difficulty in activities of daily life (p = 0.002). In the regression model analysis, aging and ADL impairment were the principal clinical predictors that differentiated drivers from ex-drivers. Although overall driving impairment in PD is associated with advancing disease severity, driving ability seems to be more strongly influenced by age and ADL impairment. Multi-disciplinary teams are required to assess driving ability in patients with PD and develop rehabilitation measures for safer driving.

Research and education in thoracic surgery: the European trainees' perspective.

PubMed

Ilonen, Ilkka K; McElnay, Philip J

2015-04-01

Thoracic surgery training within Europe is diverse and a consensus may help to harmonise the training. Currently, training for thoracic surgery compromises thoracic, cardiothoracic and aspects of general surgical training. The recognition of specialist degrees should be universal and equal. Between different nations significant differences in training exist, especially in general surgery rotations and in the role of oesophageal surgery. The European board examination for thoracic surgery is one of the key ways to achieve harmonisation within the European Union (EU) and internationally. Further support and encouragement may be beneficial to promote diverse and engaging fellowships and clinical exchange programmes between nations. International fellowships may even benefit young residents, in both clinical and academic settings. Many studies currently would benefit from multi-centre and multi-national design, enhancing the results and giving better understanding of clinical scenarios. Educational content provided by independent organisations should be more recognised as an integral part in both resident training and continuing development throughout surgeons' careers. During annual society meetings, trainees should have some sessions that are aimed at enhancing their training and establishing networks of international peers.

The reliability of glomerular filtration rate measured from plasma clearance: a multi-centre study of 1,878 healthy potential renal transplant donors.

PubMed

Peters, A Michael; Howard, Bethany; Neilly, Mark D J; Seshadri, Nagabhushan; Sobnack, Ravin; Hooker, Claire A; Irwin, Andrew; Snelling, Hayley; Gruning, Thomas; Perry, Laura; Patel, Neva H; Lawson, Richard S; Shabo, Gregory; Williams, Nigel; Dave, Surendra; Barnfield, Mark C

2012-04-01

The objective of the study was to undertake a clinical audit of departmental performance in the measurement of glomerular filtration rate (GFR) using the coefficient of variation (CV) of extracellular fluid volume (ECFV) as the benchmark. ECFV is held within narrow limits in healthy subjects, narrower than GFR, and should therefore have a low CV. Fifteen departments participated in this retrospective study of healthy renal transplant donors. Data were analysed separately for men (n ranged from 28 to 115 per centre; total = 819) and women (n = 28-146; 1,059). All centres used the slope-intercept method with blood sample numbers ranging from two to five. Subjects did not fast prior to GFR measurement. GFR was scaled to body surface area (BSA) and corrected for the single compartment assumption. GFR scaled to ECFV was calculated as the terminal slope rate constant and corrected for the single compartment assumption. ECFV/BSA was calculated as the ratio of GFR/BSA to GFR/ECFV. The departmental CVs of ECFV/BSA and GFR/BSA ranged from 8.3 to 25.8% and 12.8 to 21.9%, respectively, in men, and from 9.6 to 21.1% and 14.8 to 23.7%, respectively, in women. Both CVs correlated strongly between men and women from the same centre, suggesting department-specific systematic errors. GFR/BSA was higher in men in 14 of 15 centres, whereas GFR/ECFV was higher in women in 14 of 15 centres. Both correlated strongly between men and women, suggesting regional variation in GFR. The CV of ECFV/BSA in normal subjects is a useful indicator of the technical robustness with which GFR is measured and, in this study, indicated a wide variation in departmental performance.

Learner-centred teaching in a non-learner-centred world: An interpretive phenomenological study of the lived experience of clinical nursing faculty.

PubMed

Oyelana, Olabisi; Martin, Donna; Scanlan, Judith; Temple, Beverley

2018-08-01

With the growing complexities in the contemporary health care system, there is a challenge of preparing nurses for the practice demands. To this end, learner-centred teaching has emerged in many nursing curricula in Canada and evidence indicates its effectiveness in developing the essential practice skills in nursing students. It is important to examine the experience of the clinical faculty members who implement learner-centred teaching, as doing so would provide an insight to the factors that may hinder the implementation of learner-centred teaching in the practice settings. This phenomenological study aimed to address two research questions: what does learner-centred teaching mean to clinical nurse faculty? What is the lived experience of clinical nursing faculty who incorporate learner-centred teaching? Ten clinical nurse faculty members who had at least two years of clinical teaching experience volunteered to participate in the study. Data were collected using a semi-structured interview guide and audio recorder. Additional data sources included a demographic survey and a reflective journal. Multiple sub-themes emerged from this study from which three significant themes were consolidated: diversity of meanings, facilitators of LCT, and barriers to LCT. However, an overarching theme of "learner-centred teaching in a non-learner-centred world" was coined from participants' accounts of their experiences of barriers in incorporating LCT in the practice settings. A collaborative effort between faculty and the stakeholders is paramount to a successful implementation of learner-centred teaching in practice settings. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Sci-Fri PM: Radiation Therapy, Planning, Imaging, and Special Techniques - 10: Results from Canada Wide Survey on Total Body Irradiation Practice

DOE Office of Scientific and Technical Information (OSTI.GOV)

Studinski, Ryan; Fraser, Danielle; Samant, Rajiv

Purpose: Total Body Irradiation (TBI) is delivered to a relatively small number of patients with a variety of techniques; it has been a challenge to develop consensus studies for best practice. This survey was created to assess the current state of TBI in Canada. Methods: The survey was created with questions focusing on the radiation prescription, delivery technique and resources involved. The survey was circulated electronically to the heads of every clinical medical physics department in Canada. Responses were gathered and collated, and centres that were known to deliver TBI were urged to respond. Results: Responses from 20 centres weremore » received, including 12 from centres that perform TBI. Although a variety of TBI dose prescriptions were reported, 12 Gy in 6 fractions was used in 11 centres while 5 centres use unique prescriptions. For dose rate, a range of 9 to 51 cGy/min was reported. Most centres use an extended SSD technique, with the patient standing or lying down against a wall. The rest use either a “sweeping” technique or a more complicated multi-field technique. All centres but one indicated that they shield the lungs, and only a minority shield other organs. The survey also showed that considerable resources are used for TBI including extra staffing, extended planning and treatment times and the use of locally developed hardware or software. Conclusions: This survey highlights that both similarities and important discrepancies exist between TBI techniques across the country, and is an opportunity to prompt more collaboration between centres.« less

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 utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART).

PubMed

Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

2013-10-01

An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants' knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (p<0.001). The first cohort pre scores increased from 67 ± 11 to 79 ± 8 (p<0.001) post. The long term same question score was 73 ± 14 (p=0.025, comparing to pre-test), and different questions' score was 77 ± 13 (p=0.014). In the second cohort, pre-test scores were 64 ± 10, post-test same question score 78 ± 9 (p<0.001) and different questions' score 81 ± 11 (p<0.001). e-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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.

LIS–lnterlink—connecting laboratory information systems to remote primary health–care centres via the Internet

PubMed Central

Clark, Barry; Wachowiak, Bartosz; Crawford, Ewan W.; Jakubowski, Zenon; Kabata, Janusz

1998-01-01

A pilot study was performed to evaluate the feasibility of using the Internet to securely deliver patient laboratory results, and the system has subsequently gone into routine use in Poland. The system went from design to pilot and then to live implementation within a four-month period, resulting in the LIS-Interlink software product. Test results are retrieved at regular intervals from the BioLinkTM LIS (Laboratory Information System), encrypted and transferred to a secure area on the Web server. The primary health-care centres dial into the Internet using a local-cell service provided by Polish Telecom (TP), obtain a TCP/IP address using the TP DHCP server, and perform HTTP ‘get’ and ‘post’ operations to obtain the files by secure handshaking. The data are then automatically inserted into a local SQL database (with optional printing of incoming reports)for cumulative reporting and searching functions. The local database is fully multi-user and can be accessed from different clinics within the centres by a variety of networking protocols. PMID:18924820

LIS-lnterlink-connecting laboratory information systems to remote primary health-care centres via the Internet.

PubMed

Clark, B; Wachowiak, B; Crawford, E W; Jakubowski, Z; Kabata, J

1998-01-01

A pilot study was performed to evaluate the feasibility of using the Internet to securely deliver patient laboratory results, and the system has subsequently gone into routine use in Poland. The system went from design to pilot and then to live implementation within a four-month period, resulting in the LIS-Interlink software product. Test results are retrieved at regular intervals from the BioLink(TM) LIS (Laboratory Information System), encrypted and transferred to a secure area on the Web server. The primary health-care centres dial into the Internet using a local-cell service provided by Polish Telecom (TP), obtain a TCP/IP address using the TP DHCP server, and perform HTTP 'get' and 'post' operations to obtain the files by secure handshaking. The data are then automatically inserted into a local SQL database (with optional printing of incoming reports)for cumulative reporting and searching functions. The local database is fully multi-user and can be accessed from different clinics within the centres by a variety of networking protocols.

Multi-centre evaluation of the Determine HIV Combo assay when used for point of care testing in a high risk clinic-based population.

PubMed

Conway, Damian P; Holt, Martin; McNulty, Anna; Couldwell, Deborah L; Smith, Don E; Davies, Stephen C; Cunningham, Philip; Keen, Phillip; Guy, Rebecca

2014-01-01

Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics. We compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months. Of 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives. The DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.

Study protocol. IDUS - Instrumental delivery & ultrasound: a multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

PubMed

Murphy, Deirdre J; Burke, Gerard; Montgomery, Alan A; Ramphul, Meenakshi

2012-09-13

Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 - 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Current Controlled Trials ISRCTN72230496.

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.

Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

PubMed

Reiter-Theil, Stella; Mertz, Marcel; Schürmann, Jan; Stingelin Giles, Nicola; Meyer-Zehnder, Barbara

2011-09-01

In this paper we assume that 'theory' is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES. A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including 'how-to' questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics). In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three 'pillars' as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP. We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. © 2011 Blackwell Publishing Ltd.

Presence of quinolone resistance to qnrB1 genes and blaOXA-48 carbapenemase in clinical isolates of Klebsiella pneumoniae in Spain.

PubMed

Rodríguez Martínez, J M; Díaz-de Alba, P; Lopez-Cerero; Ruiz-Carrascoso, G; Gomez-Gil, R; Pascual, A

2014-01-01

A study is presented on the presence of quinolone resistance qnrB1 genes in clinical isolates belonging to the largest series of infections caused by OXA-48-producing Klebsiella pneumoniae in a single-centre outbreak in Spain. Evidence is also provided, according to in vitro results, that there is a possibility of co-transfer of plasmid harbouring blaOXA-48 with an other plasmid harbouring qnrB1 in presence of low antibiotic concentrations of fluoroquinolones, showing the risk of multi-resistance screening. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

[Tissue bank of the National Centre for Tumour Disease. An innovative platform for translational tumour].

PubMed

Herpel, E; Koleganova, N; Schirmacher, P

2008-11-01

The tissue bank of the National Centre for Tumour Diseases (NCT) in Heidelberg, Germany, was founded in 2005 by the University Hospital of Heidelberg and the German Cancer Research Centre as a section of the NCT. It is a nonprofit organization with a completely evaluated legal and ethical framework and supports the Comprehensive Cancer Centre concept. Its main aim is the acquisition and characterization of fresh-frozen and paraffin-embedded human tissues according to the standards of good scientific practice and the promotion of interdisciplinary tumour research of the comprehensive cancer centre and its cooperating partners. It also offers expert project assistance: a project leader can submit a short proposal, and the tissue collecting/preparing process will be performed in cooperation with a specialised pathologist and, if applicable, an experienced clinical researcher. The tissue bank is also a central platform for further developing of innovative technologies for tissue handling, e.g. multi-tissue-array and virtual microscopy, with links to digital image analysis and bioinformatics. Thus, the NCT tissue bank represents a model for innovative biobanking and for institutions with active interdisciplinary cancer research.

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

Occupational therapy in India: focus on functional recovery and need for empowerment

PubMed Central

Samuel, Reema; Jacob, K. S.

2017-01-01

While there have been significant advances in treatments for mental disorders over the past century, cure for many mental disorders remains elusive. The complex problems of mental illness require a multi-sectoral, multi-disciplinary and multi-dimensional approach to care. The need for focus on biopsychosocial model rather than on biomedical practise, client-centred rather than physician-oriented care, personal rather than clinical recovery, are often preached but rarely practiced. The lack of emphasis on functioning and the limited workforce and evidence base complicate issues related to the care of people with chronic mental illness in India. The role of occupational therapy in bridging the gap between symptomatic improvement and functional recovery is discussed. PMID:28827877

A European multi-centre External Quality Assessment (EQA) study on phenotypic and genotypic methods used for Herpes Simplex Virus (HSV) drug resistance testing.

PubMed

Afshar, Baharak; Bibby, David F; Piorkowska, Renata; Ohemeng-Kumi, Natasha; Snoeck, Robert; Andrei, Graciela; Gillemot, Sarah; Morfin, Florence; Frobert, Emilie; Burrel, Sonia; Boutolleau, David; Crowley, Brendan; Mbisa, Jean L

2017-11-01

Herpes Simplex Virus (HSV) drug resistance is a significant public health concern among immunocompromised individuals. Phenotypic assays are considered the gold standard method for detecting HSV drug resistance. However, plaque reduction assays (PRAs) are technically demanding, often with long turnaround times of up to four weeks. In contrast, genotypic tests can be performed within a few days. The development and coordination of the first European External Quality Assessment (EQA) study to evaluate phenotypic and genotypic methods used for HSV drug resistance testing in specialised reference laboratories. Four HSV-1 or HSV-2 strains with different antiviral susceptibility profiles were isolated from clinical samples. Isolates were quantified by qPCR, and aliquoted in culture medium. One isolate was distributed at two dilutions to help assess assay sensitivity. The panel was distributed to five European centres with a six-week deadline for the return of phenotypic and genotypic results, together with clinical reports. Four out of five participating labs returned results by the deadline. Limited results were later available from the fifth lab. Phenotypic and genotypic data were largely, but not completely, concordant. An unusual resistance profile shown by one of the samples was explained by the detection of a mixed virus population after extensive further investigation by one of the centres. Discordant clinical outputs reflecting the diversity of phenotypic methodologies demonstrated the utility of this exercise. With emerging genotypic technologies looking to supplant phenotyping, there is a need for curated public databases, accessible interpretation tools and standardised control materials for quality management. By establishing a network of testing laboratories, we hope that this EQA scheme will facilitate ongoing progress in this area. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

Developing a community based service model for disability: Listening to the needs of all beneficiaries and providers.

PubMed

Collins, Katrina

2017-12-11

To inform the strategic and operational development of a community based service model at the Crann Centre, Cork, Ireland for SB children, adults, their families and providers. A needs assessment was conducted by gathering the views of multiple stakeholder perspectives within the SB community in the geographical region the Centre will serve. The intention is to create project deliverables that are responsive to the needs highlighted through this research. The study used a multi method design with a participatory research approach to explore the needs of SB individuals, families and providers. This involved in depth interviews, focus groups and online surveys. One hundred and fifty-nine respondents contributed to this qualitative needs assessment. The research established a range of psychosocial, clinical, vocational and educational issues causing ongoing difficulties for SB individuals and families. Providers highlighted supports that would benefit the social and clinical wellbeing of persons with SB. Collectively participants in the study reported that there was an absence of coordinated, continuous and comprehensive service delivery for the SB community in the region. This was amplified by geographical location of services and access to relevant supports. Consensus across stakeholders in this research pointed to the necessity for an innovative model of community based provision at the Crann Centre. This was described as offering a service with family at the core of an assets based model of practice. A key finding was the lack of importance placed on the social and emotional development of SB individuals. Traditionally participants described a singular focus on physical health through clinically defined treatment models. The desire for a social model of disability that informed health and wellbeing of SB individuals and families emerged as a prominent recommendation from the research.

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.

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…

A clinical study of the LiVac laparoscopic liver retractor system.

PubMed

Gan, Philip; Bingham, Judy

2016-02-01

All retractors for laparoscopic operations on the gallbladder or stomach apply an upward force to the under-surface of the liver or gallbladder, most requiring an additional skin incision. The LiVac laparoscopic liver retractor system (LiVac retractor) comprises a soft silicone ring attached to suction tubing and connected to a regulated source of suction. The suction tubing extends alongside existing ports. When placed between the liver and diaphragm, and suction applied, a vacuum is created within the ring, keeping these in apposition. Following successful proof-of-concept animal testing, a clinical study was conducted to evaluate the performance and safety of the retractor in patients. The study was a dual-centre, single-surgeon, open-label study and recruited ten patients scheduled to undergo routine upper abdominal laparoscopic surgery including cholecystectomy, primary gastric banding surgery or fundoplication. The study was conducted at two sites and was approved by the institutions' ethics committees. The primary objective of the study was to evaluate the performance of the LiVac retractor in patients undergoing upper abdominal single- or multi-port laparoscopic surgery. Performance was measured by the attainment of milestones for the retractor and accessory bevel, where used, and safety outcomes through the recording of adverse events, physical parameters, pain scales, blood tests and a post-operative liver ultrasound. The LiVac retractor achieved both primary and secondary performance and safety objectives in all patients. No serious adverse events and no device-related adverse events or device deficiencies were reported. The LiVac retractor achieved effective liver retraction without clinically significant trauma and has potential application in multi- or single-port laparoscopic upper abdominal surgery. As a separate incision is not required, the use of the LiVac retractor in multi-port surgery therefore reduces the number of incisions.

A pilot study on understanding the journey of advanced prostate cancer patients.

PubMed

Wagholikar, Amol; Fung, Maggie; Nelson, Colleen

2011-01-01

To understand the journey of advanced prostate cancer patients for supporting development of an innovative patient journey browser. Prostate cancer is one of the common cancers in Australia. Due to the chronic nature of the disease, it is important to have effective disease management strategy and care model. Multi-disciplinary care is a well-proven approach for chronic disease management. The Multi-disciplinary team (MDT) can function more effectively if all the required information is available for the clinical decision support. The development of innovative technology relies on an accurate understanding of the advanced prostate cancer patient's journey over a prolonged period. This need arises from the fact that advanced prostate cancer patients may follow various treatment paths and change their care providers. As a result of this, it is difficult to understand the actual sources of patient's clinical records and their treatment patterns. The aim of the research is to understand variable sources of clinical records, treatment patterns, alternative therapies, over the counter (OTC) medications of advanced prostate cancer patients. This study provides better and holistic understanding of advanced prostate cancer journey. The study was conducted through an on-line survey developed to seek and analyse the responses from the participants. The on-line questionnaire was carefully developed through consultations with the clinical researchers at the Australian Prostate Cancer Research Centre-Queensland, prostate cancer support group representatives and health informaticians at the Australian E-Health Research Centre. The non-identifying questionnaire was distributed to the patients through prostate cancer support groups in Queensland, Australia. The pilot study was carried out between August 2010 and December 2010. The research made important observations about the advanced prostate cancer journey. It showed that General Practitioner (GP) was the common source of patient's clinical records (41%) followed by Urologist (14%) and other clinicians (14%). The data analysis also showed that selenium was the common complementary supplement (55%) used by the patients and about 48% patients did not use any OTC drugs. The most common OTC used by the patients was Paracetamol (about 45%). The results have provided a foundation to the architecture of the proposed technology solution. The outcomes of this study are incorporated in design of the proposed patient journey browser system. A basic version of the system is currently being used at the advanced prostate cancer MDT meetings.

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.

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

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.

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.

DEMAT: A multi-institutional dosimetry audit of rotational and static intensity-modulated radiotherapy.

PubMed

Lafond, Caroline; Chiavassa, Sophie; Bertaut, Cindy; Boussion, Nicolas; Chapel, Nathalie; Chapron, Lucie; Coste, Frédéric; Crespin, Sylvain; Dy, Gilles; Faye, Papa Abdoulaye; Leleu, Cyril; Bouvier, Jeanne; Madec, Ludovic; Mesgouez, Jérôme; Palisson, Jérémy; Vela, Anthony; Delpon, Grégory

2016-05-01

Static beam intensity-modulated-radiation-therapy (IMRT) and/or Volumetric-Modulated-Arc-Therapy (VMAT) are now available in many regional radiotherapy departments. The aim of this multi-institutional audit was to design a new methodology based on radiochromic films to perform an independent quality control. A set of data were sent to all participating centres for two clinical localizations: prostate and Head and Neck (H&N) cancers. The agreement between calculations and measurements was verified in the Octavius phantom (PTW) by point measurements using ionization chambers and by 2D measurements using EBT3 radiochromic films. Due to uncertainties in the whole procedure, criteria were set to 5% and 3% in local dose and 3mm in distance excluding doses lower than 10% of the maximum doses. No normalization point or area was used for the quantitative analysis. 13 radiotherapy centres participated in this audit involving 28 plans (12 IMRT, 16 VMAT). For point measurements, mean errors were -0.18±1.54% and 0.00±1.58% for prostate and H&N cases respectively. For 2D measurements with 5%/3mm criteria, gamma map analysis showed a pixel pass rate higher than 95% for prostate and H&N. Mean gamma index was lower than 0.4 for prostate and 0.5 for H&N. Both techniques yielded similar results. This study showed the feasibility of an independent quality control by peers for conventional IMRT and VMAT. Results from all participating centres were found to be in good agreement. This regional study demonstrated the feasibility of our new methodology based on radiochromic films without dose normalization on a specific point. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Cognitive Stimulation Therapy (CST) is a psychosocial evidence-based group intervention for people with dementia recommended by the UK NICE guidelines. In clinical trials, CST has been shown to improve cognition and quality of life, but little is known about the best way of ensuring implementation of CST in practice settings. A recent pilot study found that a third of people who attend CST training go on to run CST in practice, but staff identified a lack of support as a key reason for the lack of implementation. Methods/design There are three projects in this study: The first is a pragmatic multi-centre, randomised controlled trial (RCT) of staff training, comparing CST training and outreach support with CST training only; the second, the monitoring and outreach trial, is a phase IV trial that evaluates implementation of CST in practice by staff members who have previously had the CST manual or attended training. Centres will be randomised to receive outreach support. The primary outcome measure for both of these trials is the number of CST sessions run for people with dementia. Secondary outcomes include the number of attenders at sessions, job satisfaction, dementia knowledge and attitudes, competency, barriers to change, approach to learning and a controllability of beliefs and the level of adherence. Focus groups will assess staff members’ perceptions of running CST groups and receiving outreach support. The third study involves monitoring centres running groups in their usual practice and looking at basic outcomes of cognition and quality of life for the person with dementia. Discussion These studies assess the effects of outreach support on putting CST into practice and running groups effectively in a variety of care settings with people with dementia; evaluate the effectiveness of CST in standard clinical practice; and identify key factors promoting or impeding the successful running of groups. Trial registration Clinical trial ISRCTN28793457. PMID:22735077

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…

Standing up in multiple sclerosis (SUMS): protocol for a multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis.

PubMed

Freeman, J A; Hendrie, W; Creanor, S; Jarrett, L; Barton, A; Green, C; Marsden, J; Rogers, E; Zajicek, J

2016-05-05

Multiple sclerosis (MS) is an incurable, unpredictable but typically progressive neurological condition. It is the most common cause of neurological disability in young adults. Within 15 years of diagnosis, approximately 50 % of affected people are unable to walk unaided, and over time an estimated 25 % depend on a wheelchair. Typically, people with such limited mobility are excluded from clinical trials. Severely impaired people with MS spend much of their day sitting, often with limited ability to change position. In response, secondary complications can occur including: muscle wasting, pain, reduced skin integrity, spasms, limb stiffness, constipation, and associated psychosocial problems such as depression and lowered self-esteem. Effective self-management strategies, which can be implemented relatively easily and cheaply within people's homes, are needed to improve or maintain mobility and reduce sedentary behaviour. However this is challenging, particularly in the latter stages of disease. Regular supported standing using standing frames is one potential option. SUMS is a pragmatic multi-centre randomised controlled trial evaluating use of Oswestry standing frames with blinded outcome assessment and full economic evaluation. Participants will be randomly allocated (1:1) to either a home-based, self-management standing programme (with advice and support) along with their usual care or to usual care alone. Those in the intervention group will be asked to stand for a minimum of 30 min three times weekly over 20 weeks. Each participant will be followed-up at 20 and 36 weeks post baseline. The primary clinical outcome is motor function, assessed using the Amended Motor Club Assessment. The primary economic endpoint is quality-adjusted life years. The secondary outcomes include measures of explanatory physical impairments, key clinical outcomes, and health-related quality of life. An embedded qualitative component will explore participant's and carer's experiences of the standing programme. This is the first large scale multi-centre trial to assess the clinical and cost effectiveness of a home based standing frame programme for people who are severely impaired by MS. If demonstrated to be effective and cost-effective, we will use this evidence to develop recommendations for a health service delivery model which could be implemented across the United Kingdom. ISRCTN69614598 DATE OF REGISTRATION: 3.2.16 (retrospectively registered).

Traumatic injury to the colon and rectum in Scotland: demographics and outcome.

PubMed

Brady, R R; O'Neill, S; Berry, O; Kerssens, J J; Yalamarthi, S; Parks, R W

2012-01-01

An analysis of a multi-centred database of trauma patients was performed. The study used data from a prospective multi-centre trauma database containing details of 52 887 trauma patients admitted to participating Scottish Hospitals over an 11-year period. Three hundred and forty (0.64%) of 52 887 trauma patients (284 male) with colorectal injuries were identified; 43.9% of colorectal injuries occurred following blunt trauma and 56.1% following penetrating injury. Patients in the latter group were younger, had less haemodynamic compromise and were less likely to die than those with blunt trauma (P < 0.01). The overall mortality rate was 25.6% and after rectal injury it was 21.2% (P > 0.05). Female gender, increased age, road traffic accidents and those admitted as a result of a blunt traumatic injury were associated with increased mortality. Age > 65 years (P = 0.01), increasing injury severity score (ISS) at presentation (P < 0.001), haemodynamic compromise (P = 0.045) and decreased Glasgow Coma Score (GCS) (P < 0.001) had the strongest independent associations with mortality. Colorectal injury after trauma has a high morbidity. Clinical features associated with death allow stratification of mortality risk. © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.

[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.

A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

PubMed

Dryden, M; Dickinson, A; Brooks, J; Hudgell, L; Saeed, K; Cutting, K F

2016-03-01

This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a consultant to Matoke Holdings.

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.

Prevalence of upper airway obstruction in patients with apparently asymptomatic euthyroid multi nodular goitre

PubMed Central

Menon, Sunil K.; Jagtap, Varsha S.; Sarathi, Vijaya; Lila, Anurag R.; Bandgar, Tushar R.; Menon, Padmavathy S; Shah, Nalini S.

2011-01-01

Aims: To study the prevalence of upper airway obstruction (UAO) in “apparently asymptomatic” patients with euthyroid multinodular goitre (MNG) and find correlation between clinical features, UAO on pulmonary function test (PFT) and tracheal narrowing on computerised tomography (CT). Materials and Methods: Consecutive patients with apparently asymptomatic euthyroid MNG attending thyroid clinic in a tertiary centre underwent clinical examination to elicit features of UAO, PFT, and CT of neck and chest. Statistical Analysis Used: Statistical analysis was done with SPSS version 11.5 using paired t-test, Chi square test, and Fisher's exact test. P value of <0.05 was considered to be significant. Results: Fifty-six patients (52 females and four males) were studied. The prevalence of UAO (PFT) and significant tracheal narrowing (CT) was 14.3%. and 9.3%, respectively. Clinical features failed to predict UAO or significant tracheal narrowing. Tracheal narrowing (CT) did not correlate with UAO (PFT). Volume of goitre significantly correlated with degree of tracheal narrowing. Conclusions: Clinical features do not predict UAO on PFT or tracheal narrowing on CT in apparently asymptomatic patients with euthyroid MNG. PMID:21966649

The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

PubMed

Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

2015-12-15

Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and physiotherapy, measures many known confounders, and includes a post-discharge follow-up of complication rates, functional capacity, and health-related quality of life. This trial is currently recruiting. Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.

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.

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.

Integrated telemedicine applications and services for oncological positron emission tomography.

PubMed

Kontaxakis, George; Visvikis, Dimitris; Ohl, Roland; Sachpazidis, Ilias; Suarez, Juan Pablo; Selby, Peter; Cheze-Le Rest, Catherine; Santos, Andres; Ortega, Fernando; Diaz, Javier; Pan, Leyun; Strauss, Ludwig; Dimitrakopoulou-Strauss, Antonia; Sakas, Georgios; Pozo, Miguel Angel

2006-01-01

TENPET (Trans European Network for Positron Emission Tomography) aims to evaluate the provision of integrated teleconsultation and intelligent computer supported cooperative work services for clinical positron emission tomography (PET) in Europe at its current stage, as it is a multi-centre project financially supported by the European Commission (Information Society, eTEN Program). It addresses technological challenges by linking PET centres and developing supporting services that permit remote consultation between professionals in the field. The technological platform (CE-marked) runs on Win2000/NT/XP systems and incorporates advanced techniques for image visualization, analysis and fusion, as well as for interactive communication and message handling for off-line communications. Four PET Centres from Spain, France and Germany participate to the pilot system trials. The performance evaluation of the system is carried out via log files and user-filled questionnaires on the frequency of the teleconsultations, their duration and efficacy, quality of the images received, user satisfaction, as well as on privacy, ethical and security issues. TENPET promotes the co-operation and improved communication between PET practitioners that are miles away from their peers or on mobile units, offering options for second opinion and training and permitting physicians to remotely consult patient data if they are away from their centre. It is expected that TENPET will have a significant impact in the development of new skills by PET professionals and will support the establishment of peripheral PET units. To our knowledge, TENPET is the first telemedicine service specifically designed for oncological PET. This report presents the technical innovations incorporated in the TENPET platform and the initial pilot studies at real and diverse clinical environments in the field of oncology.

Multiattribute selection of acute stroke imaging software platform for Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) clinical trial.

PubMed

Churilov, Leonid; Liu, Daniel; Ma, Henry; Christensen, Soren; Nagakane, Yoshinari; Campbell, Bruce; Parsons, Mark W; Levi, Christopher R; Davis, Stephen M; Donnan, Geoffrey A

2013-04-01

The appropriateness of a software platform for rapid MRI assessment of the amount of salvageable brain tissue after stroke is critical for both the validity of the Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) Clinical Trial of stroke thrombolysis beyond 4.5 hours and for stroke patient care outcomes. The objective of this research is to develop and implement a methodology for selecting the acute stroke imaging software platform most appropriate for the setting of a multi-centre clinical trial. A multi-disciplinary decision making panel formulated the set of preferentially independent evaluation attributes. Alternative Multi-Attribute Value Measurement methods were used to identify the best imaging software platform followed by sensitivity analysis to ensure the validity and robustness of the proposed solution. Four alternative imaging software platforms were identified. RApid processing of PerfusIon and Diffusion (RAPID) software was selected as the most appropriate for the needs of the EXTEND trial. A theoretically grounded generic multi-attribute selection methodology for imaging software was developed and implemented. The developed methodology assured both a high quality decision outcome and a rational and transparent decision process. This development contributes to stroke literature in the area of comprehensive evaluation of MRI clinical software. At the time of evaluation, RAPID software presented the most appropriate imaging software platform for use in the EXTEND clinical trial. The proposed multi-attribute imaging software evaluation methodology is based on sound theoretical foundations of multiple criteria decision analysis and can be successfully used for choosing the most appropriate imaging software while ensuring both robust decision process and outcomes. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures.

PubMed

2014-06-26

Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

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

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.

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.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

PubMed

Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

2006-12-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study

PubMed Central

Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Kapczynski, W.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

2006-01-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) – hence, reducing dependence on hormone therapy programs. PMID:23675005

A clinical decision-making mechanism for context-aware and patient-specific remote monitoring systems using the correlations of multiple vital signs.

PubMed

Forkan, Abdur Rahim Mohammad; Khalil, Ibrahim

2017-02-01

In home-based context-aware monitoring patient's real-time data of multiple vital signs (e.g. heart rate, blood pressure) are continuously generated from wearable sensors. The changes in such vital parameters are highly correlated. They are also patient-centric and can be either recurrent or can fluctuate. The objective of this study is to develop an intelligent method for personalized monitoring and clinical decision support through early estimation of patient-specific vital sign values, and prediction of anomalies using the interrelation among multiple vital signs. In this paper, multi-label classification algorithms are applied in classifier design to forecast these values and related abnormalities. We proposed a completely new approach of patient-specific vital sign prediction system using their correlations. The developed technique can guide healthcare professionals to make accurate clinical decisions. Moreover, our model can support many patients with various clinical conditions concurrently by utilizing the power of cloud computing technology. The developed method also reduces the rate of false predictions in remote monitoring centres. In the experimental settings, the statistical features and correlations of six vital signs are formulated as multi-label classification problem. Eight multi-label classification algorithms along with three fundamental machine learning algorithms are used and tested on a public dataset of 85 patients. Different multi-label classification evaluation measures such as Hamming score, F1-micro average, and accuracy are used for interpreting the prediction performance of patient-specific situation classifications. We achieved 90-95% Hamming score values across 24 classifier combinations for 85 different patients used in our experiment. The results are compared with single-label classifiers and without considering the correlations among the vitals. The comparisons show that multi-label method is the best technique for this problem domain. The evaluation results reveal that multi-label classification techniques using the correlations among multiple vitals are effective ways for early estimation of future values of those vitals. In context-aware remote monitoring this process can greatly help the doctors in quick diagnostic decision making. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Outcomes of burns in the elderly: revised estimates from the Birmingham Burn Centre.

PubMed

Wearn, Christopher; Hardwicke, Joseph; Kitsios, Andreas; Siddons, Victoria; Nightingale, Peter; Moiemen, Naiem

2015-09-01

Outcomes after burn have continued to improve over the last 70 years in all age groups including the elderly. However, concerns have been raised that survival gains have not been to the same magnitude in elderly patients compared to younger age groups. The aims of this study were to analyze the recent outcomes of elderly burn injured patients admitted to the Birmingham Burn Centre, compare data with a historical cohort and published data from other burn centres worldwide. A retrospective review was conducted of all patients ≥65 years of age, admitted to our centre with cutaneous burns, between 2004 and 2012. Data was compared to a previously published historical cohort (1999-2003). 228 patients were included. The observed mortality for the study group was 14.9%. The median age of the study group was 79 years, the male to female ratio was 1:1 and median Total Body Surface Area (TBSA) burned was 5%. The incidence of inhalation injury was 13%. Median length of stay per TBSA burned for survivors was 2.4 days/% TBSA. Mortality has improved in all burn size groups, but differences were highly statistically significant in the medium burn size group (10-20% TBSA, p≤0.001). Burn outcomes in the elderly have improved over the last decade. This reduction has been impacted by a reduction in overall injury severity but is also likely due to general improvements in burn care, improved infrastructure, implementation of clinical guidelines and increased multi-disciplinary support, including Geriatric physicians. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

[The effect of donepezil in comparison with conventional treatment on cognitive functioning and the performance of the patient in a prospective cohort of patients with Alzheimer's disease treated in routine clinical practice in Spain].

PubMed

López-Pousa, S; Bermejo-Pareja, F; Frank, A; Hernández, F; León, T; Rejas-Gutiérrez, J

2010-11-16

Our aim was to perform a secondary analysis of a 12-month-long, non-blind, multi-centre prospective cost-of-illness study. The analysis assessed the effect of donepezil on cognitive functioning and the performance of patients with possible or probable Alzheimer's disease, compared to that of other drugs for dementia. A sample of 700 patients took part in the study (76.8 ± 6.6 years of age, 67.3% females): 600 (31.4% drug-naive) received donepezil and 100 (9% drug-naive) were given other drugs for dementia. The mean variations corrected by the baseline values and the centre of the total scores on the Folstein minimental test, the clinical dementia rating and Blessed dementia rating scales at 12 months were significantly lower in patients treated with donepezil: -1.23 ± 3.41 versus -2.26 ± 3.07 (p = 0.006), 0.20 ± 0.68 versus 0.39 ± 1.03 (p = 0.014) and 1.28 ± 3.31 versus 2.04 ± 2.84 (p = 0.027), respectively. This secondary analysis shows that the deterioration in the cognitive functioning and performance of patients with the passage of time is slower with donepezil than with other drugs for dementia in routine medical practice. Since these results were observed in a post hoc analysis, formal prospective clinical trials should be conducted to confirm these findings.

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…

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.

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

PubMed Central

2012-01-01

Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study. PMID:22937765

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol.

PubMed

Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Sagap, Ismail; Zakaria, Jasiah; Blazeby, Jane M; Law, Chee Wei

2012-09-03

Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers' guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study.

Antimicrobial resistance pattern of Neisseria gonorrhoeae isolates from peripheral health centres and STD clinic attendees of a tertiary care centre in India.

PubMed

Bala, M; Ray, K; Gupta, S M

2008-06-01

The aim of the study was to compare the antimicrobial resistance pattern of Neisseria gonorrhoeae isolates from urban and rural peripheral health centres and from sexually transmitted disease (STD) clinic attendees. Antimicrobial susceptibility testing of 191 N. gonorrhoeae isolates (165 isolates from STD clinic attendees and 26 from peripheral health centres) was carried out in Delhi, India, using the calibrated dichotomous sensitivity technique for penicillin, tetracycline, ceftriaxone, ciprofloxacin, spectinomycin and nalidixic acid, and minimum inhibitory concentrations were determined using E-test. Penicillin-resistant, ciprofloxacin-resistant, penicillinase-producing N. gonorrhoeae and tetracycline-resistant N. gonorrhoeae strains were higher in STD clinic attendees than in peripheral health centres, probably because of less antibiotic pressure in the peripheral areas. High-level resistance to ciprofloxacin and multiresistant strains were also higher in STD clinic attendees. The present study emphasizes the importance of surveillance of antimicrobial resistance of N. gonorrhoeae in different population subgroups in order to monitor the spread of multiresistant strains and to update the national treatment recommendations.

Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

NASA Astrophysics Data System (ADS)

Driscoll, Brandon; Jaffray, David; Coolens, Catherine

2014-03-01

Purpose: To provide clinicians & researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

Comparison of a minimally invasive procedure versus standard microscopic discotomy: a prospective randomised controlled clinical trial

PubMed Central

Greiner-Perth, R.; Boehm, H.; Mahlfeld, K.; Grasshoff, H.; Allam, Y.; Awiszus, F.

2009-01-01

A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse surgery by comparing operation duration and clinical outcome. Additionally, the transferability of the results was determined by a bicentric design. The microscopic assisted percutaneous nucleotomy (MAPN) has been advocated as a minimally invasive tubular technique. Proponents have claimed that minimally invasive procedures reduce postoperative pain and accelerate the recovery. In addition, there exist only a limited number of well-designed comparison studies comparing standard microdiscotomy to a tubular minimally invasive technique that support this claim. Furthermore, there are no well-designed studies looking at the transferability of those results and possible learning curve phenomena. We studied 100 patients, who were planned for disc prolapse surgery at two centres [50 patients at the developing centre (index) and 50 patients at the less experienced (transfer) centre]. The randomisation was done separately for each centre, employing a block-randomisation procedure with respect to age and preoperative Oswestry score. Operation duration was chosen as a primary outcome parameter as there was a distinguished shortening observed in a preliminary study at the index centre enabling a sound case number estimation. The following data were compared between the two groups and the centres with a 12-month follow-up: surgical times (operation duration and approach duration), the clinical results, leg and back pain by visual analogue scale, the Oswestry disability index, length of hospital stay, return to work time, and complications. The operation duration was statistically identical for MC (57.8 ± 20.2 min) at the index centre and for MAPN (50.3 ± 18.3 min) and MC (54.7 ± 18.1 min) at the transfer centre. The operation duration was only significantly shorter for the MAPN technique at the index centre with 33.3 min (SD 12.1 min). There was a huge clinical improvement for all patients regardless of centre or method revealed by a repeated measures ANOVA for all follow-up visits Separate post hoc ANOVAs for each centre revealed that there was a significant time–method (MAPN vs. MC) interaction at the index centre (F = 3.75, P = 0.006), whereas this crucial interaction was not present at the transfer centre (F = 0.5, P = 0.7). These results suggest a slightly faster clinical recovery for the MAPN patients only at the index centre. This was due to a greater reduction in VAS score for back pain at discharge, 8-week and 6-month follow up (P < 0.002). The Oswestry-disability scores reached a significant improvement compared to the initial values extending over the complete follow-up at both centres for both methods without revealing any differences for the two methods in either centre. There was no difference regarding complications. The results demonstrate that a shorter operation duration and concomitant quicker recovery is comprehensible at an experienced minimally invasively operating centre. These advantages could not be found at the transfer centre within 25 minimally invasive procedures. In conclusion both procedures show equal mid term clinical results and the same complication rate even if the suggested advantages for the minimally invasive procedure could not be confirmed for the transfer centre within the framework of this study. PMID:19360440

A multi-centre study of interactional style in nurse specialist- and physician-led Rheumatology clinics in the UK.

PubMed

Vinall-Collier, Karen; Madill, Anna; Firth, Jill

2016-07-01

Nurse-led care is well established in Rheumatology in the UK and provides follow-up care to people with inflammatory arthritis including treatment, monitoring, patient education and psychosocial support. The aim of this study is to compare and contrast interactional style with patients in physician-led and nurse-led Rheumatology clinics. A multi-centre mixed methods approach was adopted. Nine UK Rheumatology out-patient clinics were observed and audio-recorded May 2009-April 2010. Eighteen practitioners agreed to participate in clinic audio-recordings, researcher observations, and note-taking. Of 9 nurse specialists, 8 were female and 5 of 9 physicians were female. Eight practitioners in each group took part in audio-recorded post-clinic interviews. All patients on the clinic list for those practitioners were invited to participate and 107 were consented and observed. In the nurse specialist cohort 46% were female; 71% had a diagnosis of Rheumatoid Arthritis (RA). The physician cohort comprised 31% female; 40% with RA and 16% unconfirmed diagnosis. Nineteen (18%) of the patients observed were approached for an audio-recorded telephone interview and 15 participated (4 male, 11 female). Forty-four nurse specialist and 63 physician consultations with patients were recorded. Roter's Interactional Analysis System (RIAS) was used to code this data. Thirty-one semi-structured interviews were conducted (16 practitioner, 15 patients) within 24h of observed consultations and were analyzed using thematic analysis. RIAS results illuminated differences between practitioners that can be classified as 'socio-emotional' versus 'task-focussed'. Specifically, nurse specialists and their patients engaged significantly more in the socio-emotional activity of 'building a relationship'. Across practitioners, the greatest proportion of 'patient initiations' were in 'giving medical information' and reflected what patients wanted the practitioner to know rather than giving insight into what patients wanted to know from practitioners. Interviews revealed that continuity of practitioner was highly valued by patients as offering the benefits of an established relationship and of emotional support beyond that of the clinical encounter. This fostered familiarity not only with their particular medical history, but also their individual personal circumstances, and this encouraged patient participation. In contrast, practitioners (mis)perceived waiting times to have a greater impact on patient satisfaction. However, practitioner interviews also revealed that clinic structure is often outside of the practitioner control and can undermine the possibility of maintaining patient-practitioner continuity. This research enhances understanding of nurse specialist consultation styles in Rheumatology, specifically the value of their socio-emotional communication skills to enhance patient participation. Copyright © 2016 Elsevier Ltd. All rights reserved.

A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome?

PubMed

Rath, Ana; Salamon, Valérie; Peixoto, Sandra; Hivert, Virginie; Laville, Martine; Segrestin, Berenice; Neugebauer, Edmund A M; Eikermann, Michaela; Bertele, Vittorio; Garattini, Silvio; Wetterslev, Jørn; Banzi, Rita; Jakobsen, Janus C; Djurisic, Snezana; Kubiak, Christine; Demotes-Mainard, Jacques; Gluud, Christian

2017-11-22

Evidence-based clinical practice is challenging in all fields, but poses special barriers in the field of rare diseases. The present paper summarises the main barriers faced by clinical research in rare diseases, and highlights opportunities for improvement. Systematic literature searches without meta-analyses and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Barriers specific to rare diseases comprise the difficulty to recruit participants because of rarity, scattering of patients, limited knowledge on natural history of diseases, difficulties to achieve accurate diagnosis and identify patients in health information systems, and difficulties choosing clinically relevant outcomes. Evidence-based clinical practice for rare diseases should start by collecting clinical data in databases and registries; defining measurable patient-centred outcomes; and selecting appropriate study designs adapted to small study populations. Rare diseases constitute one of the most paradigmatic fields in which multi-stakeholder engagement, especially from patients, is needed for success. Clinical research infrastructures and expertise networks offer opportunities for establishing evidence-based clinical practice within rare diseases.

Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

PubMed

Beran, Roy G

2004-01-01

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal obligations were addressed in a fashion which allowed the conduct of a trial adopting a proven methodology but novel infrastructure such that it was a totally independent study with regards conduct and reporting of final data, irrespective of the results being either positive or negative. This may represent a more acceptable way to ensure that future clinical trials are devoid of undue influence from the pharmaceutical industry which may still fund the study.

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

Nutritional advice and treatment by dietitians to patients with amyotrophic lateral sclerosis/motor neurone disease: a survey of current practice in England, Wales, Northern Ireland and Canada.

PubMed

Rio, A; Cawadias, E

2007-02-01

The management of amyotrophic lateral sclerosis/motor neurone disease (ALS/MND) has shifted from an attitude of nihilism to treatments that prolong survival and offer hope. Nutrition is an integral component of ALS/MND care requiring coordination among acute and community multi-disciplinary teams (MDT). Evidence-based nutrition guidelines exist for this patient group but their use among dietitians is unknown. The aim of this study was to survey the knowledge, practice and guideline use of dietitians working in ALS/MND centres/clinics across England, Wales, Northern Ireland (EWNI) and Canada. Dietetic contact details were obtained from the Motor Neurone Disease Association (MNDA) and the ALS Society of Canada (ALSSC) websites. Telephone interviews were conducted with 23 dietitians using a standardized questionnaire. Multi-disciplinary team membership was high (78%). Only 22% dietitians had >4-years experience in ALS/MND care. Dietitians reported using body weight, percentage weight loss (PWL) and body mass index (BMI) to assess nutritional status. Equations used to estimate energy and protein requirements differed. Most frequent dietary advice was high calorie, texture modification and prescription nutritional supplements. Artificial nutrition and hydration (ANH) was discussed when patients developed dysphagia, energy intake was inadequate, weight loss of 10% or forced vital capacity (FVC) was reduced. A percutaneous endoscopic gastrostomy (PEG) service was available at all clinics/centres. Nutritional assessment techniques and dietary advice should be standardized. Dietetic collaboration at national and international level is recommended to reduce professional isolation. Training and support in ALS/MND nutrition should be made available as part of post-dietetic registration. Further dietetic research is required to stimulate nutritional care.

Banding versus bonding of first permanent molars: a multi-centre randomized controlled trial.

PubMed

Nazir, Mariyah; Walsh, Tanya; Mandall, Nicky A; Matthew, Susie; Fox, Dee

2011-06-01

To assess the effectiveness of banding versus bonding of first permanent molars during fixed appliance treatment; in terms of attachment failure, patient discomfort and post-treatment enamel demineralization. Multi-centre randomized clinical trial. One District General Hospital Orthodontic Department and two Specialist Orthodontic Practices. Orthodontic patients aged between 10 and 18 years old, randomly allocated to either receive molar bands (n=40) or molar bonds (n=40). Bands were cemented with a conventional glass ionomer cement and tubes were bonded with light-cured composite to all four first permanent molar teeth for each subject. Attachments were reviewed at each recall appointment to assess loosening or loss. The clinical end point of the trial was the day of appliance debond. Enamel demineralization at debond was assessed using the modified International Caries Assessment and Detection System (ICDAS). The first time failure rate for molar bonds was 18·4% and 2·6% for molar bands (P=0·0002). Survival analysis demonstrated molar bonds were more likely to fail compared with molar bands. First permanent molars with bonded tubes experienced more demineralization than those with cemented bands (P=0·027). There was no statistically significant difference in discomfort experienced by patients after banding or bonding first permanent molars (P>0·05). This study shows that as part of fixed appliance therapy, American Orthodontics photoetched first permanent molar bands cemented with 3M ESPE Ketac-Cem perform better than American Orthodontics low profile photo-etched and mesh-based first permanent molar tubes bonded with 3M Unitek Transbond XT in terms of failure behaviour and molar enamel demineralization.

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.

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.

Implementation and evaluation of a community-based medication reconciliation (CMR) system at the hospital-community interface of care.

PubMed

Bailey, Allan L; Moe, Grace; Moe, Jessica; Oland, Ryan

2009-01-01

The WestView community-based medication reconciliation (CMR) aims to decrease medication error risk. A clinical pharmacist visits patients' homes within 72 hours of hospital discharge and compares medications in discharge orders, family physicians' charts, community pharmacy profiles and in the home. Discrepancies are discussed and reconciled with the dispenser, hospital prescriber and follow-up care provider. The CMR demonstrates successful integration that is patient-centred and standardized, bridging the hospital-community interface and improving information flow and communication channels across a family-physician-led multi-disciplinary team. A concurrent research study will evaluate the impact of CMR on health services utilization and to develop a risk prediction model.

Students learning from patients: let's get real in medical education.

PubMed

Bleakley, Alan; Bligh, John

2008-03-01

Medical students must be prepared for working in inter-professional and multi-disciplinary clinical teams centred on a patient's care pathway. While there has been a good deal of rhetoric surrounding patient-centred medical education, there has been little attempt to conceptualise such a practice beyond the level of describing education of communication skills and empathy within a broad 'professionalism' framework. Paradoxically, while aiming to strengthen patient-student interactions, this approach tends to refocus on the role modelling of the physician, and opportunities for potentially deep collaborative working relationships between students and patients are missed. A radical overhaul of conventional doctor-led medical education may be necessary, that also challenges the orthodoxies of individualistic student-centred approaches, leading to an authentic patient-centred model that shifts the locus of learning from the relationship between doctor as educator and student to the relationship between patient and student, with expert doctor as resource. Drawing on contemporary poststructuralist theory of text and identity construction, and on innovative models of work-based learning, the potential quality of relationship between student and patient is articulated in terms of collaborative knowledge production, involving close reading with the patient as text, through dialogue. Here, a medical 'education' displaces traditional forms of medical 'training' that typically involve individual information reproduction. Students may, paradoxically, improve clinical acumen through consideration of silences, gaps, and contradictions in patients as texts, rather than treating communication as transparent. Such paradoxical effects have been systematically occluded or denied in traditional medical education.

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.

Participation in research improves overall patient management: insights from the Global Rheumatic Heart Disease registry (REMEDY).

PubMed

Prendergast, E A; Perkins, S; Engel, M E; Cupido, B; Francis, V; Joachim, A; Al Kebsi, M; Bode-Thomas, F; Damasceno, A; Abul Fadl, A; El Sayed, A; Gitura, B; Kennedy, N; Ibrahim, A; Mucumbitsi, J; Adeoye, A M; Musuku, J; Okello, E; Olunuga, T; Sheta, S; Mayosi, B M; Zühlke, L J

Rheumatic heart disease (RHD) is a major public health problem in low- and middle-income countries (LIMCs), with a paucity of high-quality trial data to improve patient outcomes. Investigators felt that involvement in a recent large, observational RHD study impacted positively on their practice, but this was poorly defined. The purpose of this study was to document the experience of investigators and research team members from LMICs who participated in a prospective, multi-centre study, the global Rheumatic Heart Disease Registry (REMEDY), conducted in 25 centres in 14 countries from 2010 to 2012. We conducted an online survey of site personnel to identify and quantify their experiences. Telephone interviews were conducted with a subset of respondents to gather additional qualitative data. We asked about their experiences, positive and negative, and about any changes in RHD management practices resulting from their participation in REMEDY as a registry site. The majority of respondents in both the survey and telephone interviews indicated that participation as a registry site improved their management of RHD patients. Administrative changes included increased attention to follow-up appointments and details in patient records. Clinical changes included increased use of penicillin prophylaxis, and more frequent INR monitoring and contraceptive counselling. Our study demonstrates that participation in clinical research on RHD can have a positive impact on patient management. Furthermore, REMEDY has led to increased patient awareness and improved healthcare workers' knowledge and efficiency in caring for RHD patients.

Burnout, psychological morbidity and use of coping mechanisms among palliative care practitioners: A multi-centre cross-sectional study.

PubMed

Koh, Mervyn Yong Hwang; Chong, Poh Heng; Neo, Patricia Soek Hui; Ong, Yew Jin; Yong, Woon Chai; Ong, Wah Ying; Shen, Mira Li Juan; Hum, Allyn Yin Mei

2015-07-01

The prevalence of burnout, psychological morbidity and the use of coping mechanisms among palliative care practitioners in Singapore have not been studied. We aimed to study the prevalence of burnout and psychological morbidity among palliative care practitioners in Singapore and its associations with demographic and workplace factors as well as the use of coping mechanisms. This was a multi-centre, cross-sectional study of all the palliative care providers within the public healthcare sector in Singapore. The study was conducted in hospital palliative care services, home hospice and inpatient hospices in Singapore. The participants were doctors, nurses and social workers. The prevalence of burnout among respondents in our study was 91 of 273 (33.3%) and psychological morbidity was 77 (28.2%). Working >60 h per week was significantly associated with burnout (odds ratio: 9.02, 95% confidence interval: 2.3-35.8, p = 0.002) and psychological morbidity (odds ratio: 7.21, 95% confidence interval: 1.8-28.8, p = 0.005). Home hospice care practitioners (41.5%) were more at risk of developing psychological morbidity compared to hospital-based palliative care (17.5%) or hospice inpatient care (26.0%) (p = 0.007). Coping mechanisms like physical well-being, clinical variety, setting boundaries, transcendental (meditation and quiet reflection), passion for one's work, realistic expectations, remembering patients and organisational activities were associated with less burnout. Our results reveal that burnout and psychological morbidity are significant in the palliative care community and demonstrate a need to look at managing long working hours and promoting the use of coping mechanisms to reduce burnout and psychological morbidity. © The Author(s) 2015.

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.

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

[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.

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.

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

A structured tool to improve clinical outcomes of Type 2 diabetes mellitus patients: A randomised controlled trial.

PubMed

Ayadurai, Shamala; Sunderland, V Bruce; Tee, Lisa Bg; Md Said, Siti Norlina; Hattingh, H Laetitia

2018-06-07

A review of pharmacist diabetes intervention studies revealed lack of structured process in providing diabetes care which consequently produced varied results from increased to minimal improvements. This study aimed to determine the effectiveness of a structured clinical guidelines tool, the Simpler™ tool, in the delivery of diabetes care. The primary outcome was significant improvement in HbA1c (glycated haemoglobin). Secondary outcomes were improved lipid profiles and blood pressure (BP). A 6-month, parallel, multi-centre, two arms, randomised controlled trial involving 14 pharmacists at seven primary care clinics was conducted in Johor, Malaysia. Pharmacists without prior specialised diabetes training were trained to use the tool. Patients were randomised within each centre to: 1) Simpler™ care (SC), receiving care from pharmacists who applied the tool (n=55); 2) Usual care (UC), receiving usual care and dispensing services (n=69). SC reduced HbA1c significantly by 1.59% (95%CI: -2.2, -0.9) compared to 0.25% (95%CI: -0.62, 0.11), (P=<0.001) in UC. In addition, SC patients had significantly improved systolic BP: (-6.28 mmHg (95%CI: -10.5, 2.0), p=0.005). The proportion of patients who reached the Malaysian guideline treatment goals were significantly more in the SC arm (14.3% vs 1.5% for HbA1c, p=0.020; 80% vs 42% for systolic BP, p=0.001; 60.5% vs 40.4% for LDL cholesterol, p=0.046). Use of the Simpler™ tool facilitated delivery of comprehensive evidence-based diabetes management and significantly improved clinical outcomes. The Simpler™ tool supported pharmacists in providing enhanced structured diabetes care. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

MO-DE-BRA-03: The Ottawa Medical Physics Institute (OMPI): A Practical Model for Academic Program Collaboration in a Multi-Centre City

DOE Office of Scientific and Technical Information (OSTI.GOV)

McEwen, M; Rogers, D; Johns, P

Purpose: To build a world-class medical physics educational program that capitalizes on expertise distributed over several clinical, government, and academic centres. Few if any of these centres would have the critical mass to solely resource a program. Methods: In order to enable an academic program, stakeholders from five institutions made a proposal to Carleton University for a) a research network with defined membership requirements and a process for accepting new members, and b) a graduate specialization (MSc and PhD) in medical physics. Both proposals were accepted and the program has grown steadily. Our courses are taught by medical physicists frommore » across the collaboration. Our students have access to physicists in: clinical radiotherapy (the Ottawa Cancer Centre treats 4500 new patients/y), radiology, cardiology and nuclear medicine, Canada’s primary standards dosimetry laboratory, radiobiology, and university-based medical physics research. Our graduate courses emphasize the foundational physics plus applied aspects of imaging, radiotherapy, and radiobiology. Active researchers in the city-wide volunteer-run network are appointed as adjunct professors by Physics, giving them access to national funding competitions and partial student funding through teaching assistantships while opening up facilities in their institutions for student thesis research. Results: The medical physics network has grown to ∼40 members from eight institutions and includes five full-time faculty in Physics and 17 adjunct research professors. The graduate student population is ∼20. Our graduates have proceeded to a spectrum of careers. Our alumni list includes a CCPM Past-President, the current COMP President, many clinical physicists, and the heads of at least three major clinical medical physics departments. Our PhD was Ontario’s first CAMPEP-accredited program. Conclusion: A self-governing volunteer network is the foundational element that enables an MSc/PhD medical physics program in a city with multiple physicist employers. It enriches graduate education with an unusually broad range of expertise.« less

The difference in learning culture and learning performance between a traditional clinical placement, a dedicated education unit and work-based learning.

PubMed

Claeys, Maureen; Deplaecie, Monique; Vanderplancke, Tine; Delbaere, Ilse; Myny, Dries; Beeckman, Dimitri; Verhaeghe, Sofie

2015-09-01

An experiment was carried out on the bachelor's degree course in nursing with two new clinical placement concepts: workplace learning and the dedicated education centre. The aim was to establish a learning culture that creates a sufficiently high learning performance for students. The objectives of this study are threefold: (1) to look for a difference in the "learning culture" and "learning performance" in traditional clinical placement departments and the new clinical placement concepts, the "dedicated education centre" and "workplace learning"; (2) to assess factors influencing the learning culture and learning performance; and (3) to investigate whether there is a link between the learning culture and the learning performance. A non-randomised control study was carried out. The experimental group consisted of 33 final-year nursing undergraduates who were following clinical placements at dedicated education centres and 70 nursing undergraduates who undertook workplace learning. The control group consisted of 106 students who followed a traditional clinical placement. The "learning culture" outcome was measured using the Clinical Learning Environment, Supervision and Nurse Teacher scale. The "learning performance" outcome consisting of three competencies was measured using the Nursing Competence Questionnaire. The traditional clinical placement concept achieved the highest score for learning culture (p<0.001). The new concepts scored higher for learning performance of which the dedicated education centres achieved the highest scores. The 3 clinical placement concepts showed marked differences in learning performance for the "assessment" competency (p<0.05) and for the "interventions" competency (p<0.05). Traditional clinical placement, a dedicated education centre and workplace learning can be seen as complementary clinical placement concepts. The organisation of clinical placements under the dedicated education centre concept and workplace learning is recommended for final-year undergraduate nursing students. Copyright © 2015 Elsevier Ltd. All rights reserved.

Navigating the fine line between benefit and risk in chronic atrial fibrillation: rationale and design of the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY).

PubMed

Carrington, Melinda J; Ball, Jocasta; Horowitz, John D; Marwick, Thomas H; Mahadevan, Gnanadevan; Wong, Chiew; Abhayaratna, Walter P; Haluska, Brian; Thompson, David R; Scuffham, Paul A; Stewart, Simon

2013-06-20

Health outcomes associated with atrial fibrillation (AF) continue to be poor and standard management often does not provide clinical stability. The Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY) compares the efficacy of a post-discharge, nurse-led, multi-disciplinary programme to optimise AF management with usual care. SAFETY is a prospective, multi-centre, randomised controlled trial with blinded-endpoint adjudication. A target of 320 hospitalised patients with a chronic form of AF will be randomised (stratified by "rate" versus "rhythm" control) to usual post-discharge care or the SAFETY Intervention (SI). The SI involves home-based assessment, extensive clinical profiling and the application of optimal gold-standard pharmacology which is individually tailored according to a "traffic light" framework based on clinical stability, risk profile and therapeutic management. The primary endpoint is event-free survival from all-cause death or unplanned readmission during 18-36 months follow-up. Secondary endpoints include rate of recurrent hospital stay, treatment success (i.e. maintenance of rhythm or rate control and/or application of anti-thrombotic therapy without a bleeding event) and cost-efficacy. With study recruitment to be completed in early 2012, the results of this study will be available in early 2014. If positive, SAFETY will represent a potentially cost-effective and readily applicable strategy to improve health outcomes in high risk individuals discharged from hospital with chronic AF. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

French database of children and adolescents with Prader-Willi syndrome

PubMed Central

Molinas, Catherine; Cazals, Laurent; Diene, Gwenaelle; Glattard, Melanie; Arnaud, Catherine; Tauber, Maithe

2008-01-01

Background Prader-Willi syndrome (PWS) is a rare multisystem genetic disease leading to severe complications mainly related to obesity. We strongly lack information on the natural history of this complex disease and on what factors are involved in its evolution and its outcome. One of the objectives of the French reference centre for Prader-Willi syndrome set-up in 2004 was to set-up a database in order to make the inventory of Prader-Willi syndrome cases and initiate a national cohort study in the area covered by the centre. Description the database includes medical data of children and adolescents with Prader-Willi syndrome, details about their management, socio-demographic data on their families, psychological data and quality of life of the parents. The tools and organisation used to ensure data collection and data quality in respect of good clinical practice procedures are discussed, and main characteristics of our Prader-Willi population at inclusion are presented. Conclusion this database covering all the aspects of PWS clinical, psychological and social profiles, including familial psychological and quality of life will be a powerful tool for retrospective studies concerning this complex and multi factorial disease and could be a basis for the design of future prospective multicentric studies. The complete database and the Stata.do files are available to any researcher wishing to use them for non-commercial purposes and can be provided upon request to the corresponding author. PMID:18831731

Perioperative intravenous fluid prescribing: a multi-centre audit.

PubMed

Harris, Benjamin; Schopflin, Christian; Khaghani, Clare; Edwards, Mark

2015-01-01

Excessive or inadequate intravenous fluid given in the perioperative period can affect outcomes. A number of guidelines exist but these can conflict with the entrenched practice, evidence base and prescriber knowledge. We conducted a multi-centre audit of intraoperative and postoperative intravenous fluid therapy to investigate fluid administration practice and frequency of postoperative electrolyte disturbances. A retrospective audit was done in five hospitals of adult patients undergoing elective major abdominal, gastrointestinal tract or orthopaedic surgery. The type, volume and quantity of fluid and electrolytes administered during surgery and in 3 days postoperatively was calculated, and electrolyte disturbances were studied using clinical records. Data from four hundred thirty-one patients in five hospitals covering 1157 intravenous fluid days were collected. Balanced crystalloid solutions were almost universally used in the operating theatre and were also the most common fluid administered postoperatively, followed by hypotonic dextrose-saline solutions and 0.9 % sodium chloride. For three common uncomplicated elective operations, the volume of fluid administered intraoperatively demonstrated considerable variability. Over half of the patients received no postoperative fluid on day 1, and even more were commenced on free oral fluids immediately postoperatively or on day 1. Postoperative quantities of sodium exceeded the recommended amounts for maintenance in half of the patients who continued to receive intravenous fluids. Potassium administration in those receiving intravenous fluids was almost universally inadequate. Hypokalaemia and hyponatraemia were the common findings. We documented the current clinical practice and confirmed that early free oral fluids and cessation of any intravenous fluids is common postoperatively in keeping with the aims of enhanced recovery after surgery programmes. Excessive sodium and water and inadequate potassium in those given intravenous fluids postoperatively is common and needs to be investigated. The variation in intraoperative fluid volume administration for three common procedures is considerable and in keeping with other international studies. Future trials of fluid therapy should include the intraoperative and postoperative phases.

Food security is related to adult type 2 diabetes control over time in a United States safety net primary care clinic population.

PubMed

Shalowitz, M U; Eng, J S; McKinney, C O; Krohn, J; Lapin, B; Wang, C-H; Nodine, E

2017-05-15

Successful Type 2 diabetes management requires adopting a high nutrient-density diet made up of food items that both meet dietary needs and preferences and can be feasibly obtained on a regular basis. However, access to affordable, nutrient-dense foods often is lacking in poorer neighbourhoods. Therefore, low food security should directly impair glucose control, even when patients have full access to and utilize comprehensive medical management. The present study sought to determine whether food security is related longitudinally to glucose control, over-and-above ongoing medication management, among Type 2 diabetes patients receiving comprehensive care at a Midwestern multi-site federally qualified health centre (FQHC). In this longitudinal observational study, we completed a baseline assessment of patients' food security (using the US Household Food Security Module), demographics (via Census items), and diabetes history/management (using a structured clinical encounter form) when patients began receiving diabetes care at the health centre. We then recorded those patients' A1C levels several times during a 24-month follow-up period. Three hundred and ninety-nine patients (56% with low food security) had a baseline A1c measurement; a subsample of 336 (median age=52 years; 56% female; 60% Hispanic, 27% African American, and 9% White) also had at least one follow-up A1c measurement. Patients with lower (vs higher) food security were more likely to be on insulin and have higher A1c levels at baseline. Moreover, the disparity in glucose control by food security status persisted throughout the next 2 years. Although results were based on one multi-site FQHC, potentially limiting their generalizability, they seem to suggest that among Type 2 diabetes patients, low food security directly impairs glucose control-even when patients receive full access to comprehensive medical management-thereby increasing their long-term risks of high morbidity, early mortality, and high health-care utilization and cost.

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.

Making the most of person-centred education by integrating flipped and simulated teaching: An exploratory study.

PubMed

Saunders, Annette; Green, Rosy; Cross, Merylin

2017-11-01

Preparing a person-centred nursing workforce to work in diverse settings is a global health priority. Nursing students' first placement experience is a key transitional moment that shapes professional understanding and motivation to become a nurse. This paper reports the outcomes of combining flipped and simulated learning to enhance nursing students' understanding of person-centred care, the professional nursing role and preparation for placement. The study design was exploratory, the setting, an undergraduate nursing program in an Australian University. Participants included first year nursing students, academic tutors and clinical facilitators. Data collected via survey, semistructured interviews and focus group discussion were analysed descriptively and thematically. Over 90% of students surveyed considered the unit structure, content and resources prepared them well for placement. Pre-class preparation and simulated tutorial activities facilitated student engagement and knowledge translation. Students, tutors and clinical facilitators valued the person-centred approach. Tutors considered the unit materials and focus enhanced students' professional understanding. Clinical facilitators deemed students well-prepared for placement. These results from multiple perspectives, though limited, support combining the flipped classroom and person-centred simulation in nursing education as a strategy to prepare students for clinical placement, translate person-centred values into practice and promote professional understanding and role socialisation. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

Asymptomatic population reference values for three knee patient-reported outcomes measures: evaluation of an electronic data collection system and implications for future international, multi-centre cohort studies.

PubMed

McLean, James M; Brumby-Rendell, Oscar; Lisle, Ryan; Brazier, Jacob; Dunn, Kieran; Gill, Tiffany; Hill, Catherine L; Mandziak, Daniel; Leith, Jordan

2018-05-01

The aim was to assess whether the Knee Society Score, Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) were comparable in asymptomatic, healthy, individuals of different age, gender and ethnicity, across two remote continents. The purpose of this study was to establish normal population values for these scores using an electronic data collection system. There is no difference in clinical knee scores in an asymptomatic population when comparing age, gender and ethnicity, across two remote continents. 312 Australian and 314 Canadian citizens, aged 18-94 years, with no active knee pain, injury or pathology in the ipsilateral knee corresponding to their dominant arm, were evaluated. A knee examination was performed and participants completed an electronically administered questionnaire covering the subjective components of the knee scores. The cohorts were age- and gender-matched. Chi-square tests, Fisher's exact test and Poisson regression models were used where appropriate, to investigate the association between knee scores, age, gender, ethnicity and nationality. There was a significant inverse relationship between age and all assessment tools. OKS recorded a significant difference between gender with females scoring on average 1% lower score. There was no significant difference between international cohorts when comparing all assessment tools. An electronic, multi-centre data collection system can be effectively utilized to assess remote international cohorts. Differences in gender, age, ethnicity and nationality should be taken into consideration when using knee scores to compare to pathological patient scores. This study has established an electronic, normal control group for future studies using the Knee society, Oxford, and KOOS knee scores. Diagnostic Level II.

[Renal insufficiency and clinical outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a multi-centre study].

PubMed

Huo, Yong; Ho, Wa

2007-12-18

To investigate the association of renal insufficiency and clinical outcomes in patients with acute coronary syndrome(ACS). The study was a multi-centre register study including 3,589 ACS patients coming from 39 centers across China who had received percutaneous coronary intervention(PCI) prior to 1st February, 2007. Estimated glomerular filtration rate (eGFR) was calculated for all patients using the 4-variable MDRD equation with the serum creatinine obtained before angiography. The association between renal insufficiency and clinical outcomes and the presence of in-hospital death and bleeding was studied by Fisher's exact test. Multi-variable analysis on the risk factors of in-hospital bleeding was done by logistic regression test. The mean age of the study population was (61.74+/-11.37) years (ranging from 23 years to 92 years)and 76.5% (2,746/3,589) of the population was male. Only 90 patients (2.51%) were known to have chronic kidney disease at the time of admission and 144 patients(4.01%) had serum creatinine levels above 133 micromol/L. However, after the evaluation of renal status by the MDRD equation, 2,250 patients (63.1%)showed a reduction in eGFR of less than 90 mL/min, of whom, 472 (13.1%) even reached the level of moderate renal insufficiency (eGFR<60 mL/min) and above. Seven patients(0.20%) were proved to have chronic total occlusion lesions(CTO) and eight (0.22%) needed shift to coronary artery bypass grafting (CABG) after angiography. Both the presence of CTO lesions and CABG were proved to be associated with decrease of renal function through Fisher's exact test (P= 0.005 8 and 0.041, respectively). The in-hospital mortality rate was 0.47%(17/3 589) which was associated with the degree of renal insufficiency (P=0.001 3). A total of 75 patients(2.09%) of in-hospital bleeding were recorded with 26 patients(0.72%) diagnosed as major bleeding events. 92% (69/75) of the bleeding events occurred after PCI. Bleeding was found to be associated with the degree of renal insufficiency in every type of antithrombotic therapy (P<0.001). After adjusting with other variables by logistic regression test, renal insufficiency (eGFR per 10 mL/min decrease, OR=1.133, 95% CI 1.011- 1.27, P=0.032)and age (above 65 years, OR=1.907, 95% CI 1.107-3.28, P=0.02) were proved to be the risk factors of in-hospital bleeding. Renal insufficiency is very common in ACS patients but self-report rate is low among this population. Renal function evaluated by eGFR should be carried out for every patient hospitalized for ACS for risk stratification. Patients with severer renal insufficiency usually have more complicated clinical manifestations and a higher rate of in-hospital bleeding.

Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument.

PubMed

Espinoza-Zamora, José Ramiro; Portilla-Espinosa, César Miguel; Labardini-Méndez, Juan Rafael; Cervera, Eduardo; Niesvisky, Ruben; Oñate-Ocaña, Luis F

2015-06-01

Health-related quality of life (HRQL) has become an important outcome measurement in hematology. Our aim was to validate the quality of life questionnaire (QLQ)-MY20 instrument in patients with multiple myeloma (MM) in Mexico. The Mexican-Spanish versions of the QLQ-C30 and QLQ-MY20 instruments were applied to patients with MM at a cancer referral centre. Reliability and validity tests were performed. Test-retest was carried out in selected patients. Ninety-eight patients with MM were included in this study. Questionnaire compliance rates were high, and the instrument was well accepted; internal consistency tests demonstrated good convergent and divergent validity. Cronbach's α coefficients of seven of nine multi-item scales of the QLQ-C30 and of all three multi-item scales of the QLQ-MY20 instruments were >0.7 (range, 0.36-0.89). The scales of the QLQ-C30 and QLQ-MY20 instruments distinguished among clinically distinct groups of patients; 9 of 15 scales of the QLQ-C30 and all 4 scales of the QLQ-MY20 presented responsiveness after change over time. The Mexican-Spanish version of the QLQ-MY20 questionnaire is reliable and valid for the assessment of HRQL in patients with MM and can be used in clinical trials in the Mexican community.

Addiction research centres and the nurturing of creativity: The Centre for Addictions Research of British Columbia, Canada

PubMed Central

Stockwell, Tim; Reist, Dan; Macdonald, Scott; Benoit, Cecilia; Jansson, Mikael

2015-01-01

The Centre for Addictions Research of British Columbia (CARBC) was established as a multi-campus and multi-disciplinary research centre administered by the University of Victoria (UVic) in late 2003. Its core funding is provided from interest payments on an endowment of CAD$10.55 million. It is supported by a commitment to seven faculty appointments in various departments at UVic. The Centre has two offices, an administration and research office in Victoria and a knowledge exchange unit in Vancouver. The two offices are collaborating on the implementation of CARBC’s first 5-year plan which seeks to build capacity in British Columbia for integrated multi-disciplinary research and knowledge exchange in the areas substance use, addictions and harm reduction. Present challenges include losses to the endowment caused by the 2008/2009 economic crisis and difficulties negotiating faculty positions with the university administration. Despite these hurdles, to date each year has seen increased capacity for the Centre in terms of affiliated scientists, funding and staffing as well as output in terms of published reports, electronic resources and impacts on policy and practice. Areas of special research interest include: drug testing in the work-place, epidemiological monitoring, substance use and injury, pricing and taxation policies, privatization of liquor monopolies, poly-substance use, health determinants of indigenous peoples, street-involved youth and other vulnerable populations at risk of substance use problems. Further information about the Centre and its activities can be found on http://www.carbc.ca. PMID:20078479

Novel robotic catheter manipulation system integrated with remote magnetic navigation for fully remote ablation of atrial tachyarrhythmias: a two-centre evaluation.

PubMed

Nölker, Georg; Gutleben, Klaus-Jürgen; Muntean, Bogdan; Vogt, Jürgen; Horstkotte, Dieter; Dabiri Abkenari, Lara; Akca, Ferdi; Szili-Torok, Tamas

2012-12-01

Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium. This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system. The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.

UK Renal Registry 16th annual report: chapter 12 biochemical variables amongst UK adult dialysis patients in 2012: national and centre-specific analyses.

PubMed

Nicholas, Johann; Shaw, Catriona; Pitcher, David; Dawnay, Anne

2013-01-01

The UK Renal Association clinical practice guidelines include clinical performance measures for biochemical variables in dialysis patients. The UK Renal Registry (UKRR) annually audits dialysis centre performance against these measures as part of its role in promoting continuous quality improvement. Cross sectional performance analyses were undertaken to compare dialysis centre achievement of clinical audit measures for prevalent haemodialysis (HD) and peritoneal dialysis (PD) cohorts in 2012. The biochemical variables studied were phosphate, adjusted calcium, parathyroid hormone, bicarbonate and total cholesterol. In addition, longitudinal analyses were performed (2002-2012) to show changes in achievement of clinical performance measures over time. Fifty-six percent of HD and 61% of PD patients achieved a phosphate within the range recommended by the RA clinical practice guidelines. Seventy-seven percent of HD and 78% of PD patients had adjusted calcium between 2.2-2.5 mmol/L. Fifty-eight percent of HD and 65% of PD patients had parathyroid hormone between 16-72 pmol/L. Fifty-nine percent of HD and 80% of PD patients achieved the audit measure for bicarbonate. There was significant inter-centre variation for all variables studied. The UKRR consistently demonstrates significant inter-centre variation in achievement of biochemical clinical audit measures. Understanding the causes of this variation is an important part of improving the care of dialysis patients in the UK.

Chapter 9 Biochemical variables amongst UK adult dialysis patients in 2010: national and centre-specific analyses.

PubMed

Pruthi, Rishi; Pitcher, David; Dawnay, Anne

2012-01-01

The UK Renal Association clinical practice guidelines include clinical performance measures for biochemical variables in dialysis patients. The UK Renal Registry (UKRR) annually audits dialysis centre performance against these measures as part of its role in promoting continuous quality improvement. Cross sectional performance analyses were undertaken to compare dialysis centre achievement of clinical audit measures for prevalent haemodialysis (HD) and peritoneal dialysis (PD) cohorts in 2010. The biochemical variables studied were phosphate, adjusted calcium, parathyroid hormone, bicarbonate and total cholesterol. In addition longitudinal analyses were performed (2000-2010) to show changes in achievement of clinical performance measures over time. Fifty-six percent of HD and 69% of PD patients achieved a phosphate within the range recommended by the RA clinical practice guidelines. Seventy-five percent of HD and 76% of PD patients had adjusted calcium between 2.2-2.5 mmol/L. Twenty-eight percent of HD and 31% of PD patients had parathyroid hormone between 16- 32 pmol/L. Sixty percent of HD and 80% of PD patients achieved the audit measure for bicarbonate. There was significant inter-centre variation for all variables studied. The UKRR consistently demonstrates significant inter-centre variation in achievement of biochemical clinical audit measures. Understanding the causes of this variation is an important part of improving the care of dialysis patients in the UK. Copyright © 2012 S. Karger AG, Basel.

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.

Lack of efficacy of a reduced microparticle diet in a multi-centred trial of patients with active Crohn's disease.

PubMed

Lomer, Miranda C E; Grainger, Stephen L; Ede, Roland; Catterall, Adrian P; Greenfield, Simon M; Cowan, Russell E; Vicary, F Robin; Jenkins, Anthony P; Fidler, Helen; Harvey, Rory S; Ellis, Richard; McNair, Alistair; Ainley, Colin C; Thompson, Richard P H; Powell, Jonathan J

2005-03-01

Dietary microparticles, which are bacteria-sized and non-biological, found in the modern Western diet, have been implicated in both the aetiology and pathogenesis of Crohn's disease. Following on from the findings of a previous pilot study, we aimed to confirm whether a reduction in the amount of dietary microparticles facilitates induction of remission in patients with active Crohn's disease, in a single-blind, randomized, multi-centre, placebo controlled trial. Eighty-three patients with active Crohn's disease were randomly allocated in a 2 x 2 factorial design to a diet low or normal in microparticles and/or calcium for 16 weeks. All patients received a reducing dose of prednisolone for 6 weeks. Outcome measures were Crohn's disease activity index, Van Hees index, quality of life and a series of objective measures of inflammation including erythrocyte sedimentation rate, C-reactive protein, intestinal permeability and faecal calprotectin. After 16 weeks patients returned to their normal diet and were followed up for a further 36 weeks. Dietary manipulation provided no added effect to corticosteroid treatment on any of the outcome measures during the dietary trial (16 weeks) or follow-up (to 1 year); e.g., for logistic regression of Crohn's disease activity index based rates of remission (P=0.1) and clinical response (P=0.8), in normal versus low microparticle groups. Our adequately powered and carefully controlled dietary trial found no evidence that reducing microparticle intake aids remission in active Crohn's disease.

Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

PubMed

de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

2013-05-24

The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive and neuropathic pain. Therefore, pain relief can be thoroughly evaluated. NTR1089.

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.

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

PubMed Central

2014-01-01

Background Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. Methods/Design FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. Discussion This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. Trial registration The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813). PMID:24965132

Is "Object-Centred Neglect" a Homogeneous Entity?

ERIC Educational Resources Information Center

Gainotti, Guido; Ciaraffa, Francesca

2013-01-01

The nature of object-centred (allocentric) neglect and the possibility of dissociating it from egocentric (subject-centred) forms of neglect are controversial. Originally, allocentric neglect was described by and in patients who reproduced all the elements of a multi-object scene, but left unfinished the left side of one or more of them. More…

A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement

ClinicalTrials.gov

2016-08-03

Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Efficacy of ultra-micronized palmitoylethanolamide in canine atopic dermatitis: an open-label multi-centre study.

PubMed

Noli, Chiara; Della Valle, M Federica; Miolo, Alda; Medori, Cristina; Schievano, Carlo

2015-12-01

Palmitoylethanolamide is a naturally occurring bioactive lipid, produced on-demand by damage-exposed cells. Palmitoylethanolamide is documented to counteract inflammation, itch and pain. The aim of this 8-week study was to evaluate the efficacy of oral ultra-micronized palmitoylethanolamide (PEA-um) in dogs with moderate atopic dermatitis. Clinicians from 39 veterinary clinics enrolled 160 dogs with nonseasonal atopic dermatitis and moderate pruritus. This was a multi-centre open-label study. On days 0 (D0) and 56 (D56), owners evaluated pruritus with a Visual Analog Scale (VAS) and completed a validated Quality of Life (QoL) questionnaire. Veterinarians assessed the severity of skin lesions using the Canine Atopic Dermatitis Lesion Index (CADLI). Mean pruritus VAS score decreased from 5.7 ± 0.08 cm (range 3.8-7.9 cm) to 3.63 ± 0.19 cm (range 0.1-9.2 cm) (P < 0.0001). At D56, 58% of dogs showed a greater than 2 cm reduction from baseline and 30% showed an absent-to-very mild pruritus (VAS ≤ 2 cm). Mean total CADLI at D56 decreased significantly (P < 0.0001); in 62% of dogs this score reached a value in the remission range (≤5). Mean total QoL score was significantly decreased (P < 0.0001) with 45% of dogs reaching QoL values described for healthy animals. Tolerability was good-to-excellent with only four dogs reporting treatment associated reversible adverse events. PEA-um appears to be effective and safe in reducing pruritus and skin lesions, and in improving QoL in dogs with moderate atopic dermatitis and moderate pruritus. © 2015 Innovet Italia Srl. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and ACVD.

What specifications for a centre or network of excellence in clinical research?

PubMed

Diebolt, Vincent; Lang, Marie; Thoby, Frédérique

2016-02-01

The Giens 2015 Workshop Round Table entitled "What specifications for a centre or network of excellence in clinical research?" took a viewpoint distinct from earlier work and studies on changes in clinical research activities in France. The purpose of the present work was to identify, starting from concrete examples, the main strengths and advantages of clinical research activity in France related, in part, to the background environment and also to the specific characteristics of the investigation centres considered to be among the most high-performance units in activity. The criteria retained were grouped into a set of specifications that could be used to establish a "label of excellence" upon which the different teams and clinical research centres could model themselves. It was thus considered that belonging to a centre or structured network with at least a national configuration, when this is possible for the medial topic in question, constitutes a real advantage. Four benchmarks were identified: the scientific and clinical expertise of the head investigator, as well as the qualification and operational capacity of the centre's team; definition and measurement of performance using clearly displayed indicators and evaluation procedures; the quality of the overall trial "process" and of each of its component steps; communication, because know-how and promotion go hand in hand, with the main objective of informing the professional and general public about the value of the research centre meeting the above-mentioned criteria, about its networks of competencies, and more generally, about the important assets of the background of clinical research in France. This sector of research is funded by the public authorities via calls for public grants, financial aids for structures supporting clinical research in the University Hospital Centres and other healthcare institutions allowing for a professionalization of the research occupations, and the national public health plans (cancer, rare disease, HIV). Copyright © 2016. Published by Elsevier Masson SAS.

A protocol for evaluating progressive levels of simulation fidelity in the development of technical skills, integrated performance and woman centred clinical assessment skills in undergraduate midwifery students

PubMed Central

2013-01-01

Background Simulation as a pedagogical approach has been used in health professional education to address the need to safely develop effective clinical skills prior to undertaking clinical practice. However, evidence for the use of simulation in midwifery is largely anecdotal, and research evaluating the effectiveness of different levels of simulation fidelity are lacking. Woman centred care is a core premise of the midwifery profession and describes the behaviours of an individual midwife who demonstrates safe and effective care of the individual woman. Woman centred care occurs when the midwife modifies the care to ensure the needs of each individual woman are respected and addressed. However, a review of the literature demonstrates an absence of a valid and reliable tool to measure the development of woman centred care behaviours. This study aims to determine which level of fidelity in simulated learning experiences provides the most effective learning outcomes in the development of woman centred clinical assessment behaviors and skills in student midwives. Methods/Design Three-arm, randomised, intervention trial. In this research we plan to: a) trial three levels of simulation fidelity - low, medium and progressive, on student midwives performing the procedure of vaginal examination; b) measure clinical assessment skills using the Global Rating Scale (GRS) and Integrated Procedural Performance Instrument (IPPI); and c) pilot the newly developed Woman Centred Care Scale (WCCS) to measure clinical behaviors related to Woman-Centredness. Discussion This project aims to enhance knowledge in relation to the appropriate levels of fidelity in simulation that yield the best educational outcomes for the development of woman centred clinical assessment in student midwives. The outcomes of this project may contribute to improved woman centred clinical assessment for student midwives, and more broadly influence decision making regarding education resource allocation for maternity simulation. PMID:23706037

Indian Institute of Technology Bombay and Tata Memorial Centre Join the International Efforts in Clinical Proteogenomics Cancer Research | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute’s (NCI) Office of Cancer Clinical Proteomics Research, part of the National Institutes of Health, along with the Indian Institute of Technology Bombay (IITB) and Tata Memorial Centre (TMC) have signed a Memorandum of Understanding (MOU) on clinical proteogenomics cancer research. The MOU between NCI, IITB, and Tata Memorial Centre represents the thirtieth and thirty-first institutions and the twelfth country to join the International Cancer Proteogenome Consortium (ICPC). The purpose of the MOU is to facilitate scientific and programmatic collaborations between NCI, IITB, and TMC in basic and clinical proteogenomic studies leading to patient care and public dissemination and information sharing to the research community.

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.

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.

Erythropoietin as a novel brain and kidney protective agent.

PubMed

Moore, E M; Bellomo, R; Nichol, A D

2011-05-01

Erythropoietin is a 30.4 kDa glycoprotein produced by the kidney, which is mostly known for its physiological function in regulating red blood cell production in the bone marrow Accumulating evidence, however suggests that erythropoietin has additional organ protective effects, which may specifically be useful in protecting the brain and kidneys from injury. Experimental evidence suggests that these protective mechanisms are multi-factorial in nature and may include inhibition of apoptotic cell death, stimulation of cellular regeneration, inhibition of deleterious pathways and promotion of recovery. In this article we review the physiology of erythropoietin, assess previous work that supports the role of erythropoietin as a general tissue protective agent and explain the mechanisms by which it may achieve this tissue protective effect. We then focus on specific laboratory and clinical data that suggest that erythropoietin has a strong brain protective and kidney protective effect. In addition, we comment on the implications of these studies for clinicians at the bedside and for researchers designing controlled trials to further elucidate the true clinical utility of erythropoietin as a neuroprotective and nephroprotective agent. Finally, we describe EPO-TBI, a double-blinded multi-centre randomised controlled trial involving the authors that is being conducted to investigate the organ protective effects of erythropoietin on the brain, and also assesses its effect on the kidneys.

75 FR 63488 - Submission for OMB Review; Comment Request; Multi-Ethnic Study of Atherosclerosis (MESA) Event...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... of subclinical cardiovascular disease (CVD)-- that is, atherosclerosis and other forms of CVD that... Cardiovascular Sciences, NHLBI, NIH, II Rockledge Centre, 6701 Rockledge Drive, Suite 10122, MSC 7936, Bethesda...

A multi-frequency EPR and ENDOR study of Rh and Ir complexes in alkali and silver halides

NASA Astrophysics Data System (ADS)

Callens, F.; Vrielinck, H.; Matthys, P.

2003-01-01

Aliovalent Rh and Ir cations have been frequently used to influence the photographic properties of silver halide emulsions. The doping introduces several types of related defects with distinct trapping and recombination properties. EPR and ENDOR are, in principle, ideally suited for the determination of the microscopic structure of the individual centres but it will be demonstrated that well-chosen, sometimes sophisticated multi-frequency experiments are necessary in order to (partially) reach this goal. Model studies on single crystals of AgCl and NaCl also appeared indispensable for the unravelling of the spectra. In the review of Rh-centres in NaCl and AgCl special attention is paid to methods that allow to detect cation vacancies near Rh2+ complexes. An alternative explanation for the high temperature behaviour of the [RhCl6](4-) complexes in AgCl is presented.

Compliance with clothing regulations and traffic flow in the operating room: a multi-centre study of staff discipline during surgical procedures.

PubMed

Loison, G; Troughton, R; Raymond, F; Lepelletier, D; Lucet, J-C; Avril, C; Birgand, G

2017-07-01

This multi-centre study assessed operating room (OR) staff compliance with clothing regulations and traffic flow during surgical procedures. Of 1615 surgical attires audited, 56% respected the eight clothing measures. Lack of compliance was mainly due to inappropriate wearing of jewellery (26%) and head coverage (25%). In 212 procedures observed, a median of five people [interquartile range (IQR) 4-6] were present at the time of incision. The median frequency of entries to/exits from the OR was 10.6/h (IQR 6-29) (range 0-93). Reasons for entries to/exits from the OR were mainly to obtain materials required in the OR (N=364, 44.5%). ORs with low compliance with clothing regulations tended to have higher traffic flows, although the difference was not significant (P=0.12). Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Allocation of substance use disorder patients to appropriate levels of care: feasibility of matching guidelines in routine practice in Dutch treatment centres.

PubMed

Merkx, Maarten J M; Schippers, Gerard M; Koeter, Maarten J W; Vuijk, Pieter Jelle; Oudejans, Suzan; de Vries, Carlijn C Q; van den Brink, Wim

2007-03-01

To examine the feasibility of implementing evidence-based guidelines for patient-treatment-matching to levels of care in two Dutch substance abuse treatment centres. Multi-centre observational follow-up study. Two large substance abuse treatment centres (SATCs). All 4394 referrals to the two SATCs in 2003. Baseline patient characteristics needed for treatment allocation according to protocol, treatment allocation according to matching protocol, treatment allocation according to actual level of care (LOC) entered. Comparison of recommended and actual LOC entered. Evaluation of reasons for observed differences between recommended and actual LOC entered. Data needed for treatment allocation according to protocol were available for 2269 (51.6%) patients. Data needed for evaluation of actual LOC entered were available for 1765 (40.2%) patients. Of these patients, 1089 (60.8%) were allocated according to protocol: 48.4% based on the guideline algorithm and 12.4% based on clinically justified deviations from this algorithm. The main reason for deviation was a different appraisal of addiction severity, made by the intake counsellor compared to the protocol. The feasibility of guideline-based treatment allocation is seriously limited due to inadequate data collection of patient characteristics and suboptimal guideline-based treatment allocation. As a consequence, only 24.4% of the patients could be evaluated as being matched properly to the treatment planned. The results indicate several barriers which limit the adequate implementation of patient-treatment-matching guidelines: problems in the infrastructure of data collection and storage and the inertia of intake staff who did not adhere to the guidelines for assessment and matching.

An audit of half-count myocardial perfusion imaging using resolution recovery software.

PubMed

Lawson, Richard S; White, Duncan; Nijran, Kuldip; Cade, Sarah C; Hall, David O; Kenny, Bob; Knight, Andy; Livieratos, Lefteris; Murray, Anthony; Towey, David

2014-05-01

The Nuclear Medicine Software Quality Group of the Institute of Physics and Engineering in Medicine has conducted a multicentre, multivendor audit to evaluate the use of resolution recovery software from several manufacturers when applied to myocardial perfusion data with half the normal counts acquired under a variety of clinical protocols in a range of departments. The objective was to determine whether centres could obtain clinical results with half-count data processed with resolution recovery software that were equivalent to those obtained using their normal protocols. Sixteen centres selected 50 routine myocardial perfusion studies each, from which the Nuclear Medicine Software Quality Group generated simulated half-count studies using Poisson resampling. These half-count studies were reconstructed using resolution recovery and the clinical reports compared with the original reports from the full-count data. A total of 769 patient studies were processed and compared. Eight centres found only a small number of clinically relevant discrepancies between the two reports, whereas eight had an unacceptably high number of discrepancies. There were no significant differences in acquisition parameters between the two groups, although centres finding a high number of discrepancies were more likely to perform both rest and stress scans on normal studies. Half of the participating centres could potentially make use of resolution recovery to reduce the administered activity for myocardial perfusion scans without changing their routine acquisition protocols. The other half could consider adjusting the reconstruction parameters used with their resolution recovery software if they wish to use reduced activity successfully.

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

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.

Ethical guidelines for the evaluation of living organ donors

PubMed Central

Wright, Linda; Faith, Karen; Richardson, Robert; Grant, David

2004-01-01

Transplantation is an effective, life-prolonging treatment for organ failure. Demand has steadily increased over the past decade, creating a shortage in the supply of organs. In addition, the number of deceased organ donors has reached a plateau. Living-donor transplantation is increasingly an option, influenced by favourable clinical outcomes and increased waiting times at most transplant centres across North America. Living-donor kidney transplants have exceeded deceased-donor transplant rates at some centres. Organ donations from living donors have challenged transplant programs to develop a framework for determining donor acceptability. After a multidisciplinary consensus-building process of discussion and debate, the Multi-Organ Transplant Program of the University Health Network in Toronto has developed ethical guidelines for these procedures. These proposed guidelines address ethical concerns related to selection criteria and procedures, voluntariness, informed consent and disclosure of risks and benefits to both donor and recipient. PMID:15646438

Experience with using second life for medical education in a family and community medicine education unit

PubMed Central

2012-01-01

Background The application of new technologies to the education of health professionals is both a challenge and a necessity. Virtual worlds are increasingly being explored as a support for education. Aim: The aim of this work is to study the suitability of Second Life (SL) as an educational tool for primary healthcare professionals. Methods Design: Qualitative study of accredited clinical sessions in SL included in a continuing professional development (CPD) programme for primary healthcare professionals. Location: Zaragoza I Zone Family and Community Medicine Education Unit (EU) and 9 health centres operated by the Aragonese Health Service, Aragon, Spain. Method: The EU held two training workshops in SL for 16 healthcare professionals from 9 health centres by means of two workshops, and requested them to facilitate clinical sessions in SL. Attendance was open to all personnel from the EU and the 9 health centres. After a trail period of clinical sessions held at 5 health centres between May and November 2010, the CPD-accredited clinical sessions were held at 9 health centres between February and April 2011. Participants: 76 healthcare professionals attended the CPD-accredited clinical sessions in SL. Main measurements: Questionnaire on completion of the clinical sessions. Results Response rate: 42-100%. Questionnaire completed by each health centre on completion of the CPD-accredited clinical sessions: Access to SL: 2 centres were unable to gain access. Sound problems: 0% (0/9). Image problems: 0% (0/9). Voice/text chat: used in 100% (10/9); 0 incidents. Questionnaire completed by participants in the CPD-accredited clinical sessions: Preference for SL as a tool: 100% (76/76). Strengths of this method: 74% (56/76) considered it eliminated the need to travel; 68% (52/76) believed it made more effective use of educational resources; and 47% (36/76) considered it improved accessibility. Weaknesses: 91% (69/76) experienced technical problems, while; 9% (7/76) thought it was impersonal and with little interaction. 65.79% (50/76) believed it was better than other distance learning methods and 38.16% (29/76) believed it was better than face-to-face learning. Conclusions SL is a tool that allows educational activities to be designed that involve a number of health centres in different geographical locations, consequently eliminating the need to travel and making more effective use of educational resources. PMID:22587562

Experience with using second life for medical education in a family and community medicine education unit.

PubMed

Melús-Palazón, Elena; Bartolomé-Moreno, Cruz; Palacín-Arbués, Juan Carlos; Lafuente-Lafuente, Antonio; García, Inmaculada García; Guillen, Sara; Esteban, Ana B; Clemente, Silvia; Marco, Angeles M; Gargallo, Pilar M; López, Carlos; Magallón-Botaya, Rosa

2012-05-15

The application of new technologies to the education of health professionals is both a challenge and a necessity. Virtual worlds are increasingly being explored as a support for education. The aim of this work is to study the suitability of Second Life (SL) as an educational tool for primary healthcare professionals. Qualitative study of accredited clinical sessions in SL included in a continuing professional development (CPD) programme for primary healthcare professionals. Zaragoza I Zone Family and Community Medicine Education Unit (EU) and 9 health centres operated by the Aragonese Health Service, Aragon, Spain. The EU held two training workshops in SL for 16 healthcare professionals from 9 health centres by means of two workshops, and requested them to facilitate clinical sessions in SL. Attendance was open to all personnel from the EU and the 9 health centres. After a trail period of clinical sessions held at 5 health centres between May and November 2010, the CPD-accredited clinical sessions were held at 9 health centres between February and April 2011. 76 healthcare professionals attended the CPD-accredited clinical sessions in SL. Questionnaire on completion of the clinical sessions. Response rate: 42-100%. Questionnaire completed by each health centre on completion of the CPD-accredited clinical sessions: Access to SL: 2 centres were unable to gain access. Sound problems: 0% (0/9). Image problems: 0% (0/9). Voice/text chat: used in 100% (10/9); 0 incidents. Questionnaire completed by participants in the CPD-accredited clinical sessions: Preference for SL as a tool: 100% (76/76). Strengths of this method: 74% (56/76) considered it eliminated the need to travel; 68% (52/76) believed it made more effective use of educational resources; and 47% (36/76) considered it improved accessibility. Weaknesses: 91% (69/76) experienced technical problems, while; 9% (7/76) thought it was impersonal and with little interaction. 65.79% (50/76) believed it was better than other distance learning methods and 38.16% (29/76) believed it was better than face-to-face learning. SL is a tool that allows educational activities to be designed that involve a number of health centres in different geographical locations, consequently eliminating the need to travel and making more effective use of educational resources.

The ambiguity of patient-centred practices: the case of a Dutch fertility clinic.

PubMed

Gerrits, Trudie

2014-01-01

When in-vitro fertilization (IVF) was introduced in the 1970s, doctors were criticized for not properly informing prospective users about its possible risks and limited success rates as well as for medicalizing fertility problems. Nowadays, many fertility clinics are seeking to improve their accountability to stakeholders through patient-centred practices. Based on an ethnographic study of a Dutch fertility clinic, outspoken in its aims to provide patient-centred medicine and to empower clients, this paper addresses how patient-centred medicine affects couples' decision-making to use IVF and related reproductive technologies. The author contends that while patient-centred practices facilitate informed decision-making and support couples emotionally, they may also have unintended disciplining and normalizing effects. The information and support provided, the trust couples have in clinic staff, the ongoing visualization of conception mediated by medical technology--all can be seen as practices that strengthen lay people's 'medical gaze' in how they come to view their bodies, fertility problems and possible solutions. These unintended effects are labelled 'the ambiguity of patient-centeredness' as they (may) interfere with processes of autonomous decision-making.

Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer—IMIGASTRIC

PubMed Central

Desiderio, Jacopo; Jiang, Zhi-Wei; Nguyen, Ninh T; Zhang, Shu; Reim, Daniel; Alimoglu, Orhan; Azagra, Juan-Santiago; Yu, Pei-Wu; Coburn, Natalie G; Qi, Feng; Jackson, Patrick G; Zang, Lu; Brower, Steven T; Kurokawa, Yukinori; Facy, Olivier; Tsujimoto, Hironori; Coratti, Andrea; Annecchiarico, Mario; Bazzocchi, Francesca; Avanzolini, Andrea; Gagniere, Johan; Pezet, Denis; Cianchi, Fabio; Badii, Benedetta; Novotny, Alexander; Eren, Tunc; Leblebici, Metin; Goergen, Martine; Zhang, Ben; Zhao, Yong-Liang; Liu, Tong; Al-Refaie, Waddah; Ma, Junjun; Takiguchi, Shuji; Lequeu, Jean-Baptiste; Trastulli, Stefano; Parisi, Amilcare

2015-01-01

Introduction Gastric cancer represents a great challenge for healthcare providers and requires a multidisciplinary treatment approach in which surgery plays a major role. Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and recently with the spread of robotic surgery, but a number of issues are currently being debated, including the limitations in performing an effective extended lymph node dissection, the real advantages of robotic systems, the role of laparoscopy for Advanced Gastric Cancer, the reproducibility of a total intracorporeal technique and the oncological results achievable during long-term follow-up. Methods and analysis A multi-institutional international database will be established to evaluate the role of robotic, laparoscopic and open approaches in gastric cancer, comprising of information regarding surgical, clinical and oncological features. A chart review will be conducted to enter data of participants with gastric cancer, previously treated at the participating institutions. The database is the first of its kind, through an international electronic submission system and a HIPPA protected real time data repository from high volume gastric cancer centres. Ethics and dissemination This study is conducted in compliance with ethical principles originating from the Helsinki Declaration, within the guidelines of Good Clinical Practice and relevant laws/regulations. A multicentre study with a large number of patients will permit further investigation of the safety and efficacy as well as the long-term outcomes of robotic, laparoscopic and open approaches for the management of gastric cancer. Trial registration number NCT02325453; Pre-results. PMID:26482769

Automated multi-lesion detection for referable diabetic retinopathy in indigenous health care.

PubMed

Pires, Ramon; Carvalho, Tiago; Spurling, Geoffrey; Goldenstein, Siome; Wainer, Jacques; Luckie, Alan; Jelinek, Herbert F; Rocha, Anderson

2015-01-01

Diabetic Retinopathy (DR) is a complication of diabetes mellitus that affects more than one-quarter of the population with diabetes, and can lead to blindness if not discovered in time. An automated screening enables the identification of patients who need further medical attention. This study aimed to classify retinal images of Aboriginal and Torres Strait Islander peoples utilizing an automated computer-based multi-lesion eye screening program for diabetic retinopathy. The multi-lesion classifier was trained on 1,014 images from the São Paulo Eye Hospital and tested on retinal images containing no DR-related lesion, single lesions, or multiple types of lesions from the Inala Aboriginal and Torres Strait Islander health care centre. The automated multi-lesion classifier has the potential to enhance the efficiency of clinical practice delivering diabetic retinopathy screening. Our program does not necessitate image samples for training from any specific ethnic group or population being assessed and is independent of image pre- or post-processing to identify retinal lesions. In this Aboriginal and Torres Strait Islander population, the program achieved 100% sensitivity and 88.9% specificity in identifying bright lesions, while detection of red lesions achieved a sensitivity of 67% and specificity of 95%. When both bright and red lesions were present, 100% sensitivity with 88.9% specificity was obtained. All results obtained with this automated screening program meet WHO standards for diabetic retinopathy screening.

Automated Multi-Lesion Detection for Referable Diabetic Retinopathy in Indigenous Health Care

PubMed Central

Pires, Ramon; Carvalho, Tiago; Spurling, Geoffrey; Goldenstein, Siome; Wainer, Jacques; Luckie, Alan; Jelinek, Herbert F.; Rocha, Anderson

2015-01-01

Diabetic Retinopathy (DR) is a complication of diabetes mellitus that affects more than one-quarter of the population with diabetes, and can lead to blindness if not discovered in time. An automated screening enables the identification of patients who need further medical attention. This study aimed to classify retinal images of Aboriginal and Torres Strait Islander peoples utilizing an automated computer-based multi-lesion eye screening program for diabetic retinopathy. The multi-lesion classifier was trained on 1,014 images from the São Paulo Eye Hospital and tested on retinal images containing no DR-related lesion, single lesions, or multiple types of lesions from the Inala Aboriginal and Torres Strait Islander health care centre. The automated multi-lesion classifier has the potential to enhance the efficiency of clinical practice delivering diabetic retinopathy screening. Our program does not necessitate image samples for training from any specific ethnic group or population being assessed and is independent of image pre- or post-processing to identify retinal lesions. In this Aboriginal and Torres Strait Islander population, the program achieved 100% sensitivity and 88.9% specificity in identifying bright lesions, while detection of red lesions achieved a sensitivity of 67% and specificity of 95%. When both bright and red lesions were present, 100% sensitivity with 88.9% specificity was obtained. All results obtained with this automated screening program meet WHO standards for diabetic retinopathy screening. PMID:26035836

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).

A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.

PubMed

Zelen, Charles M; Gould, Lisa; Serena, Thomas E; Carter, Marissa J; Keller, Jennifer; Li, William W

2015-12-01

A prospective, randomised, controlled, parallel group, multi-centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment of chronic lower extremity diabetic ulcers with either weekly applications of Apligraf(®) (Organogenesis, Inc., Canton, MA), EpiFix(®) (MiMedx Group, Inc., Marietta, GA), or standard wound care with collagen-alginate dressing. The primary study outcome was the percent change in complete wound healing after 4 and 6 weeks of treatment. Secondary outcomes included percent change in wound area per week, velocity of wound closure and a calculation of the amount and cost of Apligraf or EpiFix used. A total of 65 subjects entered the 2-week run-in period and 60 were randomised (20 per group). The proportion of patients in the EpiFix group achieving complete wound closure within 4 and 6 weeks was 85% and 95%, significantly higher (all adjusted P-values ≤ 0·003) than for patients receiving Apligraf (35% and 45%), or standard care (30% and 35%). After 1 week, wounds treated with EpiFix had reduced in area by 83·5% compared with 53·1% for wounds treated with Apligraf. Median time to healing was significantly faster (all adjusted P-values ≤0·001) with EpiFix (13 days) compared to Apligraf (49 days) or standard care (49 days). The mean number of grafts used and the graft cost per patient were lower in the EpiFix group campared to the Apligraf group, at 2·15 grafts at a cost of $1669 versus 6·2 grafts at a cost of $9216, respectively. The results of this study demonstrate the clinical and resource utilisation superiority of EpiFix compared to Apligraf or standard of care, for the treatment of diabetic ulcers of the lower extremities. © 2014 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Teaching clinical skills in developing countries: are clinical skills centres the answer?

PubMed

Stark, Patsy; Fortune, F

2003-11-01

There is growing international interest in teaching clinical skills in a variety of contexts, one of which is Clinical Skills Centres. The drivers for change making Skills Centres an important adjunct to ward and ambulatory teaching come both from within and outside medical education. Educationally, self-directed learning is becoming the accepted norm, encouraging students to seek and maximize learning opportunities. There are global changes in health care practice, increased consumerism and increasing student numbers. In some countries, professional recommendations influence what is taught. Increasingly, core skills curricula and outcome objectives are being defined. This explicit definition encourages assessment of the core skills. In turn, all students require equal opportunities to learn how to practise the skills safely and competently. The moves towards interprofessional education make joint learning in a"neutral" setting, like a Clinical Skills Centre, appear particularly attractive. To discuss the potential role of Clinical Skills Centres in skills training in developing countries and to consider alternative options. Many developing countries seek to establish Clinical Skills Centres to ensure effective and reliable skills teaching. However, the model may not be appropriate,because fully equipped Clinical Skills Centres are expensive to set up, staff; and run. They are not the only way to achieve high quality clinical teaching. Suggested options are based on the philosophy and teaching methods successfully developed in Clinical Skills Centres that may fulfil the local needs to achieve low cost and high quality clinical teaching which is reflective of the local health needs and cultural expectations.

Clinical Audit of the Radiotherapy Process in Rectal Cancer: Clinical Practice Guidelines and Quality Certification Do Not Avert Variability in Clinical Practice.

PubMed

Torras, M G; Canals, E; Jurado-Bruggeman, D; Marín-Borras, S; Macià, M; Jové, J; Boladeras, A M; Muñoz-Montplet, C; Molero, J; Picón, C; Puigdemont, M; Aliste, L; Torrents, A; Guedea, F; Borras, J M

2018-06-01

The therapeutic approach to cancer is complex and multidisciplinary. Radiotherapy is among the essential treatments, whether used alone or in conjunction with other therapies. This study reports a clinical audit of the radiotherapy process to assess the process of care, evaluate adherence to agreed protocols and measure the variability to improve therapeutic quality for rectal cancer. Multicentre retrospective cohort study in a representative sample of patients diagnosed with rectal cancer in the Institut Català d'Oncologia, a comprehensive cancer centre with three different settings. We developed a set of indicators to assess the key areas of the radiotherapy process. The clinical audit consisted of a review of a random sample of 40 clinical histories for each centre. The demographic profile, histology and staging of patients were similar between centres. The MRI reports did not include the distance from tumour to mesorectal fascia (rCRM) in 38.3% of the cases. 96.7% of patients received the planned dose, and 57.4% received it at the planned time. Surgery followed neoadjuvant treatment in 96.7% of the patients. Among this group, postoperative CRM was recorded in 65.5% of the cases and was negative in 93.4% of these. With regard to the 34.5% (n = 40) of cases where no CRM value was stated, there were differences between the centres. Mean follow-up was 3.4 (SD 0.6) years, and overall survival at four years was 81.7%. The audit revealed a suboptimal degree of adherence to clinical practice guidelines. Significant variability between centres exists from a clinical perspective but especially with regard to organization and process. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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.

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.

Associations between community-based physiotherapy for musculoskeletal injury and health related quality of life (EQ-5D): a multi-centre retrospective analysis.

PubMed

Caplan, Nick; Robson, H; Robson, A; Barry, G; Wilkes, G

2017-10-25

Community-based musculoskeletal physiotherapy is used to improve function and health related quality of life (HRQoL). The purpose of this retrospective, multi-centre observational study was to determine the association between community-based physiotherapy management for musculoskeletal disorders and changes in HRQoL. Four thousand one hundred twelve patients' data were included in the study. Patients were included if they received a single period of treatment for a musculoskeletal injury or disorder. Patients were only included if they were being treated for a single morbidity. Patients received standard physiotherapy appropriate to their specific disorder, which could include health education/advice, exercise therapy, manual therapy, taping, soft tissue techniques, electrotherapy and/or acupuncture. Health related quality of life was assessed using the EQ-5D index. EQ-5D improved by 0.203 across all patients (d = 1.10). When grouped by anatomical site of symptom, the largest increases in EQ-5D was in foot pain (0.233; d = 1.29) and lumbar pain (0.231; d = 1.13). Improvements in EQ-5D greater than the minimum clinically important difference (MCID) were seen in 68.4% of all patients. The highest proportion of patients with positive responses to treatment were in ankle pain (74.2%) and thoracic pain (73.4%). The hand (40.5%), elbow (34.7%), and hip (33.9%) showed the greatest proportion of patients that did not respond to treatment. Community-based musculoskeletal physiotherapy is associated with improved health related quality of life. A randomised controlled trial is needed to determine any causal relationship between community-based physiotherapy and health related quality of life improvements.

A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

PubMed

Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

2012-08-01

To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.

PubMed

Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N

2010-04-20

The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that capacity development in clinical trials is best carried out in the context of preparation for specific trials. In this regard MCTA centres involved in the phase III malaria vaccine trial were, on average, more successful at consolidating the training and infrastructure support than those centres focussing only on drug trials.

Sustainable development of a GCP-compliant clinical trials platform in Africa: the Malaria Clinical Trials Alliance perspective

PubMed Central

2010-01-01

Background The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Case description Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. Conclusion In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that capacity development in clinical trials is best carried out in the context of preparation for specific trials. In this regard MCTA centres involved in the phase III malaria vaccine trial were, on average, more successful at consolidating the training and infrastructure support than those centres focussing only on drug trials. PMID:20406478

Programme of Indian Centre for Space Physics using Very Low Frequency Radio Waves

NASA Astrophysics Data System (ADS)

Chakrabarti, Sandip Kumar; Sasmal, Sudipta; Pal, Sujay; Kanta Maji, Surya; Ray, Suman

Indian Centre for Space Physics conducted two major VLF campaigns all over Indian Sub-continent to study the propagation effects of VLF radio waves. It made multi-receiver observations during solar eclipse. ICSP not only recorded multitudes of solar flares, it also reproduced VLF observation from ab initio calculation. ICSP extended its study to the field of earthquake predictions using signal anomalies and using case by case studies as well as statistical analysis, showed that anomalies are real and more studies are required to understand them. Using earth as a gigantic detector, it detected ionospheric perturbations due to soft gamma-ray repeaters and gamma-ray bursts.

Is balance performance reduced after mild traumatic brain injury?: Interim analysis from chronic effects of neurotrauma consortium (CENC) multi-centre study.

PubMed

Walker, William C; Nowak, Kayla J; Kenney, Kimbra; Franke, Laura Manning; Eapen, Blessen C; Skop, Karen; Levin, Harvey; Agyemang, Amma A; Tate, David F; Wilde, Elisabeth A; Hinds, Sidney; Nolen, Tracy L

2018-06-12

Determine if mild traumatic brain injury (mTBI) history is associated with balance disturbances. Chronic Effects of Neurotrauma Consortium (CENC) centres. The CENC multi-centre study enrols post-9/11 era Service Members and Veterans with combat exposure. This sample (n = 322) consisted of enrolees completing initial evaluation by September 2016 at the three sites conducting computerized dynamic post-urography (CDP) testing. Observational study with cross-sectional analyses using structural equation modelling. Comprehensive structured interviews were used to diagnose all lifetime mild traumatic brain injuries (mTBIs). The outcome, Sensory Organization Test (SOT), was measured on CDP dual-plate force platform. Other studied variables were measured by structured interviews, record review and questionnaires. The overall positive/negative mTBI classification did not have a significant effect on the composite equilibrium score. However, the repetitive mTBI classification showed lower scores for participants with ≥ 3 mTBI versus 1-2 lifetime mTBIs. For repetitive mTBI, pain interference acted as a mediator for the indirect effect, and a direct effect was evident on some sensory condition equilibrium scores. These findings show that repeated mTBI, partially mediated by pain, may lead to later balance disturbances among military combatants. Further study of CDP outcomes within this accruing cohort is warranted.

Comparison of three models of ownership of community health centres in China: a qualitative study.

PubMed

Wei, Xiaolin; Yang, Nan; Gao, Yang; Wong, Samuel Y S; Wong, Martin C S; Wang, Jiaji; Wang, Harry H X; Li, Donald K T; Tang, Jinling; Griffiths, Sian M

2015-07-01

Community health centres are the main form of provision of primary care in China. There are three models: government managed, hospital managed and private. Our aim was to describe and compare primary care under the three ownership models. Four aspects of primary care were studied: services, organization, financing and human resources. Interviews were undertaken with 60 managerial and professional staff in 13 community health centres in the Pearl River Delta region in 2010. Three community health centres were selected in the capital city and two were selected from each of the other five cities. Thematic framework analysis was conducted. Government-managed community health centres received the largest public funding, followed by hospital-managed community health centres, while private community health centres received the least. Private community health centres were the smallest in scale and provided lower quality public health services compared with the other two models. Patient out-of-pocket costs accounted for the majority of the revenue in all models of community health centres despite improved government funding for preventive services. General challenges such as the shortage of public funding, the exclusion of migrants in the funding for preventive services, low capacity in human resources and the separation of clinical and preventive care in community health centres were identified in all three models of community health centres. The ownership and management of a community health centre greatly influence the service it provides. Private community health centres are in a disadvantaged position to deliver high quality clinical and preventive care. © The Author(s) 2015.

A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

ClinicalTrials.gov

2016-10-06

Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Perthes Disease

A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement

ClinicalTrials.gov

2017-06-27

Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

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.

SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thwaites, D; Holloway, L; Bailey, M

2015-06-15

Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction andmore » mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions, improved treatment quality and potential practice changes. The early indications from the distributed learning and radiomics pilots strengthen this. Improved routine patient data quality should strengthen such rapid learning systems.« less

Why wait so long for child care? An analysis of waits, queues and work in a South African urban health centre.

PubMed

Bachmann, M O; Barron, P

1997-01-01

Long waits at large urban clinics obstruct primary care delivery, imposing time costs on patients, deterring appropriate utilization and causing patient dissatisfaction. This paper reports on an innovative attempt by staff in a large South African urban health centre to analyse a system of queues and preventive and curative services for pre-school children, and thereafter to evaluate changes. The study had a cross-sectional work study design, with repeated measurement of waiting times after 13 months. At baseline the preventive clinic was found to have several inessential processes and waits; these were eliminated or overlapped, and clinic sessions per week were increased. A year later median waiting times had decreased substantially in the preventive clinic, but had increased in the curative clinic. Simple research can explain long waits, inform and measure changes, and provide evidence to justify primary care integration and would be useful in health centres and hospital outpatient departments in developing countries.

Are patients bypassing paediatric cardiology outreach clinics?

PubMed

Fletcher, Alexander; Samson, Ray; McLeod, Karen

2017-07-01

Previous studies have identified that receiving specialist care close to home can positively influence patients' experience. Despite this, a review of cardiology outpatient appointments at the Royal Hospital for Children in Glasgow demonstrated that a large number of families are bypassing their local children's cardiology centre to attend cardiac clinics at the specialist children's surgical centre. We used patient questionnaire, audit of local facilities, and examined the relationship between diagnosis and bypass numbers to better understand factors influencing this trend. Our results suggest that patient preference, short travelling distance to specialist children's cardiac centre, a more severe cardiac diagnosis, and inconsistent local facilities, expertise, and support are likely to influence a family's decision to bypass their local children's cardiology centre.

The ambiguity of patient-centred practices: the case of a Dutch fertility clinic

PubMed Central

Gerrits, Trudie

2014-01-01

When in-vitro fertilization (IVF) was introduced in the 1970s, doctors were criticized for not properly informing prospective users about its possible risks and limited success rates as well as for medicalizing fertility problems. Nowadays, many fertility clinics are seeking to improve their accountability to stakeholders through patient-centred practices. Based on an ethnographic study of a Dutch fertility clinic, outspoken in its aims to provide patient-centred medicine and to empower clients, this paper addresses how patient-centred medicine affects couples’ decision-making to use IVF and related reproductive technologies. The author contends that while patient-centred practices facilitate informed decision-making and support couples emotionally, they may also have unintended disciplining and normalizing effects. The information and support provided, the trust couples have in clinic staff, the ongoing visualization of conception mediated by medical technology – all can be seen as practices that strengthen lay people's ‘medical gaze’ in how they come to view their bodies, fertility problems and possible solutions. These unintended effects are labelled ‘the ambiguity of patient-centeredness’ as they (may) interfere with processes of autonomous decision-making. PMID:24827743

Risk factors associated with repetition of self-harm in black and minority ethnic (BME) groups: a multi-centre cohort study.

PubMed

Cooper, Jayne; Steeg, Sarah; Webb, Roger; Stewart, Suzanne L K; Applegate, Eve; Hawton, Keith; Bergen, Helen; Waters, Keith; Kapur, Navneet

2013-06-01

Little information is available to inform clinical assessments on risk of self-harm repetition in ethnic minority groups. In a prospective cohort study, using data collected from six hospitals in England for self-harm presentations occurring between 2000 and 2007, we investigated risk factors for repeat self-harm in South Asian and Black people in comparison to Whites. During the study period, 751 South Asian, 468 Black and 15,705 White people presented with self-harm in the study centres. Repeat self-harm occurred in 4379 individuals, which included 229 suicides (with eight of these fatalities being in the ethnic minority groups). The risk ratios for repetition in the South Asian and Black groups compared to the White group were 0.6, 95% CI 0.5-0.7 and 0.7, 95% CI 0.5-0.8, respectively. Risk factors for repetition were similar across all three groups, although excess risk versus Whites was seen in Black people presenting with mental health symptoms, and South Asian people reporting alcohol use and not having a partner. Additional modelling of repeat self-harm count data showed that alcohol misuse was especially strongly linked with multiple repetitions in both BME groups. Ethnicity was not recorded in a third of cases which may introduce selection bias. Differences may exist due to cultural diversity within the broad ethnic groups. Known social and psychological features that infer risk were present in South Asian and Black people who repeated self-harm. Clinical assessment in these ethnic groups should ensure recognition and treatment of mental illness and alcohol misuse. Copyright © 2012 Elsevier B.V. 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

Clinical efficacy of implementing Bio Immune(G)ene MEDicine in the treatment of chronic asthma with the objective of reducing or removing effectively corticosteroid therapy: A novel approach and promising results.

PubMed

Glady, Gilbert

2018-06-01

Asthma is one of the diseases that demonstrates a wide range of variation in its clinical expression, in addition to an important heterogeneity in the pathophysiological mechanisms present in each case. The ever-increasing knowledge of the molecular signalling routes and the development of the Bio Immune(G)ene Medicine [BI(G)MED] therapy in line with this knowledge has revealed a whole novel potential set of self-regulation biological molecules, that may be used to promote the physiological immunogenic self-regulation mechanisms and re-establish the homeostatic balance at a genomic, proteomic and cellular level. The aim of the present study is to demonstrate that the sublingual use of a therapeutic protocol based on BI(G)MED regulatory BIMUREGs in the treatment of chronic asthma may reduce or suppress corticosteroid therapy and avoid its harmful side effects which some patients suffer when using this treatment on a long-term basis. The clinical efficacy of BI(G)MED for chronic asthma was evaluated through a multi-centre study carried out in 2016 implementing a 6-month BI(G)MED treatment protocol for Bronchial Asthma. A total of 61 patients from private medical centres and of European countries including Germany, Austria, France, Belgium and Spain participated. The manuscript describes in detail the clinical efficacy of Bio Immune(G)ene regulatory BI(G)MED treatment protocol that allows the reduction or total removal of the corticosteroid dose in patients with chronic asthma. No adverse reactions were observed. The BI(G)MED regulatory therapy brings novel therapeutic possibilities as an effective and safe treatment of chronic asthma. BI(G)MED was demonstrated to significantly reduce asthma severity when parameter compositions were all analysed by categorical outcomes. Therefore, it is considered a good therapeutic alternative for patients who respond poorly to steroids.

Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial.

PubMed

Simpson, A Hamish R W; Hamilton, David F; Beard, David J; Barker, Karen L; Wilton, Timothy; Hutchison, James D; Tuck, Chris; Stoddard, Andrew; Macfarlane, Gary J; Murray, Gordon D

2014-02-01

Approximately 20% of patients are not satisfied with the outcome of total knee replacement, great volumes of which are carried out yearly. Physiotherapy is often provided by the NHS to address dysfunction following knee replacement; however the efficacy of this is unknown. Although clinically it is accepted that therapy is useful, provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year. No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes. We are also investigating whether the structure of the physiotherapy provision itself influences outcomes. The study is a multi-centre prospective randomised controlled trial (RCT) of patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it. Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review, and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy. The intervention will be either 'intensive' involving both hospital and home-based functional exercise rehabilitation, or 'standard of care' consisting of home exercises. Patients will be randomised to either group using a web-based system. Both groups will receive pre and post-intervention physiotherapy review. Patients will be followed-up to one year post-operation. The primary outcome measure is the Oxford Knee Score. Secondary outcomes are patient satisfaction, functional ability, pain scores and cost-effectiveness. Current Controlled Trials ISRCTN23357609. ClinicalTrials.gov NCT01849445.

[Poison cases and types of poisons based on data obtained of patients hospitalized from 1995-2009 with acute poisoning in the second internal ward in a multi-profile provincial hospital in Tarnow].

PubMed

Lata, Stanisław; Janiszewski, Jacek

2010-01-01

The thesis presents a short history and organization of an acute poisoning centre in the1995 functioning within the internal diseases department in a multi-profile provincial hospital. The data show the number of patients treated beetween 1995-2009 an the types of toxic substances that caused poisoning. The conclusions presented refer to the role of the centre to help people suffering from acute poisoning within the city of Tarnow.

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.

Forewarning of hypotensive events using a Bayesian artificial neural network in neurocritical care.

PubMed

Donald, Rob; Howells, Tim; Piper, Ian; Enblad, P; Nilsson, P; Chambers, I; Gregson, B; Citerio, G; Kiening, K; Neumann, J; Ragauskas, A; Sahuquillo, J; Sinnott, R; Stell, A

2018-05-24

Traumatically brain injured (TBI) patients are at risk from secondary insults. Arterial hypotension, critically low blood pressure, is one of the most dangerous secondary insults and is related to poor outcome in patients. The overall aim of this study was to get proof of the concept that advanced statistical techniques (machine learning) are methods that are able to provide early warning of impending hypotensive events before they occur during neuro-critical care. A Bayesian artificial neural network (BANN) model predicting episodes of hypotension was developed using data from 104 patients selected from the BrainIT multi-center database. Arterial hypotension events were recorded and defined using the Edinburgh University Secondary Insult Grades (EUSIG) physiological adverse event scoring system. The BANN was trained on a random selection of 50% of the available patients (n = 52) and validated on the remaining cohort. A multi-center prospective pilot study (Phase 1, n = 30) was then conducted with the system running live in the clinical environment, followed by a second validation pilot study (Phase 2, n = 49). From these prospectively collected data, a final evaluation study was done on 69 of these patients with 10 patients excluded from the Phase 2 study because of insufficient or invalid data. Each data collection phase was a prospective non-interventional observational study conducted in a live clinical setting to test the data collection systems and the model performance. No prediction information was available to the clinical teams during a patient's stay in the ICU. The final cohort (n = 69), using a decision threshold of 0.4, and including false positive checks, gave a sensitivity of 39.3% (95% CI 32.9-46.1) and a specificity of 91.5% (95% CI 89.0-93.7). Using a decision threshold of 0.3, and false positive correction, gave a sensitivity of 46.6% (95% CI 40.1-53.2) and specificity of 85.6% (95% CI 82.3-88.8). With a decision threshold of 0.3, > 15 min warning of patient instability can be achieved. We have shown, using advanced machine learning techniques running in a live neuro-critical care environment, that it would be possible to give neurointensive teams early warning of potential hypotensive events before they emerge, allowing closer monitoring and earlier clinical assessment in an attempt to prevent the onset of hypotension. The multi-centre clinical infrastructure developed to support the clinical studies provides a solid base for further collaborative research on data quality, false positive correction and the display of early warning data in a clinical setting.

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.

Intercultural doctor-patient communication in daily outpatient care: relevant communication skills.

PubMed

Paternotte, Emma; Scheele, Fedde; Seeleman, Conny M; Bank, Lindsay; Scherpbier, Albert J J A; van Dulmen, Sandra

2016-10-01

Intercultural communication (ICC) between doctors and patients is often associated with misunderstandings and dissatisfaction. To develop ICC-specific medical education, it is important to find out which ICC skills medical specialists currently apply in daily clinical consultations. Doctor-patient consultations of Dutch doctors with non-Dutch patients were videotaped in a multi-ethnic hospital in the Netherlands. The consultations were analyzed using the validated MAAS-Global assessment list in combination with factors influencing ICC, as described in the literature. In total, 39 videotaped consultations were analyzed. The doctors proved to be capable of practising many communication skills, such as listening and empathic communication behaviour. Other skills were not practised, such as being culturally aware and checking the patient's language ability. We showed that doctors did practice some but not all the relevant ICC skills and that the ICC style of the doctors was mainly biomedically centred. Furthermore, we discussed the possible overlap between intercultural and patient-centred communication. Implications for practice could be to implement the relevant ICC skills in the existing communication training or develop a communication training with a patient-centred approach including ICC skills.

What Young People Say about Physical Activity: The Children's Sport Participation and Physical Activity (CSPPA) Study

ERIC Educational Resources Information Center

Tannehill, Deborah; MacPhail, Ann; Walsh, Julia; Woods, Catherine

2015-01-01

The Children's Sport Participation and Physical Activity (CSPPA) study is a unique multi-centre/discipline study undertaken by three Irish institutions, Dublin City University, University of Limerick and University College Cork. The study sought to assess participation in physical activity, physical education and sport (PAPES) among 10-18 year…

A Survey of the Pain Management of Acute Painful Crisis among Patients with Sickle Cell Disease at Two Centres in Jamaica.

PubMed

Augier, R; Jenkins, S; Bortolusso Ali, S; Tennant, I; Williams-Johnson, J; Reid, M

2014-06-01

The aim of this survey was to establish the pain management approaches to acute painful crisis (APC) in sickle cell patients at two healthcare facilities and to compare with available guidelines. A multi-centre observational survey of the management of APC in sickle cell patients was conducted. Data were collected at the Sickle Cell Unit (SCU), Tropical Medicine Research Institute (TMRI) and Accident and Emergency Department (A&E), University Hospital of the West Indies. One hundred episodes of uncomplicated APC involving 81 patients managed at the SCU clinic and 64 episodes at the A&E in a total of 28 patients were included in the data set. Drugs used at the SCU included oral morphine, codeine and paracetamol and intramuscular diclofenac. At the A&E, parenteral morphine and pethidine were most commonly used. At the SCU, the mean time to initiation of analgesics was 38 minutes (IQR 25 to 50 minutes); at the A&E, this was 111 minutes (IQR 50 to 150 minutes). At the SCU, the mean duration of stay (DOS) was 2.9 hours (IQR 1.9 to 3.8 hours) with 94% of the patients being discharged home. At the A&E, the mean DOS was 13.0 hours (IQR 8.3 to 16.9 hours) with 93% of the patients being discharged home. The A&E patient group contained multiple high frequency presenters. Documentation of pain severity scores was inconsistent. The findings of the survey indicate that the management of APC at the two centres is substantially different. Further study is required to investigate patient satisfaction, centre preference and analgesic therapy efficacy.

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.

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit

PubMed Central

Stewart, Kirsty; Hutana, Gavin; Kentish, Megan

2017-01-01

Introduction Increasing clinical use of Intrathecal baclofen (ITB) in Australian tertiary paediatric hospitals, along with the need for standardised assessment and reporting of adverse events, saw the formation of the Australian Paediatric ITB Research Group (APIRG). APIRG developed a National ITB Audit tool designed to capture clinical outcomes and adverse events data for all Australian children and adolescents receiving ITB therapy. Methods and analysis The Australian ITB Audit is a 10 year, longitudinal, prospective, clinical audit collecting all adverse events and assessment data across body functions and structure, participation and activity level domains of the ICF. Data will be collected at baseline, 6 and 12 months with ongoing capture of all adverse event data. This is the first Australian study that aims to capture clinical and adverse event data from a complete population of children with neurological impairment receiving a specific intervention between 2011 and 2021. This multi-centre study will inform ITB clinical practice in children and adolescents, direct patient selection, record and aid decision making regarding adverse events and investigate the impact of ITB therapy on family and patient quality of life. Ethics and dissemination This project was approved by the individual Human Research Ethics committees at the six Australian tertiary hospitals involved in the study. Results will be published in various peer reviewed journals and presented at national and international conferences. Trial registration number ACTRN 12610000323022; Pre-results. PMID:28637739

Risk Factors for Methicillin Resistant Staphylococcus aureus: A Multi-Laboratory Study

PubMed Central

Catry, Boudewijn; Latour, Katrien; Jans, Béatrice; Vandendriessche, Stien; Preal, Ragna; Mertens, Karl; Denis, Olivier

2014-01-01

Background The present study aimed to investigate the dose response relationship between the prescriptions of antimicrobial agents and infection/colonization with methicillin resistant Staphylococcus aureus (MRSA) taking additional factors like stay in a health care facility into account. Methods Multi-centre retrospective study on a cohort of patients that underwent microbiological diagnostics in Belgium during 2005. The bacteriological results retrieved from 17 voluntary participating clinical laboratories were coupled with the individual antimicrobial consumption patterns (July 2004-December 2005) and other variables as provided by pooled data of health insurance funds. Multivariate analysis was used to identify risk factors for MRSA colonization/infection. Results A total of 6844 patients of which 17.5% died in the year 2005, were included in a logistic regression model. More than 97% of MRSA was associated with infection (clinical samples), and only a minority with screening/colonization (1.59%). Factors (95% CI) significantly (p≤<0.01) associated with MRSA in the final multivariate model were: admission to a long term care settings (2.79–4.46); prescription of antibiotics via a hospital pharmacy (1.30–2.01); age 55+ years (3.32–5.63); age 15–54 years (1.23–2.16); and consumption of antimicrobial agent per DDD (defined daily dose) (1.25–1.40). Conclusions The data demonstrated a direct dose-response relationship between MRSA and consumption of antimicrobial agents at the individual patient level of 25–40% increased risk per every single day. In addition the study indicated an involvement of specific healthcare settings and age in MRSA status. PMID:24586887

Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial.

PubMed

Russell, Stuart J; Tan, Christine; O'Keefe, Peter; Ashraf, Saeed; Zaidi, Afzal; Fraser, Alan G; Yousef, Zaheer R

2012-02-20

Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints. A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease.After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing) for 48 hours.The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be taken in the following pacing modes: atrial inhibited; right ventricular only; atrial synchronous-right ventricular; atrial synchronous-left ventricular and biventricular pacing. Optimisation of the atrioventricular and interventricular delay will be performed in the biventricular pacing group at 18 hours. The effect of biventricular pacing on myocardial injury, post operative arrhythmias and renal function will also be quantified. ClinicalTrials.gov: NCT01027299.

Role of capsule endoscopy in suspected celiac disease: A European multi-centre study

PubMed Central

Luján-Sanchis, Marisol; Pérez-Cuadrado-Robles, Enrique; García-Lledó, Javier; Juanmartiñena Fernández, José-Francisco; Elli, Luca; Jiménez-García, Victoria-Alejandra; Egea-Valenzuela, Juan; Valle-Muñoz, Julio; Carretero-Ribón, Cristina; Fernández-Urién-Sainz, Ignacio; López-Higueras, Antonio; Alonso-Lázaro, Noelia; Sanjuan-Acosta, Mileidis; Sánchez-Ceballos, Francisco; Rosa, Bruno; González-Vázquez, Santiago; Branchi, Federica; Ruano-Díaz, Lucía; Prieto-de-Frías, César; Pons-Beltrán, Vicente; Borque-Barrera, Pilar; González-Suárez, Begoña; Xavier, Sofía; Argüelles-Arias, Federico; Herrerías-Gutiérrez, Juan-Manuel; Pérez-Cuadrado-Martínez, Enrique; Sempere-García-Argüelles, Javier

2017-01-01

AIM To analyze the diagnostic yield (DY), therapeutic impact (TI) and safety of capsule endoscopy (CE). METHODS This is a multi-centre, observational, analytical, retrospective study. A total of 163 patients with suspicion of celiac disease (CD) (mean age = 46.4 ± 17.3 years, 68.1% women) who underwent CE from 2003 to 2015 were included. Patients were divided into four groups: seronegative CD with atrophy (Group-I, n = 19), seropositive CD without atrophy (Group-II, n = 39), contraindication to gastroscopy (Group-III, n = 6), seronegative CD without atrophy, but with a compatible context (Group-IV, n = 99). DY, TI and the safety of CE were analysed. RESULTS The overall DY was 54% and the final diagnosis was villous atrophy (n = 65, 39.9%), complicated CD (n = 12, 7.4%) and other enteropathies (n = 11, 6.8%; 8 Crohn’s). DY for groups I to IV was 73.7%, 69.2%, 50% and 44.4%, respectively. Atrophy was located in duodenum in 24 cases (36.9%), diffuse in 19 (29.2%), jejunal in 11 (16.9%), and patchy in 10 cases (15.4%). Factors associated with a greater DY were positive serology (68.3% vs 49.2%, P = 0.034) and older age (P = 0.008). On the other hand, neither sex nor clinical presentation, family background, positive histology or HLA status were associated with DY. CE results changed the therapeutic approach in 71.8% of the cases. Atrophy was associated with a greater TI (92.3% vs 45.3%, P < 0.001) and 81.9% of the patients responded to diet. There was one case of capsule retention (0.6%). Agreement between CE findings and subsequent histology was 100% for diagnosing normal/other conditions, 70% for suspected CD and 50% for complicated CD. CONCLUSION CE has a high DY in cases of suspicion of CD and it leads to changes in the clinical course of the disease. CE is safe procedure with a high degree of concordance with histology and it helps in the differential diagnosis of CD. PMID:28216978

12 A multi-centre randomised feasibility study evaluating the impact of a prognostic model for management of blunt chest wall trauma patients: stumbl trial.

PubMed

Battle, Ceri; Hutchings, Hayley; Abbott, Zoe; O'neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona; Jones, Sally; Gagg, James; Body, Rick; Evans, Phillip

2017-12-01

A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the Emergency Department (ED). A definitive randomised controlled trial (impact trial), is required to assess the clinical and cost effectiveness of the new model, before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multi-centre, cluster-randomised (stepped wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a five month period; in the initial period acting as the controls (normal care) and the second period, acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a six week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory).Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Health Care Research Wales Research Permissions and the HRA have granted approval for the study. Patient recruitment commenced in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at Professional Meetings. © 2017, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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.

OxMaR: open source free software for online minimization and randomization for clinical trials.

PubMed

O'Callaghan, Christopher A

2014-01-01

Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

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.

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.

Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

PubMed

Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

2014-01-01

In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

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.

Addiction research centres and the nurturing of creativity: National Drug Dependence Treatment Centre, India--a profile.

PubMed

Ray, Rajat; Dhawan, Anju; Chopra, Anita

2013-10-01

The National Drug Dependence Treatment Centre (NDDTC) is a part of the All India Institute of Medical Sciences, a premier autonomous medical university in India. This article provides an account of its origin and its contribution to the field of substance use disorder at the national and international levels. Since its establishment, the NDDTC has played a major role in the development of various replicable models of care, the training of post-graduate students of psychiatry, research, policy development and planning. An assessment of the magnitude of drug abuse in India began in the early 1990s and this was followed by a National Survey on Extent, Patterns and Trends of Drug Abuse in 2004. Several models of clinical care have been developed for population subgroups in diverse settings. The centre played an important role in producing data and resource material which helped to scale up opioid substitution treatment in India. A nationwide database on the profile of patients seeking treatment (Drug Abuse Monitoring System) at government drug treatment centres has also been created. The centre has provided valuable inputs for the Government of India's programme planning. Besides clinical studies, research has also focused on pre-clinical studies. Capacity-building is an important priority, with training curricula and resource material being developed for doctors and paramedical staff. Many of these training programmes are conducted in collaboration with other institutions in the country. The NDDTC has received funding from several national and international organizations for research and scientific meetings, and, most recently (2012), it has been designated as a World Health Organization Collaborating Centre on Substance Abuse. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

The impact of mild induced hypothermia on the rate of transfusion and the mortality in severely injured patients: a retrospective multi-centre study.

PubMed

Jensen, Kai Oliver; Held, Leonhard; Kraus, Andrea; Hildebrand, Frank; Mommsen, Philipp; Mica, Ladislav; Wanner, Guido A; Steiger, Peter; Moos, Rudolf M; Simmen, Hans-Peter; Sprengel, Kai

2016-10-06

Although under discussion, induced hypothermia (IH) is an established therapy for patients with cardiac arrest or traumatic brain injuries. The influences on coagulopathy and bleeding tendency in severely injured patients (SIP) with concomitant traumatic brain injury are most widely unclear. Therefore, the aim of this study was to quantify the effect of mild IH in SIP with concomitant severe traumatic brain injuries on transfusion rate and mortality. In this retrospective multi-centre study, SIP from three European level-1 trauma centres with an ISS ≥16 between 2009 and 2011 were included. At hospital A, patients qualified for IH with age ≤70 years and a severe head injury with an abbreviated injury scale (AIS Head ) of ≥3. IH was defined as target core body temperature of 35 °C. Hypothermic patients were matched with two patients, one from hospital B and one from hospital C using age and AIS Head . The effect of IH on the transfusion rate, complications and mortality was quantified with 95 % confidence intervals (CI). Patients not treated with IH in hospital A and those from hospital B and C, who were not matched, were used to adjust the CI for the effect of inter-hospital therapy protocol differences. Mean age of patients in the IH-group (n = 43) was 35.7 years, mean ISS 30 points and sex distribution showed 83.7 % male. Mean age of matched patients in the normotherm-group (n = 86) was 36.7 years, mean ISS 33 points and there were 75.6 % males. For the hypothermic patients, we pointed out an estimate of mean difference for the number of transfused units of packed red blood cells as well as for mortality which does not indicate a decrease in the benefit gained by hypothermia. It is suggested that hypothermic patients tend to a higher rate of lung failure and thromboembolisms. Though tending to an increased rate of complications, there is no evidence for a difference in both; rate of transfusion and mortality in SIP. Mild IH as an option for severe head injuries seems as well-being practicable in the presence of multiple severe injuries. Further, clinical studies regarding the side effects are necessary.

Data warehousing methods and processing infrastructure for brain recovery research.

PubMed

Gee, T; Kenny, S; Price, C J; Seghier, M L; Small, S L; Leff, A P; Pacurar, A; Strother, S C

2010-09-01

In order to accelerate translational neuroscience with the goal of improving clinical care it has become important to support rapid accumulation and analysis of large, heterogeneous neuroimaging samples and their metadata from both normal control and patient groups. We propose a multi-centre, multinational approach to accelerate the data mining of large samples and facilitate data-led clinical translation of neuroimaging results in stroke. Such data-driven approaches are likely to have an early impact on clinically relevant brain recovery while we simultaneously pursue the much more challenging model-based approaches that depend on a deep understanding of the complex neural circuitry and physiological processes that support brain function and recovery. We present a brief overview of three (potentially converging) approaches to neuroimaging data warehousing and processing that aim to support these diverse methods for facilitating prediction of cognitive and behavioral recovery after stroke, or other types of brain injury or disease.

The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis

PubMed Central

Badia, Xavier; Díez-Pérez, Adolfo; Lahoz, Raquel; Lizán, Luis; Nogués, Xavier; Iborra, Jordi

2004-01-01

Background The aim of this study is to validate the questionnaire ECOS-16 (Assessment of health related quality of life in osteoporosis) for the evaluation of health related quality of life (HRQoL) in post-menopausal women with osteoporosis. Methods An observational, prospective and multi-centre study was carried out among post-menopausal women with osteoporosis in primary care centres and hospital outpatient clinics. All patients attended 2 visits: at baseline and at 6 months. In addition, the subgroup of outpatients attended another visit a month after the baseline to assess the test-retest reliability. The psychometric properties of the questionnaire were evaluated in terms of feasibility, validity (content validity and construct validity) and internal consistency in baseline, and in terms of test-retest reliability and responsiveness to change in visit at month and visit at 6 months, respectively. In all visits, ECOS-16, EUROQoL-5D (EQ-5D) and four 7-point items about health status (general health status, back pain, limitation in daily activities and emotional status) were administered, whereas only outpatients were given MINI-OQLQ (Mini Osteoporosis Quality of Life Questionnaire), besides all clinical variables; and sociodemographic variables at baseline. Results 316 women were consecutively included, 212 from primary care centres and 104 from hospital outpatient clinics. Feasibility: 94.3% of patients answered all items of the questionnaire. The mean administration time was 12.3 minutes. Validity: factor analysis suggested that the questionnaire was unidimensional. In the multivariate analysis, patients with vertebral fractures, co-morbidity and a lower education level showed to have worse HRQoL. Moderate to high correlations were found between the ECOS-16 score and the other health status questionnaires (0.47–0.82). Reliability: internal consistency (Cronbach's α) was 0.92 and test-retest reliability (ICC) was 0.80. Responsiveness to change: ECOS-16 scores increased according to change perceived by the patient, as well as the effect size (ranges between 1.35 to 0.43), the greater the perception of change in patients' general health status, the greater the changes in patients' scores. The Minimal Clinically Important Difference (MCID) suggested a change of 0.5 points in the ECOS-16 score, representing the least improvement in general health status due to their osteoporosis: "slightly better". Conclusion ECOS-16 has been proven preliminarily to have good psychometric properties, so that it can be potentially a useful tool to evaluate HRQoL of post-menopausal women with osteoporosis in research and routine clinical practice. PMID:15291959

Proteins as templates for complex synthetic metalloclusters: towards biologically programmed heterogeneous catalysis

PubMed Central

Fehl, Charlie

2016-01-01

Despite nature’s prevalent use of metals as prosthetics to adapt or enhance the behaviour of proteins, our ability to programme such architectural organization remains underdeveloped. Multi-metal clusters buried in proteins underpin the most remarkable chemical transformations in nature, but we are not yet in a position to fully mimic or exploit such systems. With the advent of copious, relevant structural information, judicious mechanistic studies and the use of accessible computational methods in protein design coupled with new synthetic methods for building biomacromolecules, we can envisage a ‘new dawn’ that will allow us to build de novo metalloenzymes that move beyond mono-metal centres. In particular, we highlight the need for systems that approach the multi-centred clusters that have evolved to couple electron shuttling with catalysis. Such hybrids may be viewed as exciting mid-points between homogeneous and heterogeneous catalysts which also exploit the primary benefits of biocatalysis. PMID:27279776

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.

Developing a European grid infrastructure for cancer research: vision, architecture and services

PubMed Central

Tsiknakis, M; Rueping, S; Martin, L; Sfakianakis, S; Bucur, A; Sengstag, T; Brochhausen, M; Pucaski, J; Graf, N

2007-01-01

Life sciences are currently at the centre of an information revolution. The nature and amount of information now available opens up areas of research that were once in the realm of science fiction. During this information revolution, the data-gathering capabilities have greatly surpassed the data-analysis techniques. Data integration across heterogeneous data sources and data aggregation across different aspects of the biomedical spectrum, therefore, is at the centre of current biomedical and pharmaceutical R&D. This paper reports on original results from the ACGT integrated project, focusing on the design and development of a European Biomedical Grid infrastructure in support of multi-centric, post-genomic clinical trials (CTs) on cancer. Post-genomic CTs use multi-level clinical and genomic data and advanced computational analysis and visualization tools to test hypotheses in trying to identify the molecular reasons for a disease and the stratification of patients in terms of treatment. The paper provides a presentation of the needs of users involved in post-genomic CTs and presents indicative scenarios, which drive the requirements of the engineering phase of the project. Subsequently, the initial architecture specified by the project is presented, and its services are classified and discussed. A range of such key services, including the Master Ontology on sCancer, which lie at the heart of the integration architecture of the project, is presented. Special efforts have been taken to describe the methodological and technological framework of the project, enabling the creation of a legally compliant and trustworthy infrastructure. Finally, a short discussion of the forthcoming work is included, and the potential involvement of the cancer research community in further development or utilization of the infrastructure is described. PMID:22275955

Mesh fixation in endoscopic inguinal hernia repair: evaluation of methodology based on a systematic review of randomised clinical trials.

PubMed

Lederhuber, Hans; Stiede, Franziska; Axer, Stephan; Dahlstrand, Ursula

2017-11-01

The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned. PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life. Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions. High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.

'Act on oncology' as a new comprehensive approach to assess prostate cancer centres--method description and results of a pilot study.

PubMed

Voigt, Wieland; Hoellthaler, Josef; Magnani, Tiziana; Corrao, Vito; Valdagni, Riccardo

2014-01-01

Multidisciplinary care of prostate cancer is increasingly offered in specialised cancer centres. It requires the optimisation of medical and operational processes and the integration of the different medical and non-medical stakeholders. To develop a standardised operational process assessment tool basing on the capability maturity model integration (CMMI) able to implement multidisciplinary care and improve process quality and efficiency. Information for model development was derived from medical experts, clinical guidelines, best practice elements of renowned cancer centres, and scientific literature. Data were organised in a hierarchically structured model, consisting of 5 categories, 30 key process areas, 172 requirements, and more than 1500 criteria. Compliance with requirements was assessed through structured on-site surveys covering all relevant clinical and management processes. Comparison with best practice standards allowed to recommend improvements. 'Act On Oncology'(AoO) was applied in a pilot study on a prostate cancer unit in Europe. Several best practice elements such as multidisciplinary clinics or advanced organisational measures for patient scheduling were observed. Substantial opportunities were found in other areas such as centre management and infrastructure. As first improvements the evaluated centre administration described and formalised the organisation of the prostate cancer unit with defined personnel assignments and clinical activities and a formal agreement is being worked on to have structured access to First-Aid Posts. In the pilot study, the AoO approach was feasible to identify opportunities for process improvements. Measures were derived that might increase the operational process quality and efficiency.

Staff regard towards working with substance users: a European multi-centre study.

PubMed

Gilchrist, Gail; Moskalewicz, Jacek; Slezakova, Silvia; Okruhlica, Lubomir; Torrens, Marta; Vajd, Rajko; Baldacchino, Alex

2011-06-01

To compare regard for working with different patient groups (including substance users) among different professional groups in different health-care settings in eight European countries. A multi-centre, cross-sectional comparative study. Primary care, general psychiatry and specialist addiction services in Bulgaria, Greece, Italy, Poland, Scotland, Slovakia, Slovenia and Spain. A multi-disciplinary convenience sample of 866 professionals (physicians, psychiatrists, psychologists, nurses and social workers) from 253 services. The Medical Condition Regard Scale measured regard for working with different patient groups. Multi-factor between-subjects analysis of variance determined the factors associated with regard for each condition by country and all countries. Regard for working with alcohol (mean score alcohol: 45.35, 95% CI 44.76, 45.95) and drug users (mean score drugs: 43.67, 95% CI 42.98, 44.36) was consistently lower than for other patient groups (mean score diabetes: 50.19, 95% CI 49.71, 50.66; mean score depression: 51.34, 95% CI 50.89, 51.79) across all countries participating in the study, particularly among staff from primary care compared to general psychiatry or specialist addiction services (P<0.001). After controlling for sex of staff, profession and duration of time working in profession, treatment entry point and country remained the only statistically significant variables associated with regard for working with alcohol and drug users. Health professionals appear to ascribe lower status to working with substance users than helping other patient groups, particularly in primary care; the effect is larger in some countries than others. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Clinical Outcomes in Duchenne Muscular Dystrophy: A Study of 5345 Patients from the TREAT-NMD DMD Global Database

PubMed Central

Koeks, Zaïda; Bladen, Catherine L.; Salgado, David; van Zwet, Erik; Pogoryelova, Oksana; McMacken, Grace; Monges, Soledad; Foncuberta, Maria E.; Kekou, Kyriaki; Kosma, Konstantina; Dawkins, Hugh; Lamont, Leanne; Bellgard, Matthew I.; Roy, Anna J.; Chamova, Teodora; Guergueltcheva, Velina; Chan, Sophelia; Korngut, Lawrence; Campbell, Craig; Dai, Yi; Wang, Jen; Barišić, Nina; Brabec, Petr; Lähdetie, Jaana; Walter, Maggie C.; Schreiber-Katz, Olivia; Karcagi, Veronika; Garami, Marta; Herczegfalvi, Agnes; Viswanathan, Venkatarman; Bayat, Farhad; Buccella, Filippo; Ferlini, Alessandra; Kimura, En; van den Bergen, Janneke C.; Rodrigues, Miriam; Roxburgh, Richard; Lusakowska, Anna; Kostera-Pruszczyk, Anna; Santos, Rosário; Neagu, Elena; Artemieva, Svetlana; Rasic, Vedrana Milic; Vojinovic, Dina; Posada, Manuel; Bloetzer, Clemens; Klein, Andrea; Díaz-Manera, Jordi; Gallardo, Eduard; Karaduman, A. Ayşe; Oznur, Tunca; Topaloğlu, Haluk; El Sherif, Rasha; Stringer, Angela; Shatillo, Andriy V.; Martin, Ann S.; Peay, Holly L.; Kirschner, Jan; Flanigan, Kevin M.; Straub, Volker; Bushby, Kate; Béroud, Christophe; Verschuuren, Jan J.; Lochmüller, Hanns

2017-01-01

Background: Recent short-term clinical trials in patients with Duchenne Muscular Dystrophy (DMD) have indicated greater disease variability in terms of progression than expected. In addition, as average life-expectancy increases, reliable data is required on clinical progression in the older DMD population. Objective: To determine the effects of corticosteroids on major clinical outcomes of DMD in a large multinational cohort of genetically confirmed DMD patients. Methods: In this cross-sectional study we analysed clinical data from 5345 genetically confirmed DMD patients from 31 countries held within the TREAT-NMD global DMD database. For analysis patients were categorised by corticosteroid background and further stratified by age. Results: Loss of ambulation in non-steroid treated patients was 10 years and in corticosteroid treated patients 13 years old (p = 0.0001). Corticosteroid treated patients were less likely to need scoliosis surgery (p < 0.001) or ventilatory support (p < 0.001) and there was a mild cardioprotective effect of corticosteroids in the patient population aged 20 years and older (p = 0.0035). Patients with a single deletion of exon 45 showed an increased survival in contrast to other single exon deletions. Conclusions: This study provides data on clinical outcomes of DMD across many healthcare settings and including a sizeable cohort of older patients. Our data confirm the benefits of corticosteroid treatment on ambulation, need for scoliosis surgery, ventilation and, to a lesser extent, cardiomyopathy. This study underlines the importance of data collection via patient registries and the critical role of multi-centre collaboration in the rare disease field. PMID:29125504

Clinical Outcomes in Duchenne Muscular Dystrophy: A Study of 5345 Patients from the TREAT-NMD DMD Global Database.

PubMed

Koeks, Zaïda; Bladen, Catherine L; Salgado, David; van Zwet, Erik; Pogoryelova, Oksana; McMacken, Grace; Monges, Soledad; Foncuberta, Maria E; Kekou, Kyriaki; Kosma, Konstantina; Dawkins, Hugh; Lamont, Leanne; Bellgard, Matthew I; Roy, Anna J; Chamova, Teodora; Guergueltcheva, Velina; Chan, Sophelia; Korngut, Lawrence; Campbell, Craig; Dai, Yi; Wang, Jen; Barišić, Nina; Brabec, Petr; Lähdetie, Jaana; Walter, Maggie C; Schreiber-Katz, Olivia; Karcagi, Veronika; Garami, Marta; Herczegfalvi, Agnes; Viswanathan, Venkatarman; Bayat, Farhad; Buccella, Filippo; Ferlini, Alessandra; Kimura, En; van den Bergen, Janneke C; Rodrigues, Miriam; Roxburgh, Richard; Lusakowska, Anna; Kostera-Pruszczyk, Anna; Santos, Rosário; Neagu, Elena; Artemieva, Svetlana; Rasic, Vedrana Milic; Vojinovic, Dina; Posada, Manuel; Bloetzer, Clemens; Klein, Andrea; Díaz-Manera, Jordi; Gallardo, Eduard; Karaduman, A Ayşe; Oznur, Tunca; Topaloğlu, Haluk; El Sherif, Rasha; Stringer, Angela; Shatillo, Andriy V; Martin, Ann S; Peay, Holly L; Kirschner, Jan; Flanigan, Kevin M; Straub, Volker; Bushby, Kate; Béroud, Christophe; Verschuuren, Jan J; Lochmüller, Hanns

2017-01-01

Recent short-term clinical trials in patients with Duchenne Muscular Dystrophy (DMD) have indicated greater disease variability in terms of progression than expected. In addition, as average life-expectancy increases, reliable data is required on clinical progression in the older DMD population. To determine the effects of corticosteroids on major clinical outcomes of DMD in a large multinational cohort of genetically confirmed DMD patients. In this cross-sectional study we analysed clinical data from 5345 genetically confirmed DMD patients from 31 countries held within the TREAT-NMD global DMD database. For analysis patients were categorised by corticosteroid background and further stratified by age. Loss of ambulation in non-steroid treated patients was 10 years and in corticosteroid treated patients 13 years old (p = 0.0001). Corticosteroid treated patients were less likely to need scoliosis surgery (p < 0.001) or ventilatory support (p < 0.001) and there was a mild cardioprotective effect of corticosteroids in the patient population aged 20 years and older (p = 0.0035). Patients with a single deletion of exon 45 showed an increased survival in contrast to other single exon deletions. This study provides data on clinical outcomes of DMD across many healthcare settings and including a sizeable cohort of older patients. Our data confirm the benefits of corticosteroid treatment on ambulation, need for scoliosis surgery, ventilation and, to a lesser extent, cardiomyopathy. This study underlines the importance of data collection via patient registries and the critical role of multi-centre collaboration in the rare disease field.

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.

Developing person-centred practice in hip fracture care for older people.

PubMed

Christie, Jane; Macmillan, Maureen; Currie, Colin; Matthews-Smith, Gerardine

2016-12-14

To facilitate a multidisciplinary collaborative approach to developing person-centred practice in hip fracture care for older people. Collaborative inquiry, a form of action research, was used to collect data for this study. It involved exploration of dilemmas, questions and problems that are part of human experience. Clinical leaders from different disciplines (n=16), who work with older people with hip fractures at different stages of the care pathway, participated in a series of facilitated action meetings. The practice development techniques used in this study included: identifying the strengths and limitations of the current service, values clarification, creating a shared vision, sharing clinical stories, reviewing case records, and reflecting on the experiences of three older people and two caregivers. Hip fracture care was based on meeting service targets, national guidelines and audits. Care was fragmented across different service delivery units, with professional groups working independently. This resulted in suboptimal communication between members of the multidisciplinary group of clinical leaders and care that was process-driven rather than person-centred. Spending time away from clinical practice enabled the multidisciplinary group to collaborate to understand care from the patients' and caregivers' perspectives, and to reflect critically on the care experience as a whole. To develop a person-centred workplace culture, the multidisciplinary team requires facilitated time for reflection. Ongoing facilitative leadership would enable the multidisciplinary team to collaborate effectively to deliver safe, effective person-centred practice in hip fracture care for older people.

Endoscopic non-technical skills team training: the next step in quality assurance of endoscopy training.

PubMed

Matharoo, Manmeet; Haycock, Adam; Sevdalis, Nick; Thomas-Gibson, Siwan

2014-12-14

To investigate whether novel, non-technical skills training for Bowel Cancer Screening (BCS) endoscopy teams enhanced patient safety knowledge and attitudes. A novel endoscopy team training intervention for BCS teams was developed and evaluated as a pre-post intervention study. Four multi-disciplinary BCS teams constituting BCS endoscopist(s), specialist screening practitioners, endoscopy nurses and administrative staff (A) from English BCS training centres participated. No patients were involved in this study. Expert multidisciplinary faculty delivered a single day's training utilising real clinical examples. Pre and post-course evaluation comprised participants' patient safety awareness, attitudes, and knowledge. Global course evaluations were also collected. Twenty-three participants attended and their patient safety knowledge improved significantly from 43%-55% (P ≤ 0.001) following the training intervention. 12/41 (29%) of the safety attitudes items significantly improved in the areas of perceived patient safety knowledge and awareness. The remaining safety attitude items: perceived influence on patient safety, attitudes towards error management, error management actions and personal views following an error were unchanged following training. Both qualitative and quantitative global course evaluations were positive: 21/23 (91%) participants strongly agreed/agreed that they were satisfied with the course. Qualitative evaluation included mandating such training for endoscopy teams outside BCS and incorporating team training within wider endoscopy training. Limitations of the study include no measure of increased patient safety in clinical practice following training. A novel comprehensive training package addressing patient safety, non-technical skills and adverse event analysis was successful in improving multi-disciplinary teams' knowledge and safety attitudes.

Endoscopic non-technical skills team training: The next step in quality assurance of endoscopy training

PubMed Central

Matharoo, Manmeet; Haycock, Adam; Sevdalis, Nick; Thomas-Gibson, Siwan

2014-01-01

AIM: To investigate whether novel, non-technical skills training for Bowel Cancer Screening (BCS) endoscopy teams enhanced patient safety knowledge and attitudes. METHODS: A novel endoscopy team training intervention for BCS teams was developed and evaluated as a pre-post intervention study. Four multi-disciplinary BCS teams constituting BCS endoscopist(s), specialist screening practitioners, endoscopy nurses and administrative staff (A) from English BCS training centres participated. No patients were involved in this study. Expert multidisciplinary faculty delivered a single day’s training utilising real clinical examples. Pre and post-course evaluation comprised participants’ patient safety awareness, attitudes, and knowledge. Global course evaluations were also collected. RESULTS: Twenty-three participants attended and their patient safety knowledge improved significantly from 43%-55% (P ≤ 0.001) following the training intervention. 12/41 (29%) of the safety attitudes items significantly improved in the areas of perceived patient safety knowledge and awareness. The remaining safety attitude items: perceived influence on patient safety, attitudes towards error management, error management actions and personal views following an error were unchanged following training. Both qualitative and quantitative global course evaluations were positive: 21/23 (91%) participants strongly agreed/agreed that they were satisfied with the course. Qualitative evaluation included mandating such training for endoscopy teams outside BCS and incorporating team training within wider endoscopy training. Limitations of the study include no measure of increased patient safety in clinical practice following training. CONCLUSION: A novel comprehensive training package addressing patient safety, non-technical skills and adverse event analysis was successful in improving multi-disciplinary teams’ knowledge and safety attitudes. PMID:25516665

When Triple Helix Unravels: A Multi-Case Analysis of Failures in Industry-University Cooperative Research Centres

ERIC Educational Resources Information Center

Gray, Denis; Sundstrom, Eric; Tornatzky, Louis G.; McGowen, Lindsey

2011-01-01

Cooperative research centres (CRCs) increasingly foster Triple Helix (industry-university-government) collaboration and represent significant vehicles for cooperation across sectors, the promotion of knowledge and technology transfer and ultimately the acceleration of innovation. A growing social science literature on CRCs focuses on their…

A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control.

PubMed

Shannon, Ronald; Nelson, Andrea

2017-08-01

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof-of-concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score-matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi-layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow-up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan-Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ 2 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison. © 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Factors influencing practice variation in the management of nephrotic syndrome: a qualitative study of pediatric nephrology care providers

PubMed Central

Samuel, Susan M.; Flynn, Rachel; Zappitelli, Michael; Dart, Allison; Parekh, Rulan; Pinsk, Maury; Mammen, Cherry; Wade, Andrew; Scott, Shannon D.

2017-01-01

Background: Treatment protocols for childhood nephrotic syndrome are highly variable between providers and care centres. We conducted a qualitative study to understand the complex multilevel processes that lead to practice variation and influence provider management of nephrotic syndrome. Methods: Focus groups with multidisciplinary pediatric nephrology care providers (n = 67) from 10 Canadian pediatric nephrology centres that had more than 1 pediatric nephrologist were conducted between September 2013 and April 2015. Focus group discussions were guided by the Ottawa Model for Research Use. We used a semistructured interview guide to elicit participants' perspectives regarding 1) the work setting and context of the clinical environment, 2) reasons for variation at the provider level and 3) clinical practice guidelines for nephrotic syndrome. Focus group discussions were transcribed and analyzed concurrently with the use of qualitative content analysis. Results: Emerging themes were grouped into 2 categories: centre-level factors and provider-level factors. At the centre level, the type of care model used, clinic structures and resources, and lack of communication and collaboration within and between Canadian centres influenced care variation. At the provider level, use of experiential knowledge versus empirical knowledge and interpretation of patient characteristics influenced provider management of nephrotic syndrome. Interpretation: Centre- and provider-level factors play an important role in shaping practice differences in the management of childhood nephrotic syndrome. Further research is needed to determine whether variation in care is associated with disparities in outcomes. PMID:28592406

Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre.

PubMed

Adams, Mary; Caffrey, Louise; McKevitt, Christopher

2015-03-12

In the UK, the recruitment of patients into clinical research is a national health research and development policy priority. There has been limited investigation of how national level factors operate as barriers or facilitators to recruitment work, particularly from the perspective of staff undertaking patient recruitment work. The aim of this study is to identify and examine staff views of the key organisational barriers and facilitators to patient recruitment work in one clinical research group located in an NHS Academic Health Science Centre. A qualitative study utilizing in-depth, one-to-one semi-structured interviews with 11 purposively selected staff with particular responsibilities to recruit and retain patients as clinical research subjects. Thematic analysis classified interview data by recurring themes, concepts, and emergent categories for the purposes of establishing explanatory accounts. The findings highlight four key factors that staff perceived to be most significant for the successful recruitment and retention of patients in research and identify how staff located these factors within patients, studies, the research centre, the trust, and beyond the trust. Firstly, competition for research participants at an organisational and national level was perceived to undermine recruitment success. Secondly, the tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs. Thirdly, staff perceived an imbalance between personal patient burden and benefit. Ethical committee regulation, designed to protect patients, was perceived by some staff to detract from clarification and systematisation of incentivisation strategies. Finally, the structure and relationships within clinical research teams, in particular the low tacit status of recruitment skills, was seen as influential. The results of this case-study, conducted in an exemplary NHS academic research centre, highlight current systematic challenges to patient recruitment and retention in clinical studies more generally as seen from the perspective of staff at the 'sharp end' of recruiting. Staff experience is that, beyond individual clinical research design and protocol factors, wider organisational and extra-organisational norms, structures, and processes operate as significant facilitators or hindrances in the recruitment of patients as research subjects.

European Network of Bipolar Research Expert Centre (ENBREC): a network to foster research and promote innovative care.

PubMed

Henry, Chantal; Andreassen, Ole A; Barbato, Angelo; Demotes-Mainard, Jacques; Goodwin, Guy; Leboyer, Marion; Vieta, Eduard; Nolen, Willem A; Kessing, Lars Vedel; Scott, Jan; Bauer, Michael

2013-01-01

Bipolar disorders rank as one of the most disabling illnesses in working age adults worldwide. Despite this, the quality of care offered to patients with this disorder is suboptimal, largely due to limitations in our understanding of the pathology. Improving this scenario requires the development of a critical mass of expertise and multicentre collaborative projects. Within the framework of the European FP7 programme, we developed a European Network of Bipolar Research Expert Centres (ENBREC) designed specifically to facilitate EU-wide studies. ENBREC provides an integrated support structure facilitating research on disease mechanisms and clinical outcomes across six European countries (France, Germany, Italy, Norway, Spain and the UK). The centres are adopting a standardised clinical assessment that explores multiple aspects of bipolar disorder through a structured evaluation designed to inform clinical decision-making as well as being applicable to research. Reliable, established measures have been prioritised, and instruments have been translated and validated when necessary. An electronic healthcare record and monitoring system (e-ENBREC©) has been developed to collate the data. Protocols to conduct multicentre clinical observational studies and joint studies on cognitive function, biomarkers, genetics, and neuroimaging are in progress; a pilot study has been completed on strategies for routine implementation of psycho-education. The network demonstrates 'proof of principle' that expert centres across Europe can collaborate on a wide range of basic science and clinical programmes using shared protocols. This paper is to describe the network and how it aims to improve the quality and effectiveness of research in a neglected priority area.

[Post launch studies].

PubMed

Akaza, Hideyuki; Ohashi, Yasuo; Shimada, Yasuhiro; Ikeda, Tadashi; Saijo, Nagahiro; Isonishi, Seiji; Hirao, Yoshihiko; Tsuruo, Takashi; Tsukagoshi, Shigeru; Sone, Saburo; Nakamura, Seigo; Kato, Masuhiro; Mikami, Osamu; von Euler, Mikael; Blackledge, George; Milsted, Bob; Vose, Brent

2002-11-01

Evidence Based Medicine (EBM) is a growing concept in Japan as it is elsewhere. Central to improving the use of EBM is generation of data through well conducted controlled clinical studies. There are many problems associated with conduct of clinical studies after launch in Japan, and many initiatives are ongoing to improve the situation. Development of Clinical Research Coordinators (CRO) and central Data Management centers are key to improving the quality of clinical research in Japan. Currently Japan has an undeveloped legal system with regard to post-launch trials and off-label use of registered drugs. There is no reimbursement for off-label and various restrictions imposed on the recipients of the Ministry of Health, Labour and Welfare's (MHLW) funds. Maybe the biggest problem is the high cost of post-marketing studies sponsored by pharmaceutical manufacturers. A high quality system to support post launch clinical studies need a solid financial base. There is a need for a suitable review system for investigator initiated multi-centre studies, as the current IRB system is not sufficient. There are also challenges regarding the differences, perceived or real, in treatment practice and available registrations in Japan and in the West, causing problems in choosing suitable comparators and study designs. At the present time it is not clear whether investigator initiated trials will be acceptable for registration purposes in Japan. The agreed first priority is to build a suitable and strong infrastructure within the academic community to support researchers to investigate important questions with or without pharmaceutical company support. Despite all these issues, several groundbreaking projects are under way throughout Japan, in many different areas and by different collaborative groups, some with government support. In fact, researcher-initiated clinical trials achieved a rapid growth in Japan in the past year.

Improving our understanding of multi-tasking in healthcare: Drawing together the cognitive psychology and healthcare literature.

PubMed

Douglas, Heather E; Raban, Magdalena Z; Walter, Scott R; Westbrook, Johanna I

2017-03-01

Multi-tasking is an important skill for clinical work which has received limited research attention. Its impacts on clinical work are poorly understood. In contrast, there is substantial multi-tasking research in cognitive psychology, driver distraction, and human-computer interaction. This review synthesises evidence of the extent and impacts of multi-tasking on efficiency and task performance from health and non-healthcare literature, to compare and contrast approaches, identify implications for clinical work, and to develop an evidence-informed framework for guiding the measurement of multi-tasking in future healthcare studies. The results showed healthcare studies using direct observation have focused on descriptive studies to quantify concurrent multi-tasking and its frequency in different contexts, with limited study of impact. In comparison, non-healthcare studies have applied predominantly experimental and simulation designs, focusing on interleaved and concurrent multi-tasking, and testing theories of the mechanisms by which multi-tasking impacts task efficiency and performance. We propose a framework to guide the measurement of multi-tasking in clinical settings that draws together lessons from these siloed research efforts. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Exposure of health workers in primary health care to glutaraldehyde

PubMed Central

2013-01-01

Background In order to avoid proliferation of microorganisms, cleaning, disinfection and sterilisation in health centres is of utmost importance hence reducing exposure of workers to biological agents and of clients that attend these health centres to potential infections. One of the most commonly-used chemical is glutaraldehyde. The effects of its exposure are well known in the hospital setting; however there is very little information available with regards to the primary health care domain. Objective To determine and measure the exposure of health workers in Primary Health Care Centres. Environmental to glutaraldehyde and staff concentration will be measured and compared with regulated Occupational Exposure Limits. Methods/Design Observational, cross-sectional and multi-centre study. The study population will be composed of any health professionals in contact with the chemical substance that work in the Primary Health Care Centres in the areas of Barcelonès Nord, Maresme, and Barcelona city belonging to the Catalan Institute of Health. Data will be collected from 1) Glutaraldhyde consumption from the previous 4 years in the health centres under study. 2) Semi-structured interviews and key informants to gather information related to glutaraldehyde exposure. 3) Sampling of the substance in the processes considered to be high exposure. Discussion Although glutaraldehyde is extensively used in health centres, scientific literature only deals with certain occupational hazards in the hospital setting. This study attempts to take an in-depth look into the risk factors and environmental conditions that exist in the primary care workplace with exposure to glutaraldehyde. PMID:24180250

Autonomous Systems: Issues for Defence Policymakers

DTIC Science & Technology

2015-09-30

Unmanned Surveillance Target Acquisition System, and being co-leader of the multi- research centre Manned-Unmanned Aerial Vehicle Interactions study . He...Assessment Scale’ was derived from research into external autonomy applications (Sheridan, Parasuraman, etc.) and other studies . The scale’s...system. This roadmap covers annexes on the regulatory approach, a strategic research plan, and a study of the societal impact of the challenges of RPAS

Paediatric type 1 diabetes in Ireland--results of the first national audit.

PubMed

Hawkes, C P; Murphy, N P

2014-04-01

The aim of this study was to describe the services provided for children with type 1 diabetes in the Republic of Ireland, and to identify a baseline from which services and outcomes might be improved. Lead clinicians in 17 of the 19 centres providing paediatric type 1 diabetes care responded to requests for information from 2012 regarding demographics, patient numbers, diagnostics, outpatient management, multidisciplinary team resources, comorbidity screening, transition policy, clinical guidelines, and use of insulin pumps. The total number of patients attending these centres was 2518. Eight centres initiate insulin pump therapy. Insulin pump usage ranged from 0 to 42% of patients attending each centre. Self reported clinic mean haemoglobin A1c ranged from 8.2 to 9.4% (66.1 to 79.2 mmol/mol). Variation existed in guideline availability, frequency of clinic appointments, age of transition and insulin types used. We recommend a national approach to standardising and improving care for these patients.

A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

PubMed

Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Elders, Andrew; Hernández, Rodolfo; Boyers, Dwayne; Norrie, John; Kinsella, John; Brittenden, Julie; Cook, Jonathan; Rae, Daniela; Cotton, Seonaidh C; Alcorn, David; Addison, Jennifer; Grant, Adrian

2011-01-01

Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Prospective Clinical Trials, ISRCTN32188676.

A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study

PubMed Central

2011-01-01

Introduction Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. Methods This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. Results A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Conclusions Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Trial registration Prospective Clinical Trials, ISRCTN32188676 PMID:22177541

Evaluation of a combined strategy directed towards health-care professionals and patients with chronic obstructive pulmonary disease (COPD): information and health education feedback for improving clinical monitoring and quality-of-life.

PubMed

Valero, Carles; Monteagudo, Mònica; Llagostera, Maria; Bayona, Xavier; Granollers, Sílvia; Acedo, Mateo; Ferro, Juan J; Rodríguez-Latre, Lluïsa; Almeda, Jesús; Muñoz, Laura

2009-12-01

Chronic obstructive pulmonary disease (COPD) is a health problem that is becoming increasingly attended-to in Primary Care (PC). However, there is a scarcity of health-care programs and studies exploring the implementation of Clinical Practice Guidelines (CPG). The principal objective of the present study is to evaluate the effectiveness of a combined strategy directed towards health-care professionals and patients to improve the grade of clinical control and the quality-of-life (QoL) of the patients via a feedback on their state-of-health. A training plan for the health-care professionals is based on CPG and health education. Multi-centred, before-after, quasi experimental, prospective study involving an intervention group and a control group of individuals followed-up for 12 months. The patients receive attention from urban and semi-urban Primary Care Centres (PCC) within the administrative area of the Costa de Ponent (near Barcelona). All the pacients corresponding to the PCC of one sub-area were assigned to the intervention group and patients from the rest of sub-areas to the group control. The intervention includes providing data to the health-care professionals (clinician/nurse) derived from a clinical history and an interview. A course of training focused on aspects of CPG, motivational interview and health education (tobacco, inhalers, diet, physical exercise, physiotherapy). The sample random includes a total of 801 patients (> or = 40 years of age), recorded as having COPD, receiving attention in the PCC or at home, who have had at least one clinical visit, and who provided written informed consent to participation in the study. Data collected include socio-demographic characteristics, drug treatment, exacerbations and hospital admissions, evaluation of inhaler use, tobacco consumption and life-style and health-care resources consumed. The main endpoints are dyspnoea, according to the modified scale of the Medical Research Council (MRC) and the QoL, evaluated with the St George's Respiratory Questionnaire (SGRQ). The variables are obtained at the start and the end of the intervention. Information from follow-up visits focuses on the changes in life-style activities of the patient. This study is conducted with the objective of generating evidence that shows that implementation of awareness programs directed towards health-care professionals as well as patients in the context of PC can produce an increase in the QoL and a decrease in the disease exacerbation, compared to standard clinical practice. Clinical Trials.gov Identifier: NCT00922545;

An optical investigation of nano-crystalline CaF2 particles doped with Nd3+ ions

NASA Astrophysics Data System (ADS)

O'Dwyer, C.; James, H. J.; Cheu, B.; Jaque, F.; Han, T. P. J.

2017-10-01

Good crystalline quality CaF2 sub-micron size particles doped with neodymium ions have been produced by the co-precipitation process and their crystallinity have been further improved by thermal treatment at 500 °C. Core and surface related luminescence defect centres have been identified and the effects of Y3+ and Yb3+ codopants are also investigated. Core defects centres are associated with single-ion and multi-ion defect centres as observed in bulk single crystal whereas the origin of the surface or near surface defect, A‧, centre has been ascertained to be derived from a single-ion centre most probably charge compensated by a hydroxyl group.

Developing Online Learning Resources: Big Data, Social Networks, and Cloud Computing to Support Pervasive Knowledge

ERIC Educational Resources Information Center

Anshari, Muhammad; Alas, Yabit; Guan, Lim Sei

2016-01-01

Utilizing online learning resources (OLR) from multi channels in learning activities promise extended benefits from traditional based learning-centred to a collaborative based learning-centred that emphasises pervasive learning anywhere and anytime. While compiling big data, cloud computing, and semantic web into OLR offer a broader spectrum of…

Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

PubMed Central

Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

2009-01-01

Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

‘Act on Oncology’ as a New Comprehensive Approach to Assess Prostate Cancer Centres – Method Description and Results of a Pilot Study

PubMed Central

Voigt, Wieland; Hoellthaler, Josef; Magnani, Tiziana; Corrao, Vito; Valdagni, Riccardo

2014-01-01

Background Multidisciplinary care of prostate cancer is increasingly offered in specialised cancer centres. It requires the optimisation of medical and operational processes and the integration of the different medical and non-medical stakeholders. Objective To develop a standardised operational process assessment tool basing on the capability maturity model integration (CMMI) able to implement multidisciplinary care and improve process quality and efficiency. Design, Setting, and Participants Information for model development was derived from medical experts, clinical guidelines, best practice elements of renowned cancer centres, and scientific literature. Data were organised in a hierarchically structured model, consisting of 5 categories, 30 key process areas, 172 requirements, and more than 1500 criteria. Compliance with requirements was assessed through structured on-site surveys covering all relevant clinical and management processes. Comparison with best practice standards allowed to recommend improvements. ‘Act On Oncology’(AoO) was applied in a pilot study on a prostate cancer unit in Europe. Results and Limitations Several best practice elements such as multidisciplinary clinics or advanced organisational measures for patient scheduling were observed. Substantial opportunities were found in other areas such as centre management and infrastructure. As first improvements the evaluated centre administration described and formalised the organisation of the prostate cancer unit with defined personnel assignments and clinical activities and a formal agreement is being worked on to have structured access to First-Aid Posts. Conclusions In the pilot study, the AoO approach was feasible to identify opportunities for process improvements. Measures were derived that might increase the operational process quality and efficiency. PMID:25192213

Diagnostic work-up and loss of tuberculosis suspects in Jogjakarta, Indonesia.

PubMed

Ahmad, Riris Andono; Matthys, Francine; Dwihardiani, Bintari; Rintiswati, Ning; de Vlas, Sake J; Mahendradhata, Yodi; van der Stuyft, Patrick

2012-02-15

Early and accurate diagnosis of pulmonary tuberculosis (TB) is critical for successful TB control. To assist in the diagnosis of smear-negative pulmonary TB, the World Health Organisation (WHO) recommends the use of a diagnostic algorithm. Our study evaluated the implementation of the national tuberculosis programme's diagnostic algorithm in routine health care settings in Jogjakarta, Indonesia. The diagnostic algorithm is based on the WHO TB diagnostic algorithm, which had already been implemented in the health facilities. We prospectively documented the diagnostic work-up of all new tuberculosis suspects until a diagnosis was reached. We used clinical audit forms to record each step chronologically. Data on the patient's gender, age, symptoms, examinations (types, dates, and results), and final diagnosis were collected. Information was recorded for 754 TB suspects; 43.5% of whom were lost during the diagnostic work-up in health centres, 0% in lung clinics. Among the TB suspects who completed diagnostic work-ups, 51.1% and 100.0% were diagnosed without following the national TB diagnostic algorithm in health centres and lung clinics, respectively. However, the work-up in the health centres and lung clinics generally conformed to international standards for tuberculosis care (ISTC). Diagnostic delays were significantly longer in health centres compared to lung clinics. The high rate of patients lost in health centres needs to be addressed through the implementation of TB suspect tracing and better programme supervision. The national TB algorithm needs to be revised and differentiated according to the level of care.

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.

Continuous infusion vs. bolus dosing: implications for beta-lactam antibiotics.

PubMed

Mohd Hafiz, Abdul-Aziz; Staatz, C E; Kirkpatrick, C M J; Lipman, J; Roberts, J A

2012-01-01

Beta-lactam antibiotics display time-dependant pharmacodynamics whereby constant antibiotic concentrations rather than high peak concentrations are most likely to result in effective treatment of infections caused by susceptible bacteria. Continuous administration has been suggested as an alternative strategy, to conventional intermittent dosing, to optimise beta-lactam pharmacokinetic/pharmacodynamic (PK/PD) properties. With the availability of emerging data, we elected to systematically investigate the published literature describing the comparative PK/PD and clinical outcomes of beta-lactam antibiotics administered by continuous or intermittent infusion. We found that the studies have been performed in various patient populations including critically ill, cancer and cystic fibrosis patients. Available in vitro PK/PD data conclusively support the administration of beta-lactams via continuous infusion for maximizing bacterial killing from consistent attainment of pharmacodynamic end-points. In addition, clinical outcome data supports equivalence, even with the use of a lower dose by continuous infusion. However, the present clinical data is limited with small sample sizes common with insufficient power to detect advantages in favour of either dosing strategy. With abundant positive pre-clinical data as well as document in vivo PK/PD advantages, large multi-centre trials are needed to describe whether continuous administration of beta-lactams is truly more effective than intermittent dosing.

Elaboration of the Gothenburg model of person-centred care.

PubMed

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

2017-06-01

Person-centred care (PCC) is increasingly advocated as a new way of delivering health care, but there is little evidence that it is widely practised. The University of Gothenburg Centre for Person-Centred Care (GPCC) was set up in 2010 to develop and implement person-centred care in clinical practice on the basis of three routines. These routines are based on eliciting the patient's narrative to initiate a partnership; working the partnership to achieve commonly agreed goals; and using documentation to safeguard the partnership and record the person's narrative and shared goals. In this paper, we aimed to explore professionals' understanding of PCC routines as they implement the GPCC model in a range of different settings. We conducted a qualitative study and interviewed 18 clinician-researchers from five health-care professions who were working in seven diverse GPCC projects. Interviewees' accounts of PCC emphasized the ways in which persons are seen as different from patients; the variable emphasis placed on the person's goals; and the role of the person's own resources in building partnerships. This study illustrates what is needed for health-care professionals to implement PCC in everyday practice: the recognition of the person is as important as the specific practical routines. Interviewees described the need to change the clinical mindset and to develop the ways of integrating people's narratives with clinical practice. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

Efficacy and safety of artemisinin-naphthoquine versus dihydroartemisinin-piperaquine in adult patients with uncomplicated malaria: a multi-centre study in Indonesia

PubMed Central

2012-01-01

Background A practical and simple regimen for all malaria species is needed towards malaria elimination in Indonesia. It is worth to compare the efficacy and safety of a single dose of artemisinin-naphthoquine (AN) with a three-day regimen of dihydroartemisinin-piperaquine (DHP), the existing programme drug, in adults with uncomplicated symptomatic malaria. Methods This is a phase III, randomized, open label using sealed envelopes, multi-centre, comparative study between a single dose of AN and a three-day dose of DHP in Jayapura and Maumere. The modified WHO inclusion and exclusion criteria for efficacy study were used in this trial. A total of 401 eligible adult malaria subjects were hospitalized for three days and randomly treated with AN four tablets single dose on day 0 or DHP three to four tablets single daily dose for three days, and followed for 42 days for physical examination, thick and thin smears microscopy, and other necessary tests. The efficacy of drug was assessed by polymerase chain reaction (PCR) uncorrected and corrected. Results There were 153 Plasmodium falciparum, 158 Plasmodium vivax and 90 P. falciparum/P. vivax malaria. Mean of fever clearance times were similar, 13.0 ± 10.3 hours in AN and 11.3 ± 7.3 hours in DHP groups. The mean of parasite clearance times were longer in AN compared with DHP (28.0 ± 11.7 hours vs 25.5 ± 12.2 hours, p = 0.04). There were only 12 PCR-corrected P. falciparum late treatment failures: seven in AN and five in DHP groups. The PCR uncorrected and corrected on day −42 of adequate clinical and parasitological responses for treatment of any malaria were 93.7% (95% Cl: 90.3–97.2) and 96.3% (95% Cl: 93.6–99.0) in AN, 96.3% (95% Cl: 93.5–99.0) and 97.3% (95% Cl: 95.0–99.6) in DHP groups. Few and mild adverse events were reported. All the abnormal haematology and blood chemistry values had no clinical abnormality. Conclusion AN and DHP are confirmed very effective, safe and tolerate for treatment of any malaria. Both drugs are promising for multiple first-line therapy policies in Indonesia. PMID:22554203

X-ray structural studies of the fungal laccase from Cerrena maxima.

PubMed

Lyashenko, Andrey V; Bento, Isabel; Zaitsev, Viatcheslav N; Zhukhlistova, Nadezhda E; Zhukova, Yuliya N; Gabdoulkhakov, Azat G; Morgunova, Ekaterina Y; Voelter, Wolfgang; Kachalova, Galina S; Stepanova, Elena V; Koroleva, Ol'ga V; Lamzin, Victor S; Tishkov, Vladimir I; Betzel, Christian; Lindley, Peter F; Mikhailov, Al'bert M

2006-11-01

Laccases are members of the blue multi-copper oxidase family. These enzymes oxidize substrate molecules by accepting electrons at a mononuclear copper centre and transferring them to a trinuclear centre. Dioxygen binds to the trinuclear centre and following the transfer of four electrons is reduced to two molecules of water. The X-ray structure of a laccase from Cerrena maxima has been elucidated at 1.9 A resolution using synchrotron data and the molecular replacement technique. The final refinement coefficients are Rcryst = 16.8% and Rfree = 23.0%, with root mean square deviations on bond lengths and bond angles of 0.015 A and 1.51 degrees , respectively. The type 1 copper centre has an isoleucine residue at the axial position and the "resting" state of the trinuclear centre comprises a single oxygen (OH) moiety asymmetrically disposed between the two type 3 copper ions and a water molecule attached to the type 2 ion. Several carbohydrate binding sites have been identified and the glycan chains appear to promote the formation of well-ordered crystals. Two tyrosine residues near the protein surface have been found in a nitrated state.

Problem-oriented patient record model as a conceptual foundation for a multi-professional electronic patient record.

PubMed

De Clercq, Etienne

2008-09-01

It is widely accepted that the development of electronic patient records, or even of a common electronic patient record, is one possible way to improve cooperation and data communication between nurses and physicians. Yet, little has been done so far to develop a common conceptual model for both medical and nursing patient records, which is a first challenge that should be met to set up a common electronic patient record. In this paper, we describe a problem-oriented conceptual model and we show how it may suit both nursing and medical perspectives in a hospital setting. We started from existing nursing theory and from an initial model previously set up for primary care. In a hospital pilot site, a multi-disciplinary team refined this model using one large and complex clinical case (retrospective study) and nine ongoing cases (prospective study). An internal validation was performed through hospital-wide multi-professional interviews and through discussions around a graphical user interface prototype. To assess the consistency of the model, a computer engineer specified it. Finally, a Belgian expert working group performed an external assessment of the model. As a basis for a common patient record we propose a simple problem-oriented conceptual model with two levels of meta-information. The model is mapped with current nursing theories and it includes the following concepts: "health care element", "health approach", "health agent", "contact", "subcontact" and "service". These concepts, their interrelationships and some practical rules for using the model are illustrated in this paper. Our results are compatible with ongoing standardization work at the Belgian and European levels. Our conceptual model is potentially a foundation for a multi-professional electronic patient record that is problem-oriented and therefore patient-centred.

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit.

PubMed

Stewart, Kirsty; Hutana, Gavin; Kentish, Megan

2017-06-21

Increasing clinical use of Intrathecal baclofen (ITB) in Australian tertiary paediatric hospitals, along with the need for standardised assessment and reporting of adverse events, saw the formation of the Australian Paediatric ITB Research Group (APIRG). APIRG developed a National ITB Audit tool designed to capture clinical outcomes and adverse events data for all Australian children and adolescents receiving ITB therapy. The Australian ITB Audit is a 10 year, longitudinal, prospective, clinical audit collecting all adverse events and assessment data across body functions and structure, participation and activity level domains of the ICF. Data will be collected at baseline, 6 and 12 months with ongoing capture of all adverse event data. This is the first Australian study that aims to capture clinical and adverse event data from a complete population of children with neurological impairment receiving a specific intervention between 2011 and 2021. This multi-centre study will inform ITB clinical practice in children and adolescents, direct patient selection, record and aid decision making regarding adverse events and investigate the impact of ITB therapy on family and patient quality of life. This project was approved by the individual Human Research Ethics committees at the six Australian tertiary hospitals involved in the study. Results will be published in various peer reviewed journals and presented at national and international conferences. ACTRN 12610000323022; Pre-results. © 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.

Physical activity monitoring in COPD: compliance and associations with clinical characteristics in a multicenter study.

PubMed

Waschki, Benjamin; Spruit, Martijn A; Watz, Henrik; Albert, Paul S; Shrikrishna, Dinesh; Groenen, Miriam; Smith, Cayley; Man, William D-C; Tal-Singer, Ruth; Edwards, Lisa D; Calverley, Peter M A; Magnussen, Helgo; Polkey, Michael I; Wouters, Emiel F M

2012-04-01

Little is known about COPD patients' compliance with physical activity monitoring and how activity relates to disease characteristics in a multi-center setting. In a prospective study at three Northern European sites physical activity and clinical disease characteristics were measured in 134 COPD patients (GOLD-stage II-IV; BODE index 0-9) and 46 controls. Wearing time, steps per day, and the physical activity level (PAL) were measured by a multisensory armband over a period of 6 consecutive days (in total, 144 h). A valid measurement period was defined as ≥22 h wearing time a day on at least 5 days. The median wearing time was 142 h:17 min (99%), 141 h:1 min (98%), and 142 h:24 min (99%), respectively in the three centres. A valid measurement period was reached in 94%, 97%, and 94% of the patients and did not differ across sites (P = 0.53). The amount of physical activity did not differ across sites (mean steps per day, 4725 ± 3212, P = 0.58; mean PAL, 1.45 ± 0.20, P = 0.48). Multivariate linear regression analyses revealed significant associations of FEV1, 6-min walk distance, quadriceps strength, fibrinogen, health status, and dyspnoea with both steps per day and PAL. Previously unrecognized correlates of activity were grade of fatigue, degree of emphysema, and exacerbation rate. The excellent compliance with wearing a physical activity monitor irrespective of study site and consistent associations with relevant disease characteristics support the use of activity monitoring as a valid outcome in multi-center studies. Copyright © 2011 Elsevier Ltd. All rights reserved.

Time pressured deprioritization of COPD in primary care: a qualitative study.

PubMed

Sandelowsky, Hanna; Hylander, Ingrid; Krakau, Ingvar; Modin, Sonja; Ställberg, Björn; Nager, Anna

2016-01-01

To identify factors that hinder discussions regarding chronic obstructive pulmonary disease (COPD) between primary care physicians (PCPs) and their patients in Sweden. Primary health care centres (PHCCs) in Stockholm, Sweden. A total of 59 PCPs. Semi-structured individual and focus-group interviews between 2012 and 2014. Data were analysed inspired by grounded theory methods (GTM). Time-pressured patient-doctor consultations lead to deprioritization of COPD. During unscheduled visits, deprioritization resulted from focusing only on acute health concerns, while during routine care visits, COPD was deprioritized in multi-morbid patients. The reasons PCPs gave for deprioritizing COPD are: "Not becoming aware of COPD", "Not becoming concerned due to clinical features", "Insufficient local routines for COPD care", "Negative personal attitudes and views about COPD", "Managing diagnoses one at a time", and "Perceiving a patient's motivation as low''. De-prioritization of COPD was discovered during PCP consultations and several factors were identified associated with time constraints and multi-morbidity. A holistic consultation approach is suggested, plus extended consultation time for multi-morbid patients, and better documentation and local routines. Under-diagnosis and insufficient management of chronic obstructive pulmonary disease (COPD) are common in primary health care. A patient-doctor consultation offers a key opportunity to identify and provide COPD care. Time pressure, due to either high number of patients or multi-morbidity, leads to omission or deprioritization of COPD during consultation. Deprioritization occurs due to lack of awareness, concern, and local routines, negative personal views, non-holistic consultation approach, and low patient motivation. Better local routines, extended consultation time, and a holistic approach are needed when managing multi-morbid patients with COPD.

Cognitive Dysfunction in Asian Patients with Depression (CogDAD): A Cross-Sectional Study

PubMed Central

Manit, Srisurapanont; Yee Ming, Mok; Yen Kuang, Yang; Herng-Nieng, Chan; Constantine D, Della; Zuraida, Zainal, Nor; Stephen, Jambunathan; Nurmiati, Amir; Pranabi, Kalita

2017-01-01

Background: Cognitive dysfunction is a predominant symptom of Major Depressive Disorder (MDD), contributing to functional impairment. Objective: The primary objective of this study was to assess and describe perceived cognitive dysfunction amongst Asian patients diagnosed with MDD. The secondary objective was to explore the associations between depression severity, perceived cognitive dysfunction and functional disability. Methods: This was a multi-country, multi-centre, cross-sectional study. Adults with a current episode of MDD were recruited from 9 university/general hospital clinics in Asia. During a single study visit, psychiatrists assessed depression severity (Clinical Global Impression-Severity, CGI-S); patients completed questionnaires assessing depression severity (Patient Health Questionnaire-9 items, PHQ-9), perceived cognitive dysfunction (Perceived Deficit Questionnaire-Depression, PDQ-D) and functional disability (Sheehan Disability Scale, SDS). Results: Patients (n=664), predominantly women (66.3%), were aged 46.5±12.5 years, lived in urban areas (81.3%) and were employed (84.6%). 51.5% of patients were having their first depressive episode; 86.7% were receiving treatment; 82.2% had a current episode duration >8 weeks. Patients had mild-to-moderate depression (CGI-S=3.3±1.0; PHQ-9=11.3±6.9). Patients reported perceived cognitive dysfunction (PDQ-D=22.6±16.2) and functional disability (SDS=11.3±7.9). PHQ-9, PDQ-D and SDS were moderately-to-highly correlated (PHQ-9 and SDS: r=0.72; PHQ-9 and PDQ-D: r=0.69; PDQ-D and SDS, r=0.63). ANCOVA showed that after controlling for patient-reported depression severity (PHQ-9), perceived cognitive dysfunction (PDQ-D) was significantly associated with functional disability (SDS) (p<0.001). Conclusions: Asian patients with MDD reported perceived cognitive dysfunction. There is a need for physicians to evaluate cognitive dysfunction in the clinical setting in order to reach treatment goals, including functional recovery beyond remission of mood symptoms. PMID:29238395

Optimal service using Matlab - simulink controlled Queuing system at call centers

NASA Astrophysics Data System (ADS)

Balaji, N.; Siva, E. P.; Chandrasekaran, A. D.; Tamilazhagan, V.

2018-04-01

This paper presents graphical integrated model based academic research on telephone call centres. This paper introduces an important feature of impatient customers and abandonments in the queue system. However the modern call centre is a complex socio-technical system. Queuing theory has now become a suitable application in the telecom industry to provide better online services. Through this Matlab-simulink multi queuing structured models provide better solutions in complex situations at call centres. Service performance measures analyzed at optimal level through Simulink queuing model.

Resolving controversies in hip fracture care: the need for large collaborative trials in hip fractures.

PubMed

Bhandari, Mohit; Sprague, Sheila; Schemitsch, Emil H

2009-07-01

Hip fractures are a significant cause of morbidity and mortality worldwide and the burden of disability associated with hip fractures globally vindicate the need for high-quality research to advance the care of patients with hip fractures. Historically, large, multi-centre randomized controlled trials have been rare in the orthopaedic trauma literature. Similar to other medical specialties, orthopaedic research is currently undergoing a paradigm shift from single centre initiatives to larger collaborative groups. This is evident with the establishment of several collaborative groups in Canada, in the United States, and in Europe, which has proven that multi-centre trials can be extremely successful in orthopaedic trauma research.Despite ever increasing literature on the topic of his fractures, the optimal treatment of hip fractures remains unknown and controversial. To resolve this controversy large multi-national collaborative randomized controlled trials are required. In 2005, the International Hip Fracture Research Collaborative was officially established following funding from the Canadian Institute of Health Research International Opportunity Program with the mandate of resolving controversies in hip fracture management. This manuscript will describe the need, the information, the organization, and the accomplishments to date of the International Hip Fracture Research Collaborative.

Investigating composition and production rate of healthcare waste and associated management practices in Bandar Abbass, Iran.

PubMed

Koolivand, Ali; Mahvi, Amir Hossein; Alipoor, Vali; Azizi, Kourosh; Binavapour, Mohammad

2012-06-01

The objective of this study was to identify the composition and production rate of healthcare waste and associated management practices in healthcare centres in Bandar Abbas, southern Iran. A total of 90 centres, including 30 physician offices, 30 dental offices and 30 clinics were selected in random way. Two samples in summer and two samples in winter were taken and weighed from each selected centre at the end of successive working day on Mondays and Tuesdays. Results showed that the mean of daily production rate for each clinic, dental and physician office were 2125.3, 498.3 and 374.9 g, respectively. Domestic-type and potentially infectious waste had the highest and chemical and pharmaceutical waste and sharps had the lowest percentages in all centres. Questionnaire results indicated that there were no effective activity for waste minimization, separation, reuse and recycling in healthcare centres and management of sharps, potentially infectious and other hazardous waste was poor.

Characterisation of the opposing effects of G6PD deficiency on cerebral malaria and severe malarial anaemia.

PubMed

Clarke, Geraldine M; Rockett, Kirk; Kivinen, Katja; Hubbart, Christina; Jeffreys, Anna E; Rowlands, Kate; Jallow, Muminatou; Conway, David J; Bojang, Kalifa A; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D; Bougouma, Edith C; Sirima, Sodiomon B; Modiano, David; Amenga-Etego, Lucas N; Ghansah, Anita; Koram, Kwadwo A; Wilson, Michael D; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi K; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N; Manjurano, Alphaxard; Sepúlveda, Nuno; Clark, Taane G; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J; Phu, Nguyen Hoan; Quyen, Nguyen Ngoc; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy Me; Michon, Pascal; Mueller, Ivo; Molloy, Síle F; Campino, Susana; Kerasidou, Angeliki; Cornelius, Victoria J; Hart, Lee; Shah, Shivang S; Band, Gavin; Spencer, Chris Ca; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara K; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P

2017-01-09

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is believed to confer protection against Plasmodium falciparum malaria, but the precise nature of the protective effecthas proved difficult to define as G6PD deficiency has multiple allelic variants with different effects in males and females, and it has heterogeneous effects on the clinical outcome of P. falciparum infection. Here we report an analysis of multiple allelic forms of G6PD deficiency in a large multi-centre case-control study of severe malaria, using the WHO classification of G6PD mutations to estimate each individual's level of enzyme activity from their genotype. Aggregated across all genotypes, we find that increasing levels of G6PD deficiency are associated with decreasing risk of cerebral malaria, but with increased risk of severe malarial anaemia. Models of balancing selection based on these findings indicate that an evolutionary trade-off between different clinical outcomes of P. falciparum infection could have been a major cause of the high levels of G6PD polymorphism seen in human populations.

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

Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission

PubMed Central

De Feo, Gianfranco; Chiabrando, Giacomo; Cannovo, Nunzia; Galluccio, Antonio; Tomino, Carlo

2012-01-01

Aim The high variability of “centre-specific” documentation required by Independent Ethics Committee (IEC) plays a role in the time required for activation of participating centres of multicentre clinical trials. This study (a) provides a picture of the different activities, structural requirements and resources dedicated to the operation of the local IEC in Italy; (b) defines a detailed list of “centre-specific” documents considered as essential by the IEC for issuing its opinion and (c) suggests a “single document” to reduce the variability of the “centre-specific” documents required by the IEC. Methodology Two surveys were conducted through the portal of National Monitoring Centre of Clinical Trials (https://oss-sper-clin.agenziafarmaco.it/). The first survey focused on the local IEC resources and on the “centre-specific” documentation that local IEC required from the Sponsor and local Principal Investigator (PI). The second focused on “single document” required in the form of statements from the Sponsor and the PI. Answers were discussed and extended during regular scheduled teleconferences and plenary meeting. Principal Findings From 22/07/2009 to 15/12/2009, and from 19/04/2010 to 14/05/2010, 131 and 125 IECs responded to the first and the second surveys, respectively. 67% and 51% of IECs consider the structural requirements and the staff dedicated to the activity of the IECs as sufficient, respectively. Most of the IECs consider the “centre-specific” documentation as necessary for issuing the opinion, and a high percentage of IECs consider the proposed documentation as acceptable in substitution to any other “centre-specific” documentation already in use. Conclusions The harmonization of IECs practice in Italy is the first step to facilitate multicentre clinical trials. Similar efforts should be directed to reduce the total number of IECs and to standardize clinical trials approval procedures, focusing on administrative procedures as well. PMID:23145015

Exploring the Use of Actigraphy to Investigate Sleep Problems in Older People with Intellectual Disability

ERIC Educational Resources Information Center

van Dijk, E.; Hilgenkamp, T. I. M.; Evenhuis, H. M.; Echteld, M. A.

2012-01-01

Background: The aim of this study was to explore the use of actigraphy to investigate sleep problems in a convenience sample of clients of Dutch intellectual disability (ID) care providers. Based on data obtained in a large multi-centre study on healthy ageing in people with ID, research questions were: "To what degree are actigraphic…

The learner's perspective in GP teaching practices with multi-level learners: a qualitative study.

PubMed

Thomson, Jennifer S; Anderson, Katrina; Haesler, Emily; Barnard, Amanda; Glasgow, Nicholas

2014-03-19

Medical students, junior hospital doctors on rotation and general practice (GP) registrars are undertaking their training in clinical general practices in increasing numbers in Australia. Some practices have four levels of learner. This study aimed to explore how multi-level teaching (also called vertical integration of GP education and training) is occurring in clinical general practice and the impact of such teaching on the learner. A qualitative research methodology was used with face-to-face, semi-structured interviews of medical students, junior hospital doctors, GP registrars and GP teachers in eight training practices in the region that taught all levels of learners. Interviews were audio-recorded and transcribed. Qualitative analysis was conducted using thematic analysis techniques aided by the use of the software package N-Vivo 9. Primary themes were identified and categorised by the co-investigators. 52 interviews were completed and analysed. Themes were identified relating to both the practice learning environment and teaching methods used.A practice environment where there is a strong teaching culture, enjoyment of learning, and flexible learning methods, as well as learning spaces and organised teaching arrangements, all contribute to positive learning from a learners' perspective.Learners identified a number of innovative teaching methods and viewed them as positive. These included multi-level learner group tutorials in the practice, being taught by a team of teachers, including GP registrars and other health professionals, and access to a supernumerary GP supervisor (also termed "GP consultant teacher"). Other teaching methods that were viewed positively were parallel consulting, informal learning and rural hospital context integrated learning. Vertical integration of GP education and training generally impacted positively on all levels of learner. This research has provided further evidence about the learning culture, structures and teaching processes that have a positive impact on learners in the clinical general practice setting where there are multiple levels of learners. It has also identified some innovative teaching methods that will need further examination. The findings reinforce the importance of the environment for learning and learner centred approaches and will be important for training organisations developing vertically integrated practices and in their training of GP teachers.

The learner’s perspective in GP teaching practices with multi-level learners: a qualitative study

PubMed Central

2014-01-01

Background Medical students, junior hospital doctors on rotation and general practice (GP) registrars are undertaking their training in clinical general practices in increasing numbers in Australia. Some practices have four levels of learner. This study aimed to explore how multi-level teaching (also called vertical integration of GP education and training) is occurring in clinical general practice and the impact of such teaching on the learner. Methods A qualitative research methodology was used with face-to-face, semi-structured interviews of medical students, junior hospital doctors, GP registrars and GP teachers in eight training practices in the region that taught all levels of learners. Interviews were audio-recorded and transcribed. Qualitative analysis was conducted using thematic analysis techniques aided by the use of the software package N-Vivo 9. Primary themes were identified and categorised by the co-investigators. Results 52 interviews were completed and analysed. Themes were identified relating to both the practice learning environment and teaching methods used. A practice environment where there is a strong teaching culture, enjoyment of learning, and flexible learning methods, as well as learning spaces and organised teaching arrangements, all contribute to positive learning from a learners’ perspective. Learners identified a number of innovative teaching methods and viewed them as positive. These included multi-level learner group tutorials in the practice, being taught by a team of teachers, including GP registrars and other health professionals, and access to a supernumerary GP supervisor (also termed “GP consultant teacher”). Other teaching methods that were viewed positively were parallel consulting, informal learning and rural hospital context integrated learning. Conclusions Vertical integration of GP education and training generally impacted positively on all levels of learner. This research has provided further evidence about the learning culture, structures and teaching processes that have a positive impact on learners in the clinical general practice setting where there are multiple levels of learners. It has also identified some innovative teaching methods that will need further examination. The findings reinforce the importance of the environment for learning and learner centred approaches and will be important for training organisations developing vertically integrated practices and in their training of GP teachers. PMID:24645670

Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

PubMed Central

2010-01-01

Background The use of Clinical Data Management Systems (CDMS) has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at investigator sites with "electronic Case Report Forms". Although more and more of these electronic data management systems are used in academic research centres an overview of CDMS products and of available data management and quality management resources for academic clinical trials in Europe is missing. Methods The ECRIN (European Clinical Research Infrastructure Network) data management working group conducted a two-part standardized survey on data management, software tools, and quality management for clinical trials. The questionnaires were answered by nearly 80 centres/units (with an overall response rate of 47% and 43%) from 12 European countries and EORTC. Results Our survey shows that about 90% of centres have a CDMS in routine use. Of these CDMS nearly 50% are commercial systems; Open Source solutions don't play a major role. In general, solutions used for clinical data management are very heterogeneous: 20 different commercial CDMS products (7 Open Source solutions) in addition to 17/18 proprietary systems are in use. The most widely employed CDMS products are MACRO™ and Capture System™, followed by solutions that are used in at least 3 centres: eResearch Network™, CleanWeb™, GCP Base™ and SAS™. Although quality management systems for data management are in place in most centres/units, there exist some deficits in the area of system validation. Conclusions Because the considerable heterogeneity of data management software solutions may be a hindrance to cooperation based on trial data exchange, standards like CDISC (Clinical Data Interchange Standard Consortium) should be implemented more widely. In a heterogeneous environment the use of data standards can simplify data exchange, increase the quality of data and prepare centres for new developments (e.g. the use of EHR for clinical research). Because data management and the use of electronic data capture systems in clinical trials are characterized by the impact of regulations and guidelines, ethical concerns are discussed. In this context quality management becomes an important part of compliant data management. To address these issues ECRIN will establish certified data centres to support electronic data management and associated compliance needs of clinical trial centres in Europe. PMID:20663165

Physical activity and asthma: A longitudinal and multi-country study.

PubMed

Russell, Melissa A; Janson, Christer; Real, Francisco Gómez; Johannessen, Ane; Waatevik, Marie; Benediktsdóttir, Bryndis; Holm, Mathias; Lindberg, Eva; Schlünssen, Vivi; Raza, Wasif; Dharmage, Shyamali C; Svanes, Cecilie

2017-11-01

To investigate the impact of physical activity on asthma in middle-aged adults, in one longitudinal analysis, and one multi-centre cross-sectional analysis. The Respiratory Health in Northern Europe (RHINE) is a population-based postal questionnaire cohort study. Physical activity, height and weight were self-reported in Bergen, Norway, at RHINE II (1999-2001) and all centres at RHINE III (2010-2012). A longitudinal analysis of Bergen data investigated the association of baseline physical activity with follow-up asthma, incident asthma and symptoms, using logistic and zero-inflated Poisson regression (n = 1782). A cross-sectional analysis of all RHINE III centres investigated the association of physical activity with concurrent asthma and symptoms (n = 13,542) using mixed-effects models. Body mass index (BMI) was categorised (<20, 20-24.99, 25-29.99, 30+ kg/m 2 ) and physical activity grouped by amount and frequency of lighter (no sweating/heavy breathing) and vigorous (sweating/heavy breathing) activity. In the Bergen longitudinal analysis, undertaking light activity 3+ times/week at baseline was associated with less follow-up asthma (odds ratio [OR] 0.44, 95% confidence interval [CI] 0.22, 0.89), whilst an effect from undertaking vigorous activity 3+ times/week was not detected (OR 1.22, 95% CI 0.44, 2.76). The associations were attenuated with BMI adjustment. In the all-centre cross-sectional analysis an interaction was found, with the association between physical activity and asthma varying across BMI categories. These findings suggest potential longer-term benefit from lighter physical activity, whilst improvement in asthma outcomes from increasing activity intensity was not evident. Additionally, it appears the benefit from physical activity may differ according to BMI.

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.

Differences in Bordetella pertussis DNA load according to clinical and epidemiological characteristics of patients with whooping cough.

PubMed

Brotons, Pedro; de Paz, Hector D; Toledo, Diana; Villanova, Marta; Plans, Pedro; Jordan, Iolanda; Dominguez, Angela; Jane, Mireia; Godoy, Pere; Muñoz-Almagro, Carmen

2016-04-01

To identify associations between nasopharyngeal Bordetella pertussis DNA load and clinical and epidemiological characteristics and evaluate DNA load prognostic value in pertussis severity. Prospective observational multi-centre study including nasopharyngeal samples positive to pertussis DNA by real-time PCR collected from children and adult patients in more than 200 health centres of Catalonia (Spain) during 2012-2013. B. pertussis load was inversely correlated with age (rho = -0.32, p < 0.001), time to diagnosis (rho = -0.33, p < 0.001) and number of symptoms (rho = 0.13, p = 0.002). Median bacterial load was significantly higher in inpatients versus outpatients (4.91 vs. 2.55 log10 CFU/mL, p < 0.001), patients with complications versus those without (6.05 vs. 2.82 log10 CFU/mL, p < 0.001), disease incidence in summer and autumn versus spring and winter (3.50 vs. 2.21 log10 CFU/mL, p = 0.002), and unvaccinated-partially vaccinated patients versus vaccinated (4.20 vs. 2.76 log10 CFU/mL, p = 0.004). A logistic regression model including bacterial load and other candidate prognostic factors showed good prediction for hospital care (AUC = 0.94) although only age and unvaccinated status were found to be prognostic factors. We observed strong positive associations of nasopharyngeal bacterial load with severity outcomes of hospitalisation and occurrence of complications. Bacterial load and other independent variables contributed to an accurate prognostic model for hospitalisation. Copyright © 2016 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Management of thyroid eye disease in the United Kingdom: A multi-centre thyroid eye disease audit.

PubMed

Mellington, F E; Dayan, C M; Dickinson, A J; Hickey, J L; MacEwen, C J; McLaren, J; Perros, P; Rose, G E; Uddin, J; Vaidya, B; Foley, P; Lazarus, J H; Mitchell, A; Ezra, D G

2017-06-01

This article aims to provide baseline data and highlight any major deficiencies in the current level of care provided for adult patients with thyroid eye disease (TED). We undertook a prospective, nonrandomized cross-sectional multicenter observational study. During a 3-month period June-August 2014, consecutive adult patients with TED who presented to nominated specialist eye clinics in the United Kingdom, completed a standardized questionnaire. Main outcome measures were: demographics, time from diagnosis to referral to tertiary centre, time from referral to review in specialist eye clinic, management of thyroid dysfunction, radioiodine and provision of steroid prophylaxis, smoking, and TED classification. 91 patients (mean age 47.88 years) were included. Female-to-male ratio was 6:1. Mean time since first symptoms of TED = 27.92 (73.71) months; from first visit to any doctor with symptoms to diagnosis = 9.37 (26.03) months; from hyperthyroidism diagnosis to euthyroidism 12.45 (16.81) months. First, 13% had received radioiodine. All those with active TED received prophylactic steroids. Seven patients who received radioiodine and did not have TED at the time went on to develop it. Then, 60% patients were current or ex-smokers. 63% current smokers had been offered smoking cessation advice. 65% patients had active TED; 4% had sight-threatening TED. A large proportion of patients (54%) were unaware of their thyroid status. Not enough patients are being provided with smoking cessation advice and information on the impact of smoking on TED and control of thyroid function.

Can an online clinical data management service help in improving data collection and data quality in a developing country setting?

PubMed

Wildeman, Maarten A; Zandbergen, Jeroen; Vincent, Andrew; Herdini, Camelia; Middeldorp, Jaap M; Fles, Renske; Dalesio, Otilia; van der Donk, Emile; Tan, I Bing

2011-08-08

Data collection by electronic medical record (EMR) systems have been proven to be helpful in data collection for scientific research and in improving healthcare. For a multi-centre trial in Indonesia and the Netherlands a web based system was selected to enable all participating centres to easily access data. This study assesses whether the introduction of a clinical trial data management service (CTDMS) composed of electronic case report forms (eCRF) can result in effective data collection and treatment monitoring. Data items entered were checked for inconsistencies automatically when submitted online. The data were divided into primary and secondary data items. We analysed both the total number of errors and the change in error rate, for both primary and secondary items, over the first five month of the trial. In the first five months 51 patients were entered. The primary data error rate was 1.6%, whilst that for secondary data was 2.7% against acceptable error rates for analysis of 1% and 2.5% respectively. The presented analysis shows that after five months since the introduction of the CTDMS the primary and secondary data error rates reflect acceptable levels of data quality. Furthermore, these error rates were decreasing over time. The digital nature of the CTDMS, as well as the online availability of that data, gives fast and easy insight in adherence to treatment protocols. As such, the CTDMS can serve as a tool to train and educate medical doctors and can improve treatment protocols.

Continuous infusion of antibiotics in critically ill patients.

PubMed

Smuszkiewicz, Piotr; Szałek, Edyta; Tomczak, Hanna; Grześkowiak, Edmund

2013-02-01

Antibiotics are the most commonly used drugs in intensive care unit patients and their supply should be based on pharmacokinetic/pharmacodynamic rules. The changes that occur in septic patients who are critically ill may be responsible for subtherapeutic antibiotic concentrations leading to poorer clinical outcomes. Evolving in time the disturbed pathophysiology in severe sepsis (high cardiac output, glomerular hyperfiltration) and therapeutic interventions (e.g. haemodynamically active drugs, mechanical ventilation, renal replacement therapy) alters antibiotic pharmacokinetics mainly through an increase in the volume of distribution and altered drug clearance. The lack of new and efficacious drugs and increased bacterial resistance are current problems of contemporary antibiotic therapy. Although intermittent administration is a standard clinical practice, alternative methods of antibiotic administration are sought, which may potentialise effects and reduce toxicity as well as contribute to inhibition of bacterial resistance. A wide range of studies prove that the application of continuous infusion of time-dependent antibiotics (beta-lactams, glycopeptides) is more rational than standard intermittent administration. However, there are also studies which do not confirm the advantage of one method over the other. In spite of controversy the continuous administration of this group of antibiotics is common practice, because the results of both studies point to the higher efficacy of this method in critically ill patients. Authors reviewed the literature to determine whether any clinical benefits exist for administration of time-dependent antibiotics by continuous infusion. Definite specification of the clinical advantage of administration this way over standard dosage requires a large-scale multi-centre randomised controlled trial.

Towards a shared service centre for telemedicine: Telemedicine in Denmark, and a possible way forward.

PubMed

Larsen, Simon Bo; Sørensen, Nanna Skovgaard; Petersen, Matilde Grøndahl; Kjeldsen, Gitte Friis

2016-12-01

Although evidence of the effectiveness of telemedicine is accumulating, knowledge of how to make best use of telemedicine is limited. This article presents results from a multi-stakeholder project that developed a new concept, a 'shared service centre' for telemedicine that is envisioned as working across different telemedical initiatives to support the implementation and wider adoption of telemedicine. One year of participatory design and analysis of the shared service centre concept involved stakeholders, such as clinicians, patients, technicians, policy makers, lawyers, economists and information technology architects. More than 100 people contributed to the findings. Most of the ideas generated for potential centre support for telemedicine could be categorised under four service categories. The need for such support services was verified in the cases investigated, and by agreement among stakeholders from regional health authorities, municipalities, and general practice. Therefore, it is probable that a shared service centre could help enable the wider deployment of telemedicine. In this article, we use 'telemedicine' as an umbrella term for all the 'tele-' labels that are sometimes used rather indiscriminately to denote the use of information and technology to support healthcare services, including 'telehealth', 'telemonitoring', 'telehomecare', 'e-health', and so on. As per our definition, telemedicine may be synchronous and/or asynchronous, and may apply to any information and technology-based means of connecting healthcare actors and the patient, such as video communication, e-mail, electronic monitoring equipment, and Internet portals. Furthermore, the term 'telemedical initiative' covers projects in which telemedicine is conducted by a temporary project organisation, as well as self-contained telemedicine services used in daily, clinical practice in existing organisations. © The Author(s) 2015.

Understanding resident ratings of teaching in the workplace: a multi-centre study.

PubMed

Fluit, Cornelia R M G; Feskens, Remco; Bolhuis, Sanneke; Grol, Richard; Wensing, Michel; Laan, Roland

2015-08-01

Providing clinical teachers with feedback about their teaching skills is a powerful tool to improve teaching. Evaluations are mostly based on questionnaires completed by residents. We investigated to what extent characteristics of residents, clinical teachers, and the clinical environment influenced these evaluations, and the relation between residents' scores and their teachers' self-scores. The evaluation and feedback for effective clinical teaching questionnaire (EFFECT) was used to (self)assess clinical teachers from 12 disciplines (15 departments, four hospitals). Items were scored on a five-point Likert scale. Main outcome measures were residents' mean overall scores (MOSs), specific scale scores (MSSs), and clinical teachers' self-evaluation scores. Multilevel regression analysis was used to identify predictors. Residents' scores and self-evaluations were compared. Residents filled in 1,013 questionnaires, evaluating 230 clinical teachers. We received 160 self-evaluations. 'Planning Teaching' and 'Personal Support' (4.52, SD .61 and 4.53, SD .59) were rated highest, 'Feedback Content' (CanMEDS related) (4.12, SD .71) was rated lowest. Teachers in affiliated hospitals showed highest MOS and MSS. Medical specialty did not influence MOS. Female clinical teachers were rated higher for most MSS, achieving statistical significance. Residents in year 1-2 were most positive about their teachers. Residents' gender did not affect the mean scores, except for role modeling. At group level, self-evaluations and residents' ratings correlated highly (Kendall's τ 0.859). Resident evaluations of clinical teachers are influenced by teacher's gender, year of residency training, type of hospital, and to a lesser extent teachers' gender. Clinical teachers and residents agree on strong and weak points of clinical teaching.

[Portuguese Respiratory Society guidelines for the management of community-acquired pneumonia in immunocompetent adults].

PubMed

2003-01-01

The Portuguese Respiratory Society makes a series of recommendations as to the state of the art of the diagnostic, therapeutic and preventive approach to community-acquired pneumonia in immunocompetent adults in Portugal. These proposals should be regarded as general guidelines and are not intended to replace the clinical sense used in resolving each individual case. Our main goal is to stratify the patients according to the risk of morbidity and mortality in order to justify the following decisions more rationally: the choice of place of treatment (outpatient or inpatient), diagnostic tests and antimicrobial therapy. We also make a set of recommendations for the prevention of CAP. We plan to conduct multi-centre prospective studies, preferably in collaboration with other scientific societies, in order to be able to characterise the situation in Portugal more accurately and regularly update this document.

Reappraisal of known malaria resistance loci in a large multi-centre study

PubMed Central

Rockett, Kirk A.; Clarke, Geraldine M.; Fitzpatrick, Kathryn; Hubbart, Christina; Jeffreys, Anna E.; Rowlands, Kate; Craik, Rachel; Jallow, Muminatou; Conway, David J.; Bojang, Kalifa A.; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A.; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D.; Bougouma, Edith C.; Sirima, Sodiomon B.; Modiano, David; Amenga-Etego, Lucas N.; Ghansah, Anita; Koram, Kwadwo A.; Wilson, Michael D.; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M.; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N.; Manjurano, Alphaxard; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J.; Phu, Nguyen Hoan; Ngoc Quyen, Nguyen Thi; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy M. E.; Michon, Pascal; Mueller, Ivo; Green, Angie; Molloy, Sile; Johnson, Kimberly J.; Kerasidou, Angeliki; Cornelius, Victoria; Hart, Lee; Vanderwal, Aaron; SanJoaquin, Miguel; Band, Gavin; Le, Si Quang; Pirinen, Matti; Sepúlveda, Nuno; Spencer, Chris C.A.; Clark, Taane G.; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P.

2015-01-01

Many human genetic associations with resistance to malaria have been reported but few have been reliably replicated. We collected data on 11,890 cases of severe malaria due to Plasmodium falciparum and 17,441 controls from 12 locations in Africa, Asia and Oceania. There was strong evidence of association with the HBB, ABO, ATP2B4, G6PD and CD40LG loci but previously reported associations at 22 other loci did not replicate in the multi-centre analysis. The large sample size made it possible to identify authentic genetic effects that are heterogeneous across populations or phenotypes, a striking example being the main African form of G6PD deficiency, which reduced the risk of cerebral malaria but increased the risk of severe malarial anaemia. The finding that G6PD deficiency has opposing effects on different fatal complications of P. falciparum infection indicates that the evolutionary origins of this common human genetic disorder are more complex than previously supposed. PMID:25261933

Meeting the privacy requirements for the development of a multi-centre patient registry in Canada: the Rick Hansen Spinal Cord Injury Registry.

PubMed

Noonan, Vanessa K; Thorogood, Nancy P; Joshi, Phalgun B; Fehlings, Michael G; Craven, B Catharine; Linassi, Gary; Fourney, Daryl R; Kwon, Brian K; Bailey, Christopher S; Tsai, Eve C; Drew, Brian M; Ahn, Henry; Tsui, Deborah; Dvorak, Marcel F

2013-05-01

Privacy legislation addresses concerns regarding the privacy of personal information; however, its interpretation by research ethics boards has resulted in significant challenges to the collection, management, use and disclosure of personal health information for multi-centre research studies. This paper describes the strategy used to develop the national Rick Hansen Spinal Cord Injury Registry (RHSCIR) in accordance with privacy statutes and benchmarked against best practices. An analysis of the regional and national privacy legislation was conducted to determine the requirements for each of the 31 local RHSCIR sites and the national RHSCIR office. A national privacy and security framework was created for RHSCIR that includes a governance structure, standard operating procedures, training processes, physical and technical security and privacy impact assessments. The framework meets a high-water mark in ensuring privacy and security of personal health information nationally and may assist in the development of other national or international research initiatives. Copyright © 2013 Longwoods Publishing.

Meeting the Privacy Requirements for the Development of a Multi-Centre Patient Registry in Canada: The Rick Hansen Spinal Cord Injury Registry

PubMed Central

Noonan, Vanessa K.; Thorogood, Nancy P.; Joshi, Phalgun B.; Fehlings, Michael G.; Craven, B. Catharine; Linassi, Gary; Fourney, Daryl R.; Kwon, Brian K.; Bailey, Christopher S.; Tsai, Eve C.; Drew, Brian M.; Ahn, Henry; Tsui, Deborah; Dvorak, Marcel F.

2013-01-01

Privacy legislation addresses concerns regarding the privacy of personal information; however, its interpretation by research ethics boards has resulted in significant challenges to the collection, management, use and disclosure of personal health information for multi-centre research studies. This paper describes the strategy used to develop the national Rick Hansen Spinal Cord Injury Registry (RHSCIR) in accordance with privacy statutes and benchmarked against best practices. An analysis of the regional and national privacy legislation was conducted to determine the requirements for each of the 31 local RHSCIR sites and the national RHSCIR office. A national privacy and security framework was created for RHSCIR that includes a governance structure, standard operating procedures, training processes, physical and technical security and privacy impact assessments. The framework meets a high-water mark in ensuring privacy and security of personal health information nationally and may assist in the development of other national or international research initiatives. PMID:23968640

Comparative dosimetry study of three UK centres implementing total skin electron treatment through external audit.

PubMed

Misson-Yates, S; Gonzalez, R; McGovern, M; Greener, A

2015-05-01

This article describes the external audit measurements conducted in two UK centres implementing total skin electron beam therapy (TSEBT) and the results obtained. Measurements of output, energy, beam flatness and symmetry at a standard distance (95 or 100 cm SSD) were performed using a parallel plate chamber in solid water. Similarly, output and energy measurements were also performed at the treatment plane for single and dual fields. Clinical simulations were carried out using thermoluminescent dosemeters (TLDs) and Gafchromic® film (International Specialty Products, Wayne, NJ) on an anthropomorphic phantom. Extended distance measurements confirmed that local values for the beam dosimetry at Centres A and B were within 2% for outputs and 1-mm agreement of the expected depth at which the dose is 50% of the maximum for the depth-dose curve in water (R50,D) value. Clinical simulation using TLDs) showed an agreement of -1.6% and -6.7% compared with the expected mean trunk dose for each centre, respectively, and a variation within 10% (±1 standard deviation) across the trunk. The film results confirmed that the delivery of the treatment technique at each audited centre complies with the European Organisation for Research and Treatment of Cancer recommendations. This audit methodology has proven to be a successful way to confirm the agreement of dosimetric parameters for TSEBT treatments at both audited centres and could serve as the basis for an audit template to be used by other audit groups. TSEBT audits are not established in the UK owing to a limited number of centres carrying out the treatment technique. This article describes the audits performed at two UK centres prior to their clinical implementation.

Comparative dosimetry study of three UK centres implementing total skin electron treatment through external audit

PubMed Central

Gonzalez, R; McGovern, M; Greener, A

2015-01-01

Objective: This article describes the external audit measurements conducted in two UK centres implementing total skin electron beam therapy (TSEBT) and the results obtained. Methods: Measurements of output, energy, beam flatness and symmetry at a standard distance (95 or 100 cm SSD) were performed using a parallel plate chamber in solid water. Similarly, output and energy measurements were also performed at the treatment plane for single and dual fields. Clinical simulations were carried out using thermoluminescent dosemeters (TLDs) and Gafchromic® film (International Specialty Products, Wayne, NJ) on an anthropomorphic phantom. Results: Extended distance measurements confirmed that local values for the beam dosimetry at Centres A and B were within 2% for outputs and 1-mm agreement of the expected depth at which the dose is 50% of the maximum for the depth–dose curve in water (R50,D) value. Clinical simulation using TLDs) showed an agreement of −1.6% and −6.7% compared with the expected mean trunk dose for each centre, respectively, and a variation within 10% (±1 standard deviation) across the trunk. The film results confirmed that the delivery of the treatment technique at each audited centre complies with the European Organisation for Research and Treatment of Cancer recommendations. Conclusion: This audit methodology has proven to be a successful way to confirm the agreement of dosimetric parameters for TSEBT treatments at both audited centres and could serve as the basis for an audit template to be used by other audit groups. Advances in knowledge: TSEBT audits are not established in the UK owing to a limited number of centres carrying out the treatment technique. This article describes the audits performed at two UK centres prior to their clinical implementation. PMID:25761213

Multi-centre audit of VMAT planning and pre-treatment verification.

PubMed

Jurado-Bruggeman, Diego; Hernández, Victor; Sáez, Jordi; Navarro, David; Pino, Francisco; Martínez, Tatiana; Alayrach, Maria-Elena; Ailleres, Norbert; Melero, Alejandro; Jornet, Núria

2017-08-01

We performed a multi-centre intercomparison of VMAT dose planning and pre-treatment verification. The aims were to analyse the dose plans in terms of dosimetric quality and deliverability, and to validate whether in-house pre-treatment verification results agreed with those of an external audit. The nine participating centres encompassed different machines, equipment, and methodologies. Two mock cases (prostate and head and neck) were planned using one and two arcs. A plan quality index was defined to compare the plans and different complexity indices were calculated to check their deliverability. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit (global 3D gamma, absolute dose differences, 10% of maximum dose threshold). Log-file analysis was performed to look for delivery errors. All centres fulfilled the dosimetric goals but plan quality and delivery complexity were heterogeneous and uncorrelated, depending on the manufacturer and the planner's methodology. Pre-treatment verifications results were within tolerance in all cases for gamma 3%-3mm evaluation. Nevertheless, differences between the external audit and in-house measurements arose due to different equipment or methodology, especially for 2%-2mm criteria with differences up to 20%. No correlation was found between complexity indices and verification results amongst centres. All plans fulfilled dosimetric constraints, but plan quality and complexity did not correlate and were strongly dependent on the planner and the vendor. In-house measurements cannot completely replace external audits for credentialing. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical guideline for nurse-led early extubation after coronary artery bypass: an evaluation.

PubMed

Hawkes, Claire; Foxcroft, David R; Yerrell, Paul

2010-09-01

This paper is a report of an investigation of the development, implementation and outcomes of a clinical guideline for nurse-led early extubation of adult coronary artery bypass graft patients. Healthcare knowledge translation and utilization is an emerging but under-developed research area. The complex context for guideline development and use is methodologically challenging for robust and rigorous evaluation. This study contributes one such evaluation. This was a mixed methods evaluation, with a dominant quantitative study with a secondary qualitative study in a single UK cardiac surgery centre. An interrupted time series study (N = 567 elective coronary artery bypass graft patients) with concurrent within person controls was used to measure the impact of the guideline on the primary outcome: time to extubation. Semi-structured interviews with 11 clinical staff, informed by applied practitioner ethnography, explored the process of guideline development and implementation. The data were collected between January 2001 and January 2003. There was no change in the interrupted time series study primary outcome as a consequence of the guideline implementation. The qualitative study identified three themes: context, process and tensions highlighting that the guideline did not require clinicians to change their practice, although it may have helped maintain practice through its educative role. Further investigation and development of appropriate methods to capture the dynamism in healthcare contexts and its impact on guideline implementation seems warranted. Multi-site mixed methods investigations and programmes of research exploring knowledge translation and utilization initiatives, such as guideline implementation, are needed.

Phlebitis risk varies by peripheral venous catheter site and increases after 96 hours: a large multi-centre prospective study.

PubMed

Cicolini, Giancarlo; Manzoli, Lamberto; Simonetti, Valentina; Flacco, Maria Elena; Comparcini, Dania; Capasso, Lorenzo; Di Baldassarre, Angela; Eltaji Elfarouki, Ghaleb

2014-11-01

This multi-centre prospective field study evaluated whether peripheral venous catheter site of insertion influences the risk of catheter-related phlebitis. Potential predictors of phlebitis were also investigated. Millions of patients worldwide use peripheral venous catheters, which frequently cause local complications including phlebitis, infection and obstruction. Although phlebitis predictors have been broadly investigated, uncertainties remain on the potential effect of cannulation anatomical site, duration and the appropriate time for catheter removal. A prospective cohort design was carried out from January-June 2012. The clinical course of each patient who received a new peripheral venous catheter for any cause in five Italian hospitals was followed by trained nurses until catheter removal. The presence of phlebitis was assessed every 24 hours using the Visual Infusion Phlebitis score. Analyses were based upon multilevel mixed-effects regression. The final sample consisted of 1498 patients. The average time for catheters in situ was 65·6 hours and 23·6% of the catheters were in place beyond 96 hours. Overall phlebitis incidence was 15·4%, 94·4% of which were grade 1. The likelihood of phlebitis independently increased with increasing catheter duration, being highest after 96 hours. Compared with patients with catheter placed in the dorsum of the hand (22·8% of the sample), those with the catheter located in the antecubital fossa (34·1%) or forearm were less likely to have a phlebitis of any grade. Antecubital fossa and forearm veins may be preferential sites for peripheral venous cannulation. Our results support Centers for Disease Control and Prevention recommendations to replace catheters in adults no later than 96 hours. A relevant proportion of healthcare personnel did not adhere to such guidelines - more attention to this issue is required. © 2014 John Wiley & Sons Ltd.

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.

Cross-validation of clinical characteristics and treatment patterns associated with phenotypes for lithium response defined by the Alda scale.

PubMed

Scott, Jan; Geoffroy, Pierre Alexis; Sportiche, Sarah; Brichant-Petit-Jean, Clara; Gard, Sebastien; Kahn, Jean-Pierre; Azorin, Jean-Michel; Henry, Chantal; Etain, Bruno; Bellivier, Frank

2017-01-15

It is increasingly recognised that reliable and valid assessments of lithium response are needed in order to target more efficiently the use of this medication in bipolar disorders (BD) and to identify genotypes, endophenotypes and biomarkers of response. In a large, multi-centre, clinically representative sample of 300 cases of BD, we assess external clinical validators of lithium response phenotypes as defined using three different recommended approaches to scoring the Alda lithium response scale. The scale comprises an A scale (rating lithium response) and a B scale (assessing confounders). Analysis of the two continuous scoring methods (A scale score minus the B scale score, or A scale score in those with a low B scale score) demonstrated that 21-23% of the explained variance in lithium response was accounted for by a positive family history of BD I and the early introduction of lithium. Categorical definitions of response suggest poor response is also associated with a positive history of alcohol and/or substance use comorbidities. High B scale scores were significantly associated with longer duration of illness prior to receiving lithium and the presence of psychotic symptoms. The original sample was not recruited specifically to study lithium response. The Alda scale is designed to assess response retrospectively. This cross-validation study identifies different clinical phenotypes of lithium response when defined by continuous or categorical measures. Future clinical, genetic and biomarker studies should report both the findings and the method employed to assess lithium response according to the Alda scale. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

Diagnostic work-up and loss of tuberculosis suspects in Jogjakarta, Indonesia

PubMed Central

2012-01-01

Background Early and accurate diagnosis of pulmonary tuberculosis (TB) is critical for successful TB control. To assist in the diagnosis of smear-negative pulmonary TB, the World Health Organisation (WHO) recommends the use of a diagnostic algorithm. Our study evaluated the implementation of the national tuberculosis programme's diagnostic algorithm in routine health care settings in Jogjakarta, Indonesia. The diagnostic algorithm is based on the WHO TB diagnostic algorithm, which had already been implemented in the health facilities. Methods We prospectively documented the diagnostic work-up of all new tuberculosis suspects until a diagnosis was reached. We used clinical audit forms to record each step chronologically. Data on the patient's gender, age, symptoms, examinations (types, dates, and results), and final diagnosis were collected. Results Information was recorded for 754 TB suspects; 43.5% of whom were lost during the diagnostic work-up in health centres, 0% in lung clinics. Among the TB suspects who completed diagnostic work-ups, 51.1% and 100.0% were diagnosed without following the national TB diagnostic algorithm in health centres and lung clinics, respectively. However, the work-up in the health centres and lung clinics generally conformed to international standards for tuberculosis care (ISTC). Diagnostic delays were significantly longer in health centres compared to lung clinics. Conclusions The high rate of patients lost in health centres needs to be addressed through the implementation of TB suspect tracing and better programme supervision. The national TB algorithm needs to be revised and differentiated according to the level of care. PMID:22333111

[What illegal substances are used by sportsmen? a study in Midi-Pyrénées Doping Preventing Medical Centre (AMPD-MP)].

PubMed

Senard-Ojero, Ana; Durrieu, Geneviève; Depiesse, Frédéric; Schmitt, Laurent; Riviere, Daniel; Montastruc, Jean-Louis

2010-01-01

Doping Preventing Medical Centres (Antennes Médicales de Prévention du Dopage) were established in France in 2000 in order to help sportsmen using illegal substances. These services are also information centres on illegal substances (drugs or others) used in sport. The aim of the study was to analyze the characteristics of sportsmen outpatient clinics in Antenne Médicale de Prevention du Dopage Midi-Pyrénées (AMPD-MP). We present the results of outpatient clinics in AMPD-MP from 2002 to 2008. A descriptive analysis of demographic data, substances used and sports practised were performed. During this 7 year-period, 35 outpatient clinics were performed [32 men, 3 women, mean age: 28 years (extreme values: 18-47; 10 patients ≥ 30 years)]. They were mainly involved in national (16), international (8) or regional (7) competitions. The main sports involved were rugby (9) followed by cycling (5), athletics (3) and body-building (3). The most frequently used illegal substances were cannabis (15) followed by glucocorticoïds (9), androgens (4), indirect sympathomimetics amphetaminics (4), beta 2 adrenergic agonists (2) and NSAIDs (2). Two veterinary substances (clenbuterol, boldone-veterinaire) were also found in body-builders. This study shows a clear under use of Doping Preventing Medical Centres by sportsmen and practitioners. It also indicates a relative high age for sportsmen referred to the centre. The main sports involved were rugby and cycling. Cannabis and glucocorticoïds were the drugs more often involved in doping behaviours.

Influence of fibre design and curvature on crosstalk in multi-core fibre

NASA Astrophysics Data System (ADS)

Egorova, O. N.; Astapovich, M. S.; Melnikov, L. A.; Salganskii, M. Yu; Mishkin, V. P.; Nishchev, K. N.; Semjonov, S. L.; Dianov, E. M.

2016-03-01

We have studied the influence of cross-sectional structure and bends on optical cross-talk in a multicore fibre. A reduced refractive index layer produced between the cores of such fibre with a small centre-to-centre spacing between neighbouring cores (27 μm) reduces optical cross-talk by 20 dB. The cross-talk level achieved, 30 dB per kilometre of the length of the multicore fibre, is acceptable for a number of applications where relatively small lengths of fibre are needed. Moreover, a significant decrease in optical cross-talk has been ensured by reducing the winding diameter of multicore fibres with identical cores.

Retracted: Aetiology and clinical profile of children with 46, XY differences of sex development at an Indian referral centre.

PubMed

Chauhan, V; Dada, R; Jain, V

2017-11-01

Retraction: 'Aetiology and clinical profile of children with 46, XY differences of sex development at an Indian referral centre' by Vasundhera Chauhan, Rima Dada, Vandana Jain The above article, published online on 8 August 2016 in Wiley Online Library (http://wileyonlinelibrary.com), has been retracted by agreement between the authors, the Journal Editors-in-Chief, Wolf-Bernhard Schill and Ralf Henkel, and Blackwell Verlag GmbH. The retraction has been agreed as the result of an unresolved dispute between the first author and a colleague research fellow due to the inclusion of data from patients who were simultaneously enrolled in two studies being conducted separately by the two parties. Reference Chauhan, V., Dada, R. and Jain, V. (2016), Aetiology and clinical profile of children with 46, XY differences of sex development at an Indian referral centre. Andrologia. doi:10.1111/and.12663. © 2016 Blackwell Verlag GmbH.

Multi-region analysis of longitudinal FDG-PET for the classification of Alzheimer’s disease

PubMed Central

Gray, Katherine R.; Wolz, Robin; Heckemann, Rolf A.; Aljabar, Paul; Hammers, Alexander; Rueckert, Daniel

2012-01-01

Imaging biomarkers for Alzheimer’s disease are desirable for improved diagnosis and monitoring, as well as drug discovery. Automated image-based classification of individual patients could provide valuable diagnostic support for clinicians, when considered alongside cognitive assessment scores. We investigate the value of combining cross-sectional and longitudinal multi-region FDG-PET information for classification, using clinical and imaging data from the Alzheimer’s Disease Neuroimaging Initiative. Whole-brain segmentations into 83 anatomically defined regions were automatically generated for baseline and 12-month FDG-PET images. Regional signal intensities were extracted at each timepoint, as well as changes in signal intensity over the follow-up period. Features were provided to a support vector machine classifier. By combining 12-month signal intensities and changes over 12 months, we achieve significantly increased classification performance compared with using any of the three feature sets independently. Based on this combined feature set, we report classification accuracies of 88% between patients with Alzheimer’s disease and elderly healthy controls, and 65% between patients with stable mild cognitive impairment and those who subsequently progressed to Alzheimer’s disease. We demonstrate that information extracted from serial FDG-PET through regional analysis can be used to achieve state-of-the-art classification of diagnostic groups in a realistic multi-centre setting. This finding may be usefully applied in the diagnosis of Alzheimer’s disease, predicting disease course in individuals with mild cognitive impairment, and in the selection of participants for clinical trials. PMID:22236449

Exploring the Rationale for Group Music Activities for Parents and Young Children: Parents' and Practitioners' Perspectives

ERIC Educational Resources Information Center

Pitt, Jessica; Hargreaves, David

2017-01-01

Children's Centres are widespread in England and comprise multi-professional staff teams seeking to work with families with children aged 0-5 years. Although parent-child group music sessions appear frequently in Children's Centre activity programmes, the rationale for their inclusion remains unclear. This article presents the results from phase…

[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…

Multicentre prospective survey of SeHCAT provision and practice in the UK.

PubMed

Summers, Jennifer A; Peacock, Janet; Coker, Bolaji; McMillan, Viktoria; Ofuya, Mercy; Lewis, Cornelius; Keevil, Stephen; Logan, Robert; McLaughlin, John; Reid, Fiona

2016-01-01

A clinical diagnosis of bile acid malabsorption (BAM) can be confirmed using SeHCAT (tauroselcholic ((75)selenium) acid), a radiolabelled synthetic bile acid. However, while BAM can be the cause of chronic diarrhoea, it is often overlooked as a potential diagnosis. Therefore, we investigated the use of SeHCAT for diagnosis of BAM in UK hospitals. A multicentre survey was conducted capturing centre and patient-level information detailing patient care-pathways, clinical history, SeHCAT results, treatment with bile acid sequestrants (BAS), and follow-up in clinics. Eligible data from 38 centres and 1036 patients were entered into a validated management system. SeHCAT protocol varied between centres, with no standardised patient positioning, and differing referral systems. Surveyed patients had a mean age of 50 years and predominantly women (65%). The mean SeHCAT retention score for all patients was 19% (95% CI 17.8% to 20.3%). However, this differed with suspected BAM type: type 1: 9% (95% CI 6.3% to 11.4%), type 2: 21% (95% CI 19.2% to 23.0%) and type 3: 22% (95% CI 19.6% to 24.2%). Centre-defined 'abnormal' and 'borderline' results represented over 50% of the survey population. BAS treatment was prescribed to only 73% of patients with abnormal results. The study identified a lack of consistent cut-off/threshold values, with differing centre criteria for defining an 'abnormal' SeHCAT result. BAS prescription was not related in a simple way to the SeHCAT result, nor to the centre-defined result, highlighting a lack of clear patient care-pathways. There is a clear need for a future diagnostic accuracy study and a better understanding of optimal management pathways.

Multicentre prospective survey of SeHCAT provision and practice in the UK

PubMed Central

Peacock, Janet; Coker, Bolaji; McMillan, Viktoria; Ofuya, Mercy; Lewis, Cornelius; Keevil, Stephen; Logan, Robert; McLaughlin, John; Reid, Fiona

2016-01-01

Objective A clinical diagnosis of bile acid malabsorption (BAM) can be confirmed using SeHCAT (tauroselcholic (75selenium) acid), a radiolabelled synthetic bile acid. However, while BAM can be the cause of chronic diarrhoea, it is often overlooked as a potential diagnosis. Therefore, we investigated the use of SeHCAT for diagnosis of BAM in UK hospitals. Design A multicentre survey was conducted capturing centre and patient-level information detailing patient care-pathways, clinical history, SeHCAT results, treatment with bile acid sequestrants (BAS), and follow-up in clinics. Eligible data from 38 centres and 1036 patients were entered into a validated management system. Results SeHCAT protocol varied between centres, with no standardised patient positioning, and differing referral systems. Surveyed patients had a mean age of 50 years and predominantly women (65%). The mean SeHCAT retention score for all patients was 19% (95% CI 17.8% to 20.3%). However, this differed with suspected BAM type: type 1: 9% (95% CI 6.3% to 11.4%), type 2: 21% (95% CI 19.2% to 23.0%) and type 3: 22% (95% CI 19.6% to 24.2%). Centre-defined ‘abnormal’ and ‘borderline’ results represented over 50% of the survey population. BAS treatment was prescribed to only 73% of patients with abnormal results. Conclusions The study identified a lack of consistent cut-off/threshold values, with differing centre criteria for defining an ‘abnormal’ SeHCAT result. BAS prescription was not related in a simple way to the SeHCAT result, nor to the centre-defined result, highlighting a lack of clear patient care-pathways. There is a clear need for a future diagnostic accuracy study and a better understanding of optimal management pathways. PMID:27252882

Examining chronic care patient preferences for involvement in health-care decision making: the case of Parkinson's disease patients in a patient-centred clinic.

PubMed

Zizzo, Natalie; Bell, Emily; Lafontaine, Anne-Louise; Racine, Eric

2017-08-01

Patient-centred care is a recommended model of care for Parkinson's disease (PD). It aims to provide care that is respectful and responsive to patient preferences, values and perspectives. Provision of patient-centred care should entail considering how patients want to be involved in their care. To understand the participation preferences of patients with PD from a patient-centred care clinic in health-care decision-making processes. Mixed-methods study with early-stage Parkinson's disease patients from a patient-centred care clinic. Study involved a modified Autonomy Preference Index survey (N=65) and qualitative, semi-structured in-depth interviews, analysed using thematic qualitative content analysis (N=20, purposefully selected from survey participants). Interviews examined (i) the patient preferences for involvement in health-care decision making; (ii) patient perspectives on the patient-physician relationship; and (iii) patient preferences for communication of information relevant to decision making. Preferences for participation in decision making varied between individuals and also within individuals depending on decision type, relational and contextual factors. Patients had high preferences for communication of information, but with acknowledged limits. The importance of communication in the patient-physician relationship was emphasized. Patient preferences for involvement in decision making are dynamic and support shared decision making. Relational autonomy corresponds to how patients envision their participation in decision making. Clinicians may need to assess patient preferences on an on-going basis. Our results highlight the complexities of decision-making processes. Improved understanding of individual preferences could enhance respect for persons and make for patient-centred care that is truly respectful of individual patients' wants, needs and values. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

Issues in conducting cross-cultural research: implementation of an agreed international protocol [corrected] designed by the WHOQOL Group for the conduct of focus groups eliciting the quality of life of older adults.

PubMed

Hawthorne, Graeme; Davidson, Natasha; Quinn, Kathryn; McCrate, Farah; Winkler, Ines; Lucas, Ramona; Kilian, Reinhold; Molzahn, Anita

2006-09-01

Multi-centre and cross-cultural research require the use of common protocols if the results are to be either pooled or compared. All too often adherence to protocols is not discussed in reports and where it is reported poor adherence is frequently noted. This paper discusses the use of international guidelines developed by WHOQOL Field Centres to conduct and report focus groups aimed at eliciting key concepts of quality of life among older adults. This was the first step in the development of the WHOQOL-OLD instrument. Although there was overall adherence to the agreed guidelines, there were some differences in the level of reporting, even after participating Field Centres had the opportunity to explain their reports. The reasons for these discrepancies are reported. It is concluded that because of local situations, it is difficult to achieve identical implementation of multi-centre cross-cultural protocols and that the highest standards of auditing are required if findings are to be compared. Suggestions for how such protocols can be improved are given.

Development of multi-mission satellite data systems at the German Remote Sensing Data Centre

NASA Astrophysics Data System (ADS)

Lotz-Iwen, H. J.; Markwitz, W.; Schreier, G.

1998-11-01

This paper focuses on conceptual aspects of the access to multi-mission remote sensing data by online catalogue and information systems. The system ISIS of the German Remote Sensing Data Centre is described as an example of a user interface to earth observation data. ISIS has been designed to support international scientific research as well as operational applications by offering online access to the database via public networks. It provides catalogue retrieval, visualisation and transfer of image data, and is integrated in international activities dedicated to catalogue and archive interoperability. Finally, an outlook is given on international projects dealing with access to remote sensing data in distributed archives.

Nine-Months Clinical Outcome of Biodegradable Polymer Coated Sirolimus-eluting Stent System: A Multi-Centre "Real-World" Experience.

PubMed

Sarma, Raghava; Prajapati, Jayesh; Raheem, Asif; Thakkar, Kamlesh; Kothari, Shivani; Thakkar, Ashok

2015-08-01

The main culprit in first-generation drug eluting stents is 'durable' polymer, whose continuous presence may impair arterial healing and ultimately have a negative impact on late outcomes. The main enigma behind the biodegradable polymer usage is its degradation after elution of drug. This reduces adverse events in unselected patients with complex coronary artery lesions treated with biodegradable polymer coated sirolimus-eluting stents. The aim of the INDOLIMUS-G Registry was to evaluate safety and efficacy of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stents in large cohorts of unselected patients with complex coronary artery lesions. It is a multi-centre, non-randomized retrospective registry with a clear aim of evaluating safety and efficacy of the Indolimus sirolimus-eluting stents in consecutive patients enrolled between April 2012 and May 2014. The primary end-point of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis (ST) at the end of follow-up. Clinical follow-up were scheduled at the end of 30-days, 6-months, and 9-months period. The mean age of enrolled patients was 52.6 ± 11.0 years. A total of 1137 lesions were intervened successfully with 1242 stents (1.09 ± 0.30 stent per lesion). The average stent length and diameter was 27.42 ± 9.01 mm and 3.12 ± 0.36 mm respectively. There were 740 (73.40%) male patients, indicating their high prevalence. Diabetes, hypertension and totally occluded lesions were found in 372 (36.90%), 408 (40.47%) and 170 (16.86%) patients, respectively. This showed that study also included high risk complex lesions and not ideal recruited lesions. The incidence of MACE at 30-days, 6-months and 9-months were 3 (0.30%), 18 (1.80%) and 22 (2.20%) respectively. At 9-months, TLR was found in 6 (0.50%) patients. There were 2 (0.20%) cases of ST, 10 (1.0%) cases of MI and 4 (0.40%) cases of cardiac death at 9-month follow-up. The lower incidence of MACE, TLR and ST at 9-month follow-up clearly delineates safety and efficacy of Indolimus SES in large cohorts of unselected patients with complex coronary lesions.

Why Do Centre Staff Do the Things They Do? The Multi-Layered Motivation Model.

ERIC Educational Resources Information Center

Barnes, Peter

2001-01-01

A study examining the motivation of staff at British residential outdoor centers found that motivation was affected by work environment, nature of work, entry motivation, intrinsic belief, and external and internal motivators and de-motivators. The strongest motivational factor among outdoor center staff revolved around doing a good job. Increased…

Every Which Way We Can: A Literacy and Social Inclusion Position Paper

ERIC Educational Resources Information Center

Bird, Viv; Akerman, Rodie

2005-01-01

According to a recent study by the Centre for Analysis of Social Exclusion (CASE) at the London School of Economics, poverty and social exclusion have been taken very seriously by this Government, resulting in high-profile targets, new policies and funding streams. Social exclusion was recognised to consist of multi-faceted and interlinked…

Psychological Problems in Children with Cerebral Palsy: A Cross-Sectional European Study

ERIC Educational Resources Information Center

Parkes, Jackie; White-Koning, Melanie; Dickinson, Heather O.; Thyen, Ute; Arnaud, Catherine; Beckung, Eva; Fauconnier, Jerome; Marcelli, Marco; McManus, Vicki; Michelsen, Susan I.; Parkinson, Kathryn; Colver, Allan

2008-01-01

Objectives: To describe psychological symptoms in 8-12-year-old children with cerebral palsy; to investigate predictors of these symptoms and their impact on the child and family. Design: A cross-sectional multi-centre survey. Participants: Eight hundred and eighteen children with cerebral palsy, aged 8-12 years, identified from population-based…

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…

Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study.

PubMed

Harvey, James R; Lim, Yit; Murphy, John; Howe, Miles; Morris, Julie; Goyal, Amit; Maxwell, Anthony J

2018-06-01

Wire localization has several disadvantages, notably wire migration and difficulty scheduling the procedure close to surgery. Radioactive seed localization overcomes these disadvantages, but implementation is limited due to radiation safety requirements. Magnetic seeds potentially offer the logistical benefits and transcutaneous detection equivalence of a radioactive seed, with easier implementation. This study was designed to evaluate the feasibility and safety of using magnetic seeds for breast lesion localization. A two-centre open-label cohort study to assess the feasibility and safety of magnetic seed (Magseed) localization of breast lesions. Magseeds were placed under radiological guidance into women having total mastectomy surgery. The primary outcome measure was seed migration distance. Secondary outcome measures included accuracy of placement, ease of transcutaneous detection, seed integrity and safety. Twenty-nine Magseeds were placed into the breasts of 28 patients under ultrasound guidance. There was no migration of the seeds between placement and surgery. Twenty-seven seeds were placed directly in the target lesion with the other seeds being 2 and 3 mm away. All seeds were detectable transcutaneously in all breast sizes and at all depths. There were no complications or safety issues. Magnetic seeds are a feasible and safe method of breast lesion localization. They can be accurately placed, demonstrate no migration in this feasibility study and are detectable in all sizes and depths of breast tissue. Now that safety and feasibility have been demonstrated, further clinical studies are required to evaluate the seed's effectiveness in wide local excision surgery.

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.

[New drugs of abuse on the Web: the role of the Psychonaut Web Mapping Project].

PubMed

Schifano, Fabrizio; Ricciardi, Alessandra; Corazza, Ornella; Deluca, Paolo; Davey, Zoe; Rafanelli, Chiara

2010-01-01

In the rapid change of drug scenarios, as the powerful development in the drug market, particularly in the number and the kind of the compound available, Internet plays a dominant role to become one of the major "drug market". The European Commission funded the Psychonaut Web Mapping Project (carried out in the time-frame January 2008-December 2009), with the aim to start/implement an Early Warning System (through the data/information collected from the Web virtual market), to identify and categorise novel recreational drugs/psychoactive compounds (synthetical/herbal drugs), and new trends in drug use to provide information for immediate and prevention intervention. The Psychonaut is a multi-site research project involving 8 research centres (De Sleutel, Belgium; University of Hertfordshire School of Pharmacy, St George's University of London, England; A-klinikkasäätiö, Finlandia; Klinik für Psychiatrie und Psychotherapie, Germany; Assessorato Salute Regione Marche, Italy; Drug Abuse Unit, Spain; Centre of Competence Bergen Clinics Foundation, Norway) based in 7 European Countries (England, Italy, Belgium, Finland, Germany, Spain, Norway).

Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost.

PubMed

Zelen, Charles M; Serena, Thomas E; Gould, Lisa; Le, Lam; Carter, Marissa J; Keller, Jennifer; Li, William W

2016-04-01

Advanced therapies such as bioengineered skin substitutes (BSS) and dehydrated human amnion/chorion membrane (dHACM) have been shown to promote healing of chronic diabetic ulcers. An interim analysis of data from 60 patients enrolled in a prospective, randomised, controlled, parallel group, multi-centre clinical trial showed that dHACM (EpiFix, MiMedx Group Inc., Marietta, GA) is superior to standard wound care (SWC) and BSS (Apligraf, Organogenesis, Inc., Canton, MA) in achieving complete wound closure within 4-6 weeks. Rates and time to closure at a longer time interval and factors influencing outcomes remained unassessed; therefore, the study was continued in order to achieve at least 100 patients. With the larger cohort, we compare clinical outcomes at 12 weeks in 100 patients with chronic lower extremity diabetic ulcers treated with weekly applications of Apligraf (n = 33), EpiFix (n = 32) or SWC (n = 35) with collagen-alginate dressing as controls. A Cox regression was performed to analyse the time to heal within 12 weeks, adjusting for all significant covariates. A Kaplan-Meier analysis was conducted to compare time-to-heal within 12 weeks for the three treatment groups. Clinical characteristics were well matched across study groups. The proportion of wounds achieving complete closure within the 12-week study period were 73% (24/33), 97% (31/32), and 51% (18/35) for Apligraf, EpiFix and SWC, respectively (adjusted P = 0·00019). Subjects treated with EpiFix had a very significant higher probability of their wounds healing [hazard ratio (HR: 5·66; adjusted P: 1·3 x 10(-7) ] compared to SWC alone. No difference in probability of healing was observed for the Apligraf and SWC groups. Patients treated with Apligraf were less likely to heal than those treated with EpiFix [HR: 0·30; 95% confidence interval (CI): 0·17-0·54; unadjusted P: 5·8 x 10(-5) ]. Increased wound size and presence of hypertension were significant factors that influenced healing. Mean time-to-heal within 12 weeks was 47·9 days (95% CI: 38·2-57·7) with Apligraf, 23·6 days (95% CI: 17·0-30·2) with EpiFix group and 57·4 days (95%CI: 48·2-66·6) with the SWC alone group (adjusted P = 3·2 x 10(-7) ). Median number of grafts used per healed wound were six (range 1-13) and 2·5 (range 1-12) for the Apligraf and EpiFix groups, respectively. Median graft cost was $8918 (range $1,486-19,323) per healed wound for the Apligraf group and $1,517 (range $434-25,710) per healed wound in the EpiFix group (P < 0·0001). These results provide further evidence of the clinical and resource utilisation superiority of EpiFix compared to Apligraf for the treatment of lower extremity diabetic wounds. © 2015 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Evaluation of the clinical effect of an on-line course for community nurses on post-partum emotional distress: a community-based longitudinal time-series quasi-experiment.

PubMed

Thome, Marga; Orlygsdottir, Brynja; Elvarsson, Bjarki Thor

2012-09-01

About 14% of Icelandic women suffer post-partum from frequent depressive symptoms, and of those, 12% also report a high degree of parenting stress. Education of nurses and midwives on post-partum distress is crucial in reducing its degree. The purpose of the study is to evaluate the clinical effect of an on-line course for community nurses on post-partum emotional distress. A community-based, longitudinal, time-series quasi-experiment was conducted in four stages from 2001 to 2005. Mothers attending 16 health centres throughout Iceland and scoring ≥ 12 on the Edinburgh Postnatal Depression Scale (EPDS) at the 9th week post-partum were eligible to participate. Health centres were divided into experimental (EHC) and control centres (CHC), and control centres were crossed over to experimental centres the following year and new control centres recruited. Nurses at EHC attended an on-line course on post-partum emotional distress. Participating mothers answered the EPDS; the Parenting Stress Index/Short form and the Fatigue Scale. Nursing diagnoses and interventions were recorded at all study centres. Of the women who were eligible (n = 163), 57% (n = 93) participated. At baseline, 9 weeks post-partum, there were no significant differences between groups of women in the rate of depressive symptoms, fatigue or parenting stress. Women in all groups improved on all distress indicators over time; however, those from the EHC improved statistically and clinically significantly more on depressive symptoms than those from the CHC. Documentation of particular nursing diagnoses and interventions was significantly more frequent at the EHC, but referrals to specialists were significantly less frequent. On-line education for nurses on post-partum emotional distress is feasible and is related to improvement in post-partum depressive symptoms. © 2011 The Authors. Scandinavian Journal of Caring Sciences © 2011 Nordic College of Caring Science.

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.

Person-generated Data in Self-quantification. A Health Informatics Research Program.

PubMed

Gray, Kathleen; Martin-Sanchez, Fernando J; Lopez-Campos, Guillermo H; Almalki, Manal; Merolli, Mark

2017-01-09

The availability of internet-connected mobile, wearable and ambient consumer technologies, direct-to-consumer e-services and peer-to-peer social media sites far outstrips evidence about the efficiency, effectiveness and efficacy of using them in healthcare applications. The aim of this paper is to describe one approach to build a program of health informatics research, so as to generate rich and robust evidence about health data and information processing in self-quantification and associated healthcare and health outcomes. The paper summarises relevant health informatics research approaches in the literature and presents an example of developing a program of research in the Health and Biomedical Informatics Centre (HaBIC) at the University of Melbourne. The paper describes this program in terms of research infrastructure, conceptual models, research design, research reporting and knowledge sharing. The paper identifies key outcomes from integrative and multiple-angle approaches to investigating the management of information and data generated by use of this Centre's collection of wearable, mobiles and other devices in health self-monitoring experiments. These research results offer lessons for consumers, developers, clinical practitioners and biomedical and health informatics researchers. Health informatics is increasingly called upon to make sense of emerging self-quantification and other digital health phenomena that are well beyond the conventions of healthcare in which the field of informatics originated and consolidated. To make a substantial contribution to optimise the aims, processes and outcomes of health self-quantification needs further work at scale in multi-centre collaborations for this Centre and for health informatics researchers generally.

Recruitment strategies for an osteoporosis clinical trial: analysis of effectiveness.

PubMed

Heard, Allison; March, Rachel; Maguire, Patricia; Reilly, Penny; Helmore, Joy; Cameron, Sheryl; Frampton, Christopher; Nicholls, Gary; Gilchrist, Nigel

2012-09-01

To examine the effectiveness of a planned rapid recruitment strategy in an osteoporosis clinical trial. Multiple recruitment methods were explored, including media advertising, searching bone density scan and X-ray results in specialist and primary practice databases, community initiatives, and generation of research centre and study-specific pamphlets. Of 246 women screened, 41 consenting to the study, only 14 were randomised. Thus, 232 (94%) volunteers were screen failures, ineligible or declined to participate. With regard to the cost-effectiveness of all recruitment strategies, searching the research centre database was the most successful, with four women randomised at a cost of approximately NZ$302 per volunteer. Other strategies were less cost-effective. Obtaining a specific study cohort can be achieved by a comprehensive, targeted, rapid recruitment program. A research centre database search was the most successful and cost-effective recruitment modality in this small study. © 2012 Canterbury Geriatric Medical Research Trust. Australasian Journal on Ageing © 2012 ACOTA.

Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care.

PubMed

Vekemans, Johan; Marsh, Kevin; Greenwood, Brian; Leach, Amanda; Kabore, William; Soulanoudjingar, Solange; Asante, Kwaku Poku; Ansong, Daniel; Evans, Jennifer; Sacarlal, Jahit; Bejon, Philip; Kamthunzi, Portia; Salim, Nahya; Njuguna, Patricia; Hamel, Mary J; Otieno, Walter; Gesase, Samwel; Schellenberg, David

2011-08-04

An effective malaria vaccine, deployed in conjunction with other malaria interventions, is likely to substantially reduce the malaria burden. Efficacy against severe malaria will be a key driver for decisions on implementation. An initial study of an RTS, S vaccine candidate showed promising efficacy against severe malaria in children in Mozambique. Further evidence of its protective efficacy will be gained in a pivotal, multi-centre, phase III study. This paper describes the case definitions of severe malaria used in this study and the programme for standardized assessment of severe malaria according to the case definition. Case definitions of severe malaria were developed from a literature review and a consensus meeting of expert consultants and the RTS, S Clinical Trial Partnership Committee, in collaboration with the World Health Organization and the Malaria Clinical Trials Alliance. The same groups, with input from an Independent Data Monitoring Committee, developed and implemented a programme for standardized data collection.The case definitions developed reflect the typical presentations of severe malaria in African hospitals. Markers of disease severity were chosen on the basis of their association with poor outcome, occurrence in a significant proportion of cases and on an ability to standardize their measurement across research centres. For the primary case definition, one or more clinical and/or laboratory markers of disease severity have to be present, four major co-morbidities (pneumonia, meningitis, bacteraemia or gastroenteritis with severe dehydration) are excluded, and a Plasmodium falciparum parasite density threshold is introduced, in order to maximize the specificity of the case definition. Secondary case definitions allow inclusion of co-morbidities and/or allow for the presence of parasitaemia at any density. The programmatic implementation of standardized case assessment included a clinical algorithm for evaluating seriously sick children, improvements to care delivery and a robust training and evaluation programme for clinicians. The case definition developed for the pivotal phase III RTS, S vaccine study is consistent with WHO recommendations, is locally applicable and appropriately balances sensitivity and specificity in the diagnosis of severe malaria. Processes set up to standardize severe malaria data collection will allow robust assessment of the efficacy of the RTS, S vaccine against severe malaria, strengthen local capacity and benefit patient care for subjects in the trial. Clinicaltrials.gov NCT00866619.

Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

PubMed

Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

2017-11-15

SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial. The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol. The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 .

Comparison of oral robenacoxib and ketoprofen for the treatment of acute pain and inflammation associated with musculoskeletal disorders in cats: a randomised clinical trial.

PubMed

Sano, Tadashi; King, Jonathan N; Seewald, Wolfgang; Sakakibara, Nobuhiro; Okumura, Masahiro

2012-08-01

The objective of the study was to evaluate the efficacy and tolerability of robenacoxib, a selective cyclooxygenase-2 inhibitor, for the treatment of acute pain and inflammation associated with musculoskeletal disorders in cats. The study was a prospective, multi-centre, randomised, blinded, non-inferiority design clinical trial comparing robenacoxib to ketoprofen. A total of 68 cats presenting with pain and inflammation associated with acute musculoskeletal disorders were recruited and allocated randomly to receive, orally once daily for 5-6 days, either 1.0-2.4 mg/kg robenacoxib (n=47) or 1mg/kg ketoprofen (n=21). The primary efficacy endpoint was the total clinician score, which was the sum of clinician numerical rating scale scores for pain, inflammation and mobility. Assessments were made at baseline, on day 2, and day 4 or 5. For the total clinician score, non-inferior efficacy of robenacoxib was demonstrated with a relative efficacy of 1.151 (95% confidence interval 0.872-1.494). Non-inferior efficacy of robenacoxib was also demonstrated for the secondary endpoint of the total owner score. Robenacoxib was superior (P<0.05) to ketoprofen for the owner's assessment of activity and human/animal relationship. The tolerability of both treatments was good as assessed by monitoring adverse events, clinical signs and haematology and serum biochemistry variables. Copyright © 2012. Published by Elsevier Ltd.

Stem cell research and policy in India: current scenario and future perspective.

PubMed

Sharma, Alka

2009-01-01

Stem cell research is an exciting area of biomedical research, with potential to advance cell biology, and other new modalities of treatment for many untreatable diseases. The potential resides in the ability of these cells to develop into many different cell types in the body. In India, efforts are being made on several fronts to promote this area in an integrated way. The main features of the strategy are: explore the full potential of adult and embryonic stem cells (ESCs) through basic and translational research; generate patient specific human ESC lines; enhance creation of animal models for pre-clinical studies; virtual network of Centres; creation institutions; generation of well trained manpower; build partnership with large companies in path-breaking areas; promote closer interactions amongst basic scientists, clinical researchers and the industry. Newer initiatives include: establishment of a dedicated institute for stem cell science and regenerative medicine with its translational units; GMP and clean room facilities in medical schools; creation of a system for multi-centric clinical studies using autologous adult stem cells; national and international training courses for providing training to the students and the young scientists in the both embryonic and adult stem cells; and formulation of guidelines to conduct stem cell research in a responsible and ethically sensitive manner in the country. The core capacity must be nurtured and built to create the required critical mass to have impact.

Study protocol: national research partnership to improve primary health care performance and outcomes for Indigenous peoples.

PubMed

Bailie, Ross; Si, Damin; Shannon, Cindy; Semmens, James; Rowley, Kevin; Scrimgeour, David J; Nagel, Tricia; Anderson, Ian; Connors, Christine; Weeramanthri, Tarun; Thompson, Sandra; McDermott, Robyn; Burke, Hugh; Moore, Elizabeth; Leon, Dallas; Weston, Richard; Grogan, Haylene; Stanley, Andrew; Gardner, Karen

2010-05-19

Strengthening primary health care is critical to reducing health inequity between Indigenous and non-Indigenous Australians. The Audit and Best practice for Chronic Disease Extension (ABCDE) project has facilitated the implementation of modern Continuous Quality Improvement (CQI) approaches in Indigenous community health care centres across Australia. The project demonstrated improvements in health centre systems, delivery of primary care services and in patient intermediate outcomes. It has also highlighted substantial variation in quality of care. Through a partnership between academic researchers, service providers and policy makers, we are now implementing a study which aims to 1) explore the factors associated with variation in clinical performance; 2) examine specific strategies that have been effective in improving primary care clinical performance; and 3) work with health service staff, management and policy makers to enhance the effective implementation of successful strategies. The study will be conducted in Indigenous community health centres from at least six States/Territories (Northern Territory, Western Australia, New South Wales, South Australia, Queensland and Victoria) over a five year period. A research hub will be established in each region to support collection and reporting of quantitative and qualitative clinical and health centre system performance data, to investigate factors affecting variation in quality of care and to facilitate effective translation of research evidence into policy and practice. The project is supported by a web-based information system, providing automated analysis and reporting of clinical care performance to health centre staff and management. By linking researchers directly to users of research (service providers, managers and policy makers), the partnership is well placed to generate new knowledge on effective strategies for improving the quality of primary health care and fostering effective and efficient exchange and use of data and information among service providers and policy makers to achieve evidence-based resource allocation, service planning, system development, and improvements of service delivery and Indigenous health outcomes.

Posttraumatic stress among women after induced abortion: a Swedish multi-centre cohort study

PubMed Central

2013-01-01

Background Induced abortion is a common medical intervention. Whether psychological sequelae might follow induced abortion has long been a subject of concern among researchers and little is known about the relationship between posttraumatic stress disorder (PTSD) and induced abortion. Thus, the aim of the study was to assess the prevalence of PTSD and posttraumatic stress symptoms (PTSS) before and at three and six months after induced abortion, and to describe the characteristics of the women who developed PTSD or PTSS after the abortion. Methods This multi-centre cohort study included six departments of Obstetrics and Gynaecology in Sweden. The study included 1457 women who requested an induced abortion, among whom 742 women responded at the three-month follow-up and 641 women at the six-month follow-up. The Screen Questionnaire-Posttraumatic Stress Disorder (SQ-PTSD) was used for research diagnoses of PTSD and PTSS, and anxiety and depressive symptoms were evaluated by the Hospital Anxiety and Depression Scale (HADS). Measurements were made at the first visit and at three and six months after the abortion. The 95% confidence intervals for the prevalence of lifetime or ongoing PTSD and PTSS were calculated using the normal approximation. The chi-square test and the Student’s t-test were used to compare data between groups. Results The prevalence of ongoing PTSD and PTSS before the abortion was 4.3% and 23.5%, respectively, concomitant with high levels of anxiety and depression. At three months the corresponding rates were 2.0% and 4.6%, at six months 1.9% and 6.1%, respectively. Dropouts had higher rates of PTSD and PTSS. Fifty-one women developed PTSD or PTSS during the observation period. They were young, less well educated, needed counselling, and had high levels of anxiety and depressive symptoms. During the observation period 57 women had trauma experiences, among whom 11 developed PTSD or PTSS and reported a traumatic experience in relation to the abortion. Conclusion Few women developed PTSD or PTSS after the abortion. The majority did so because of trauma experiences unrelated to the induced abortion. Concomitant symptoms of depression and anxiety call for clinical alertness and support. PMID:24364878

Posttraumatic stress among women after induced abortion: a Swedish multi-centre cohort study.

PubMed

Wallin Lundell, Inger; Georgsson Öhman, Susanne; Frans, Örjan; Helström, Lotti; Högberg, Ulf; Nyberg, Sigrid; Sundström Poromaa, Inger; Sydsjö, Gunilla; Östlund, Ingrid; Skoog Svanberg, Agneta

2013-12-23

Induced abortion is a common medical intervention. Whether psychological sequelae might follow induced abortion has long been a subject of concern among researchers and little is known about the relationship between posttraumatic stress disorder (PTSD) and induced abortion. Thus, the aim of the study was to assess the prevalence of PTSD and posttraumatic stress symptoms (PTSS) before and at three and six months after induced abortion, and to describe the characteristics of the women who developed PTSD or PTSS after the abortion. This multi-centre cohort study included six departments of Obstetrics and Gynaecology in Sweden. The study included 1457 women who requested an induced abortion, among whom 742 women responded at the three-month follow-up and 641 women at the six-month follow-up. The Screen Questionnaire-Posttraumatic Stress Disorder (SQ-PTSD) was used for research diagnoses of PTSD and PTSS, and anxiety and depressive symptoms were evaluated by the Hospital Anxiety and Depression Scale (HADS). Measurements were made at the first visit and at three and six months after the abortion. The 95% confidence intervals for the prevalence of lifetime or ongoing PTSD and PTSS were calculated using the normal approximation. The chi-square test and the Student's t-test were used to compare data between groups. The prevalence of ongoing PTSD and PTSS before the abortion was 4.3% and 23.5%, respectively, concomitant with high levels of anxiety and depression. At three months the corresponding rates were 2.0% and 4.6%, at six months 1.9% and 6.1%, respectively. Dropouts had higher rates of PTSD and PTSS. Fifty-one women developed PTSD or PTSS during the observation period. They were young, less well educated, needed counselling, and had high levels of anxiety and depressive symptoms. During the observation period 57 women had trauma experiences, among whom 11 developed PTSD or PTSS and reported a traumatic experience in relation to the abortion. Few women developed PTSD or PTSS after the abortion. The majority did so because of trauma experiences unrelated to the induced abortion. Concomitant symptoms of depression and anxiety call for clinical alertness and support.

Success of a weight loss plan for overweight dogs: The results of an international weight loss study

PubMed Central

Flanagan, John; Bissot, Thomas; Hours, Marie-Anne; Moreno, Bernabe; Feugier, Alexandre

2017-01-01

Introduction Obesity is a global concern in dogs with an increasing prevalence, and effective weight loss solutions are required that work in different geographical regions. The main objective was to conduct an international, multi-centre, weight loss trial to determine the efficacy of a dietary weight loss intervention in obese pet dogs. Methods A 3-month prospective observational cohort study of weight loss in 926 overweight dogs was conducted at 340 veterinary practices in 27 countries. Commercially available dry or wet weight loss diets were used, with the initial energy allocation being 250–335 kJ/kg target body weight0.75/day (60–80 kcal/kg target body weight0.75/day) depending on sex and neuter status. The primary outcome measure was percentage weight loss; the main secondary outcomes were changes in activity, quality of life, and food-seeking behaviour, which were subjectively determined from owner descriptions. Results At baseline, median (range) age was 74 (12 to 193) months and median body condition score was 8 (range 7–9). 896 of the 926 dogs (97%) lost weight, with mean weight loss being 11.4 ±5.84%. Sexually intact dogs lost more weight than neutered dogs (P = 0.001), whilst female dogs lost more weight than male dogs (P = 0.007), with the difference being more pronounced in North and South American dogs (median [Q1, Q3]: female: 11.5% [8.5%, 14.5%]; male: 9.1% [6.3%, 12.1%], P = 0.053) compared with those from Europe (female: 12.3% [8.9%, 14.9%]; male: 10.9% [8.6%, 15.4%]). Finally, subjective scores for activity (P<0.001) and quality of life (P<0.001) increased sequentially, whilst scores for food-seeking behaviour decreased sequentially (P<0.001) during the study. Conclusion This is the largest international multi-centre weight loss study conducted to date in obese dogs. Most dogs lost a clinically significant amount of weight, although there were notable differences between dogs of different sex, neuter status and in different geographical locations. PMID:28886096

Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

PubMed

Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, David J; McGuinness, Shay

2015-12-24

Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first). This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial. NCT01847534 (First registered 5 February 2013, last updated 14 October 2015).

One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

PubMed Central

Hopkins, L. Nelson; Siddiqui, Adnan H.

2017-01-01

Atherosclerotic carotid artery stenosis (CS) continues to be a common cause of acute ischaemic stroke. Optimised medical therapy (OMT), the first-line treatment modality in CS, may reduce or delay – but it does not abolish – CS-related strokes. As per current AHA/ASA and ESC/ESVS/ESO guidelines, carotid artery stenting (CAS) is a less-invasive alternative to carotid endarterectomy (CEA) for CS revascularisation in primary and secondary stroke prevention. Ten-year follow-up from the CREST trial in patients with symptomatic and asymptomatic CS confirmed equipoise of CAS and CEA in the primary endpoint. Nevertheless CAS – using a widely open-cell, first-generation stent and first-generation (distal/filter) neuroprotection – has been criticised for its relative excess of (mostly minor) strokes by 30 days, a significant proportion of which were post-procedural. Atherosclerotic plaque protrusion through conventional carotid stent struts, confirmed on intravascular imaging, has been implicated as a leading mechanism of the relative excess of strokes with CAS vs. CEA, including delayed strokes with CAS. Different designs of mesh-covered carotid stents have been developed to prevent plaque prolapse. Several multi-centre/multi-specialty clinical studies with CGurad MicroNet-Covered Embolic Prevention Stent System (EPS) and RoadSaver/Casper were recently published and included routine DW-MRI cerebral imaging peri-procedurally and at 30 days (CGuard EPS). Data from more than 550 patients in mesh-covered carotid stent clinical studies to-date show an overall 30-day complication rate of ~1% with near-elimination of post-procedural events. While more (and long-term) evidence is still anticipated, these results – taken together with optimised intra-procedural neuroprotection in CAS (increased use of proximal systems including trans-carotid dynamic flow reversal) and the positive 12-month mesh-covered stent data reports in 2017 – are transforming the carotid revascularisation field today. Establishing effective algorithms to identify the asymptomatic subjects at stroke risk despite OMT, and large-scale studies with mesh-covered stents including long-term clinical and duplex ultrasound outcomes, are the next major goals. PMID:28798779

Methods and implementation of a central biosample and data management in a three-centre clinical study.

PubMed

Angelow, Aniela; Schmidt, Matthias; Weitmann, Kerstin; Schwedler, Susanne; Vogt, Hannes; Havemann, Christoph; Hoffmann, Wolfgang

2008-07-01

In our report we describe concept, strategies and implementation of a central biosample and data management (CSDM) system in the three-centre clinical study of the Transregional Collaborative Research Centre "Inflammatory Cardiomyopathy - Molecular Pathogenesis and Therapy" SFB/TR 19, Germany. Following the requirements of high system resource availability, data security, privacy protection and quality assurance, a web-based CSDM was developed based on Java 2 Enterprise Edition using an Oracle database. An efficient and reliable sample documentation system using bar code labelling, a partitioning storage algorithm and an online documentation software was implemented. An online electronic case report form is used to acquire patient-related data. Strict rules for access to the online applications and secure connections are used to account for privacy protection and data security. Challenges for the implementation of the CSDM resided at project, technical and organisational level as well as at staff level.

First clinical and microbiological characterization of Clostridium difficile infection in a Croatian University Hospital.

PubMed

Novak, Anita; Spigaglia, Patrizia; Barbanti, Fabrizio; Goic-Barisic, Ivana; Tonkic, Marija

2014-12-01

Clinical background and molecular epidemiology of Clostridium difficile infection (CDI) in the University Hospital Centre Split were investigated from January 2010 to December 2011. In total, 54 patients with first episode of CDI were consecutively included in the study based on the positive EIA test specific for A and B toxins. Demographic and clinical data were prospectively analyzed from medical records. CDI incidence rate was 0.6 per 10,000 patient-days. Thirty six cases (70.6%) were healthcare-associated, twelve cases (23.5%) were community-associated and three (5.9%) were indeterminate. Six patients (11.7%) had suffered one or more recurrences and 37 patients (72.5%) showed severe CDI. Prior therapy with third generation cephalosporin was significantly associated with severe CDI (P<0.021). Fifty four toxigenic C. difficile strains were isolated and 50 of them were available for PCR-ribotyping. Sixteen different PCR-ribotypes were identified. The most prevalent were PCR-ribotype 001 (27.8%) and 014/020 (24.1%). Twenty three strains were resistant to at least one of the antibiotics tested. Among resistant strains, three (13.0%)--all PCR-ribotype 001--were multi-resistant. Resistance to fluoroquinolones was significantly higher in strains that caused infection after previous use of fluoroquinolones (P=0.04). Copyright © 2014 Elsevier Ltd. All rights reserved.

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 .

Adverse Effects of Plant Food Supplements and Plants Consumed as Food: Results from the Poisons Centres-Based PlantLIBRA Study.

PubMed

Lüde, Saskia; Vecchio, Sarah; Sinno-Tellier, Sandra; Dopter, Aymeric; Mustonen, Harriet; Vucinic, Slavica; Jonsson, Birgitta; Müller, Dieter; Veras Gimenez Fruchtengarten, Ligia; Hruby, Karl; De Souza Nascimento, Elizabeth; Di Lorenzo, Chiara; Restani, Patrizia; Kupferschmidt, Hugo; Ceschi, Alessandro

2016-06-01

Plant food supplements (PFS) are products of increasing popularity and wide-spread distribution. Nevertheless, information about their risks is limited. To fill this gap, a poisons centres-based study was performed as part of the EU project PlantLIBRA. Multicentre retrospective review of data from selected European and Brazilian poisons centres, involving human cases of adverse effects due to plants consumed as food or as ingredients of food supplements recorded between 2006 and 2010. Ten poisons centres provided a total of 75 cases. In 57 cases (76%) a PFS was involved; in 18 (24%) a plant was ingested as food. The 10 most frequently reported plants were Valeriana officinalis, Camellia sinensis, Paullinia cupana, Melissa officinalis, Passiflora incarnata, Mentha piperita, Glycyrrhiza glabra, Ilex paraguariensis, Panax ginseng, and Citrus aurantium. The most frequently observed clinical effects were neurotoxicity and gastro-intestinal symptoms. Most cases showed a benign clinical course; however, five cases were severe. PFS-related adverse effects seem to be relatively infrequent issues for poisons centres. Most cases showed mild symptoms. Nevertheless, the occurrence of some severe adverse effects and the increasing popularity of PFS require continuous active surveillance, and further research is warranted. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Multi-criteria correlation of tephra deposits to source centres applied in the Auckland Volcanic Field, New Zealand

NASA Astrophysics Data System (ADS)

Hopkins, Jenni L.; Wilson, Colin J. N.; Millet, Marc-Alban; Leonard, Graham S.; Timm, Christian; McGee, Lucy E.; Smith, Ian E. M.; Smith, Euan G. C.

2017-07-01

Linking tephras back to their source centre(s) in volcanic fields is crucial not only to reconstruct the eruptive history of the volcanic field but also to understand tephra dispersal patterns and thus the potential hazards posed by a future eruption. Here we present a multi-disciplinary approach to correlate distal basaltic tephra deposits from the Auckland Volcanic Field (AVF) to their source centres using proximal whole-rock geochemical signatures. In order to achieve these correlations, major and trace element tephra-derived glass compositions are compared with published and newly obtained whole-rock geochemical data for the entire field. The results show that incompatible trace element ratios (e.g. (Gd/Yb)N, (La/Yb)N, (Zr/Yb)N) vary widely across the AVF (e.g. (La/Yb)N = 5 to 40) but show a more restricted range within samples from a single volcanic centre (e.g. (La/Yb)N = 5 to 10). These ratios are also the least affected by fractional crystallisation and are therefore the most appropriate geochemical tools for correlation between tephra and whole-rock samples. However, findings for the AVF suggest that each volcanic centre does not have a unique geochemical signature in the field as a whole, thus preventing unambiguous correlation of tephras to source centre using geochemistry alone. A number of additional criteria are therefore combined to further constrain the source centres of the distal tephras including age, eruption scale, and location (of centres, and sites where tephra were sampled). The combination of tephrostratigraphy, 40Ar/39Ar dating and morphostratigraphic constraints allow, for the first time, the relative and absolute ordering of 48 of 53 volcanic centres of the Auckland Volcanic Field to be resolved. Eruption frequencies are shown to vary between 0.13 and 1.5 eruptions/kyr and repose periods between individual eruptions vary from <0.1 to 13 kyr, with 23 of the 48 centres shown to have pre-eruptive repose periods of <1000 years. No spatial evolutionary trends are noted, although a relationship between short repose periods and closely spaced eruption locations is identified for a number of centres. In addition, no temporal-geochemical trends are noted, but a relationship between geochemical signature and eruption volume is highlighted.

The Contribution of Command and Control to Unity of Effort

DTIC Science & Technology

2002-09-01

Engineering and Evaluation Centre University of South Australia Mawson Lakes, South Australia Author contact: 6 Frank Street St Morris SA 5068... Mawson Lakes, South Australia, , 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S...Noel Sproles PhD Systems Engineering and Evaluation Centre University of South Australia Mawson Lakes, South Australia While joint and multi-national

The foundation of NCVD PCI Registry: the Malaysia's first multi-centre interventional cardiology project.

PubMed

Liew, H B; Rosli, M A; Wan Azman, W A; Robaayah, Z; Sim, K H

2008-09-01

The National Cardiovascular Database for Percutaneous Coronary Intervention (NCVD PCI) Registry is the first multicentre interventional cardiology project, involving the main cardiac centres in the country. The ultimate goal of NCVD PCI is to provide a contemporary appraisal of PCI in Malaysia. This article introduces the foundation, the aims, methodology, database collection and preliminary results of the first six-month database.

Severe liver disease related to chronic hepatitis C virus infection in treatment-naive patients: epidemiological characteristics and associated factors at first expert centre visit, France, 2000 to 2007 and 2010 to 2014

PubMed Central

Sanna, Alice; Le Strat, Yann; Roudot-Thoraval, Françoise; Deuffic Burban, Sylvie; Carrieri, Patrizia; Delarocque-Astagneau, Elisabeth; Larsen, Christine

2017-01-01

Given recent profound improvements in the effectiveness of antiviral treatment for chronic Hepatitis C virus (HCV) infection, we aimed to describe the characteristics of patients referred to hepatology expert centres in France from 2000 to 2007 and from 2010 to 2014, and to identify factors associated with severe liver disease at their first visit for evaluation. We analysed data from two sources covering all of France: the former hepatitis C surveillance network, which included patients between 2000 and 2007, and the ANRS CO22 HEPATHER multi-centre cohort, which included patients between 2012 and 2014. Severe liver disease (SLD) was defined as the presence of either cirrhosis (histological, biochemical or clinical) or hepatocellular carcinoma. Multivariable Poisson regression models were used to identify the factors associated with SLD in complete-case analysis and after multiple imputation. Overall, 16,851 patients were included in the analysis and SLD was diagnosed in 11.6%. SLD at first visit was significantly associated with known risk factors (male sex, history of excessive alcohol intake, HCV genotype 3), late referral to hepatologists after diagnosis and HCV diagnosis at an older age. Providing earlier specialised care and treatment may be an important target for public health action. PMID:28797326

Haloperidol versus placebo for delirium prevention in acutely hospitalised older at risk patients: a multi-centre double-blind randomised controlled clinical trial.

PubMed

Schrijver, Edmée J M; de Vries, Oscar J; van de Ven, Peter M; Bet, Pierre M; Kamper, Ad M; Diepeveen, Sabine H A; van Marum, Rob J; van Strien, Astrid M; Anten, Sander; Lagaay, Anne M; Boelaarts, Leo; Bloemers, Frank W; Kramer, Mark H H; Nanayakkara, Prabath W B

2018-01-01

because the few randomised placebo-controlled trials investigating the potential role for prophylactic haloperidol in delirium prevention have focused on specific surgical populations, we investigated its efficacy and safety in acutely hospitalised older patients. this multi-centre, double-blind, stratified, block randomised, placebo-controlled trial was conducted at six Dutch hospitals. Patients age ≥70 years, acutely admitted through the emergency department for general medicine or surgical specialties and at risk for delirium were randomised (n = 245) to haloperidol or placebo 1 mg orally twice-daily (maximum of 14 doses) on top of standard nonpharmacological prevention strategies. The primary outcome was delirium incidence. Other endpoints included delirium severity and duration, drug safety and clinical outcomes. intention-to-treat analysis included 242 participants (calculated sample size n = 390, statistical power of current sample 59%) allocated to haloperidol (n = 118) or placebo (n = 124). In the haloperidol and placebo group, delirium incidence was 19.5 versus 14.5% (OR 1.43, 95% CI 0.72 to 2.78); median (IQR) delirium duration 4 (2, 5) versus 3 (1, 6) days (P = 0.366); maximum DRS-R-98 score 16 (9.8, 19.5) versus 10 (5.5, 22.5) (P = 0.549; 53.7% missing data); hospital LOS 7 (4, 10.3) versus 7 (5, 11.8) days (P = 0.343); 3-month mortality 9.9 versus 12.5% (OR 0.77, 95% CI 0.34 to 1.75), respectively. No treatment-limiting side effects were noted. prophylactic low-dose oral haloperidol did not reduce delirium incidence in acutely hospitalised older patients. Therefore, prophylactic use of haloperidol in this population is not recommended. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.All rights reserved. For permissions, please email: journals.permissions@oup.com

Multi-centre diagnostic classification of individual structural neuroimaging scans from patients with major depressive disorder.

PubMed

Mwangi, Benson; Ebmeier, Klaus P; Matthews, Keith; Steele, J Douglas

2012-05-01

Quantitative abnormalities of brain structure in patients with major depressive disorder have been reported at a group level for decades. However, these structural differences appear subtle in comparison with conventional radiologically defined abnormalities, with considerable inter-subject variability. Consequently, it has not been possible to readily identify scans from patients with major depressive disorder at an individual level. Recently, machine learning techniques such as relevance vector machines and support vector machines have been applied to predictive classification of individual scans with variable success. Here we describe a novel hybrid method, which combines machine learning with feature selection and characterization, with the latter aimed at maximizing the accuracy of machine learning prediction. The method was tested using a multi-centre dataset of T(1)-weighted 'structural' scans. A total of 62 patients with major depressive disorder and matched controls were recruited from referred secondary care clinical populations in Aberdeen and Edinburgh, UK. The generalization ability and predictive accuracy of the classifiers was tested using data left out of the training process. High prediction accuracy was achieved (~90%). While feature selection was important for maximizing high predictive accuracy with machine learning, feature characterization contributed only a modest improvement to relevance vector machine-based prediction (~5%). Notably, while the only information provided for training the classifiers was T(1)-weighted scans plus a categorical label (major depressive disorder versus controls), both relevance vector machine and support vector machine 'weighting factors' (used for making predictions) correlated strongly with subjective ratings of illness severity. These results indicate that machine learning techniques have the potential to inform clinical practice and research, as they can make accurate predictions about brain scan data from individual subjects. Furthermore, machine learning weighting factors may reflect an objective biomarker of major depressive disorder illness severity, based on abnormalities of brain structure.

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.

Evaluation of a combined strategy directed towards health-care professionals and patients with chronic obstructive pulmonary disease (COPD): Information and health education feedback for improving clinical monitoring and quality-of-life

PubMed Central

2009-01-01

Background Chronic obstructive pulmonary disease (COPD) is a health problem that is becoming increasingly attended-to in Primary Care (PC). However, there is a scarcity of health-care programs and studies exploring the implementation of Clinical Practice Guidelines (CPG). The principal objective of the present study is to evaluate the effectiveness of a combined strategy directed towards health-care professionals and patients to improve the grade of clinical control and the quality-of-life (QoL) of the patients via a feedback on their state-of-health. A training plan for the health-care professionals is based on CPG and health education. Method/Design Multi-centred, before-after, quasi experimental, prospective study involving an intervention group and a control group of individuals followed-up for 12 months. The patients receive attention from urban and semi-urban Primary Care Centres (PCC) within the administrative area of the Costa de Ponent (near Barcelona). All the pacients corresponding to the PCC of one sub-area were assigned to the intervention group and patients from the rest of sub-areas to the group control. The intervention includes providing data to the health-care professionals (clinician/nurse) derived from a clinical history and an interview. A course of training focused on aspects of CPG, motivational interview and health education (tobacco, inhalers, diet, physical exercise, physiotherapy). The sample random includes a total of 801 patients (≥ 40 years of age), recorded as having COPD, receiving attention in the PCC or at home, who have had at least one clinical visit, and who provided written informed consent to participation in the study. Data collected include socio-demographic characteristics, drug treatment, exacerbations and hospital admissions, evaluation of inhaler use, tobacco consumption and life-style and health-care resources consumed. The main endpoints are dyspnoea, according to the modified scale of the Medical Research Council (MRC) and the QoL, evaluated with the St George's Respiratory Questionnaire (SGRQ). The variables are obtained at the start and the end of the intervention. Information from follow-up visits focuses on the changes in life-style activities of the patient. Discussion This study is conducted with the objective of generating evidence that shows that implementation of awareness programs directed towards health-care professionals as well as patients in the context of PC can produce an increase in the QoL and a decrease in the disease exacerbation, compared to standard clinical practice. Trial Registration Clinical Trials.gov Identifier: NCT00922545; PMID:20128887

The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol

PubMed Central

2014-01-01

Background Insertion of a ventriculoperitoneal shunt (VPS) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK, but failures caused by infection occur in approximately 8% of primary cases. VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service. Antibiotic-impregnated (rifampicin and clindamycin) and silver-impregnated VPS have been developed to reduce infection rates. Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection, there are no randomised controlled trials (RCTs) to support their routine use. Methods/design Overall, 1,200 patients will be recruited from 17 regional neurosurgical units in the UK and Ireland. Patients of any age undergoing insertion of their first VPS are eligible. Patients with previous indwelling VPS, active and on-going cerebrospinal fluid (CSF) or peritoneal infection, multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy, and ventriculoatrial or ventriculopleural shunt planned will be excluded. Patients will be randomised 1:1:1 to either standard silicone (comparator), antibiotic-impregnated, or silver-impregnated VPS. The primary outcome measure is time to VPS infection. Secondary outcome measures include time to VPS failure of any cause, reason for VPS failure (infection, mechanical failure, or patient failure), types of bacterial VPS infection (organism type and antibiotic resistance), and incremental cost per VPS failure averted. Discussion The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS. The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN49474281. PMID:24383496

Transdisciplinary synthesis for ecosystem science, policy and management: The Australian experience.

PubMed

Lynch, A J J; Thackway, R; Specht, A; Beggs, P J; Brisbane, S; Burns, E L; Byrne, M; Capon, S J; Casanova, M T; Clarke, P A; Davies, J M; Dovers, S; Dwyer, R G; Ens, E; Fisher, D O; Flanigan, M; Garnier, E; Guru, S M; Kilminster, K; Locke, J; Mac Nally, R; McMahon, K M; Mitchell, P J; Pierson, J C; Rodgers, E M; Russell-Smith, J; Udy, J; Waycott, M

2015-11-15

Mitigating the environmental effects of global population growth, climatic change and increasing socio-ecological complexity is a daunting challenge. To tackle this requires synthesis: the integration of disparate information to generate novel insights from heterogeneous, complex situations where there are diverse perspectives. Since 1995, a structured approach to inter-, multi- and trans-disciplinary(1) collaboration around big science questions has been supported through synthesis centres around the world. These centres are finding an expanding role due to ever-accumulating data and the need for more and better opportunities to develop transdisciplinary and holistic approaches to solve real-world problems. The Australian Centre for Ecological Analysis and Synthesis (ACEAS ) has been the pioneering ecosystem science synthesis centre in the Southern Hemisphere. Such centres provide analysis and synthesis opportunities for time-pressed scientists, policy-makers and managers. They provide the scientific and organisational environs for virtual and face-to-face engagement, impetus for integration, data and methodological support, and innovative ways to deliver synthesis products. We detail the contribution, role and value of synthesis using ACEAS to exemplify the capacity for synthesis centres to facilitate trans-organisational, transdisciplinary synthesis. We compare ACEAS to other international synthesis centres, and describe how it facilitated project teams and its objective of linking natural resource science to policy to management. Scientists and managers were brought together to actively collaborate in multi-institutional, cross-sectoral and transdisciplinary research on contemporary ecological problems. The teams analysed, integrated and synthesised existing data to co-develop solution-oriented publications and management recommendations that might otherwise not have been produced. We identify key outcomes of some ACEAS working groups which used synthesis to tackle important ecosystem challenges. We also examine the barriers and enablers to synthesis, so that risks can be minimised and successful outcomes maximised. We argue that synthesis centres have a crucial role in developing, communicating and using synthetic transdisciplinary research. Copyright © 2015 Elsevier B.V. All rights reserved.

A review of squamous cell vulvar cancers in Waikato region, New Zealand.

PubMed

Dass, Prashanth Hari; Kuper-Hommel, Marion Jj

2017-11-10

Squamous cell vulvar cancers (SCVC) are rare. Although management guidelines have recently been published, New Zealand studies presenting "real world" outcomes are limited. Retrospective single-centre review of SCVC diagnosed between 1 January 2000 and 31 August 2015. Clinical characteristics and outcomes were reviewed. Among 47 cases reviewed, 38 were ethnically European and 9 Māori. Cases identified as Stage 1 (16), Stage 2 (5), Stage 3 (17), Stage 4 (9). For Stages 1, 2, 3 and 4, (16, 4, 17 and 6) were managed by local excision; (9, 1, 14 and 2) by node dissection and (2, 1, 3 and 5) by chemoradiotherapy respectively. Wound cellulitis (10) and lymphedema (8) were the commonest acute and late complication, respectively. Seven patients were treated with 5-Fluorouracil and Mitomycin, and four received weekly Cisplatin. Grade 3 toxicities seen in five cases treated with 5-Fluorouracil and Mitomycin versus none in the Cisplatin group. No local recurrences observed in patients treated with chemoradiation. Patients with Age Adjusted Charlson Comorbid Index Score (ACCIS) <5 had better overall survival (OS) compared to scores ≥5 (60% versus 41%) with 33 months median follow-up. Five-year OS and disease-free specific survival was 73% and 94% (Stage 1), 40% and 60% (Stage 2), 44% and 59% (Stage 3) and 29% (Stage 4) respectively. We present "real world" outcomes of vulvar cancers in this older and comorbid population. Larger, prospective multi-centre studies are proposed.

Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial.

PubMed

Morley, Kirsten C; Teesson, Maree; Reid, Sophie C; Sannibale, Claudia; Thomson, Clare; Phung, Nghi; Weltman, Martin; Bell, James R; Richardson, Kylie; Haber, Paul S

2006-10-01

To compare the efficacy of acamprosate and naltrexone in the treatment of alcohol dependence. A double-blind, placebo-controlled trial. Three treatment centres in Australia. A total of 169 alcohol dependent subjects were given naltrexone (50 mg/day), acamprosate (1998 mg/day) or placebo for 12 weeks. All subjects were offered manualized compliance therapy, a brief intervention that targets problems that may affect treatment compliance such as ambivalence and misperceptions about medication. Time to the first drink, time to first relapse, drinks per drinking day and cumulative abstinence. In intention-to-treat analyses, there were no differences between groups on outcome measures of drinking, craving or biochemical markers. Similarly, analyses of the 94 subjects that completed the study in full and demonstrated 80% compliance, revealed no significant treatment effects. Differential treatment effects were identified after stratification according to scores on the Alcohol Dependence Scale (ADS) and Depression Anxiety and Stress Scale (DASS). A significant beneficial treatment effect on time to first relapse was revealed for subjects with 'no depression' allocated to naltrexone (n = 56; P < 0.01). In addition, a significant beneficial treatment effect was revealed in subjects with 'low dependence' allocated to naltrexone (n = 34; P < 0.05). The results of this study support the efficacy of naltrexone in the relapse prevention of alcoholism amongst those with low levels of clinical depression and alcohol dependence severity. No effect of acamprosate was found in our sample.

Elucidation of the Strongest Predictors of Cardiovascular Events in Patients with Heart Failure.

PubMed

Fukuda, Hiroki; Shindo, Kazuhiro; Sakamoto, Mari; Ide, Tomomi; Kinugawa, Shintaro; Fukushima, Arata; Tsutsui, Hiroyuki; Ito, Shin; Ishii, Akira; Washio, Takashi; Kitakaze, Masafumi

2018-06-20

In previous retrospective studies, we identified the 50 most influential clinical predictors of cardiovascular outcomes in patients with heart failure (HF). The present study aimed to use the novel limitless-arity multiple-testing procedure to filter these 50 clinical factors and thus yield combinations of no more than four factors that could potentially predict the onset of cardiovascular events. A Kaplan-Meier analysis was used to investigate the importance of the combinations. In a multi-centre observational trial, we prospectively enrolled 213 patients with HF who were hospitalized because of exacerbation, discharged according to HF treatment guidelines and observed to monitor cardiovascular events. After the observation period, we stratified patients according to whether they experienced cardiovascular events (rehospitalisation or cardiovascular death). Among 77,562 combinations of fewer than five clinical parameters, we identified 151 combinations that could potentially explain the occurrence of cardiovascular events. Of these, 145 combinations included the use of inotropic agents, whereas the remaining 6 included the use of diuretics without bradycardia or tachycardia, suggesting that the high probability of cardiovascular events is exclusively determined by these two clinical factors. Importantly, Kaplan-Meier curves demonstrated that the use of inotropes or of diuretics without bradycardia or tachycardia were independent predictors of a markedly worse cardiovascular prognosis. Patients treated with either inotropic agents or diuretics without bradycardia or tachycardia were at a higher risk of cardiovascular events. The uses of these drugs, regardless of heart rate, are the strongest clinical predictors of cardiovascular events in patients with HF. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Risk based monitoring (RBM) tools for clinical trials: A systematic review.

PubMed

Hurley, Caroline; Shiely, Frances; Power, Jessica; Clarke, Mike; Eustace, Joseph A; Flanagan, Evelyn; Kearney, Patricia M

2016-11-01

In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools. Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists. This review included academic and commercial instruments that met the Organisation for Economic Co-operation and Development (OECD) classification of RBM tools. Ninety-one potential RBM tools were identified and 24 were eligible for inclusion. These tools were published between 2000 and 2015. Eight tools were paper based or electronic questionnaires and 16 operated as Service as a System (SaaS). Risk associated with the investigational medicinal product (IMP), phase of the clinical trial and study population were examined by all tools and suitable mitigation guidance through on-site and centralised monitoring was provided. RBM tools for clinical trials are relatively new, their features and use varies widely and they continue to evolve. This makes it difficult to identify the "best" RBM technique or tool. For example, equivalence testing is required to determine if RBM strategies directed by paper based and SaaS based RBM tools are comparable. Such research could be embedded within multi-centre clinical trials and conducted as a SWAT (Study within a Trial). Copyright © 2016 Elsevier Inc. All rights reserved.

Critical Care Health Informatics Collaborative (CCHIC): Data, tools and methods for reproducible research: A multi-centre UK intensive care database.

PubMed

Harris, Steve; Shi, Sinan; Brealey, David; MacCallum, Niall S; Denaxas, Spiros; Perez-Suarez, David; Ercole, Ari; Watkinson, Peter; Jones, Andrew; Ashworth, Simon; Beale, Richard; Young, Duncan; Brett, Stephen; Singer, Mervyn

2018-04-01

To build and curate a linkable multi-centre database of high resolution longitudinal electronic health records (EHR) from adult Intensive Care Units (ICU). To develop a set of open-source tools to make these data 'research ready' while protecting patient's privacy with a particular focus on anonymisation. We developed a scalable EHR processing pipeline for extracting, linking, normalising and curating and anonymising EHR data. Patient and public involvement was sought from the outset, and approval to hold these data was granted by the NHS Health Research Authority's Confidentiality Advisory Group (CAG). The data are held in a certified Data Safe Haven. We followed sustainable software development principles throughout, and defined and populated a common data model that links to other clinical areas. Longitudinal EHR data were loaded into the CCHIC database from eleven adult ICUs at 5 UK teaching hospitals. From January 2014 to January 2017, this amounted to 21,930 and admissions (18,074 unique patients). Typical admissions have 70 data-items pertaining to admission and discharge, and a median of 1030 (IQR 481-2335) time-varying measures. Training datasets were made available through virtual machine images emulating the data processing environment. An open source R package, cleanEHR, was developed and released that transforms the data into a square table readily analysable by most statistical packages. A simple language agnostic configuration file will allow the user to select and clean variables, and impute missing data. An audit trail makes clear the provenance of the data at all times. Making health care data available for research is problematic. CCHIC is a unique multi-centre longitudinal and linkable resource that prioritises patient privacy through the highest standards of data security, but also provides tools to clean, organise, and anonymise the data. We believe the development of such tools are essential if we are to meet the twin requirements of respecting patient privacy and working for patient benefit. The CCHIC database is now in use by health care researchers from academia and industry. The 'research ready' suite of data preparation tools have facilitated access, and linkage to national databases of secondary care is underway. Copyright © 2018 Elsevier B.V. All rights reserved.

Implementing healthy lifestyle promotion in primary care: a quasi-experimental cross-sectional study evaluating a team initiative.

PubMed

Thomas, Kristin; Krevers, Barbro; Bendtsen, Preben

2015-01-22

Non-communicable diseases are a leading cause of death and can largely be prevented by healthy lifestyles. Health care organizations are encouraged to integrate healthy lifestyle promotion in routine care. This study evaluates the impact of a team initiative on healthy lifestyle promotion in primary care. A quasi-experimental, cross-sectional design compared three intervention centres that had implemented lifestyle teams with three control centres that used a traditional model of care. Outcomes were defined using the RE-AIM framework: reach, the proportion of patients receiving lifestyle promotion; effectiveness, self-reported attitudes and competency among staff; adoption, proportion of staff reporting regular practice of lifestyle promotion; implementation, fidelity to the original lifestyle team protocol. Data collection methods included a patient questionnaire (n = 888), a staff questionnaire (n = 120) and structured interviews with all practice managers and, where applicable, team managers (n = 8). The chi square test and problem-driven content analysis was used to analyse the questionnaire and interview data, respectively. Reach: patients at control centres (48%, n = 211) received lifestyle promotion significantly more often compared with patients at intervention centres (41%, n = 169). Effectiveness: intervention staff was significantly more positive towards the effectiveness of lifestyle promotion, shared competency and how lifestyle promotion was prioritized at their centre. Adoption: 47% of staff at intervention centres and 58% at control centres reported that they asked patients about their lifestyle on a daily basis. all intervention centres had implemented multi-professional teams and team managers and held regular meetings but struggled to implement in-house referral structures for lifestyle promotion, which was used consistently among staff. Intervention centres did not show higher rates than control centres on reach of patients or adoption among staff at this stage. All intervention centres struggled to implement working referral structures for lifestyle promotion. Intervention centres were more positive on effectiveness outcomes, attitudes and competency among staff, however. Thus, lifestyle teams may facilitate lifestyle promotion practice in terms of increased responsiveness among staff, illustrated by positive attitudes and perceptions of shared competency. More research is needed on lifestyle promotion referral structures in primary care regarding their configuration and implementation.

The burden of endometriosis: costs and quality of life of women with endometriosis and treated in referral centres.

PubMed

Simoens, Steven; Dunselman, Gerard; Dirksen, Carmen; Hummelshoj, Lone; Bokor, Attila; Brandes, Iris; Brodszky, Valentin; Canis, Michel; Colombo, Giorgio Lorenzo; DeLeire, Thomas; Falcone, Tommaso; Graham, Barbara; Halis, Gülden; Horne, Andrew; Kanj, Omar; Kjer, Jens Jørgen; Kristensen, Jens; Lebovic, Dan; Mueller, Michael; Vigano, Paola; Wullschleger, Marcel; D'Hooghe, Thomas

2012-05-01

This study aimed to calculate costs and health-related quality of life of women with endometriosis-associated symptoms treated in referral centres. A prospective, multi-centre, questionnaire-based survey measured costs and quality of life in ambulatory care and in 12 tertiary care centres in 10 countries. The study enrolled women with a diagnosis of endometriosis and with at least one centre-specific contact related to endometriosis-associated symptoms in 2008. The main outcome measures were health care costs, costs of productivity loss, total costs and quality-adjusted life years. Predictors of costs were identified using regression analysis. Data analysis of 909 women demonstrated that the average annual total cost per woman was €9579 (95% confidence interval €8559-€10 599). Costs of productivity loss of €6298 per woman were double the health care costs of €3113 per woman. Health care costs were mainly due to surgery (29%), monitoring tests (19%) and hospitalization (18%) and physician visits (16%). Endometriosis-associated symptoms generated 0.809 quality-adjusted life years per woman. Decreased quality of life was the most important predictor of direct health care and total costs. Costs were greater with increasing severity of endometriosis, presence of pelvic pain, presence of infertility and a higher number of years since diagnosis. Our study invited women to report resource use based on endometriosis-associated symptoms only, rather than drawing on a control population of women without endometriosis. Our study showed that the economic burden associated with endometriosis treated in referral centres is high and is similar to other chronic diseases (diabetes, Crohn's disease, rheumatoid arthritis). It arises predominantly from productivity loss, and is predicted by decreased quality of life.

International differences in sport medicine access and clinical management

PubMed Central

Heron, Neil; Malliaropoulos, Nikolaos G.

2012-01-01

Summary I undertook the 2012 ECOSEP travelling fellowship, sponsored by Bauerfeind, between May and August 2012, which involved visiting 5 European sport medicine centres and spending approximately one week in each centre. The 5 centres included: National Track and Field Centre, SEGAS, Thessaloniki, Greece; Professional School in Sport & Exercise Medicine, University of Barcelona, Spain; Sport Medicine Frankfurt Institute, Germany; Isokinetic Medical Group, FIFA Medical Centre of Excellence, Bologna, Italy, and Centre for Sports and Exercise Medicine, Barts and the London School of Medicine and Dentistry, Mile End Hospital, England. Throughout the fellowship, the clinical cases which were routinely encountered were documented. The following sections detail my experiences throughout the fellowship, the sports of the athletes and the injuries which were treated at each of the sport medicine centres during the fellowship visit and the different forms of management employed. PMID:23738305

Long term outcomes data for the Burns Registry of Australia and New Zealand: Is it feasible?

PubMed

Gabbe, Belinda J; Cleland, Heather; Watterson, Dina M; Schrale, Rebecca; McRae, Sally; Parker, Christine; Taggart, Susan; Edgar, Dale W

2015-12-01

Incorporating routine and standardised collection of long term outcomes following burn into burn registries would improve the capacity to quantify burn burden and evaluate care. To evaluate methods for collecting the long term functional and quality of life outcomes of burns patients and establish the feasibility of implementing these outcomes into a multi-centre burns registry. Five Burns Registry of Australia and New Zealand (BRANZ) centres participated in this prospective, longitudinal study. Patients admitted to the centres between November 2009 and November 2010 were followed-up at 1, 6, 12 and 24-months after injury using measures of burn specific health, health status, fatigue, itch and return to work. Participants in the study were compared to BRANZ registered patients at the centres over the study timeframe to identify participation bias, predictors of successful follow-up were established using a Generalised Estimating Equation model, and the completion rates by mode of administration were assessed. 463 patients participated in the study, representing 24% of all BRANZ admissions in the same timeframe. Compared to all BRANZ patients in the same timeframe, the median %TBSA and hospital length of stay was greater in the study participants. The follow-up rates were 63% at 1-month, 47% at 6-months; 40% at 12-months, and 21% at 24-months after injury, and there was marked variation in follow-up rates between the centres. Increasing age, greater %TBSA and opt-in centres were associated with greater follow-up. Centres which predominantly used one mode of administration experienced better follow-up rates. The low participation rates, high loss to follow-up and responder bias observed indicate that greater consideration needs to be given to alternative models for follow-up, including tailoring the follow-up protocol to burn severity or type. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

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.

A Journey toward Excellence: An Interview with Bruce M. Shore

ERIC Educational Resources Information Center

Henshon, Suzanna E.

2010-01-01

Bruce M. Shore is in his 39th year as a Professor of Educational Psychology in the Department of Educational and Counseling Psychology at McGill University in Montreal, Quebec, Canada, and Associate Director (McGill) of the multi-campus Centre for the Study of Learning and Performance. For 21 years he was jointly appointed as a member of the…

Role Play in Blended Learning: A Case Study Exploring the Impact of Story and Other Elements

ERIC Educational Resources Information Center

Dracup, Mary

2008-01-01

Role play is an increasingly popular technique in tertiary education, being student centred, constructivist and suitable for a range of subject areas. The choice of formats is wide open, with options ranging from the traditional face to face performance through to multi-user online computer games. Some teachers prefer to take advantage of features…

Functional Literacy Projects and Project Proposals: Selected Examples. A Special Study for the World Conference on Education for All (Thailand, March 5-9, 1990).

ERIC Educational Resources Information Center

Linder, Kjell

Part I of this report describes projects in progress in nine countries: Bangladesh (Mass Education through Small Local Organizations), China (Multi-purpose Adult Education Schools and Resource Centres), Ethiopia (Literacy and Post-Literacy Programme), Jamaica (Jamaican Movement for the Advancement of Literacy), Nepal (Training for Vocational…

Pain responses of Pascal 20 ms multi-spot and 100 ms single-spot panretinal photocoagulation: Manchester Pascal Study, MAPASS report 2.

PubMed

Muqit, M M K; Marcellino, G R; Gray, J C B; McLauchlan, R; Henson, D B; Young, L B; Patton, N; Charles, S J; Turner, G S; Stanga, P E

2010-11-01

To evaluate pain responses following Pascal 20 ms multi-spot and 100 ms single-spot panretinal photocoagulation (PRP). Single-centre randomised clinical trial. 40 eyes of 24 patients with treatment-naive proliferative diabetic retinopathy randomised to 20 and 100 ms PRP under topical 0.4% oxybuprocaine. A masked grader used a pain questionnaire within 1 h (numerical pain score (NPS)) and 1 month after treatment (numerical headache score (NHS)). Primary outcome measure was NPS immediately post-PRP. Secondary outcome measures were mean NHS scores and levels of photophobia reported within 4 weeks of primary PRP. Mean laser fluence was significantly lower using 20 ms PRP (4.8 J/cm²) compared to 100 ms PRP (11.8 J/cm²); p < 0.001). Mean NPS scores for treatment were 2.4 (2.3) (mild) for 20 ms PRP group compared to 4.9 (3.3) (moderate) in 100 ms PRP group-a significant difference (95% CI 4.3 to 0.68; p = 0.006). Mean NHS score within 1 month was 1.5 (2.7) in 20 ms PRP group compared to 3.2 (3.5) in the 100 ms PRP group (p < 0.05). The median duration of photophobia after 20 ms PRP was 3 h, and significantly less compared to 100 ms PRP after which 72 h of photophobia was reported (p < 0.001). Multi-spot 20 ms PRP was associated with significantly lower levels of anxiety, headache, pain and photophobia compared to 100 ms single-spot PRP treatment. Possible reasons include lower fluence, shorter-pulse duration, and spatial summation of laser nociception with multi-spot Pascal technique.

The Cambridge Centre for Ageing and Neuroscience (Cam-CAN) data repository: Structural and functional MRI, MEG, and cognitive data from a cross-sectional adult lifespan sample.

PubMed

Taylor, Jason R; Williams, Nitin; Cusack, Rhodri; Auer, Tibor; Shafto, Meredith A; Dixon, Marie; Tyler, Lorraine K; Cam-Can; Henson, Richard N

2017-01-01

This paper describes the data repository for the Cambridge Centre for Ageing and Neuroscience (Cam-CAN) initial study cohort. The Cam-CAN Stage 2 repository contains multi-modal (MRI, MEG, and cognitive-behavioural) data from a large (approximately N=700), cross-sectional adult lifespan (18-87years old) population-based sample. The study is designed to characterise age-related changes in cognition and brain structure and function, and to uncover the neurocognitive mechanisms that support healthy cognitive ageing. The database contains raw and preprocessed structural MRI, functional MRI (active tasks and resting state), and MEG data (active tasks and resting state), as well as derived scores from cognitive behavioural experiments spanning five broad domains (attention, emotion, action, language, and memory), and demographic and neuropsychological data. The dataset thus provides a depth of neurocognitive phenotyping that is currently unparalleled, enabling integrative analyses of age-related changes in brain structure, brain function, and cognition, and providing a testbed for novel analyses of multi-modal neuroimaging data. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

A multi-centre qualitative study exploring the experiences of UK South Asian and white diabetic patients referred for renal care.

PubMed

Wilkinson, Emma; Randhawa, Gurch; Feehally, John; Farrington, Ken; Greenwood, Roger; Choi, Peter; Lightstone, Liz

2012-11-23

An exploration of renal complications of diabetes from the patient perspective is important for developing quality care through the diabetic renal disease care pathway. Newly referred South Asian and White diabetic renal patients over 16 years were recruited from nephrology outpatient clinics in three UK centres--Luton, West London and Leicester--and their experiences of the diabetes and renal care recorded.A semi-structured qualitative interview was conducted with 48 patients. Interview transcripts were analysed thematically and comparisons made between the White and South Asian groups. 23 South Asian patients and 25 White patients were interviewed. Patient experience of diabetes ranged from a few months to 35 years with a mean time since diagnosis of 12.1 years and 17.1 years for the South Asian and White patients respectively. Confusion emerged as a response to referral shared by both groups. This sense of confusion was associated with reported lack of information at the time of referral, but also before referral. Language barriers exacerbated confusion for South Asian patients. The diabetic renal patients who have been referred for specialist renal care and found the referral process confusing have poor of awareness of kidney complications of diabetes. Healthcare providers should be more aware of the ongoing information needs of long term diabetics as well as the context of any information exchange including language barriers.

Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial.

PubMed

Beadle, Roger M; Williams, Lynne K; Abozguia, Khaild; Patel, Kiran; Leon, Francisco Leyva; Yousef, Zaheer; Wagenmakers, Anton; Frenneaux, Michael P

2011-06-06

Heart failure is a major cause of morbidity and mortality in society. Current medical therapy centres on neurohormonal modulation with angiotensin converting enzyme inhibitors and β-blockers. There is growing evidence for the use of metabolic manipulating agents as adjunctive therapy in patients with heart failure. We aim to determine the effect of perhexiline on cardiac energetics and alterations in substrate utilisation in patients with non-ischaemic dilated cardiomyopathy. A multi-centre, prospective, randomised double-blind, placebo-controlled trial of 50 subjects with non-ischaemic dilated cardiomyopathy recruited from University Hospital Birmingham NHS Foundation Trust and Cardiff and Vale NHS Trust. Baseline investigations include magnetic resonance spectroscopy to assess cardiac energetic status, echocardiography to assess left ventricular function and assessment of symptomatic status. Subjects are then randomised to receive 200 mg perhexiline maleate or placebo daily for 4 weeks with serum drug level monitoring. All baseline investigations will be repeated at the end of the treatment period. A subgroup of patients will undergo invasive investigations with right and left heart catheterisation to calculate respiratory quotient, and mechanical efficiency. The primary endpoint is an improvement in the phosphocreatine to adenosine triphosphate ratio at 4 weeks. Secondary end points are: i) respiratory quotient; ii) mechanical efficiency; iii) change in left ventricular (LV) function. ClinicalTrials.gov: NCT00841139 ISRCTN: ISRCTN72887836.

Influence of fibre design and curvature on crosstalk in multi-core fibre

DOE Office of Scientific and Technical Information (OSTI.GOV)

Egorova, O N; Astapovich, M S; Semjonov, S L

2016-03-31

We have studied the influence of cross-sectional structure and bends on optical cross-talk in a multicore fibre. A reduced refractive index layer produced between the cores of such fibre with a small centre-to-centre spacing between neighbouring cores (27 μm) reduces optical cross-talk by 20 dB. The cross-talk level achieved, 30 dB per kilometre of the length of the multicore fibre, is acceptable for a number of applications where relatively small lengths of fibre are needed. Moreover, a significant decrease in optical cross-talk has been ensured by reducing the winding diameter of multicore fibres with identical cores. (fiber optics)

Cooperative Working towards Family-Centred Health Education in Acute Care: Improvement in Client Satisfaction

ERIC Educational Resources Information Center

Bastani, Farideh; Golaghaie, Farzaneh; Farahani, Mansoureh A.; Rafeie, Mohammad

2014-01-01

Objective: To establish family-centred health education for patients in a neurosurgery unit and to evaluate its impact on patients' and families' satisfaction. Design: Cooperative participatory research through which a group of clinical nurses and an academic researcher engaged in cycles of action and reflection. Setting: The study was conducted…

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.

Automatic Clustering Using Multi-objective Particle Swarm and Simulated Annealing

PubMed Central

Abubaker, Ahmad; Baharum, Adam; Alrefaei, Mahmoud

2015-01-01

This paper puts forward a new automatic clustering algorithm based on Multi-Objective Particle Swarm Optimization and Simulated Annealing, “MOPSOSA”. The proposed algorithm is capable of automatic clustering which is appropriate for partitioning datasets to a suitable number of clusters. MOPSOSA combines the features of the multi-objective based particle swarm optimization (PSO) and the Multi-Objective Simulated Annealing (MOSA). Three cluster validity indices were optimized simultaneously to establish the suitable number of clusters and the appropriate clustering for a dataset. The first cluster validity index is centred on Euclidean distance, the second on the point symmetry distance, and the last cluster validity index is based on short distance. A number of algorithms have been compared with the MOPSOSA algorithm in resolving clustering problems by determining the actual number of clusters and optimal clustering. Computational experiments were carried out to study fourteen artificial and five real life datasets. PMID:26132309

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

PubMed

Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

2011-01-01

New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

PubMed Central

Walden, Anita; Nahm, Meredith; Barnett, M. Edwina; Conde, Jose G.; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E.; Eisenstein, Eric L.

2012-01-01

Background New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. Methods We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. Main Outcome Measures The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Results Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Conclusion Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs. PMID:21335692

Operational Efficiency of an Immunization Clinic Attached to Rural Health Training Centre in Delhi, India: A Time and Motion Study

PubMed Central

Kumar, Varun; Mangal, Abha; Panesar, Sanjeet; Yadav, Geeta; Talwar, Richa; Raut, Deepak; Singh, Saudan

2014-01-01

Background. Obtaining baseline data about current patterns of work is important for assessing the effects of interventions designed to improve care delivery. Time and motion studies allow for the most accurate measurement of structured components. Therefore, the present study was conducted to study the operational efficiency of an immunization clinic in Delhi, India. Methods. An observational cross-sectional study was conducted at the immunization clinic of Rural Health Training Centre in Delhi, India, from January 2014 to March 2014. The study composed two stage evaluations, a passive observation and a time and motion study. Systemic random sampling method was used to select 863 mothers/caregivers attending the immunization clinic. Results. At the immunization clinic, the study participants spent 64.1% of their total time in waiting. For new cases, the mean time taken for initial registration and receiving postvaccination advice was found to be significantly longer than old cases. Delivering health care services took more time during Mondays and also during the first hour of the day. Conclusion. Results of this study will guide public health decision-makers at all government levels in planning and implementation of immunization programs in developing countries. PMID:25431679

Mortality associated with heart failure with preserved vs. reduced ejection fraction in a prospective international multi-ethnic cohort study.

PubMed

Lam, Carolyn S P; Gamble, Greg D; Ling, Lieng H; Sim, David; Leong, Kui Toh Gerard; Yeo, Poh Shuan Daniel; Ong, Hean Yee; Jaufeerally, Fazlur; Ng, Tze P; Cameron, Vicky A; Poppe, Katrina; Lund, Mayanna; Devlin, Gerry; Troughton, Richard; Richards, A Mark; Doughty, Robert N

2018-05-21

Whether prevalence and mortality of patients with heart failure with preserved or mid-range (40-49%) ejection fraction (HFpEF and HFmREF) are similar to those of heart failure with reduced ejection fraction (HFrEF), as reported in some epidemiologic studies, remains highly controversial. We determined and compared characteristics and outcomes for patients with HFpEF, HFmREF, and HFrEF in a prospective, international, multi-ethnic population. Prospective multi-centre longitudinal study in New Zealand (NZ) and Singapore. Patients with HF were assessed at baseline and followed over 2 years. The primary outcome was death from any cause. Secondary outcome was death and HF hospitalization. Cox proportional hazards models were used to compare outcomes for patients with HFpEF, HFmrEF, and HFrEF. Of 2039 patients enrolled, 28% had HFpEF, 13% HFmrEF, and 59% HFrEF. Compared with HFrEF, patients with HFpEF were older (62 vs. 72 years), more commonly female (17% vs. 48%), and more likely to have a history of hypertension (61% vs. 78%) but less likely to have coronary artery disease (55% vs. 41%). During 2 years of follow-up, 343 (17%) patients died. Adjusting for age, sex, and clinical risk factors, patients with HFpEF had a lower risk of death compared with those with HFrEF (hazard ratio 0.62, 95% confidence interval 0.46-0.85). Plasma (NT-proBNP) was similarly related to mortality in both HFpEF, HFmrEF, and HFrEF independent of the co-variates listed and of ejection fraction. Results were similar for the composite endpoint of death or HF and were consistent between Singapore and NZ. These prospective multinational data showed that the prevalence of HFpEF within the HF population was lower than HFrEF. Death rate was comparable in HFpEF and HFmrEF and lower than in HFrEF. Plasma levels of NT-proBNP were independently and similarly predictive of death in the three HF phenotypes. Australian New Zealand Clinical Trial Registry (ACTRN12610000374066).

Mindfulness based cognitive therapy versus treatment as usual in adults with attention deficit hyperactivity disorder (ADHD).

PubMed

Janssen, Lotte; Kan, Cornelis C; Carpentier, Pieter J; Sizoo, Bram; Hepark, Sevket; Grutters, Janneke; Donders, Rogier; Buitelaar, Jan K; Speckens, Anne E M

2015-09-15

Adults with attention deficit hyperactivity disorder (ADHD) often present with a lifelong pattern of core symptoms that is associated with impairments of functioning in daily life. This has a substantial personal and economic impact. In clinical practice there is a high need for additional or alternative interventions for existing treatments, usually consisting of pharmacotherapy and/or psycho-education. Although previous studies show preliminary evidence for the effectiveness of mindfulness-based interventions in reducing ADHD symptoms and improving executive functioning, these studies have methodological limitations. This study will take account of these limitations and will examine the effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in further detail. A multi-centre, parallel-group, randomised controlled trial will be conducted in N = 120 adults with ADHD. Patients will be randomised to MBCT in addition to treatment as usual (TAU) or TAU alone. Assessments will take place at baseline and at three, six and nine months after baseline. Primary outcome measure will be severity of ADHD symptoms rated by a blinded clinician. Secondary outcome measures will be self-reported ADHD symptoms, executive functioning, mindfulness skills, self-compassion, positive mental health and general functioning. In addition, a cost-effectiveness analysis will be conducted. This trial will offer valuable information about the clinical and cost-effectiveness of MBCT in addition to TAU compared to TAU alone in adults swith ADHD. ClinicalTrials.gov NCT02463396. Registered 8 June 2015.

Practice patterns of image guided particle therapy in Europe: A 2016 survey of the European Particle Therapy Network (EPTN).

PubMed

Bolsi, Alessandra; Peroni, Marta; Amelio, Dante; Dasu, Alexandru; Stock, Markus; Toma-Dasu, Iuliana; Nyström, Petra Witt; Hoffmann, Aswin

2018-03-28

Image guidance is critical in achieving accurate and precise radiation delivery in particle therapy, even more than in photon therapy. However, equipment, quality assurance procedures and clinical workflows for image-guided particle therapy (IGPT) may vary substantially between centres due to a lack of standardization. A survey was conducted to evaluate the current practice of IGPT in European particle therapy centres. In 2016, a questionnaire was distributed among 19 particle therapy centres in 12 European countries. The questionnaire consisted of 30 open and 37 closed questions related to image guidance in the general clinical workflow, for moving targets, current research activities and future perspectives of IGPT. All centres completed the questionnaire. The IGPT methods used by the 10 treating centres varied substantially. The 9 non-treating centres were in the process to introduce IGPT. Most centres have developed their own IGPT strategies, being tightly connected to their specific technical implementation and dose delivery methods. Insight into the current clinical practice of IGPT in European particle therapy centres was obtained. A variety in IGPT practices and procedures was confirmed, which underlines the need for harmonisation of practice parameters and consensus guidelines. Copyright © 2018 Elsevier B.V. All rights reserved.

A certification/accreditation model for Haemophilia Centres in Italy

PubMed Central

Mannucci, Pier Mannuccio; Menichini, Ivana

2014-01-01

Background The Italian Association of Haemophilia Centres has developed a voluntary programme of professional accreditation of Haemophilia Centres, run by its members. Participation in the programme, which aims to foster staff involvement in clinical governance, includes both medical personnel and nurses. Materials and methods Accreditation is awarded provided the candidate Haemophilia Centre is able to adhere to a pre-established set of quality standards and meet a number of clinical and organisational requirements, previously defined on the basis of evidence-based medicine. Self-evaluation is the first step in the programme, followed by a site visit by a team of peer professionals experienced in quality auditing. Results The programme has so far involved 21 Italian Haemophilia Centres. The comparison between self- and peer-evaluation revealed less discrepancies for disease-related than for organisational requirements, the latter being met to a lesser degree by most Haemophilia Centres. Discussion This programme of professional accreditation developed by the Italian Association of Haemophilia Centres has the potential to describe, monitor and improve clinical and organisational performances in the management of patients with haemophilia and allied inherited coagulation disorders. It should also be seen as a contribution to the implementation of the strategy for improving professional governance in Haemophilia Centres. PMID:24922289

High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab - a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO).

PubMed

Ylisaukko-Oja, Tero; Aaltonen, Jaakko; Nuutinen, Heikki; Blomster, Timo; Jussila, Airi; Pajala, Markku; Salminen, Kimmo; Moilanen, Veikko; Hakala, Kalle; Kellokumpu, Mikko; Toljamo, Kari; Rautiainen, Henna; Kuisma, Juha; Peräaho, Markku; Molander, Pauliina; Silvennoinen, Jouni; Liukkonen, Ville; Henricson, Hans; Tillonen, Jyrki; Esterinen, Mirva; Nielsen, Christian; Hirsi, Eija; Lääne, Margus; Suhonen, Ulla-Maija; Vihriälä, Ilkka; Mäkelä, Petri; Puhto, Mika; Punkkinen, Jari; Sulonen, Hannu; Herrala, Sauli; Jokelainen, Jari; Tamminen, Klaus; Sipponen, Taina

2018-02-01

The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn's disease (CD) and ulcerative colitis (UC) patients. This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation. A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=-5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =-0.5, p = .003) at month 6. Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

Severe and moderate haemophilia A and B in US females.

PubMed

Di Michele, D M; Gibb, C; Lefkowitz, J M; Ni, Q; Gerber, L M; Ganguly, A

2014-03-01

Haemophilia A and B are rare X-lined hemorrhagic disorders that typically affect men. Women are usually asymptomatic carriers, but may be symptomatic and, rarely, also express severe (factor VIII (FVIII) or factor IX (FIX) <0.01 U mL(-1)) or moderately severe (FVIII/FIX 0.01-0.05 U mL(-1)) phenotypes. However, data on clinical manifestations, genotype and the psychosocial ramifications of illness in severely affected females remain anecdotal. A national multi-centre retrospective study was conducted to collect a comprehensive data set on affected US girls and women, and to compare clinical observations to previously published information on haemophilic males of comparable severity and mildly affected haemophilic females. Twenty-two severe/moderate haemophilia A/B subjects were characterized with respect to clinical manifestations and disease complications; genetic determinants of phenotypic severity; and health-related quality of life (HR-QoL). Clinical data were compared as previously indicated. Female patients were older than male patients at diagnosis, but similarly experienced joint haemorrhage, disease- and treatment-related complications and access to treatment. Gynaecological and obstetrical bleeding was unexpectedly infrequent. F8 or F9 mutations, accompanied by extremely skewed X-chromosome inactivation pattern (XIP), were primary determinants of severity. HR-QoL was diminished by arthropathy and viral infection. Using systematic case verification of participants in a national surveillance registry, this study elucidated the genetics, clinical phenotype and quality of life issues in female patients with severe/moderate haemophilia. An ongoing international case-controlled study will further evaluate these observations. Novel mechanistic questions are raised about the relationship between XIP and both age and tissue-specific FVIII and FIX expression. © 2014 John Wiley & Sons Ltd.

A multi-frequency analysis of possible dark matter contributions to M31 gamma-ray emissions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beck, G.; Colafrancesco, S., E-mail: geoffrey.beck@wits.ac.za, E-mail: sergio.colafrancesco@wits.ac.za

We examine the possibility of a dark matter (DM) contribution to the recently observed gamma-ray spectrum seen in the M31 galaxy. In particular, we apply limits on Weakly Interacting Massive Particle DM annihilation cross-sections derived from the Coma galaxy cluster and the Reticulum II dwarf galaxy to determine the maximal flux contribution by DM annihilation to both the M31 gamma-ray spectrum and that of the Milky-Way Galactic Centre. We limit the energy range between 1 and 12 GeV in M31 and Galactic Centre spectra due to the limited range of former's data, as well as to encompass the high-energy gamma-raymore » excess observed in the latter target. In so doing, we will make use of Fermi-LAT data for all mentioned targets, as well as diffuse radio data for the Coma cluster. The multi-target strategy using both Coma and Reticulum II to derive cross-section limits, as well as multi-frequency data, ensures that our results are robust against the various uncertainties inherent in modelling of indirect DM emissions. Our results indicate that, when a Navarro-Frenk-White (or shallower) radial density profile is assumed, severe constraints can be imposed upon the fraction of the M31 and Galactic Centre spectra that can be accounted for by DM, with the best limits arising from cross-section constraints from Coma radio data and Reticulum II gamma-ray limits. These particular limits force all the studied annihilation channels to contribute 1% or less to the total integrated gamma-ray flux within both M31 and Galactic Centre targets. In contrast, considerably more, 10−100%, of the flux can be attributed to DM when a contracted Navarro-Frenk-White profile is assumed. This demonstrates how sensitive DM contributions to gamma-ray emissions are to the possibility of cored profiles in galaxies. The only channel consistently excluded for all targets and profiles (except for ∼ 10 GeV WIMPs) is the direct annihilation into photons. Finally, we discuss the ramifications of evidence in favour of cored halo density profiles for DM explanations of galactic gamma-ray emission.« less

A radial map of multi-whisker correlation selectivity in the rat barrel cortex

PubMed Central

Estebanez, Luc; Bertherat, Julien; Shulz, Daniel E.; Bourdieu, Laurent; Léger, Jean- François

2016-01-01

In the barrel cortex, several features of single-whisker stimuli are organized in functional maps. The barrel cortex also encodes spatio-temporal correlation patterns of multi-whisker inputs, but so far the cortical mapping of neurons tuned to such input statistics is unknown. Here we report that layer 2/3 of the rat barrel cortex contains an additional functional map based on neuronal tuning to correlated versus uncorrelated multi-whisker stimuli: neuron responses to uncorrelated multi-whisker stimulation are strongest above barrel centres, whereas neuron responses to correlated and anti-correlated multi-whisker stimulation peak above the barrel–septal borders, forming rings of multi-whisker synchrony-preferring cells. PMID:27869114

A radial map of multi-whisker correlation selectivity in the rat barrel cortex.

PubMed

Estebanez, Luc; Bertherat, Julien; Shulz, Daniel E; Bourdieu, Laurent; Léger, Jean-François

2016-11-21

In the barrel cortex, several features of single-whisker stimuli are organized in functional maps. The barrel cortex also encodes spatio-temporal correlation patterns of multi-whisker inputs, but so far the cortical mapping of neurons tuned to such input statistics is unknown. Here we report that layer 2/3 of the rat barrel cortex contains an additional functional map based on neuronal tuning to correlated versus uncorrelated multi-whisker stimuli: neuron responses to uncorrelated multi-whisker stimulation are strongest above barrel centres, whereas neuron responses to correlated and anti-correlated multi-whisker stimulation peak above the barrel-septal borders, forming rings of multi-whisker synchrony-preferring cells.

European hospital managers' perceptions of patient-centred care.

PubMed

Taylor, Angelina; Groene, Oliver

2015-01-01

The spotlight has recently been placed on managers' responsibility for patient-centred care as a result of Mid Staffordshire NHS Foundation Trust failings. In previous research, clinicians reported that managers do not have an adequate structured plan for implementing patient-centred care. The purpose of this paper is to assess the perceptions of European hospital management with respect to factors affecting the implementation of a patient-centred approach. In total, 15 semi-structured interviews were conducted with hospital managers (n=10), expert country informants (n=2), patient organisations (n=2) and a user representative (n=1) from around Europe. Participants were purposively and snowball sampled. Interviews were analysed using framework analysis. Most participants felt that current levels of patient-centred care are inadequate, but accounted that there were a number of macro, meso and micro challenges they faced in implementing this approach. These included budget constraints, political and historical factors, the resistance of clinicians and other frontline staff. Organisational culture emerged as a central theme, shaped by these multi-level factors and influencing the way in which patient-centred care was borne out in the hospital. Participants proposed that the needs of patients might be better met through increasing advocacy by patient organisations and greater staff contact with patients. This study is the first of its kind to obtain management views from around Europe. It offers an insight into different models of how patient-centred care is realised by management. It indicates that managers see the value of a patient-centred approach but that they feel restricted by a number of factors at multiple levels.

Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate

PubMed Central

2013-01-01

Background Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the ‘vigilance regulation model of mania’ which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania. Methods/design A multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18 years will be randomised to treatment with either methylphenidate (20 to 40 mg/day) or placebo for 2.5 days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5 days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression–Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-‘Vigilance Algorithm Leipzig’ (VIGALL). Discussion A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives. Trial registration ClinicalTrials.gov: NCT 01541605 PMID:23446109

Regional Workshop on Strengthening Linkages and Networks through Community Learning Centres (CLCs) (Bandung, Indonesia, September 5-9, 2005)

ERIC Educational Resources Information Center

Online Submission, 2006

2006-01-01

The Community Learning Centre (CLC) Project has been carried out since 1998 within the framework of the Asia Pacific Program of Education for All (APPEAL). CLC is a multi-purpose learning center that serves as a local venue for adults, youth and children to engage in all kinds of learning. After a few years' implementation, some countries have…

Open pre-schools at integrated health services-A program theory.

PubMed

Abrahamsson, Agneta; Samarasinghe, Kerstin

2013-04-01

Family centres in Sweden are integrated services that reach all prospective parents and parents with children up to their sixth year, because of the co-location of the health service with the social service and the open pre-school. The personnel on the multi-professional site work together to meet the needs of the target group. The article explores a program theory focused on the open pre-schools at family centres. A multi-case design is used and the sample consists of open pre-schools at six family centres. The hypothesis is based on previous research and evaluation data. It guides the data collection which is collected and analysed stepwise. Both parents and personnel are interviewed individually and in groups at each centre. The hypothesis was expanded to a program theory. The compliance of the professionals was the most significant element that explained why the open access service facilitated positive parenting. The professionals act in a compliant manner to meet the needs of the children and parents as well as in creating good conditions for social networking and learning amongst the parents. The compliance of the professionals in this program theory of open pre-schools at family centres can be a standard in integrated and open access services, whereas the organisation form can vary. The best way of increasing the number of integrative services is to support and encourage professionals that prefer to work in a compliant manner.

Prospective, Multi-Centre, Single-Arm Study of Mechanical Thrombectomy using Solitaire FR in Acute Ischemic Stroke-STAR

PubMed Central

Pereira, Vitor M; Gralla, Jan; Davalos, Antoni; Bonafé, Alain; Castaño, Carlos; Chapot, Rene; Liebeskind, David S; Nogueira, Raul G; Arnold, Marcel; Sztajzel, Roman; Liebig, Thomas; Goyal, Mayank; Besselmann, Michael; Moreno, Alfredo; Schroth, Gerhard

2013-01-01

Background and Purpose Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire FR in patients with acute ischemic stroke. Methods STAR was an international, multicenter, prospective, single-arm study of Solitaire FR thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary endpoint was the revascularization rate (3TICI 2b) of the occluded vessel as determined by an independent core lab. The secondary endpoint was the rate of good functional outcome (defined as 90-day modified Rankin scale (mRS) 0–2). Results A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale (NIHSS) was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and/or procedure related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions In this single arm study, treatment with the Solitaire™ FR device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration This study is registered with ClinicalTrials.gov, number NCT01327989. PMID:23908066

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.

Characterisation of the opposing effects of G6PD deficiency on cerebral malaria and severe malarial anaemia

PubMed Central

Clarke, Geraldine M; Rockett, Kirk; Kivinen, Katja; Hubbart, Christina; Jeffreys, Anna E; Rowlands, Kate; Jallow, Muminatou; Conway, David J; Bojang, Kalifa A; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D; Bougouma, Edith C; Sirima, Sodiomon B; Modiano, David; Amenga-Etego, Lucas N; Ghansah, Anita; Koram, Kwadwo A; Wilson, Michael D; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi K; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N; Manjurano, Alphaxard; Sepúlveda, Nuno; Clark, Taane G; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J; Phu, Nguyen Hoan; Quyen, Nguyen Ngoc; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy ME; Michon, Pascal; Mueller, Ivo; Molloy, Síle F; Campino, Susana; Kerasidou, Angeliki; Cornelius, Victoria J; Hart, Lee; Shah, Shivang S; Band, Gavin; Spencer, Chris CA; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara K; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P

2017-01-01

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is believed to confer protection against Plasmodium falciparum malaria, but the precise nature of the protective effect has proved difficult to define as G6PD deficiency has multiple allelic variants with different effects in males and females, and it has heterogeneous effects on the clinical outcome of P. falciparum infection. Here we report an analysis of multiple allelic forms of G6PD deficiency in a large multi-centre case-control study of severe malaria, using the WHO classification of G6PD mutations to estimate each individual’s level of enzyme activity from their genotype. Aggregated across all genotypes, we find that increasing levels of G6PD deficiency are associated with decreasing risk of cerebral malaria, but with increased risk of severe malarial anaemia. Models of balancing selection based on these findings indicate that an evolutionary trade-off between different clinical outcomes of P. falciparum infection could have been a major cause of the high levels of G6PD polymorphism seen in human populations. DOI: http://dx.doi.org/10.7554/eLife.15085.001 PMID:28067620

GIFT-Cloud: A data sharing and collaboration platform for medical imaging research.

PubMed

Doel, Tom; Shakir, Dzhoshkun I; Pratt, Rosalind; Aertsen, Michael; Moggridge, James; Bellon, Erwin; David, Anna L; Deprest, Jan; Vercauteren, Tom; Ourselin, Sébastien

2017-02-01

Clinical imaging data are essential for developing research software for computer-aided diagnosis, treatment planning and image-guided surgery, yet existing systems are poorly suited for data sharing between healthcare and academia: research systems rarely provide an integrated approach for data exchange with clinicians; hospital systems are focused towards clinical patient care with limited access for external researchers; and safe haven environments are not well suited to algorithm development. We have established GIFT-Cloud, a data and medical image sharing platform, to meet the needs of GIFT-Surg, an international research collaboration that is developing novel imaging methods for fetal surgery. GIFT-Cloud also has general applicability to other areas of imaging research. GIFT-Cloud builds upon well-established cross-platform technologies. The Server provides secure anonymised data storage, direct web-based data access and a REST API for integrating external software. The Uploader provides automated on-site anonymisation, encryption and data upload. Gateways provide a seamless process for uploading medical data from clinical systems to the research server. GIFT-Cloud has been implemented in a multi-centre study for fetal medicine research. We present a case study of placental segmentation for pre-operative surgical planning, showing how GIFT-Cloud underpins the research and integrates with the clinical workflow. GIFT-Cloud simplifies the transfer of imaging data from clinical to research institutions, facilitating the development and validation of medical research software and the sharing of results back to the clinical partners. GIFT-Cloud supports collaboration between multiple healthcare and research institutions while satisfying the demands of patient confidentiality, data security and data ownership. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Epidemiological and clinical characteristics of inflammatory bowel diseases in Cairo, Egypt.

PubMed

Esmat, Serag; El Nady, Mohamed; Elfekki, Mohamed; Elsherif, Yehia; Naga, Mazen

2014-01-21

To study the natural history, patterns and clinical characteristics of inflammatory bowel diseases (IBD) in Egypt. We designed a case-series study in the gastroenterology centre of the Internal Medicine department of Cairo University, which is a tertiary care referral centre in Egypt. We included all patients in whom the diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) was confirmed by clinical, laboratory, endoscopic, histological and/or radiological criteria over the 15 year period from 1995 to 2009, and we studied their sociodemographic and clinical characteristics. Endoscopic examinations were performed by 2 senior experts. This hospital centre serves patients from Cairo, as well as patients referred from all other parts of Egypt. Our centre received 24156 patients over the described time period for gastro-intestinal consultations and/or interventions. A total of 157 patients with established IBD were included in this study. Of these, 135 patients were diagnosed with UC (86% of the total), and 22 patients, with CD (14% of the total). The mean ages at diagnosis were 27.3 and 29.7, respectively. Strikingly, we noticed a marked increase in the frequency of both UC and CD diagnoses during the most recent 10 years of the 15 year period studied. Regarding the gender distribution, the male:female ratio was 1:1.15 for UC and 2.6:1 for CD. The mean duration of follow up for patients with UC was 6.2 ± 5.18 years, while the mean duration of follow up for patients with CD was 5.52 ± 2.83 years. For patients with UC we found no correlation between the severity of the disease and the presence of extraintestinal manifestations. Eleven patients had surgical interventions during the studied years: 4 cases of total colectomy and 7 cases of anal surgery. We observed a ratio of 6:1 for UC to CD in our series. The incidence of IBD seems to be rising in Egypt.

Epidemiological and clinical characteristics of inflammatory bowel diseases in Cairo, Egypt

PubMed Central

Esmat, Serag; El Nady, Mohamed; Elfekki, Mohamed; Elsherif, Yehia; Naga, Mazen

2014-01-01

AIM: To study the natural history, patterns and clinical characteristics of inflammatory bowel diseases (IBD) in Egypt. METHODS: We designed a case-series study in the gastroenterology centre of the Internal Medicine department of Cairo University, which is a tertiary care referral centre in Egypt. We included all patients in whom the diagnosis of ulcerative colitis (UC) or Crohn’s disease (CD) was confirmed by clinical, laboratory, endoscopic, histological and/or radiological criteria over the 15 year period from 1995 to 2009, and we studied their sociodemographic and clinical characteristics. Endoscopic examinations were performed by 2 senior experts. This hospital centre serves patients from Cairo, as well as patients referred from all other parts of Egypt. Our centre received 24156 patients over the described time period for gastro-intestinal consultations and/or interventions. RESULTS: A total of 157 patients with established IBD were included in this study. Of these, 135 patients were diagnosed with UC (86% of the total), and 22 patients, with CD (14% of the total). The mean ages at diagnosis were 27.3 and 29.7, respectively. Strikingly, we noticed a marked increase in the frequency of both UC and CD diagnoses during the most recent 10 years of the 15 year period studied. Regarding the gender distribution, the male:female ratio was 1:1.15 for UC and 2.6:1 for CD. The mean duration of follow up for patients with UC was 6.2 ± 5.18 years, while the mean duration of follow up for patients with CD was 5.52 ± 2.83 years. For patients with UC we found no correlation between the severity of the disease and the presence of extraintestinal manifestations. Eleven patients had surgical interventions during the studied years: 4 cases of total colectomy and 7 cases of anal surgery. CONCLUSION: We observed a ratio of 6:1 for UC to CD in our series. The incidence of IBD seems to be rising in Egypt. PMID:24574754

The safe and responsible disposal of unused controlled drugs.

PubMed

Ahmed, Iftikhar; Majeed, Amer

There are well-defined legal requirements for the safe storage, handling and disposal of controlled drugs (CDs): The Misuse of Drugs Act 1971, and Safer Management of Controlled Drugs (Department of Health, 2007). Clinical staff involved in the prescription and administration of CDs to patients are responsible and accountable for the appropriate disposal of these drugs because of the risk of substance abuse. A review of current practice, as followed by staff involved in the use and disposal of CDs, has been evaluated in a multi-centre audit. This audit showed that a wide variation in attitude towards disposal of CDs exists among medical and non-medical staff, and that the sample hospitals are falling short of meeting proposed standards.

Epidemiology and clinical features of patients with visceral leishmaniasis treated by an MSF clinic in Bakool region, Somalia, 2004-2006.

PubMed

Raguenaud, Marie-Eve; Jansson, Anna; Vanlerberghe, Veerle; Van der Auwera, Geert; Deborggraeve, Stijn; Dujardin, Jean-Claude; Orfanos, Giannos; Reid, Tony; Boelaert, Marleen

2007-10-31

There are few reports describing the epidemiology of visceral leishmaniasis (VL) in Somalia. Over the years 2002 to 2005, a yearly average of 140 patients were reported from the Huddur centre in Bakool region, whereas in 2006, this number rose to 1002 patients. Given the limited amount of information on VL and the opportunity to compare features with the studies done in 2000 in this part of Somalia, we describe the epidemiologic and clinical features of patients who presented to the Huddur treatment centre of Bakool region, Somalia, using data routinely collected over a five-year observation period (2002-2006). Methods used included the analysis of routine data on VL cases treated in the Huddur treatment centre, a retrospective study of records of patients admitted between 2004 and 2006, community leaders interviews, and analysis of blood specimens taken for parasite species identification in Antwerp Institute of Tropical Medicine. A total of 1671 VL patients were admitted to the Huddur centre from January 2002 until December 2006. Nearly all patients presented spontaneously to the health centre. Since 2002, the average patient load was stable, with an average of 140 admissions per year. By the end of 2005, the number of admissions dramatically increased to reach a 7-fold increase in 2006. The genotype of L. donovani identified in 2006 was similar to the one reported in 2002. 82% of total patients treated for VL originated from two districts of Bakool region, Huddur and Tijelow districts. Clinical recovery rate was 93.2% and case fatality rate 3.9%. After four years of low but constant VL case findings, a major increase in VL was observed over a 16-month period in the Huddur VL centre. The profile of the patients was pediatric and mortality relatively low. Decentralized treatment centers, targeted active screening, and community sensitization will help decrease morbidity and mortality from VL in this endemic area. The true magnitude of VL in Somalia remains unknown. Further documentation to better understand transmission dynamics and thus define appropriate control measures will depend on the stability of the context and safe access to the Somali population.

WHO multicentre study for the development of growth standards from fetal life to childhood: the fetal component.

PubMed

Merialdi, Mario; Widmer, Mariana; Gülmezoglu, Ahmet Metin; Abdel-Aleem, Hany; Bega, George; Benachi, Alexandra; Carroli, Guillermo; Cecatti, Jose Guilherme; Diemert, Anke; Gonzalez, Rogelio; Hecher, Kurt; Jensen, Lisa N; Johnsen, Synnøve L; Kiserud, Torvid; Kriplani, Alka; Lumbiganon, Pisake; Tabor, Ann; Talegawkar, Sameera A; Tshefu, Antoinette; Wojdyla, Daniel; Platt, Lawrence

2014-05-02

In 2006 WHO presented the infant and child growth charts suggested for universal application. However, major determinants for perinatal outcomes and postnatal growth are laid down during antenatal development. Accordingly, monitoring fetal growth in utero by ultrasonography is important both for clinical and scientific reasons. The currently used fetal growth references are derived mainly from North American and European population and may be inappropriate for international use, given possible variances in the growth rates of fetuses from different ethnic population groups. WHO has, therefore, made it a high priority to establish charts of optimal fetal growth that can be recommended worldwide. This is a multi-national study for the development of fetal growth standards for international application by assessing fetal growth in populations of different ethnic and geographic backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry will be scheduled at 14, 18, 24, 28, 32, 36, and 40 weeks (+/- 1 week) to be performed by trained ultrasonographers.The main outcome of the proposed study will be the development of fetal growth standards (either global or population specific) for international applications. The data from this study will be incorporated into obstetric practice and national health policies at country level in coordination with the activities presently conducted by WHO to implement the use of the Child Growth Standards.

The accuracy of colonoscopic localisation of colorectal tumours: a prospective, multi-centred observational study.

PubMed

Johnstone, M S; Moug, S J

2014-05-01

Colonoscopy is essential for accurate pre-operative colorectal tumour localisation, but its accuracy for localisation remains undetermined due to limitations of previous work. This study aimed to establish the accuracy of colonoscopic localisation and to determine how frequently inaccuracy results in altered surgical management. A prospective, multi-centred, powered observational study recruited 79 patients with colorectal tumours that underwent curative surgical resection. Patient and colonoscopic factors were recorded. Pre-operative colonoscopic and radiological lesion localisations were compared to intra-operative localisation using pre-defined anatomical bowel segments to determine accuracy, with changes in planned surgical management documented. Colonoscopy accurately located the colorectal tumour in 64/79 patients (81%). Five out of 15 inaccurately located patients required on-table alteration in planned surgical management. Pre-operative imaging was unable to visualise the primary tumour in 23.1% of cases, a finding that was more prevalent amongst bowel screener patients compared to symptomatic patients (45.8% vs. 13%; p = 0.003). Colonoscopic lesion localisation is inaccurate in 19.0% of cases and occurred throughout the colon with a change in on-table surgical management in 6.3%. With CT unable to visualise lesions in just under a quarter of cases, particularly in the screening population, preoperative localisation is heavily reliant on colonoscopy.

Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

PubMed

Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

2013-08-01

Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

Rational use of medicines: assessing progress using primary health centres in Shomolu local government area of Lagos, Nigeria.

PubMed

Oyeyemi, A S; Ogunleye, O A

2013-01-01

Medicines (drugs) are a critical component in the prevention and treatment of diseases. Their rational use is important to maximize their benefits and prevent undesirable effects. This study was conducted to assess progress with rational use of medicines at primary care level using recommended indicators. The cross-sectional descriptive study was conducted in four primary health centres in Somolu Local Government Area (LGA) of Lagos State, Nigeria. It employed retrospective and prospective data collection methods. From the four centres, prescription notes of 600 clinical encounters spanning one year were analyzed for prescribing indicators and a checklist was administered for facility indicators. For the 600 clinical encounters studied, 2802 drugs were prescribed. The mean number of drugs per encounter was 4.7 ± 2.1; 75.6% of drugs were prescribed by generic name; prescriptions containing at least an antibiotic averaged 48.5%, while those with at least an injection prescribed were 21%. Of all the drugs prescribed, 83.2% were from the National Essential Drugs List (NEDL). On the average, 86.5% of key essential drugs were available in the health centres but none of the centres had a copy of the NEDL or drug formulary. There were wide variations in some of the indicators across the four facilities. The study showed progress in some indicators when compared with previous studies but gaps still exist. We recommend training on rational use of medicines for health workers in the facilities and distribution of copies of NEDL to all the facilities.

Septic arthritis in haemodialysis patients: a seven-year multi-centre review.

PubMed

Al-Nammari, S S; Gulati, V; Patel, R; Bejjanki, N; Wright, M

2008-04-01

To determine relevant demographics, clinical features, and outcomes for septic arthritis in patients on haemodialysis for end-stage renal failure. A multi-centre retrospective review was performed from 1999 to 2005. 15 cases were identified. The mean age of the patients at diagnosis was 67 (range, 23-89) years and 11 were male. All had multiple co-morbidities and additional risk factors for sepsis. The primary sources of sepsis were dialysis access-related (n=12), unknown in 2, and unrelated soft tissue infection in one. All patients presented with acute monoarticular symptoms; the knee joint was affected in 11 patients. The white cell count, neutrophil count, and C-reactive protein concentration were elevated in 10, 10, and 15 patients, respectively. All patients had positive synovial fluid cultures and blood cultures were positive in 14. Organisms isolated were all skin commensals, being staphylococcal in 13 and streptococcal in 2. Six patients had concomitant rheumatological disease (gout in 4, pseudogout in one, and rheumatoid arthritis in one). Two had urate crystals in the synovial fluid (noted by microscopy). All patients underwent antimicrobial therapy for a mean of 36 days, together with joint washouts and debridement. 12 patients were cured of infection; 2 developed chronic sepsis secondary to localised osteomyelitis; and one died of sepsis. Septic arthritis is a potentially devastating condition. Early and aggressive joint lavage and debridement combined with appropriate antimicrobial therapy is imperative. A high index of suspicion is necessary in haemodialysis patients; the diagnosis of septic arthritis must be presumed until proven otherwise.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

PubMed

Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

2011-12-01

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

PubMed Central

Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

2013-01-01

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

Dosimetry and field matching for radiotherapy to the breast and superclavicular fossa

NASA Astrophysics Data System (ADS)

Winfield, Elizabeth

Radiotherapy for early breast cancer aims to achieve local disease control and decrease loco-regional recurrence rates. Treatment may be directed to breast or chest wall alone or, include regional lymph nodes. When using tangential fields to treat the breast a separate anterior field directed to the axilla and supraclavicular fossa (SCF) is needed to treat nodal areas. The complex geometry of this region necessitates matching of adjacent radiation fields in three dimensions. The potential exists for zones of overdosage or underdosage along the match line. Cosmetic results may be compromised if treatment fields are not accurately aligned. Techniques for field matching vary between centres in the UK. A study of dosimetry across the match line region using different techniques, as reported in the multi-centre START Trial Quality Assurance (QA) programme, was undertaken. A custom-made anthropomorphic phantom was designed to assess dose distribution in three dimensions using film dosimetry. Methods with varying degrees of complexity were employed to match tangential and SCF beams. Various techniques combined half beam blocking and machine rotations to achieve geometric alignment. Matching of asymmetric beams allowed a single isocentre technique to be used. Where field matching was not undertaken a gap between tangential and SCF fields was employed. Results demonstrated differences between techniques in addition to variations within the same technique between different centres. Geometric alignment techniques produced more homogenous dose distributions in the match region than gap techniques or those techniques not correcting for field divergence. For this multi-centre assessment of match plane techniques film dosimetry used in conjunction with a breast shaped phantom provided relative dose information. This study has highlighted the difficulties of matching treatment fields to achieve homogenous dose distribution through the region of the match plane and the degree of inhomogeneity as a consequence of a gap between treatment fields.

5 A study analysing the diagnostic performance of ECG interpretation for 30-day major cardiac events in the emergency department.

PubMed

Morris, Niall; Body, Rick

2017-12-01

This study evaluates the diagnostic accuracy of an Emergency Medicine (EM) clinician at identifying ischaemia on an ECG using 30-day major adverse cardiac events (MACE) as the primary outcome. This is a secondary analysis of a prospective, multi-centre, observational cohort at 14 centres: the Bedside Evaluation of Sensitive Troponin study. All fourteen Emergency Departments were based in the United Kingdom. Emergency physicians' assessments of the ECG were collected using a standardised form. Clinicians were asked to judge whether the ECG demonstrated ischaemia, the presence of ST depression (STD) and if there was abnormal T wave inversion (ATWI). Patients provided written informed consent and underwent serial high sensitivity troponin testing. 30 day follow-up was performed by research nurses using a standardised form via telephone. The primary outcome was 30-day major adverse cardiac events, defined as acute myocardial infarction, any cause of death and coronary revascularisation. In total, 756 patients were included in the analysis. Clinicians' ECG diagnosis of ischaemia for 30-day MACE: ECG ischaemia produces a sensitivity (Sn) of 19.54% (95% CI:11.81% to 29.43%), specificity (Sp) of 93.27% (95% CI:91.10% to 95.05%), positive predictive value (PPV) of 27.42% (95% CI:18.47% to 38.65%) and negative predictive value (NPV) of 89.91% (95%CI 88.92% to 90.83%). ECG ST depression produces Sn of 16.09% (9.09% to 25.52%), Sp of 89.69% (87.13% to 91.89%), PPV 16.87 (10.68% to 25.62%), and NPV 89.15% (88.19% to 90.04%). ECG ATWI produces Sn of 4.60% (1.27% to 11.36%), Sp of 91.63% (89.27% to 93.62%), PPV of 6.67% (2.59% to 16.12%) and NPV of 88.07% (87.52% to 88.6). This is the first prospective, multi-centre cohort study, that assess the diagnostic performance of EM clinician's ECG interpretation, with 30-day MACE as the primary outcome. The findings are highly relevant to EM as they represent the ECG terms used by popular acute coronary syndrome clinical decision rules. In this study a clinician's overall judgement of ischaemia has a better diagnostic performance compared to simple STD and ATWI. This may be due to an appreciation of morphology and the amount of deviation; future work should explore the effect of measuring deviation and analysing morphology. © 2017, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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.

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 Regulation of Multi-Age Groupings in Canadian Centre-based Child Care Settings: An Analysis of Provincial and Territorial Policies, Legislation and Regulations.

ERIC Educational Resources Information Center

Bernhard, Judith; Pollard, June; Chud, Gyda; Vukelich, Goranka; Pacini-Ketchabaw, Veronica

2000-01-01

Examined the ways Canadian provincial and territorial policies address the inclusion of infants in multi-age early childhood education settings and the ways practitioners and licensing personnel interpret these policies. Noted policy patterns that affect the inclusion of infants and older children. Derived recommendations for policymakers and…

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.

Towards a shared service centre for telemedicine: Telemedicine in Denmark, and a possible way forward

PubMed Central

Larsen, Simon Bo; Sørensen, Nanna Skovgaard; Petersen, Matilde Grøndahl; Kjeldsen, Gitte Friis

2015-01-01

Although evidence of the effectiveness of telemedicine is accumulating, knowledge of how to make best use of telemedicine is limited. This article presents results from a multi-stakeholder project that developed a new concept, a ‘shared service centre’ for telemedicine that is envisioned as working across different telemedical initiatives to support the implementation and wider adoption of telemedicine. One year of participatory design and analysis of the shared service centre concept involved stakeholders, such as clinicians, patients, technicians, policy makers, lawyers, economists and information technology architects. More than 100 people contributed to the findings. Most of the ideas generated for potential centre support for telemedicine could be categorised under four service categories. The need for such support services was verified in the cases investigated, and by agreement among stakeholders from regional health authorities, municipalities, and general practice. Therefore, it is probable that a shared service centre could help enable the wider deployment of telemedicine. Definitions In this article, we use ‘telemedicine’ as an umbrella term for all the ‘tele-’ labels that are sometimes used rather indiscriminately to denote the use of information and technology to support healthcare services, including ‘telehealth’, ‘telemonitoring’, ‘telehomecare’, ‘e-health’, and so on. As per our definition, telemedicine may be synchronous and/or asynchronous, and may apply to any information and technology-based means of connecting healthcare actors and the patient, such as video communication, e-mail, electronic monitoring equipment, and Internet portals. Furthermore, the term ‘telemedical initiative’ covers projects in which telemedicine is conducted by a temporary project organisation, as well as self-contained telemedicine services used in daily, clinical practice in existing organisations. PMID:26261216

Predicting mortality in sick African children: the FEAST Paediatric Emergency Triage (PET) Score.

PubMed

George, Elizabeth C; Walker, A Sarah; Kiguli, Sarah; Olupot-Olupot, Peter; Opoka, Robert O; Engoru, Charles; Akech, Samuel O; Nyeko, Richard; Mtove, George; Reyburn, Hugh; Berkley, James A; Mpoya, Ayub; Levin, Michael; Crawley, Jane; Gibb, Diana M; Maitland, Kathryn; Babiker, Abdel G

2015-07-31

Mortality in paediatric emergency care units in Africa often occurs within the first 24 h of admission and remains high. Alongside effective triage systems, a practical clinical bedside risk score to identify those at greatest risk could contribute to reducing mortality. Data collected during the Fluid As Expansive Supportive Therapy (FEAST) trial, a multi-centre trial involving 3,170 severely ill African children, were analysed to identify clinical and laboratory prognostic factors for mortality. Multivariable Cox regression was used to build a model in this derivation dataset based on clinical parameters that could be quickly and easily assessed at the bedside. A score developed from the model coefficients was externally validated in two admissions datasets from Kilifi District Hospital, Kenya, and compared to published risk scores using Area Under the Receiver Operating Curve (AUROC) and Hosmer-Lemeshow tests. The Net Reclassification Index (NRI) was used to identify additional laboratory prognostic factors. A risk score using 8 clinical variables (temperature, heart rate, capillary refill time, conscious level, severe pallor, respiratory distress, lung crepitations, and weak pulse volume) was developed. The score ranged from 0-10 and had an AUROC of 0.82 (95 % CI, 0.77-0.87) in the FEAST trial derivation set. In the independent validation datasets, the score had an AUROC of 0.77 (95 % CI, 0.72-0.82) amongst admissions to a paediatric high dependency ward and 0.86 (95 % CI, 0.82-0.89) amongst general paediatric admissions. This discriminative ability was similar to, or better than other risk scores in the validation datasets. NRI identified lactate, blood urea nitrogen, and pH to be important prognostic laboratory variables that could add information to the clinical score. Eight clinical prognostic factors that could be rapidly assessed by healthcare staff for triage were combined to create the FEAST Paediatric Emergency Triage (PET) score and externally validated. The score discriminated those at highest risk of fatal outcome at the point of hospital admission and compared well to other published risk scores. Further laboratory tests were also identified as prognostic factors which could be added if resources were available or as indices of severity for comparison between centres in future research studies.

An exploratory, large-scale study of pain and quality of life outcomes in cancer patients with moderate or severe pain, and variables predicting improvement.

PubMed

Maximiano, Constanza; López, Iker; Martín, Cristina; Zugazabeitia, Luis; Martí-Ciriquián, Juan L; Núñez, Miguel A; Contreras, Jorge; Herdman, Michael; Traseira, Susana; Provencio, Mariano

2018-01-01

There have been few large-scale, real world studies in Spain to assess change in pain and quality of life (QOL) outcomes in cancer patients with moderate to severe pain. This study aimed to assess changes on both outcomes after 3 months of usual care and to investigate factors associated with change in QoL. Large, multi-centre, observational study in patients with lung, head and neck, colorectal or breast cancer experiencing a first episode of moderate to severe pain while attending one of the participating centres. QoL was assessed using the EuroQol-5D questionnaire and pain using the Brief Pain Inventory (BPI). Instruments were administered at baseline and after 3 months of follow up. Multivariate analyses were used to assess the impact of treatment factors, demographic and clinical variables, pain and other symptoms on QoL scores. 1711 patients were included for analysis. After 3 months of usual care, a significant improvement was observed in pain and QoL in all four cancer groups (p<0.001). Effect sizes were medium to large on the BPI and EQ-5D Index and Visual Analogue Scale (VAS). Improvements were seen on the majority of EQ-5D dimensions in all patient groups, though breast cancer patients showed the largest gains. Poorer baseline performance status (ECOG) and the presence of anxiety/depression were associated with significantly poorer QOL outcomes. Improvements in BPI pain scores were associated with improved QoL. In the four cancer types studied, pain and QoL outcomes improved considerably after 3 months of usual care. Improvements in pain made a substantial contribution to QoL gains whilst the presence of anxiety and depression and poor baseline performance status significantly constrained improvement.

Hidden dangers revealed by misdiagnosed diabetic neuropathy: A comparison of simple clinical tests for the screening of vibration perception threshold at primary care level.

PubMed

Azzopardi, Kurt; Gatt, Alfred; Chockalingam, Nachiappan; Formosa, Cynthia

2018-04-01

Diabetic peripheral neuropathy is an important complication and contributes to the morbidity of diabetes mellitus. Evidence indicates early detection of diabetic peripheral neuropathy results in fewer foot ulcers and amputations. The aim of this study was to compare different screening modalities in the detection of diabetic peripheral neuropathy in a primary care setting. A prospective non-experimental comparative multi-centre cross sectional study was conducted in various Primary Health Centres. One hundred participants living with Type 2 diabetes for at least 10 years were recruited using a convenience sampling method. The Vibratip, 128Hz tuning fork and neurothesiometer were compared in the detection of vibration perception. This study showed different results of diabetic peripheral neuropathy screening tests, even in the same group of participants. This study has shown that the percentage of participants who did not perceive vibrations was highest when using the VibraTip (28.5%). This was followed by the neurothesiometer (21%) and the 128Hz tuning fork (12%) (p<0.001). Correct diagnosis and treatment of neuropathy in patients with diabetes is crucial. This study demonstrates that some instruments are more sensitive to vibration perception than others. We recommend that different modalities should be used in patients with diabetes and when results do not concur, further neurological evaluation should be performed. This would significantly reduce the proportion of patients with diabetes who would be falsely identified as having no peripheral neuropathy and subsequently denied the benefit of beneficial and effective secondary risk factor control. Copyright © 2017 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Multispectral photoacoustic imaging of nerves with a clinical ultrasound system

NASA Astrophysics Data System (ADS)

Mari, Jean Martial; West, Simeon; Beard, Paul C.; Desjardins, Adrien E.

2014-03-01

Accurate and efficient identification of nerves is of great importance during many ultrasound-guided clinical procedures, including nerve blocks and prostate biopsies. It can be challenging to visualise nerves with conventional ultrasound imaging, however. One of the challenges is that nerves can have very similar appearances to nearby structures such as tendons. Several recent studies have highlighted the potential of near-infrared optical spectroscopy for differentiating nerves and adjacent tissues, as this modality can be sensitive to optical absorption of lipids that are present in intra- and extra-neural adipose tissue and in the myelin sheaths. These studies were limited to point measurements, however. In this pilot study, a custom photoacoustic system with a clinical ultrasound imaging probe was used to acquire multi-spectral photoacoustic images of nerves and tendons from swine ex vivo, across the wavelength range of 1100 to 1300 nm. Photoacoustic images were processed and overlaid in colour onto co-registered conventional ultrasound images that were acquired with the same imaging probe. A pronounced optical absorption peak centred at 1210 nm was observed in the photoacoustic signals obtained from nerves, and it was absent in those obtained from tendons. This absorption peak, which is consistent with the presence of lipids, provides a novel image contrast mechanism to significantly enhance the visualization of nerves. In particular, image contrast for nerves was up to 5.5 times greater with photoacoustic imaging (0.82 +/- 0.15) than with conventional ultrasound imaging (0.148 +/- 0.002), with a maximum contrast of 0.95 +/- 0.02 obtained in photoacoustic mode. This pilot study demonstrates the potential of photoacoustic imaging to improve clinical outcomes in ultrasound-guided interventions in regional anaesthesia and interventional oncology.

Evaluation of a pediatric liquid formulation to improve 6-mercaptopurine therapy in children.

PubMed

Tiphaine, Adam de Beaumais; Hjalgrim, Lisa Lynqsie; Nersting, Jacob; Breitkreutz, Joerg; Nelken, Brigitte; Schrappe, Martin; Stanulla, Martin; Thomas, Caroline; Bertrand, Yves; Leverger, Guy; Baruchel, André; Schmiegelow, Kjeld; Jacqz-Aigrain, Evelyne

2016-02-15

6-mercaptopurine (6-MP), a key drug for treatment of acute lymphoblastic leukemia (ALL), has until recently had no adequate formulation for pediatric patients. Several approaches have been taken but the only oral paraben-free 6-MP liquid formulation named Loulla was developed and evaluated in the target population. Preclinical and clinical evaluations were performed according to a Pediatric Investigation Plan, in order to apply for a Pediatric Use Marketing Authorization. The pre-clinical study assessed the maximum tolerated dosage-volume and evaluated local mucosal toxicity of 28 daily administrations in treated compared to controls gold hamsters. The multi-centre clinical study was single-dose, open-label, crossover trial, conducted in 15 ALL children during maintenance therapy. The bioavailability and palatability of a single 50mg fixed dose of Loulla compared to 50mg registered tablets were evaluated in a random order on two consecutive days. Seven blood samples over 9h were obtained each day to determine 6-MP pharmacokinetic parameters, including Tmax, Cmax, AUC0-9 and AUC0-∞. A questionnaire adapted to children testing Loulla palatability and preference for either Loulla or the usual 6-MP tablet was completed. Occurrence of adverse events was determined at study visits by vital sign measurements, patient's spontaneous reporting, investigator's questioning and clinical examination. The preclinical study in gold hamsters showed that dosage-volume of 75 mg/kg/day was well tolerated. The relative bioavailability of liquid Loulla formulation compared to the reference presentation is 76% for AUC0-9 and AUC0-∞ and 80% for Cmax. The taste of Loulla and the mouth feeling after ingestion compare favorably to the tablet. No adverse event occurred. Pharmacokinetic, palatability and safety data support the use of Loulla in children. Copyright © 2015 Elsevier B.V. All rights reserved.

Acne at the Regional Dermatology Training Centre (RDTC), Tanzania. Clinical, social, and demografic characteristics of patients with focus on severity factors.

PubMed

Amani, U A; Mshana, J; Kiprono, S; Mavura, D; Masenga, E J; Cazzaniga, S; Todd, G; Beltraminelli, H

2018-05-05

Acne is a common dermatosis and is associated with a significant disease burden. Despite this, studies from Sub-Saharan Africa are rare. However, the prevalence of acne vulgaris in developing countries is increasing, eventually due to the adoption of a western life style especially in urban areas. We conducted an analytical, cross-sectional, hospital-based study between September 2012 and February 2013 (6 months) at the Regional Dermatology Training Centre (RDTC) in Moshi, Tanzania. The clinical, social, and demographic characteristics of patients with acne were assessed. The study was approved by the KCMU-CO Ethical Board. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Service provision and outcome for deliberate self-poisoning in adults--results from a six centre descriptive study.

PubMed

Kapur, Navneet; House, Allan; May, Chris; Creed, Francis

2003-07-01

The aim of the study was to compare the hospital management and direct costs of self-poisoning in six United Kingdom hospitals and to investigate whether hospital management influences outcome. This was a prospective descriptive study carried out at three teaching hospitals and three district general hospitals in North West England on adults (aged 16 or over) presenting to the study centres with deliberate self-poisoning over a 5-month period. Data were based on demographic and clinical characteristics, management of the current episode, direct costs and repetition of self-poisoning within 12 weeks of index episode. There were 1778 episodes of self-poisoning during the study period. There were marked differences in management between centres. There was a fivefold difference in the rate of admission to a medical bed (16.5%-81.3%), and a twofold difference in the rate of psychosocial assessment (28.5%-57.7%). These differences remained after adjustment for demographic and clinical factors. Hospital costs per episode varied from pound 228 to pound 422 and repetition rate ranged from 10% to 16%. Psychosocial assessment was associated with a twofold reduction in the risk of repetition. The marked variability of services for self-poisoning continue. It seems likely that this is having a detrimental effect on patient outcomes. Large scale intervention studies are required to inform both clinical practice and service provision.

Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: The EQUIP-ACS project protocol and design

PubMed Central

2010-01-01

Background Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of health care resources, and have a major negative economic and social impact through days lost at work, support for disability, and coping with the psychological consequences of illness. Several registries have shown that evidence based treatments are under-utilised in this patient population, particularly in high-risk patients. There is evidence that systematic educational programmes can lead to improvement in the management of these patients. Since application of the results of important clinical trials and expert clinical guidelines into clinical practice leads to improved patient care and outcomes, we propose to test a quality improvement programme in a general group of hospitals in Europe. Methods/Design This will be a multi-centre cluster-randomised study in 5 European countries: France, Spain, Poland, Italy and the UK. Thirty eight hospitals will be randomised to receive a quality improvement programme or no quality improvement programme. Centres will enter data for all eligible non-ST segment elevation acute coronary syndrome patients admitted to their hospital for a period of approximately 10 months onto the study database and the sample size is estimated at 2,000-4,000 patients. The primary outcome is a composite of eight measures to assess aggregate potential for improvement in the management and treatment of this patient population (risk stratification, early coronary angiography, anticoagulation, beta-blockers, statins, ACE-inhibitors, clopidogrel as a loading dose and at discharge). After the quality improvement programme, each of the eight measures will be compared between the two groups, correcting for cluster effect. Discussion If we can demonstrate important improvements in the quality of patient care as a result of a quality improvement programme, this could lead to a greater acceptance that such programmes should be incorporated into routine health training for health professionals and hospital managers. Trial registration Clinicaltrials.gov NCT00716430 PMID:20074348

Obstetrical brachial plexus injury (OBPI): Canada's national clinical practice guideline

PubMed Central

Coroneos, Christopher J; Voineskos, Sophocles H; Christakis, Marie K; Thoma, Achilleas; Bain, James R; Brouwers, Melissa C

2017-01-01

Objective The objective of this study was to establish an evidence-based clinical practice guideline for the primary management of obstetrical brachial plexus injury (OBPI). This clinical practice guideline addresses 4 existing gaps: (1) historic poor use of evidence, (2) timing of referral to multidisciplinary care, (3) Indications and timing of operative nerve repair and (4) distribution of expertise. Setting The guideline is intended for all healthcare providers treating infants and children, and all specialists treating upper extremity injuries. Participants The evidence interpretation and recommendation consensus team (Canadian OBPI Working Group) was composed of clinicians representing each of Canada's 10 multidisciplinary centres. Outcome measures An electronic modified Delphi approach was used for consensus, with agreement criteria defined a priori. Quality indicators for referral to a multidisciplinary centre were established by consensus. An original meta-analysis of primary nerve repair and review of Canadian epidemiology and burden were previously completed. Results 7 recommendations address clinical gaps and guide identification, referral, treatment and outcome assessment: (1) physically examine for OBPI in newborns with arm asymmetry or risk factors; (2) refer newborns with OBPI to a multidisciplinary centre by 1 month; (3) provide pregnancy/birth history and physical examination findings at birth; (4) multidisciplinary centres should include a therapist and peripheral nerve surgeon experienced with OBPI; (5) physical therapy should be advised by a multidisciplinary team; (6) microsurgical nerve repair is indicated in root avulsion and other OBPI meeting centre operative criteria; (7) the common data set includes the Narakas classification, limb length, Active Movement Scale (AMS) and Brachial Plexus Outcome Measure (BPOM) 2 years after birth/surgery. Conclusions The process established a new network of opinion leaders and researchers for further guideline development and multicentre research. A structured referral form is available for primary care, including referral recommendations. PMID:28132014

Zika virus infection in 18 travellers returning from Surinam and the Dominican Republic, The Netherlands, November 2015-March 2016.

PubMed

Duijster, Janneke W; Goorhuis, Abraham; van Genderen, Perry J J; Visser, Leo G; Koopmans, Marion P; Reimerink, Johan H; Grobusch, Martin P; van der Eijk, Annemiek A; van den Kerkhof, Johannes H C T; Reusken, Chantal B; Hahné, Susan J M

2016-12-01

We report 18 cases of confirmed Zika virus (ZIKV) infection in travellers returning to the Netherlands from Surinam (South America, bordering northern Brazil) and the Dominican Republic. In a multi-centre study, we collected epidemiological, virological and clinical characteristics, as well as data on travel history, underlying illness and laboratory results of the 18 imported ZIKV infection cases using a standardised form. Most cases had a self-limiting course of disease, two patients developed complications, one had Guillain-Barré and another had severe thrombocytopenia. Four patients had underlying illness. One of the reported cases was pregnant. Three of 13 patients tested had a weak-positive result for dengue IgM. The majority of patients were born in Suriname and/or visiting friends and relatives (VFR). Providing pre-travel advice among travellers, especially VFR travellers, is needed to enhance the use of preventive measures against ZIKV infection. Further evidence on health risks associated with ZIKV infection is urgently needed.

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.

CADC and CANFAR: Extending the role of the data centre

NASA Astrophysics Data System (ADS)

Gaudet, Severin

2015-12-01

Over the past six years, the CADC has moved beyond the astronomy archive data centre to a multi-service system for the community. This evolution is based on two major initiatives. The first is the adoption of International Virtual Observatory Alliance (IVOA) standards in both the system and data architecture of the CADC, including a common characterization data model. The second is the Canadian Advanced Network for Astronomical Research (CANFAR), a digital infrastructure combining the Canadian national research network (CANARIE), cloud processing and storage resources (Compute Canada) and a data centre (Canadian Astronomy Data Centre) into a unified ecosystem for storage and processing for the astronomy community. This talk will describe the architecture and integration of IVOA and CANFAR services into CADC operations, the operational experiences, the lessons learned and future directions

'Mind the gap' between the development of therapeutic innovations and the clinical practice in oncology: A proposal of the European Organisation for Research and Treatment of Cancer (EORTC) to optimise cancer clinical research.

PubMed

Kempf, Emmanuelle; Bogaerts, Jan; Lacombe, Denis; Liu, Lifang

2017-11-01

In Europe, most of the cancer clinical research dedicated to therapeutic innovations aims primarily at regulatory approval. Once an anticancer drug enters the common market, each member state determines its real-world use based on its own criteria: pricing, reimbursement and clinical indications. Such an innovation-centred clinical research landscape might neglect patient-relevant issues in real-world setting, such as comparative effectiveness of distinct treatment options or long-term safety monitoring. The European Organisation for Research and Treatment of Cancer (EORTC) advocates reforming the current 'innovation-centred' system to a truly 'patient-centred' paradigm with systematically coordinated applied clinical research in conjunction with drug development, featuring the following strategy. Copyright © 2017 Elsevier Ltd. All rights reserved.

So how do you see our teaching? Some observations received from past and present students at the Maurice Wohl Dental Centre.

PubMed

Davies, B; Leung, A; Dunne, S

2012-08-01

This study explores student perceptions of clinical teaching delivered at the Maurice Wohl Dental Centre, King's College London Dental Institute. An on-line survey together with two paper-based questionnaires were used to invite three immediate past cohorts of final-year dental students to reflect and comment on their experiences during their year of attendance. Supporting data from current student focus group and face-to-face interviews were also included in the study. The principal findings from these triangulated methodologies were that the overwhelming majority of students felt they got on very well with their teachers. The development of a positive professional relationship with the teacher appeared to motivate students to work better. Teaching thought to be overly didactic and authoritarian would not be well received. The principal teaching style identified at the Centre was considered to be supportive and nurturing, encouraging a self-motivated and reflective approach to clinical practice. © 2012 John Wiley & Sons A/S.

Gastroenteritis Aggressive Versus Slow Treatment For Rehydration (GASTRO). A pilot rehydration study for severe dehydration: WHO plan C versus slower rehydration

PubMed Central

Houston, Kirsty A.; Gibb, Jack G.; Mpoya, Ayub; Obonyo, Nchafatso; Olupot-Olupot, Peter; Nakuya, Margeret; Evans, Jennifer A; George, Elizabeth C; Gibb, Diana M; Maitland, Kathryn

2017-01-01

Background: The World Health Organization (WHO) rehydration management guidelines (Plan C) for children with acute gastroenteritis (AGE) and severe dehydration are widely practiced in resource-poor settings, yet have never been formally evaluated in a clinical trial. A recent audit of outcome of AGE at Kilifi County Hospital, Kenya noted that 10% of children required high dependency care (20% mortality) and a number developed fluid-related complications. The fluid resuscitation trial, FEAST, conducted in African children with severe febrile illness, demonstrated higher mortality with fluid bolus therapy and raised concerns regarding the safety of rapid intravenous rehydration therapy. Those findings warrant a detailed physiological study of children’s responses to rehydration therapy incorporating quantification of myocardial performance and haemodynamic changes.  Methods: GASTRO is a multi-centre, unblinded Phase II randomised controlled trial of 120 children aged 2 months to 12 years admitted to hospital with severe dehydration secondary to AGE. Children with severe malnutrition, chronic diarrhoea and congenital/rheumatic heart disease are excluded. Children will be enrolled over 18 months in 3 centres in Kenya and Uganda and followed until 7 days post-discharge. The trial will randomise children 1:1 to standard rapid rehydration using Ringers Lactate  (WHO plan ‘C’ – 100mls/kg over 3-6 hours according to age, plus additional 0.9% saline boluses for children presenting in shock) or to a slower rehydration regimen (100mls/kg given over 8 hours and without the addition of fluid boluses). Enrolment started in November 2016 and is on-going. Primary outcome is frequency of adverse events, particularly related to cardiovascular compromise and neurological sequelae.  Secondary outcomes focus on clinical, biochemical, and physiological measures related to assessment of severity of dehydration, and response to treatment by intravenous rehydration. Discussion: Results from this pilot will contribute to generating robust definitions of outcomes (in particular for non-mortality endpoints) for a larger Phase III trial. PMID:28905004

Capacity of non-invasive hepatic fibrosis algorithms to replace transient elastography to exclude cirrhosis in people with hepatitis C virus infection: A multi-centre observational study

PubMed Central

Riordan, Stephen M.; Bopage, Rohan; Lloyd, Andrew R.

2018-01-01

Introduction Achievement of the 2030 World Health Organisation (WHO) global hepatitis C virus (HCV) elimination targets will be underpinned by scale-up of testing and use of direct-acting antiviral treatments. In Australia, despite publically-funded testing and treatment, less than 15% of patients were treated in the first year of treatment access, highlighting the need for greater efficiency of health service delivery. To this end, non-invasive fibrosis algorithms were examined to reduce reliance on transient elastography (TE) which is currently utilised for the assessment of cirrhosis in most Australian clinical settings. Materials and methods This retrospective and prospective study, with derivation and validation cohorts, examined consecutive patients in a tertiary referral centre, a sexual health clinic, and a prison-based hepatitis program. The negative predictive value (NPV) of seven non-invasive algorithms were measured using published and newly derived cut-offs. The number of TEs avoided for each algorithm, or combination of algorithms, was determined. Results The 850 patients included 780 (92%) with HCV mono-infection, and 70 (8%) co-infected with HIV or hepatitis B. The mono-infected cohort included 612 men (79%), with an overall prevalence of cirrhosis of 16% (125/780). An ‘APRI’ algorithm cut-off of 1.0 had a 94% NPV (95%CI: 91–96%). Newly derived cut-offs of ‘APRI’ (0.49), ‘FIB-4’ (0.93) and ‘GUCI’ (0.5) algorithms each had NPVs of 99% (95%CI: 97–100%), allowing avoidance of TE in 40% (315/780), 40% (310/780) and 40% (298/749) respectively. When used in combination, NPV was retained and TE avoidance reached 54% (405/749), regardless of gender or co-infection. Conclusions Non-invasive algorithms can reliably exclude cirrhosis in many patients, allowing improved efficiency of HCV assessment services in Australia and worldwide. PMID:29438397

Capacity of non-invasive hepatic fibrosis algorithms to replace transient elastography to exclude cirrhosis in people with hepatitis C virus infection: A multi-centre observational study.

PubMed

Kelly, Melissa Louise; Riordan, Stephen M; Bopage, Rohan; Lloyd, Andrew R; Post, Jeffrey John

2018-01-01

Achievement of the 2030 World Health Organisation (WHO) global hepatitis C virus (HCV) elimination targets will be underpinned by scale-up of testing and use of direct-acting antiviral treatments. In Australia, despite publically-funded testing and treatment, less than 15% of patients were treated in the first year of treatment access, highlighting the need for greater efficiency of health service delivery. To this end, non-invasive fibrosis algorithms were examined to reduce reliance on transient elastography (TE) which is currently utilised for the assessment of cirrhosis in most Australian clinical settings. This retrospective and prospective study, with derivation and validation cohorts, examined consecutive patients in a tertiary referral centre, a sexual health clinic, and a prison-based hepatitis program. The negative predictive value (NPV) of seven non-invasive algorithms were measured using published and newly derived cut-offs. The number of TEs avoided for each algorithm, or combination of algorithms, was determined. The 850 patients included 780 (92%) with HCV mono-infection, and 70 (8%) co-infected with HIV or hepatitis B. The mono-infected cohort included 612 men (79%), with an overall prevalence of cirrhosis of 16% (125/780). An 'APRI' algorithm cut-off of 1.0 had a 94% NPV (95%CI: 91-96%). Newly derived cut-offs of 'APRI' (0.49), 'FIB-4' (0.93) and 'GUCI' (0.5) algorithms each had NPVs of 99% (95%CI: 97-100%), allowing avoidance of TE in 40% (315/780), 40% (310/780) and 40% (298/749) respectively. When used in combination, NPV was retained and TE avoidance reached 54% (405/749), regardless of gender or co-infection. Non-invasive algorithms can reliably exclude cirrhosis in many patients, allowing improved efficiency of HCV assessment services in Australia and worldwide.

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.

Management of large bowel obstruction with self-expanding metal stents. A multicentre retrospective study of factors determining outcome.

PubMed

Geraghty, J; Sarkar, S; Cox, T; Lal, S; Willert, R; Ramesh, J; Bodger, K; Carlson, G L

2014-06-01

UK cancer guidelines recommend patients with colonic obstruction due to suspected malignancy be considered for stenting with a self-expanding metal stent (SEMS). Considerable variation in practice exists due to a lack of expertise, technical difficulties and other, as yet ill-defined features. This retrospective multi-centre study aims to determine the outcome following colonic stenting for large bowel obstruction and identify factors associated with successful intervention. A regional programme of colonic stenting for large bowel obstruction, in five UK centres from 2005 to 2010 was evaluated for outcome including technical and clinical success, survival, complications and reoperation. A SEMS was inserted in 334 patients, including 264 (79.0%) for palliation and 52 (15.6%) as a bridge to surgery. Technical success was achieved in 292 (87.4%) patients, with 46 (13.8%) experiencing a complication or technical failure. Reoperation was required in 39 (14.8%) patients stented for palliation of colorectal cancer of whom 16 (6.1%) subsequently required a colostomy. A one-stage primary anastomosis was achieved in 35 (67.3%) of the 52 patients undergoing stenting as a bridge to resection. Technical success did not vary by indication or site of obstruction (P = 0.60) but was higher for operators who had performed more than 10 procedures (OR 3.34, P = 0.001). ASA grade ≥3 predicted a worse clinical outcome (OR 0.43, P = 0.04). The through-the-scope (TTS) endoscopy technique was more successful than radiological placement alone (90.3% vs 74.8%, P < 0.001). Experienced operators using a TTS technique achieved a better outcome for the emergency management of large bowel obstruction. Older, sicker patients and those with extracolonic and benign strictures fared less well. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

A qualitative study on barriers in the prevention of anaemia during pregnancy in public health centres: perceptions of Indonesian nurse-midwives.

PubMed

Widyawati, Widyawati; Jans, Suze; Utomo, Sutarti; van Dillen, Jeroen; Janssen, A L M Lagro

2015-02-26

Anemia in pregnancy remains a major problem in Indonesia over the past decade. Early detection of anaemia in pregnancy is one of the components which is unsuccessfully implemented by nurse-midwives. This study aims to explore nurse-midwives' experiences in managing pregnant women with anaemia in Public Health Centres. We conducted a qualitative study with semi-structured face to face interviews from November 2011 to February 2012 with 23 nurse-midwives in five districts in Yogyakarta Special Province. Data analysis was thematic, using the constant comparison method, making comparison between participants and supported by ATLAS.ti software. Twelve nurse-midwives included in the interviews had less than or equal to 10 years' working experience (junior nurse-midwives) and 11 nurse-midwives had more than 10 years' working experience (senior nurse-midwives) in Public Health Centres. The senior nurse-midwives mostly worked as coordinators in Public Health Centres. Three main themes emerged: 1) the lack of competence and clinical skill; 2) cultural beliefs and low participation of family in antenatal care programme; 3) insufficient facilities and skilled support staff in Public Health Centres. The nurse-midwives realized that they need to improve their communication and clinical skills to manage pregnant women with anaemia. The husband and family involvement in antenatal care was constrained by the strength of cultural beliefs and lack of health information. Moreover, unfavourable work environment of the Public Health Centres made it difficult to apply antenatal care the pregnant womens' need. The availability of facilities and skilled staffs in Public Health Centre as well as pregnant women's husbands or family members contribute to the success of managing anaemia in pregnancy. Nurse-midwives and pregnant women need to be empowered to achieve the optimum result of anaemia management. We recommend a more comprehensive approach in managing pregnant women with anaemia, which synergizes the available resources and empowers nurse-midwives and pregnant women.

Organizational and operational capabilities of specialist centres for children with psychomotor disability in Abidjan.

PubMed

Alloh, D; Nandjui, B; Bombo, J; Manou, B; Twoolys, A; Alloukou, R; Ake, N; Konate-Konan, E; Pillah, L; Coulibaly, A

2009-06-01

To describe the organizational and operational capabilities of specialized centres for children with psychomotor disability in Abidjan, Republic of Côte d'Ivoire. This descriptive study was carried out from February to May, 2006 at the various specialized centres for children with psychomotor disability that exist in the district of Abidjan. The procedure comprised a clinical description of the disabled children admitted to these centres and an assessment of the centres' organization and operational capabilities. Six specialist centres for children with psychomotor disability were identified, namely the Infant Guidance Centre, the Awakening and Stimulation Centre for disabled Children, the "Sainte-Magdeleine" Centre, the Medical and Training Institute, the "Page Blanche" institute and the "Colombes Notre Dame de la Paix" Centre. Among the children, 97.15% were day patients, 66.37% were mentally challenged, 30.96% had psychomotor impairment and 2.66% had motor impairments. The level of organization varied but the centres nevertheless had operational administrative, medical and paramedical staff, despite the absence of certain specialties. However, the lack of personnel, equipment and infrastructure is hindering the delivery of adequate services to the children. In Abidjan District, reception centres for children with psychomotor impairments are essentially privately run. Organizational and operational performances were suboptimal, with a low carer-to-patient ratio. Reinforcement of the centres' operational capabilities appears to be necessary.

Recombinant tissue plasminogen activator as a novel treatment option for infective endocarditis: a retrospective clinical study in 32 children.

PubMed

Levitas, Aviva; Krymko, Hanna; Richardson, Justin; Zalzstein, Eli; Ioffe, Viktoriya

2016-01-01

Infective endocarditis is a life-threatening infectious syndrome, with high morbidity and mortality. Current treatments for infective endocarditis include intravenous antibiotics, surgery, and involve a lengthy hospital stay. We hypothesised that adjunctive recombinant tissue plasminogen activator treatment for infective endocarditis may facilitate faster resolution of vegetations and clearance of positive blood cultures, and therefore decrease morbidity and mortality. This retrospective study included follow-up of patients, from 1997 through 2014, including clinical presentation, causative organism, length of treatment, morbidity, and mortality. We identified 32 patients, all of whom were diagnosed with endocarditis and were treated by recombinant tissue plasminogen activator. Among all, 27 patients (93%) had positive blood cultures, with the most frequent organisms being Staphylococcus epidermis (nine patients), Staphylococcus aureus (six patients), and Candida (nine patients). Upon treatment, in 31 patients (97%), resolution of vegetations and clearance of blood cultures occurred within hours to few days. Out of 32 patients, one patient (3%) died and three patients (9%) suffered embolic or haemorrhagic events, possibly related to the recombinant tissue plasminogen activator. None of the patients required surgical intervention to assist vegetation resolution. In conclusion, it appears that recombinant tissue plasminogen activator may become an adjunctive treatment for infective endocarditis and may decrease morbidity as compared with current guidelines. Prospective multi-centre studies are required to validate our findings.

The African Lupus Genetics Network (ALUGEN) registry: standardized, prospective follow-up studies in African patients with systemic lupus erythematosus.

PubMed

Hodkinson, B; Mapiye, D; Jayne, D; Kalla, A; Tiffin, N; Okpechi, I

2016-03-01

The prevalence and severity of systemic lupus erythematosus (SLE) differs between ethnic groups and geographical regions. Although initially reported as rare, there is growing evidence that SLE is prevalent and runs a severe course in Africa. There is a paucity of prospective studies on African SLE patients. The African Lupus Genetics Network (ALUGEN) is a multicentred framework seeking to prospectively assess outcomes in SLE patients in Africa. Outcomes measured will be death, hospital admission, disease activity flares, and SLE-related damage. We will explore predictors for these outcomes including clinical, serological, socio-demographic, therapeutic and genetic factors. Further, we will investigate comorbidities and health-related quality of life amongst these patients. Data of patients recently (≤ 5 yrs) diagnosed with SLE will be collected at baseline and annual follow-up visits, and captured electronically. The ALUGEN project will facilitate standardized data capture for SLE cases in Africa, allowing participating centres to develop their own SLE registries, and enabling collaboration to enrich our understanding of inter-ethnic and regional variations in disease expression. Comprehensive, high-quality multi-ethnic data on African SLE patients will expand knowledge of the disease and inform clinical practice, in addition to augmenting research capacity and networking links and providing a platform for future biomarker and interventional studies. © The Author(s) 2015.

Emergency nurses' perceptions of the role of confidence, self-efficacy and reflexivity in managing the cognitively impaired older person in pain.

PubMed

Fry, Margaret; MacGregor, Casimir; Hyland, Simone; Payne, Barbara; Chenoweth, Lynn

2015-06-01

The study aimed to explore the practice of care among emergency nurses caring for older persons with cognitive impairment and who presented in pain from a long bone fracture, to highlight nurse confidence and self-efficacy in practice. Cognitive impairment is an issue increasingly facing emergency departments. Older persons with cognitive impairment have complex care needs, requiring effective clinical decision-making and provision of care. Nurse confidence and self-efficacy are critical to meeting the necessary standards of care for this vulnerable patient group. A multi-centre study. The study was undertaken across four emergency departments in Sydney, Australia. Sixteen focus group discussions were conducted with 80 emergency departments of nurses. Four main themes emerged: confidence and self-efficacy through experience; confidence and self-efficacy as a balancing act; confidence and self-efficacy as practice; and confidence and self-efficacy and interpersonal relations. Our findings demonstrate that confidence, self-efficacy and reflexivity enabled the delivery of appropriate, timely and compassionate care. Further, confidence and self-efficacy within nursing praxis relied on clinical experience and reflective learning and was crucial to skill and knowledge acquisition. Our research suggests that confidence, self-efficacy and reflexivity need to be developed and valued in nurses' careers to better meet the needs of complex older persons encountered within everyday practice. © 2015 John Wiley & Sons Ltd.

AB0 blood groups and rhesus factor expression as prognostic parameters in patients with epithelial ovarian cancer - a retrospective multi-centre study.

PubMed

Seebacher, Veronika; Polterauer, Stephan; Reinthaller, Alexander; Koelbl, Heinz; Achleitner, Regina; Berger, Astrid; Concin, Nicole

2018-04-19

AB0 blood groups and Rhesus factor expression have been associated with carcinogenesis, response to treatment and tumor progression in several malignancies. The aim of the present study was to test the hypothesis that AB0 blood groups and Rhesus factor expression are associated with clinical outcome in patients with epithelial ovarian cancer (EOC). AB0 blood groups and Rhesus factor expression were evaluated in a retrospective multicenter study including 518 patients with EOC. Their association with patients' survival was assessed using univariate and multivariable analyses. Neither AB0 blood groups nor Rhesus factor expression were associated with clinico-pathological parameters, recurrence-free, cancer-specific, or overall survival. In a subgroup of patients with high-grade serous adenocarcinoma, however, blood groups B and AB were associated with a better 5-year cancer-specific survival rate compared to blood groups A and 0 (60.3 ± 8.6% vs. 43.8 ± 3.6%, p = 0.04). Yet, this was not significant in multivariable analysis. AB0 blood groups and Rhesus factor expression are both neither associated with features of biologically aggressive disease nor clinical outcome in patients with EOC. Further investigation of the role of the blood group B antigen on cancer-specific survival in the subgroup of high-grade serous should be considered.

Peptic Ulcer Disease in Bangladesh: A Multi-centre Study.

PubMed

Ghosh, C K; Khan, M R; Alam, F; Shil, B C; Kabir, M S; Mahmuduzzaman, M; Das, S C; Masud, H; Roy, P K

2017-01-01

The incidence of peptic ulcer has steadily declined through out the world. This decreasing trend is also noticeable in this subcontinent. The point prevalence of peptic ulcer (PUD) in Bangladesh was around 15% in eighties. The aim of this study was to see the present prevalence of peptic ulcer at endoscopy and to identify changing trends in the occurrence of peptic ulcer in Bangladesh. This retrospective analysis of the endoscopic records of multiple tertiary referral centres of Dhaka city were done from January 2012 to July 2013. A total of 5608 subjects were the study samples. We included those patients having peptic ulcer in the form of duodenal ulcer, benign gastric ulcer including pre-pyloric ulcer and gastric outlet obstruction due to peptic ulcer. Duodenal ulcer and benign gastric ulcer were found in 415(7.4%) and 184(3.28%) patients respectively and gastric outlet obstruction due to peptic ulcer was found in 23(0.40%) patients.

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.

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.

A student-centred electronic health record system for clinical education.

PubMed

Elliott, Kristine; Judd, Terry; McColl, Geoff

2011-01-01

Electronic Health Record (EHR) systems are an increasingly important feature of the national healthcare system [1]. However, little research has investigated the impact this will have on medical students' learning. As part of an innovative technology platform for a new masters level program in medicine, we are developing a student-centred EHR system for clinical education. A prototype was trialed with medical students over several weeks during 2010. This paper reports on the findings of the trial, which had the overall aim of assisting our understanding of how trainee doctors might use an EHR system for learning and communication in a clinical setting. In primary care and hospital settings, EHR systems offer potential benefits to medical students' learning: Longitudinal tracking of clinical progress towards established learning objectives [2]; Capacity to search across a substantial body of records [3]; Integration with online medical databases [3]; Development of expertise in creating, accessing and managing high quality EHRs [4]. While concerns have been raised that EHR systems may alter the interaction between teachers and students [3], and may negatively influence physician-patient communication [6], there is general consensus that the EHR is changing the current practice environment and teaching practice needs to respond. Final year medical students on clinical placement at a large university teaching hospital were recruited for the trial. Following a four-week period of use, semi-structured interviews were conducted with 10 participants. Audio-recorded interviews were transcribed and data analysed for emerging themes. Study participants were also surveyed about the importance of EHR systems in general, their familiarity with them, and general perceptions of sharing patient records. Medical students in this pilot study identified a number of educational, practical and administrative advantages that the student-centred EHR system offered over their existing ad-hoc procedures for recording patient encounters. Findings from this preliminary study point to the need to introduce and instruct students' on the use of EHR systems from their earliest clinical encounters, and to closely integrate learning activities based on the EHR system with established learning objectives. Further research is required to evaluate the impact of student-centred EHR systems on learning outcomes.

Mitochondrial imaging in live or fixed tissues using a luminescent iridium complex.

PubMed

Sorvina, Alexandra; Bader, Christie A; Darby, Jack R T; Lock, Mitchell C; Soo, Jia Yin; Johnson, Ian R D; Caporale, Chiara; Voelcker, Nicolas H; Stagni, Stefano; Massi, Massimiliano; Morrison, Janna L; Plush, Sally E; Brooks, Douglas A

2018-05-29

Mitochondrial morphology is important for the function of this critical organelle and, accordingly, altered mitochondrial structure is exhibited in many pathologies. Imaging of mitochondria can therefore provide important information about disease presence and progression. However, mitochondrial imaging is currently limited by the availability of agents that have the capacity to image mitochondrial morphology in both live and fixed samples. This can be particularly problematic in clinical studies or large, multi-centre cohort studies, where tissue archiving by fixation is often more practical. We previously reported the synthesis of an iridium coordination complex [Ir(ppy) 2 (MeTzPyPhCN)] + ; where ppy is a cyclometalated 2-phenylpyridine and TzPyPhCN is the 5-(5-(4-cyanophen-1-yl)pyrid-2-yl)tetrazolate ligand; and showed that this complex (herein referred to as IraZolve-Mito) has a high specificity for mitochondria in live cells. Here we demonstrate that IraZolve-Mito can also effectively stain mitochondria in both live and fixed tissue samples. The staining protocol proposed is versatile, providing a universal procedure for cell biologists and pathologists to visualise mitochondria.

Assessment of quality of care for the management of type 2 diabetes: a multicentre study from a developing country.

PubMed

Azam, Iqbal Syed; Khuwaja, Ali Khan; Rafique, Ghazala; White, Franklin

2010-01-01

Complications of diabetes can be prevented or delayed by providing high quality care. This study aimed to document the quality of care provided to people with type 2 diabetes in Pakistan and to identify the difference in care offered at various clinics. Cross-sectional multi-centre study. Interviews were undertaken with 672 people with type 2 diabetes attending three different types of diabetes clinic (private clinic (A), non-governmental organisation (B) and public clinic (C)) in Karachi, Pakistan. A structured questionnaire was used to collect socio-demographic and clinical information from patients; quality of care indicators were also confirmed by reference to patients' medical records. Overall, 68% (A: 92%, B: 58% and C: 52%, P<0.001) of study subjects were informed about diabetes complications. Blood pressure (BP) monitoring at every visit was completed for 80% of study respondents (A: 100%, B: 79% and C: 57%, P<0.001). Foot examination was infrequent (53%, A: 98%, B: 52% and C: 8% (P<0.001). Lipid profiles of 48% of patients had been done in the past 12 months (A: 77%, B: 16% and C: 50%, P<0.001). Microalbumin testing had been performed in 32% of patients in the previous year (A: 77%, B: 09% and C: 05%; P<0.001). Most participants had elevated glycaemic (58.2%) and BP levels (84.7%) with higher prevalence among people who attended clinics B and C (P<0.001). Overall, 82.6% of study subjects had an elevated body mass index; this was almost equally prevalent across clinics. Many patients with type 2 diabetes do not receive optimal diabetes care in Karachi. Among the different settings, care provided in private health sector clinics was of a better standard. However, our results reveal a need for overall improvement in the quality of diabetes care. Further research is also needed to evaluate the reasons for poor diabetes care, and to identify the most cost-effective means to address these.

A comparison of the efficacy of fixed versus removable functional appliances in children with Class II malocclusion: A systematic review.

PubMed

Pacha, Moaiyad Moussa; Fleming, Padhraig S; Johal, Ama

2016-12-01

To systematically compare the efficacy of fixed and removable functional appliances in Class II malocclusion in terms of morphological and patient-centred outcomes. A comprehensive search of electronic databases without language or time restrictions was undertaken, applying a pre-specified search strategy. Supplementary electronic searching of orthodontics journals and references list of included studies was performed. Randomized (RCTs) and controlled (CCTs) clinical trials involving children under 16 years with Class II malocclusion and overjet more than 5mm were included. A range of clinician- and patient-centred outcomes were evaluated and compared. Risk of bias assessment was carried out using the Cochrane Collaboration tool. Only four clinical trials were found to meet our criteria, of which two were RCTs, comparing the Herbst and the Twin Block appliances. Two further CCTs, compared the Activator to the Forsus and the Twin Force Bite Corrector, respectively. One study was assessed to be at unclear and the remaining at high risk of bias, precluding meta-analysis. There was also significant clinical heterogeneity in terms of methodology, type of intervention and the measured outcomes. Both modalities were effective in correcting the overjet with little differences found in cephalometric changes and a shortage of data concerning patient-centred outcomes. There is little evidence concerning the relative effectiveness of fixed and functional appliances or in relation to patient experiences and perceptions of these treatment modalities. Further well-designed clinical trials assessing the relative merits of both clinician- and patient-centred outcomes are needed. © The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Practice-centred evaluation and the privileging of care in health information technology evaluation.

PubMed

Darking, Mary; Anson, Rachel; Bravo, Ferdinand; Davis, Julie; Flowers, Steve; Gillingham, Emma; Goldberg, Lawrence; Helliwell, Paul; Henwood, Flis; Hudson, Claire; Latimer, Simon; Lowes, Paul; Stirling, Ian

2014-06-05

Our contribution, drawn from our experience of the case study provided, is a protocol for practice-centred, participative evaluation of technology in the clinical setting that privileges care. In this context 'practice-centred' evaluation acts as a scalable, coordinating framework for evaluation that recognises health information technology supported care as an achievement that is contingent and ongoing. We argue that if complex programmes of technology-enabled service innovation are understood in terms of their contribution to patient care and supported by participative, capability-building evaluation methodologies, conditions are created for practitioners and patients to realise the potential of technologies and make substantive contributions to the evidence base underpinning health innovation programmes. Electronic Patient Records (EPRs) and telemedicine are positioned by policymakers as health information technologies that are integral to achieving improved clinical outcomes and efficiency savings. However, evaluating the extent to which these aims are met poses distinct evaluation challenges, particularly where clinical and cost outcomes form the sole focus of evaluation design. We propose that a practice-centred approach to evaluation - in which those whose day-to-day care practice is altered (or not) by the introduction of new technologies are placed at the centre of evaluation efforts - can complement and in some instances offer advantages over, outcome-centric evaluation models. We carried out a regional programme of innovation in renal services where a participative approach was taken to the introduction of new technologies, including: a regional EPR system and a system to support video clinics. An 'action learning' approach was taken to procurement, pre-implementation planning, implementation, ongoing development and evaluation. Participants included clinicians, technology specialists, patients and external academic researchers. Whilst undergoing these activities we asked: how can a practice-centred approach be embedded into evaluation of health information technologies? Organising EPR and telemedicine evaluation around predetermined outcome measures alone can be impractical given the complex and contingent nature of such projects. It also limits the extent to which unforeseen outcomes and new capabilities are recognised. Such evaluations often fail to improve understanding of 'when' and 'under what conditions' technology-enabled service improvements are realised, and crucially, how such innovation improves care. Our contribution, drawn from our experience of the case study provided, is a protocol for practice-centred, participative evaluation of technology in the clinical setting that privileges care. In this context 'practice-centred' evaluation acts as a scalable, coordinating framework for evaluation that recognises health information technology supported care as an achievement that is contingent and ongoing. We argue that if complex programmes of technology-enabled service innovation are understood in terms of their contribution to patient care and supported by participative, capability-building evaluation methodologies, conditions are created for practitioners and patients to realise the potential of technologies and make substantive contributions to the evidence base underpinning health innovation programmes.

Patient-centred assessment of social support, health status and quality of life in patients with acute coronary syndrome.

PubMed

de Jong-Watt, Wynne; Sherifi, Ines

2011-01-01

Measurement of health status (HS) and social support are becoming increasingly accepted as tools to guide clinical decision-making and patient-centred practice. To assess self-reported HS, cardiac-health related quality of life and social support in subjects with a diagnosis of acute coronary syndrome (ACS). The study used a quantitative descriptive design. 36 subjects with a diagnosis of ACS were selected from patients admitted to medical units at a teaching hospital in Toronto, Ontario. One-time, semi-structured interviews were conducted using valid and reliable cardiac-specific HS and social support measures. Analysis indicated that subjects with higher perceived social support and patients with higher income reported greater treatment satisfaction and C-HROL. Subjects with severe angina reported a higher perceived level of social support than those with more moderate physical limitation due to angina. Patients' social environment and HS significantly impact their satisfaction with treatment. Patient-centred measures assist in clinical decision-making, patient-centred care planning and patient involvement in their care.

[Description of clinical pathological concordance and patient satisfaction in minor surgery in a Primary Care centre].

PubMed

Ramírez Arriola, María Gabriela; Hamido Mohamed, Naima; Abad Vivás-Pérez, Juan José; Bretones Alcaráz, Juan José; García Torrecillas, Juan Manuel; Huber, Evelyn

2017-02-01

To describe the minor surgery (MS) characteristics in a Primary Care (PC) centre, and to evaluate the clinical pathological concordance and patient satisfaction. Descriptive and retrospective study. Primary Care, urban health care centre, Almería, Spain. The population were the patients belonging to urban Primary Health Care centre, referred by their family physicians or paediatricians for the performing of MS during year 2013, and who consented to the intervention. A sample of 223 patients was obtained. Variables analysed were: sex, age, locations of the lesions, type of intervention, clinical diagnosis, histopathology diagnosis, complications, and patient satisfaction. The data were extracted from the medical history, the histopathology reports, and by using a satisfaction questionnaire completed by post or telephone by the patients. The population consisted of 53.8% males, and had a mean age of 51.12 years (SD 19.02). The location of the most intervened lesions was in the head (35.4%). Electro-surgery was the most used procedure (62.8%), with only 16.9% of the lesions being biopsied, of which the most frequent was fibroids (32.3%). The clinical pathological concordance was >80% and the Kappa index was 0.783 (P<.001). The complications presented were low. The patient's satisfaction was high. Although a simple MS technique like electro-surgery has become more extensive, MS in PC remains safe and satisfactory for the user. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

[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.

Cancer-cell intrinsic gene expression signatures overcome intratumoural heterogeneity bias in colorectal cancer patient classification

PubMed Central

Dunne, Philip D.; Alderdice, Matthew; O'Reilly, Paul G.; Roddy, Aideen C.; McCorry, Amy M. B.; Richman, Susan; Maughan, Tim; McDade, Simon S.; Johnston, Patrick G.; Longley, Daniel B.; Kay, Elaine; McArt, Darragh G.; Lawler, Mark

2017-01-01

Stromal-derived intratumoural heterogeneity (ITH) has been shown to undermine molecular stratification of patients into appropriate prognostic/predictive subgroups. Here, using several clinically relevant colorectal cancer (CRC) gene expression signatures, we assessed the susceptibility of these signatures to the confounding effects of ITH using gene expression microarray data obtained from multiple tumour regions of a cohort of 24 patients, including central tumour, the tumour invasive front and lymph node metastasis. Sample clustering alongside correlative assessment revealed variation in the ability of each signature to cluster samples according to patient-of-origin rather than region-of-origin within the multi-region dataset. Signatures focused on cancer-cell intrinsic gene expression were found to produce more clinically useful, patient-centred classifiers, as exemplified by the CRC intrinsic signature (CRIS), which robustly clustered samples by patient-of-origin rather than region-of-origin. These findings highlight the potential of cancer-cell intrinsic signatures to reliably stratify CRC patients by minimising the confounding effects of stromal-derived ITH. PMID:28561046

Evaluation of the geriatric co-management for patients with fragility fractures of the proximal femur (Geriatric Fracture Centre (GFC) concept): protocol for a prospective multicentre cohort study.

PubMed

Joeris, Alexander; Hurtado-Chong, Anahí; Hess, Denise; Kalampoki, Vasiliki; Blauth, Michael

2017-07-12

Treatment of fractures in the elderly population is a clinical challenge due partly to the presence of comorbidities. In a Geriatric Fracture Centre (GFC), patients are co-managed by a geriatrician in an attempt to improve clinical outcomes and reduce morbidity and mortality. Until now the beneficial effect of orthogeriatric co-management has not been definitively proven. The primary objective of this study is to determine the effect of GFC on predefined major adverse events related to a hip fracture compared to usual care centres (UCC). The secondary objectives include assessments in quality of life, patient-reported outcomes and cost-effectiveness. Two hundred and sixty-six elderly patients diagnosedwith hip fracture and planned to be treated with osteosynthesis or endoprosthesis in either a GFC or UCC study site will be recruited, 133 per type of centre. All procedures and management will be done according to the site's standard of care. Study-related visits will be performed at the following time points: preoperative, intraoperative, discharge from the orthopaedic/trauma department, discharge to definite residential status, 12 weeks and 12 months postsurgery. Data collected include demographics, residential status, adverse events, patient-reported outcomes, fall history, costs and resources related to treatment. The risk of major adverse events at 12 months will be calculated for each centre type; patient-reported outcomes will be analysed by mixed effects regression models to estimate differences in mean scores between baseline and follow-ups whereas cost-effectiveness will be assessed using the incremental cost-effectiveness ratio. Ethics approval for this study was granted from the local Ethics Committees or Institutional Review Board from each of the participating sites prior to patient enrolment. The results of this study will be published in peer-reviewed journals and presented at different conferences. ClinicalTrials.gov: NCT02297581; pre-results. © 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.

'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. Methods and design The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams. The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video-assessed team performance and on selected clinical performance. Discussion The perspective is to provide new knowledge on contextual effects of different simulation settings. Trial registration ClincialTrials.gov NCT01792674. PMID:23870501

'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial.

PubMed

Sørensen, Jette Led; Van der Vleuten, Cees; Lindschou, Jane; Gluud, Christian; Østergaard, Doris; LeBlanc, Vicki; Johansen, Marianne; Ekelund, Kim; Albrechtsen, Charlotte Krebs; Pedersen, Berit Woetman; Kjærgaard, Hanne; Weikop, Pia; Ottesen, Bent

2013-07-17

Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams.The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video-assessed team performance and on selected clinical performance. The perspective is to provide new knowledge on contextual effects of different simulation settings. ClincialTrials.gov NCT01792674.

Towards implementing coordinated healthy lifestyle promotion in primary care: a mixed method study.

PubMed

Thomas, Kristin; Bendtsen, Preben; Krevers, Barbro

2015-01-01

Primary care is increasingly being encouraged to integrate healthy lifestyle promotion in routine care. However, implementation has been suboptimal. Coordinated care could facilitate lifestyle promotion practice but more empirical knowledge is needed about the implementation process of coordinated care initiatives. This study aimed to evaluate the implementation of a coordinated healthy lifestyle promotion initiative in a primary care setting. A mixed method, convergent, parallel design was used. Three primary care centres took part in a two-year research project. Data collection methods included individual interviews, document data and questionnaires. The General Theory of Implementation was used as a framework in the analysis to integrate the data sources. Multi-disciplinary teams were implemented in the centres although the role of the teams as a resource for coordinated lifestyle promotion was not fully embedded at the centres. Embedding of the teams was challenged by differences among the staff, patients and team members on resources, commitment, social norms and roles. The study highlights the importance of identifying and engaging key stakeholders early in an implementation process. The findings showed how the development phase influenced the implementation and embedding processes, which add aspects to the General Theory of Implementation.

Calculation of Direct Antiretroviral Treatment Costs and Potential Cost Savings by Using Generics in the German HIV ClinSurv Cohort

PubMed Central

Stoll, Matthias; Kollan, Christian; Bergmann, Frank; Bogner, Johannes; Faetkenheuer, Gerd; Fritzsche, Carlos; Hoeper, Kirsten; Horst, Heinz-August; van Lunzen, Jan; Plettenberg, Andreas; Reuter, Stefan; Rockstroh, Jürgen; Stellbrink, Hans-Jürgen; Hamouda, Osamah; Bartmeyer, Barbara

2011-01-01

Background/Aim of the Study The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART,-regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. Methods Antiretroviral regimens (ART) from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART,-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC)-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. Results During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70). Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively). Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. Conclusions Analysis of the data of this nationwide study reflects disease-specific health services research and will give insights into the cost impacts of antiretroviral therapy, and might allow a more rational allocation of resources within the German health care system. PMID:21931626

Calculation of direct antiretroviral treatment costs and potential cost savings by using generics in the German HIV ClinSurv cohort.

PubMed

Stoll, Matthias; Kollan, Christian; Bergmann, Frank; Bogner, Johannes; Faetkenheuer, Gerd; Fritzsche, Carlos; Hoeper, Kirsten; Horst, Heinz-August; van Lunzen, Jan; Plettenberg, Andreas; Reuter, Stefan; Rockstroh, Jürgen; Stellbrink, Hans-Jürgen; Hamouda, Osamah; Bartmeyer, Barbara

2011-01-01

BACKGROUND/AIM OF THE STUDY: The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART, -regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. Antiretroviral regimens (ART) from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC)-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70). Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively). Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. Analysis of the data of this nationwide study reflects disease-specific health services research and will give insights into the cost impacts of antiretroviral therapy, and might allow a more rational allocation of resources within the German health care system.

Evaluating change in virtual reality adoption for brain injury rehabilitation following knowledge translation.

PubMed

Glegg, Stephanie M N; Holsti, Liisa; Stanton, Sue; Hanna, Steven; Velikonja, Diana; Ansley, Barbara; Sartor, Denise; Brum, Christine

2017-04-01

To evaluate the impact of knowledge translation (KT) on factors influencing virtual reality (VR) adoption and to identify support needs of therapists. Intervention will be associated with improvements in therapists' perceived ease of use and self-efficacy, and an associated increase in intentions to use VR. Single group mixed-methods pre-test-post-test evaluation of convenience sample of physical, occupational and rehabilitation therapists (n=37) from two brain injury rehabilitation centres. ADOPT-VR administered pre/post KT intervention, consisting of interactive education, clinical manual, technical and clinical support. Increases in perceived ease of use (p=0.000) and self-efficacy (p=0.001), but not behavioural intention to use VR (p=0.158) were found following KT, along with decreases in the frequency of perceived barriers. Post-test changes in the frequency and nature of perceived facilitators and barriers were evident, with increased emphasis on peer influence, organisational-level supports and client factors. Additional support needs were related to clinical reasoning, treatment programme development, technology selection and troubleshooting. KT strategies hold potential for targeting therapists' perceptions of low self-efficacy and ease of use of this technology. Changes in perceived barriers, facilitators and support needs at post-test demonstrated support for repeated evaluation and multi-phased training initiatives to address therapists' needs over time. Implications for Rehabilitation Therapists' learning and support needs in integrating virtual reality extend beyond technical proficiency to include clinical decision-making and application competencies spanning the entire rehabilitation process. Phased, multi-faceted strategies may be valuable in addressing therapists' changing needs as they progress from novice to experienced virtual reality users. The ADOPT-VR is a sensitive measure to re-evaluate the personal, social, environmental, technology-specific and system-level factors influencing virtual reality adoption over time.

The ascent to competence conceptual framework: an outcome of a study of belongingness.

PubMed

Levett-Jones, Tracy; Lathlean, Judith

2009-10-01

This paper presents qualitative findings from a study that explored nursing students' experience of belongingness when undertaking clinical placements. The aim is to locate the professional and practical implications of the research within an Ascent to Competence conceptual framework. The need to belong exerts a powerful influence on cognitive processes, emotional patterns, behavioural responses, health and well-being and failure to satisfy this need can have devastating consequences. The literature suggests that diminished belongingness may impede students' motivation for learning and influence the degree to which they are willing to conform rather than adopt a questioning approach to clinical practice. A mixed methods, cross national, multi-site case study approach was adopted with third-year preregistration nursing students from three universities (two in Australia and one in England) participating; 362 in the quantitative phase and 18 in the qualitative phase. Qualitative findings demonstrated that, although the primary purpose of clinical education is to facilitate students' progress towards the attainment of competence, the realisation of this goal is impacted by a wide range of individual, interpersonal, contextual and organisational factors which can be conceptualised hierarchically. By this structuring it is possible to see how belongingness is a crucial precursor to students' learning and success. The framework demonstrates that students progress to a stage where attainment of competence is possible only after their previous needs for safety and security, belongingness, healthy self-concept and learning have been met. The future of the nursing profession depends upon the development of confident, competent professionals with a healthy self-concept and a commitment to patient-centred care and self-directed learning. This paper demonstrates that the realisation of this goal is strongly influenced by the extent to which students' clinical placement experiences promote and enhance their sense of belonging.

Emergence of VIM-4 metallo-β-lactamase-producing Klebsiella pneumoniae ST15 clone in the Clinical Centre University of Pécs, Hungary.

PubMed

Melegh, S; Kovács, K; Gám, T; Nyul, A; Patkó, B; Tóth, A; Damjanova, I; Mestyán, G

2014-01-01

Since November 2009 carbapenemase-producing Klebsiella pneumoniae isolates have been detected in increasing numbers at the Clinical Centre University of Pécs. Molecular typing was performed for 102 clinical isolates originating from different time periods and various departments of the Clinical Centre. Pulsed-field gel electrophoresis revealed the predominance of a single clone (101/102), identified as sequence type ST15. PCR and sequencing showed the presence of blaCTX-M-15 and blaVIM-4 genes. The blaVIM-4 was located on a class 1 integron designated In238b. To our knowledge, this is the first description of a blaVIM-4 gene in the predominant CTX-M-15 extended spectrum β-lactamase-producing Hungarian Epidemic Clone/ST15. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Criteria for EASO-collaborating centres for obesity management.

PubMed

Tsigos, Constantine; Hainer, Vojtech; Basdevant, Arnaud; Finer, Nick; Mathus-Vliegen, Elisabeth; Micic, Dragan; Maislos, Maximo; Roman, Gabriela; Schutz, Yves; Toplak, Hermann; Yumuk, Volkan; Zahorska-Markiewicz, Barbara

2011-01-01

Obesity is recognised as a global epidemic and the most prevalent metabolic disease world-wide. Specialised obesity services, however, are not widely available in Europe, and obesity care can vary enormously across European regions. The European Association for the Study of Obesity (EASO, www.easo.org) has developed these criteria to form a pan-European network of accredited EASO-Collaborating Centres for Obesity Management (EASO-COMs) in accordance with accepted European and academic guidelines. This network will include university, public and private clinics and will ensure that the obese and overweight patient is managed by a holistic team of specialists and receives comprehensive state-ofthe-art clinical care. Furthermore, the participating centres, under the umbrella of EASO, will work closely for quality control, data collection, and analysis as well as for education and research for the advancement of obesity care and obesity science. Copyright © 2011 S. Karger AG, Basel.

Inpatient antibiotic consumption in a regional secondary hospital in New Zealand.

PubMed

Hopkins, C J

2014-02-01

Reporting of antibiotic consumption in hospitals is a crucial component of antibiotic stewardship, but data from Australasian secondary hospitals are scarce. The hypothesis of this audit is that antibiotic consumption in secondary hospitals would be lower than in tertiary centres. The study aims to present the first published audit of antibiotic consumption from a secondary hospital in New Zealand compared with two tertiary centres. Hospital population-level data were retrospectively accessed to identify all systemic antibiotics dispensed to adult inpatients at Taranaki District Health Board during 2011. Consumption was calculated in defined daily doses per 100 inpatient-days and per 100 admissions, stratified by drug class. Comparison was against published data from two tertiary centres. Total consumption was lower, but that of high-risk antibiotic classes was higher than both tertiary centres. The relative consumption of lincosamides was 4.0 and 2.6 times higher than the two tertiary centres, with an associated 14% incidence of Clostridium difficile associated diarrhoea within 3 months. Our secondary hospital appears to consume the wrong types of antibiotic rather than too much. Data from all Australasian hospitals, stratified by clinical service area and hospital level, are required for clinically relevant benchmarking. © 2014 The Author; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

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.

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.

Multi-wavelength analysis of Ellerman Bomb Light Curves

NASA Astrophysics Data System (ADS)

Herlender, M.; Berlicki, A.

We present the results of a multi-wavelength photometric analysis of Ellerman Bomb (EB) observations obtained from the Dutch Open Telescope. In our data we have found 6 EBs located in the super-penumbra of the main spot in the active region NOAA 10781. We present light curves of EB observed in the Hα line centre and wing +0.7 Å, in the Ca II H line centre and wing~+2.35 Å, in the G-band and in the TRACE 1600 Å filter. We have shown that EBs were visible in the G-band and moreover, there was a good correlation between the light curves in the G-band and in the Hα line wings. We also found quasi-periodic oscillations of EBs brightness in the G-band, CaII H line and TRACE 1600 Å filter.

A joint procedural position statement on imaging in cardiac sarcoidosis: from the Cardiovascular and Inflammation & Infection Committees of the European Association of Nuclear Medicine, the European Association of Cardiovascular Imaging, and the American Society of Nuclear Cardiology.

PubMed

2017-10-01

This joint position paper illustrates the role and the correct use of echocardiography, radionuclide imaging with 18F-fluorodeoxyglucose positron emission tomography, radionuclide myocardial perfusion imaging and cardiovascular magnetic resonance imaging for the evaluation and management of patients with known or suspected cardiac sarcoidosis. This position paper will aid in standardizing imaging for cardiac sarcoidosis and may facilitate clinical trials and pooling of multi-centre data on cardiac sarcoidosis. Proposed flow charts for the work up and management of cardiac sarcoidosis are included. Copyright © 2017 European Association of Nuclear Medicine, the European Association of Cardiovascular Imaging, and the American Society of Nuclear Cardiology.

Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care

PubMed Central

2011-01-01

Background An effective malaria vaccine, deployed in conjunction with other malaria interventions, is likely to substantially reduce the malaria burden. Efficacy against severe malaria will be a key driver for decisions on implementation. An initial study of an RTS, S vaccine candidate showed promising efficacy against severe malaria in children in Mozambique. Further evidence of its protective efficacy will be gained in a pivotal, multi-centre, phase III study. This paper describes the case definitions of severe malaria used in this study and the programme for standardized assessment of severe malaria according to the case definition. Methods Case definitions of severe malaria were developed from a literature review and a consensus meeting of expert consultants and the RTS, S Clinical Trial Partnership Committee, in collaboration with the World Health Organization and the Malaria Clinical Trials Alliance. The same groups, with input from an Independent Data Monitoring Committee, developed and implemented a programme for standardized data collection. The case definitions developed reflect the typical presentations of severe malaria in African hospitals. Markers of disease severity were chosen on the basis of their association with poor outcome, occurrence in a significant proportion of cases and on an ability to standardize their measurement across research centres. For the primary case definition, one or more clinical and/or laboratory markers of disease severity have to be present, four major co-morbidities (pneumonia, meningitis, bacteraemia or gastroenteritis with severe dehydration) are excluded, and a Plasmodium falciparum parasite density threshold is introduced, in order to maximize the specificity of the case definition. Secondary case definitions allow inclusion of co-morbidities and/or allow for the presence of parasitaemia at any density. The programmatic implementation of standardized case assessment included a clinical algorithm for evaluating seriously sick children, improvements to care delivery and a robust training and evaluation programme for clinicians. Conclusions The case definition developed for the pivotal phase III RTS, S vaccine study is consistent with WHO recommendations, is locally applicable and appropriately balances sensitivity and specificity in the diagnosis of severe malaria. Processes set up to standardize severe malaria data collection will allow robust assessment of the efficacy of the RTS, S vaccine against severe malaria, strengthen local capacity and benefit patient care for subjects in the trial. Trial registration Clinicaltrials.gov NCT00866619 PMID:21816031

Measurement of sitting balance using the Manchester Active Position Seat (MAPS): a feasibility study.

PubMed

Powell, E S; Pyburn, R E; Hill, E; Smith, K S; Ribbands, M S; Mickelborough, J; Pomeroy, V M

2002-09-01

Evaluation of the effectiveness of therapy to improve sitting balance has been hampered by the limited number of sensitive objective clinical measures. We developed the Manchester Active Position Seat (MAPS) to provide a portable system to track change in the position of centre of force over time. (1) To investigate whether there is correspondence between the measurement of position change by a forceplate and by MAPS. (2) To explore whether and how MAPS measures changes in position when seated healthy adults change posture. A feasibility study. (1) An adult subject sat on MAPS placed on top of a forceplate. The x and y coordinates of the centre of pressure recorded from the forceplate and centre of force from MAPS during movement were compared graphically. (2) Four adults sat on MAPS using a standardized starting position and moving into six sets of six standardized target postures in a predetermined randomized order. The absolute shift in centre of force from the starting position was calculated. (1) The pattern of change of position over time was similar for the forceplate and for MAPS although there was a measurement difference, which increased with distance from the centre. (2) The direction of change of position corresponded to the direction of movement to the target postures but the amount of change varied between subjects. MAPS shows promise as an objective clinical measure of sitting balance, but peripheral accuracy of measurement needs to be improved.

Structured assessment of current mental state in clinical practice: an international study of the reliability and validity of the Current Psychiatric State interview, CPS-50.

PubMed

Falloon, I R H; Mizuno, M; Murakami, M; Roncone, R; Unoka, Z; Harangozo, J; Pullman, J; Gedye, R; Held, T; Hager, B; Erickson, D; Burnett, K

2005-01-01

To develop a reliable standardized assessment of psychiatric symptoms for use in clinical practice. A 50-item interview, the Current Psychiatric State 50 (CPS-50), was used to assess 237 patients with a range of psychiatric diagnoses. Ratings were made by interviewers after a 2-day training. Comparisons of inter-rater reliability on each item and on eight clinical subscales were made across four international centres and between psychiatrists and non-psychiatrists. A principal components analysis was used to validate these clinical scales. Acceptable inter-rater reliability (intra-class coefficient > 0.80) was found for 46 of the 50 items, and for all eight subscales. There was no difference between centres or between psychiatrists and non-psychiatrists. The principal components analysis factors were similar to the clinical scales. The CPS-50 is a reliable standardized assessment of current mental status that can be used in clinical practice by all mental health professionals after brief training. Blackwell Munksgaard 2004

Clinical and imaging services for TIA and minor stroke: results of two surveys of practice across the UK

PubMed Central

Brazzelli, Miriam; Shuler, Kirsten; Quayyum, Zahid; Hadley, Donald; Muir, Keith; McNamee, Paul; De Wilde, Janet; Dennis, Martin; Sandercock, Peter; Wardlaw, Joanna M

2013-01-01

Objectives Transient ischaemic attack (TIA) is a medical emergency requiring rapid access to effective, organised, stroke prevention. There are about 90 000 TIAs per year in the UK. We assessed whether stroke-prevention services in the UK meet Government targets. Design Cross-sectional survey. Setting All UK clinical and imaging stroke-prevention services. Intervention Electronic structured survey delivered over the web with automatic recording of responses into a database; reminders to non-respondents. The survey sought information on clinic frequency, staff, case-mix, details of brain and carotid artery imaging, medical and surgical treatments. Results 114 stroke clinical and 146 imaging surveys were completed (both response rates 45%). Stroke-prevention services were available in most (97%) centres but only 31% operated 7 days/week. Half of the clinic referrals were TIA mimics, most patients (75%) were prescribed secondary prevention prior to clinic referral, and nurses performed the medical assessment in 28% of centres. CT was the most common and fastest first-line investigation; MR, used in 51% of centres, mostly after CT, was delayed up to 2 weeks in 26%; 51% of centres omitted blood-sensitive (GRE/T2*) MR sequences. Carotid imaging was with ultrasound in 95% of centres and 59% performed endarterectomy within 1 week of deciding to operate. Conclusions Stroke-prevention services are widely available in the UK. Delays to MRI, its use in addition to CT while omitting key sequences to diagnose haemorrhage, limit the potential benefit of MRI in stroke prevention, but inflate costs. Assessing TIA mimics requires clinical neurology expertise yet nurses run 28% of clinics. Further improvements are still required for optimal stroke prevention. PMID:23929917

Efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of sarcoptic mange and otoacariosis in dogs: results af a European field study.

PubMed

Krieger, K; Heine, J; Dumont, P; Hellmann, K

2005-10-01

Efficacy and safety of treatment with imidacloprid 10%+moxidectin 2.5% spot-on (Advocate, Advantage multi; Bayer AG, Leverkusen, Germany) were tested in dogs naturally infested with Sarcoptes scabiei or Otodectes cynotis in a multi-centre, controlled, randomized, blinded field study conducted in France, Germany, Albania and the UK. The study was performed according to a non-inferiority design to demonstrate that the efficacy of imidacloprid/moxidectin spot-on was not inferior to that of a control product containing selamectin (Stronghold spot-on; Pfizer). All Sarcoptes-infested dogs were topically treated twice (days 0 and 28) with the dosage recommended by the respective manufacturer (27 dogs with imidacloprid/moxidectin, 26 with selamectin). All Otodectes-infested dogs were treated on day 0 (35 dogs with imidacloprid/moxidectin, 34 with selamectin), and only those still positive on day 28 received a second treatment. Parasitological cure rate in Sarcoptes-infested dogs was 100% for both treatments, while parasitological cures rates in the Otodectes-infested dogs at day 28 and day 56 were 68.6 and 85.7% with imidacloprid/moxidectin, and 64.7 and 88.2% with Stronghold. Non-inferiority of Advocate was confirmed statistically. Clinical assessment of skin lesion scores at day 56 showed that with either product >96% of the dogs treated against sarcoptic mange were improved or cured, the difference between the groups being non-significant. On the basis of a final clinical assessment of lesion scores, 80% of the dogs treated with imidacloprid/moxidectin against otoacariosis and 85.3% of those treated with selamectin were rated cured or improved. Only three mild, possibly drug-related adverse reactions were observed among alI treated animals (two in the imidacloprid/moxidectin group, one in the selamectin group). It is concluded that imidacloprid/moxidectin spot-on is an effective and safe treatment for sarcoptic mange and otoacariosis in the dog.

Adaptive capacity of the Adjusted Clinical Groups Case-Mix System to the cost of primary healthcare in Catalonia (Spain): a observational study.

PubMed

Sicras-Mainar, Antoni; Velasco-Velasco, Soledad; Navarro-Artieda, Ruth; Prados-Torres, Alexandra; Bolibar-Ribas, Buenaventura; Violan-Fors, Concepción

2012-01-01

To describe the adaptive capacity of the Adjusted Clinical Groups (ACG) system to the cost of care in primary healthcare centres in Catalonia (Spain). Retrospective study (multicentres) conducted using computerised medical records. 13 primary care teams in 2008 were included. All patients registered in the study centres who required care between 1 January and 31 December 2008 were finally studied. Patients not registered in the study centres during the study period were excluded. Demographic (age and sex), dependent (cost of care) and case-mix variables were studied. The cost model for each patient was established by differentiating the fixed and variable costs. To evaluate the adaptive capacity of the ACG system, Pearson's coefficient of variation and the percentage of outliers were calculated. To evaluate the explanatory power of the ACG system, the authors used the coefficient of determination (R(2)). The number of patients studied was 227 235 (frequency: 5.9 visits per person per year), with a mean of 4.5 (3.2) episodes and 8.1 (8.2) visits per patient per year. The mean total cost was €654.2. The explanatory power of the ACG system was 36.9% for costs (56.5% without outliers). 10 ACG categories accounted for 60.1% of all cases and 19 for 80.9%. 5 categories represented 71% of poor performance (N=78 887, 34.7%), particularly category 0300-Acute Minor, Age 6+ (N=26 909, 11.8%), which had a coefficient of variation =139% and 6.6% of outliers. The ACG system is an appropriate manner of classifying patients in routine clinical practice in primary healthcare centres in Catalonia, although improvements to the adaptive capacity through disaggregation of some categories according to age groups and, especially, the number of acute episodes in paediatric patients would be necessary to reduce intra-group variation.

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).

Assessing decision quality in patient-centred care requires a preference-sensitive measure

PubMed Central

Kaltoft, Mette; Cunich, Michelle; Salkeld, Glenn; Dowie, Jack

2014-01-01

A theory-based instrument for measuring the quality of decisions made using any form of decision technology, including both decision-aided and unaided clinical consultations is required to enable person- and patient-centred care and to respond positively to individual heterogeneity in the value aspects of decision making. Current instruments using the term ‘decision quality’ have adopted a decision- and thus condition-specific approach. We argue that patient-centred care requires decision quality to be regarded as both preference-sensitive across multiple relevant criteria and generic across all conditions and decisions. MyDecisionQuality is grounded in prescriptive multi criteria decision analysis and employs a simple expected value algorithm to calculate a score for the quality of a decision that combines, in the clinical case, the patient’s individual preferences for eight quality criteria (expressed as importance weights) and their ratings of the decision just taken on each of these criteria (expressed as performance rates). It thus provides an index of decision quality that encompasses both these aspects. It also provides patients with help in prioritizing quality criteria for future decision making by calculating, for each criterion, the Incremental Value of Perfect Rating, that is, the increase in their decision quality score that would result if their performance rating on the criterion had been 100%, weightings unchanged. MyDecisionQuality, which is a web-based generic and preference-sensitive instrument, can constitute a key patient-reported measure of the quality of the decision-making process. It can provide the basis for future decision improvement, especially when the clinician (or other stakeholders) completes the equivalent instrument and the extent and nature of concordance and discordance can be established. Apart from its role in decision preparation and evaluation, it can also provide real time and relevant documentation for the patient’s record. PMID:24335587

A multi-centre qualitative study exploring the experiences of UK South Asian and White Diabetic Patients referred for renal care

PubMed Central

2012-01-01

Background An exploration of renal complications of diabetes from the patient perspective is important for developing quality care through the diabetic renal disease care pathway. Methods Newly referred South Asian and White diabetic renal patients over 16 years were recruited from nephrology outpatient clinics in three UK centres - Luton, West London and Leicester – and their experiences of the diabetes and renal care recorded. A semi-structured qualitative interview was conducted with 48 patients. Interview transcripts were analysed thematically and comparisons made between the White and South Asian groups. Results 23 South Asian patients and 25 White patients were interviewed. Patient experience of diabetes ranged from a few months to 35 years with a mean time since diagnosis of 12.1 years and 17.1 years for the South Asian and White patients respectively. Confusion emerged as a response to referral shared by both groups. This sense of confusion was associated with reported lack of information at the time of referral, but also before referral. Language barriers exacerbated confusion for South Asian patients. Conclusions The diabetic renal patients who have been referred for specialist renal care and found the referral process confusing have poor of awareness of kidney complications of diabetes. Healthcare providers should be more aware of the ongoing information needs of long term diabetics as well as the context of any information exchange including language barriers. PMID:23176053

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.

Primary Care Collaborative Memory Clinics: Building Capacity for Optimized Dementia Care.

PubMed

Lee, Linda; Hillier, Loretta M; Molnar, Frank; Borrie, Michael J

2017-01-01

Increasingly, primary care collaborative memory clinics (PCCMCs) are being established to build capacity for person-centred dementia care. This paper reflects on the significance of PCCMCs within the system of care for older adults, supported with data from ongoing evaluation studies. Results highlight timelier access to assessment with a high proportion of patients being managed in primary care within a person-centred approach to care. Enhancing primary care capacity for dementia care with interprofessional and collaborative care will strengthen the system's ability to respond to increasing demands for service and mitigate the growth of wait times to access geriatric specialist assessment.

Structure, organisation and clinical outcomes in cancer patients of hospital support teams in Spain.

PubMed

Tuca-Rodriguez, Albert; Gómez-Batiste, Xavier; Espinosa-Rojas, Jose; Martínez-Muñoz, Marisa; Codorniu, Nuria; Porta-Sales, Josep

2012-12-01

To describe the structure, characteristics of patients and basic clinical outcomes in cancer patients receiving care from palliative care hospital support teams (HSTs) in Spain. A multi-centre observational two phase study. Phase I: A descriptive survey of all HSTs in Spain. Phase II: A quasi-experimental prospective cohort study to describe the clinical outcomes, symptom severity and survival. 60 HSTs in Spain met the inclusion criteria. All HSTs were multidisciplinary with wide experience (mean 6.8 years). HSTs coverage was 21.5% of all cancer deaths in Spain. A total number of 364 advanced cancer patients were included in the cohort study; 76% were classified as moderate or high complexity. Overall, 64% were male subjects and the most frequent primary cancer site was lung (26%). Half of the patients had no detailed information about cancer staging and only 19% knew their short-term prognosis. The mean length of intervention was 6.5 days (mean three visits per patient). Outcomes were: 34% deaths during the admission process; 38% were discharged home; and 28% were transferred to another medium-term-stay specialist unit. The main symptoms were pain (68%), dyspnoea (43%), vomiting (24%), anorexia (72%), asthenia (78%), insomnia (50%), anxiety (45%) and depression (35%). After the HSTs intervention, the symptom severity was significantly reduced (p<0.001) for all symptoms, except for weakness and anorexia. The mean survival from inclusion was 111 days. Palliative intervention of HSTs is characterised by being adjusted to patient needs and short duration. Their care was focused on the preterminal phase of cancer patients of moderate-high complexity.

Antimicrobial resistance in patients with urinary tract infections and the impact on empiric therapy in Serbia.

PubMed

Zec, Simon; Despotovic, Aleksa; Spurnic-Radovanovic, Aleksandra; Milosevic, Ivana; Jovanovic, Milica; Pelemis, Mijomir; Stevanovic, Goran

2016-10-31

Surveillance of antimicrobial resistance is essential in establishing treatment guidelines for urinary tract infections. The aim of this pilot study was to analyse resistance rates of pathogens, across different demographics and determine whether adjustments in empiric therapy should be considered for different age and gender groups. A 5-year retrospective study included 256 patients hospitalised, under the initial diagnosis of Fever of Unknown Origin who were then subsequently diagnosed with a urinary tract infection at the Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia. Patients were evaluated using demographic, clinical, and antimicrobial resistance data with appropriate statistical analysis including ANOVA significance testing, univariate, and multivariate analysis. Resistance rates were above the threshold of 20% for the majority of the antimicrobials tested, the only exception being carbapenems. Amikacin, cefepime, and norfloxacin were agents that could be effectively used as empiric therapy in younger adults with resistance rates of 4.2, 8.0, and 10.0%, respectively. Moderate resistance rates of 17.4% for amikacin and 19.1% for cefepime were observed in the age group 35-64 years. High resistance rates were observed for all antimicrobials among patients 65 years and over. Among male patients, resistance rates to most antimicrobials were high. In female patients, amikacin and cefepime had resistance rates less than 20%. Younger age presented as a negative risk factor for infection by a multi-drug resistant pathogen. Age and gender demonstrated to be significant factors for determining proper empiric therapy; large-scale studies from Serbia are needed to solidify these findings.

Functional Imaging in Radiotherapy in the Netherlands: Availability and Impact on Clinical Practice.

PubMed

Vogel, W V; Lam, M G E H; Pameijer, F A; van der Heide, U A; van de Kamer, J B; Philippens, M E; van Vulpen, M; Verheij, M

2016-12-01

Functional imaging with positron emission tomography/computed tomography (PET/CT) and multiparametric magnetic resonance (mpMR) is increasingly applied for radiotherapy purposes. However, evidence and experience are still limited, and this may lead to clinically relevant differences in accessibility, interpretation and decision making. We investigated the current patterns of care in functional imaging for radiotherapy in the Netherlands in a care evaluation study. The availability of functional imaging in radiotherapy centres in the Netherlands was evaluated; features available in >80% of academic and >80% of non-academic centres were considered standard of care. The impact of functional imaging on clinical decision making was evaluated using case questionnaires on lung, head/neck, breast and prostate cancer, with multiple-choice questions on primary tumour delineation, nodal involvement, distant metastasis and incidental findings. Radiation oncologists were allowed to discuss cases in a multidisciplinary approach. Ordinal answers were evaluated by median and interquartile range (IQR) to identify the extent and variability of clinical impact; additional patterns were evaluated descriptively. Information was collected from 18 radiotherapy centres in the Netherlands (all except two). PET/CT was available for radiotherapy purposes to 94% of centres; 67% in the treatment position and 61% with integrated planning CT. mpMR was available to all centres; 61% in the treatment position. Technologists collaborated between departments to acquire PET/CT or mpMR for radiotherapy in 89%. All sites could carry out image registration for target definition. Functional imaging generally showed a high clinical impact (average median 4.3, scale 1-6) and good observer agreement (average IQR 1.1, scale 0-6). However, several issues resulted in ignoring functional imaging (e.g. positional discrepancies, central necrosis) or poor observer agreement (atelectasis, diagnostic discrepancies, conformation strategies). Access to functional imaging with PET/CT and mpMR for radiotherapy purposes, with collaborating technologists and multimodal delineation, can be considered standard of care in the Netherlands. For several specific clinical situations, the interpretation of images may benefit from further standardisation. Copyright © 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Ascertainment bias in dementias: a secondary to tertiary centre analysis in Central Italy and conceptual review.

PubMed

Bonanni, L; Bontempo, G; Borrelli, I; Bifolchetti, S; Buongarzone, M P; Carlesi, N; Carolei, A; Ciccocioppo, F; Colangelo, U; Colonna, G; Desiderio, M; Ferretti, S; Fiorelli, L; D'Alessio, O; D'Amico, A; D'Amico, M C; De Lucia, R; Del Re, L; Di Blasio, F; Di Giacomo, R; Di Iorio, A; Di Santo, E; Di Giuseppe, M; Felice, N; Litterio, P; Gabriele, A; Mancino, E; Manzoli, L; Maruotti, V; Mearelli, S; Molino, G; Monaco, D; Nuccetelli, F; Onofrj, M; Perfetti, B; Sacchet, C; Sensi, F; Sensi, S; Sucapane, P; Taylor, J P; Thomas, A; Viola, P; Viola, S; Zito, M; Zhuzhuni, H

2013-06-01

Ascertainment bias (AB) indicates a bias of an evaluation centre in estimating the prevalence/incidence of a disease due to the specific expertise of the centre. The aim of our study was to evaluate classification of different types of dementia in new cases appearing in secondary and tertiary centres, in order to evidence possible occurrence of AB in the various (secondary to tertiary) dementia centres. To assess the mechanism of AB, the rates of new cases of the different forms of dementia reported by different centres were compared. The centres involved in the study were 11 hospital-based centres including a tertiary centre, located in the University Department of Clinical Neurology. The tertiary centre is endowed with state-of-the-art diagnostic facilities and its scientific production is prominently focused on dementia with Lewy bodies (DLB) thus suggesting the possible occurrence of a bias. Four main categories of dementia were identified: Alzheimer's disease (AD), DLB, fronto-temporal dementia (FTD), vascular dementia (VaD), with other forms in a category apart. The classification rate of new cases of dementia in the tertiary centre was compared with rates reported by secondary centres and rates of recoding were calculated during a follow-up of 2 years. The study classified 2,042 newly diagnosed cases of dementia in a population of 1,370,000 inhabitants of which 315,000 were older than 65. AD was categorized in 48-52 % of cases, DLB in 25-28 %, FTD in 2-4 % and VaD in 17-28 %. During the 2-year follow-up the diagnosis was re-classified in 40 patients (3 %). The rate of recoding was 5 % in the tertiary centre, 2-8 % in referrals from secondary to tertiary centre, 2-10 % in recodings performed in secondary centres and addressed to tertiary centre. Recoding or percentages of new cases of AD or DLB were not different in the comparison between secondary or between secondary and tertiary centres. FTD and VaD were instead significantly recoded. The results of the study suggest that in a homogeneous area, AB is not interfering with diagnosis of AD or DLB.