Sample records for people study protocol

  1. Multitask protocols to evaluate activities of daily living performance in people with COPD: a systematic review.

    PubMed

    Paes, Thaís; Machado, Felipe Vilaça Cavallari; Cavalheri, Vinícius; Pitta, Fabio; Hernandes, Nidia Aparecida

    2017-07-01

    People with chronic obstructive pulmonary disease (COPD) present symptoms such as dyspnea and fatigue, which hinder their performance in activities of daily living (ADL). A few multitask protocols have been developed to assess ADL performance in this population, although measurement properties of such protocols were not yet systematically reviewed. Areas covered: Studies were included if an assessment of the ability to perform ADL was conducted in people with COPD using a (objective) performance-based protocol. The search was conducted in the following databases: Pubmed, EMBASE, Cochrane Library, PEDro, CINAHL and LILACS. Furthermore, hand searches were conducted. Expert commentary: Up to this moment, only three protocols had measurement properties described: the Glittre ADL Test, the Monitored Functional Task Evaluation and the Londrina ADL Protocol were shown to be valid and reliable whereas only the Glittre ADL Test was shown to be responsive to change after pulmonary rehabilitation. These protocols can be used in laboratory settings and clinical practice to evaluate ADL performance in people with COPD, although there is need for more in-depth information on their validity, reliability and especially responsiveness due to the growing interest in the accurate assessment of ADL performance in this population.

  2. Surgical versus non-surgical management of abdominal injury.

    PubMed

    Oyo-Ita, Angela; Chinnock, Paul; Ikpeme, Ikpeme A

    2015-11-13

    Injury to the abdomen can be blunt or penetrating. Abdominal injury can damage internal organs such as the liver, spleen, kidneys, intestine, and large blood vessels. There are controversies about the best approach to manage abdominal injuries. To assess the effects of surgical and non-surgical interventions in the management of abdominal trauma in a haemodynamically stable and non-peritonitic abdomen. We searched the Cochrane Injuries Group's Specialised Register, The Cochrane Library, Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), EMBASE Classic+EMBASE (Ovid), ISI WOS (SCI-EXPANDED, SSCI, CPCI-S & CPSI-SSH), CINAHL Plus (EBSCO), and clinical trials registers, and screened reference lists. We ran the most recent search on 17 September 2015. Randomised controlled trials of surgical interventions and non-surgical interventions involving people with abdominal injury who were haemodynamically stable with no signs of peritonitis. The abdominal injury could be blunt or penetrating. Two review authors independently applied the selection criteria. Data were extracted by two authors using a standard data extraction form, and are reported narratively. Two studies are included, which involved a total of 114 people with penetrating abdominal injuries. Both studies are at moderate risk of bias because the randomisation methods are not fully described, and the original study protocols are no longer available. The studies were undertaken in Finland between 1992 and 2002, by the same two researchers.In one study, 51 people were randomised to surgery or an observation protocol. None of the participants in the study died. Seven people had complications: 5 (18.5%) in the surgical group and 2 (8.3%) in the observation group; the difference was not statistically significant (P = 0.42; Fischer's exact). Among the 27 people who had surgery, 6 (22.2%) surgeries were negative laparotomies, and 15 (55.6%) were non-therapeutic.In the other study, 63 people were randomised to diagnostic laparoscopy (surgery) or an observation protocol. There were no deaths and no unnecessary surgeries in either group. Four people did not receive the intervention they were assigned. There was no difference in therapeutic operations between the two groups: 3 of 28 in the diagnostic laparoscopy group versus 1 of 31 in the observation protocol group (P = 0.337). Based on the findings of 2 studies involving a total of 114 people, there is no evidence to support the use of surgery over an observation protocol for people with penetrating abdominal trauma who have no signs of peritonitis and are stable.

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

    Vogt

    This report describes a U.S. Department of Energy, (DOE) Chemical and Biological National Security Program project that sought to establish what is known about decontamination of structures, objects, and people following an exposure to chemical or biological materials. Specifically we sought to identify the procedures and protocols used to determine when and how people or buildings are considered ''clean'' following decontamination. To fulfill this objective, the study systematically examined reported decontamination experiences to determine what procedures and protocols are currently employed for decontamination, the timeframe involved to initiate and complete the decontamination process, how the contaminants were identified, the factorsmore » determining when people were (or were not) decontaminated, the problems encountered during the decontamination process, how response efforts of agencies were coordinated, and the perceived social psychological effects on people who were decontaminated or who participated in the decontamination process. Findings and recommendations from the study are intended to aid decision-making and to improve the basis for determining appropriate decontamination protocols for recovery planners and policy makers for responding to chemical and biological events.« less

  4. Lessons Learned from Decontamination Experiences

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

    Sorensen, JH

    2000-11-16

    This interim report describes a DOE project currently underway to establish what is known about decontamination of buildings and people and the procedures and protocols used to determine when and how people or buildings are considered ''clean'' following decontamination. To fulfill this objective, the study systematically examined reported decontamination experiences to determine what procedures and protocols are currently employed for decontamination, the timeframe involved to initiate and complete the decontamination process, how the contaminants were identified, the problems encountered during the decontamination process, how response efforts of agencies were coordinated, and the perceived social psychological effects on people who weremore » decontaminated or who participated in the decontamination process. Findings and recommendations from the study are intended to aid decision-making and to improve the basis for determining appropriate decontamination protocols for recovery planners and policy makers for responding to chemical and biological events.« less

  5. Interdisciplinary collaboration in the use of a music-with-movement intervention to promote the wellbeing of people with dementia and their families: Development of an evidence-based intervention protocol.

    PubMed

    Lai, Claudia K Y; Lai, Daniel L L; Ho, Jacqueline S C; Wong, Kitty K Y; Cheung, Daphne S K

    2016-03-01

    The music-with-movement intervention is particularly suitable for people with dementia because their gross motor ability is preserved until the later stage of dementia. This study examines the effect of music-with-movement on reducing anxiety, sleep disturbances, and improving the wellbeing of people with dementia. This paper reports the first stage of the study - developing the intervention protocol that staff can use to teach family caregivers. A registered music therapist developed a music-with-movement protocol and taught staff of two social service centers over five weekly 1.5 h sessions, with center-in-charges (social workers and occupational therapists) and our research team joining these sessions to provide comments from their professional perspective. Each discipline had different expectations about the content; therefore, numerous meetings and discussions were held to bridge these differences and fine-tune the protocol. Few healthcare professionals doubt the merits of interdisciplinary collaboration at all levels of health promotion. In practice, interdisciplinary collaboration is complex and requires commitment. Openness and persistence is required from all stakeholders to achieve a successful intervention for consumers. © 2015 Wiley Publishing Asia Pty Ltd.

  6. Evaluation of the clinical protocol quality for family planning services of people living with HIV/AIDS.

    PubMed

    Brasil, Raquel Ferreira Gomes; Silva, Maria Josefina da; Moura, Escolástica Rejane Ferreira

    2018-01-01

    To evaluate the quality of a clinical protocol for family planning care for people living with HIV/AIDS. An evaluative study based on the six domains of the Appraisal of Guidelines for Research & Evaluation II and on Pearson's Coefficient of Variation. The protocol reached between 88.8% and 100.0% quality in the domains of the Appraisal of Guidelines for Research & Evaluation II and 93.3% in the overall evaluation. The obtained Pearson's coefficient of variation was between zero and 18.6. Considering that a minimum percentage of 70.0% was adopted for the quality attributed by the evaluators, quality has been achieved for all domains of the Appraisal of Guidelines for Research & Evaluation II. As a coefficient for all domains was less than 25%, we can infer that the scores attributed by the evaluators were linear or homogeneous, meaning high agreement between them. The protocol was evaluated as a quality instrument, recommended for use by health professionals who deal with family planning for people living with HIV/AIDS.

  7. Validity, reliability and feasibility of commercially available activity trackers in physical therapy for people with a chronic disease: a study protocol of a mixed methods research.

    PubMed

    Beekman, Emmylou; Braun, Susy M; Ummels, Darcy; van Vijven, Kim; Moser, Albine; Beurskens, Anna J

    2017-01-01

    For older people and people with a chronic disease, physical activity provides health benefits. Patients and healthcare professionals can use commercially available activity trackers to objectively monitor (alterations in) activity levels and patterns and to support physical activity. However, insight in the validity, reliability, and feasibility of these trackers in people with a chronic disease is needed. In this article, a study protocol is described in which the validity, reliability (part A), and feasibility from a patient and therapist's point of view (part B) of commercially available activity trackers in daily life and health care is investigated. In part A, a quantitative cross-sectional study, an activity protocol that simulates everyday life activities will be used to determine the validity and reliability of nine commercially available activity trackers. Video recordings will act as the gold standard. In part B, a qualitative participatory action research study will be performed to gain insight in the use of activity trackers in peoples' daily life and therapy settings. Objective feasibility of the activity trackers will be measured with questionnaires, and subjective feasibility (experiences) will be explored in a community of practice. Physical therapists ( n  = 8) will regularly meet during 6 months to learn from each other regarding the actual use of activity trackers in therapy. Therapists and patients ( n  = 48) will decide together which tracker will be used in therapy and for which purpose (e.g., monitoring, goal setting). Data from the therapist' and patients' experiences will be collected by interviews (individual and focus groups) and analyzed by a directed content analysis. At the time of submission, selection of activity trackers, development of the activity protocol, and the ethical approval process are finished. Data collection and data processing are ongoing. The relevance of the study as well as the advantages and disadvantages of several aspects of the chosen design are discussed. The results acquired from both study parts can be used to create decision aids that may assist therapists and people with a chronic disease in choosing a suitable activity tracker, and to facilitate use of these activity trackers in health care settings. Ethical approval has been obtained from two medical-ethical committees (nr. 15-N-109, 15-N-48 and MEC-15-07).

  8. Evaluating the effectiveness of different approaches to home support for people in later stage dementia: a protocol for an observational study.

    PubMed

    Chester, Helen; Clarkson, Paul; Hughes, Jane; Russell, Ian; Beresford, Joan; Davies, Linda; Jolley, David; Peconi, Julie; Poland, Fiona; Roberts, Chris; Sutcliffe, Caroline; Challis, David

    2017-07-01

    Dementia is a major health problem with a growing number of people affected by the condition, both directly and indirectly through caring for someone with dementia. Many live at home but little is known about the range and intensity of the support they receive. Previous studies have mainly reported on discrete services within a single geographical area. This paper presents a protocol for study of different services across several sites in England. The aim is to explore the presence, effects, and cost-effectiveness of approaches to home support for people in later stage dementia and their carers. This is a prospective observational study employing mixed methods. At least 300 participants (people with dementia and their carers) from geographical areas with demonstrably different ranges of services available for people with dementia will be selected. Within each area, participants will be recruited from a range of services. Participants will be interviewed on two occasions and data will be collected on their characteristics and circumstances, quality of life, carer health and burden, and informal and formal support for the person with dementia. The structured interviews will also collect qualitative data to explore the perceptions of older people and carers. This national study will explore the components of appropriate and effective home support for people with late stage dementia and their carers. It aims to inform commissioners and service providers across health and social care.

  9. Safety of 8-aminoquinolines given to people with G6PD deficiency: protocol for systematic review of prospective studies

    PubMed Central

    Uthman, Olalekan A; Saunders, Rachel; Sinclair, David; Graves, Patricia; Gelband, Hellen; Clarke, Aileen; Garner, Paul

    2014-01-01

    Introduction A single dose or short course of primaquine given to people infected with malaria may reduce transmission of Plasmodium falciparum through its effects on gametocytes. Primaquine is also known to cause haemolysis in people with variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency. The objective of this systematic review was to assess the risk of adverse effects in people with G6PD deficiency given primaquine or other 8-aminoquinoline (8AQ) as a single dose or short course (less than 7 days). Methods and analysis We will search the following databases: Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. Prospective cohort studies, randomised and quasi-randomised trials that evaluated 8AQs for whatever reason in adults or children with a known G6PD deficiency will be included. Two authors will independently assess each study for eligibility, risk of bias and extract data. Ethics and dissemination This systematic review will be published in a peer-reviewed journal. Brief reports of the review findings will be disseminated directly to the appropriate audiences and the WHO Technical Expert Group in Malaria Chemotherapy. As no primary data collection will be undertaken, no additional formal ethical assessment and informed consent are required. Protocol registration in PROSPERO The protocol is registered with PROSPERO, registration number CRD42013006518. PMID:24833685

  10. Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial

    PubMed Central

    Haran, Mark J; Lord, Stephen R; Cameron, Ian D; Ivers, Rebecca Q; Simpson, Judy M; Lee, Bonsan B; Porwal, Mamta; Kwan, Marcella MS; Severino, Connie

    2009-01-01

    Background Recent research has shown that wearing multifocal glasses increases the risk of trips and falls in older people. The aim of this study is to determine whether the provision of single-lens distance glasses to older multifocal glasses wearers, with recommendations for wearing them for walking and outdoor activities, can prevent falls. We will also measure the effect of the intervention on health status, lifestyle activities and fear of falling, as well as the extent of adherence to the program. Methods/Design Approximately 580 older people who are regular wearers of multifocal glasses people will be recruited. Participants will be randomly allocated to either an intervention group (provision of single lens glasses, with counselling and advice about appropriate use) or a control group (usual care). The primary outcome measure will be falls (measured with 13 monthly calendars). Secondary measures will be quality of life, falls efficacy, physical activity levels and adverse events. Discussions The study will determine the impact of providing single-lens glasses, with advice about appropriate use, on preventing falls in older regular wearers of multifocal glasses. This pragmatic intervention, if found to be effective, will guide practitioners with regard to recommending appropriate glasses for minimising the risk of falls in older people. Trial Registration The protocol for this study was registered with the Clinical Trials.gov Protocol Registration System on June 7th 2006 (#350855). PMID:19321012

  11. Peer-led diabetes self-management programme for community-dwelling older people in China: study protocol for a quasi-experimental design.

    PubMed

    Shen, Huixia; Edwards, Helen; Courtney, Mary; McDowell, Jan; Wu, Ming

    2012-12-01

    A protocol for a new peer-led self-management programme for community-dwelling older people with diabetes in Shanghai, China. The increasing prevalence of type 2 diabetes poses major public health challenges. Appropriate education programmes could help people with diabetes to achieve self-management and better health outcomes. Providing education programmes to the fast growing number of people with diabetes present a real challenge to Chinese healthcare system, which is strained for personnel and funding shortages. Empirical literature and expert opinions suggest that peer education programmes are promising. Quasi-experimental. This study is a non-equivalent control group design (protocol approved in January, 2008). A total of 190 people, with 95 participants in each group, will be recruited from two different, but similar, communities. The programme, based on Social Cognitive Theory, will consist of basic diabetes instruction and social support and self-efficacy enhancing group activities. Basic diabetes instruction sessions will be delivered by health professionals, whereas social support and self-efficacy enhancing group activities will be led by peer leaders. Outcome variables include: self-efficacy, social support, self-management behaviours, depressive status, quality of life and healthcare utilization, which will be measured at baseline, 4 and 12 weeks. This theory-based programme tailored to Chinese patients has potential for improving diabetes self-management and subsequent health outcomes. In addition, the delivery mode, through involvement of peer leaders and existing community networks, is especially promising considering healthcare resource shortage in China. © 2012 Blackwell Publishing Ltd.

  12. [A novel method for targeting and characterizing healthy older people].

    PubMed

    Carrasco, Marcela; Martínez, Gabriel; Foradori, Arnaldo; Hoyl, Trinidad; Valenzuela, Eduardo; Quiroga, Teresa; Gac, Homero; Ihle, Sofia; Marin, Pedro Paulo

    2010-09-01

    there is no established definition of healthy aging in clinical practice, although it is a World Health Organization goal. to develop a clinical protocol to identify healthy older people living in the community and study their clinical, laboratory and functional characteristics. healthy people aged 60 years or older, were invited to participate in the study, by newspapers and radio, if they selfperceived as healthy, lived in the community, were functionally independent and had low disease burden. Potential participants were initially screened by telephone, and those who met the inclusion criteria were included. They had a comprehensive geriatric assessment which included clinical, anthropometric, laboratory and functional assessments. of 384 people who answered the call, 83 subjects aged 60 to 98 years (57% women) met the inclusion criteria of healthy older people. Seventy eight percent did not consume any medication, 100% were able to perform physical activities that required at least three metabolic equivalents (Mets). Basic laboratory showed that approximately 90% of subjects had normal values, using standard benchmarks established for an adult population. the protocol used in this work was able to identify healthy older people with low disease burden and good functionality. It also validated history and comprehensive geriatric assessment as reliable instruments to identify these subjects.

  13. [Nutritional self-care promotion in community-dwelling older people: a protocol of mixed method research].

    PubMed

    Raffaele, Barbara; Matarese, Maria; Piredda, Michela; De Marinis, Maria Grazia

    2016-01-01

    To describe a research protocol designed to promote nutritional self-care in older people. The aims of the research are: a) to evaluate the effectiveness of a nutritional education intervention in changing knowledge, attitudes, and behaviors; b) to describe the nutritional self-care ability and activities; c) to identify the promoting factors and barriers that influence the changes in nutritional knowledge, behaviors and attitudes in home-dwelling older people. Sequential explanatory mixed method design. The study will enroll 50 people aged 65 years and over. In the first quantitative phase, a pre-test and post-test design will be used to deliver a nutritional intervention aimed to change knowledge, behaviors and attitudes toward nutrition. Using the quantitative study results, the qualitative study phase will be conducted by interviews in sub-groups of older people. In a third phase, the quantitative and qualitative study results will be integrated. Quantitative data will be analyzed using descriptive and inferential statistics and qualitative data will be analyzed through content analysis. The study will provide new knowledge on nutritional self-care in home-dwelling older adults and the factors promoting nutritional self-care. Nutritional self-care promotion is of pivotal importance for the nursing care provided to home-dwelling older people. Educational programs aimed at the maintenance of proper nutrition in the older adults may reduce malnutrition and the related diseases. Nutrition educational programs should be based on knowledge derived from research to tailor individualized nutritional interventions and to realize effective educational programs.

  14. Protocol Analysis as a Method for Analyzing Conversational Data.

    ERIC Educational Resources Information Center

    Aleman, Carlos G.; Vangelisti, Anita L.

    Protocol analysis, a technique that uses people's verbal reports about their cognitions as they engage in an assigned task, has been used in a number of applications to provide insight into how people mentally plan, assess, and carry out those assignments. Using a system of networked computers where actors communicate with each other over…

  15. Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study.

    PubMed

    Marthick, Michael; Dhillon, Haryana M; Alison, Jennifer A; Cheema, Birinder S; Shaw, Tim

    2018-05-15

    Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioral change interventions in this population. Access to Web portals and provision of activity monitors to provide feedback may support behavior change by encouraging patient engagement in physical therapy. The Web portal evaluated in this study will provide a system to monitor physical activity and sleep, for use by both clinician and patient, along with symptom and health-related quality of life tracking capabilities. The aim of this study was to outline a protocol for a feasibility study focused on a Web-based portal that provides activity monitoring and personalized messaging to increase physical activity in people with cancer. Using a longitudinal cohort design, people with cancer will be serially allocated to 3 intervention cohorts of 20 participants each and followed for 10 weeks. Cohort 1 will be provided a wearable activity monitor and access to a Web-based portal. Cohort 2 will receive the same content as Cohort 1 and in addition will receive a weekly activity summary message. Cohort 3 will receive the same content as Cohorts 1 and 2 and in addition will receive a personalized weekly coaching message. Feasibility of the use of the portal is the primary outcome. Results are expected in early 2018. Outcome measures will include goal attainment and completion rate. This study will provide information about the feasibility of investigating eHealth initiatives to promote physical activity in people with cancer. RR1-10.2196/9586. ©Michael Marthick, Haryana M Dhillon, Jennifer A Alison, Birinder S Cheema, Tim Shaw. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.05.2018.

  16. Cognitive behaviour therapy for generalized anxiety disorder: Is CBT equally efficacious in adults of working age and older adults?

    PubMed

    Kishita, Naoko; Laidlaw, Ken

    2017-03-01

    The current meta-analysis compared the efficacy of CBT for GAD between adults of working age and older people. In addition, we conducted a qualitative content analysis of treatment protocols used in studies with older clients to explore potential factors that may enhance treatment outcomes with this particular client group. Applying the inclusion criteria resulted in the identification of 15 studies with 22 comparisons between CBT and control groups (770 patients). When examining overall effect sizes for CBT for GAD between older people and adults of working age there were no statistically significant differences in outcome. However, overall effect size of CBT for GAD was moderate for older people (g=0.55, 95% CI 0.22-0.88) and large for adults of working age (g=0.94, 95% CI 0.52-1.36), suggesting that there is still room for improvement in CBT with older people. The main difference in outcome between CBT for GAD between the two age groups was related to methodological quality in that no older people studies used an intention-to-treat design. The content analysis demonstrated that studies with older clients were conducted according to robust CBT protocols but did not take account of gerontological evidence to make them more age-appropriate. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  17. Lingual-Alveolar Contact Pressure during Speech in Amyotrophic Lateral Sclerosis: Preliminary Findings

    ERIC Educational Resources Information Center

    Searl, Jeff; Knollhoff, Stephanie; Barohn, Richard J.

    2017-01-01

    Purpose: This preliminary study on lingual-alveolar contact pressures (LACP) in people with amyotrophic lateral sclerosis (ALS) had several aims: (a) to evaluate whether the protocol induced fatigue, (b) to compare LACP during speech (LACP-Sp) and during maximum isometric pressing (LACP-Max) in people with ALS (PALS) versus healthy controls, (c)…

  18. Internet-Based Acceptance and Commitment Therapy for Psychological Distress Experienced by People With Hearing Problems: Study Protocol for a Randomized Controlled Trial.

    PubMed

    Molander, Peter; Hesser, Hugo; Weineland, Sandra; Bergwall, Kajsa; Buck, Sonia; Hansson-Malmlöf, Johan; Lantz, Henning; Lunner, Thomas; Andersson, Gerhard

    2015-09-01

    Psychological distress and psychiatric symptoms are prevalent among people with hearing loss or other audiological conditions, but psychological interventions for these groups are rare. This article describes the study protocol for a randomized controlled trial for evaluating the effect of a psychological treatment delivered over the Internet for individuals with hearing problems and concurrent psychological distress. Participants who are significantly distressed will be randomized to either an 8-week Internet-delivered acceptance-based cognitive behavioral therapy (i.e., acceptance and commitment therapy [ACT]), or wa it-list control. We aim to include measures of distress associated with hearing difficulties, anxiety, and depression. In addition, we aim to measure acceptance associated with hearing difficulties as well as quality of life. The results of the trial may further our understanding of how to best treat people who present problems with both psychological distress and hearing in using the Internet.

  19. A protocol for a systematic literature review: comparing the impact of seasonal and meteorological parameters on acute respiratory infections in Indigenous and non-Indigenous peoples.

    PubMed

    Bishop-Williams, Katherine E; Sargeant, Jan M; Berrang-Ford, Lea; Edge, Victoria L; Cunsolo, Ashlee; Harper, Sherilee L

    2017-01-26

    Acute respiratory infections (ARI) are a leading cause of morbidity and mortality globally, and are often linked to seasonal and/or meteorological conditions. Globally, Indigenous peoples may experience a different burden of ARI compared to non-Indigenous peoples. This protocol outlines our process for conducting a systematic review to investigate whether associations between ARI and seasonal or meteorological parameters differ between Indigenous and non-Indigenous groups residing in the same geographical region. A search string will be used to search PubMed ® , CAB Abstracts/CAB Direct © , and Science Citation Index ® aggregator databases. Articles will be screened using inclusion/exclusion criteria applied first at the title and abstract level, and then at the full article level by two independent reviewers. Articles maintained after full article screening will undergo risk of bias assessment and data will be extracted. Heterogeneity tests, meta-analysis, and forest and funnel plots will be used to synthesize the results of eligible studies. This protocol paper describes our systematic review methods to identify and analyze relevant ARI, season, and meteorological literature with robust reporting. The results are intended to improve our understanding of potential associations between seasonal and meteorological parameters and ARI and, if identified, whether this association varies by place, population, or other characteristics. The protocol is registered in the PROSPERO database (#38051).

  20. Improving health outcomes for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people - LYNC study protocol.

    PubMed

    Griffiths, Frances E; Atherton, Helen; Barker, Jack R; Cave, Jonathan Ak; Dennick, Kathryn; Dowdall, Peter; Fraser, Joe; Huxley, Caroline; Kim, Sung-Wook; Madan, Jason J; Matharu, Harjit; Musumadi, Luhanga; Palmer, Tom M; Paul, Moli; Sankaranarayanan, Sailesh; Slowther, Anne-Marie; Sujan, Mark A; Sutcliffe, Paul A; Sturt, Jackie

    2015-01-01

    Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. In this article we aim to present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers (LYNC study: Long term conditions, Young people, Networked Communications). The research involves: (a) patient and public involvement activities with 16-24 year olds with and without long term health conditions; (b) six literature reviews; (c) case studies - the main empirical part of the study - and (d) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data) on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA (did not attend) rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety.

  1. Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations.

    PubMed

    Traub-Dargatz, Josie L; Weese, J Scott; Rousseau, Joyce D; Dunowska, Magdalena; Morley, Paul S; Dargatz, David A

    2006-07-01

    Reduction factors (RFs) for bacterial counts on examiners' hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations.

  2. Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations

    PubMed Central

    Traub-Dargatz, Josie L.; Weese, J. Scott; Rousseau, Joyce D.; Dunowska, Magdalena; Morley, Paul S.; Dargatz, David A.

    2006-01-01

    Abstract Reduction factors (RFs) for bacterial counts on examiners’ hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations. PMID:16898109

  3. Giving Voice to Study Volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research

    PubMed Central

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-01-01

    Motivation Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Methods Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Results Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy=−0.04, CI [−0.46, 0.39]; physically ill – healthy= −0.13, CI [−0.62, −.36]). Conclusions Clinical research volunteers and healthy clinical research-“naive” individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. PMID:24931849

  4. Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

    PubMed

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-09-01

    Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy = -0.04, CI [-0.46, 0.39]; physically ill - healthy = -0.13, CI [-0.62, -.36]). Clinical research volunteers and healthy clinical research-"naïve" individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. A Mobile Phone App to Support Young People in Making Shared Decisions in Therapy (Power Up): Study Protocol.

    PubMed

    Chapman, Louise; Edbrooke-Childs, Julian; Martin, Kate; Webber, Helen; Craven, Michael P; Hollis, Chris; Deighton, Jessica; Law, Roslyn; Fonagy, Peter; Wolpert, Miranda

    2017-10-30

    Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision-making tools available to support young people in child and adolescent mental health services (CAMHS). The primary aim of this paper is to present the protocol of a feasibility trial for Power Up, a mobile phone app to empower young people in CAMHS to make their voices heard and participate in decisions around their care. In the development phase, 30 young people, parents, and clinicians will take part in interviews and focus groups to elicit opinions on an early version of the app. In the feasibility testing phase, 60 young people from across 7 to 10 London CAMHS sites will take part in a trial looking at the feasibility and acceptability of measuring the impact of Power Up on shared decision making. Data collection for the development phase ended in December 2016. Data collection for the feasibility testing phase will end in December 2017. Findings will inform the planning of a cluster controlled trial and contribute to the development and implementation of a shared decision-making app to be integrated into CAMHS. ISRCTN77194423; http://www.isrctn.com/ISRCTN77194423 (Archived by WebCite at http://www.webcitation.org/6td6MINP0). ClinicalTrials.gov NCT02987608; https://clinicaltrials.gov/ct2/show/NCT02987608 (Archived by WebCite at http://www.webcitation.org/6td6PNBZM). ©Louise Chapman, Julian Edbrooke-Childs, Kate Martin, Helen Webber, Michael P Craven, Chris Hollis, Jessica Deighton, Roslyn Law, Peter Fonagy, Miranda Wolpert. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.10.2017.

  6. The Development of a Design and Construction Process Protocol to Support the Home Modification Process Delivered by Occupational Therapists

    PubMed Central

    Ormerod, Marcus; Newton, Rita

    2018-01-01

    Modifying the home environments of older people as they age in place is a well-established health and social care intervention. Using design and construction methods to redress any imbalance caused by the ageing process or disability within the home environment, occupational therapists are seen as the experts in this field of practice. However, the process used by occupational therapists when modifying home environments has been criticised for being disorganised and not founded on theoretical principles and concepts underpinning the profession. To address this issue, research was conducted to develop a design and construction process protocol specifically for home modifications. A three-stage approach was taken for the analysis of qualitative data generated from an online survey, completed by 135 occupational therapists in the UK. Using both the existing occupational therapy intervention process model and the design and construction process protocol as the theoretical frameworks, a 4-phase, 9-subphase design and construction process protocol for home modifications was developed. Overall, the study is innovative in developing the first process protocol for home modifications, potentially providing occupational therapists with a systematic and effective approach to the design and delivery of home modification services for older and disabled people. PMID:29682348

  7. The Development of a Design and Construction Process Protocol to Support the Home Modification Process Delivered by Occupational Therapists.

    PubMed

    Russell, Rachel; Ormerod, Marcus; Newton, Rita

    2018-01-01

    Modifying the home environments of older people as they age in place is a well-established health and social care intervention. Using design and construction methods to redress any imbalance caused by the ageing process or disability within the home environment, occupational therapists are seen as the experts in this field of practice. However, the process used by occupational therapists when modifying home environments has been criticised for being disorganised and not founded on theoretical principles and concepts underpinning the profession. To address this issue, research was conducted to develop a design and construction process protocol specifically for home modifications. A three-stage approach was taken for the analysis of qualitative data generated from an online survey, completed by 135 occupational therapists in the UK. Using both the existing occupational therapy intervention process model and the design and construction process protocol as the theoretical frameworks, a 4-phase, 9-subphase design and construction process protocol for home modifications was developed. Overall, the study is innovative in developing the first process protocol for home modifications, potentially providing occupational therapists with a systematic and effective approach to the design and delivery of home modification services for older and disabled people.

  8. Evaluation of a 15-week CHOP protocol for the treatment of canine multicentric lymphoma.

    PubMed

    Burton, J H; Garrett-Mayer, E; Thamm, D H

    2013-12-01

    Dose intense CHOP protocols have been shown to improve outcome for people with non-Hodgkin's lymphoma, but evaluation of dose intense CHOP protocols for canine lymphoma is currently limited. The hypothesis of this retrospective study was that a 15-week dose intense CHOP protocol would have shorter treatment duration with similar efficacy to other doxorubicin-based multidrug protocols. Thirty-one client owned dogs with multicentric lymphoma were treated with a 15-week CHOP chemotherapy protocol with an overall response rate of 100% and a median progression-free interval (PFI) of 140 days [95% confidence interval (CI) 91-335 days]. Dogs that had two or more treatment delays had significantly prolonged PFI and overall survival in multivariate analysis. Dose intensity did not correlate with patient outcome. Dogs experiencing multiple treatment delays secondary to adverse events may receive their individual maximally tolerated dose while dogs with no adverse events may be underdosed. Future studies should focus on individual patient dose optimization. © 2012 Blackwell Publishing Ltd.

  9. The MOBI-Kids Study Protocol: Challenges in Assessing Childhood and Adolescent Exposure to Electromagnetic Fields from Wireless Telecommunication Technologies and Possible Association with Brain Tumor Risk

    PubMed Central

    Sadetzki, Siegal; Langer, Chelsea Eastman; Bruchim, Revital; Kundi, Michael; Merletti, Franco; Vermeulen, Roel; Kromhout, Hans; Lee, Ae-Kyoung; Maslanyj, Myron; Sim, Malcolm R.; Taki, Masao; Wiart, Joe; Armstrong, Bruce; Milne, Elizabeth; Benke, Geza; Schattner, Rosa; Hutter, Hans-Peter; Woehrer, Adelheid; Krewski, Daniel; Mohipp, Charmaine; Momoli, Franco; Ritvo, Paul; Spinelli, John; Lacour, Brigitte; Delmas, Dominique; Remen, Thomas; Radon, Katja; Weinmann, Tobias; Klostermann, Swaantje; Heinrich, Sabine; Petridou, Eleni; Bouka, Evdoxia; Panagopoulou, Paraskevi; Dikshit, Rajesh; Nagrani, Rajini; Even-Nir, Hadas; Chetrit, Angela; Maule, Milena; Migliore, Enrica; Filippini, Graziella; Miligi, Lucia; Mattioli, Stefano; Yamaguchi, Naohito; Kojimahara, Noriko; Ha, Mina; Choi, Kyung-Hwa; Mannetje, Andrea ’t; Eng, Amanda; Woodward, Alistair; Carretero, Gema; Alguacil, Juan; Aragones, Nuria; Suare-Varela, Maria Morales; Goedhart, Geertje; Schouten-van Meeteren, A. Antoinette Y. N.; Reedijk, A. Ardine M. J.; Cardis, Elisabeth

    2014-01-01

    The rapid increase in mobile phone use in young people has generated concern about possible health effects of exposure to radiofrequency (RF) and extremely low frequency (ELF) electromagnetic fields (EMF). MOBI-Kids, a multinational case–control study, investigates the potential effects of childhood and adolescent exposure to EMF from mobile communications technologies on brain tumor risk in 14 countries. The study, which aims to include approximately 1,000 brain tumor cases aged 10–24 years and two individually matched controls for each case, follows a common protocol and builds upon the methodological experience of the INTERPHONE study. The design and conduct of a study on EMF exposure and brain tumor risk in young people in a large number of countries is complex and poses methodological challenges. This manuscript discusses the design of MOBI-Kids and describes the challenges and approaches chosen to address them, including: (1) the choice of controls operated for suspected appendicitis, to reduce potential selection bias related to low response rates among population controls; (2) investigating a young study population spanning a relatively wide age range; (3) conducting a large, multinational epidemiological study, while adhering to increasingly stricter ethics requirements; (4) investigating a rare and potentially fatal disease; and (5) assessing exposure to EMF from communication technologies. Our experience in thus far developing and implementing the study protocol indicates that MOBI-Kids is feasible and will generate results that will contribute to the understanding of potential brain tumor risks associated with use of mobile phones and other wireless communications technologies among young people. PMID:25295243

  10. The MOBI-Kids Study Protocol: Challenges in Assessing Childhood and Adolescent Exposure to Electromagnetic Fields from Wireless Telecommunication Technologies and Possible Association with Brain Tumor Risk.

    PubMed

    Sadetzki, Siegal; Langer, Chelsea Eastman; Bruchim, Revital; Kundi, Michael; Merletti, Franco; Vermeulen, Roel; Kromhout, Hans; Lee, Ae-Kyoung; Maslanyj, Myron; Sim, Malcolm R; Taki, Masao; Wiart, Joe; Armstrong, Bruce; Milne, Elizabeth; Benke, Geza; Schattner, Rosa; Hutter, Hans-Peter; Woehrer, Adelheid; Krewski, Daniel; Mohipp, Charmaine; Momoli, Franco; Ritvo, Paul; Spinelli, John; Lacour, Brigitte; Delmas, Dominique; Remen, Thomas; Radon, Katja; Weinmann, Tobias; Klostermann, Swaantje; Heinrich, Sabine; Petridou, Eleni; Bouka, Evdoxia; Panagopoulou, Paraskevi; Dikshit, Rajesh; Nagrani, Rajini; Even-Nir, Hadas; Chetrit, Angela; Maule, Milena; Migliore, Enrica; Filippini, Graziella; Miligi, Lucia; Mattioli, Stefano; Yamaguchi, Naohito; Kojimahara, Noriko; Ha, Mina; Choi, Kyung-Hwa; Mannetje, Andrea 't; Eng, Amanda; Woodward, Alistair; Carretero, Gema; Alguacil, Juan; Aragones, Nuria; Suare-Varela, Maria Morales; Goedhart, Geertje; Schouten-van Meeteren, A Antoinette Y N; Reedijk, A Ardine M J; Cardis, Elisabeth

    2014-01-01

    The rapid increase in mobile phone use in young people has generated concern about possible health effects of exposure to radiofrequency (RF) and extremely low frequency (ELF) electromagnetic fields (EMF). MOBI-Kids, a multinational case-control study, investigates the potential effects of childhood and adolescent exposure to EMF from mobile communications technologies on brain tumor risk in 14 countries. The study, which aims to include approximately 1,000 brain tumor cases aged 10-24 years and two individually matched controls for each case, follows a common protocol and builds upon the methodological experience of the INTERPHONE study. The design and conduct of a study on EMF exposure and brain tumor risk in young people in a large number of countries is complex and poses methodological challenges. This manuscript discusses the design of MOBI-Kids and describes the challenges and approaches chosen to address them, including: (1) the choice of controls operated for suspected appendicitis, to reduce potential selection bias related to low response rates among population controls; (2) investigating a young study population spanning a relatively wide age range; (3) conducting a large, multinational epidemiological study, while adhering to increasingly stricter ethics requirements; (4) investigating a rare and potentially fatal disease; and (5) assessing exposure to EMF from communication technologies. Our experience in thus far developing and implementing the study protocol indicates that MOBI-Kids is feasible and will generate results that will contribute to the understanding of potential brain tumor risks associated with use of mobile phones and other wireless communications technologies among young people.

  11. Assessment protocols of maximum oxygen consumption in young people with Down syndrome--a review.

    PubMed

    Seron, Bruna Barboza; Greguol, Márcia

    2014-03-01

    Maximum oxygen consumption is considered the gold standard measure of cardiorespiratory fitness. Young people with Down syndrome (DS) present low values of this indicator compared to their peers without disabilities and to young people with an intellectual disability but without DS. The use of reliable and valid assessment methods provides more reliable results for the diagnosis of cardiorespiratory fitness and the response of this variable to exercise. The aim of the present study was to review the literature on the assessment protocols used to measure maximum oxygen consumption in children and adolescents with Down syndrome giving emphasis to the protocols used, the validation process and their feasibility. The search was carried out in eight electronic databases--Scopus, Medline-Pubmed, Web of science, SportDiscus, Cinhal, Academic Search Premier, Scielo, and Lilacs. The inclusion criteria were: (a) articles which assessed VO2peak and/or VO2max (independent of the validation method), (b) samples composed of children and/or adolescents with Down syndrome, (c) participants of up to 20 years old, and (d) studies performed after 1990. Fifteen studies were selected and, of these, 11 measured the VO2peak using tests performed in a laboratory, 2 used field tests and the remaining 2 used both laboratory and field tests. The majority of the selected studies used maximal tests and conducted familiarization sessions. All the studies took into account the clinical conditions that could hamper testing or endanger the individuals. However, a large number of studies used tests which had not been specifically validated for the evaluated population. Finally, the search emphasized the small number of studies which use field tests to evaluate oxygen consumption. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol

    PubMed Central

    Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Haxby Abbott, J.; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S.

    2015-01-01

    Background Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. Objective The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist–instructed home exercise leads to greater reductions in pain and improvements in function. Design An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. Setting The study will be conducted in a community setting. Participants The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Intervention Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Measurements Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. Limitations A self-reported diagnosis of persistent hip pain will be used. Conclusions The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist–instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. PMID:26023213

  13. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

    PubMed

    Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

    2015-10-01

    Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. © 2015 American Physical Therapy Association.

  14. Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Sandiago, Chile: A cluster randomized controlled trial. A study protocol(ISRCTN 02694183)

    USDA-ARS?s Scientific Manuscript database

    BACKGROUND: Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment. CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older peo...

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

    PubMed

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

    2017-02-16

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

  16. Promoting physical activity in sedentary elderly Malays with type 2 diabetes: a protocol for randomised controlled trial.

    PubMed

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2012-01-01

    Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care. A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. ETHICAL AND DISSEMINATION: The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals. This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials.com/ISRCTN71447000/).

  17. Development of a protocol for the ecological assessment of a special species

    Treesearch

    David Burton

    2004-01-01

    Developing consistent inventory and assessment protocols is important to people working on aspen issues in California and Nevada. Efforts have focused on identifying key indicators of ecological condition within aspen stands. The protocols have incorporated a range of factors that create or affect those indicators. Resulting ecological assessments conducted through the...

  18. Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol.

    PubMed

    Porter, Sam; Holmes, Valerie; McLaughlin, Katrina; Lynn, Fiona; Cardwell, Chris; Braiden, Hannah-Jane; Doran, Jackie; Rogan, Sheelagh

    2012-10-01

    This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Music in mind is a multi-centred single-blind randomized controlled trial involving 200 young people (aged 8-16 years) and their parents. Eligible participants will have a working diagnosis within the ambit of international classification of disease 10 mental and behavioural disorders and will be recruited over 15 months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collected from young people and their parents using standardized outcome measures for communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13 weeks after the final music therapy session. A cost-effectiveness analysis will also be carried out. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204. Ethical approval was gained in October 2010. © 2012 Blackwell Publishing Ltd.

  19. Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

    PubMed

    Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria

    2017-11-08

    Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © 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.

  20. Barriers and facilitators to physical activity in people with hip or knee osteoarthritis: protocol for a systematic review of qualitative evidence

    PubMed Central

    Kanavaki, Archontissa M; Rushton, Alison; Klocke, Rainer; Abhishek, Abhishek; Duda, Joan L

    2016-01-01

    Introduction This protocol aims to describe the objective and methods to be followed in a systematic review of qualitative studies on barriers and facilitators to physical activity (PA) in people with hip or knee osteoarthritis (OA). Methods and analysis MEDLINE, EMBASE, PhychINFO, Web of Science, CINAHL, SPORTDiscus, Scopus and grey literature sources will be electronically searched. Hand search of qualitative research-centred journals, reference screening of relevant reviews and inquiries to researchers active in the field will complement the search. Studies will be selected if they apply qualitative or mixed-methods designs to directly explore factors that correspond to engagement in PA/exercise or, the perceptions regarding PA/exercise in people with hip or knee OA. The Critical Appraisal Skills Programme Qualitative Checklist and the evaluative criteria of credibility, transferability, dependability and confirmability will be applied for the study appraisal. 2 independent reviewers will perform the search, study selection and study appraisal. Thematic synthesis will be used for synthesising the findings of the primary studies and the process and product of the synthesis will be checked by a second researcher. ConQual approach will be used for assessing the confidence in the qualitative findings. Ethics and dissemination This systematic review will inform our understanding of the PA determinants and how to optimise behaviour change in people living with hip or knee OA. The review findings will be reported in a peer-reviewed journal and presented at national or international conferences. The study raises no ethical issues. Trial registration number CRD42016030024. PMID:27810971

  1. Exploring representations and experiences of case-management users: towards difficulties and solutions to leading qualitative interviews with older people with complex living conditions.

    PubMed

    Balard, Frédéric; Corre, Stéphanie Pin Le; Trouvé, Hélène; Saint-Jean, Olivier; Somme, Dominique

    2013-01-01

    By matching needs to resource services, case management could be a useful tool for improving the care of older people with complex living conditions. Collecting and analysing the users' experiences represents a good way to evaluate the effectiveness and efficiency of a case-management service. However, in the literature, fieldwork is very rarely considered and the users included in qualitative research seem to be the most accessible. This study was undertaken to describe the challenges of conducting qualitative research with older people with complex living conditions in order to understand their experiences with case-management services. Reflective analysis was applied to describe the process of recruiting and interviewing older people with complex living conditions in private homes, describing the protocol with respect to fieldwork chronology. The practical difficulties inherent in this type of study are addressed, particularly in terms of defining a sample, the procedure for contacting the users and conducting the interview. The users are people who suffer from a loss of autonomy because of cognitive impairment, severe disease and/or psychiatric or social problems. Notably, most of them refuse care and assistance. Reflective analysis of our protocol showed that the methodology and difficulties encountered constituted the first phase of data analysis. Understanding the experience of users of case management to analyse the outcomes of case-management services requires a clear methodology for the fieldwork.

  2. The Work-It Study for people with arthritis: Study protocol and baseline sample characteristics.

    PubMed

    Keysor, Julie J; AlHeresh, Rawan; Vaughan, Molly; LaValley, Michael P; Allaire, Saralynn

    2016-06-14

    People with arthritis are at risk of work disability. Job accommodation and educational programs delivered before imminent work loss can minimize work disability, yet are not currently being widely implemented. The Work-It Study is a randomized controlled trial testing the efficacy of a problem solving program delivered by physical and occupational therapy practitioners to prevent work loss over a two-year period among people with arthritis and rheumatological conditions. The purpose of this paper is to describe the protocol of the randomized controlled trial, and describe the baseline characteristics of the subjects and their work outcomes. 287 participants were recruited from the Boston area in Massachusetts, USA. Eligible participants were aged between 21-65, self-reported a physicians' diagnosis of arthritis, rheumatic condition, or chronic back pain, reported a concern about working now or in the near future due to your health, worked at least 15 hours a week, had plans to continue working, and worked or lived in Massachusetts. Subjects were recruited through community sources and rheumatology offices. Participants in the experimental group received a structured interview and an education and resource packet, while participants in the control received the resource packet only. The baseline characteristics and work related outcomes of the participants were analyzed. To our knowledge, the Work-It Study is the largest and most diverse randomized controlled trial to date aiming to identify and problem solve work-related barriers, promote advocacy, and foster work disability knowledge among people with chronic disabling musculoskeletal conditions. Despite advances in medical management of arthritis and other rheumatological and musculoskeletal conditions, many people still have concerns about their ability to remain employed and are seeking strategies to help them sustain employment.

  3. Barriers, supports, and effective interventions for uptake of human papillomavirus- and other vaccines within global and Canadian Indigenous peoples: a systematic review protocol.

    PubMed

    Mrklas, Kelly J; MacDonald, Shannon; Shea-Budgell, Melissa A; Bedingfield, Nancy; Ganshorn, Heather; Glaze, Sarah; Bill, Lea; Healy, Bonnie; Healy, Chyloe; Guichon, Juliet; Colquhoun, Amy; Bell, Christopher; Richardson, Ruth; Henderson, Rita; Kellner, James; Barnabe, Cheryl; Bednarczyk, Robert A; Letendre, Angeline; Nelson, Gregg S

    2018-03-02

    Despite the existence of human papilloma virus (HPV) vaccines with demonstrated safety and effectiveness and funded HPV vaccination programs, coverage rates are persistently lower and cervical cancer burden higher among Canadian Indigenous peoples. Barriers and supports to HPV vaccination in Indigenous peoples have not been systematically documented, nor have interventions to increase uptake in this population. This protocol aims to appraise the literature in Canadian and global Indigenous peoples, relating to documented barriers and supports to vaccination and interventions to increase acceptability/uptake or reduce hesitancy of vaccination. Although HPV vaccination is the primary focus, we anticipate only a small number of relevant studies to emerge from the search and will, therefore, employ a broad search strategy to capture literature related to both HPV vaccination and vaccination in general in global Indigenous peoples. Eligible studies will include global Indigenous peoples and discuss barriers or supports and/or interventions to improve uptake or to reduce hesitancy, for the HPV vaccine and/or other vaccines. Primary outcomes are documented barriers or supports or interventions. All study designs meeting inclusion criteria will be considered, without restricting by language, location, or data type. We will use an a priori search strategy, comprised of key words and controlled vocabulary terms, developed in consultation with an academic librarian, and reviewed by a second academic librarian using the PRESS checklist. We will search several electronic databases from date of inception, without restrictions. A pre-defined group of global Indigenous websites will be reviewed for relevant gray literature. Bibliographic searches will be conducted for all included studies to identify relevant reviews. Data analysis will include an inductive, qualitative, thematic synthesis and a quantitative analysis of measured barriers and supports, as well as a descriptive synthesis and quantitative summary of measures for interventions. To our knowledge, this study will contribute the first systematic review of documented barriers, supports, and interventions for vaccination in general and for HPV vaccination. The results of this study are expected to inform future research, policies, programs, and community-driven initiatives to enhance acceptability and uptake of HPV vaccination among Indigenous peoples. PROSPERO Registration Number: CRD42017048844.

  4. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

    PubMed

    Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

    2016-03-09

    Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way mHealth programs have yet to be tested for HIV prevention in a community-based setting with this population. ClinicalTrials.gov NCT02437123 https://clinicaltrials.gov/show/NCT02437123 (registered 4 May 2015). Protocol version: 24 July 2015.

  5. Study design for a randomized controlled trial to increase the relative reinforcing value of vegetable consumption using incentive sensitization among obese and overweight people

    USDA-ARS?s Scientific Manuscript database

    Federal dietary guidance recommends consumption of a variety of vegetables, but Americans only consume a small fraction of recommended amounts. Studies have attempted to increase consumption with modest results. In this manuscript, we present the protocol for a study that applies incentive sensitiza...

  6. Barriers and facilitators to physical activity in people with hip or knee osteoarthritis: protocol for a systematic review of qualitative evidence.

    PubMed

    Kanavaki, Archontissa M; Rushton, Alison; Klocke, Rainer; Abhishek, Abhishek; Duda, Joan L

    2016-11-03

    This protocol aims to describe the objective and methods to be followed in a systematic review of qualitative studies on barriers and facilitators to physical activity (PA) in people with hip or knee osteoarthritis (OA). MEDLINE, EMBASE, PhychINFO, Web of Science, CINAHL, SPORTDiscus, Scopus and grey literature sources will be electronically searched. Hand search of qualitative research-centred journals, reference screening of relevant reviews and inquiries to researchers active in the field will complement the search. Studies will be selected if they apply qualitative or mixed-methods designs to directly explore factors that correspond to engagement in PA/exercise or, the perceptions regarding PA/exercise in people with hip or knee OA. The Critical Appraisal Skills Programme Qualitative Checklist and the evaluative criteria of credibility, transferability, dependability and confirmability will be applied for the study appraisal. 2 independent reviewers will perform the search, study selection and study appraisal. Thematic synthesis will be used for synthesising the findings of the primary studies and the process and product of the synthesis will be checked by a second researcher. ConQual approach will be used for assessing the confidence in the qualitative findings. This systematic review will inform our understanding of the PA determinants and how to optimise behaviour change in people living with hip or knee OA. The review findings will be reported in a peer-reviewed journal and presented at national or international conferences. The study raises no ethical issues. CRD42016030024. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  7. [Transsexualism : an obsolete nosological category].

    PubMed

    Alessandrin, Arnaud

    2012-01-01

    Transsexualism is a recent medical invention. In France, the diagnosis and clinical assessment of transsexualism are carried out jointly by lawyers, doctors and psychiatrists. However, recent quantitative and qualitative studies have shown that current uses of the concept of "transsexualism" no longer meet the demands of all trans people. Only a minority of trans people undergo a public protocol of transsexualization for the transition process. This finding is supported by evidence from a quantitative survey conducted by Alain Giami, and is apparent in the life stories of people who avoid using the "transsexual" label and criticize the clinical process for mistreating people. The purpose of this paper is to analyze the mechanisms of the subjective depsychiatrization and depathologization of trans identities and to examine current conceptions of trans "becomings".

  8. [Benefits of Decumanum Phlebodium intake on the muscle damage in the response to intense physical exercise in sedentary subjects].

    PubMed

    Vargas Corzo, M C; Aguilar Cordero, M J; de Teresa Galván, C; Segura Millán, D; Miranda Leon, M T; Castillo Rueda, G; Guisado Barrilao, R

    2014-06-01

    Intense physical exercise provoke muscle damage, that in sedentary people can increase cardiovascular risk. Phlebodium decumanum (PD) has shown to have immunomodulator effects in models of moderate intense physical activities in well conditioned groups. To evaluate the PD effects during eccentric exercise, as a model of muscle inflammation protocol, on a sedentary population with cardiovascular risk. This is an experimental, double-blind, multigroup randomized study. Experimental Group 1 (n = 17)received PD, 9 doses of 400 mg (total amount 3.6 g) every 8 hours during 3 days, and Control Group 2 (n = 16)received a placebo. All the subjects performed two treadmill ergoespirometry tests: first, a modified Bruce protocol to discard ischemic responses during exercise and to evaluate VO2max before the experimental phase;and second, with an eccentric protocol (14% descending ramp test) during 10 minutes in stable state at 70-80%VO2max, as experimental inflammatory protocol.We compared intra and inter groups to evaluate differences in the pre and post-test differences results on blood muscle damage variables. The study shown statistically significant differences in all pre-post intra-groups results in muscle damage variables (CK, LDH and Myoglobin, but not in Cardiac Troponin), and in functional lower-limb test (SJand CMJ). The comparison of inter-group results shown less muscle damage and less functional lower-limb deterioration in Group 1 compared with Control group, with statistical significance in both cases. Differences in handgrip dynamometry were no statistically significant. The eccentric exercise protocol in that study has proven to be a good model to induce muscle and functional damage in sedentary people. Short PD treatment has shown to reduce muscle and functional acute damages compared with placebo control group in this specific population. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  9. Cognitive behavioral intervention in the Chinese cultural context: a case report.

    PubMed

    Ng, Petrus; Tsun, Angela; Su, Susan; Young, Daniel

    2013-09-01

    Depression is predicted to become the world's second leading cause of disability by 2020 according to the World Health Organization. Cognitive behavioral intervention (CBI), recognized as a viable and effective treatment for depression, is becoming more widely used among Chinese clients. However, information about the application of this Western approach in the Chinese population is very limited. This paper discusses adaptations of CBI protocols for Chinese patients, considering the major Chinese cultural characteristics of predestination, losing face, avoiding conflict, and Yin-Yang balance (PLAY) for persons with depression. Illustrated is the application of the PLAY protocol in the actual case of a 35-year-old woman with depression. Implications for integrating Chinese cultural characteristics with CBI are discussed. There is evidence for adaptations of CBI for enhancing its effectiveness among Chinese people within their cultural context. Since there are limited studies on cultural-sensitive CBI for Chinese people, the conclusions drawn from this study are only preliminary. Further studies that verify the findings reported in this paper are necessary. Copyright © 2013 Wiley Publishing Asia Pty Ltd.

  10. Real-world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.

    PubMed

    Wing, Kevin; Williamson, Elizabeth; Carpenter, James R; Wise, Lesley; Schneeweiss, Sebastian; Smeeth, Liam; Quint, Jennifer K; Douglas, Ian

    2018-03-25

    Chronic obstructive pulmonary disease (COPD) is a progressive disease affecting 3 million people in the UK, in which patients exhibit airflow obstruction that is not fully reversible. COPD treatment guidelines are largely informed by randomised controlled trial results, but it is unclear if these findings apply to large patient populations not studied in trials. Non-interventional studies could be used to study patient groups excluded from trials, but the use of these studies to estimate treatment effectiveness is in its infancy. In this study, we will use individual trial data to validate non-interventional methods for assessing COPD treatment effectiveness, before applying these methods to the analysis of treatment effectiveness within people excluded from, or under-represented in COPD trials. Using individual patient data from the landmark COPD Towards a Revolution in COPD Health (TORCH) trial and validated methods for detecting COPD and exacerbations in routinely collected primary care data, we will assemble a cohort in the UK Clinical Practice Research Datalink (selecting people between 1 January 2004 and 1 January 2017) with similar characteristics to TORCH participants and test whether non-interventional data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. We will then use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (>80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Ethical approval has been granted by the London School of Hygiene & Tropical Medicine Ethics Committee (Ref: 11997). The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency (protocol no. 17_114R). An application to use the TORCH trial data made to clinicalstudydatarequest.com has been approved. In addition to scientific publications, dissemination methods will be developed based on discussions with patient groups with COPD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. A Mobile Phone App to Support Young People in Making Shared Decisions in Therapy (Power Up): Study Protocol

    PubMed Central

    Martin, Kate; Webber, Helen; Craven, Michael P; Hollis, Chris; Deighton, Jessica; Law, Roslyn; Fonagy, Peter; Wolpert, Miranda

    2017-01-01

    Background Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision-making tools available to support young people in child and adolescent mental health services (CAMHS). Objective The primary aim of this paper is to present the protocol of a feasibility trial for Power Up, a mobile phone app to empower young people in CAMHS to make their voices heard and participate in decisions around their care. Methods In the development phase, 30 young people, parents, and clinicians will take part in interviews and focus groups to elicit opinions on an early version of the app. In the feasibility testing phase, 60 young people from across 7 to 10 London CAMHS sites will take part in a trial looking at the feasibility and acceptability of measuring the impact of Power Up on shared decision making. Results Data collection for the development phase ended in December 2016. Data collection for the feasibility testing phase will end in December 2017. Conclusions Findings will inform the planning of a cluster controlled trial and contribute to the development and implementation of a shared decision-making app to be integrated into CAMHS. Trial Registration ISRCTN77194423; http://www.isrctn.com/ISRCTN77194423 (Archived by WebCite at http://www.webcitation.org/6td6MINP0). ClinicalTrials.gov NCT02987608; https://clinicaltrials.gov/ct2/show/NCT02987608 (Archived by WebCite at http://www.webcitation.org/6td6PNBZM) PMID:29084708

  12. Chameleon Changes: An Exploration of Racial Identity Themes of Multiracial People

    ERIC Educational Resources Information Center

    Miville, Marie L.; Constantine, Madonna G.; Baysden, Matthew F.; So-Lloyd, Gloria

    2005-01-01

    The current study explored essential themes of racial identity development among 10 self-identified multiracial adults from a variety of racial backgrounds. Participants were interviewed using a semistructured protocol, and the interviews were recorded, transcribed, and then coded for themes by research team members. Four primary themes were…

  13. Adolescents' Perceptions of the Words "Health" and "Happy"

    ERIC Educational Resources Information Center

    O'Higgins, Siobhan; Sixsmith, Jane; Gabhainn, Saoirse Nic

    2010-01-01

    Purpose: The shared language of youth includes understandings of concepts that can be different from those of adults. Researchers, in their efforts to explore and illuminate the health behaviours and decision-making processes of young people, use generic terms in their data collecting protocols. This study aims to explore what adolescents…

  14. Safety of 8-aminoquinolines given to people with G6PD deficiency: protocol for systematic review of prospective studies.

    PubMed

    Uthman, Olalekan A; Saunders, Rachel; Sinclair, David; Graves, Patricia; Gelband, Hellen; Clarke, Aileen; Garner, Paul

    2014-05-14

    A single dose or short course of primaquine given to people infected with malaria may reduce transmission of Plasmodium falciparum through its effects on gametocytes. Primaquine is also known to cause haemolysis in people with variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency. The objective of this systematic review was to assess the risk of adverse effects in people with G6PD deficiency given primaquine or other 8-aminoquinoline (8AQ) as a single dose or short course (less than 7 days). We will search the following databases: Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. Prospective cohort studies, randomised and quasi-randomised trials that evaluated 8AQs for whatever reason in adults or children with a known G6PD deficiency will be included. Two authors will independently assess each study for eligibility, risk of bias and extract data. This systematic review will be published in a peer-reviewed journal. Brief reports of the review findings will be disseminated directly to the appropriate audiences and the WHO Technical Expert Group in Malaria Chemotherapy. As no primary data collection will be undertaken, no additional formal ethical assessment and informed consent are required. The protocol is registered with PROSPERO, registration number CRD42013006518. 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.

  15. The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    PubMed Central

    2011-01-01

    Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control). Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277 PMID:21288341

  16. Feasibility randomised multicentre, double-blind, double-dummy controlled trial of anakinra, an interleukin-1 receptor antagonist versus intramuscular methylprednisolone for acute gout attacks in patients with chronic kidney disease (ASGARD): protocol study.

    PubMed

    Balasubramaniam, Gowrie; Parker, Trisha; Turner, David; Parker, Mike; Scales, Jonathan; Harnett, Patrick; Harrison, Michael; Ahmed, Khalid; Bhagat, Sweta; Marianayagam, Thiraupathy; Pitzalis, Costantino; Mallen, Christian; Roddy, Edward; Almond, Mike; Dasgupta, Bhaskar

    2017-09-05

    Acute gout occurs in people with chronic kidney disease, who are commonly older people with comorbidities such as hypertension, heart disease and diabetes. Potentially harmful treatments are administered to these vulnerable patients due to a lack of clear evidence. Newly available treatment that targets a key inflammatory pathway in acute gout attacks provides an opportunity to undertake the first-ever trial specifically looking treating people with kidney disease. This paper describes the protocol for a feasibility randomised controlled trial (RCT) comparing anakinra, a novel interleukin-1 antagonist versus steroids in people with chronic kidney disease (ASGARD). ASGARD is a two-parallel group double-blind, double-dummy multicentre RCT comparing anakinra 100 mg, an interleukin-1 antagonist, subcutaneous for 5 days against intramuscular methylprednisolone 120 mg. The primary objective is to assess the feasibility of the trial design and procedures for a definitive RCT. The specific aims are: (1) test recruitment and retention rates and willingness to be randomised; (2) test eligibility criteria; (3) collect and analyse outcome data to inform sample and power calculations for a trial of efficacy; (4) collect economic data to inform a future economic evaluation estimating costs of treatment and (5) assess capacity of the project to scale up to a national multicentre trial. We will also gather qualitative insights from participants. It aims to recruit 32 patients with a 1:1 randomisation. Information from this feasibility study will help design a definitive trial and provide general information in designing acute gout studies. The London-Central Ethics Committee approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences. EudraCT No. 2015-001787-19, NCT/Clinicalstrials.gov No. NCT02578394, pre-results, WHO Universal Trials Reference No. U1111-1175-1977. NIHR Grant PB-PG-0614-34090. © 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.

  17. Net Results: Online Protocols Boost Group Learning Potential

    ERIC Educational Resources Information Center

    Dichter, Alan; Zydney, Janet Mannheimer

    2015-01-01

    Educators have begun to use protocols to facilitate professional development in online spaces--partly because people need to connect from different places, but also to take advantage of new environments for learning. For example, asynchronous tools, such as discussion forums, blogs, or Google+, where participants post messages to one another at…

  18. Broadening and Simplifying the First SETI Protocol

    NASA Astrophysics Data System (ADS)

    Michaud, M. A. G.

    The Declaration of Principles Concerning Activities Following the Detection of Extraterrestrial Intelligence, known informally as the First SETI Protocol, is the primary existing international guidance on this subject. During the fifteen years since the document was issued, several people have suggested revisions or additional protocols. This article proposes a broadened and simplified text that would apply to the detection of alien technology in our solar system as well as to electromagnetic signals from more remote sources.

  19. Characterizing urban areas with good sound quality: development of a research protocol.

    PubMed

    van Kempen, Elise; Devilee, Jeroen; Swart, Wim; van Kamp, Irene

    2014-01-01

    Due to rapid urbanization, the spatial variation between wanted and unwanted sounds will decrease or even disappear. Consequently, the characteristics of (urban) areas where people can temporarily withdraw themselves from urban stressors such as noise may change or become increasingly scarce. Hardly any research has been carried out into the positive health effects of spending time in areas with a good sound quality. One of the problems is that an overview of what aspects determines good sound quality in urban areas and how these are interrelated is lacking. This paper reviews the literature pertaining to the sound quality of urban areas. Aim is to summarize what is known about the influence of social, spatial, and physical aspects other than sounds, on peoples' perception of urban sound qualities. Literature from both conventional sound research and from the so-called soundscape field, published between 2000 and the beginning of 2013 in English or Dutch, was evaluated. Although a general set of validated indicators that can be directly applied, is not available yet, a set of indicators was derived from the literature. These form the basis of a study protocol that will be applied in "Towards a Sustainable acoustic Environment", a project that aims to describe sound qualities at a low-scale level. Key-elements of this study protocol, including a questionnaire and the systematic audit of neighborhoods, were presented in this paper.

  20. [After "transsexualism"].

    PubMed

    Alessandrin, Arnaud

    2012-01-01

    Sex reassignment protocols in France do not meet the demands of people in transition. Consequently, transsexual people draw up what are called "free" transitions, without any psychiatric follow-up, opening the way for discussion on the place of the law and the need for psychiatry in these cases.

  1. Falls in long-term care institutions for elderly people: protocol validation.

    PubMed

    Baixinho, Cristina Rosa Soares Lavareda; Dixe, Maria Dos Anjos Coelho Rodrigues; Henriques, Maria Adriana Pereira

    2017-01-01

    To validate the content of a fall management risk protocol in long-term institutions for elderly people. Methodological, quanti-qualitative study using the Delphi technique. The tool, based on the literature, was sent electronically to obtain consensus among the 14 experts that meet the defined inclusion criteria. The 27 indicators of the protocol are organized in three dimensions: prepare for the institutionalization (IRA=.88); manage the risk of falls throughout the institutionalization (IRA=.9); and lead the communication and formation (IRA=1), with a CVI=.91. Two rounds were performed to get a consensus superior to 80% in every item. The values obtained in the reliability test (>0.8) show that the protocol can be used to meet the intended goal. The next step is the clinic validation of the protocol with residents of long-term care institutions for elderly people. Validar o conteúdo de um protocolo para a gestão do risco de queda em Instituições de Longa Permanência para Idosos. Estudo metodológico, de abordagem quantiqualitativa, utilizando a técnica de Delphi. O instrumento, construído com base na literatura, foi enviado por via electrónica, para obter consenso entre os 14 peritos que respeitam os critérios de inclusão definidos. Os 27 indicadores do protocolo estão organizados em três dimensões: Preparar a Institucionalização (IRA=,88); Gerir o Risco de Queda ao longo da Institucionalização (IRA=,9) e Liderar a comunicação e formação (IRA=1), com um CVI=,91. Foram efetuadas duas rodadas para se obter consenso superior a 80% em todos os itens. Os valores obtidos no teste de fidedignidade (>0,8) atestam que o protocolo pode ser utilizado para atingir o fim que se pretende. A próxima etapa é a validação clínica do protocolo com idosos residentes em Instituições de Longa Permanência para Idosos.

  2. Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial.

    PubMed

    Close, Jacqueline C T; Wesson, Jacqueline; Sherrington, Catherine; Hill, Keith D; Kurrle, Sue; Lord, Stephen R; Brodaty, Henry; Howard, Kirsten; Gitlin, Laura N; O'Rourke, Sandra D; Clemson, Lindy

    2014-08-15

    The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken. Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life. The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people. The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry - ACTRN12614000603617.

  3. An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial.

    PubMed

    van Luenen, Sanne; Kraaij, Vivian; Spinhoven, Philip; Garnefski, Nadia

    2016-03-31

    Many people living with HIV suffer from depressive symptoms. In a previous pilot study, self-help cognitive behavioral therapy (in booklet format) was found to be effective in treating depressive symptoms in people with HIV. We developed an online self-help program in Dutch and English (based on the booklet) for people with HIV and depressive symptoms. Besides the main question regarding the effectiveness of the program aimed at lowering depressive symptoms, sub-questions will focus on the moderators of treatment success (for which patients is the program especially beneficial?) and the mechanisms of change underlying the treatment outcome (which mediators affect the outcome of treatment?). In this paper, the protocol of the study will be described. The effectiveness of the program will be investigated by comparing the intervention group with a waiting list-control group in a randomized controlled design, by including a pretest and three post-tests. The self-help program contains four main components: activation, relaxation, changing maladaptive cognitions, and goal attainment. Participants with mild to moderate depressive symptoms will work on the program for 6 to 10 weeks, during which a coach will provide motivational support by telephone once a week. Participants in the control condition will receive weekly minimal support from a coach for 8 weeks, and after the second post-test, they can gain access to the self-help program. Depressive symptoms and possible mediators (e.g., activation, cognitive coping, self-efficacy, and goal adjustment) will be assessed by self-report three times during the intervention/waiting period and at the pretest and first post-test. The proposed study aims to evaluate the effectiveness of an online self-help intervention for people with HIV and depressive symptoms. If the intervention is shown to be effective, the program will be implemented. Consequently, many patients with HIV could be reached, and their psychological care may be improved. Netherlands Trial Register: NTR5407.

  4. Optimizing Libraries’ Content Findability Using Simple Object Access Protocol (SOAP) With Multi-Tier Architecture

    NASA Astrophysics Data System (ADS)

    Lahinta, A.; Haris, I.; Abdillah, T.

    2017-03-01

    The aim of this paper is to describe a developed application of Simple Object Access Protocol (SOAP) as a model for improving libraries’ digital content findability on the library web. The study applies XML text-based protocol tools in the collection of data about libraries’ visibility performance in the search results of the book. Model from the integrated Web Service Document Language (WSDL) and Universal Description, Discovery and Integration (UDDI) are applied to analyse SOAP as element within the system. The results showed that the developed application of SOAP with multi-tier architecture can help people simply access the website in the library server Gorontalo Province and support access to digital collections, subscription databases, and library catalogs in each library in Regency or City in Gorontalo Province.

  5. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

    PubMed

    Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

    2018-05-11

    Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of this study confirm the effectiveness of mindfulness programmes in this population, it will be possible to improve quality of life and health while optimising public resources and reaching a greater number of people. In addition, on the basis of the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. ClinicalTrials.gov, NCT02893150 . Registered retrospectively on 30 March 2017.

  6. Natural prevalence of resistance-associated variants in hepatitis C virus NS5A in genotype 3a-infected people who inject drugs in Germany.

    PubMed

    Walker, Andreas; Siemann, Holger; Groten, Svenja; Ross, R Stefan; Scherbaum, Norbert; Timm, Jörg

    2015-09-01

    People who inject drugs (PWID) are the most important risk group for incident Hepatitis C virus (HCV) infection. In PWID in Europe HCV genotype 3a is highly prevalent. Unfortunately, many of the recently developed directly acting antiviral drugs against HCV (DAAs) are suboptimal for treatment of this genotype. Detection of resistance-associated variants (RAV) in genotype 3a may help to optimize treatment decisions, however, robust protocols for amplification and sequencing of HCV NS5A as an important target for treatment of genotype 3a are currently lacking. The aim of this study was to establish a protocol for sequencing of HCV NS5A in genotype 3a and to determine the frequency of RAVs in treatment-naïve PWID living in Germany. The full NS5A region was amplified and sequenced from 110 HCV genotype 3a infected PWID using an in-house PCR protocol. With the established protocol the complete NS5A region was successfully amplified and sequenced from 110 out of 112 (98.2%) genotype 3a infected PWID. Phylogenetic analysis of sequences from PWID together with unrelated genotype 3a sequences from a public database showed a scattered distribution without geographic clustering. Viral polymorphisms A30K and Y93H known to confer resistance in a GT3a replication model were present in 8 subjects (7.2%). A protocol for amplification of nearly all GT3a samples was successfully established. Substitutions conferring resistance to NS5A inhibitors were detected in a few treatment-naive PWID. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. Support and assessment for fall emergency referrals (SAFER 2) research protocol: cluster randomised trial of the clinical and cost effectiveness of new protocols for emergency ambulance paramedics to assess and refer to appropriate community-based care

    PubMed Central

    Snooks, Helen; Anthony, Rebecca; Chatters, Robin; Cheung, Wai-Yee; Dale, Jeremy; Donohoe, Rachael; Gaze, Sarah; Halter, Mary; Koniotou, Marina; Logan, Phillippa; Lyons, Ronan; Mason, Suzanne; Nicholl, Jon; Phillips, Ceri; Phillips, Judith; Russell, Ian; Siriwardena, A Niroshan; Wani, Mushtaq; Watkins, Alan; Whitfield, Richard; Wilson, Lynsey

    2012-01-01

    Introduction Emergency calls to ambulance services are frequent for older people who have fallen, but ambulance crews often leave patients at the scene without ongoing care. Evidence shows that when left at home with no further support older people often experience subsequent falls which result in injury and emergency-department attendances. SAFER 2 is an evaluation of a new clinical protocol which allows paramedics to assess and refer older people who have fallen, and do not need hospital care, to community-based falls services. In this protocol paper, we report methods and progress during trial implementation. SAFER 2 is recruiting patients through three ambulance services. A successful trial will provide robust evidence about the value of this new model of care, and enable ambulance services to use resources efficiently. Design Pragmatic cluster randomised trial. Methods and analysis We randomly allocated 25 participating ambulance stations (clusters) in three services to intervention or control group. Intervention paramedics received training and clinical protocols for assessing and referring older people who have fallen to community-based falls services when appropriate, while control paramedics deliver care as usual. Patients are eligible for the trial if they are aged 65 or over; resident in a participating falls service catchment area; and attended by a trial paramedic following an emergency call coded as a fall without priority symptoms. The principal outcome is the rate of further emergency contacts (or death), for any cause and for falls. Secondary outcomes include further falls, health-related quality of life, ‘fear of falling’, patient satisfaction reported by participants through postal questionnaires at 1 and 6 months, and quality and pathways of care at the index incident. We shall compare National Health Service (NHS) and patient/carer costs between intervention and control groups and estimate quality-adjusted life years (QALYs) gained from the intervention and thus incremental cost per QALY. We shall estimate wider system effects on key-performance indicators. We shall interview 60 intervention patients, and conduct focus groups with contributing NHS staff to explore their experiences of the assessment and referral service. We shall analyse quantitative trial data by ‘treatment allocated’; and qualitative data using content analysis. Ethics and dissemination The Research Ethics Committee for Wales gave ethical approval and each participating centre gave NHS Research and Development approval. We shall disseminate study findings through peer-reviewed publications and conference presentations. Trial Registration: ISRCTN 60481756 PMID:23148348

  8. Using environmental engineering to increase hand hygiene compliance: a cross-over study protocol

    PubMed Central

    Schmidtke, Kelly Ann; Aujla, Navneet; Marshall, Tom; Hussain, Abid; Hodgkinson, Gerard P; Arheart, Kristopher; Marti, Joachim; Birnbach, David J; Vlaev, Ivo

    2017-01-01

    Introduction Compliance with hand hygiene recommendations in hospital is typically less than 50%. Such low compliance inevitably contributes to hospital-acquired infections that negatively affect patients’ well-being and hospitals’ finances. The design of the present study is predicated on the assumption that most people who fail to clean their hands are not doing so intentionally, they just forget. The present study will test whether psychological priming can be used to increase the number of people who clean their hands on entering a ward. Here, we present the protocol for this study. Methods and analysis The study will use a randomised cross-over design. During the study, each of four wards will be observed during four conditions: olfactory prime, visual prime, both primes and neither prime. Each condition will be experienced for 42 days followed by a 7-day washout period (total duration of trial=189 days). We will record the number of people who enter each ward and whether they clean their hands during observation sessions, the amount of cleaning material used from the dispensers each week and the number of hospital-acquired infections that occur in each period. The outcomes will be compared using a regression analysis. Following the initial trail, the most effective priming condition will be rolled out for 3 months in all the wards. Ethics and dissemination Research ethics approval was obtained from the South Central—Oxford C Research Ethics Committee (16/SC/0554), the Health Regulatory Authority and the sponsor. Trial registration number ISRCTN (15397624); Edge ID 86357. PMID:28893752

  9. A dyadic protocol for training complex skills: a replication using female participants.

    PubMed

    Sanchez-Ku, M L; Arthur, W

    2000-01-01

    The effectiveness and efficiency of the active interlocked modeling (AIM) dyadic protocol in training complex skills has been extensively demonstrated. However, past evaluation studies have all used male participants exclusively. Consequently, the present study investigated the generalizability of the effectiveness and efficiency gains to women. We randomly assigned 108 female participants to either the AIM-dyad condition or a standard individual control training condition. The results supported the robustness and viability of the AIM protocol. Although their overall performance was lower than that obtained for men in previous studies, women trained in the AIM-dyad condition performed as well as those trained in the individual condition. Thus, the efficiency gains associated with the AIM-dyad protocol, which result from the ability to train two people simultaneously to reach the same performance level as a single person with no increase in training time or machine cost, are generalizable to female participants. The applied and basic research implications of the present study are discussed within the context of well-documented male/female differences in the performance of complex psychomotor tasks. For instance, given the number of women entering the workforce and the significant proportion of women in professions previously deemed to be male-dominated (e.g., air navigation), it is reassuring to know that sex differences in task performance do not necessarily imply sex differences in the effectiveness of training protocols.

  10. Fluoroquinolone-based protocols for eradication of Helicobacter pylori.

    PubMed

    Rispo, Antonio; Capone, Pietro; Castiglione, Fabiana; Pasquale, Luigi; Rea, Matilde; Caporaso, Nicola

    2014-07-21

    Helicobacter pylori (H. pylori) is a widespread pathogen infecting about 40% of people living in urban areas and over 90% of people living in the developing regions of the world. H. pylori is well-documented as the main factor in the pathogenesis of peptic ulcer disease, chronic gastritis, and gastric malignancies such as cancer and mucosa-associated lymphoid tissue-lymphoma; hence, its eradication is strongly recommended. The Maastricht IV consensus, which focused on the management of H. pylori infection, set important new strategies in terms of treatment approaches, particularly with regards to first- and second-line treatment protocols and led to improved knowledge and understanding of H. pylori resistance to antibiotics. In recent years, various fluoroquinolone-based protocols, mainly including levofloxacin, have been proposed and effectively tested at all therapeutic lines for H. pylori eradication. The aim of the present paper is to review the scientific literature focused on the use of fluoroquinolones in eradicating H. pylori.

  11. The Impact of Staff Initiated Referral and Intervention Protocols on Symptoms of Depression in People with Mild Intellectual Disability

    ERIC Educational Resources Information Center

    McGillivray, Jane A.; Kershaw, Mavis M.

    2013-01-01

    It has been estimated that people with ID experience the same and possibly higher levels of depression than the general population. Referral to a General Medical Practitioner (GP) for primary care is recommended practice for people with depression and cognitive behavioural (CB) therapy is now an accepted evidence based intervention. A growing body…

  12. Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: study protocol for a pragmatic randomised controlled trial.

    PubMed

    Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

    2013-10-18

    Restorative home care services help older people maximise their independence using a multi-dimensional approach. They usually include an exercise program designed to improve the older person's strength, balance and function. The types of programs currently offered require allocation of time during the day to complete specific exercises. This is not how the majority of home care clients prefer to be active and may be one of the reasons that few older people do the exercises regularly and continue the exercises post discharge.This paper describes the study protocol to test whether a Lifestyle Functional Exercise (LiFE) program: 1) is undertaken more often; 2) is more likely to be continued over the longer term; and, 3) will result in greater functional gains compared to a standard exercise program for older people receiving a restorative home care service. A pragmatic randomised controlled trial (RCT) design was employed with two study arms: LiFE program (intervention) and the current exercise program (control). Silver Chain, a health and community care organisation in Perth, Western Australia. One hundred and fifty restorative home care clients, aged 65 years and older. The primary outcome is a composite measure incorporating balance, strength and mobility. Other outcome measures include: physical functioning, falls efficacy, and levels of disability and functioning. If LiFE is more effective than the current exercise program, the evidence will be presented to the service management accompanied by the recommendation that it be adopted as the generic exercise program to be used within the restorative home care service. Australian and New Zealand Clinical Trials Registry ACTRN12611000788976.

  13. Dimensions of tinnitus-related complaints reported by patients and their significant others: protocol for a systematic review

    PubMed Central

    Haider, Haúla; Fackrell, Kathryn; Kennedy, Veronica; Hall, Deborah A

    2016-01-01

    Introduction Over 70 million people in Europe and >50 million people in the USA are reported to experience tinnitus (the sensation of noise in the absence of any corresponding sound source). Tinnitus is a multidimensional concept. Individual patients may report different profiles of tinnitus-related symptoms which may each require a tailored management approach and an appropriate measure of therapeutic benefit. This systematic review concerns the patient perspective and has the purpose to find what symptoms are reported by people who experience tinnitus and by their significant others. Methods and analysis This protocol lays out the methodology to define what dimensions of tinnitus-related symptoms patients and their significant others report as being a problem. Methods are defined according to the Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols (PRISMA-P) 2015 and data will be collated in a narrative synthesis. Findings will contribute to the eventual establishment of a Core Domain Set for clinical trials of tinnitus. Ethics and dissemination No ethical issues are foreseen. Findings will be reported at national and international ENT and audiology conferences and in a peer-reviewed journal. Trial registration number CRD42015020629. PMID:27855082

  14. A scoping review protocol on social participation of indigenous elders, intergenerational solidarity and their influence on individual and community wellness

    PubMed Central

    Viscogliosi, Chantal; Asselin, Hugo; Basile, Suzy; Couturier, Yves; Drolet, Marie-Josée; Gagnon, Dominique; Torrie, Jill; Levasseur, Mélanie

    2017-01-01

    Introduction Indigenous elders have traditionally played an important role in maintaining social cohesion within their communities. Today, part of this role has been taken over by government social and healthcare services, but they are having limited success in addressing social challenges. Increasing elders’ social participation and intergenerational solidarity might foster community development and benefit young people, families, communities and the elders themselves. However, knowledge of the contribution of elders’ social participation and intergenerational solidarity to wellness is scattered and needs to be synthesised. This protocol presents a scoping review on the social participation of indigenous elders, intergenerational solidarity and their influence on individual and community wellness. Methods and analysis This scoping review protocol is based on an innovative methodological framework designed to gather information from the scientific and grey literature and from indigenous sources. It was developed by an interdisciplinary team including indigenous scholars/researchers, knowledge users and key informants. In addition to searching information databases in fields such as public health and indigenous studies, an advisory committee will ensure that information is gathered from grey literature and indigenous sources. Ethics The protocol was approved by the Ethics Review Board of the Université du Québec en Abitibi-Témiscamingue and the First Nations of Quebec and Labrador Health and Social Services Commission. Discussion The comprehensive synthesis of the scientific and grey literature and indigenous sources proposed in this protocol will not only raise awareness within indigenous communities and among healthcare professionals and community organisations, but will also enable decision-makers to better meet the needs of indigenous people. Conclusion The innovative methodological framework proposed in this scoping review protocol will yield richer information on the contribution of elders to community wellness. This work is an essential preliminary step towards developing research involving indigenous communities, drawing on the social participation of elders and intergenerational solidarity. PMID:28501814

  15. Cognitive-behavioral treatment groups for people with chronic physical illness in Hong Kong: reflections on a culturally attuned model.

    PubMed

    Wong, Daniel Fu Keung; Chau, Phyllis; Kwok, Anna; Kwan, Jackie

    2007-07-01

    This study describes and evaluates a cognitive-behavioral treatment group for people with chronic physical illness in Hong Kong. We developed a group protocol based on the understanding that Chinese people generally prefer a structured group format, expect group leaders to be active and directive, and are not used to expressing opinions and emotions in groups. The experimental and waitlist control groups had 38 and 35 participants, respectively. A standardized questionnaire was administered to all participants before and after the group treatment. Results suggest that members of the experimental group showed improvements in mental health, negative automatic thoughts, and negative emotions when compared to those in the waitlist control groups, and at the end of group treatment. Implications for designing and running a culturally attuned CBT group for Chinese people are discussed.

  16. Transitions of care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): a study of protocols in Greater London.

    PubMed

    Singh, Swaran P; Paul, Moli; Ford, Tamsin; Kramer, Tami; Weaver, Tim

    2008-06-23

    Although young people's transition from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. A questionnaire survey (Jan-April 2005) of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Forty two of the 65 teams contacted (65%) responded to the survey. Teams varied in type (generic/targeted/in-patient), catchment area (locality-based, wider or national) and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0-70, SD 14.5, n = 37) was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0-50, SD 9.5, n = 33). In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in protocol-sharing organisational units and transition process suggest that practice may vary. There is discontinuity of care provision for some patients who 'graduate' from CAMHS services but are not accepted by adult services.

  17. Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): A study of protocols in Greater London

    PubMed Central

    Singh, Swaran P; Paul, Moli; Ford, Tamsin; Kramer, Tami; Weaver, Tim

    2008-01-01

    Background Although young people's transition from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. Methods A questionnaire survey (Jan-April 2005) of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Results Forty two of the 65 teams contacted (65%) responded to the survey. Teams varied in type (generic/targeted/in-patient), catchment area (locality-based, wider or national) and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0–70, SD 14.5, n = 37) was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0–50, SD 9.5, n = 33). In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. Conclusion At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in protocol-sharing organisational units and transition process suggest that practice may vary. There is discontinuity of care provision for some patients who 'graduate' from CAMHS services but are not accepted by adult services. PMID:18573214

  18. Isolation of high-quality total RNA from leaves of Myrciaria dubia "CAMU CAMU".

    PubMed

    Gómez, Juan Carlos Castro; Reátegui, Alina Del Carmen Egoavil; Flores, Julián Torres; Saavedra, Roberson Ramírez; Ruiz, Marianela Cobos; Correa, Sixto Alfredo Imán

    2013-01-01

    Myrciaria dubia is a main source of vitamin C for people in the Amazon region. Molecular studies of M. dubia require high-quality total RNA from different tissues. So far, no protocols have been reported for total RNA isolation from leaves of this species. The objective of this research was to develop protocols for extracting high-quality total RNA from leaves of M. dubia. Total RNA was purified following two modified protocols developed for leaves of other species (by Zeng and Yang, and by Reid et al.) and one modified protocol developed for fruits of the studied species (by Silva). Quantity and quality of purified total RNA were assessed by spectrophotometric and electrophoretic analysis. Additionally, quality of total RNA was evaluated with reverse-transcription polymerase chain reaction (RT-PCR). With these three modified protocols we were able to isolate high-quality RNA (A260nm/A280nm >1.9 and A260nm/A230nm >2.0). Highest yield was produced with the Zeng and Yang modified protocol (384±46µg ARN/g fresh weight). Furthermore, electrophoretic analysis showed the integrity of isolated RNA and the absence of DNA. Another proof of the high quality of our purified RNA was the successful cDNA synthesis and amplification of a segment of the M. dubia actin 1 gene. We report three modified protocols for isolation total RNA from leaves of M. dubia. The modified protocols are easy, rapid, low in cost, and effective for high-quality and quantity total RNA isolation suitable for cDNA synthesis and polymerase chain reaction.

  19. Does a fall prevention educational programme improve knowledge and change exercise prescribing behaviour in health and exercise professionals? A study protocol for a randomised controlled trial.

    PubMed

    Tiedemann, A; Sturnieks, D L; Hill, A-M; Lovitt, L; Clemson, L; Lord, S R; Harvey, L; Sherrington, C

    2014-11-19

    Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people. A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants' confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial. The trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants' newsletters. Trial protocol was registered with the Australian and New Zealand Clinical Trials Registry (Number ACTRN12614000224628) on 3 March 2014. 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.

  20. [The factors that influence the use of clinical protocols according to the opinion of health center coordinators. The Research Group on the Evaluation and Improvement of Clinical Protocols].

    PubMed

    Saura-Llamas, J; Saturno Hernández, P J; Gaona Ramón, J M; Romero Román, J R; González Barberá, M

    1999-11-15

    To find the factors that affect the use of clinical protocols in primary care, in the view of primary care team coordinators, and the reasons why they are little followed, and to bring together suggestions for improvement. An opinion study, through a telephone survey. Primary health care. The health centres in Murcia with protocolized activity: 31 at the start of the project. The coordinators and those in charge of nursing, 62 people in all. After a pilot study, a structured telephone survey was carried out, administered by a trained interviewer who posed two open questions: why do you think that the professionals at your centre do not use the existing protocols more often? and: what suggestions would you make to improve the protocols and have them used more? A specialist company did the field-work in June and July 1996. There was a 98% reply rate. To the first question, coordinators thought that low use could be explained by excess demand and lack of time for consultations (33% of all replies), although they also cited other organisational problems in the centre, defects in protocols and lack of training. Those in charge of nursing gave very similar replies, with excess demand (39%) predominating. To the second question, on increasing the use of protocols, coordinators suggested that the protocols needed to be improved (44.8% of replies), and also cited the need for improvements in organisation and on-going training. Very similar answers came from the nursing side, where 43.5% highlighted the need to improve the protocol documents. The coordinators assumed that the clinical protocols were used little and could be improved. In their view the basic reason for their low use is excessive pressure from the patient-load. The key to using them more is improvement in the protocol documents.

  1. Prophylactic platelet transfusions prior to surgery for people with a low platelet count

    PubMed Central

    Estcourt, Lise J; Malouf, Reem; Doree, Carolyn; Trivella, Marialena; Hopewell, Sally; Birchall, Janet

    2017-01-01

    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the clinical effectiveness and safety of prophylactic platelet transfusions prior to surgery for people with a low platelet count or platelet dysfunction (inherited or acquired). PMID:29151812

  2. Interventions for preventing silent cerebral infarcts in people with sickle cell disease

    PubMed Central

    Estcourt, Lise J; Fortin, Patricia M; Hopewell, Sally; Trivella, Marialena; Doree, Carolyn; Abboud, Miguel R

    2017-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effectiveness of red blood transfusions and hydroxyurea alone or in combination and HSCT to reduce or prevent SCI in people with SCD. PMID:28344510

  3. Family Carers' Experiences Using Support Services in Europe: Empirical Evidence from the EUROFAMCARE Study

    ERIC Educational Resources Information Center

    Lamura, Giovanni; Mnich, Eva; Nolan, Mike; Wojszel, Beata; Krevers, Barbro; Mestheneos, Liz; Dohner, Hanneli

    2008-01-01

    Purpose: This article explores the experiences of family carers of older people in using support services in six European countries: Germany, Greece, Italy, Poland, Sweden, and the UK. Design and Methods: Following a common protocol, data were collected from national samples of approximately 1,000 family carers per country and clustered into…

  4. 6,220 institutionalised people with intellectual disability referred for visual assessment between 1993 and 2003: overview and trends.

    PubMed

    van Isterdael, C E D; Stilma, J S; Bezemer, P D; Tijmes, N T

    2006-10-01

    To summarise the results of visual performance tests and other data of institutionalised people with intellectual disability referred to a visual advisory centre (VAC) between 1993 and 2003, and to determine trends in these data. A retrospective medical record review was undertaken of 6,220 consecutive people examined ophthalmologically according to a standard protocol by one VAC that specialised in visual assessment and treatment of people with intellectual disability, between 1993 and 2003. chi2 test for linear trend was used and linear regression coefficients were calculated. The proportion of people aged > or =50 years increased from 19.3% to 34.2% between 1995 and 2003 (p<0.001); the combined figure of severe or profound intellectual disability decreased from 80.0% to 52.6% (p<0.001); the proportion of mobile people increased from 52.1% to 98.0% (p<0.001); the combined proportion of people with visual impairment or blindness decreased from 70.9% to 22.9% (p<0.001), and that of people with visual disorders decreased from 89.6% to 75.3% (p<0.001). Causes of intellectual disability were identified in 58.4% people; 20.8% had Down's syndrome. Many ocular diagnoses were found, indicating the need for ophthalmological monitoring. Specialised centres are helpful, because assessment and treatment of people with intellectual disability is complicated and time consuming. Protocols for efficient referral will have to be developed. A major task lies ahead to improve the treatment rates of refractive errors, cataract and strabismus, and to find specific causes of intellectual disability.

  5. Addressing Viral Hepatitis in People with Substance Use Disorders. Treatment Improvement Protocol (TIP) Series 53

    ERIC Educational Resources Information Center

    Substance Abuse and Mental Health Services Administration, 2011

    2011-01-01

    Treatment Improvement Protocols (TIPs) are developed by the Center for Substance Abuse Treatment (CSAT), part of the Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S. Department of Health and Human Services (HHS). Each TIP involves the development of topic-specific best-practice guidelines for the prevention and…

  6. Comparing dietary patterns of depressed patients versus healthy people in a case control protocol

    PubMed Central

    Khosravi, Maryam; Sotoudeh, Gity; Raisi, Firoozeh; Majdzadeh, Reza; Foroughifar, Tahereh

    2014-01-01

    Introduction Major depressive disorder is the leading cause of disability around the world. Because of the high rate of medication discontinuation by patients and the risk of recurrence, factors such as nutrition could be useful for the prevention or treatment of depression. The relationship between depression and dietary patterns has been reported in a few studies but with controversial results. Therefore, we have decided to study the possible effects of cultural, social, racial, geographic and environmental conditions on this relationship in an Iranian population. Methods and analysis In our case control protocol, 110 cases and 220 controls will be individually matched based on age, sex and area of residence. New cases of depression, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), will be recruited from two psychiatric clinics in Tehran. Interviewers will then go to each patient's home and invite qualified individuals to participate in the study as controls. Food intakes of all participants will be obtained by semiquantitative food frequency questionnaires covering the past year; these will be transformed into actual food intake (g/day). Dietary patterns will be determined by the principal components method. Conditional logistic regression, as a multivariate analysis, will be used for assessing the relationship between dietary patterns and depression, taking into consideration the potential role of different variables. The results may help to identify differences in dietary patterns between depressed and healthy people. Ethics and dissemination The study protocol has been approved by ethics committee of Tehran University of Medical Sciences. At the beginning of the study, a written informed consent form will be signed and dated by subjects and investigators. The results will be published in due time. PMID:24525387

  7. Internet-based interventions for the prevention and treatment of depression in people living in developing countries: A systematic review.

    PubMed

    Martínez, Pablo; Rojas, Graciela; Martínez, Vania; Lara, María Asunción; Pérez, J Carola

    2018-07-01

    Internet-based interventions for depression may be a valuable resource to reduce the treatment gap for those living in developing countries. However, evidence comes mainly from developed countries. This systematic review summarized the evidence on preventive or therapeutic Internet-based interventions for depression for people who reside in developing countries. CINAHL, EMBASE, PubMed, SciELO Citation Indexes, the Journal of Medical Internet Research, and the Telemedicine and e-Health journal, were searched up to June 2017, to identify feasibility or effectiveness studies of preventive or therapeutic Internet-based interventions for depression, with or without human support. Studies included subjects residing in developing countries, and were published in English or Spanish. Study protocols were included. Risk of bias and/or quality of the reporting of the studies included was assessed. Five feasibility studies, aimed at the prevention of depression, and a study protocol were included in this systematic review. Reports came mostly from the Americas (n = 4). Internet-based interventions aimed at the prevention of depression presented low levels of human support, were useful and acceptable to their users, and require further design refinements to improve their use and retention. No gray literature was searched or included in this systematic review. Searches were limited to English and Spanish languages. Internet-based interventions aimed at the prevention of depression in people who reside in developing countries are in an early phase of development, limiting the generalizability of the results. Future studies must employ persuasive designs to improve user retention, incorporating larger samples and a control group to conclusively determine feasibility. Copyright © 2018 Elsevier B.V. All rights reserved.

  8. Touch, the essence of caring for people with end-stage dementia: a mental health perspective in Namaste Care.

    PubMed

    Nicholls, Daniel; Chang, Esther; Johnson, Amanda; Edenborough, Michel

    2013-01-01

    This article presents the mental health aspects of 'touch' associated with a funded research project: Avoiding 'high tech' through 'high touch' in end-stage dementia: Protocol for care at the end-of-life. These mental health aspects highlight the human need for touch that continues up until and inclusive of the final stages of life. This study was informed by Simard's (2007) 'high touch' protocol based on the End-of-Life Namaste Care programme for people with dementia. The article is situated in relation to the research project which used a three-phase mixed methods approach. Data explored in this article are derived from focus groups conducted at three residential aged care facilities located in metropolitan and regional areas of NSW, Australia. The exploration of touch vis-a-vis mental health fell under two broad themes: touch by others and touch by the person. Sub-elements of these themes comprised touch towards a physical objective, touch towards an emotional objective, touch of objects and touch of others. The overarching outcome of interconnectedness embraced environmental awareness and human and life awareness. These two broad themes, with their accompanying elements, express the essential nature of mental health as a reciprocal connectedness, with reciprocal impacts on both those people with advanced dementia and their carers.

  9. Measuring the quality of life of people with dementia in nursing homes in Germany - the study protocol for the Qol-Dem Project.

    PubMed

    Dichter, Martin Nikolaus; Halek, Margareta; Dortmann, Olga; Meyer, Gabriele; Bartholomeyczik, Sabine

    2013-01-01

    QUALIDEM is a standardized dementia-specific quality of life (Qol) measurement, which was developed and validated in the Netherlands. A German version has been available since 2008. This study protocol describes the design and methodology for the quality of life of people with dementia (Qol-Dem) project. This project aims to evaluate the reliability and validity of the German version of the QUALIDEM. Due to the lack of both a universal definition of Qol and of standards to verify the validity of Qol measurements, this study is divided into three phases. The aim of the first theoretical phase is the development of a dementia-specific Qol model as a result of a meta-synthesis of qualitative studies. The second empirical phase consists of the three following steps: (a) an investigation of the scalability and internal consistency of the measure, (b) an evaluation of the interrater and intrarater reliability, and (c) an extensive evaluation of the validity of the QUALIDEM. The resulting Qol model (phase 1) will be used for the selection of appropriate comparators for validity testing. In the third phase, the QUALIDEM will be adapted, if necessary, based on the knowledge generated in the first two phases. The findings of the Qol-Dem project should deliver an accurate assessment of the psychometric properties of the German version of the QUALIDEM. The results will contribute to the further development of the instrument. Furthermore, the results will contribute to the theoretical development of the concept of Qol among people with dementia.

  10. Modulation of error-sensitivity during a prism adaptation task in people with cerebellar degeneration

    PubMed Central

    Shadmehr, Reza; Ohminami, Shinya; Tsutsumi, Ryosuke; Shirota, Yuichiro; Shimizu, Takahiro; Tanaka, Nobuyuki; Terao, Yasuo; Tsuji, Shoji; Ugawa, Yoshikazu; Uchimura, Motoaki; Inoue, Masato; Kitazawa, Shigeru

    2015-01-01

    Cerebellar damage can profoundly impair human motor adaptation. For example, if reaching movements are perturbed abruptly, cerebellar damage impairs the ability to learn from the perturbation-induced errors. Interestingly, if the perturbation is imposed gradually over many trials, people with cerebellar damage may exhibit improved adaptation. However, this result is controversial, since the differential effects of gradual vs. abrupt protocols have not been observed in all studies. To examine this question, we recruited patients with pure cerebellar ataxia due to cerebellar cortical atrophy (n = 13) and asked them to reach to a target while viewing the scene through wedge prisms. The prisms were computer controlled, making it possible to impose the full perturbation abruptly in one trial, or build up the perturbation gradually over many trials. To control visual feedback, we employed shutter glasses that removed visual feedback during the reach, allowing us to measure trial-by-trial learning from error (termed error-sensitivity), and trial-by-trial decay of motor memory (termed forgetting). We found that the patients benefited significantly from the gradual protocol, improving their performance with respect to the abrupt protocol by exhibiting smaller errors during the exposure block, and producing larger aftereffects during the postexposure block. Trial-by-trial analysis suggested that this improvement was due to increased error-sensitivity in the gradual protocol. Therefore, cerebellar patients exhibited an improved ability to learn from error if they experienced those errors gradually. This improvement coincided with increased error-sensitivity and was present in both groups of subjects, suggesting that control of error-sensitivity may be spared despite cerebellar damage. PMID:26311179

  11. Randomized controlled trial of parent-enhanced CBT compared with individual CBT for obsessive-compulsive disorder in young people.

    PubMed

    Reynolds, Shirley A; Clark, Sarah; Smith, Holly; Langdon, Peter E; Payne, Ruth; Bowers, Gemma; Norton, Elisabeth; McIlwham, Harriet

    2013-12-01

    Obsessive-compulsive disorder (OCD) in young people can be effectively treated with Cognitive Behavior Therapy (CBT). Practice guidelines in the United Kingdom recommend that CBT be delivered with parental or family involvement; however, there is no evidence from randomized trials that this enhances effectiveness. The aim of this trial was to assess if CBT with high parental involvement was more effective than CBT with low parental involvement (individual CBT) in reducing symptoms of OCD. Fifty young people ages 12-17 years with OCD were randomly allocated to individual CBT or parent-enhanced CBT. In parent-enhanced CBT parents attended all treatment sessions; in individual CBT, parents attended only Sessions 1, 7, and the final session. Participants received up to 14 sessions of CBT. Data were analyzed using intent-to-treat and per-protocol methods. The primary outcome measure was the Children's Yale-Brown Obsessive Compulsion Scale (Scahill et al., 1997). Both forms of CBT significantly reduced symptoms of OCD and anxiety. Change in OCD symptoms was maintained at 6 months. Per-protocol analysis suggested that parent-enhanced CBT may be associated with significantly larger reductions in anxiety symptoms. High and low parental involvement in CBT for OCD in young people were both effective, and there was no evidence that 1 method of delivery was superior on the primary outcome measure. However, this study was small. Future trials should be adequately powered and examine interactions with the age of the young person and comorbid anxiety disorders.

  12. IDEA intervention to prevent depressive symptoms and promote well-being in early-stage dementia: protocol for a randomised controlled feasibility study.

    PubMed

    Tuijt, Remco; Livingston, Gill; Gould, Rebecca L; Jones, Rebecca; Verdaguer, Elisabet Sole; Orgeta, Vasiliki

    2018-02-08

    Depressive symptoms are common among people with dementia, impacting quality of life and cognitive and functional decline. Currently, little is known about the acceptability and feasibility of psychological interventions for people with mild dementia, with recent reviews identifying the need for further evidence. Developing and evaluating psychological interventions to prevent and treat these symptoms is, therefore, an important clinical and research priority. This protocol describes a study testing the acceptability and feasibility of a manual-based behavioural activation (BA) intervention for preventing and treating depressive symptoms in people with mild dementia. The aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial of clinical effectiveness of an eight-session intervention. The Intervention to prevent Depressive symptoms and promote well-being in EArly-stage dementia (IDEA) programme supports people with dementia and their family carers in identifying and scheduling enjoyable and meaningful activities. Sixty people who have received a diagnosis of dementia of any type in the last 6 months will be recruited via memory clinics. Further criteria are a Mini-Mental State Examination score of ≥20, and a family carer who can assist with the intervention. Consenting participants will be randomised in a ratio of 2:1 to BA or to treatment as usual. Analyses will estimate parameters such as rates of recruitment, retention and number of sessions completed. Questionnaires measuring depressive symptoms and quality of life for both the person with dementia and their carer will be completed at baseline, 3 and 6 months. Qualitative interviews will explore acceptability of the intervention, study procedures and experiences of the sessions. This study received a favourable ethical opinion from the London Camberwell St Giles Research Ethics Committee (16/LO/0540). We will disseminate findings at key conferences, the Alzheimer's Society and University College London websites and local stakeholder events. ISRCTN75503960; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Teaching Young People Who Are Blind and Have Autism to Make Requests Using a Variation on the Picture Exchange Communication System with Tactile Symbols: A Preliminary Investigation

    ERIC Educational Resources Information Center

    Lund, Shelley K.; Troha, Jeanette M.

    2008-01-01

    This study used a single-subject multiple baseline across participants design to evaluate the effectiveness of a modified picture exchange communication system (PECS) teaching protocol with tactile symbols. Three students (two male, one female) aged 12-17 years who had autism and were blind participated in the study. The instructional program…

  14. Systematic reviews: guidance relevant for studies of older people

    PubMed Central

    Wilkinson, Tim; Dodds, Richard M.; Ioannidis, John P. A.

    2017-01-01

    Abstract Systematic reviews and meta-analyses are increasingly common. This article aims to provide guidance for people conducting systematic reviews relevant to the healthcare of older people. An awareness of these issues will also help people reading systematic reviews to determine whether the results will influence their clinical practice. It is essential that systematic reviews are performed by a team which includes the required technical and clinical expertise. Those performing reviews for the first time should ensure they have appropriate training and support. They must be planned and performed in a transparent and methodologically robust way: guidelines are available. The protocol should be written—and if possible published—before starting the review. Geriatricians will be interested in a table of baseline characteristics, which will help to determine if the studied samples or populations are similar to their patients. Reviews of studies of older people should consider how they will manage issues such as different age cut-offs; non-specific presentations; multiple predictors and outcomes; potential biases and confounders. Systematic reviews and meta-analyses may provide evidence to improve older people's care, or determine where new evidence is required. Newer methodologies, such as meta-analyses of individual level data, network meta-analyses and umbrella reviews, and realist synthesis, may improve the reliability and clinical utility of systematic reviews. PMID:28655142

  15. Study protocol: a mixed methods study to assess mental health recovery, shared decision-making and quality of life (Plan4Recovery).

    PubMed

    Coffey, Michael; Hannigan, Ben; Meudell, Alan; Hunt, Julian; Fitzsimmons, Deb

    2016-08-17

    Recovery in mental health care is complex, highly individual and can be facilitated by a range of professional and non-professional support. In this study we will examine how recovery from mental health problems is promoted in non-medical settings. We hypothesise a relationship between involvement in decisions about care, social support and recovery and quality of life outcomes. We will use standardised validated instruments of involvement in decision-making, social contacts, recovery and quality of life with a random sample of people accessing non-statutory mental health social care services in Wales. We will add to this important information with detailed one to one case study interviews with people, their family members and their support workers. We will use a series of these interviews to examine how people build recovery over time to help us understand more about their involvement in decisions and the social links they build. We want to see how being involved in decisions about care and the social links people have are related to recovery and quality of life for people with experience of using mental health support services. We want to understand the different perspectives of the people involved in making recovery possible. We will use this information to guide further studies of particular types of social interventions and their use in helping recovery from mental health problems.

  16. Integrated Models of Care for People Living with Hepatitis C Virus and a Substance Use Disorder: Protocol for a Systematic Review.

    PubMed

    Ti, Lianping; Parent, Stephanie; Socías, María Eugenia

    2018-05-09

    People living with a substance use disorder (SUD) are a key population within the hepatitis C virus (HCV) epidemic. While integrated and community-based models of care have shown positive outcomes among this population, the literature has been primarily focused on the HIV context. This paper outlines a systematic review protocol on the impact of various integrated models of care, which includes HCV and SUD services, on various treatment, and health-related outcomes among this population. The objective of this review is to determine the impact of integrated models of care on HCV and addiction treatment and health-related outcomes for adults living with HCV and an SUD. We will search 5 databases, article reference lists, and abstracts from relevant conferences that investigate the impact of integrated models of care on treatment and health-related outcomes among people living with HCV and an SUD. Database searches will be conducted and titles, abstracts, and the full-text of the relevant studies will be independently reviewed in separate stages. The methodological quality of included studies will be assessed using a validated tool. Data from included articles will be extracted using a standardized form and synthesized in a narrative account. For this project, we have received funding from the Canadian Institute of Health Research. To date, we have completed the search strategy, reviewed the titles, abstracts, and full-texts. Grading the selected studies and qualitative synthesis of the results are currently under way, and we expect the final results to be submitted for publication in the fall of 2018. The systematic review will describe different integrated models of care that could be effective in improving the health and well-being of people living with HCV and an SUD. Results of this review could also identify quality improvement strategies to minimize the health and cost burden imposed on patients, healthcare professionals, and the healthcare system. PROSPERO CRD42017078445; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=78445 (Archived by WebCite at http://www.webcitation.org/6z4YnkE9G). ©Lianping Ti, Stephanie Parent, María Eugenia Socías. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.05.2018.

  17. Using environmental engineering to increase hand hygiene compliance: a cross-over study protocol.

    PubMed

    Schmidtke, Kelly Ann; Aujla, Navneet; Marshall, Tom; Hussain, Abid; Hodgkinson, Gerard P; Arheart, Kristopher; Marti, Joachim; Birnbach, David J; Vlaev, Ivo

    2017-09-11

    Compliance with hand hygiene recommendations in hospital is typically less than 50%. Such low compliance inevitably contributes to hospital-acquired infections that negatively affect patients' well-being and hospitals' finances. The design of the present study is predicated on the assumption that most people who fail to clean their hands are not doing so intentionally, they just forget. The present study will test whether psychological priming can be used to increase the number of people who clean their hands on entering a ward. Here, we present the protocol for this study. The study will use a randomised cross-over design. During the study, each of four wards will be observed during four conditions: olfactory prime, visual prime, both primes and neither prime. Each condition will be experienced for 42 days followed by a 7-day washout period (total duration of trial=189 days). We will record the number of people who enter each ward and whether they clean their hands during observation sessions, the amount of cleaning material used from the dispensers each week and the number of hospital-acquired infections that occur in each period. The outcomes will be compared using a regression analysis. Following the initial trail, the most effective priming condition will be rolled out for 3 months in all the wards. Research ethics approval was obtained from the South Central-Oxford C Research Ethics Committee (16/SC/0554), the Health Regulatory Authority and the sponsor. ISRCTN (15397624); Edge ID 86357. © 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.

  18. The Tehran Eye Study: research design and eye examination protocol

    PubMed Central

    Hashemi, Hassan; Fotouhi, Akbar; Mohammad, Kazem

    2003-01-01

    Background Visual impairment has a profound impact on society. The majority of visually impaired people live in developing countries, and since most disorders leading to visual impairment are preventable or curable, their control is a priority in these countries. Considering the complicated epidemiology of visual impairment and the wide variety of factors involved, region specific intervention strategies are required for every community. Therefore, providing appropriate data is one of the first steps in these communities, as it is in Iran. The objectives of this study are to describe the prevalence and causes of visual impairment in the population of Tehran city; the prevalence of refractive errors, lens opacity, ocular hypertension, and color blindness in this population, and also the familial aggregation of refractive errors, lens opacity, ocular hypertension, and color blindness within the study sample. Methods Design Through a population-based, cross-sectional study, a total of 5300 Tehran citizens will be selected from 160 clusters using a stratified cluster random sampling strategy. The eligible people will be enumerated through a door-to-door household survey in the selected clusters and will be invited. All participants will be transferred to a clinic for measurements of uncorrected, best corrected and presenting visual acuity; manifest, subjective and cycloplegic refraction; color vision test; Goldmann applanation tonometry; examination of the external eye, anterior segment, media, and fundus; and an interview about demographic characteristics and history of eye diseases, eye trauma, diabetes mellitus, high blood pressure, and ophthalmologic cares. The study design and eye examination protocol are described. Conclusion We expect that findings from the TES will show the status of visual problems and their causes in the community. This study can highlight the people who should be targeted by visual impairment prevention programs. PMID:12859794

  19. The Tehran Eye Study: research design and eye examination protocol.

    PubMed

    Hashemi, Hassan; Fotouhi, Akbar; Mohammad, Kazem

    2003-07-15

    Visual impairment has a profound impact on society. The majority of visually impaired people live in developing countries, and since most disorders leading to visual impairment are preventable or curable, their control is a priority in these countries. Considering the complicated epidemiology of visual impairment and the wide variety of factors involved, region specific intervention strategies are required for every community. Therefore, providing appropriate data is one of the first steps in these communities, as it is in Iran. The objectives of this study are to describe the prevalence and causes of visual impairment in the population of Tehran city; the prevalence of refractive errors, lens opacity, ocular hypertension, and color blindness in this population, and also the familial aggregation of refractive errors, lens opacity, ocular hypertension, and color blindness within the study sample. Through a population-based, cross-sectional study, a total of 5300 Tehran citizens will be selected from 160 clusters using a stratified cluster random sampling strategy. The eligible people will be enumerated through a door-to-door household survey in the selected clusters and will be invited. All participants will be transferred to a clinic for measurements of uncorrected, best corrected and presenting visual acuity; manifest, subjective and cycloplegic refraction; color vision test; Goldmann applanation tonometry; examination of the external eye, anterior segment, media, and fundus; and an interview about demographic characteristics and history of eye diseases, eye trauma, diabetes mellitus, high blood pressure, and ophthalmologic cares. The study design and eye examination protocol are described. We expect that findings from the TES will show the status of visual problems and their causes in the community. This study can highlight the people who should be targeted by visual impairment prevention programs.

  20. Effects of Vestibular Rehabilitation on Balance Control in Older People with Chronic Dizziness: A Randomized Clinical Trial.

    PubMed

    Ricci, Natalia Aquaroni; Aratani, Mayra Cristina; Caovilla, Heloísa Helena; Ganança, Fernando Freitas

    2016-04-01

    The aim of this study was to compare the effects of vestibular rehabilitation protocols on balance control in elderly with dizziness. This is a randomized clinical trial with 3-mo follow-up period. The sample was composed of 82 older individuals with chronic dizziness from vestibular disorders. The control group was treated according to the Conventional Cawthorne & Cooksey protocol (n = 40), and the experimental group was submitted to a Multimodal Cawthorne & Cooksey protocol (n = 42). Measures included Dynamic Gait Index, fall history, hand grip strength, Time Up-and-Go Test, sit-to-stand test, multidirectional reach, and static balance tests. With the exception of history of falls, Forward Functional Reach, Unipedal Right and Left Leg Eyes Closed, and Sensorial Romberg Eyes Open, all outcomes improved after treatments. Such results persisted at follow-up period, with the exception of the Tandem Eyes Open and the Timed Up-and-Go manual. The between-group differences for Sensorial Romberg Eyes Closed (4.27 secs) and Unipedal Left Leg Eyes Open (4.08 secs) were significant after treatment, favoring the Multimodal protocol. Both protocols resulted in improvement on elderly's balance control, which was maintained during a short-term period. The multimodal protocol presented better performance on specific static balance tests.

  1. Effect of reading on blood flow changes in the posterior cerebral artery in early blind and sighted people--A transcranial Doppler study.

    PubMed

    Viski, Sandor; Orgovan, David; Szabo, Katalin; Rosengarten, Bernhard; Csiba, Laszlo; Olah, Laszlo

    2016-04-15

    Neuroimaging studies proved that Braille reading resulted in visual cortex activation in blind people, however, very few data are available about the measure of flow increase in these subjects. Therefore, we investigated the flow response in the posterior cerebral artery (PCA) of eleven early blind and ten sighted subjects induced by reading Braille and print, respectively. Two experimental protocols were used in both groups: PCA flow velocity during reading was compared to the resting phase and "NLC" phase (volunteers "read" non-lexical characters; e.g. .,-.:,-.:...,). The use of these experimental protocols allowed to investigate separately the effect of "light stimulus+print reading" versus "print reading alone" in sighted, and "hand/finger movement+Braille reading" versus "Braille reading alone" in blind subjects. The flow response in the PCA evoked by "Braille reading alone" in blind (10.5±4.5%) and "print reading alone" in sighted subjects (8.1±3.5%) was similar. The flow increase induced by "hand/finger movement+Braille reading" and by "Braille reading alone" did not differ in blind people, however, "light stimulus+print reading" in sighted subjects caused higher PCA flow increase (25.9±6.9%) than "print reading alone" (8.1±3.5%). The similar PCA flow response induced by Braille and print reading alone suggested a similar degree of occipital cortex activation in blind and sighted subjects. In sighted people, the 3-times higher flow velocity increase induced by "light stimulus+print reading" compared with "print reading alone" indicated that 2/3 of PCA flow increase during reading was due to the light stimulus and only 1/3 of flow response was caused by reading alone. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Home-based exercise and support programme for people with dementia and their caregivers: study protocol of a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Dementia affects the mood of people with dementia but also of their caregivers. In the coming years, the number of people with dementia will increase worldwide and most of them will continue to live in the community as long as possible. Home-based psychosocial interventions reducing the depressive symptoms of both people with dementia and their caregivers in their own home are highly needed. Methods/Design This manuscript describes the design of a Randomised Controlled Trial (RCT) of the effects of a home-based exercise and support programme for people with dementia and their caregivers. The aim is to randomly assign 156 dyads (caregiver and dementia diagnosed person) to an intervention group or a comparison group. The experimental group receives a home programme in which exercise and support for the people with dementia and their caregivers are combined and integrated. The comparison group receives a minimal intervention. Primary outcomes are physical health (people with dementia) and mood (people with dementia and caregivers). In addition, to get more insight in the working components of the intervention and the impact of the intervention on the relationship of the dyads a qualitative sub-study is carried out. Discussion This study aims to contribute to an evidence-based treatment to reduce depressive symptoms among people with dementia and their caregivers independently living in the community. Trial Registration The study has been registered at the Netherlands National Trial Register (NTR), which is connected to the International Clinical Trials Registry Platform of the WHO. Trial number: NTR1802. PMID:22117691

  3. Verification and large scale clinical evaluation of a national standard protocol for Salmonella spp./Shigella spp. screening using real-time PCR combined with guided culture.

    PubMed

    Tang, Xi-Jun; Yang, Ze; Chen, Xin-Bin; Tian, Wen-Fang; Tu, Cheng-Ning; Wang, Hai-Bo

    2018-02-01

    Salmonella spp./Shigella spp. are often associated with food poisoning and fecal-oral transmission of acute gastroenteritis that requires strict monitoring, especially among people who would handle food and water. In 2014, the National Health and Family Planning Commission of the P. R. China issued a national standard protocol (recommendatory) for the screening of Salmonella spp./Shigella spp.. However, its performance has not been fully studied. Whether it was suitable for use in our laboratory was still unknown. In the current study, the new protocol was first verified by various experiments and then its clinical performance was evaluated in about 20,000 stool samples over a three-year period. Verification results showed that the new protocol was highly specific and reproducible. Sensitivity (as defined as the lower limit of detection) of the new protocol at the PCR step was 10 3 CFU/mL and 10 1 CFU/mL for Salmonella spp. and Shigella spp., while that at the guided culture step was 10 4 CFU/mL and 10 3 CFU/mL, respectively. The large scale clinical evaluation indicated that the new protocol could increase the positivity rate by two fold and decrease the workload/median turnaround time significantly. In conclusion, the protocol was verified and evaluated and was proven to be a valuable platform for the rapid, specific, sensitive and high-throughput screening of Salmonella spp./Shigella spp. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Dimensions of tinnitus-related complaints reported by patients and their significant others: protocol for a systematic review.

    PubMed

    Haider, Haúla; Fackrell, Kathryn; Kennedy, Veronica; Hall, Deborah A

    2016-10-08

    Over 70 million people in Europe and >50 million people in the USA are reported to experience tinnitus (the sensation of noise in the absence of any corresponding sound source). Tinnitus is a multidimensional concept. Individual patients may report different profiles of tinnitus-related symptoms which may each require a tailored management approach and an appropriate measure of therapeutic benefit. This systematic review concerns the patient perspective and has the purpose to find what symptoms are reported by people who experience tinnitus and by their significant others. This protocol lays out the methodology to define what dimensions of tinnitus-related symptoms patients and their significant others report as being a problem. Methods are defined according to the Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols (PRISMA-P) 2015 and data will be collated in a narrative synthesis. Findings will contribute to the eventual establishment of a Core Domain Set for clinical trials of tinnitus. No ethical issues are foreseen. Findings will be reported at national and international ENT and audiology conferences and in a peer-reviewed journal. CRD42015020629. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  5. How people respond to contingent valuation question: A verbal protocol analysis of willingness to pay for an environmental regulation

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

    Schkade, D.A.; Payne, J.W.

    This paper investigates what a respondent is thinking when answering a willingness-to-pay question in a contingent valuation, using a [open quotes]think aloud[close quotes] technique for psychology called verbal protocol analysis. The willingness-to-pay responses we observed seem to be constructed from a variety of considerations, including an obligation to pay a fair share of the cost of the solution and signaling concern for a larger set of environmental issues. The finding that respondents seem to construct their values at the time they are asked, rather than reporting a more well-defined value, is seen as consistent with over two decades of researchmore » on the psychology of decision making. Potential uses of verbal protocols in contingent valuation studies are also discussed. 64 refs., 6 tabs.« less

  6. A randomised controlled trial testing a web-based, computer-tailored self-management intervention for people with or at risk for chronic obstructive pulmonary disease: a study protocol

    PubMed Central

    2013-01-01

    Background Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality. Effective self-management support interventions are needed to improve the health and functional status of people with COPD or at risk for COPD. Computer-tailored technology could be an effective way to provide this support. Methods/Design This paper presents the protocol of a randomised controlled trial testing the effectiveness of a web-based, computer-tailored self-management intervention to change health behaviours of people with or at risk for COPD. An intervention group will be compared to a usual care control group, in which the intervention group will receive a web-based, computer-tailored self-management intervention. Participants will be recruited from an online panel and through general practices. Outcomes will be measured at baseline and at 6 months. The primary outcomes will be smoking behaviour, measuring the 7-day point prevalence abstinence and physical activity, measured in minutes. Secondary outcomes will include dyspnoea score, quality of life, stages of change, intention to change behaviour and alternative smoking behaviour measures, including current smoking behaviour, 24-hour point prevalence abstinence, prolonged abstinence, continued abstinence and number of quit attempts. Discussion To the best of our knowledge, this will be the first randomised controlled trial to test the effectiveness of a web-based, computer-tailored self-management intervention for people with or at risk for COPD. The results will be important to explore the possible benefits of computer-tailored interventions for the self-management of people with or at risk for COPD and potentially other chronic health conditions. Dutch trial register NTR3421 PMID:23742208

  7. Individual and environmental factors underlying life space of older people – study protocol and design of a cohort study on life-space mobility in old age (LISPE)

    PubMed Central

    2012-01-01

    Background A crucial issue for the sustainability of societies is how to maintain health and functioning in older people. With increasing age, losses in vision, hearing, balance, mobility and cognitive capacity render older people particularly exposed to environmental barriers. A central building block of human functioning is walking. Walking difficulties may start to develop in midlife and become increasingly prevalent with age. Life-space mobility reflects actual mobility performance by taking into account the balance between older adults internal physiologic capacity and the external challenges they encounter in daily life. The aim of the Life-Space Mobility in Old Age (LISPE) project is to examine how home and neighborhood characteristics influence people’s health, functioning, disability, quality of life and life-space mobility in the context of aging. In addition, examine whether a person’s health and function influence life-space mobility. Design This paper describes the study protocol of the LISPE project, which is a 2-year prospective cohort study of community-dwelling older people aged 75 to 90 (n = 848). The data consists of a baseline survey including face-to-face interviews, objective observation of the home environment and a physical performance test in the participant’s home. All the baseline participants will be interviewed over the phone one and two years after baseline to collect data on life-space mobility, disability and participation restriction. Additional home interviews and environmental evaluations will be conducted for those who relocate during the study period. Data on mortality and health service use will be collected from national registers. In a substudy on walking activity and life space, 358 participants kept a 7-day diary and, in addition, 176 participants also wore an accelerometer. Discussion Our study, which includes extensive data collection with a large sample, provides a unique opportunity to study topics of importance for aging societies. A novel approach is employed which enables us to study the interactions of environmental features and individual characteristics underlying the life-space of older people. Potentially, the results of this study will contribute to improvements in strategies to postpone or prevent progression to disability and loss of independence. PMID:23170987

  8. Proximal and distal muscle fatigue differentially affect movement coordination

    PubMed Central

    Cowley, Jeffrey C.

    2017-01-01

    Muscle fatigue can cause people to change their movement patterns and these changes could contribute to acute or overuse injuries. However, these effects depend on which muscles are fatigued. The purpose of this study was to determine the differential effects of proximal and distal upper extremity muscle fatigue on repetitive movements. Fourteen subjects completed a repetitive ratcheting task before and after a fatigue protocol on separate days. The fatigue protocol either fatigued the proximal (shoulder flexor) or distal (finger flexor) muscles. Pre/Post changes in trunk, shoulder, elbow, and wrist kinematics were compared to determine how proximal and distal fatigue affected multi-joint movement patterns and variability. Proximal fatigue caused a significant increase (7°, p < 0.005) in trunk lean and velocity, reduced humeral elevation (11°, p < 0.005), and increased elbow flexion (4°, p < 0.01). In contrast, distal fatigue caused small but significant changes in trunk angles (2°, p < 0.05), increased velocity of wrench movement relative to the hand (17°/s, p < 0.001), and earlier wrist extension (4%, p < 0.005). Movement variability increased at proximal joints but not distal joints after both fatigue protocols (p < 0.05). Varying movements at proximal joints may help people adapt to fatigue at either proximal or distal joints. The identified differences between proximal and distal muscle fatigue adaptations could facilitate risk assessment of occupational tasks. PMID:28235005

  9. The protocols for the 10/66 dementia research group population-based research programme.

    PubMed

    Prince, Martin; Ferri, Cleusa P; Acosta, Daisy; Albanese, Emiliano; Arizaga, Raul; Dewey, Michael; Gavrilova, Svetlana I; Guerra, Mariella; Huang, Yueqin; Jacob, K S; Krishnamoorthy, E S; McKeigue, Paul; Rodriguez, Juan Llibre; Salas, Aquiles; Sosa, Ana Luisa; Sousa, Renata M M; Stewart, Robert; Uwakwe, Richard

    2007-07-20

    Latin America, China and India are experiencing unprecedentedly rapid demographic ageing with an increasing number of people with dementia. The 10/66 Dementia Research Group's title refers to the 66% of people with dementia that live in developing countries and the less than one tenth of population-based research carried out in those settings. This paper describes the protocols for the 10/66 population-based and intervention studies that aim to redress this imbalance. Cross-sectional comprehensive one phase surveys have been conducted of all residents aged 65 and over of geographically defined catchment areas in ten low and middle income countries (India, China, Nigeria, Cuba, Dominican Republic, Brazil, Venezuela, Mexico, Peru and Argentina), with a sample size of between 1000 and 3000 (generally 2000). Each of the studies uses the same core minimum data set with cross-culturally validated assessments (dementia diagnosis and subtypes, mental disorders, physical health, anthropometry, demographics, extensive non communicable disease risk factor questionnaires, disability/functioning, health service utilisation, care arrangements and caregiver strain). Nested within the population based studies is a randomised controlled trial of a caregiver intervention for people with dementia and their families (ISRCTN41039907; ISRCTN41062011; ISRCTN95135433; ISRCTN66355402; ISRCTN93378627; ISRCTN94921815). A follow up of 2.5 to 3.5 years will be conducted in 7 countries (China, Cuba, Dominican Republic, Venezuela, Mexico, Peru and Argentina) to assess risk factors for incident dementia, stroke and all cause and cause-specific mortality; verbal autopsy will be used to identify causes of death. The 10/66 DRG baseline population-based studies are nearly complete. The incidence phase will be completed in 2009. All investigators are committed to establish an anonymised file sharing archive with monitored public access. Our aim is to create an evidence base to empower advocacy, raise awareness about dementia, and ensure that the health and social care needs of older people are anticipated and met.

  10. The protocols for the 10/66 dementia research group population-based research programme

    PubMed Central

    Prince, Martin; Ferri, Cleusa P; Acosta, Daisy; Albanese, Emiliano; Arizaga, Raul; Dewey, Michael; Gavrilova, Svetlana I; Guerra, Mariella; Huang, Yueqin; Jacob, KS; Krishnamoorthy, ES; McKeigue, Paul; Rodriguez, Juan Llibre; Salas, Aquiles; Sosa, Ana Luisa; Sousa, Renata MM; Stewart, Robert; Uwakwe, Richard

    2007-01-01

    Background Latin America, China and India are experiencing unprecedentedly rapid demographic ageing with an increasing number of people with dementia. The 10/66 Dementia Research Group's title refers to the 66% of people with dementia that live in developing countries and the less than one tenth of population-based research carried out in those settings. This paper describes the protocols for the 10/66 population-based and intervention studies that aim to redress this imbalance. Methods/design Cross-sectional comprehensive one phase surveys have been conducted of all residents aged 65 and over of geographically defined catchment areas in ten low and middle income countries (India, China, Nigeria, Cuba, Dominican Republic, Brazil, Venezuela, Mexico, Peru and Argentina), with a sample size of between 1000 and 3000 (generally 2000). Each of the studies uses the same core minimum data set with cross-culturally validated assessments (dementia diagnosis and subtypes, mental disorders, physical health, anthropometry, demographics, extensive non communicable disease risk factor questionnaires, disability/functioning, health service utilisation, care arrangements and caregiver strain). Nested within the population based studies is a randomised controlled trial of a caregiver intervention for people with dementia and their families (ISRCTN41039907; ISRCTN41062011; ISRCTN95135433; ISRCTN66355402; ISRCTN93378627; ISRCTN94921815). A follow up of 2.5 to 3.5 years will be conducted in 7 countries (China, Cuba, Dominican Republic, Venezuela, Mexico, Peru and Argentina) to assess risk factors for incident dementia, stroke and all cause and cause-specific mortality; verbal autopsy will be used to identify causes of death. Discussion The 10/66 DRG baseline population-based studies are nearly complete. The incidence phase will be completed in 2009. All investigators are committed to establish an anonymised file sharing archive with monitored public access. Our aim is to create an evidence base to empower advocacy, raise awareness about dementia, and ensure that the health and social care needs of older people are anticipated and met. PMID:17659078

  11. Non-pharmacological interventions on cognitive functions in older people with mild cognitive impairment (MCI).

    PubMed

    Teixeira, Camila Vieira Ligo; Gobbi, Lilian Teresa Bucken; Corazza, Danilla Icassatti; Stella, Florindo; Costa, José Luiz Riani; Gobbi, Sebastião

    2012-01-01

    Mild cognitive impairment (MCI) can be a stage of pre-dementia. There is no consensus about pharmacological treatment for this population, so it is important to structure non-pharmacological interventions for increasing their cognitive reserve. We intended to analyze the effects of non-pharmacological interventions in the cognitive functions in older people with MC, in form of a systemic review. Data sources were the Web of Science, Biological Abstracts, Medline, Pub Med, EBSCHost, Scirus and Google Scholar. All studies were longitudinal trials, with MCI sample, aged>60 years, community-dwelling, and having cognitive functions as dependent variable. Seven studies, from 91 previously selected ones, were identified according to the inclusion criteria. Six studies used cognitive intervention, improving memory and one study used physical activity as intervention, improving executive functions. The results show evidence that physical activity and cognitive exercise may improve memory and executive functions in older people with MCI. But yet, more controlled studies are needed to establish a protocol of recommendations regarding the systemization of exercise, necessary to produce benefits in the cognitive functioning in older people with MCI. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  12. Social support systems as determinants of self-management and quality of life of people with diabetes across Europe: study protocol for an observational study.

    PubMed

    Koetsenruijter, Jan; van Lieshout, Jan; Vassilev, Ivaylo; Portillo, Mari Carmen; Serrano, Manuel; Knutsen, Ingrid; Roukova, Poli; Lionis, Christos; Todorova, Elka; Foss, Christina; Rogers, Anne; Wensing, Michel

    2014-03-04

    Long-term conditions pose major challenges for healthcare systems. Optimizing self-management of people with long-term conditions is an important strategy to improve quality of life, health outcomes, patient experiences in healthcare, and the sustainability of healthcare systems. Much research on self-management focuses on individual competencies, while the social systems of support that facilitate self-management are underexplored. The presented study aims to explore the role of social systems of support for self-management and quality of life, focusing on the social networks of people with diabetes and community organisations that serve them. The protocol concerns a cross-sectional study in 18 geographic areas in six European countries, involving a total of 1800 individuals with diabetes and 900 representatives of community organisations. In each country, we include a deprived rural area, a deprived urban area, and an affluent urban area. Individuals are recruited through healthcare practices in the targeted areas. A patient questionnaire comprises measures for quality of life, self-management behaviours, social network and social support, as well as individual characteristics. A community organisations' survey maps out interconnections between community and voluntary organisations that support patients with chronic illness and documents the scope of work of the different types of organisations. We first explore the structure of social networks of individuals and of community organisations. Then linkages between these social networks, self-management and quality of life will be examined, taking deprivation and other factors into account. This study will provide insight into determinants of self-management and quality of life in individuals with diabetes, focusing on the role of social networks and community organisations.

  13. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol.

    PubMed

    Drahota, Amy; Gal, Diane; Windsor, Julie; Dixon, Simon; Udell, Julie; Ward, Derek; Soilemezi, Dia; Dean, Taraneh; Severs, Martin

    2011-12-01

    Falls are an issue disproportionately affecting older people who are at increased risk of falls and injury. This protocol describes a pilot study investigating shock-absorbing flooring for fall-related injuries in wards for older people. To inform future research by evaluating fall-related injuries on the intervention and existing flooring, assessing the sustainability of the flooring in ward environments, estimating the cost-effectiveness of the floor and assessing how the floor affects patients and other users. This study uses mixed methods a pilot cluster randomised controlled trial, observation via mechanical testing and interviews. Eight participating wards (clusters) are randomised using a computer-generated list. No blinding is incorporated into the study. Each site has a baseline period of approximately 6 months. Then, four sites receive the intervention floor, while four continue using standard floors. Sites are then followed up for approximately 1 year. Any person admitted to a bed in the 'study area' of a participating ward can be entered into the trial. Orientated patients, visitors and any hospital staff who use the floor in a study area are eligible for inclusion in an interview. An 8.3 mm thick vinyl floor covering with polyvinyl chloride foam backing (Tarkett Omnisports EXCEL). The primary outcome is fall-related injuries. Severity of injuries, falls, cost-effectiveness, user views and mechanical performance (shock absorbency and slip resistance) are also being assessed.

  14. Patient Engagement and Coaching for Health: The PEACH study--a cluster randomised controlled trial using the telephone to coach people with type 2 diabetes to engage with their GPs to improve diabetes care: a study protocol.

    PubMed

    Young, Doris; Furler, John; Vale, Margarite; Walker, Christine; Segal, Leonie; Dunning, Patricia; Best, James; Blackberry, Irene; Audehm, Ralph; Sulaiman, Nabil; Dunbar, James; Chondros, Patty

    2007-04-11

    The PEACH study is based on an innovative 'telephone coaching' program that has been used effectively in a post cardiac event trial. This intervention will be tested in a General Practice setting in a pragmatic trial using existing Practice Nurses (PN) as coaches for people with type 2 diabetes (T2D). Actual clinical care often fails to achieve standards, that are based on evidence that self-management interventions (educational and psychological) and intensive pharmacotherapy improve diabetes control. Telephone coaching in our study focuses on both. This paper describes our study protocol, which aims to test whether goal focused telephone coaching in T2D can improve diabetes control and reduce the treatment gap between guideline based standards and actual clinical practice. In a cluster randomised controlled trial, general practices employing Practice Nurses (PNs) are randomly allocated to an intervention or control group. We aim to recruit 546 patients with poorly controlled T2D (HbA1c >7.5%) from 42 General Practices that employ PNs in Melbourne, Australia. PNs from General Practices allocated to the intervention group will be trained in diabetes telephone coaching focusing on biochemical targets addressing both patient self-management and engaging patients to work with their General Practitioners (GPs) to intensify pharmacological treatment according to the study clinical protocol. Patients of intervention group practices will receive 8 telephone coaching sessions and one face-to-face coaching session from existing PNs over 18 months plus usual care and outcomes will be compared to the control group, who will only receive only usual care from their GPs. The primary outcome is HbA1c levels and secondary outcomes include cardiovascular disease risk factors, behavioral risk factors and process of care measures. Understanding how to achieve comprehensive treatment of T2D in a General Practice setting is the focus of the PEACH study. This study explores the potential role for PNs to help reduce the treatment and outcomes gap in people with T2D by using telephone coaching. The intervention, if found to be effective, has potential to be sustained and embedded within real world General Practice.

  15. Interventions for chronic kidney disease in people with sickle cell disease

    PubMed Central

    Roy, Noemi BA; Fortin, Patricia M; Bull, Katherine R; Doree, Carolyn; Trivella, Marialena; Hopewell, Sally; Estcourt, Lise J

    2017-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effectiveness of any intervention in preventing or reducing kidney complications or CKD in people with SCD (including red blood cell transfusions, hydroxyurea and ACEI (either alone or in combination with each other)). PMID:28344511

  16. Comparison of a therapeutic-only versus prophylactic platelet transfusion policy for people with congenital or acquired bone marrow failure disorders

    PubMed Central

    Ashraf, Asma; Hadjinicolaou, Andreas V; Doree, Carolyn; Hopewell, Sally; Trivella, Marialena; Estcourt, Lise J

    2016-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows: To compare a therapeutic-only versus prophylactic platelet transfusion policy for people with myelodysplasia, inherited or acquired aplastic anaemia, and other congenital bone marrow failure disorders. PMID:27660553

  17. Feasibility and first results of a group program to increase the frequency of cognitively stimulating leisure activities in people with mild cognitive impairment (AKTIVA-MCI)

    PubMed Central

    Tesky, Valentina A; Köbe, Theresa; Witte, A Veronica; Flöel, Agnes; Schuchardt, Jan Philipp; Hahn, Andreas; Pantel, Johannes

    2017-01-01

    AKTIVA-MCI is a program for patients with mild cognitive impairment (MCI) that aims to enhance participation in cognitively stimulating leisure activities. Participation in cognitively stimulating activities seems to be a potential strategy for people with MCI delaying cognitive decline for a while. In total, 35 MCI patients were enrolled in the pilot study of whom 29 completed the whole program (16 female, 71.1±7.5 years; Mini Mental Status Examination score: 28±2.2). Daily activity protocols were used to measure the frequency of participation in cognitively stimulating activities during the program (12 sessions). Additional standardized psychometric tests and questionnaires were used to assess cognition, mood, and subjective memory decline. Analyses of the daily activity protocols showed that during the intervention participants increased the frequency of several cognitively stimulating leisure activities. Comparison of pre-post data indicates no changes in cognitive status, mood, and subjective memory decline. These findings indicate that the program is suitable for patients with MCI. PMID:28979108

  18. An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

    PubMed

    Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

    2013-05-29

    Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.

  19. Weaving Common Threads: Reaching out to American Indians and Native Peoples of Alaska and the Pacific Islands

    NASA Technical Reports Server (NTRS)

    2002-01-01

    This report outlines the activities of the GLOBE (Global Learning and Observations to Benefit the Environment) Train-the-Trainer Workshop. Educators were introduced to the GLOBE protocols for Atmosphere, Hydrology, Soil and Land Cover. These protocols included measurement of pH, temperature, precipitation, salinity, and soil moisture content. Each topic included implementation plans and learning activities.

  20. Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

    PubMed

    Roberts, Laura Weiss; Warner, Teddy D; Anderson, Charles T; Smithpeter, Megan V; Rogers, Melinda K

    2004-04-01

    To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol. The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

  1. Access 3 project protocol: young people and health system navigation in the digital age: a multifaceted, mixed methods study

    PubMed Central

    Kang, Melissa; Robards, Fiona; Sanci, Lena; Steinbeck, Katharine; Jan, Stephen; Hawke, Catherine; Kong, Marlene; Usherwood, Tim

    2017-01-01

    Background The integration of digital technology into everyday lives of young people has become widespread. It is not known whether and how technology influences barriers and facilitators to healthcare, and whether and how young people navigate between face-to-face and virtual healthcare. To provide new knowledge essential to policy and practice, we designed a study that would explore health system access and navigation in the digital age. The study objectives are to: (1) describe experiences of young people accessing and navigating the health system in New South Wales (NSW), Australia; (2) identify barriers and facilitators to healthcare for young people and how these vary between groups; (3) describe health system inefficiencies, particularly for young people who are marginalised; (4) provide policy-relevant knowledge translation of the research data. Methods and analysis This mixed methods study has four parts, including: (1) a cross-sectional survey of young people (12–24 years) residing in NSW, Australia; (2) a longitudinal, qualitative study of a subsample of marginalised young people (defined as young people who: identify as Aboriginal and/or Torres Strait Islander; are experiencing homelessness; identify as sexuality and/or gender diverse; are of refugee or vulnerable migrant background; and/or live in rural or remote NSW); (3) interviews with professionals; (4) a knowledge translation forum. Ethics and dissemination Ethics approvals were sought and granted. Data collection commenced in March 2016 and will continue until June 2017. This study will gather practice and policy-relevant intelligence about contemporary experiences of young people and health services, with a unique focus on five different groups of marginalised young people, documenting their experiences over time. Access 3 will explore navigation around all levels of the health system, determine whether digital technology is integrated into this, and if so how, and will translate findings into policy-relevant recommendations. PMID:28790044

  2. A systematic review of the relationship between internet use, self-harm and suicidal behaviour in young people: The good, the bad and the unknown.

    PubMed

    Marchant, Amanda; Hawton, Keith; Stewart, Ann; Montgomery, Paul; Singaravelu, Vinod; Lloyd, Keith; Purdy, Nicola; Daine, Kate; John, Ann

    2017-01-01

    Research exploring internet use and self-harm is rapidly expanding amidst concerns regarding influences of on-line activities on self-harm and suicide, especially in young people. We aimed to systematically review evidence regarding the potential influence of the internet on self-harm/suicidal behaviour in young people. We conducted a systematic review based on an electronic search for articles published between 01/01/2011 and 26/01/2015 across databases including Medline, Cochrane and PsychInfo. Articles were included if: the study examined internet use by individuals who engaged in self-harm/ suicidal behaviour, or internet use clearly related to self-harm content; reported primary empirical data; participants were aged under 25 years. New studies were combined with those identified in a previous review and subject to data extraction, quality rating and narrative synthesis. Forty-six independent studies (51 articles) of varying quality were included. Perceived influences were: positive for 11 studies (38191 participants); negative for 18 studies (119524 participants); and mixed for 17 studies (35235 participants). In contrast to previous reviews on this topic studies focused on a wide range of internet mediums: general internet use; internet addiction; online intervention/treatment; social media; dedicated self-harm websites; forums; video/image sharing and blogs. A relationship between internet use and self-harm/suicidal behaviour was particularly associated with internet addiction, high levels of internet use, and websites with self-harm or suicide content. While there are negative aspects of internet use the potential for isolation reduction, outreach and as a source of help and therapy were also identified. There is significant potential for harm from online behaviour (normalisation, triggering, competition, contagion) but also the potential to exploit its benefits (crisis support, reduction of social isolation, delivery of therapy, outreach). Young people appear to be increasingly using social media to communicate distress, particularly to peers. The focus should now be on how specific mediums' (social media, video/image sharing) might be used in therapy and recovery. Clinicians working with young people who self-harm or have mental health issues should engage in discussion about internet use. This should be a standard item during assessment. A protocol for this review was registered with the PROSPERO systematic review protocol registry: (http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42015019518).

  3. A scoping review protocol on social participation of indigenous elders, intergenerational solidarity and their influence on individual and community wellness.

    PubMed

    Viscogliosi, Chantal; Asselin, Hugo; Basile, Suzy; Couturier, Yves; Drolet, Marie-Josée; Gagnon, Dominique; Torrie, Jill; Levasseur, Mélanie

    2017-05-12

    Indigenous elders have traditionally played an important role in maintaining social cohesion within their communities. Today, part of this role has been taken over by government social and healthcare services, but they are having limited success in addressing social challenges. Increasing elders' social participation and intergenerational solidarity might foster community development and benefit young people, families, communities and the elders themselves. However, knowledge of the contribution of elders' social participation and intergenerational solidarity to wellness is scattered and needs to be synthesised. This protocol presents a scoping review on the social participation of indigenous elders, intergenerational solidarity and their influence on individual and community wellness. This scoping review protocol is based on an innovative methodological framework designed to gather information from the scientific and grey literature and from indigenous sources. It was developed by an interdisciplinary team including indigenous scholars/researchers, knowledge users and key informants. In addition to searching information databases in fields such as public health and indigenous studies, an advisory committee will ensure that information is gathered from grey literature and indigenous sources. The protocol was approved by the Ethics Review Board of the Université du Québec en Abitibi-Témiscamingue and the First Nations of Quebec and Labrador Health and Social Services Commission. The comprehensive synthesis of the scientific and grey literature and indigenous sources proposed in this protocol will not only raise awareness within indigenous communities and among healthcare professionals and community organisations, but will also enable decision-makers to better meet the needs of indigenous people. The innovative methodological framework proposed in this scoping review protocol will yield richer information on the contribution of elders to community wellness. This work is an essential preliminary step towards developing research involving indigenous communities, drawing on the social participation of elders and intergenerational solidarity. © 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.

  4. An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Chronic heart failure (CHF) is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important risk reduction strategies in the management of CHF. The Home-Heart-Walk is a self-monitoring intervention. This model of intervention has adapted the 6-minute walk test as a home-based activity that is self-administered and can be used for monitoring physical functional capacity in people with CHF. The aim of the Home-Heart-Walk program is to promote adherence to physical activity recommendations and improving self-management in people with CHF. Methods/Design A randomised controlled trial is being conducted in English speaking people with CHF in four hospitals in Sydney, Australia. Individuals diagnosed with CHF, in New York Heart Association Functional Class II or III, with a previous admission to hospital for CHF are eligible to participate. Based on a previous CHF study and a loss to follow-up of 10%, 166 participants are required to be able to detect a 12-point difference in the study primary endpoint (SF-36 physical function domain). All enrolled participant receive an information session with a cardiovascular nurse. This information session covers key self-management components of CHF: daily weight; diet (salt reduction); medication adherence; and physical activity. Participants are randomised to either intervention or control group through the study randomisation centre after baseline questionnaires and assessment are completed. For people in the intervention group, the research nurse also explains the weekly Home-Heart-Walk protocol. All participants receive monthly phone calls from a research coordinator for six months, and outcome measures are conducted at one, three and six months. The primary outcome of the trial is the physical functioning domain of quality of life, measured by the physical functioning subscale of the Medical Outcome Study Short Form -36. Secondary outcomes include physical functional capacity measured by the standard six minute walk test, self-management capacity, health related quality of life measured by Medical Outcome Study Short Form -36 and Minnesota Living With Heart Failure Questionnaire, self-efficacy and self-care behaviour. Discussion A self-monitoring intervention that can improve individual's exercise self-efficacy, self-management capacity could have potential significance in improving the management of people with chronic heart failure in community settings. Trial Registration Australian New Zealand Clinical Trial Registry 12609000437268 PMID:21366927

  5. An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial.

    PubMed

    Du, Hui Y; Newton, Phillip J; Zecchin, Robert; Denniss, Robert; Salamonson, Yenna; Everett, Bronwyn; Currow, David C; Macdonald, Peter S; Davidson, Patricia M

    2011-03-02

    Chronic heart failure (CHF) is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important risk reduction strategies in the management of CHF. The Home-Heart-Walk is a self-monitoring intervention. This model of intervention has adapted the 6-minute walk test as a home-based activity that is self-administered and can be used for monitoring physical functional capacity in people with CHF. The aim of the Home-Heart-Walk program is to promote adherence to physical activity recommendations and improving self-management in people with CHF. A randomised controlled trial is being conducted in English speaking people with CHF in four hospitals in Sydney, Australia. Individuals diagnosed with CHF, in New York Heart Association Functional Class II or III, with a previous admission to hospital for CHF are eligible to participate. Based on a previous CHF study and a loss to follow-up of 10%, 166 participants are required to be able to detect a 12-point difference in the study primary endpoint (SF-36 physical function domain).All enrolled participant receive an information session with a cardiovascular nurse. This information session covers key self-management components of CHF: daily weight; diet (salt reduction); medication adherence; and physical activity. Participants are randomised to either intervention or control group through the study randomisation centre after baseline questionnaires and assessment are completed. For people in the intervention group, the research nurse also explains the weekly Home-Heart-Walk protocol. All participants receive monthly phone calls from a research coordinator for six months, and outcome measures are conducted at one, three and six months. The primary outcome of the trial is the physical functioning domain of quality of life, measured by the physical functioning subscale of the Medical Outcome Study Short Form -36. Secondary outcomes include physical functional capacity measured by the standard six minute walk test, self-management capacity, health related quality of life measured by Medical Outcome Study Short Form -36 and Minnesota Living With Heart Failure Questionnaire, self-efficacy and self-care behaviour. A self-monitoring intervention that can improve individual's exercise self-efficacy, self-management capacity could have potential significance in improving the management of people with chronic heart failure in community settings. Australian New Zealand Clinical Trial Registry 12609000437268.

  6. A study protocol to investigate the management of depression and challenging behaviors associated with dementia in aged care settings.

    PubMed

    McCabe, Marita P; Mellor, David; Davison, Tanya E; Karantzas, Gery; von Treuer, Kathryn; O'Connor, Daniel W

    2013-09-19

    The high occurrence and under-treatment of clinical depression and behavioral and psychological symptoms of dementia (BPSD) within aged care settings is concerning, yet training programs aimed at improving the detection and management of these problems have generally been ineffective. This article presents a study protocol to evaluate a training intervention for facility managers/registered nurses working in aged care facilities that focuses on organisational processes and culture as well as knowledge, skills and self-efficacy. A Randomised Control Trial (RCT) will be implemented across 18 aged care facilities (divided into three conditions). Participants will be senior registered nurses and personal care attendants employed in the aged care facility. The first condition will receive the training program (Staff as Change Agents - Enhancing and Sustaining Mental Health in Aged Care), the second condition will receive the training program and clinical support, and the third condition will receive no intervention. Pre-, post-, 6-month and 12-month follow-up measures of staff and residents will be used to demonstrate how upskilling clinical leaders using our transformational training approach, as well as the use of a structured screening, referral and monitoring protocol, can address the mental health needs of older people in residential care. The expected outcome of this study is the validation of an evidence-based training program to improve the management of depression and BPSD among older people in residential care settings by establishing routine practices related to mental health. This relatively brief but highly focussed training package will be readily rolled out to a larger number of residential care facilities at a relatively low cost. Australia and New Zealand Clinical Trials Register (ANZCTR): The Universal Trial Number (UTN) is U1111-1141-0109.

  7. Comparing the effects of whole-body vibration to standard exercise in ambulatory people with Multiple Sclerosis: a randomised controlled feasibility study.

    PubMed

    Uszynski, Marcin Kacper; Purtill, Helen; Donnelly, Alan; Coote, Susan

    2016-07-01

    This study aimed firstly to investigate the feasibility of the study protocol and outcome measures, secondly to obtain data in order to inform the power calculations for a larger randomised controlled trial, and finally to investigate if whole-body vibration (WBV) is more effective than the same duration and intensity of standard exercises (EXE) in people with Multiple Sclerosis (PwMS). Randomised controlled feasibility study. Outpatient MS centre. Twenty seven PwMS (age mean (SD) 48.1 (11.2)) with minimal gait impairments. Twelve weeks of WBV or standard EXE, three times weekly. Participants were measured with isokinetic muscle strength, vibration threshold, Timed Up and Go test (TUG), Mini-BESTest (MBT), 6 Minute Walk test (6MWT), Multiple Sclerosis Impact Scale 29 (MSIS 29), Modified Fatigue Impact Scale (MFIS) and Verbal Analogue scale for sensation (VAS) pre and post 12 week intervention. WBV intervention was found feasible with low drop-out rate (11.1%) and high compliance (90%). Data suggest that a sample of 52 in each group would be sufficient to detect a moderate effect size, with 80% power and 5% significance for 6 minute walk test. Large effect sizes in favour of standard exercise were found for vibration threshold at 5th metatarsophalangeal joint and heel (P=0.014, r= 0.5 and P=0.005, r=0.56 respectively). No between group differences were found for muscle strength, balance or gait (P>0.05). Data suggest that the protocol is feasible, there were no adverse effects. A trial including 120 people would be needed to detect an effect on walking endurance. © The Author(s) 2015.

  8. Development of a physical activity monitoring tool for Thai medical schools: a protocol for a mixed methods study

    PubMed Central

    Wattanapisit, Apichai; Vijitpongjinda, Surasak; Saengow, Udomsak; Amaek, Waluka; Thanamee, Sanhapan; Petchuay, Prachyapan

    2017-01-01

    Introduction Physical activity (PA) is important in promoting health, as well as in the treatment and prevention of diseases. However, insufficient PA is still a global health problem and it is also a problem in medical schools. PA training in medical curricula is still sparse or non-existent. There is a need for a comprehensive understanding of the extent of PA in medical schools through several indicators, including people, places and policies. This study includes a survey of the PA prevalence in a medical school and development of a tool, the Medical School Physical Activity Report Card (MSPARC), which will contain concise and understandable infographics and information for exploring, monitoring and reporting information relating to PA prevalence. Methods and analysis This mixed methods study will run from January to September 2017. We will involve the School of Medicine, Walailak University, Thailand, and its medical students (n=285). Data collection will consist of both primary and secondary data, divided into four parts: general information, people, places and policies. We will investigate the PA metrics about (1) people: the prevalence of PA and sedentary behaviours; (2) place: the quality and accessibility of walkable neighbourhoods, bicycle facilities and recreational areas; and (3) policy: PA promotion programmes for medical students, education metrics and investments related to PA. The MSPARC will be developed using simple symbols, infographics and short texts to evaluate the PA metrics of the medical school. Ethics and dissemination This study has been approved by the Human Research Ethics Committee of Walailak University (protocol number: WUEC-16-005-01). Findings will be published in peer-reviewed journals and presented at national or international conferences. The MSPARC and full report will be disseminated to relevant stakeholders, policymakers, staff and clients. PMID:28963299

  9. Study protocol for a randomized controlled trial of telephone-delivered cognitive behavior therapy compared with befriending for treating depression and anxiety in older adults with COPD.

    PubMed

    Doyle, Colleen; Dunt, David; Ames, David; Fearn, Marcia; You, Emily Chuanmei; Bhar, Sunil

    2016-01-01

    COPD is an umbrella term to describe chronic lung diseases that cause limitations in lung airflow, including emphysema and chronic bronchitis. The prevalence of depression and anxiety in people with COPD is high, although these comorbidities are often undiagnosed, untreated, or undertreated. There is a need to identify efficacious treatments for depression and anxiety in people with COPD. Cognitive behavior therapy (CBT) for the treatment of anxiety and depression has a strong evidence base. There has been some success delivering this treatment over the telephone in limited studies. The aim of this study is to evaluate the efficacy of both telephone-administered CBT and befriending on outcomes for patients with diagnosed COPD who have at least mild levels of depression and/or anxiety. The protocol described in this paper is of a pragmatic randomized controlled trial comparing eight sessions of telephone CBT to an active social control, referred to as befriending. Primary outcome measures will include depression and anxiety symptoms, and secondary outcome measures will include quality of life, self-efficacy, and COPD symptom severity. Participants' satisfaction with the intervention and therapeutic alliance will also be assessed. Measures will be taken pre- and postdelivery of the intervention and again at 8 weeks following the intervention. People with COPD often have limitations to their mobility because of their breathlessness. They are often already attending many medical appointments and could be reluctant to attend for face-to-face psychological treatment. The results of this study should identify the relative efficacy of CBT delivered over the telephone to this population, which, if successful, may be a cost-effective and more palatable alternative to face-to-face treatment of depression or anxiety for this population.

  10. Land-based versus aquatic resistance therapeutic exercises for older women with sarcopenic obesity: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Sarcopenic obesity is a health condition that combines excess adipose tissue and loss of muscle mass and strength. Sarcopenic obesity predisposes to more functional disabilities than obesity or sarcopenia alone. Progressive resistance exercises are recommended for older people as a potential treatment for sarcopenia and also for obesity. However, there is a lack of evidence indicating which programmes are best applied to older people, and no studies have investigated their effects on sarcopenic obese people. The aims of this protocol study are to investigate and compare the efficacy of land-based and aquatic resistance exercise programmes on improving muscle performance, functional capacity and quality of life of older women with sarcopenic obesity. Methods/Design This is a protocol study for a parallel randomised controlled clinical trial. Eligible participants are older women (≥65 years) with a body mass index ≥30 kg/m 2 and hand grip strength ≤21 kg force. A total sample of 36 participants will be randomly allocated to one of the intervention groups in blocks of three: land-based, aquatic or control. Each intervention group will undergo 2-week sessions of a 10-week therapeutic exercise programme for strength, power and endurance training of the lower-limb muscles. Participants in the control group will not participate in any strengthening activity for lower limbs and will receive telephone calls once a week. Baseline and final evaluation of outcomes will encompass muscle performance of the lower limbs assessed by an isokinetic dynamometer; functional tests of usual walking speed, maximal walking speed (shuttle walking test), stair speed and the Short Physical Performance Battery; and health-related quality of life (Medical Outcomes Study Short Form Questionnaire – SF-36). Data collectors will be blinded to randomisation and will not be in touch with participants during the interventions. Discussion This study is the first randomised controlled trial designed to evaluate resistance exercises in older patients with sarcopenic obesity. If our hypothesis proves correct, both intervention programmes will be effective, with the land-based exercises conferring better results in muscle performance. Trial registration Registro Brasileiro de Ensaios Clínicos: RBR-9p5q67 PMID:24041219

  11. The effect of functional electrical stimulation on the physiological cost of gait in people with multiple sclerosis.

    PubMed

    Paul, L; Rafferty, D; Young, S; Miller, L; Mattison, P; McFadyen, A

    2008-08-01

    Functional electrical stimulation (FES) is used clinically in the management of drop foot in people suffering from neurological conditions. The aim of the study was to investigate the effects of FES, in terms of speed and physiological cost of gait, in people with multiple sclerosis (pwMS). Twelve pwMS and 12 healthy matched controls walked at their own preferred walking speed (PWS) for 5 min around a 10 m elliptical course. Subjects with MS completed the protocol with and without using their FES. In addition, control subjects completed the protocol twice more walking at the same PWS of the pwMS to which they were matched. Wearing FES lead to a significant improvement in walking speed (0.49 ms(-1) and 0.43 ms(-1) with and without their FES respectively; P<0.001) and a significant reduction in the physiological cost of gait (0.41 mL min(-1) kg(-1) m(-1) and 0.46 mL min(-1) kg(-1) m(-1) with and without FES respectively; P=0.017) in pwMS. The speed of walking, oxygen uptake, and physiological cost were significantly different between pwMS and controls both at preferred and matched speeds. Although pwMS exhibit a higher physiological cost of walking, FES offers an orthotic benefit to pwMS and should be considered as a possible treatment option.

  12. Systematic reviews: guidance relevant for studies of older people.

    PubMed

    Shenkin, Susan D; Harrison, Jennifer K; Wilkinson, Tim; Dodds, Richard M; Ioannidis, John P A

    2017-09-01

    Systematic reviews and meta-analyses are increasingly common. This article aims to provide guidance for people conducting systematic reviews relevant to the healthcare of older people. An awareness of these issues will also help people reading systematic reviews to determine whether the results will influence their clinical practice. It is essential that systematic reviews are performed by a team which includes the required technical and clinical expertise. Those performing reviews for the first time should ensure they have appropriate training and support. They must be planned and performed in a transparent and methodologically robust way: guidelines are available. The protocol should be written-and if possible published-before starting the review. Geriatricians will be interested in a table of baseline characteristics, which will help to determine if the studied samples or populations are similar to their patients. Reviews of studies of older people should consider how they will manage issues such as different age cut-offs; non-specific presentations; multiple predictors and outcomes; potential biases and confounders. Systematic reviews and meta-analyses may provide evidence to improve older people's care, or determine where new evidence is required. Newer methodologies, such as meta-analyses of individual level data, network meta-analyses and umbrella reviews, and realist synthesis, may improve the reliability and clinical utility of systematic reviews. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.

  13. Online and Social Media Suicide Prevention Interventions for Young People: A Focus on Implementation and Moderation

    PubMed Central

    Rice, Simon; Robinson, Jo; Bendall, Sarah; Hetrick, Sarah; Cox, Georgina; Bailey, Eleanor; Gleeson, John; Alvarez-Jimenez, Mario

    2016-01-01

    Objective: Suicide remains a major global public health issue for young people. The reach and accessibility of online and social media-based interventions herald a unique opportunity for suicide prevention. To date, the large body of research into suicide prevention has been undertaken atheoretically. This paper provides a rationale and theoretical framework (based on the interpersonal theory of suicide), and draws on our experiences of developing and testing online and social media-based interventions. Method: The implementation of three distinct online and social media-based intervention studies, undertaken with young people at risk of suicide, are discussed. We highlight the ways that these interventions can serve to bolster social connectedness in young people, and outline key aspects of intervention implementation and moderation. Results: Insights regarding the implementation of these studies include careful protocol development mindful of risk and ethical issues, establishment of suitably qualified teams to oversee development and delivery of the intervention, and utilisation of key aspects of human support (i.e., moderation) to encourage longer-term intervention engagement. Conclusions: Online and social media-based interventions provide an opportunity to enhance feelings of connectedness in young people, a key component of the interpersonal theory of suicide. Our experience has shown that such interventions can be feasibly and safely conducted with young people at risk of suicide. Further studies, with controlled designs, are required to demonstrate intervention efficacy. PMID:27274743

  14. Online and Social Media Suicide Prevention Interventions for Young People: A Focus on Implementation and Moderation.

    PubMed

    Rice, Simon; Robinson, Jo; Bendall, Sarah; Hetrick, Sarah; Cox, Georgina; Bailey, Eleanor; Gleeson, John; Alvarez-Jimenez, Mario

    2016-01-01

    Suicide remains a major global public health issue for young people. The reach and accessibility of online and social media-based interventions herald a unique opportunity for suicide prevention. To date, the large body of research into suicide prevention has been undertaken atheoretically. This paper provides a rationale and theoretical framework (based on the interpersonal theory of suicide), and draws on our experiences of developing and testing online and social media-based interventions. The implementation of three distinct online and social media-based intervention studies, undertaken with young people at risk of suicide, are discussed. We highlight the ways that these interventions can serve to bolster social connectedness in young people, and outline key aspects of intervention implementation and moderation. Insights regarding the implementation of these studies include careful protocol development mindful of risk and ethical issues, establishment of suitably qualified teams to oversee development and delivery of the intervention, and utilisation of key aspects of human support (i.e., moderation) to encourage longer-term intervention engagement. Online and social media-based interventions provide an opportunity to enhance feelings of connectedness in young people, a key component of the interpersonal theory of suicide. Our experience has shown that such interventions can be feasibly and safely conducted with young people at risk of suicide. Further studies, with controlled designs, are required to demonstrate intervention efficacy.

  15. Protocol for a national prevalence study of advance care planning documentation and self-reported uptake in Australia

    PubMed Central

    Ruseckaite, Rasa; Detering, Karen M; Perera, Veronica; Walker, Lynne; Sinclair, Craig; Clayton, Josephine M; Nolte, Linda

    2017-01-01

    Introduction Advance care planning (ACP) is a process between a person, their family/carer(s) and healthcare providers that supports adults at any age or stage of health in understanding and sharing their personal values, life goals and preferences regarding future medical care. The Australian government funds a number of national initiatives aimed at increasing ACP uptake; however, there is currently no standardised Australian data on formal ACP documentation or self-reported uptake. This makes it difficult to evaluate the impact of ACP initiatives. This study aims to determine the Australian national prevalence of ACP and completion of Advance Care Directives (ACDs) in hospitals, aged care facilities and general practices. It will also explore people’s self-reported use of ACP and views about the process. Methods and analysis Researchers will conduct a national multicentre cross-sectional prevalence study, consisting of a record audit and surveys of people aged 65 years or more in three sectors. From 49 participating Australian organisations, 50 records will be audited (total of 2450 records). People whose records were audited, who speak English and have a decision-making capacity will also be invited to complete a survey. The primary outcome measure will be the number of people who have formal or informal ACP documentation that can be located in records within 15 min. Other outcomes will include demographics, measure of illness and functional capacity, details of ACP documentation (including type of document), location of documentation in the person’s records and whether current clinical care plans are consistent with ACP documentation. People will be surveyed, to measure self-reported interest, uptake and use of ACP/ACDs, and self-reported quality of life. Ethics and dissemination This protocol has been approved by the Austin Health Human Research Ethics Committee (reference HREC/17/Austin/83). Results will be submitted to international peer-reviewed journals and presented at international conferences. Trial registration number ACTRN12617000743369 PMID:29101142

  16. Protocol for a national prevalence study of advance care planning documentation and self-reported uptake in Australia.

    PubMed

    Ruseckaite, Rasa; Detering, Karen M; Evans, Sue M; Perera, Veronica; Walker, Lynne; Sinclair, Craig; Clayton, Josephine M; Nolte, Linda

    2017-11-03

    Advance care planning (ACP) is a process between a person, their family/carer(s) and healthcare providers that supports adults at any age or stage of health in understanding and sharing their personal values, life goals and preferences regarding future medical care. The Australian government funds a number of national initiatives aimed at increasing ACP uptake; however, there is currently no standardised Australian data on formal ACP documentation or self-reported uptake. This makes it difficult to evaluate the impact of ACP initiatives. This study aims to determine the Australian national prevalence of ACP and completion of Advance Care Directives (ACDs) in hospitals, aged care facilities and general practices. It will also explore people's self-reported use of ACP and views about the process. Researchers will conduct a national multicentre cross-sectional prevalence study, consisting of a record audit and surveys of people aged 65 years or more in three sectors. From 49 participating Australian organisations, 50 records will be audited (total of 2450 records). People whose records were audited, who speak English and have a decision-making capacity will also be invited to complete a survey. The primary outcome measure will be the number of people who have formal or informal ACP documentation that can be located in records within 15 min. Other outcomes will include demographics, measure of illness and functional capacity, details of ACP documentation (including type of document), location of documentation in the person's records and whether current clinical care plans are consistent with ACP documentation. People will be surveyed, to measure self-reported interest, uptake and use of ACP/ACDs, and self-reported quality of life. This protocol has been approved by the Austin Health Human Research Ethics Committee (reference HREC/17/Austin/83). Results will be submitted to international peer-reviewed journals and presented at international conferences. ACTRN12617000743369. © 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.

  17. Systematic Assessment of the Impact of User Roles on Network Flow Patterns

    DTIC Science & Technology

    2017-09-01

    Protocol SNMP Simple Network Management Protocol SQL Structured Query Language SSH Secure Shell SYN TCP Sync Flag SVDD Support Vector Data Description SVM...and evaluating users based on roles provide the best approach for defining normal digital behaviors? People are individuals, with different interests...activities on the network. We evaluate the assumption that users sharing similar roles exhibit similar network behaviors, and contrast the level of similarity

  18. The Ideals of Today’s Modernizing People’s Liberation Army

    DTIC Science & Technology

    2010-06-01

    Government. IRB Protocol number ___N/A_____________. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited...was a tutor and teacher for the children of the de facto ruler of Lu, Meng Xizi, where he taught ritual etiquette observed at state religious...appropriately to one’s circumstances and role. One must observe the proper rituals, ceremonies, and protocols to promote social cohesion and individual

  19. Tailoring and field-testing the use of a knowledge translation peer support shared decision making strategy with First Nations, Inuit and Métis people making decisions about their cancer care: a study protocol.

    PubMed

    Jull, Janet; Mazereeuw, Maegan; Sheppard, Amanada; Kewayosh, Alethea; Steiner, Richard; Graham, Ian D

    2018-01-01

    Tailoring and testing a peer support decision making strategy with First Nations, Inuit and Métis people making decisions about their cancer care: A study protocol.First Nations, Inuit and Métis (FNIM) people face higher risks for cancer compared to non-FNIM populations. They also face cultural barriers to health service use. Within non-FNIM populations an approach to health decision making, called shared decision making (SDM), has been found to improve the participation of people in their healthcare. Peer support with SDM further improves these benefits. The purpose of this study is to tailor and test a peer support SDM strategy with community support workers to increase FNIM people's participation in their cancer care.This project has two phases that will be designed and conducted with a Steering Committee that includes members of the FNIM and cancer care communities. First, a peer support SDM strategy will be tailored to meet the needs of cancer system users who are receiving care in urban settings, and training in the SDM strategy developed for community support workers. Three communities will be supported for participation in the study and community support workers who are peers from each community will be trained to use the SDM strategy.Next, each community support worker will work with a community member who has a diagnosis of cancer or who has supported a family member with cancer. Each community support worker and community member pair will use the SDM strategy. The participation and experience of the community support worker and community member will be evaluated.The research will be used to develop strategies to support people who are making decisions about their health. Tailoring and field-testing the use of a knowledge translation peer support shared decision making strategy with First Nations, Inuit and Métis people making decisions about their cancer care: A study protocol Background First Nations, Inuit and Métis ("FNIM") people face increased cancer risks in relation to general populations and experience barriers to health service use. Shared decision making (SDM) has been found to improve peoples' participation and outcomes in healthcare and peer support with SDM further improves these benefits. The purpose of this study is to tailor and then field test, by and with FNIM communities, a peer support SDM strategy for use in cancer care. Methods This project has 2 theory-driven phases and 5 stages (a-e). A core research team that includes members of the Aboriginal Cancer Control Unit of Cancer Care Ontario communities and academic researchers, will work with a Steering Committee. In phase 1 , (stage a) a peer support SDM strategy will be tailored to meet the needs of cancer system users who are receiving care in urban settings and (stage b), training developed that will i) introduce participant communities to SDM, and ii) train community support workers (CSWs) within these communities. Next (stage c), three communities will be approached for voluntary participation in the study. These communities will be introduced to SDM in community meetings, and if in agreement then CSWs from each community will be recruited to participate in the study. One volunteer CSW from each community will be trained to use the peer support SDM strategy to enable phase 2 (field test of the peer support SDM strategy).During phase 2 (stage d), each CSW will be matched to a volunteer community member who has had a diagnosis of cancer or has supported a family member with cancer and is familiar with Ontario cancer systems. Each CSW-community member pair (3 to 4 pairs/community) will use the tailored peer support SDM strategy; their interaction will be audio-recorded and their participation and experience evaluated (total of 9 to 12 interviews). As well (stage e), data will be collected on health systems' factors related to the use of the peer support SDM strategy. Discussion Findings will develop peer support SDM strategies to enhance participation of FNIM people in cancer care decisions, advance knowledge translation science, and support a proposal to conduct a multi-site implementation trial.

  20. Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial.

    PubMed

    Leavy, Breiffni; Kwak, Lydia; Hagströmer, Maria; Franzén, Erika

    2017-02-07

    If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings. This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants. An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice. ClinicalTrials.gov march 2016, NCT02727478 .

  1. Understanding User Reactions and Interactions With an Internet-Based Intervention for Tinnitus Self-Management: Mixed-Methods Process Evaluation Protocol

    PubMed Central

    Sereda, Magdalena; Coulson, Neil; Hoare, Derek J

    2016-01-01

    Background Tinnitus is a common medical symptom that can affect an individual’s emotional and functional quality of life. Psychological therapies are acknowledged as beneficial to people with tinnitus; however, such therapies are not always readily accessible. With their global reach, automated Internet-based interventions have the potential to reduce the disparity in access to psychological support that people with tinnitus currently experience. However, the evidence on the acceptability and efficacy of these interventions is lacking. Process evaluations that develop an in-depth understanding of how users experience these interventions provide an essential first step when evaluating complex psychological interventions. Objective To describe the protocol for a study that will explore past, current, and new users’ reactions to and interactions with the Tinnitus E-Programme, an Internet-based intervention for the self-management of tinnitus. Methods Two parallel mixed-methods studies will be carried out with 2 different populations. Study 1 will use an online survey to gather past and current users’ views of the program. Study 2 will recruit new program users to take part in an interview and complete a relaxation log to explore how well they were able to implement the skills they learned during the program in their everyday lives. The findings from both studies will be triangulated to develop an in-depth understanding of the program’s mechanisms of impact and identify any implementation or contextual factors that strengthen or impede its delivery and functioning. Results Study 1 is open for recruitment with a projected completion in June 2016 and Study 2 was completed November 2015. At the time of submission, 36 participants have been recruited to Study 1 and 12 participants have taken part in Study 2. Conclusions Findings will inform the optimization of the Tinnitus E-Programme and guide future evaluation work to assess the program’s effectiveness as a therapy for people with tinnitus. PMID:27009548

  2. What People Talk About in Virtual Worlds

    NASA Astrophysics Data System (ADS)

    Maher, Mary Lou

    This chapter examines what people talk about in virtual worlds, employing protocol analysis. Each of two scenario studies was developed to assess the impact of virtual worlds as a collaborative environment for a specific purpose: one for learning and one for designing. The first designed a place in Active Worlds for a course on Web Site Design, having group learning spaces surrounded by individual student galleries. Student text chat was analyzed through a coding scheme with four major categories: control, technology, learning, and place. The second studied expert architects in a Second Life environment called DesignWorld that combined 3D modeling and sketching tools. Video and audio recordings were coded in terms of four categories of communication content (designing, representation of the model, awareness of each other, and software features), and in terms of synthesis comparing alternative designs versus analysis of how well the proposed solution satisfies the given design task. Both studies found that people talk about their avatars, identity, and location in the virtual world. However, the discussion is chiefly about the task and not about the virtual world, implying that virtual worlds provide a viable environment for learning and designing that does not distract people from their task.

  3. Web-Based and Mobile Suicide Prevention Interventions for Young People: A Systematic Review

    PubMed Central

    Perry, Yael; Werner-Seidler, Aliza; Calear, Alison L.; Christensen, Helen

    2016-01-01

    Objective: Suicide is a significant public health issue, and is especially concerning in adolescents and young adults, who are over-represented both in attempts and completed suicide. Emerging technologies represent a promising new approach to deliver suicide prevention interventions to these populations. The current systematic review aims to identify online and mobile psychosocial suicide prevention interventions for young people, and evaluate the effectiveness of these interventions. Method: PsycINFO, Medline, Embase and The Cochrane Library were electronically searched for all articles published between January, 2000 and May, 2015. Peer-reviewed journal articles reporting on interventions for young people aged 12–25 years with suicidality as a primary outcome were eligible for inclusion. No exclusions were placed on study design. Results: One study met inclusion criteria, and found significant reductions in the primary outcome of suicidal ideation, as well as depression and hopelessness. Two relevant protocol papers of studies currently underway were also identified. Conclusions: There is a paucity of current evidence for online and mobile interventions for suicide prevention in youth. More high quality empirical evidence is required to determine the effectiveness of these novel approaches to improving suicide outcomes in young people. PMID:27274742

  4. Circadian temperature rhythms of older people

    NASA Technical Reports Server (NTRS)

    Monk, T. H.; Buysse, D. J.; Reynolds, C. F. 3rd; Kupfer, D. J.; Houck, P. R.

    1995-01-01

    This collection of studies had the aim of exploring whether older (77+ years) men and women have circadian body temperature rhythms different from those of younger adults. A total of 20 older men and 28 older women were compared with either 22 young men or 14 middle-aged men in four protocols; all but the first protocol using a subset of the sample. The four protocols were: 1) 24 h, and 2) 72 h data collections on a normal laboratory routine (sleeping at night); 3) between 36 h and 153 h of field data collection at home; and 4) 36 h of a constant conditions routine (wakeful bedrest under temporal isolation) in the laboratory. There was some evidence for an age-related phase advance in temperature rhythm, especially for the older men on a normal routine, though this was not present in the constant conditions protocol, where 5 of the older subjects showed major delays in the timing of the body temperature trough (10:00 or later). There was no statistically significant evidence from any of the protocols that older subjects generally had lower temperature rhythm amplitudes than younger adults. Only when older men were compared with younger men in 24-h rhythm amplitude by simple t-test did any comparison involving amplitude achieve statistical significance (p < 0.05).

  5. Smoking cessation treatment outcomes among people with and without mental and substance use disorders: An observational real-world study.

    PubMed

    Castaldelli-Maia, João Mauricio; Loreto, Aline Rodrigues; Guimarães-Pereira, Bruna Beatriz Sales; Carvalho, Carlos Felipe Cavalcanti; Gil, Felipe; Frallonardo, Fernanda Piotto; Ismael, Flávia; Andrade, Arthur Guerra de; Ventriglio, Antonio; Richter, Kimber P; Bhugra, Dinesh

    2018-03-30

    There is a lack of studies evaluating smoking cessation treatment protocols which include people with and without mental and substance use disorders (MSUD), and which allows for individuals with MSUD undergoing their psychiatric treatment. We compared treatment success between participants with (n = 277) and without (n = 419) MSUD among patients in a 6-week treatment provided by a Brazilian Psychosocial Care Center (CAPS) from 2007 to 2013. Sociodemographic, medical and tobacco use characteristics were assessed at baseline. Tobacco treatment consisted of 1) group cognitive behavior therapy, which included people with and without MSUD in the same groups, and 2) pharmacotherapy, which could include either nicotine patches, nicotine gum, bupropion or nortriptyline. For participants with MSUD, tobacco treatment was integrated into their ongoing mental health treatment. The main outcome was 30-day point prevalence abstinence, measured at last day of treatment. Abstinence rates did not differ significantly between participants with and without MSUD (31.1% and 34.4%, respectively). Variables that were significantly associated with treatment success included years smoking, the Heaviness of Smoking Index, and use of nicotine patch or bupropion. The inclusion of individuals with and without MSUD in the same protocol, allowing for individuals with MSUD undergoing their psychiatric treatment, generates at least comparable success rates between the groups. Predictors of treatment success were similar to those found in the general population. Facilities that treat patients with MSUD should treat tobacco use in order to reduce the disparities in morbidity and mortality experienced by this population. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  6. Changing physical activity behaviour for people with multiple sclerosis: protocol of a randomised controlled feasibility trial (iStep-MS).

    PubMed

    Ryan, Jennifer M; Fortune, Jennifer; Stennett, Andrea; Kilbride, Cherry; Anokye, Nana; Victor, Christina; Hendrie, Wendy; Abdul, Mohamed; DeSouza, Lorraine; Lavelle, Grace; Brewin, Debbie; David, Lee; Norris, Meriel

    2017-11-15

    Although physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behaviour. Behaviour change interventions may assist people with MS to increase physical activity and reduce sedentary behaviour. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims to determine the safety, feasibility and acceptability of a behaviour change intervention to increase physical activity and reduce sedentary behaviour among people with MS. Sixty people with MS will be randomised (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behaviour (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the programme and semistructured interviews exploring participants' and therapists' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use. Research ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists. ISRCTN15343862 (doi 10.1186/ISRCTN15343862). Protocol version: 1.0; 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.

  7. Changing physical activity behaviour for people with multiple sclerosis: protocol of a randomised controlled feasibility trial (iStep-MS)

    PubMed Central

    Ryan, Jennifer M; Fortune, Jennifer; Stennett, Andrea; Kilbride, Cherry; Anokye, Nana; Victor, Christina; Hendrie, Wendy; Abdul, Mohamed; DeSouza, Lorraine; Lavelle, Grace; Brewin, Debbie; David, Lee; Norris, Meriel

    2017-01-01

    Introduction Although physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behaviour. Behaviour change interventions may assist people with MS to increase physical activity and reduce sedentary behaviour. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims to determine the safety, feasibility and acceptability of a behaviour change intervention to increase physical activity and reduce sedentary behaviour among people with MS. Methods and analysis Sixty people with MS will be randomised (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behaviour (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the programme and semistructured interviews exploring participants’ and therapists’ experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use. Ethics and dissemination Research ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists. Trial registration number ISRCTN15343862 (doi 10.1186/ISRCTN15343862). Protocol version: 1.0; Pre-results. PMID:29146660

  8. Lingual–Alveolar Contact Pressure During Speech in Amyotrophic Lateral Sclerosis: Preliminary Findings

    PubMed Central

    Knollhoff, Stephanie; Barohn, Richard J.

    2017-01-01

    Purpose This preliminary study on lingual–alveolar contact pressures (LACP) in people with amyotrophic lateral sclerosis (ALS) had several aims: (a) to evaluate whether the protocol induced fatigue, (b) to compare LACP during speech (LACP-Sp) and during maximum isometric pressing (LACP-Max) in people with ALS (PALS) versus healthy controls, (c) to compare the percentage of LACP-Max utilized during speech (%Max) for PALS versus controls, and (d) to evaluate relationships between LACP-Sp and LACP-Max with word intelligibility. Method Thirteen PALS and 12 healthy volunteers produced /t, d, s, z, l, n/ sounds while LACP-Sp was recorded. LACP-Max was obtained before and after the speech protocol. Word intelligibility was obtained from auditory–perceptual judgments. Results LACP-Max values measured before and after completion of the speech protocol did not differ. LACP-Sp and LACP-Max were statistically lower in the ALS bulbar group compared with controls and PALS with only spinal symptoms. There was no statistical difference between groups for %Max. LACP-Sp and LACP-Max were correlated with word intelligibility. Conclusions It was feasible to obtain LACP-Sp measures without inducing fatigue. Reductions in LACP-Sp and LACP-Max for bulbar speakers might reflect tongue weakness. Although confirmation of results is needed, the data indicate that individuals with high word intelligibility maintained LACP-Sp at or above 2 kPa and LACP-Max at or above 50 kPa. PMID:28335033

  9. Does assistive technology contribute to social inclusion for people with intellectual disability? A systematic review protocol

    PubMed Central

    Larkan, Fiona; Kayabu, Bonnix; Fitzgerald, Geraldine; Sheaf, Greg; Dinsmore, John; McConkey, Roy; Clarke, Mike; MacLachlan, Malcolm

    2018-01-01

    Introduction The aim of this review is to answer the following question: Does assistive technology contribute to social inclusion for people with intellectual disability? Previous research on assistive technology has focused on socioeconomic impacts such as education, employment and access to healthcare by people with intellectual disability. There is a need to consolidate evidence on the interaction between intellectual disability, assistive technology, community living and social inclusion. Methods and analysis The review will consider studies from all settings: geographical, socioeconomic and care (institutional and community care), published in English. Studies reported in other languages with abstracts in English will be included if they can be translated using Google Translate, otherwise such studies will be included in the appendix. The review will include both qualitative and quantitative studies. The intervention in this review refers to the use of assistive technology to promote community participation or interpersonal relationships (social inclusion) for people with intellectual disability. The outcomes will be behavioural and social benefits of using assistive technology by people with intellectual disability. Enhanced interpersonal relationships and community participation by people with intellectual disability. Data analysis will be in two phases. The first phase will involve analysis of individual study designs separately. The second phase will be narrative/thematic synthesis of all study groups. Ethics The review will not create any ethical or safety concerns. Dissemination At least one peer-reviewed article in a leading journal such as the BMJ is planned. The findings will also be disseminated through a seminar session involving internal audience at Trinity College Dublin and within the Assistive Technologies for people with Intellectual Disability and Autism research programme. PROSPERO registration number CRD42017065447; Pre-results. PMID:29440153

  10. A cluster randomized controlled trial on the effects and costs of advance care planning in elderly care: study protocol.

    PubMed

    Korfage, Ida J; Rietjens, Judith A C; Overbeek, Anouk; Jabbarian, Lea J; Billekens, Pascalle; Hammes, Bernard J; Hansen-van der Meer, Ellen; Polinder, Suzanne; Severijnen, Johan; Swart, Siebe J; Witkamp, Frederika E; van der Heide, Agnes

    2015-07-22

    Currently, health care and medical decision-making at the end of life for older people are often insufficiently patient-centred. In this trial we study the effects of Advance Care Planning (ACP), a formalised process of timely communication about care preferences at the end of life, for frail older people. We will conduct a cluster randomised controlled trial among older people residing in care homes or receiving home care in the Netherlands. The intervention group will receive the ACP program Respecting Choices® in addition to usual care. The control group will receive usual care only. Participants in both groups will fill out questionnaires at baseline and after 12 months. We hypothesize that ACP will lead to better patient activation in medical decision making and quality of life, while reducing the number of medical interventions and thus health care costs. Multivariate analysis will be used to compare differences between the intervention group and the control group at baseline and to compare differences in changes after 12 months following the inclusion. Our study can contribute to more understanding of the effects of ACP on patient activation and quality of life in frail older people. Further, we will gain insight in the costs and cost-effectiveness of ACP. This study will facilitate ACP policy for older people in the Netherlands. Nederlands Trial Register: NTR4454.

  11. Enabling participation for disabled young people: study protocol.

    PubMed

    Carroll, Penelope; Witten, Karen; Calder-Dawe, Octavia; Smith, Melody; Kearns, Robin; Asiasiga, Lanuola; Lin, Judy; Kayes, Nicola; Mavoa, Suzanne

    2018-06-08

    Participation in community life is vital for health and wellbeing, promoting a sense of belonging, networks of social support and opportunities for physical activity. Disabled young people have lower levels of mobility and participation in recreational activities (physical, social and cultural), education and employment, than their peers without disabilities. This has implications for their health and wellbeing and life course opportunities. Previous research on the participation levels of disabled young people has primarily relied on parent/caregiver reports and been oriented to home and school environments. This study investigates how physical and social environmental factors cohere to support or restrict the everyday mobility and participation of disabled young people. The study is located in Auckland, Aotearoa/New Zealand (NZ). Participants comprise 35 young people aged 12-25 years with mobility, vision or hearing impairments. A mixed-methods research design combines objective (global positioning systems, accelerometers, geographical information systems) and self-report measures (travel diaries, and questionnaires) to assess young people's mobility and levels of participation in leisure/educational and employment activities with in-depth interviews exploring their everyday experiences of inclusion/exclusion, and factors enabling or constraining community participation. Parents/caregivers and disability sector key informant viewpoints on the community participation of disabled young people have also been gathered through in-depth interviews. Follow-up workshops with young people and parents/caregivers will identify pathways to increase participation and challenge current disabling practices. This study looks beyond barriers in the physical environment to the interplay of personal, social and physical factors that enable or constrain the community participation of disabled young people. In keeping with the study's overarching goal of increasing opportunities for effective community participation and full citizenship of disabled young people, research methods were applied flexibily - negotiated and adapted to maximise each young person's participation in light of their abilities and preferences.

  12. Novel strategies to improve immunomodulation and non invasive clinical monitoring in VCA

    DTIC Science & Technology

    2017-08-01

    and motor vehicle accidents, amongst others. People with these types of traumatic injuries have decreased quality of life, and are often disabled ...ability to restore form and function after these injuries. Disability with associated long-term medical care and disability benefit costs is common...entirely new IRB protocol that is specific and inclusive only of the work stated in the Statement of Work for this award. This protocol has been

  13. Talk Is Cheap: Skype Can Make VoIP a Very Real Communication Option for Your School

    ERIC Educational Resources Information Center

    Branzburg, Jeffrey

    2007-01-01

    There have been many tools that people can use to get connected with each other worldwide. Cell phones, blogs, wikis, podcasts, e-mail--the world hinges upon people's ability to connect, share, collaborate, and communicate. Voice over Internet Protocol (VoIP) is another tool schools can use to help their students get connected with the world. One…

  14. About machine-readable travel documents

    NASA Astrophysics Data System (ADS)

    Vaudenay, S.; Vuagnoux, M.

    2007-07-01

    Passports are documents that help immigration officers to identify people. In order to strongly authenticate their data and to automatically identify people, they are now equipped with RFID chips. These contain private information, biometrics, and a digital signature by issuing authorities. Although they substantially increase security at the border controls, they also come with new security and privacy issues. In this paper, we survey existing protocols and their weaknesses.

  15. Searching for best practices of youth friendly services - a study protocol using qualitative comparative analysis in Sweden.

    PubMed

    Goicolea, Isabel; Christianson, Monica; Hurtig, Anna-Karin; Marchal, Bruno; San Sebastian, Miguel; Wiklund, Maria

    2016-07-29

    Swedish youth clinics constitute one of the most comprehensive and consolidated examples of a nationwide network of health care services for young people. However, studies evaluating their 'youth-friendliness' and the combination of factors that makes them more or less 'youth-friendly' have not been conducted. This protocol will scrutinise the current youth-friendliness of youth clinics in northern Sweden and identify the best combination of conditions needed in order to implement the criteria of youth-friendliness within Swedish youth clinics and elsewhere. In this study, we will use qualitative comparative analysis to analyse the conditions that are sufficient and/or necessary to implement Youth Friendly Health Services in 20 selected youth-clinics (cases). In order to conduct Qualitative Comparative Analysis, we will first identify the outcomes and the conditions to be assessed. The overall outcome - youth-friendliness - will be assessed together with specific outcomes for each of the five domains - accessible, acceptable, equitable, appropriate and effective. This will be done using a questionnaire to be applied to a sample of young people coming to the youth clinics. In terms of conditions, we will first identify what might be the key conditions, to ensure the youth friendliness of health care services, through literature review, interviews with professionals working at youth clinics, and with young people. The combination of conditions and outcomes will form the hypothesis to be further tested later on in the qualitative comparative analysis of the 20 cases. Once information on outcomes and conditions is gathered from each of the 20 clinics, it will be analysed using Qualitative Comparative Analysis. The added value of this study in relation to the findings is twofold: on the one hand it will allow a thorough assessment of the youth-friendliness of northern Swedish youth clinics. On the other hand, it will extract lessons from one of the most consolidated examples of differentiated services for young people. Methodologically, this study can contribute to expanding the use of Qualitative Comparative Analysis in health systems research.

  16. Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment.

    PubMed

    Kelly, Peter J; Baker, Amanda L; Deane, Frank P; Callister, Robin; Collins, Clare E; Oldmeadow, Christopher; Attia, John R; Townsend, Camilla J; Ingram, Isabella; Byrne, Gerard; Keane, Carol A

    2015-05-03

    Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders. These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use, smoking, low intake of fruit and vegetables and physical inactivity. In addition to addressing problematic alcohol use, there is the potential for substance abuse treatment services to also address these other behaviours. Healthy Recovery is an 8-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment. This protocol describes a Cancer Institute NSW funded study that assesses the effectiveness of delivering Healthy Recovery for people who are attending residential alcohol and other substance abuse treatment. The study uses a stepped wedge randomised controlled design, where randomisation occurs at the service level. Participants will be recruited from residential rehabilitation programs provided by The Australian Salvation Army. All participants who (1) currently smoke tobacco and (2) are expected to be in the residential program for the duration of the 5-week intervention will be asked to participate in the study. Those participants residing at the facilities assigned to the treatment condition will complete Healthy Recovery. The intervention is manual guided and will be delivered over a 5-week period, with participants attending 8 group sessions. All participants will continue to complete The Salvation Army residential program, a predominantly 12-step based, modified therapeutic community. Participants in the control condition will complete treatment as usual. Research staff blind to treatment allocation will complete the primary and secondary outcome assessments at baseline and then at weeks 8, 20 and 32 weeks post intervention. This study will provide comprehensive data on the effect of delivering a healthy lifestyle intervention (i.e. Healthy Recovery) within a residential substance abuse setting. If shown to be effective, this intervention can be disseminated within other residential substance abuse programs. Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12615000165583. Registered 19(th) February 2015.

  17. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

    PubMed Central

    Klonoff, David C.; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubin, Guillermo; Burk, Robert D.; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W.

    2015-01-01

    Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. PMID:26481642

  18. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

    PubMed

    Klonoff, David C; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A; Arreaza-Rubin, Guillermo; Burk, Robert D; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W

    2016-05-01

    Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. © 2015 Diabetes Technology Society.

  19. A gradient-free method for the purification of infective dengue virus for protein-level investigations.

    PubMed

    Jensen, Stephanie M; Nguyen, Celina T; Jewett, John C

    2016-09-01

    Dengue virus (DENV) is a mosquito-transmitted flavivirus that infects approximately 100 million people annually. Multi-day protocols for purification of DENV reduce the infective titer due to viral sensitivity to both temperature and pH. Herein we describe a 5-h protocol for the purification of all DENV serotypes, utilizing traditional gradient-free ultracentrifugation followed by selective virion precipitation. This protocol allows for the separation of DENV from contaminating proteins - including intact C6/36 densovirus, for the production of infective virus at high concentration for protein-level analysis. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Application of the Sketch Match method in Sulina coastal study area within PEGASO project

    NASA Astrophysics Data System (ADS)

    Marin, Eugenia; Nichersu, Iuliana; Mierla, Marian; Trifanov, Cristian; Nichersu, Iulian

    2013-04-01

    The Sketch Match approach for Sulina pilot case was carried out in the frame of the project "People for Ecosystem Based Governance in Assessing Sustainable Development of Ocean and Coast" - PEGASO, funded by the Seventh Framework Programme. The PEGASO project has been designed to identify common threats and solutions in relation to the long-term sustainable development and environmental protection of coastal zones bordering the Mediterranean and Black Seas in ways relevant to the implementation of the Integrated Coastal Zone Management Protocol (ICZM) for the Mediterranean. PEGASO will use the model of the existing ICZM Protocol for the Mediterranean and adjust it to the needs of the Black Sea through innovative actions, one of them being Refine and develop efficient and easy to use tools for making sustainability assessments in the coastal zone tested through a number of relevant pilot sites. Thus, for the Romania case study, the Sketch Match approach was selected, being an interactive public participation planning method, developed by the Dutch Government, and applied for Sulina area in order to stimulate support and involvement from stakeholders regarding Integrated Coastal Zone Management Protocol by consulting and involving these people in the planning process and making use of a coherent package of interactive methods. Participants were representatives of a wide range of stakeholders, varying from local fisherman to representatives of the Local and County council and Danube Delta Biosphere Reserve Authority. They participated in a two-day design session, focused on problems and potentials of the area, with the aim to work out possible solutions for an integrated coastal spatial planning, focusing on the parallel enhance of the various local functions in the spatial design (coastal area protection next to industry, tourism, nature, recreation, and other activities).

  1. Development of imaging techniques to study the pathogenesis of biosafety level 2/3 infectious agents

    PubMed Central

    Rella, Courtney E.; Ruel, Nancy; Eugenin, Eliseo A.

    2015-01-01

    Despite significant advances in microbiology and molecular biology over the last decades, several infectious diseases remain global concerns, resulting in the death of millions of people worldwide each year. According to the Center for Disease Control (CDC) in 2012, there were 34 million people infected with HIV, 8.7 million new cases of tuberculosis, 500 million cases of hepatitis, and 50–100 million people infected with dengue. Several of these pathogens, despite high incidence, do not have reliable clinical detection methods. New or improved protocols have been generated to enhance detection and quantitation of several pathogens using high-end microscopy (light, confocal, and STORM microscopy) and imaging software. In the current manuscript, we discuss these approaches and the theories behind these methodologies. Thus, advances in imaging techniques will open new possibilities to discover therapeutic interventions to reduce or eliminate the devastating consequences of infectious diseases. PMID:24990818

  2. Exploring the development of existing sex education programmes for people with intellectual disabilities: an intervention mapping approach.

    PubMed

    Schaafsma, Dilana; Stoffelen, Joke M T; Kok, Gerjo; Curfs, Leopold M G

    2013-03-01

    People with intellectual disabilities face barriers that affect their sexual health. Sex education programmes have been developed by professionals working in the field of intellectual disabilities with the aim to overcome these barriers. The aim of this study was to explore the development of these programmes. Sex education programmes geared to people with intellectual disabilities were examined in the context of the Intervention Mapping protocol. Data were obtained via interviews with the programme developers. All programmes lack specific programme outcomes, do not have a theoretical basis, did not involve members of relevant groups in the development process and lack systematic evaluation. Based on our findings and the literature, we conclude that these programmes are unlikely to be effective. Future programmes should be developed using a more systematic and theory- and evidence-based approach. © 2012 Blackwell Publishing Ltd.

  3. Advanced dementia pain management protocols.

    PubMed

    Montoro-Lorite, Mercedes; Canalias-Reverter, Montserrat

    Pain management in advanced dementia is complex because of neurological deficits present in these patients, and nurses are directly responsible for providing interventions for the evaluation, management and relief of pain for people suffering from this health problem. In order to facilitate and help decision-makers, pain experts recommend the use of standardized protocols to guide pain management, but in Spain, comprehensive pain management protocols have not yet been developed for advanced dementia. This article reflects the need for an integrated management of pain in advanced dementia. From the review and analysis of the most current and relevant studies in the literature, we performed an approximation of the scales for the determination of pain in these patients, with the observational scale PAINAD being the most recommended for the hospital setting. In addition, we provide an overview for comprehensive management of pain in advanced dementia through the conceptual framework «a hierarchy of pain assessment techniques by McCaffery and Pasero» for the development and implementation of standardized protocols, including a four-phase cyclical process (evaluation, planning/performance, revaluation and recording), which can facilitate the correct management of pain in these patients. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  4. Long-term Recovery in Stroke Accompanied by Aphasia: A Reconsideration.

    PubMed

    Holland, Audrey; Fromm, Davida; Forbes, Margaret; MacWhinney, Brian

    2017-01-01

    This work focuses on the twenty-six individuals who provided data to AphasiaBank on at least two occasions, with initial testing between 6 months and 5.8 years post-onset of aphasia. The data are archival in nature and were collected from the extensive database of aphasic discourse in AphasiaBank. The aim is to furnish data on the nature of long-term changes in both the impairment of aphasia as measured by the Western Aphasia Battery-Revised (WAB-R) and its expression in spoken discourse. AphasiaBank's demographic database was searched to discover all individuals who were tested twice at an interval of at least a year with either: 1) the AphasiaBank protocol; or 2) the AphasiaBank protocol at first testing, and the Famous People Protocol (FPP) at second testing. The Famous People Protocol is a measure developed to assess the communication strategies of individuals whose spoken language limitations preclude full participation in the AphasiaBank protocol. The 26 people with aphasia (PWA) who were identified had completed formal speech therapy before being seen for AphasiaBank. However, all were participants in aphasia centers where at least three hours of planned activities were available, in most cases, twice weekly. WAB-R Aphasia Quotient scores (AQ) were examined, and in those cases where AQ scores improved, changes were assessed on a number of measures from the AphasiaBank discourse protocol. Sixteen individuals demonstrated improved WAB-R AQ scores, defined as positive AQ change scores greater than the WAB-R AQ standard error of the mean (WAB-SEM); seven maintained their original WAB quotients, defined as AQ change scores that were not greater than the WAB-SEM; and the final three showed negative WAB-R change scores, defined as a negative WAB-R AQ change score greater than the WAB-SEM. Concurrent changes on several AphasiaBank tasks were also found, suggesting that the WAB-R improvements were noted in more natural discourse as well. These data are surprising, since conventional wisdom suggests that spontaneous improvement in language is unlikely to occur beyond one year. Long-term improvement or maintenance of early test scores, such as that shown here, has seldom been demonstrated in the absence of formal treatment. Speculations about why these PWA improved, maintained or declined in their scores are considered.

  5. The Social Dimension of Stress: Experimental Manipulations of Social Support and Social Identity in the Trier Social Stress Test

    PubMed Central

    Frisch, Johanna U.; Häusser, Jan A.; van Dick, Rolf; Mojzisch, Andreas

    2015-01-01

    In many situations humans are influenced by the behavior of other people and their relationships with them. For example, in stressful situations supportive behavior of other people as well as positive social relationships can act as powerful resources to cope with stress. In order to study the interplay between these variables, this protocol describes two effective experimental manipulations of social relationships and supportive behavior in the laboratory. In the present article, these two manipulations are implemented in the Trier Social Stress Test (TSST)—a standard stress induction paradigm in which participants are subjected to a simulated job interview. More precisely, we propose (a) a manipulation of the relationship between different protagonists in the TSST by making a shared social identity salient and (b) a manipulation of the behavior of the TSST-selection committee, which acts either supportively or unsupportively. These two experimental manipulations are designed in a modular fashion and can be applied independently of each other but can also be combined. Moreover, these two manipulations can also be integrated into other stress protocols and into other standardized social interactions such as trust games, negotiation tasks, or other group tasks. PMID:26649856

  6. Limits on quality of life in communication after total laryngectomy

    PubMed Central

    Chaves, Adriana Di Donato; Pernambuco, Leandro de Araújo; Balata, Patrícia Maria Mendes; Santos, Veridiana da Silva; de Lima, Leilane Maria; de Souza, Síntia Ribeiro; da Silva, Hilton Justino

    2012-01-01

    Summary Introduction: Among people affected by cancer, the impairment of quality of life of people affected by cancer can cause have devastating effects. The self-image of patients after post-laryngectomyzed patients may be find themselves compromised, affecting the quality of life in this population. Objective: To characterize quality of life in related to communication in people who have undergone went total laryngectomy surgery. Methods: This is an observational study, with a cross-sectional and descriptive series. Design of series study. The sample were comprised 15 patients interviewed the period from January to February of 2011. We used the Quality Protocol for Life Communication in Post-laryngectomy adapted from Bertocello (2004); which this questionnaire contains 55 questions. The protocol was organized from the nature of using responses classified as positive and negative aspects, proposals in with respect to five 5 communication domains: family relationships, social relationships, personal analysis; morphofunctional aspect, and use of writing. To promote and guarantee the autonomy of the respondents, was examiners made use of used assistive technology with the Visual Response Scale. Results: The responses that total laryngectomy compromises the quality of life in communication amounted to 463 occurrences (65.7%), and that who responses suggesting good quality of life were represented with amounted to 242 occurrences (34.3%), from a total of 705 occurrencesresponses. From Among the five 5 Communication domains, four 4 had percentages of above 63% for occurrences of negative content for impact on communication. Appearance Morphofunctional appearance gave the had the highest percentage of negative content, amounting to 77.3% of cases. Conclusions: The results showed important limitations of a personal and social nature due to poor communication with their peers. Thus, there is a need for multidisciplinary interventions that aim to minimize the entrapment of negative impact on these people communication among these patients. PMID:25991977

  7. Limits on quality of life in communication after total laryngectomy.

    PubMed

    Chaves, Adriana Di Donato; Pernambuco, Leandro de Araújo; Balata, Patrícia Maria Mendes; Santos, Veridiana da Silva; de Lima, Leilane Maria; de Souza, Síntia Ribeiro; da Silva, Hilton Justino

    2012-10-01

     Among people affected by cancer, the impairment of quality of life of people affected by cancer can cause have devastating effects. The self-image of patients after post-laryngectomyzed patients may be find themselves compromised, affecting the quality of life in this population.  To characterize quality of life in related to communication in people who have undergone went total laryngectomy surgery.  This is an observational study, with a cross-sectional and descriptive series. Design of series study. The sample were comprised 15 patients interviewed the period from January to February of 2011. We used the Quality Protocol for Life Communication in Post-laryngectomy adapted from Bertocello (2004); which this questionnaire contains 55 questions. The protocol was organized from the nature of using responses classified as positive and negative aspects, proposals in with respect to five 5 communication domains: family relationships, social relationships, personal analysis; morphofunctional aspect, and use of writing. To promote and guarantee the autonomy of the respondents, was examiners made use of used assistive technology with the Visual Response Scale.  The responses that total laryngectomy compromises the quality of life in communication amounted to 463 occurrences (65.7%), and that who responses suggesting good quality of life were represented with amounted to 242 occurrences (34.3%), from a total of 705 occurrencesresponses. From Among the five 5 Communication domains, four 4 had percentages of above 63% for occurrences of negative content for impact on communication. Appearance Morphofunctional appearance gave the had the highest percentage of negative content, amounting to 77.3% of cases.  The results showed important limitations of a personal and social nature due to poor communication with their peers. Thus, there is a need for multidisciplinary interventions that aim to minimize the entrapment of negative impact on these people communication among these patients.

  8. A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy.

    PubMed

    Barker, Anna L; McNeil, John J; Seeman, Ego; Ward, Stephanie A; Sanders, Kerrie M; Khosla, Sundeep; Cumming, Robert G; Pasco, Julie A; Bohensky, Megan A; Ebeling, Peter R; Woods, Robyn L; Lockery, Jessica E; Wolfe, Rory; Talevski, Jason

    2016-08-01

    Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people. ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture-vertebral, hip and non-vert-non-hip-occurring post randomisation. Fall-related hospital presentations are a secondary outcome. This substudy will determine whether a widely available, simple and inexpensive health intervention-aspirin-reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention. The protocol for this substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. Study protocol of the YP Face IT feasibility study: comparing an online psychosocial intervention versus treatment as usual for adolescents distressed by appearance-altering conditions/injuries.

    PubMed

    Williamson, Heidi; Hamlet, Claire; White, Paul; Marques, Elsa M R; Cadogan, Julia; Perera, Rohan; Rumsey, Nichola; Hayward, Leighton; Harcourt, Diana

    2016-10-03

    A significant number of adolescents suffer extensive and enduring difficulties such as social anxiety, body image dissatisfaction, low self-esteem and bullying as a result of conditions or injuries that affect their appearance (eg, craniofacial and skin conditions, treatment side effects and scarring). Evidence-based psychosocial interventions to meet their specific needs are currently lacking. YP Face IT, developed by the UK's Centre for Appearance Research in collaboration with clinical experts and young people, is an innovative online psychosocial intervention designed to offer this group immediate support, advice and coping strategies. It has been endorsed by young people, their parents/carers, GPs, clinical psychologists and health professionals working with those affected by appearance-related conditions. Young people aged 12-17 with an appearance-altering condition/injury that self-identify as experiencing appearance-related distress, teasing or bullying will be invited to participate via GP practices and UK charities. Consenting participants will be randomised to the intervention (YP Face IT) or the treatment as usual (TAU) control group. Outcome measures will be completed by young people and their parents/carers at baseline, 13, 26 and 52 weeks. Primary outcome measures will be the Body Esteem Scale and the Social Anxiety Scale for Adolescents. Participants will complete other health-related outcome measures and resource use questionnaires for health economic analysis. We will assess recruitment rates, acceptability of the YP Face IT programme, adherence and retention to treatment, questionnaire completion rates, variation of TAU in Primary Care and the feasibility of GP practice staff supervising young people's use of YP Face IT. This feasibility trial protocol (V.1, 3 March 2014), received a favourable ethical opinion from the NRES Committee South West-Frenchay (reference number 14/SW/0058). Findings will be disseminated through academic peer-reviewed publications, conferences and to participating GP practices and charities supporting those with conditions affecting appearance. ISRCTN40650639; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Access 3 project protocol: young people and health system navigation in the digital age: a multifaceted, mixed methods study.

    PubMed

    Kang, Melissa; Robards, Fiona; Sanci, Lena; Steinbeck, Katharine; Jan, Stephen; Hawke, Catherine; Kong, Marlene; Usherwood, Tim

    2017-08-07

    The integration of digital technology into everyday lives of young people has become widespread. It is not known whether and how technology influences barriers and facilitators to healthcare, and whether and how young people navigate between face-to-face and virtual healthcare. To provide new knowledge essential to policy and practice, we designed a study that would explore health system access and navigation in the digital age. The study objectives are to: (1) describe experiences of young people accessing and navigating the health system in New South Wales (NSW), Australia; (2) identify barriers and facilitators to healthcare for young people and how these vary between groups; (3) describe health system inefficiencies, particularly for young people who are marginalised; (4) provide policy-relevant knowledge translation of the research data. This mixed methods study has four parts, including: (1) a cross-sectional survey of young people (12-24 years) residing in NSW, Australia; (2) a longitudinal, qualitative study of a subsample of marginalised young people (defined as young people who: identify as Aboriginal and/or Torres Strait Islander; are experiencing homelessness; identify as sexuality and/or gender diverse; are of refugee or vulnerable migrant background; and/or live in rural or remote NSW); (3) interviews with professionals; (4) a knowledge translation forum. Ethics approvals were sought and granted. Data collection commenced in March 2016 and will continue until June 2017. This study will gather practice and policy-relevant intelligence about contemporary experiences of young people and health services, with a unique focus on five different groups of marginalised young people, documenting their experiences over time. Access 3 will explore navigation around all levels of the health system, determine whether digital technology is integrated into this, and if so how, and will translate findings into policy-relevant recommendations. © 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.

  11. Spanning the Pacific Ocean through Voice-Over Internet Protocol Chat with the Hadley School for the Blind--China

    ERIC Educational Resources Information Center

    Gilson, Christie L.; Rongqiang, Xia

    2007-01-01

    Founded in 1920, the Hadley School for the Blind is known worldwide for its tuition-free distance-education courses for people who are visually impaired. Hadley's main school in the United States serves more than 9,000 students, and the overseas school in the People's Republic of China provides vital educational services to more than 1,000 Chinese…

  12. Quality Psychological Advice for Teachers, Parents/Carers and LEA Decision-Makers with Respect to Children and Young People with Special Needs

    ERIC Educational Resources Information Center

    Cameron, R. J. (Sean); Monsen, Jeremy J.

    2005-01-01

    The main aim of this paper is to describe a working protocol which can offer practising educational psychologists a rational framework within which to investigate and understand the complex problems of children and young people in school and to provide appropriate advice to teachers, parents/carers and LEA decision makers on how they can best…

  13. Restoring walking after spinal cord injury: operant conditioning of spinal reflexes can help.

    PubMed

    Thompson, Aiko K; Wolpaw, Jonathan R

    2015-04-01

    People with incomplete spinal cord injury (SCI) frequently suffer motor disabilities due to spasticity and poor muscle control, even after conventional therapy. Abnormal spinal reflex activity often contributes to these problems. Operant conditioning of spinal reflexes, which can target plasticity to specific reflex pathways, can enhance recovery. In rats in which a right lateral column lesion had weakened right stance and produced an asymmetrical gait, up-conditioning of the right soleus H-reflex, which increased muscle spindle afferent excitation of soleus, strengthened right stance and eliminated the asymmetry. In people with hyperreflexia due to incomplete SCI, down-conditioning of the soleus H-reflex improved walking speed and symmetry. Furthermore, modulation of electromyographic activity during walking improved bilaterally, indicating that a protocol that targets plasticity to a specific pathway can trigger widespread plasticity that improves recovery far beyond that attributable to the change in the targeted pathway. These improvements were apparent to people in their daily lives. They reported walking faster and farther, and noted less spasticity and better balance. Operant conditioning protocols could be developed to modify other spinal reflexes or corticospinal connections; and could be combined with other therapies to enhance recovery in people with SCI or other neuromuscular disorders. © The Author(s) 2014.

  14. Sticky tunes: how do people react to involuntary musical imagery?

    PubMed

    Williamson, Victoria J; Liikkanen, Lassi A; Jakubowski, Kelly; Stewart, Lauren

    2014-01-01

    The vast majority of people experience involuntary musical imagery (INMI) or 'earworms'; perceptions of spontaneous, repetitive musical sound in the absence of an external source. The majority of INMI episodes are not bothersome, while some cause disruption ranging from distraction to anxiety and distress. To date, little is known about how the majority of people react to INMI, in particular whether evaluation of the experience impacts on chosen response behaviours or if attempts at controlling INMI are successful or not. The present study classified 1046 reports of how people react to INMI episodes. Two laboratories in Finland and the UK conducted an identical qualitative analysis protocol on reports of INMI reactions and derived visual descriptive models of the outcomes using grounded theory techniques. Combined analysis carried out across the two studies confirmed that many INMI episodes were considered neutral or pleasant, with passive acceptance and enjoyment being among the most popular response behaviours. A significant number of people, however, reported on attempts to cope with unwanted INMI. The most popular and effective behaviours in response to INMI were seeking out the tune in question, and musical or verbal distraction. The outcomes of this study contribute to our understanding of the aetiology of INMI, in particular within the framework of memory theory, and present testable hypotheses for future research on successful INMI coping strategies.

  15. Sticky Tunes: How Do People React to Involuntary Musical Imagery?

    PubMed Central

    Williamson, Victoria J.; Liikkanen, Lassi A.; Jakubowski, Kelly; Stewart, Lauren

    2014-01-01

    The vast majority of people experience involuntary musical imagery (INMI) or ‘earworms’; perceptions of spontaneous, repetitive musical sound in the absence of an external source. The majority of INMI episodes are not bothersome, while some cause disruption ranging from distraction to anxiety and distress. To date, little is known about how the majority of people react to INMI, in particular whether evaluation of the experience impacts on chosen response behaviours or if attempts at controlling INMI are successful or not. The present study classified 1046 reports of how people react to INMI episodes. Two laboratories in Finland and the UK conducted an identical qualitative analysis protocol on reports of INMI reactions and derived visual descriptive models of the outcomes using grounded theory techniques. Combined analysis carried out across the two studies confirmed that many INMI episodes were considered neutral or pleasant, with passive acceptance and enjoyment being among the most popular response behaviours. A significant number of people, however, reported on attempts to cope with unwanted INMI. The most popular and effective behaviours in response to INMI were seeking out the tune in question, and musical or verbal distraction. The outcomes of this study contribute to our understanding of the aetiology of INMI, in particular within the framework of memory theory, and present testable hypotheses for future research on successful INMI coping strategies. PMID:24497938

  16. The Association of Health Literacy and Electronic Health Literacy With Self-Efficacy, Coping, and Caregiving Perceptions Among Carers of People With Dementia: Research Protocol for a Descriptive Correlational Study.

    PubMed

    Efthymiou, Areti; Middleton, Nicos; Charalambous, Andreas; Papastavrou, Evridiki

    2017-11-13

    In the last decade, electronic health (eHealth) literacy has attracted the attention of the scientific community, as it is associated with the self-management of patients with chronic diseases and the quality and cost of care. It is estimated that 80% of people with chronic diseases are cared for at home by a family member, friend, or relative. Informal carers are susceptible to physical and mental health problems, as well as social and financial hardships. Nevertheless, there seems to be a research gap in terms of carers' needs, skills, and available resources in the age of new technologies, with the vital role of eHealth literacy of the carers remaining unexplored. The aim of this study was to investigate the level of eHealth literacy and health literacy of primary and secondary carers of people with dementia, to explore the association between health and eHealth literacy, as well as their association with the caregiving variables: self-efficacy, coping, and caring perceptions. A sample of 200 primary carers (the carer who supports the people with dementia in everyday living) and 200 secondary carers (family member, friend, or other person in the social network assisting the primary carer in their role) will be recruited from dementia day care centers and Alzheimer's associations in Greece and Cyprus. The study will be a cross-sectional correlational descriptive study. Tools to be used include the eHealth Literacy Scale adapted for carers to measure eHealth literacy, European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16), Single Item Literacy Screener, Revised Scale for Caregiving Self-Efficacy, Carers of Older People in Europe (COPE) index for caregiving perceptions, and COPE brief to measure selected coping strategies. Descriptive statistics will be reported, and correlations between different variables will be explored with parametric and nonparametric measures. As a preliminary study, the HLS-EU-Q16 has been validated in 107 older people. The internal consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Carers' eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers' perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers' eHealth and health literacy level, which will also be explored. By confirming the above hypotheses, tailored eHealth literacy interventions for carers of people with dementia and their families will be developed as a direct outcome of this research. ©Areti Efthymiou, Nicos Middleton, Andreas Charalambous, Evridiki Papastavrou. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.11.2017.

  17. Challenges in diagnosing and treating snakebites in a rural population of Tamil Nadu, India: The views of clinicians.

    PubMed

    Williams, Harry F; Vaiyapuri, Rajendran; Gajjeraman, Prabu; Hutchinson, Gail; Gibbins, Jonathan M; Bicknell, Andrew B; Vaiyapuri, Sakthivel

    2017-05-01

    Snakebites cause death, disability and economic devastation to their victims, people who live almost exclusively in rural areas. Annually an estimated two million venomous bites cause as many as 100,000 deaths worldwide as well as hundreds of thousands of deformities and amputations. Recent studies suggest that India has the highest incidence of snakebite and associated deaths worldwide. In this study, we interviewed 25 hospital-based clinicians who regularly treat snakebites in Tamil Nadu, India, in order to gauge their opinions and views on the diagnostic tools and treatment methods available at that time, the difficulties encountered in treating snakebites and improvements to snakebite management protocols they deem necessary. Clinicians identified the improvement of community education, training of medical personnel, development of standard treatment protocols and improved medication as priorities for the immediate future. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. A systematic review of the relationship between internet use, self-harm and suicidal behaviour in young people: The good, the bad and the unknown

    PubMed Central

    Marchant, Amanda; Hawton, Keith; Stewart, Ann; Montgomery, Paul; Singaravelu, Vinod; Lloyd, Keith; Purdy, Nicola; Daine, Kate

    2017-01-01

    Background Research exploring internet use and self-harm is rapidly expanding amidst concerns regarding influences of on-line activities on self-harm and suicide, especially in young people. We aimed to systematically review evidence regarding the potential influence of the internet on self-harm/suicidal behaviour in young people. Methods We conducted a systematic review based on an electronic search for articles published between 01/01/2011 and 26/01/2015 across databases including Medline, Cochrane and PsychInfo. Articles were included if: the study examined internet use by individuals who engaged in self-harm/ suicidal behaviour, or internet use clearly related to self-harm content; reported primary empirical data; participants were aged under 25 years. New studies were combined with those identified in a previous review and subject to data extraction, quality rating and narrative synthesis. Results Forty-six independent studies (51 articles) of varying quality were included. Perceived influences were: positive for 11 studies (38191 participants); negative for 18 studies (119524 participants); and mixed for 17 studies (35235 participants). In contrast to previous reviews on this topic studies focused on a wide range of internet mediums: general internet use; internet addiction; online intervention/treatment; social media; dedicated self-harm websites; forums; video/image sharing and blogs. A relationship between internet use and self-harm/suicidal behaviour was particularly associated with internet addiction, high levels of internet use, and websites with self-harm or suicide content. While there are negative aspects of internet use the potential for isolation reduction, outreach and as a source of help and therapy were also identified. Conclusions There is significant potential for harm from online behaviour (normalisation, triggering, competition, contagion) but also the potential to exploit its benefits (crisis support, reduction of social isolation, delivery of therapy, outreach). Young people appear to be increasingly using social media to communicate distress, particularly to peers. The focus should now be on how specific mediums’ (social media, video/image sharing) might be used in therapy and recovery. Clinicians working with young people who self-harm or have mental health issues should engage in discussion about internet use. This should be a standard item during assessment. A protocol for this review was registered with the PROSPERO systematic review protocol registry: (http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42015019518). PMID:28813437

  19. The feasibility and acceptability of trial procedures for a pragmatic randomised controlled trial of a structured physical activity intervention for people diagnosed with colorectal cancer: findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study.

    PubMed

    Hubbard, Gill; O'Carroll, Ronan; Munro, Julie; Mutrie, Nanette; Haw, Sally; Mason, Helen; Treweek, Shaun

    2016-01-01

    Pilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials' protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was a pilot randomised controlled trial (RCT) of cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal cancer patients. A key aim of the pilot trial was to test the feasibility and acceptability of the protocol design. A pilot RCT with embedded qualitative work was conducted in three sites. Participants were randomly allocated to cardiac rehabilitation or usual care groups. Outcomes used to assess the feasibility and acceptability of key trial parameters were screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, and intervention adherence rates. Colorectal patients' and clinicians' perceptions and experiences of the main trial procedures were explored by interview. Quantitative study. Three sites were involved. Screening, eligibility, consent, and retention rates were 79 % (156/198), 67 % (133/198), 31 % (41/133), and 93 % (38/41), respectively. Questionnaire completion rates were 97.5 % (40/41), 75 % (31/41), and 61 % (25/41) at baseline, follow-up 1, and follow-up 2, respectively. Sixty-nine percent (40) of accelerometer datasets were collected from participants; 31 % (20) were removed for not meeting wear-time validation. Qualitative study: Thirty-eight patients and eight clinicians participated. Key themes were benefits for people with colorectal cancer attending cardiac rehabilitation, barriers for people with colorectal cancer attending cardiac rehabilitation, generic versus disease-specific rehabilitation, key concerns about including people with cancer in cardiac rehabilitation, and barriers to involvement in a study about cardiac rehabilitation. The study highlights where threats to internal and external validity are likely to arise in any future studies of similar structured physical activity interventions for colorectal cancer patients using similar methods being conducted in similar contexts. This study shows that there is likely to be potential recruitment bias and potential imprecision due to sub-optimal completion of outcome measures, missing data, and sub-optimal intervention adherence. Hence, strategies to manage these risks should be developed to stack the odds in favour of conducting successful future trials. ISRCTN63510637.

  20. INTERNET PROTOCOL SUITE.

    DOT National Transportation Integrated Search

    1997-09-04

    In 1993, the North American Free Trade Agreement (NAFTA) committed the United States, Canada and Mexico to facilitate movements of people and goods among the three member countries. In a subsequent agreement in February, 1995, Canada and the United S...

  1. How do older people discuss their own sexuality? A systematic review of qualitative research studies.

    PubMed

    Gewirtz-Meydan, Ateret; Hafford-Letchfield, Trish; Ayalon, Liat; Benyamini, Yael; Biermann, Violetta; Coffey, Alice; Jackson, Jeanne; Phelan, Amanda; Voß, Peggy; Geiger Zeman, Marija; Zeman, Zdenko

    2018-06-04

    This study captured older people's attitudes and concerns about sex and sexuality in later life by synthesising qualitative research published on this issue. The systematic review was conducted between November 2015 and June 2016 based on a pre-determined protocol. Key words were used to ensure a precise search strategy. Empirically based, qualitative literature from 18 databases was found. Twenty studies met the inclusion criteria. Thomas and Harden's thematic synthesis was used to generate 'analytical themes' which summarise this body of literature. Three main themes were identified: (a) social legitimacy for sexuality in later life; (b) health, not age, is what truly impacts sexuality, and (c) the hegemony of penetrative sex. The themes illustrate the complex and delicate relation between ageing and sexuality. Older adults facing health issues that affect sexual function adopt broader definitions of sexuality and sexual activity.

  2. Cooperative studies between the United States of America and the People's Republic of China on applications of remote sensing to surveying and mapping

    USGS Publications Warehouse

    Lauer, Donald T.; Chu, Liangcai

    1992-01-01

    A Protocol established between the National Bureau of Surveying and Mapping, People's Republic of China (PRC) and the U.S. Geological Survey, United States of America (US), resulted in the exchange of scientific personnel, technical training, and exploration of the processing of remotely sensed data. These activities were directed toward the application of remotely sensed data to surveying and mapping. Data were processed and various products were generated for the Black Hills area in the US and the Ningxiang area of the PRC. The results of these investigations defined applicable processes in the creation of satellite image maps, land use maps, and the use of ancillary data for further map enhancements.

  3. Information needs in people with diabetes mellitus: a systematic review.

    PubMed

    Biernatzki, Lisa; Kuske, Silke; Genz, Jutta; Ritschel, Michaela; Stephan, Astrid; Bächle, Christina; Droste, Sigrid; Grobosch, Sandra; Ernstmann, Nicole; Chernyak, Nadja; Icks, Andrea

    2018-02-14

    The purpose of this study was to identify and analyse currently available knowledge on information needs of people with diabetes mellitus, also considering possible differences between subgroups and associated factors. Twelve databases including MEDLINE, EMBASE and the Cochrane Library were searched up until June 2015. Publications that addressed self-reported information needs of people with diabetes mellitus were included. Each study was assessed by using critical appraisal tools, e.g. from the UK National Institute for Health and Care Excellence. Extraction and content analysis were performed systematically. In total, 1993 publications were identified and 26 were finally included. Nine main categories of information needs were identified, including 'treatment-process', 'course of disease', 'abnormalities of glucose metabolism' and 'diabetes through the life cycle'. Differences between patient subgroups, such as type of diabetes or age, were sparsely analysed. Some studies analysed associations between information needs and factors such as participation preferences or information seeking. They found, for example, that information needs on social support or life tasks were associated with information seeking in Internet forums. Information needs in people with diabetes mellitus, appear to be high, yet poorly investigated. Research is needed regarding differences between diverse diabetes populations, including gender aspects or changes in information needs during the disease course. The review protocol has been registered at Prospero ( CRD42015029610 ).

  4. Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial.

    PubMed

    Worrall, Linda; Ryan, Brooke; Hudson, Kyla; Kneebone, Ian; Simmons-Mackie, Nina; Khan, Asaduzzaman; Hoffmann, Tammy; Power, Emma; Togher, Leanne; Rose, Miranda

    2016-03-22

    People with aphasia and their family members are at high risk of experiencing post stroke depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown. This study will determine whether an early intervention for both the person with aphasia after stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention Information Program). People with aphasia and their family members will be blinded to the study design and treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive usual care in addition to either the experimental or the attention control intervention. A total of 344 people with aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12 months post stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental health, and self-reported stroke risk-related behaviors of people with aphasia. This is the first known program tailored for people with aphasia and their family members that aims to prevent depression in people with aphasia by providing intervention early after the stroke. This trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as ACTRN12614000979651 . Date registered: 11 September 2014.

  5. Finger millet [Eleusine coracana (L.) Gaertn].

    PubMed

    Ceasar, Stanislaus Antony; Ignacimuthu, Savarimuthu

    2015-01-01

    Millets are the primary food source for millions of people in tropical regions of the world supplying mineral nutrition and protein. In this chapter, we describe an optimized protocol for the Agrobacterium-mediated transformation of finger millet variety GPU 45. Agrobacterium strain LBA4404 harboring plasmid pCAMBIA1301 which contains hygromycin phosphotransferase (hph) as selectable marker gene and β-glucuronidase (GUS) as reporter gene has been used. This protocol utilizes the shoot apex explants for the somatic embryogenesis and regeneration of finger millet after the transformation by Agrobacterium. Desiccation of explants during cocultivation helps for the better recovery of transgenic plants. This protocol is very useful for the efficient production of transgenic plants in finger millet through Agrobacterium-mediated transformation.

  6. Design and evaluation of prosthetic shoulder controller

    PubMed Central

    Barton, Joseph E.; Sorkin, John D.

    2015-01-01

    We developed a 2-degree-of-freedom (DOF) shoulder position transducer (sensing shoulder protraction-retraction and elevation-depression) that can be used to control two of a powered prosthetic humerus' DOFs. We also developed an evaluation protocol based on Fitts' law to assess the performance of our device. The primary motivation for this work was to support development of powered prosthetic shoulder joints of a new generation of prosthetic arms for people with shoulder disarticulation and very high-level transhumeral amputation. We found that transducers that provided resistance to shoulder movement performed better than those providing no resistance. We also found that a position control scheme, where effector position is proportional to shoulder position, performed better than a velocity control scheme, where effector velocity is proportional to shoulder position. More generally, our transducer can be used to control motion along any two DOFs. It can also be used in a more general 4-DOF control scheme by sequentially controlling two DOFs at a time. The evaluation protocol has general applicability for researchers and practitioners. Researchers can employ it to compare different prosthesis designs and control schemes, while practitioners may find the evaluation protocol useful in evaluating and training people with amputation in the use of prostheses. PMID:25357185

  7. Protocol for Co-Design, Development, and Open Trial of a Prototype Game-Based eHealth Intervention to Treat Anxiety in Young People With Long-Term Physical Conditions.

    PubMed

    Thabrew, Hiran; Stasiak, Karolina; Merry, Sally

    2017-09-22

    Approximately 10% to 12% of New Zealand young people (and 21% of Maori young people) have long-term physical conditions and are more likely to develop psychological problems, particularly anxiety and depression. Delayed treatment leads to worse management of physical conditions, school absence, and poorer long-term outcomes. Recently, electronic health (eHealth) interventions have been shown to be as good as face-to-face therapy and biofeedback techniques have been shown to enhance relaxation during the treatment of anxiety. In addition, young people with long-term physical conditions have expressed a preference for more technologically based support, including game-based interventions, to deal with psychological issues, particularly anxiety. The aim of this study is to develop a prototype game-based eHealth intervention to address anxiety in young people with long-term physical conditions. The game will be based on the principles of cognitive behavior therapy (CBT) and will integrate a module of biofeedback-based relaxation. During the first phase of the study, up to 48 young people with long-term physical conditions aged 13 to 18 years, attending a tertiary pediatric hospital will be invited to participate in a 3-stage series of co-design workshops. Following the design, development, and refinement of a working prototype, during the second phase of the study, a further 20 young people with long-term physical conditions and anxiety will be recruited from the same location to participate in an open pilot trial to evaluate its acceptability, usability, and preliminary efficacy. Changes in anxiety will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Spence Child Anxiety Scales (SCAS) at the end of every module (recommended to be completed weekly), post intervention, and 3 months later. Usability of the intervention will be measured using the System Usability Scale (SUS) and by measuring frequency and quantity of use of the intervention. Acceptability of the intervention will be assessed using brief, open-ended questionnaires and semi-structured interviews, the data from which will be analyzed using a general inductive approach. Recruitment to the study commenced in January 2017 and data collection will be completed by the end of December 2017. If acceptable and useful, this game-based eHealth intervention may offer a cost-effective and clinically useful intervention for addressing the psychological needs of over 16,000 young people with long term health conditions in New Zealand. Australian New Zealand Clinical Trials Network Registry (ANZCTR): ACTRN12616001253493p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371443 (Archived by WebCite at http://www.webcitation.org/6sYB716lf). ©Hiran Thabrew, Karolina Stasiak, Sally Merry. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.09.2017.

  8. KAMEDO report no. 87: bomb attack in Finnish shopping center, 2002.

    PubMed

    Deverell, Edward; Ortenwall, Per; Almgren, Ola; Riddez, Louis

    2007-01-01

    The detonation of a bomb in a shopping center in Vantaa, Finland, took place on 11 October 2002. Seven people died as a result and > 160 people required medical attention. Because the rescue teams were inadequately trained to respond to terrorist attacks, the event was handled according to protocol. A number of problems arose, including: people from different rescue agencies were difficult to distinguish from each other; there was inadequate communication between the incident site and the main hospital; relatives of victims were not kept informed; and psychiatric problems in the wake of the disaster were not addressed sufficiently.

  9. Recovery After Prolonged Bed-Rest Deconditioning

    NASA Technical Reports Server (NTRS)

    Greenleaf, John E.; Quach, David T.

    2003-01-01

    Recovery data were analyzed from normal healthy test subjects maintained in the horizontal or head-down body position in well-controlled bed rest (BR) studies in which adherence to the well-designed protocol was monitored. Because recovery data were almost always of secondary importance to the data collected during the BR period, there was little consistency in the recovery experimental designs regarding control factors (e.g., diet or exercise), duration, or timing of data collection. Thus, only about half of the BR studies that provided appropriate data were analyzed here. These recovery data were sorted into two groups: those from BR protocols of less than 37 days, and those from protocols greater than 36 days. There was great disparity in the unchanged responses at the end of BR in these two groups. Likewise with the variables that required more than 40 days for recovery; for example, some immune variables required more than 180 days. Knowledge of the recovery process after BR in healthy people should assist rehabilitation workers in differentiating "healthy" BR recovery responses from those of the infirmity of sick or injured patients; this should result in more appropriate and efficient health care.

  10. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032

    PubMed Central

    2011-01-01

    Background Concerns about falls are frequently reported by older people. These concerns can have serious consequences such as an increased risk of falls and the subsequent avoidance of activities. Previous studies have shown the effectiveness of a multicomponent group programme to reduce concerns about falls. However, owing to health problems older people may not be able to attend a group programme. Therefore, we adapted the group approach to an individual in-home programme. Methods/Design A two-group randomised controlled trial has been developed to evaluate the in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail older people living in the community. Persons were eligible for study if they were 70 years of age or over, perceived their general health as fair or poor, had at least some concerns about falls and associated avoidance of activity. After screening for eligibility in a random sample of older people, eligible persons received a baseline assessment and were subsequently allocated to the intervention or control group. Persons assigned to the intervention group were invited to participate in the programme, while those assigned to the control group received care as usual. The programme consists of seven sessions, comprising three home visits and four telephone contacts. The sessions are aimed at instilling adaptive and realistic views about falls, as well as increasing activity and safe behaviour. An effect evaluation, a process evaluation and an economic evaluation are conducted. Follow-up measurements for the effect evaluation are carried out 5 and 12 months after the baseline measurement. The primary outcomes of the effect evaluation are concerns about falls and avoidance of activity as a result of these concerns. Other outcomes are disability and falls. The process evaluation measures: the population characteristics reached; protocol adherence by facilitators; protocol adherence by participants (engagement in exposure and homework); opinions about the programme of participants and facilitators; perceived benefits and achievements; and experienced barriers. The economic evaluation examines the impact on health-care utilisation, as well as related costs. Discussion A total number of 389 participants is included in the study. Final results are expected in 2012. Trial registration NCT01358032 PMID:21933436

  11. Examining the pathways for young people with drug and alcohol dependence: a mixed-method design to examine the role of a treatment programme

    PubMed Central

    Nathan, Sally; Rawstorne, Patrick; Hayen, Andrew; Bryant, Joanne; Baldry, Eileen; Ferry, Mark; Williams, Megan; Shanahan, Marian; Jayasinha, Ranmalie

    2016-01-01

    Introduction Young people with drug and alcohol problems are likely to have poorer health and other psychosocial outcomes than other young people. Residential treatment programmes have been shown to lead to improved health and related outcomes for young people in the short term. There is very little robust research showing longer term outcomes or benefits of such programmes. This paper describes an innovative protocol to examine the longer term outcomes and experiences of young people referred to a residential life management and treatment programme in Australia designed to address alcohol and drug issues in a holistic manner. Methods and analysis This is a mixed-methods study that will retrospectively and prospectively examine young people's pathways into and out of a residential life management programme. The study involves 3 components: (1) retrospective data linkage of programme data to health and criminal justice administrative data sets, (2) prospective cohort (using existing programme baseline data and a follow-up survey) and (3) qualitative in-depth interviews with a subsample of the prospective cohort. The study will compare findings among young people who are referred and (a) stay 30 days or more in the programme (including those who go on to continuing care and those who do not); (b) start, but stay fewer than 30 days in the programme; (c) are assessed, but do not start the programme. Ethics and dissemination Ethics approval has been sought from several ethics committees including a university ethics committee, state health departments and an Aboriginal-specific ethics committee. The results of the study will be published in peer-reviewed journals, presented at research conferences, disseminated via a report for the general public and through Facebook communications. The study will inform the field more broadly about the value of different methods in evaluating programmes and examining the pathways and trajectories of vulnerable young people. PMID:27225650

  12. Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

    PubMed

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

    2015-10-31

    Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed. ClinicalTrials.gov NCT02345668 . Registered 27 July 2015.

  13. Process evaluation of a primary healthcare validation study of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people: study protocol.

    PubMed

    Farnbach, Sara; Evans, John; Eades, Anne-Marie; Gee, Graham; Fernando, Jamie; Hammond, Belinda; Simms, Matty; DeMasi, Karrina; Hackett, Maree

    2017-11-03

    Process evaluations are conducted alongside research projects to identify the context, impact and consequences of research, determine whether it was conducted per protocol and to understand how, why and for whom an intervention is effective. We present a process evaluation protocol for the Getting it Right research project, which aims to determine validity of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people. In this process evaluation, we aim to: (1) explore the context, impact and consequences of conducting Getting It Right, (2) explore primary healthcare staff and community representatives' experiences with the research project, (3) determine if it was conducted per protocol and (4) explore experiences with the depression screening tool, including perceptions about how it could be implemented into practice (if found to be valid). We also describe the partnerships established to conduct this process evaluation and how the national Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research is met. Realist and grounded theory approaches are used. Qualitative data include semistructured interviews with primary healthcare staff and community representatives involved with Getting it Right. Iterative data collection and analysis will inform a coding framework. Interviews will continue until saturation of themes is reached, or all participants are considered. Data will be triangulated against administrative data and patient feedback. An Aboriginal and Torres Strait Islander Advisory Group guides this research. Researchers will be blinded from validation data outcomes for as long as is feasible. The University of Sydney Human Research Ethics Committee, Aboriginal Health and Medical Research Council of New South Wales and six state ethics committees have approved this research. Findings will be submitted to academic journals and presented at conferences. ACTRN12614000705684. © 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.

  14. Comparison of Gluten Extraction Protocols Assessed by LC-MS/MS Analysis.

    PubMed

    Fallahbaghery, Azadeh; Zou, Wei; Byrne, Keren; Howitt, Crispin A; Colgrave, Michelle L

    2017-04-05

    The efficiency of gluten extraction is of critical importance to the results derived from any analytical method for gluten detection and quantitation, whether it employs reagent-based technology (antibodies) or analytical instrumentation (mass spectrometry). If the target proteins are not efficiently extracted, the end result will be an under-estimation in the gluten content posing a health risk to people affected by conditions such as celiac disease (CD) and nonceliac gluten sensitivity (NCGS). Five different extraction protocols were investigated using LC-MRM-MS for their ability to efficiently and reproducibly extract gluten. The rapid and simple "IPA/DTT" protocol and related "two-step" protocol were enriched for gluten proteins, 55/86% (trypsin/chymotrypsin) and 41/68% of all protein identifications, respectively, with both methods showing high reproducibility (CV < 15%). When using multistep protocols, it was critical to examine all fractions, as coextraction of proteins occurred across fractions, with significant levels of proteins existing in unexpected fractions and not all proteins within a particular gluten class behaving the same.

  15. Effect of aquatic physical therapy on pain perception, functional capacity and quality of life in older people with knee osteoarthritis: study protocol for a randomized controlled trial.

    PubMed

    Alcalde, Guilherme Eleutério; Fonseca, Ana Carolina; Bôscoa, Thais Fernanda; Gonçalves, Mirella Regina; Bernardo, Gabriele Candido; Pianna, Bruna; Carnavale, Bianca Ferdin; Gimenes, Camila; Barrile, Silvia Regina; Arca, Eduardo Aguilar

    2017-07-11

    Aquatic therapy promotes short-term benefits for patients with knee osteoarthritis (OA), and it may be the first therapeutic option for this pathological condition. The objective of this study was to investigate the effects of an aquatic therapy program on pain intensity, functional ability, and quality of life in older people with knee OA. This is a parallel, two-arm, open, randomized controlled clinical trial with older people with knee OA. Volunteers will be allocated to an aquatic intervention group (WG), subjected to the intervention, or to a control group, not be subjected to any kind of intervention. Data collection pre- and postintervention will be composed of the evaluation of the perception of pain by visual analogue scale with application of nociceptive stimuli in four anatomical points of the knee, functional fitness tests, and application of the World Health Organization Quality of Life Scale abbreviated version and Western Ontario and McMaster Universities Osteoarthritis Index. The program will last 12 weeks, consisting of aerobic and functional exercises in the form of circuit training. The objective of this clinical trial is to evaluate the effect of aquatic therapy in elderly patients with knee OA. The study is guided by practice-based scientific evidence for the use of aquatic rehabilitation exercises. It is expected that the WG volunteers will show reduced pain intensity, increased flexibility, and improved functional capacity and quality of life. It is believed that the desired results can be attributed to physical and physiological effects of immersion in warm water associated with the exercise protocol proposed. The data will be published after completion of the study. Brazilian Registry of Clinical Trials (ReBEC) registration number: RBR-78h48d . Registered on 19 August 2015.

  16. A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review.

    PubMed

    Taylor, Johanna; Böhnke, Jan R; Wright, Judy; Kellar, Ian; Alderson, Sarah L; Hughes, Tom; Holt, Richard I G; Siddiqi, Najma

    2017-02-14

    People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed. This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist. The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups. COMET registration: http://www.comet-initiative.org/studies/details/911 . Registered on 1 July 2016.

  17. Development of a physical activity monitoring tool for Thai medical schools: a protocol for a mixed methods study.

    PubMed

    Wattanapisit, Apichai; Vijitpongjinda, Surasak; Saengow, Udomsak; Amaek, Waluka; Thanamee, Sanhapan; Petchuay, Prachyapan

    2017-09-27

    Physical activity (PA) is important in promoting health, as well as in the treatment and prevention of diseases. However, insufficient PA is still a global health problem and it is also a problem in medical schools. PA training in medical curricula is still sparse or non-existent. There is a need for a comprehensive understanding of the extent of PA in medical schools through several indicators, including people, places and policies. This study includes a survey of the PA prevalence in a medical school and development of a tool, the Medical School Physical Activity Report Card (MSPARC), which will contain concise and understandable infographics and information for exploring, monitoring and reporting information relating to PA prevalence. This mixed methods study will run from January to September 2017. We will involve the School of Medicine, Walailak University, Thailand, and its medical students (n=285). Data collection will consist of both primary and secondary data, divided into four parts: general information, people, places and policies. We will investigate the PA metrics about (1) people: the prevalence of PA and sedentary behaviours; (2) place: the quality and accessibility of walkable neighbourhoods, bicycle facilities and recreational areas; and (3) policy: PA promotion programmes for medical students, education metrics and investments related to PA. The MSPARC will be developed using simple symbols, infographics and short texts to evaluate the PA metrics of the medical school. This study has been approved by the Human Research Ethics Committee of Walailak University (protocol number: WUEC-16-005-01). Findings will be published in peer-reviewed journals and presented at national or international conferences. The MSPARC and full report will be disseminated to relevant stakeholders, policymakers, staff and clients. © 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.

  18. Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol.

    PubMed

    Maidment, David W; Barker, Alex B; Xia, Jun; Ferguson, Melanie A

    2016-10-27

    Hearing loss is a major public health concern, affecting over 11 million people in the UK. While hearing aids are the most common clinical intervention for hearing loss, the majority of people that would benefit from using hearing aids do not take them up. Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids. These include hearing aids that can be customised using a smartphone, smartphone-based 'hearing aid' apps, personal sound amplification products and wireless hearing products. However, no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss. The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic reviews and Meta-analyses Protocols (PRISMA-P) 2015 checklist. Retrospective or prospective studies, randomised controlled trials, non-randomised controlled trials, and before-after comparison studies will be eligible for inclusion. We will include studies with adult participants (≥18 years) with a mild or moderate hearing loss. The intervention should be an alternative listening device to a conventional hearing aid (comparison). Studies will be restricted to outcomes associated with the consequences of hearing loss. We will search relevant databases to identify published, completed but unpublished and ongoing trials. The overall quality of included evidence will be evaluated using the GRADE system, and meta-analysis performed if appropriate. No ethical issues are foreseen. The findings will be reported at national and international conferences, primarily audiology, and ear, nose and throat, and in a peer-reviewed journal using the PRISMA guidelines. PROSPERO CRD4201502958. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  19. Ethical issues faced by field primatologists: asking the relevant questions.

    PubMed

    Fedigan, Linda Marie

    2010-09-01

    Field primatologists face unusual ethical issues. We study animals rather than people and receive research approval from animal care rather than ethics committees. However, animal care evaluation forms are developed from concerns about laboratory animal research and are based on the "Three R's" for humane treatment of captive experimental subjects (replacement, reduction and refinement), which are only debatably relevant to field research. Scientists who study wild, free-ranging primates in host countries experience many ethical dilemmas seldom dealt with in animal care forms. This paper reviews the ethical issues many field primatologists say they face and how these might be better addressed by animal care forms. The ethical issues arising for field researchers are divided into three categories: "Presence, Protocols and People" and for each the most frequent issues are described. The most commonly mentioned ethical concern arising from our presence in the field is the possibility of disease transmission. Although most primate field studies employ only observational protocols, the practice of habituating our study animals to close human presence is an ethical concern for many since it can lessen the animals' fear of all humans, thereby facilitating undesirable behaviors (e.g., crop-raiding) and rendering them vulnerable to harm. Field primatologists who work in host countries must observe national laws and local traditions. As conservationists, primatologists must often negotiate between the resource needs and cultural practices of local people and the interests of the nonhuman primates. Many say they face more ethical dilemmas arising from human interactions than from research on the animals per se. This review concludes with suggestions for relevant questions to ask on animal care forms, and actions that field primatologists can take to better inform animal care committees about the common ethical issues we experience as well as how to develop guidelines for addressing them. (c) 2010 Wiley-Liss, Inc.

  20. Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol

    PubMed Central

    Barker, Alex B; Xia, Jun

    2016-01-01

    Introduction Hearing loss is a major public health concern, affecting over 11 million people in the UK. While hearing aids are the most common clinical intervention for hearing loss, the majority of people that would benefit from using hearing aids do not take them up. Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids. These include hearing aids that can be customised using a smartphone, smartphone-based ‘hearing aid’ apps, personal sound amplification products and wireless hearing products. However, no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss. Methods and analysis The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic reviews and Meta-analyses Protocols (PRISMA-P) 2015 checklist. Retrospective or prospective studies, randomised controlled trials, non-randomised controlled trials, and before-after comparison studies will be eligible for inclusion. We will include studies with adult participants (≥18 years) with a mild or moderate hearing loss. The intervention should be an alternative listening device to a conventional hearing aid (comparison). Studies will be restricted to outcomes associated with the consequences of hearing loss. We will search relevant databases to identify published, completed but unpublished and ongoing trials. The overall quality of included evidence will be evaluated using the GRADE system, and meta-analysis performed if appropriate. Ethics and dissemination No ethical issues are foreseen. The findings will be reported at national and international conferences, primarily audiology, and ear, nose and throat, and in a peer-reviewed journal using the PRISMA guidelines. Review registration number PROSPERO CRD4201502958. PMID:27789514

  1. Understanding influences on the uptake of pulmonary rehabilitation in the East of England: an Inclusive Design/mixed-methods study protocol

    PubMed Central

    Dickerson, Terry; Early, Frances; Fuld, Jonathan; Clarkson, P John

    2018-01-01

    Introduction 1.2 million people in the UK have chronic obstructive pulmonary disease (COPD) that causes breathlessness, difficulty with daily activities, infections and hospitalisation. Pulmonary rehabilitation (PR), a programme of supervised exercise and education, is recommended for patients with COPD. However, only 1 in 10 of those who need it receive PR. Also, the UK National COPD Audit Programme concluded that the COPD treatment might not be accessible to people with disabilities. This paper applies an Inclusive Design approach to community-based PR service provisions. It aims to inform improvements to the PR service by identifying barriers to the uptake of PR in the COPD care journey in relation to patients’ capabilities that can affect their access to PR. Methods and analysis The protocol includes four steps. Step 1 will involve interviews with healthcare professionals and patients to gather insight into their experiences and produce a hierarchical task analysis of the COPD care journeys. Step 2 will estimate the service exclusion: the demand of every task on patients’ capabilities will be rated by predefined scales, and the proportion of the population excluded from the service will be estimated by an exclusion calculator. Step 3 will identify the challenges of the PR service; a framework analysis will guide the data analysis of the interviews and care journey. Step 4 will propose recommendations to help patients manage their COPD care informed by the challenges identified in step 3 and refine recommendations through interviews and focus groups. Ethics and dissemination The Cambridge Central Research Ethics Committee gave the study protocol a positive ethical opinion (17/EE/0136). Study results will be disseminated through peer-reviewed journals, conferences and the British Lung Foundation networks. They will also be fed into a Research for Patient Benefit project on increasing the referral and uptake of PR. PMID:29691248

  2. Health Information National Trends Survey in American Sign Language (HINTS-ASL): Protocol for the Cultural Adaptation and Linguistic Validation of a National Survey.

    PubMed

    Kushalnagar, Poorna; Harris, Raychelle; Paludneviciene, Raylene; Hoglind, TraciAnn

    2017-09-13

    The Health Information National Trends Survey (HINTS) collects nationally representative data about the American's public use of health-related information. This survey is available in English and Spanish, but not in American Sign Language (ASL). Thus, the exclusion of ASL users from these national health information survey studies has led to a significant gap in knowledge of Internet usage for health information access in this underserved and understudied population. The objectives of this study are (1) to culturally adapt and linguistically translate the HINTS items to ASL (HINTS-ASL); and (2) to gather information about deaf people's health information seeking behaviors across technology-mediated platforms. We modified the standard procedures developed at the US National Center for Health Statistics Cognitive Survey Laboratory to culturally adapt and translate HINTS items to ASL. Cognitive interviews were conducted to assess clarity and delivery of these HINTS-ASL items. Final ASL video items were uploaded to a protected online survey website. The HINTS-ASL online survey has been administered to over 1350 deaf adults (ages 18 to 90 and up) who use ASL. Data collection is ongoing and includes deaf adult signers across the United States. Some items from HINTS item bank required cultural adaptation for use with deaf people who use accessible services or technology. A separate item bank for deaf-related experiences was created, reflecting deaf-specific technology such as sharing health-related ASL videos through social network sites and using video remote interpreting services in health settings. After data collection is complete, we will conduct a series of analyses on deaf people's health information seeking behaviors across technology-mediated platforms. HINTS-ASL is an accessible health information national trends survey, which includes a culturally appropriate set of items that are relevant to the experiences of deaf people who use ASL. The final HINTS-ASL product will be available for public use upon completion of this study. ©Poorna Kushalnagar. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.09.2017.

  3. Outcome for children and young people with Early T-cell precursor acute lymphoblastic leukaemia treated on a contemporary protocol, UKALL 2003.

    PubMed

    Patrick, Katharine; Wade, Rachel; Goulden, Nick; Mitchell, Chris; Moorman, Anthony V; Rowntree, Clare; Jenkinson, Sarah; Hough, Rachael; Vora, Ajay

    2014-08-01

    We investigated the outcome for children and young people with Early T-precursor acute lymphoblastic leukaemia (ETP-ALL), a recently described poor prognosis sub-group of T-ALL, treated on a contemporary protocol, UKALL 2003. After a median follow-up of 4 years and 10 months, the ETP sub-group, representing 16% of T-ALL patients, had non-significantly inferior 5-year event-free survival (76·7% vs. 84·6%, P = 0·2) and overall survival (82·4% vs. 90·9%, P = 0·1), and a higher relapse rate (18·6% vs. 9·6%, P = 0·1) compared to typical T-ALL. ETP-ALL has an intermediate risk outcome, which does not warrant experimental treatment or first remission allogeneic transplant for the group universally. © 2014 John Wiley & Sons Ltd.

  4. Demonstrating Patterns in the Views Of Stakeholders Regarding Ethically-Salient Issues in Clinical Research: A Novel Use of Graphical Models in Empirical Ethics Inquiry.

    PubMed

    Kim, Jane Paik; Roberts, Laura Weiss

    Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research. In this IRB-approved, NIH-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and post-traumatic stress disorder) and non-illness related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions. Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically-salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected. Between ill and healthy protocol participants, the pattern of views is vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical model selection has the potential to bring new insights to the field of ethics.

  5. Health care access for rural youth on equal terms? A mixed methods study protocol in northern Sweden.

    PubMed

    Goicolea, Isabel; Carson, Dean; San Sebastian, Miguel; Christianson, Monica; Wiklund, Maria; Hurtig, Anna-Karin

    2018-01-11

    The purpose of this paper is to propose a protocol for researching the impact of rural youth health service strategies on health care access. There has been no published comprehensive assessment of the effectiveness of youth health strategies in rural areas, and there is no clearly articulated model of how such assessments might be conducted. The protocol described here aims to gather information to; i) Assess rural youth access to health care according to their needs, ii) Identify and understand the strategies developed in rural areas to promote youth access to health care, and iii) Propose actions for further improvement. The protocol is described with particular reference to research being undertaken in the four northernmost counties of Sweden, which contain a widely dispersed and diverse youth population. The protocol proposes qualitative and quantitative methodologies sequentially in four phases. First, to map youth access to health care according to their health care needs, including assessing horizontal equity (equal use of health care for equivalent health needs,) and vertical equity (people with greater health needs should receive more health care than those with lesser needs). Second, a multiple case study design investigates strategies developed across the region (youth clinics, internet applications, public health programs) to improve youth access to health care. Third, qualitative comparative analysis of the 24 rural municipalities in the region identifies the best combination of conditions leading to high youth access to health care. Fourth, a concept mapping study involving rural stakeholders, care providers and youth provides recommended actions to improve rural youth access to health care. The implementation of this research protocol will contribute to 1) generating knowledge that could contribute to strengthening rural youth access to health care, as well as to 2) advancing the application of mixed methods to explore access to health care.

  6. Contextual information management: An example of independent-checking in the review of laboratory-based bloodstain pattern analysis.

    PubMed

    Osborne, Nikola K P; Taylor, Michael C

    2018-05-01

    This article describes a New Zealand forensic agency's contextual information management protocol for bloodstain pattern evidence examined in the laboratory. In an effort to create a protocol that would have minimal impact on current work-flow, while still effectively removing task-irrelevant contextual information, the protocol was designed following an in-depth consultation with management and forensic staff. The resulting design was for a protocol of independent-checking (i.e. blind peer-review) where the checker's interpretation of the evidence is conducted in the absence of case information and the original examiner's notes or interpretation(s). At the conclusion of a ten-case trial period, there was widespread agreement that the protocol had minimal impact on the number of people required, the cost, or the time to complete an item examination. The agency is now looking to adopt the protocol into standard operating procedures and in some cases the protocol has been extended to cover other laboratory-based examinations (e.g. fabric damage, shoeprint examination, and physical fits). The protocol developed during this trial provides a useful example for agencies seeking to adopt contextual information management into their workflow. Copyright © 2018 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

  7. End user and implementer experiences of mHealth technologies for noncommunicable chronic disease management in young adults: a qualitative systematic review protocol.

    PubMed

    Slater, Helen; Briggs, Andrew; Stinson, Jennifer; Campbell, Jared M

    2017-08-01

    The objective of this review is to systematically identify, review and synthesize relevant qualitative research on end user and implementer experiences of mobile health (mHealth) technologies developed for noncommunicable chronic disease management in young adults. "End users" are defined as young people aged 15-24 years, and "implementers" are defined as health service providers, clinicians, policy makers and administrators.The two key questions we wish to systematically explore from identified relevant qualitative studies or studies with qualitative components are.

  8. Sugar-sweetened beverage consumption, correlates and interventions among Australian Aboriginal and Torres Strait Islander communities: a scoping review protocol

    PubMed Central

    Avery, Jodie C; Bowden, Jacqueline A; Dono, Joanne; Gibson, Odette R; Brownbill, Aimee; Keech, Wendy; Miller, Caroline L

    2017-01-01

    Introduction Aboriginal and Torres Strait Islander communities of Australia experience poorer health outcomes in the areas of overweight and obesity, diabetes and cardiovascular disease. Contributing to this burden of disease in the Australian community generally and in Aboriginal and Torres Strait Islander communities, is the consumption of sugar-sweetened beverages (SSBs). We have described a protocol for a review to systematically scope articles that document use of SSBs and interventions to reduce their consumption with Aboriginal and Torres Strait Islander people. These results will inform future work that investigates interventions aimed at reducing harm associated with SSB consumption. Methods and analysis This scoping review draws on a methodology that uses a six-step approach to search databases including PubMed, SCOPUS, CINAHL, Informit (including Informit: Indigenous Peoples), Joanna Briggs Institute EBP Database and Mura, between January 1980 and February 2017. Two reviewers will be engaged to search for and screen studies independently, using formulated selection criteria, for inclusion in our review. We will include primary research studies, systematic reviews including meta-analysis or meta-synthesis, reports and unpublished grey literature. Results will be entered into a table identifying study details and characteristics, summarised using a Preferred Reporting Items for Systematic Reviews and Meta-Analysis chart and then critically analysed. Ethics and dissemination This review will not require ethics committee review. Results will be disseminated at appropriate scientific meetings, as well as through the Aboriginal and Torres Strait Islander community. PMID:28760797

  9. Can Healthcare Assistant Training (CHAT) improve the relational care of older people? Study protocol for a pilot cluster randomised controlled trial.

    PubMed

    Arthur, Antony; Maben, Jill; Wharrad, Heather; Aldus, Clare; Sarre, Sophie; Schneider, Justine; Nicholson, Caroline; Barton, Garry; Cox, Karen; Clark, Allan

    2015-12-09

    People aged 75 years and over account for 1 in 4 of all hospital admissions. There has been increasing recognition of problems in the care of older people, particularly in hospitals. Evidence suggests that older people judge the care they receive in terms of kindness, empathy, compassion, respectful communication and being seen as a person not just a patient. These are aspects of care to which we refer when we use the term 'relational care'. Healthcare assistants deliver an increasing proportion of direct care to older people, yet their training needs are often overlooked. This study will determine the acceptability and feasibility of a cluster randomised controlled trial of 'Older People's Shoes' a 2-day training intervention for healthcare assistants caring for older people in hospital. Within this pilot, 2-arm, parallel, cluster randomised controlled trial, healthcare assistants within acute hospital wards are randomised to either the 2-day training intervention or training as usual. Registered nurses deliver 'Older People's Shoes' over 2 days, approximately 1 week apart. It contains three components: experiential learning about ageing, exploration of older people's stories, and customer care. Outcomes will be measured at the level of patient (experience of emotional care and quality of life during their hospital stay), healthcare assistant (empathy and attitudes towards older people), and ward (quality of staff/patient interaction). Semi-structured interviews of a purposive sample of healthcare assistants receiving the intervention, and all trainers delivering the intervention, will be undertaken to gain insights into the experiences of both the intervention and the trial, and its perceived impact on practice. Few training interventions for care staff have been rigorously tested using randomised designs. This study will establish the viability of a definitive cluster randomised controlled trial of a new training intervention to improve the relational care proided by healthcare assistants working with older people in hospital. The study was registered as an International Standard Randomised Controlled Trial ( ISRCTN10385799 ) on 29 December 2014.

  10. Testing the effectivity of the mixed virtual reality training Into D'mentia for informal caregivers of people with dementia: protocol for a longitudinal, quasi-experimental study.

    PubMed

    Jütten, Linda Helena; Mark, Ruth Elaine; Maria Janssen, Ben Wilhelmus Jacobus; Rietsema, Jan; Dröes, Rose-Marie; Sitskoorn, Margriet Maria

    2017-08-21

    Informal caregivers for people with dementia (hereafter: caregivers) often feel (over)burdened by the care for a loved one with dementia, and this can have various deleterious effects on both caregivers and patients. Support for caregivers is urgently needed, and for this reason, a dementia simulator (Into D'mentia) was developed in which caregivers experience what it is like to have dementia. The simulator attempts to heighten caregivers' empathy and understanding for the patient and, in turn, diminish their own caregiver burden. The current study evaluates whether the simulator is effective on a number of outcomes. A longitudinal, quasi-experimental study is ongoing in the Netherlands. We aim to recruit 142 caregivers in total divided over two groups: 71 caregivers in the intervention group and 71 caregivers in the control group. All participants will complete interviews and questionnaires at four time points: at baseline, 1 week, 2.5 months and 15 months after the training. The primary outcomes include empathy, caregiver burden, caregiver's sense of competence, social reliance, anxiety, depression and caregivers' subjective and objective health. This study is being carried out in agreement with the Declaration of Helsinki, and the protocol has been approved by the local ethics committees. This study is registered with The Netherlands National Trial Register (NNTR5856). © 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.

  11. 1-RAAP: An Efficient 1-Round Anonymous Authentication Protocol for Wireless Body Area Networks

    PubMed Central

    Liu, Jingwei; Zhang, Lihuan; Sun, Rong

    2016-01-01

    Thanks to the rapid technological convergence of wireless communications, medical sensors and cloud computing, Wireless Body Area Networks (WBANs) have emerged as a novel networking paradigm enabling ubiquitous Internet services, allowing people to receive medical care, monitor health status in real-time, analyze sports data and even enjoy online entertainment remotely. However, because of the mobility and openness of wireless communications, WBANs are inevitably exposed to a large set of potential attacks, significantly undermining their utility and impeding their widespread deployment. To prevent attackers from threatening legitimate WBAN users or abusing WBAN services, an efficient and secure authentication protocol termed 1-Round Anonymous Authentication Protocol (1-RAAP) is proposed in this paper. In particular, 1-RAAP preserves anonymity, mutual authentication, non-repudiation and some other desirable security properties, while only requiring users to perform several low cost computational operations. More importantly, 1-RAAP is provably secure thanks to its design basis, which is resistant to the anonymous in the random oracle model. To validate the computational efficiency of 1-RAAP, a set of comprehensive comparative studies between 1-RAAP and other authentication protocols is conducted, and the results clearly show that 1-RAAP achieves the best performance in terms of computational overhead. PMID:27213384

  12. 1-RAAP: An Efficient 1-Round Anonymous Authentication Protocol for Wireless Body Area Networks.

    PubMed

    Liu, Jingwei; Zhang, Lihuan; Sun, Rong

    2016-05-19

    Thanks to the rapid technological convergence of wireless communications, medical sensors and cloud computing, Wireless Body Area Networks (WBANs) have emerged as a novel networking paradigm enabling ubiquitous Internet services, allowing people to receive medical care, monitor health status in real-time, analyze sports data and even enjoy online entertainment remotely. However, because of the mobility and openness of wireless communications, WBANs are inevitably exposed to a large set of potential attacks, significantly undermining their utility and impeding their widespread deployment. To prevent attackers from threatening legitimate WBAN users or abusing WBAN services, an efficient and secure authentication protocol termed 1-Round Anonymous Authentication Protocol (1-RAAP) is proposed in this paper. In particular, 1-RAAP preserves anonymity, mutual authentication, non-repudiation and some other desirable security properties, while only requiring users to perform several low cost computational operations. More importantly, 1-RAAP is provably secure thanks to its design basis, which is resistant to the anonymous in the random oracle model. To validate the computational efficiency of 1-RAAP, a set of comprehensive comparative studies between 1-RAAP and other authentication protocols is conducted, and the results clearly show that 1-RAAP achieves the best performance in terms of computational overhead.

  13. Does assistive technology contribute to social inclusion for people with intellectual disability? A systematic review protocol.

    PubMed

    Owuor, John; Larkan, Fiona; Kayabu, Bonnix; Fitzgerald, Geraldine; Sheaf, Greg; Dinsmore, John; McConkey, Roy; Clarke, Mike; MacLachlan, Malcolm

    2018-02-10

    The aim of this review is to answer the following question: Does assistive technology contribute to social inclusion for people with intellectual disability? Previous research on assistive technology has focused on socioeconomic impacts such as education, employment and access to healthcare by people with intellectual disability. There is a need to consolidate evidence on the interaction between intellectual disability, assistive technology, community living and social inclusion. The review will consider studies from all settings: geographical, socioeconomic and care (institutional and community care), published in English. Studies reported in other languages with abstracts in English will be included if they can be translated using Google Translate, otherwise such studies will be included in the appendix. The review will include both qualitative and quantitative studies. The intervention in this review refers to the use of assistive technology to promote community participation or interpersonal relationships (social inclusion) for people with intellectual disability. The outcomes will be behavioural and social benefits of using assistive technology by people with intellectual disability. Enhanced interpersonal relationships and community participation by people with intellectual disability. Data analysis will be in two phases. The first phase will involve analysis of individual study designs separately. The second phase will be narrative/thematic synthesis of all study groups. The review will not create any ethical or safety concerns. At least one peer-reviewed article in a leading journal such as the BMJ is planned. The findings will also be disseminated through a seminar session involving internal audience at Trinity College Dublin and within the Assistive Technologies for people with Intellectual Disability and Autism research programme. CRD42017065447; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  14. Prophylactic plasma transfusion for patients undergoing non-cardiac surgery

    PubMed Central

    Huber, Jonathan; Stanworth, Simon J; Doree, Carolyn; Trivella, Marialena; Brunskill, Susan J; Hopewell, Sally; Wilkinson, Kirstin L; Estcourt, Lise J

    2017-01-01

    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the clinical effectiveness and safety of prophylactic plasma transfusion for people with confirmed or presumed coagulopathy requiring non-cardiac surgery. PMID:29151811

  15. Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. Design The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. Discussion The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. Trial registration Current controlled trials ISRCTN62237498 Date registered: 5 September 2013 PMID:25016303

  16. The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. Methods/Design The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. Discussion The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. Trial registration Trial registration reference: ISRCTN45433299 PMID:23356861

  17. Interdisciplinary Approach to the Development of Accessible Computer-Administered Measurement Instruments.

    PubMed

    Magasi, Susan; Harniss, Mark; Heinemann, Allen W

    2018-01-01

    Principles of fairness in testing require that all test takers, including people with disabilities, have an equal opportunity to demonstrate their capacity on the construct being measured. Measurement design features and assessment protocols can pose barriers for people with disabilities. Fairness in testing is a fundamental validity issue at all phases in the design, administration, and interpretation of measurement instruments in clinical practice and research. There is limited guidance for instrument developers on how to develop and evaluate the accessibility and usability of measurement instruments. This article describes a 6-stage iterative process for developing accessible computer-administered measurement instruments grounded in the procedures implemented across several major measurement initiatives. A key component of this process is interdisciplinary teams of accessibility experts, content and measurement experts, information technology experts, and people with disabilities working together to ensure that measurement instruments are accessible and usable by a wide range of users. The development of accessible measurement instruments is not only an ethical requirement, it also ensures better science by minimizing measurement bias, missing data, and attrition due to mismatches between the target population and test administration platform and protocols. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  18. Prevalence of refractive error, presbyopia, and unmet need of spectacle coverage in a northern district of Bangladesh: Rapid Assessment of Refractive Error study.

    PubMed

    Muhit, Mohammad; Minto, Hasan; Parvin, Afroza; Jadoon, Mohammad Z; Islam, Johurul; Yasmin, Sumrana; Khandaker, Gulam

    2018-04-01

    To determine the prevalence of refractive error (RE), presbyopia, spectacle coverage, and barriers to uptake optical services in Bangladesh. Rapid assessment of refractive error (RARE) study following the RARE protocol was conducted in a northern district (i.e., Sirajganj) of Bangladesh (January 2010-December 2012). People aged 15-49 years were selected, and eligible participants had habitual distance and near visual acuity (VA) measured and ocular examinations were performed in those with VA<6/18. Those with phakic eyes with VA <6/18, but improving to ≥6/18 with pinhole or optical correction, were considered as RE and people aged ≥35 years with binocular unaided near vision of

  19. A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project.

    PubMed

    Herrman, Helen; Humphreys, Cathy; Halperin, Stephen; Monson, Katherine; Harvey, Carol; Mihalopoulos, Cathrine; Cotton, Susan; Mitchell, Penelope; Glynn, Tony; Magnus, Anne; Murray, Lenice; Szwarc, Josef; Davis, Elise; Havighurst, Sophie; McGorry, Patrick; Tyano, Sam; Kaplan, Ida; Rice, Simon; Moeller-Saxone, Kristen

    2016-12-07

    Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required. This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC. The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts: 1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention. Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers. Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system. Australian New Zealand Clinical Trials Registry ACTRN12615000501549 . Retrospectively registered 19 May 2015.

  20. TeleHealth networks: Instant messaging and point-to-point communication over the internet

    NASA Astrophysics Data System (ADS)

    Sachpazidis, Ilias; Ohl, Roland; Kontaxakis, George; Sakas, Georgios

    2006-12-01

    This paper explores the advantages and disadvantages of a medical network based on point-to-point communication and a medical network based on Jabber instant messaging protocol. Instant messaging might be, for many people, a convenient way of chatting over the Internet. We will attempt to illustrate how an instant messaging protocol could serve in the best way medical services and provide great flexibility to the involved parts. Additionally, the directory services and presence status offered by the Jabber protocol make it very attractive to medical applications that need to have real time and store and forward communication. Furthermore, doctors connected to Internet via high-speed networks could benefit by saving time due to the data transmission acceleration over Jabber.

  1. Feasibility of High-Repetition, Task-Specific Training for Individuals With Upper-Extremity Paresis

    PubMed Central

    Waddell, Kimberly J.; Birkenmeier, Rebecca L.; Moore, Jennifer L.; Hornby, T. George

    2014-01-01

    OBJECTIVE. We investigated the feasibility of delivering an individualized, progressive, high-repetition upper-extremity (UE) task-specific training protocol for people with stroke in the inpatient rehabilitation setting. METHOD. Fifteen patients with UE paresis participated in this study. Task-specific UE training was scheduled for 60 min/day, 4 days/wk, during occupational therapy for the duration of a participant’s inpatient stay. During each session, participants were challenged to complete ≥300 repetitions of various tasks. RESULTS. Participants averaged 289 repetitions/session, spending 47 of 60 min in active training. Participants improved on impairment and activity level outcome measures. CONCLUSION. People with stroke in an inpatient setting can achieve hundreds of repetitions of task-specific training in 1-hr sessions. As expected, all participants improved on functional outcome measures. Future studies are needed to determine whether this high-repetition training program results in better outcomes than current UE interventions. PMID:25005508

  2. Qualitative studies using in-depth interviews with older people from multiple language groups: methodological systematic review.

    PubMed

    Fryer, Caroline; Mackintosh, Shylie; Stanley, Mandy; Crichton, Jonathan

    2012-01-01

    This paper is a report of a methodological review of language appropriate practice in qualitative research, when language groups were not determined prior to participant recruitment. When older people from multiple language groups participate in research using in-depth interviews, additional challenges are posed for the trustworthiness of findings. This raises the question of how such challenges are addressed. The Cumulative Index to Nursing and Allied Health Literature, Scopus, Embase, Web of Science, Ageline, PsycINFO, Sociological abstracts, Google Scholar and Allied and Complementary Medicine databases were systematically searched for the period 1840 to September 2009. The combined search terms of 'ethnic', 'cultural', 'aged', 'health' and 'qualitative' were used. In this methodological review, studies were independently appraised by two authors using a quality appraisal tool developed for the review, based on a protocol from the McMaster University Occupational Therapy Evidence-Based Practice Research Group. Nine studies were included. Consideration of language diversity within research process was poor for all studies. The role of language assistants was largely absent from study methods. Only one study reported using participants' preferred languages for informed consent. More examples are needed of how to conduct rigorous in-depth interviews with older people from multiple language groups, when languages are not determined before recruitment. This will require both researchers and funding bodies to recognize the importance to contemporary healthcare of including linguistically diverse people in participant samples. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  3. The Use of Music Playlists for People with Dementia: A Critical Synthesis.

    PubMed

    Garrido, Sandra; Dunne, Laura; Chang, Esther; Perz, Janette; Stevens, Catherine J; Haertsch, Maggie

    2017-01-01

    The use of pre-recorded music to ease behavioral and psychological symptoms associated with dementia is popular in health-care contexts in both formal music therapy settings and in non-therapist led interventions. However, further understanding of how non-therapist led interventions compare to therapist led interventions is needed. This paper reviews 28 studies that used pre-recorded music with people with dementia using a critical interpretive synthesis model. Results revealed that pre-recorded music can be effective in reducing a variety of affective and behavioral symptoms, in particular agitation, even where a trained music therapist is not present. However, the results are not universally positive, suggesting the need for further clarification of protocols for music use and closer investigation of variables that influence individual responseto music.

  4. The Use of Music Playlists for People with Dementia: A Critical Synthesis

    PubMed Central

    Garrido, Sandra; Dunne, Laura; Chang, Esther; Perz, Janette; Stevens, Catherine J.; Haertsch, Maggie

    2017-01-01

    The use of pre-recorded music to ease behavioral and psychological symptoms associated with dementia is popular in health-care contexts in both formal music therapy settings and in non-therapist led interventions. However, further understanding of how non-therapist led interventions compare to therapist led interventions is needed. This paper reviews 28 studies that used pre-recorded music with people with dementia using a critical interpretive synthesis model. Results revealed that pre-recorded music can be effective in reducing a variety of affective and behavioral symptoms, in particular agitation, even where a trained music therapist is not present. However, the results are not universally positive, suggesting the need for further clarification of protocols for music use and closer investigation of variables that influence individual responseto music. PMID:28984606

  5. A cross-sectional study on person-centred communication in the care of older people: the COMHOME study protocol

    PubMed Central

    Hafskjold, Linda; Sundler, Annelie J; Holmström, Inger K; Sundling, Vibeke; van Dulmen, Sandra

    2015-01-01

    Introduction This paper presents an international cross-sectional study on person-centred communication with older people receiving healthcare (COMHOME). Person-centred care relies on effective communication, but few studies have explored this with a specific focus on older people. The main aim of the COMHOME study is to generate knowledge on person-centred communication with older people (>65 years) in home healthcare services, radiographic and optometric practice. Methods and analysis This study will explore the communication between care providers and older persons in home care services. Home healthcare visits will be audiorecorded (n=500) in Norway, the Netherlands and Sweden. Analyses will be performed with the Verona Coding Definitions for Emotional Sequences (VR-CoDES), the Roter Interaction Analysis System (RIAS) and qualitative methods. The content of the communication, communicative challenging situations as well as empathy, power distance, decision-making, preservation of dignity and respect will be explored. In Norway, an additional 100 encounters, 50 in optometric practice (video recorded) and 50 in radiographic practice (audiorecorded), will be analysed. Furthermore, healthcare providers’ self-reported communication skills, empathy, mindfulness and emotional intelligence in relation to observed person-centred communication skills will be assessed using well-established standardised instruments. Ethics and dissemination Depending on national legislation, approval of either the central ethical committees (eg, nation or university), the national data protection officials or the local ethical committees (eg, units of home healthcare) was obtained. Study findings will be disseminated widely through peer-reviewed publications and conference presentations. The research findings will add knowledge to improve services provided to this vulnerable group of patients. Additionally, the findings will underpin a training programme for healthcare students and care providers focusing on communication with older people. PMID:25877282

  6. Telecare and Social Link Solution for Ambient Assisted Living Using a Robot Companion with Visiophony

    NASA Astrophysics Data System (ADS)

    Varène, Thibaut; Hillereau, Paul; Simonnet, Thierry

    An increasing number of people are in need of help at home (elderly, isolated and/or disabled persons; people with mild cognitive impairment). Several solutions can be considered to maintain a social link while providing tele-care to these people. Many proposals suggest the use of a robot acting as a companion. In this paper we will look at an environment constrained solution, its drawbacks (such as latency) and its advantages (flexibility, integration…). A key design choice is to control the robot using a unified Voice over Internet Protocol (VoIP) solution, while addressing bandwidth limitations, providing good communication quality and reducing transmission latency

  7. Development of imaging techniques to study the pathogenesis of biosafety level 2/3 infectious agents.

    PubMed

    Rella, Courtney E; Ruel, Nancy; Eugenin, Eliseo A

    2014-12-01

    Despite significant advances in microbiology and molecular biology over the last decades, several infectious diseases remain global concerns, resulting in the death of millions of people worldwide each year. According to the Center for Disease Control (CDC) in 2012, there were 34 million people infected with HIV, 8.7 million new cases of tuberculosis, 500 million cases of hepatitis, and 50-100 million people infected with dengue. Several of these pathogens, despite high incidence, do not have reliable clinical detection methods. New or improved protocols have been generated to enhance detection and quantitation of several pathogens using high-end microscopy (light, confocal, and STORM microscopy) and imaging software. In the current manuscript, we discuss these approaches and the theories behind these methodologies. Thus, advances in imaging techniques will open new possibilities to discover therapeutic interventions to reduce or eliminate the devastating consequences of infectious diseases. © 2014 Federation of European Microbiological Societies. Published by John Wiley & Sons Ltd. All rights reserved.

  8. Addressing everyday challenges: feasibility of a family caregiver training program for people with dementia.

    PubMed

    DiZazzo-Miller, Rosanne; Samuel, Preethy S; Barnas, Jean M; Welker, Keith M

    2014-01-01

    OBJECTIVE. The purpose of this study was to examine the feasibility and efficacy of the Family Caregiver Training Program for assisting with the basic activities of daily living of people with dementia. METHOD. A one-group pretest-posttest research design with a 3-mo follow-up was used to examine the efficacy of a manualized education program for caregivers. The 6-hr training was delivered to 72 family caregivers over 3 consecutive weeks (2 hr/wk) by trained clinicians. RESULTS. Caregivers showed a significant gain in knowledge of how to effectively assist with communication and nutrition, t(52) = 7.05, p < .000; transfers and toileting, t(45) = 3.10, p < .003; and bathing and dressing, t(44) = 2.71, p < .01, of their care recipients. CONCLUSION. Our findings demonstrate that this manualized intervention protocol is a promising method of equipping family members with the skills needed to face their everyday challenges in caring for people with dementia. Copyright © 2014 by the American Occupational Therapy Association, Inc.

  9. Queensland Alcohol-related violence and Night Time Economy Monitoring project (QUANTEM): a study protocol.

    PubMed

    Miller, Peter G; Ferris, Jason; Coomber, Kerri; Zahnow, Renee; Carah, Nicholas; Jiang, Heng; Kypri, Kypros; Chikritzhs, Tanya; Clough, Alan; Livingston, Michael; de Andrade, Dominique; Room, Robin; Callinan, Sarah; Curtis, Ashlee; Mayshak, Richelle; Droste, Nicolas; Lloyd, Belinda; Matthews, Sharon; Taylor, Nicholas; Crane, Meredythe; Thorn, Michael; Najman, Jake

    2017-10-05

    Alcohol-related harm is a substantial burden on the community in Australia and internationally, particularly harm related to risky drinking practices of young people in the night-time economy. This protocol paper describes a study that will report on the changes in a wide range of health and justice outcome measures associated with major policy changes in the state of Queensland, Australia. A key element includes trading hours restrictions for licensed premises to 2 am for the state and 3 am in Safe Night Precincts (SNPs). Other measures introduced include drinks restrictions after midnight, increased patron banning measures for repeat offenders, mandatory ID scanning of patrons in late-night venues, and education campaigns. The primary aim of the study is to evaluate change in the levels of harm due to these policy changes using administrative data (e.g., police, hospital, ambulance, and court data). Other study elements will investigate the impact of the Policy by measuring foot traffic volume in SNPs, using ID scanner data to quantify the volume of people entering venues and measure the effectiveness of banning notices, using patron interviews to quantify the levels of pre-drinking, intoxication and illicit drug use within night-time economy districts, and to explore the impacts of the Policy on business and live music, and costs to the community. The information gathered through this project aims to evaluate the effectiveness of the Policy and to draw on these findings to inform future prevention and enforcement approaches by policy makers, police, and venue staff.

  10. Protocol for a feasibility study of a self-help cognitive behavioural therapy resource for the reduction of dental anxiety in young people.

    PubMed

    Marshman, Zoe; Morgan, Annie; Porritt, Jenny; Gupta, Ekta; Baker, Sarah; Creswell, Cathy; Newton, Tim; Stevens, Katherine; Williams, Christopher; Prasad, Suneeta; Kirby, Jennifer; Rodd, Helen

    2016-01-01

    Childhood dental anxiety is very common, with 10-20 % of children and young people reporting high levels of dental anxiety. It is distressing and has a negative impact on the quality of life of young people and their parents as well as being associated with poor oral health. Affected individuals may develop a lifelong reliance on general anaesthetic or sedation for necessary dental treatment thus requiring the support of specialist dental services. Children and young people with dental anxiety therefore require additional clinical time and can be costly to treat in the long term. The reduction of dental anxiety through the use of effective psychological techniques is, therefore, of high importance. However, there is a lack of high-quality research investigating the impact of cognitive behavioural therapy (CBT) approaches when applied to young people's dental anxiety. The first part of the study will develop a profile of dentally anxious young people using a prospective questionnaire sent to a consecutive sample of 100 young people referred to the Paediatric Dentistry Department, Charles Clifford Dental Hospital, in Sheffield. The second part will involve interviewing a purposive sample of 15-20 dental team members on their perceptions of a CBT self-help resource for dental anxiety, their opinions on whether they might use such a resource with patients, and their willingness to recruit participants to a future randomised controlled trial (RCT) to evaluate the resource. The third part of the study will investigate the most appropriate outcome measures to include in a trial, the acceptability of the resource, and retention and completion rates of treatment with a sample of 60 dentally anxious young people using the CBT resource. This study will provide information on the profile of dentally anxious young people who could potentially be helped by a guided self-help CBT resource. It will gain the perceptions of dental care team members of guided self-help CBT for dental anxiety in young people and their willingness to recruit participants to a trial. Acceptability of the resource to participants and retention and completion rates will also be investigated to inform a future RCT.

  11. Pharmacotherapies for fatigue in chronic liver disease (CLD): a systematic review and meta-analysis (protocol).

    PubMed

    Effiong, Andem; Kumari, Prerna

    2018-02-14

    This is the protocol for a systematic review (and meta-analysis) of an intervention. The primary objective of this systematic review will be to assess the benefits and harms of pharmacological therapies (pharmacotherapies) for the management of fatigue in adults with CLD of any etiology. The effects of pharmacological therapies on fatigue in CLD will be compared against those of placebo, no intervention, or non-pharmacological interventions. Specifically, this review will examine whether pharmacological therapies improve CLD-associated fatigue, and if they do, what key elements are associated with their effectiveness. The results of this systematic review will assist clinicians, policy-makers, researchers, and people with CLD in decision-making on how best to manage fatigue and its associated symptoms. MEDLINE, SCOPUS, EMBASE, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform, CENTRAL (The Cochrane Library), ClinicalTrials.gov, reference lists of articles and conference proceedings will be searched for relevant studies. No language or date restrictions will be applied. Eligible studies will include adults with CLD of any etiology. Included studies will be randomized controlled trials. From included studies, data on participant characteristics, study design, setting, research ethics compliance, and intervention outcomes will be extracted. Risk of bias in included studies will be assessed using the Cochrane Risk of Bias Tool. A random-effects meta-analysis will be conducted. If substantial or considerable levels of heterogeneity are detected, analysis will be limited to a narrative synthesis. This systematic review will examine the effectiveness of pharmacological therapies on fatigue reduction in people with CLD. Such therapies may be more effective than non-pharmacological interventions in treating fatigue symptoms in CLD. Evidence derived from the findings of this study will guide future practice, policy, and research. PROSPERO, CRD42017076957.

  12. Improving access to high-quality primary care for socioeconomically disadvantaged older people in rural areas: a mixed method study protocol

    PubMed Central

    Ford, John A; Jones, Andrew P; Wong, Geoff; Clark, Allan B; Porter, Tom; Shakespeare, Tom; Swart, Ann Marie; Steel, Nicholas

    2015-01-01

    Introduction The UK has an ageing population, especially in rural areas, where deprivation is high among older people. Previous research has identified this group as at high risk of poor access to healthcare. The aim of this study is to generate a theory of how socioeconomically disadvantaged older people from rural areas access primary care, to develop an intervention based on this theory and test it in a feasibility trial. Methods and analysis On the basis of the MRC Framework for Developing and Evaluating Complex Interventions, three methods will be used to generate the theory. First, a realist review will elucidate the patient pathway based on existing literature. Second, an analysis of the English Longitudinal Study of Ageing will be completed using structural equation modelling. Third, 15 semistructured interviews will be undertaken with patients and four focus groups with health professionals. A triangulation protocol will be used to allow each of these methods to inform and be informed by each other, and to integrate data into one overall realist theory. Based on this theory, an intervention will be developed in discussion with stakeholders to ensure that the intervention is feasible and practical. The intervention will be tested within a feasibility trial, the design of which will depend on the intervention. Lessons from the feasibility trial will be used to refine the intervention and gather the information needed for a definitive trial. Ethics and dissemination Ethics approval from the regional ethics committee has been granted for the focus groups with health professionals and interviews with patients. Ethics approval will be sought for the feasibility trial after the intervention has been designed. Findings will be disseminated to the key stakeholders involved in intervention development, to researchers, clinicians and health planners through peer-reviewed journal articles and conference publications, and locally through a dissemination event. PMID:26384728

  13. Efficacy of practising Tai Chi for older people with mild dementia: protocol for a randomised controlled study.

    PubMed

    Lyu, Jihui; Li, Wenjie; Rong, Xiangjiang; Wei, Lian; Huang, Nayan; Champ, Mei; Xiong, Qian; Chen, Xueli; Li, Mo; Li, Fangling

    2018-05-14

    Many studies suggest that Tai Chi exercise is a safe and appropriate mind-body exercise for older people and effectively slows down age-related cognitive decline. A set of bespoke Tai Chi exercise named 'Cognition Protecting Tai Chi' (CPT) has been created for older people with cognitive impairments by the research team of geriatricians, neurologists, rehabilitation specialists, experts of sports medicine and experienced practitioners of traditional Chinese medicine. This trial is designed to evaluate its effects on cognitive function, behaviour/moods, risk of falls and activities of daily living of the participants with mild dementia. A randomised controlled study will be conducted. Eighty participants with mild dementia will be recruited and randomly allocated to an intervention group and a control group. The intervention group will practice the CPT exercise three times a week for 20 min each time under the guidance of professional therapists. The control group will continue receiving their routine treatments. The duration of this study will be 10 months. All participants will be assessed with a battery of neuropsychological and functional evaluations, which include Mini Mental State Examination, Montreal Cognitive Assessment, the WHO-University of California Los Angeles-Auditory Verbal Learning test (WHO-UCLA-AVLT), Trail Making Test (TMT), Geriatric Depression Scale, Neuropsychological Inventory and Barthel Index, at the baseline, 5 and 10 months during the study period. Fall incident will also be recorded. The primary outcome will be the WHO-UCLA-AVLT delayed recall score. The secondary outcome will be the TMT score. This study has been approved by the ethical review committee of the Beijing Geriatric Hospital (protocol number: 2015-021). Informed consent will be obtained from all participants or their guardians. The authors intend to submit the findings of the study to peer-reviewed journals or academic conferences to be published. ChiCTR-INR-16009872; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  14. A secure medical data exchange protocol based on cloud environment.

    PubMed

    Chen, Chin-Ling; Yang, Tsai-Tung; Shih, Tzay-Farn

    2014-09-01

    In recent years, health care technologies already became matured such as electronic medical records that can be easily stored. However, how to get medical resources more convenient is currently concern issue. In spite of many literatures discussed about medical systems, but these literatures should face many security challenges. The most important issue is patients' privacy. Therefore, we propose a secure medical data exchange protocol based on cloud environment. In our scheme, we use mobile device's characteristics, allowing peoples use medical resources on the cloud environment to seek medical advice conveniently.

  15. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR)

    PubMed Central

    Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

    2018-01-01

    Introduction Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. Methods and analysis This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). Ethics and dissemination Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. Trial registration number NCT02632500. PMID:29674365

  16. The effectiveness and cost-effectiveness of shared care: protocol for a realist review.

    PubMed

    Hardwick, Rebecca; Pearson, Mark; Byng, Richard; Anderson, Rob

    2013-02-12

    Shared care (an enhanced information exchange over and above routine outpatient letters) is commonly used to improve care coordination and communication between a specialist and primary care services for people with long-term conditions. Evidence of the effectiveness and cost-effectiveness of shared care is mixed. Informed decision-making for targeting shared care requires a greater understanding of how it works, for whom it works, in what contexts and why. This protocol outlines how realist review methods can be used to synthesise evidence on shared care for long-term conditions.A further aim of the review is to explore economic evaluations of shared care. Economic evaluations are difficult to synthesise due to problems in accounting for contextual differences that impact on resource use and opportunity costs. Realist review methods have been suggested as a way to overcome some of these issues, so this review will also assess whether realist review methods are amenable to synthesising economic evidence. Database and web searching will be carried out in order to find relevant evidence to develop and test programme theories about how shared care works. The review will have two phases. Phase 1 will concentrate on the contextual conditions and mechanisms that influence how shared care works, in order to develop programme theories, which partially explain how it works. Phase 2 will focus on testing these programme theories. A Project Reference Group made up of health service professionals and people with actual experience of long-term conditions will be used to ground the study in real-life experience. Review findings will be disseminated through local and sub-national networks for integrated care and long-term conditions. This realist review will explore why and for whom shared care works, in order to support decision-makers working to improve the effectiveness of care for people outside hospital. The development of realist review methods to take into account cost and cost-effectiveness evidence is particularly innovative and challenging, and if successful will offer a new approach to synthesising economic evidence. This systematic review protocol is registered on the PROSPERO database (registration number: CRD42012002842).

  17. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

    PubMed

    Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

    2013-05-07

    It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more effective than the TPSAT protocol, this may influence standards of care and best practices for patients with dysphagia involving impaired thin-liquid control as a result of stroke. Clinicaltrials.gov http://NCT01370083.

  18. Applications of Multi-Channel Safety Authentication Protocols in Wireless Networks.

    PubMed

    Chen, Young-Long; Liau, Ren-Hau; Chang, Liang-Yu

    2016-01-01

    People can use their web browser or mobile devices to access web services and applications which are built into these servers. Users have to input their identity and password to login the server. The identity and password may be appropriated by hackers when the network environment is not safe. The multiple secure authentication protocol can improve the security of the network environment. Mobile devices can be used to pass the authentication messages through Wi-Fi or 3G networks to serve as a second communication channel. The content of the message number is not considered in a multiple secure authentication protocol. The more excessive transmission of messages would be easier to collect and decode by hackers. In this paper, we propose two schemes which allow the server to validate the user and reduce the number of messages using the XOR operation. Our schemes can improve the security of the authentication protocol. The experimental results show that our proposed authentication protocols are more secure and effective. In regard to applications of second authentication communication channels for a smart access control system, identity identification and E-wallet, our proposed authentication protocols can ensure the safety of person and property, and achieve more effective security management mechanisms.

  19. Impact of depression on quality of life in people living with human T cell lymphotropic virus type 1 (HTLV-1) in Salvador, Brazil.

    PubMed

    Galvão-Castro, Ana Verena; Boa-Sorte, Ney; Kruschewsky, Ramon Almeida; Grassi, Maria Fernanda Rios; Galvão-Castro, Bernardo

    2012-11-01

    A previous study found the prevalence of depression in HTLV-1-infected patients to be approximately 30%, but few studies have attempted to correlate depression with quality of life (QOL) in these patients. The present study investigates the association between depression and QOL in people living with HTLV-1. A clinical-epidemiological questionnaire, the Mini International Neuropsychiatric Interview and the WHOQOL-Bref were applied to 88 HTLV-1-infected patients (32 with TSP/HAM) at the HTLV Center of the Bahiana School of Medicine and Public Health, Salvador, Brazil. The prevalence of depression among people living with HTLV-1 was 34.1%. Depression was significantly associated with a poor QOL in the physical, psychological, social relationship and environment domains, when controlling for other variables, such as gender, age, time of knowledge of serological diagnosis and presence of tropical spastic paraparesis/HTLV-1associated myelopathy (TSP/HAM). Moreover, patients with TSP/HAM experienced a reduction in their QOL in the physical, psychological and environment domains. Our results showed that depression negatively affects the quality of life of people living with HTLV-1, regardless of the presence of TSP/HAM. Since it is possible to improve a patient's QOL by treating depression, psychological evaluations are strongly recommended as a measure to integrate the treatment protocols of HTLV-1 intervention programs.

  20. Do physical activity interventions in Indigenous people in Australia and New Zealand improve activity levels and health outcomes? A systematic review.

    PubMed

    Sushames, Ashleigh; van Uffelen, Jannique G Z; Gebel, Klaus

    2016-12-21

    Indigenous Australians and New Zealanders have a significantly shorter life expectancy than non-Indigenous people, mainly due to differences in prevalence of chronic diseases. Physical activity helps in the prevention and management of chronic diseases, however, activity levels are lower in Indigenous than in non-Indigenous people. To synthesise the literature on the effects of physical activity interventions for Indigenous people in Australia and New Zealand on activity levels and health outcomes. The Cochrane Library, MEDLINE, SPORTSDiscus and PsycINFO were searched for peer-reviewed articles and grey literature was searched. Interventions targeted Indigenous people in Australia or New Zealand aged 18+ years and their primary or secondary aim was to increase activity levels. Data were extracted by one author and verified by another. Risk of bias was assessed independently by two authors. Data were synthesised narratively. 407 records were screened and 13 studies included. Interventions included individual and group based exercise programs and community lifestyle interventions of four weeks to two years. Six studies assessed physical activity via subjective (n = 4) or objective (n = 2) measures, with significant improvements in one study. Weight and BMI were assessed in all but one study, with significant reductions reported in seven of 12 studies. All five studies that used fitness tests reported improvements, as did four out of eight measuring blood pressure and seven out of nine in clinical markers. There was no clear evidence for an effect of physical activity interventions on activity levels, however, there were positive effects on activity related fitness and health outcomes. The review protocol was registered with PROSPERO (registration number: CRD42015016915 ).

  1. The General Comments on HIV adopted by the African Commission on Human and Peoples' Rights as a tool to advance the sexual and reproductive rights of women in Africa.

    PubMed

    Durojaye, Ebenezer

    2014-12-01

    The present article examines the contents and importance of the General Comments adopted by the African Commission on Human and Peoples' Rights on Article 14 (1) (d) and (e) of the Protocol to the African Charter on the Rights of Women in Africa as a tool for advancing women's rights in the context of HIV. Given that discriminatory practices in all facets of life have continued to limit African women's enjoyment of their sexual and reproductive rights and render them susceptible to HIV infection, it becomes vital that African governments adopt appropriate measures to address this challenge. The provisions of the Protocol on the Rights of Women in Africa present great opportunities for this to be realized. The radical and progressive provisions of the Protocol will be of no use to women unless policymakers and other stakeholders have a clear understanding of them and are able to implement them effectively. The adoption of the General Comments is a welcome development, and states and civil society groups must maximize it to advance women's rights. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  2. Systematic content evaluation and review of measurement properties of questionnaires for measuring self-reported fatigue among older people.

    PubMed

    Egerton, Thorlene; Riphagen, Ingrid I; Nygård, Arnhild J; Thingstad, Pernille; Helbostad, Jorunn L

    2015-09-01

    The assessment of fatigue in older people requires simple and user-friendly questionnaires that capture the phenomenon, yet are free from items indistinguishable from other disorders and experiences. This study aimed to evaluate the content, and systematically review and rate the measurement properties of self-report questionnaires for measuring fatigue, in order to identify the most suitable questionnaires for older people. This study firstly involved identification of questionnaires that purport to measure self-reported fatigue, and evaluation of the content using a rating scale developed for the purpose from contemporary understanding of the construct. Secondly, for the questionnaires that had acceptable content, we identified studies reporting measurement properties and rated the methodological quality of those studies according to the COSMIN system. Finally, we extracted and synthesised the results of the studies to give an overall rating for each questionnaire for each measurement property. The protocol was registered with PROSPERO (CRD42013005589). Of the 77 identified questionnaires, twelve were selected for review after content evaluation. Methodological quality varied, and there was a lack of information on measurement error and responsiveness. The PROMIS-Fatigue item bank and short forms perform the best. The FACIT-Fatigue scale, Parkinsons Fatigue Scale, Perform Questionnaire, and Uni-dimensional Fatigue Impact Scale also perform well and can be recommended. Minor modifications to improve performance are suggested. Further evaluation of unresolved measurement properties, particularly with samples including older people, is needed for all the recommended questionnaires.

  3. Exploring Musical Activities and Their Relationship to Emotional Well-Being in Elderly People across Europe: A Study Protocol.

    PubMed

    Grau-Sánchez, Jennifer; Foley, Meabh; Hlavová, Renata; Muukkonen, Ilkka; Ojinaga-Alfageme, Olatz; Radukic, Andrijana; Spindler, Melanie; Hundevad, Bodil

    2017-01-01

    Music is a powerful, pleasurable stimulus that can induce positive feelings and can therefore be used for emotional self-regulation. Musical activities such as listening to music, playing an instrument, singing or dancing are also an important source for social contact, promoting interaction and the sense of belonging with others. Recent evidence has suggested that after retirement, other functions of music, such as self-conceptual processing related to autobiographical memories, become more salient. However, few studies have addressed the meaningfulness of music in the elderly. This study aims to investigate elderly people's habits and preferences related to music, study the role music plays in their everyday life, and explore the relationship between musical activities and emotional well-being across different countries of Europe. A survey will be administered to elderly people over the age of 65 from five different European countries (Bosnia and Herzegovina, Czechia, Germany, Ireland, and UK) and to a control group. Participants in both groups will be asked about basic sociodemographic information, habits and preferences in their participation in musical activities and emotional well-being. Overall, the aim of this study is to gain a deeper understanding of the role of music in the elderly from a psychological perspective. This advanced knowledge could help to develop therapeutic applications, such as musical recreational programs for healthy older people or elderly in residential care, which are better able to meet their emotional and social needs.

  4. Study protocol Implementation of the Veder contact method (VCM) in daily nursing home care for people with dementia: an evaluation based on the RE-AIM framework.

    PubMed

    Boersma, Petra; Van Weert, Julia C M; van Meijel, Berno; van de Ven, Peter M; Dröes, Rose-Marie

    2017-07-01

    People with dementia in nursing homes benefit from person-centred care methods. Studies examining the effect of these methods often fail to report about the implementation of these methods. The present study aims to describe the implementation of the Veder contact method (VCM) in daily nursing home care. A process analysis will be conducted based on qualitative data from focus groups with caregivers and interviews with key figures. To investigate whether the implementation of VCM is reflected in the attitude and behaviour of caregivers and in the behaviour and quality of life of people with dementia, a controlled observational cohort study will be conducted. Six nursing home wards implementing VCM will be compared with six control wards providing Care As Usual. Quantitative data from caregivers and residents will be collected before (T0), and 9-12 months after the implementation (T1). Qualitative analysis and multilevel analyses will be carried out on the collected data and structured based on the constructs of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). By using the RE-AIM framework this study introduces a structured and comprehensive way of investigating the implementation process and implementation effectiveness of person-centred care methods in daily dementia care.

  5. Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials.

    PubMed

    Curth, Nadja Kehler; Brinck-Claussen, Ursula Ødum; Davidsen, Annette Sofie; Lau, Marianne Engelbrecht; Lundsteen, Merete; Mikkelsen, John Hagel; Csillag, Claudio; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-08-16

    People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders. Three cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months. Results will add to the limited pool of information about collaborative care for patients with anxiety disorders. To our knowledge, these will be the first carried out in a Danish context and the first to report results for generalised anxiety and social phobia separately. If the trials show positive results, they could contribute to the improvement of future treatment of anxiety disorders. ClinicalTrials.gov, ID: NCT02678624 . Retrospectively registered 7 February 2016; last updated 15 August 2016.

  6. Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

    PubMed

    Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

    2018-03-26

    Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

  7. Detection and culture of Bartonella quintana, Serratia marcescens, and Acinetobacter spp. from decontaminated human body lice.

    PubMed

    La Scola, B; Fournier, P E; Brouqui, P; Raoult, D

    2001-05-01

    As part of a survey for trench fever among homeless people in Marseilles, France, we attempted isolation of Bartonella quintana from body lice. A decontamination protocol of immersion in 70% ethanol with 0.2% iodine was devised and was tested with a laboratory colony of body lice. Lice which had been experimentally contaminated with either Escherichia coli, Staphylococcus epidermidis, or Acinetobacter spp. were successfully decontaminated, and this process did not prevent the culture of B. quintana from these lice. One hundred sixty-one lice obtained from homeless patients were studied by the protocol. B. quintana was isolated on axenic medium from 15 of 161 body lice and was detected in 41 of 161 lice by PCR. Acinetobacter spp. and Serratia marcescens were also isolated from body lice. The sensitivities of PCR and culture of B. quintana were 98 and 36%, respectively. These procedures may be useful for epidemiologic studies of trench fever and for the recovery of strains for characterization and comparison.

  8. RESPOND--A patient-centred programme to prevent secondary falls in older people presenting to the emergency department with a fall: protocol for a multicentre randomised controlled trial.

    PubMed

    Barker, A L; Cameron, P A; Hill, K D; Flicker, L; Haines, T P; Lowthian, J A; Waldron, N; Arendts, G; Redfern, J; Forbes, A; Brand, C A; Etherton-Beer, C D; Hill, A M; Hunter, P; Nyman, S R; Smit, D

    2015-02-01

    Participation in falls prevention activities by older people following presentation to the emergency department (ED) with a fall is suboptimal. This randomised controlled trial (RCT) will test the RESPOND programme, an intervention designed to improve older persons' participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies. A RCT at two tertiary referral EDs in Melbourne and Perth, Australia. 528 community-dwelling people aged 60-90 years presenting to the ED with a fall and discharged home will be recruited. People who require an interpreter or hands-on assistance to walk; live in residential aged care or >50 km from the trial hospital; have terminal illness, cognitive impairment, documented aggressive behaviour or a history of psychosis; are receiving palliative care or are unable to use a telephone will be excluded. Participants will be randomly allocated to the RESPOND intervention or standard care control group. RESPOND incorporates (1) a home-based risk factor assessment; (2) education, coaching, goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions and (3) healthcare provider communication and community linkage delivered over 6 months. Primary outcomes are falls and fall injuries per person-year. RESPOND builds on prior falls prevention learnings and aims to help individuals make guided decisions about how they will manage their falls risk. Patient-centred models have been successfully trialled in chronic and cardiovascular disease; however, evidence to support this approach in falls prevention is limited. The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000336684). 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.

  9. Biopsychosocial factors associated with non-recovery after a minor transport-related injury: protocol for a systematic review.

    PubMed

    Samoborec, Stella; Ruseckaite, Rasa; Romero, Lorena; Evans, Sue M

    2017-09-03

    Globally, road transport accidents contribute substantially to the number of deaths and also to the burden of disability. Up to 50 million people suffer a transport-related non-fatal injury each year, which often leads to long-term disability. It has been shown that substantial number of people with minor injuries struggle to recover and the reasons are still not well explored.Despite the high prevalence, little is known about the factors hindering recovery following minor traffic-related injuries. The aim of this paper is to present a protocol for the systematic review aiming to understand biopsychosocial factors related to non-recovery and identify current gaps in the literature. The review will be conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol guidelines. A search of the electronic databases, MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, will be undertaken, in addition to Google Scholar and grey literature to identify studies in period from 2006 to 2016. Quantitative and qualitative research articles describing and identifying biopsychosocial factors associated with non-recovery and health outcomes such as pain, disability, functional recovery, health-related quality of life, post-traumatic stress disorder, depression, anxiety and return to work will be included. A conceptual framework developed to identify biopsychosocial factors will be applied to assure defined criterion.At present, there is little anticipation for meta-analyses due to the heterogeneity of factors and outcomes assessed. Therefore, a narrative synthesis based on study findings will be conducted. Ethical approval is not required as primary data will not be collected. Review results will be published as a part of thesis, peer-reviewed journal and conferences. PROSPEROregistration number: CRD42016052276. © 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.

  10. Protocol for an online randomised controlled trial to evaluate the clinical and cost-effectiveness of a peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives Education And Coping Toolkit (REACT).

    PubMed

    Lobban, Fiona; Robinson, Heather; Appelbe, Duncan; Barraclough, Johanna; Bedson, Emma; Collinge, Lizzi; Dodd, Susanna; Flowers, Sue; Honary, Mahsa; Johnson, Sonia; Mateus, Ceu; Mezes, Barbara; Minns, Valerie; Murray, Elizabeth; Walker, Andrew; Williamson, Paula; Wintermeyer, Catherine; Jones, Steven

    2017-07-18

    Despite clinical guidelines recommendations, many relatives of people with psychosis or bipolar disorder do not currently receive the support they need. Online information and support may offer a solution. This single-blind, parallel, online randomised controlled trial will determine clinical and cost-effectiveness of the Relatives Education And Coping Toolkit (REACT) (including an online resource directory (RD)), compared with RD only, for relatives of people with psychosis or bipolar disorder. Both groups continue to receive treatment as usual. Independent, web-based variable, block, individual randomisation will be used across 666 relatives. Primary outcome is distress at 24 weeks (measured by General Health Questionnaire; GHQ-28) compared between groups using analysis of covariance, adjusting for baseline score. Secondary clinical outcomes are carer well-being and support. Cost-effectiveness analysis will determine cost of a significant unit change (three-point reduction) in the GHQ-28. Costs include offering and supporting the intervention in the REACT arm, relevant healthcare care costs including health professional contacts, medications prescribed and time off (or ability to) work for the relative. Cost utility analysis will be calculated as the marginal cost of changes in quality-adjusted life years, based on EuroQol. We will explore relatives' beliefs, perceived coping and amount of REACT toolkit use as possible outcome mediators. We have embedded two methodological substudies in the protocol to determine the relative effectiveness of a low-value (£10) versus higher value (£20) incentive, and an unconditional versus conditional incentive, on improving follow-up rates. The trial has ethical approval from Lancaster National Research Ethics Service (NRES)Committee (15/NW/0732) and is overseen by an independent Data Monitoring and Ethics Committee and Trial Steering Committee. Protocol version 1.5 was approved on 9 January 2017. All updates to protocols are uploaded to the National Institute for Health Research (NIHR) Journals Library. A full statistical analysis plan is available at https://figshare.com/account/home#/projects/19975. Publications will be in peer-reviewed journals (open access wherever possible). Requests for access to the data at the end of the study will be reviewed and granted where appropriate by the Trial Management Group. ISRCTN72019945, 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.

  11. Trunk muscle exercises as a means of improving postural stability in people with Parkinson's disease: a protocol for a randomised controlled trial.

    PubMed

    Hubble, Ryan P; Naughton, Geraldine A; Silburn, Peter A; Cole, Michael H

    2014-12-31

    Exercise has been shown to improve clinical measures of strength, balance and mobility, and in some cases, has improved symptoms of tremor and rigidity in people with Parkinson's disease (PD). However, to date, no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population. The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD; (1) is more effective than education; (2) is more effective when training frequency is increased; and (3) provides greater long-term benefits than education. Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited. Participants will complete baseline assessments including tests of cognition, vision, disease severity, fear of falling, mobility and quality of life. Additionally, participants will complete a series of standing balance tasks to evaluate static postural stability, while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers. Following baseline testing, participants will be randomly-assigned to one of three intervention groups, who will receive either exercise once per week, exercise 3 days/week, or education. Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period. This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD. Importantly, if the programme is noted to be effective, it could be easily performed by patients within their home environment or under the guidance of available allied health professionals. The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001175763). 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.

  12. A protocol for an exploratory phase I mixed-methods study of enhanced integrated care for care home residents with advanced dementia: the Compassion Intervention.

    PubMed

    Elliott, Margaret; Harrington, Jane; Moore, Kirsten; Davis, Sarah; Kupeli, Nuriye; Vickerstaff, Victoria; Gola, Anna; Candy, Bridget; Sampson, Elizabeth L; Jones, Louise

    2014-06-17

    In the UK approximately 700,000 people are living with, and a third of people aged over 65 will die with, dementia. People with dementia may receive poor quality care towards the end of life. We applied a realist approach and used mixed methods to develop a complex intervention to improve care for people with advanced dementia and their family carers. Consensus on intervention content was achieved using the RAND UCLA appropriateness method and mapped to sociological theories of process and impact. Core components are: (1) facilitation of integrated care, (2) education, training and support, (3) investment from commissioners and care providers. We present the protocol for an exploratory phase I study to implement components 1 and 2 in order to understand how the intervention operates in practice and to assess feasibility and acceptability. An 'Interdisciplinary Care Leader (ICL)' will work within two care homes, alongside staff and associated professionals to facilitate service integration, encourage structured needs assessment, develop the use of personal and advance care plans and support staff training. We will use qualitative and quantitative methods to collect data for a range of outcome and process measures to detect effects on individual residents, family carers, care home staff, the intervention team, the interdisciplinary team and wider systems. Analysis will include descriptive statistics summarising process and care home level data, individual demographic and clinical characteristics and data on symptom burden, clinical events and quality of care. Qualitative data will be explored using thematic analysis. Findings will inform a future phase II trial. Ethical approval was granted (REC reference 14/LO/0370). We shall publish findings at conferences, in peer-reviewed journals, on the Marie Curie Cancer Care website and prepare reports for dissemination by organisations involved with end-of-life care and dementia. 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.

  13. The role of community pharmacists in screening and subsequent management of chronic respiratory diseases: a systematic review

    PubMed Central

    Fathima, Mariam; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol L.

    Objective The purpose of this review was to evaluate the role of community pharmacists in provision of screening with/without subsequent management of undiagnosed chronic obstructive pulmonary disease (COPD) and uncontrolled asthma. Methods An extensive literature search using four databases (ie. Medline, PubMed, International Pharmaceutical Abstracts (IPA) and Scopus) with search terms pharmacy, screening, asthma or COPD was conducted. Searches were limited to the years 2003-2013, those in English and those reporting research with humans. Data retrieval, analysis and result presentation employed a scoping review method. Results Seventeen articles met the inclusion/exclusion criteria, of which fifteen studies were based on people with asthma and two were based on people with COPD. Only seven asthma studies and one COPD study involved screening followed by subsequent management. More than half of the people screened were found to be poorly controlled and up to 62% of people were identified at high risk for COPD by community pharmacists. The studies varied in the method and type of asthma control assessment/screening, the type of intervention provided and the outcomes measured. The limitations of the reviewed studies included varying definitions of asthma control, different study methodologies, and the lack of long-term follow-up. While many different methods were used for risk assessment and management services by the pharmacists, all the studies demonstrated that community pharmacists were capable of identifying people with poorly controlled asthma and undiagnosed COPD and providing them with suitable interventions. Conclusions The literature review identified that community pharmacists can play an effective role in screening of people with poorly controlled asthma and undiagnosed COPD along with delivering management interventions. However, there is very little literature available on screening for these chronic respiratory conditions. Future research should focus on development of patient care delivery model incorporating a screening protocol followed by targeted management interventions delivered by the community pharmacist. PMID:24367463

  14. The role of community pharmacists in screening and subsequent management of chronic respiratory diseases: a systematic review.

    PubMed

    Fathima, Mariam; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol L

    2013-10-01

    The purpose of this review was to evaluate the role of community pharmacists in provision of screening with/without subsequent management of undiagnosed chronic obstructive pulmonary disease (COPD) and uncontrolled asthma. An extensive literature search using four databases (ie. Medline, PubMed, International Pharmaceutical Abstracts (IPA) and Scopus) with search terms pharmacy, screening, asthma or COPD was conducted. Searches were limited to the years 2003-2013, those in English and those reporting research with humans. Data retrieval, analysis and result presentation employed a scoping review method. Seventeen articles met the inclusion/exclusion criteria, of which fifteen studies were based on people with asthma and two were based on people with COPD. Only seven asthma studies and one COPD study involved screening followed by subsequent management. More than half of the people screened were found to be poorly controlled and up to 62% of people were identified at high risk for COPD by community pharmacists. The studies varied in the method and type of asthma control assessment/screening, the type of intervention provided and the outcomes measured. The limitations of the reviewed studies included varying definitions of asthma control, different study methodologies, and the lack of long-term follow-up. While many different methods were used for risk assessment and management services by the pharmacists, all the studies demonstrated that community pharmacists were capable of identifying people with poorly controlled asthma and undiagnosed COPD and providing them with suitable interventions. The literature review identified that community pharmacists can play an effective role in screening of people with poorly controlled asthma and undiagnosed COPD along with delivering management interventions. However, there is very little literature available on screening for these chronic respiratory conditions. Future research should focus on development of patient care delivery model incorporating a screening protocol followed by targeted management interventions delivered by the community pharmacist.

  15. A case for justified non-voluntary active euthanasia: exploring the ethics of the Groningen Protocol.

    PubMed

    Manninen, B A

    2006-11-01

    One of the most recent controversies to arise in the field of bioethics concerns the ethics for the Groningen Protocol: the guidelines proposed by the Groningen Academic Hospital in The Netherlands, which would permit doctors to actively euthanise terminally ill infants who are suffering. The Groningen Protocol has been met with an intense amount of criticism, some even calling it a relapse into a Hitleresque style of eugenics, where people with disabilities are killed solely because of their handicaps. The purpose of this paper is threefold. First, the paper will attempt to disabuse readers of this erroneous understanding of the Groningen Protocol by showing how such a policy does not aim at making quality-of-life judgements, given that it restricts euthanasia to suffering and terminally ill infants. Second, the paper illustrates that what the Groningen Protocol proposes to do is both ethical and also the most humane alternative for these suffering and dying infants. Lastly, responses are given to some of the worries expressed by ethicists on the practice of any type of non-voluntary active euthanasia.

  16. Anticipatory and compensatory postural adjustments in people with low back pain: a protocol for a systematic review and meta-analysis.

    PubMed

    Knox, Michael F; Chipchase, Lucy S; Schabrun, Siobhan M; Marshall, Paul W M

    2016-04-16

    Anticipatory (APAs) and compensatory (CPAs) postural adjustments are organised by the central nervous system (CNS) and serve to control postural perturbations. Ineffective APAs and CPAs have been hypothesised to contribute to the persistence of symptoms and disability in people with low back pain (LBP). Despite two decades of research, there is no systematic review investigating APAs and CPAs in people with LBP. Thus, the aim of the current review is to determine if APA and CPA onset or amplitude, as measured by electromyography (EMG), centre of pressure (COP), and kinematics, are altered in people with LBP. A systematic review and meta-analysis will be conducted. Searches will be conducted in electronic databases for full-text articles published before January 2016 using pre-defined search strategies that utilise combinations of keywords and medical subject heading terms. Two independent reviewers will screen potentially relevant articles for inclusion, extract data, and assess risk of bias for individual studies. Any disagreements will be resolved by a third reviewer. Studies comparing APA onset and amplitude and CPA onset and amplitude measured by EMG, COP, or kinematics between people with LBP and healthy individuals will be included if all aspects of the eligibility criteria are met. Data will be synthesised if studies are homogeneous; otherwise, results will be reviewed narratively. To our knowledge, this is the first systematic review to examine APAs and CPAs, as measured by EMG, COP, and kinematics in people with LBP. The findings of this review may aid in the identification of factors that play a role in the persistence of symptoms and disability and aid in the development of interventions to treat symptoms. PROSPERO CRD42016032815.

  17. Developing a framework for community-based sexual health interventions for youth in the rural setting: protocol for a participatory action research study

    PubMed Central

    Heslop, Carl William; Burns, Sharyn; Lobo, Roanna; McConigley, Ruth

    2017-01-01

    Introduction There is limited research examining community-based or multilevel interventions that address the sexual health of young people in the rural Australian context. This paper describes the Participatory Action Research (PAR) project that will develop and validate a framework that is effective for planning, implementing and evaluating multilevel community-based sexual health interventions for young people aged 16–24 years in the Australian rural setting. Methods and analysis To develop a framework for sexual health interventions with stakeholders, PAR will be used. Three PAR cycles will be conducted, using semistructured one-on-one interviews, focus groups, community mapping and photovoice to inform the development of a draft framework. Cycle 2 and Cycle 3 will use targeted Delphi studies to gather evaluation and feedback on the developed draft framework. All data collected will be reviewed and analysed in detail and coded as concepts become apparent at each stage of the process. Ethics and dissemination This protocol describes a supervised doctoral research project. This project seeks to contribute to the literature regarding PAR in the rural setting and the use of the Delphi technique within PAR projects. The developed framework as a result of the project will provide a foundation for further research testing the application of the framework in other settings and health areas. This research has received ethics approval from the Curtin University Human Research and Ethics Committee (HR96/2015). PMID:28559453

  18. Study Protocol – Diabetes and related conditions in urban Indigenous people in the Darwin, Australia region: aims, methods and participation in the DRUID Study

    PubMed Central

    Cunningham, Joan; O'Dea, Kerin; Dunbar, Terry; Weeramanthri, Tarun; Zimmet, Paul; Shaw, Jonathan

    2006-01-01

    Background Diabetes mellitus is a serious and increasing health problem in Australia and is a designated national health priority. Diabetes and related conditions represent an even greater health burden among Indigenous Australians (Aborigines and Torres Strait Islanders), but there are critical gaps in knowledge relating to the incidence and prevalence, aetiology, and prevention of diabetes in this group, including a lack of information on the burden of disease among Indigenous people in urban areas. The DRUID Study (Diabetes and Related conditions in Urban Indigenous people in the Darwin region) was designed to address this knowledge gap. Methods/design The study was conducted in a specified geographic area in and around Darwin, Australia. Eligible participants underwent a health examination, including collection of blood and urine samples, clinical and anthropometric measurements, and administration of questionnaires, with an additional assessment for people with diabetes. The study was designed to incorporate local Indigenous leadership, facilitate community engagement, and provide employment and training opportunities for local Indigenous people. A variety of recruitment methods were used. A total of 1,004 eligible people gave consent and provided at least one measurement. When compared with census data for the Indigenous population living in the study area, there was a marked under-representation of males, but no substantial differences in age, place of residence, Indigenous group, or household income. Early participants were more likely than later participants to have previously diagnosed diabetes. Discussion Despite lower than anticipated recruitment, this is, to our knowledge, the largest study ever conducted on the health of Indigenous Australians living in urban areas, a group which comprises the majority of Australia's Indigenous population but about whose health and wellbeing relatively little is known. The study is well-placed to provide new information that can be used by policy makers and service providers to improve the delivery of services and programs that affect the health of Indigenous people. It also represents a valuable opportunity to establish an urban Indigenous cohort study, provided participants can be followed successfully over time. PMID:16417641

  19. [Protocol for peripheral parenteral nutrition management ready to use in surgical patients].

    PubMed

    Pinzón Espitia, Olga Lucia; Varón Vega, Martha Liliana

    2014-10-03

    Patients undergoing elective surgery, require a comprehensive clinical treatment that tends to maintain or prevent deterioration of nutritional status and promote clinical outcomes, and in turn improve the safety of parenteral nutrition therapy through optimization of technology, as a option aimed at minimizing risk and lower operating costs in institutions providing health services. To review the literature in order to study the requirements and recommendations of peripheral parenteral nutritional support and / or complementary ready to use in people undergoing surgery. Data synthesis after reviewing the relevant literature, to allow the protocol design. The search was conducted in the following databases: PubMed, Medline, Embase and ScienceDirect. Peripheral parenteral nutrition is a ready to use alternative nutritional support that improves the contribution Protein-Energy and demonstrate improvements in patient safety, decrease costs and increase patient satisfaction. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  20. HandiVIH--A population-based survey to understand the vulnerability of people with disabilities to HIV and other sexual and reproductive health problems in Cameroon: protocol and methodological considerations.

    PubMed

    De Beaudrap, Pierre; Pasquier, Estelle; Tchoumkeu, Alice; Touko, Adonis; Essomba, Frida; Brus, Aude; Desgrées du Loû, Annabel; Aderemi, Toyin Janet; Hanass-Hancock, Jill; Eide, Arne Henning; Mont, Daniel; Mac-Seing, Muriel; Beninguisse, Gervais

    2016-02-04

    In resource-limited countries, people with disabilities seem to be particularly vulnerable to HIV infection due to barriers to accessing information and services, frequent exposure to sexual violence and social exclusion. However, they have often been left behind in the HIV response, probably because of the lack of reliable epidemiological data measuring this vulnerability. Multiple challenges in conducting good quality epidemiological surveys on people with disabilities require innovative methods to better understand the link between disability and HIV. This paper describes how the design and methods of the HandiVIH study were adapted to document the vulnerability of people with disabilities to HIV, and to compare their situation with that of people without disabilities. The HandiVIH project aims to combine quantitative and qualitative data. The quantitative component is a cross-sectional survey with a control group conducted in Yaoundé (Cameroon). A two-phase random sampling is used (1) to screen people with disabilities from the general population using the Washington Group questionnaire and, (2) to create a matched control group. An HIV test is proposed to each study participant. Additionally, a questionnaire including a life-event interview is used to collect data on respondents' life-course history of social isolation, employment, sexual partnership, HIV risk factors and fertility. Before the cross-sectional survey, a qualitative exploratory study was implemented to identify challenges in conducting the survey and possible solutions. Information on people with disabilities begging in the streets and members of disabled people's organisations is collected separately. This study has been approved by the two ethical committees. Special attention has been paid on how to adapt the consenting process to persons with intellectual disabilities. The methodological considerations discussed in this paper may contribute to the development of good practices for conducting quantitative health surveys on people with disabilities. NCT02192658. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. Clinical decision making and outcome in routine care for people with severe mental illness (CEDAR): study protocol.

    PubMed

    Puschner, Bernd; Steffen, Sabine; Slade, Mike; Kaliniecka, Helena; Maj, Mario; Fiorillo, Andrea; Munk-Jørgensen, Povl; Larsen, Jens Ivar; Egerházi, Anikó; Nemes, Zoltan; Rössler, Wulf; Kawohl, Wolfram; Becker, Thomas

    2010-11-10

    A considerable amount of research has been conducted on clinical decision making (CDM) in short-term physical conditions. However, there is a lack of knowledge on CDM and its outcome in long-term illnesses, especially in care for people with severe mental illness. The study entitled "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR) is carried out in six European countries (Denmark, Germany, Hungary, Italy, Switzerland and UK). First, CEDAR establishes a methodology to assess CDM in people with severe mental illness. Specific instruments are developed (and psychometric properties established) to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Second, these instruments are being put to use in a multi-national prospective observational study (bimonthly assessments during a one-year observation period; N = 560). This study investigates the immediate, short- and long-term effect of CDM on crucial dimensions of clinical outcome (symptom level, quality of life, needs) by taking into account significant variables moderating the relationship between CDM and outcome. The results of this study will make possible to delineate quality indicators of CDM, as well as to specify prime areas for further improvement. Ingredients of best practice in CDM in the routine care for people with severe mental illness will be extracted and recommendations formulated. With its explicit focus on the patient role in CDM, CEDAR will also contribute to strengthening the service user perspective. This project will substantially add to improving the practice of CDM in mental health care across Europe. ISRCTN75841675.

  2. The protocol of a population-based prospective cohort study in southwest of Iran to analyze common non-communicable diseases: Shahrekord cohort study.

    PubMed

    Khaledifar, Arsalan; Hashemzadeh, Morteza; Solati, Kamal; Poustchi, Hosseion; Bollati, Valentina; Ahmadi, Ali; Kheiri, Soleiman; Samani, Keihan Ghatreh; Banitalebi, Mehdi; Sedehi, Morteza; Malekzadeh, Reza

    2018-05-25

    Prospective cohort studies are considered ideal choices to study multiple outcomes and risk factors for Non-communicable diseases (NCDs). Our aim is to set-up the protocol and analyze risk factors, incidence rates, prevalence, trends, and the models of environmental and genetic determinants of NCDs and their outcomes as well as interaction among such determinants. Shahrekord cohort study (SCS) that is a population-based prospective, study on a cohort consisting of people aged 35-70 years started in November 2015 in Iran. The sample size of the original cohort is at least 10,000 people. Annual follow-ups (200,000 person-year) of the cohort were designed to be conducted up to 2036. Exposures (a detailed demographic, socioeconomic, general health, quality of life, physical activity, anthropometric indexes, stress, health literacy, social capital, nutrition and eating habits, lifestyle, occupational history, living place, blindness, deafness, electrocardiography, lung capacities, blood pressure, sleep, smoking and alcohol, contact to animals, physical examinations and medical history, dental health, used drugs and supplements, glucose and lipid profiles) were measured by relevant standard methods and questionnaires. Incidence of common NCDs (cardiovascular diseases, cancer, gastrointestinal, respiratory, renal, hepatic, accidents, injury and neurological diseases), trend of risk factors, hospitalization, disability, and death were considered the outcomes of the cohort. The definition of disease was determined based on the International Classification of Diseases 10th version (ICD-10). Routine hematologic and biochemical tests were conducted and an all-inclusive biobank (blood, hair, nail, and urine specimens) of the cohort was stored for future studies. All steps of data collection and examinations are directly monitored by the quality control team. The SCS is a unique study conducted in southwest of Iran that is a notable work given the climate conditions and ethnicity population (especially in Bakhtiari) of this region. By providing high quality the protocol and introduce it, the SCS can serve as a solid foundation for management and researchers in southwest of Iran. The SCS provides prerequisites for collaboration and regional, national, and international studies on NCDs. Data are available at the modeling in health research center, Shahrekord University of Medical Sciences, Shahrekord, Iran, for any collaboration.

  3. The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Falls in older people continue to be a major public health issue in industrialized countries. Extensive research into falls prevention has identified exercise as a proven fall prevention strategy. However, despite over a decade of promoting physical activity, hospitalisation rates due to falls injuries in older people are still increasing. This could be because efforts to increase physical activity amongst older people have been unsuccessful, or the physical activity that older people engage in is insufficient and/or inappropriate. The majority of older people choose walking as their predominant form of exercise. While walking has been shown to lower the risk of many chronic diseases its role in falls prevention remains unclear. This paper outlines the methodology of a study whose aims are to determine: if a home-based walking intervention will reduce the falls rate among healthy but inactive community-dwelling older adults (65 + years) compared to no intervention (usual activity) and; whether such an intervention can improve risk factors for falls, such as balance, strength and reaction time. Methods/Design This study uses a randomised controlled trial design. A total of 484 older people exercising less than 120 minutes per week will be recruited through the community and health care referrals throughout Sydney and neighboring regions. All participants are randomised into either the self-managed walking program group or the health-education waiting list group using a block randomization scheme. Outcome measures include prospective falls and falls injuries, quality of life, and physical activity levels. A subset of participants (n = 194) will also receive physical performance assessments comprising of tests of dynamic balance, strength, reaction time and lower limb functional status. Discussion Certain types of physical activity can reduce the risk of falls. As walking is already the most popular physical activity amongst older people, if walking is shown to reduce falls the public health implications could be enormous. Conversely, if walking does not reduce falls in older people, or even puts older people at greater risk, then health resources targeting falls prevention need to be invested elsewhere. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000380099 PMID:22115340

  4. The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol.

    PubMed

    Voukelatos, Alexander; Merom, Dafna; Rissel, Chris; Sherrington, Cathie; Watson, Wendy; Waller, Karen

    2011-11-24

    Falls in older people continue to be a major public health issue in industrialized countries. Extensive research into falls prevention has identified exercise as a proven fall prevention strategy. However, despite over a decade of promoting physical activity, hospitalisation rates due to falls injuries in older people are still increasing. This could be because efforts to increase physical activity amongst older people have been unsuccessful, or the physical activity that older people engage in is insufficient and/or inappropriate. The majority of older people choose walking as their predominant form of exercise. While walking has been shown to lower the risk of many chronic diseases its role in falls prevention remains unclear. This paper outlines the methodology of a study whose aims are to determine: if a home-based walking intervention will reduce the falls rate among healthy but inactive community-dwelling older adults (65 + years) compared to no intervention (usual activity) and; whether such an intervention can improve risk factors for falls, such as balance, strength and reaction time. This study uses a randomised controlled trial design.A total of 484 older people exercising less than 120 minutes per week will be recruited through the community and health care referrals throughout Sydney and neighboring regions. All participants are randomised into either the self-managed walking program group or the health-education waiting list group using a block randomization scheme.Outcome measures include prospective falls and falls injuries, quality of life, and physical activity levels. A subset of participants (n = 194) will also receive physical performance assessments comprising of tests of dynamic balance, strength, reaction time and lower limb functional status. Certain types of physical activity can reduce the risk of falls. As walking is already the most popular physical activity amongst older people, if walking is shown to reduce falls the public health implications could be enormous. Conversely, if walking does not reduce falls in older people, or even puts older people at greater risk, then health resources targeting falls prevention need to be invested elsewhere. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000380099.

  5. Acute Changes in Heart Rate Variability in Subjects With Diabetes Following a Highway Traffic Exposure

    PubMed Central

    Laumbach, Robert J.; Rich, David Q.; Gandhi, Sampada; Amorosa, Louis; Schneider, Stephen; Zhang, Junfeng; Ohman-Strickland, Pamela; Gong, Jicheng; Lelyanov, Oleksiy; Kipen, Howard M.

    2014-01-01

    Objective To pilot a protocol to evaluate acute cardiovascular effects in in-vehicle exposure to traffic air pollutants in people with diabetes. Methods Twenty-one volunteers with type 2 diabetes were passengers on 90- to 110-minute car rides on a busy highway. We measured in-vehicle particle number and mass (PM2.5) nitrogen dioxide, and carbon monoxide and heart rate, heart rate variability (HRV), and blood pressure. Results Compared with pre-ride measurements, we found a decrease in high frequency (HF) HRV from pre-ride to next day (ratio 0.66, 95% CI = 0.47 to 0.93) and an increase in low frequency to HF ratio at post-ride (ratio 1.92, 95% CI = 1.21 to 3.05) at post-ride. Interquartile range increases in measured pollutants were associated with next-day decreases in HR HRV. Conclusions This protocol appears useful for assessing acute adverse cardiovascular effects of in-vehicle exposures among people who have diabetes. PMID:20190650

  6. 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

  7. Effectiveness of balance training exercise in people with mild to moderate severity Alzheimer's disease: protocol for a randomised trial.

    PubMed

    Hill, Keith D; LoGiudice, Dina; Lautenschlager, Nicola T; Said, Catherine M; Dodd, Karen J; Suttanon, Plaiwan

    2009-07-16

    Balance dysfunction and falls are common problems in later stages of dementia. Exercise is a well-established intervention to reduce falls in cognitively intact older people, although there is limited randomised trial evidence of outcomes in people with dementia. The primary objective of this study is to evaluate whether a home-based balance exercise programme improves balance performance in people with mild to moderate severity Alzheimer's disease. Two hundred and fourteen community dwelling participants with mild to moderate severity Alzheimer's disease will be recruited for the randomised controlled trial. A series of laboratory and clinical measures will be used to evaluate balance and mobility performance at baseline. Participants will then be randomized to receive either a balance training home exercise programme (intervention group) from a physiotherapist, or an education, information and support programme from an occupational therapist (control group). Both groups will have six home visits in the six months following baseline assessment, as well as phone support. All participants will be re-assessed at the completion of the programme (after six months), and again in a further six months to evaluate sustainability of outcomes. The primary outcome measures will be the Limits of Stability (a force platform measure of balance) and the Step Test (a clinical measure of balance). Secondary outcomes include other balance and mobility measures, number of falls and falls risk measures, cognitive and behavioural measures, and carer burden and quality of life measures. Assessors will be blind to group allocation. Longitudinal change in balance performance will be evaluated in a sub-study, in which the first 64 participants of the control group with mild to moderate severity Alzheimer's disease, and 64 age and gender matched healthy participants will be re-assessed on all measures at initial assessment, and then at 6, 12, 18 and 24 months. By introducing a balance programme at an early stage of the dementia pathway, when participants are more likely capable of safe and active participation in balance training, there is potential that balance performance will be improved as dementia progresses, which may reduce the high falls risk at this later stage. If successful, this approach has the potential for widespread application through community based services for people with mild to moderate severity Alzheimer's disease. The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000040369).

  8. Examining the pathways for young people with drug and alcohol dependence: a mixed-method design to examine the role of a treatment programme.

    PubMed

    Nathan, Sally; Rawstorne, Patrick; Hayen, Andrew; Bryant, Joanne; Baldry, Eileen; Ferry, Mark; Williams, Megan; Shanahan, Marian; Jayasinha, Ranmalie

    2016-05-25

    Young people with drug and alcohol problems are likely to have poorer health and other psychosocial outcomes than other young people. Residential treatment programmes have been shown to lead to improved health and related outcomes for young people in the short term. There is very little robust research showing longer term outcomes or benefits of such programmes. This paper describes an innovative protocol to examine the longer term outcomes and experiences of young people referred to a residential life management and treatment programme in Australia designed to address alcohol and drug issues in a holistic manner. This is a mixed-methods study that will retrospectively and prospectively examine young people's pathways into and out of a residential life management programme. The study involves 3 components: (1) retrospective data linkage of programme data to health and criminal justice administrative data sets, (2) prospective cohort (using existing programme baseline data and a follow-up survey) and (3) qualitative in-depth interviews with a subsample of the prospective cohort. The study will compare findings among young people who are referred and (a) stay 30 days or more in the programme (including those who go on to continuing care and those who do not); (b) start, but stay fewer than 30 days in the programme; (c) are assessed, but do not start the programme. Ethics approval has been sought from several ethics committees including a university ethics committee, state health departments and an Aboriginal-specific ethics committee. The results of the study will be published in peer-reviewed journals, presented at research conferences, disseminated via a report for the general public and through Facebook communications. The study will inform the field more broadly about the value of different methods in evaluating programmes and examining the pathways and trajectories of vulnerable young people. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. The prevention access and risk taking in young people (PARTY) project protocol: a cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice.

    PubMed

    Sanci, Lena; Grabsch, Brenda; Chondros, Patty; Shiell, Alan; Pirkis, Jane; Sawyer, Susan; Hegarty, Kelsey; Patterson, Elizabeth; Cahill, Helen; Ozer, Elizabeth; Seymour, Janelle; Patton, George

    2012-06-06

    There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. clinicians' detection of risk-taking and emotional distress, young people's intention to change and reduction of risk taking. pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff's self-perceived competency in young people's care and clinicians' detection and response to risk taking behaviours and emotional distress in 14-24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation. The PARTY trial is the first to examine the effectiveness and efficiency of a psychosocial risk screening and counselling intervention for young people attending primary care. It will provide important data on health risk profiles of young people attending general practice and on the effects of the intervention on engagement with primary care and health outcomes over 12 months. ISRCTN16059206.

  10. Integrating psychological theory into the design of an online intervention for sexual health: the sexunzipped website.

    PubMed

    Carswell, Kenneth; McCarthy, Ona; Murray, Elizabeth; Bailey, Julia V

    2012-11-19

    The Internet can provide a confidential and convenient medium for sexual health promotion for young people. This paper describes the development of an interactive, theory-based website (Sexunzipped) aimed at increasing safe sexual behavior of young people, as well as an outline of the evaluation protocol. The website focuses on safer sex, relationships, and sexual pleasure. An overview of the site is provided, including a description of the theoretical constructs which form the basis of the site development. An integrated behavioral model was chosen as the guiding theory for the Sexunzipped intervention. A randomized trial design will be used to evaluate the site quantitatively. The content of the site is described in detail with examples of the main content types: information pages, quizzes, and decision-making activities. We describe the protocol for quantitative evaluation of the website using a randomized trial design and discuss the principal challenges involved in developing the site, including the challenge of balancing the requirements of theory with young people's views on website content and design. Considerations for future interventions are discussed. Developing an online behavior-change intervention is costly and time consuming. Given the large public health potential, the cost involved in developing online interventions, and the need for attractive design, future interventions may benefit from collaborating with established sites that already have a user base, a brand, and a strong Internet presence. It is vital to involve users in decisions about intervention content, design, and features, paying attention to aspects that will attract and retain users' interest. A central challenge in developing effective Internet-based interventions for young people is to find effective ways to operationalize theory in ways that address the views and perspectives of young people.

  11. Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial.

    PubMed

    Hossain, Mohammad S; Harvey, Lisa A; Rahman, Md Akhlasur; Muldoon, Stephen; Bowden, Jocelyn L; Islam, Md Shofiqul; Jan, Stephen; Taylor, Valerie; Cameron, Ian D; Chhabra, Harvinder Singh; Lindley, Richard I; Biering-Sørensen, Fin; Li, Qiang; Dhakshinamurthy, Murali; Herbert, Robert D

    2016-01-07

    In low-income and middle-income countries, people with spinal cord injury (SCI) are vulnerable to life-threatening complications after they are discharged from hospital. The aim of this trial is to determine the effectiveness and cost-effectiveness of an inexpensive and sustainable model of community-based care designed to prevent and manage complications in people with SCI in Bangladesh. A pragmatic randomised controlled trial will be undertaken. 410 wheelchair-dependent people with recent SCI will be randomised to Intervention and Control groups shortly after discharge from hospital. Participants in the Intervention group will receive regular telephone-based care and three home visits from a health professional over the 2 years after discharge. Participants in the Control group will receive standard care, which does not involve regular contact with health professionals. The primary outcome is all-cause mortality at 2 years. Recruitment started on 12 July 2015 and the trial is expected to take 5 years to complete. Ethical approval was obtained from the Institutional Ethics Committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95) and the Bangladesh Guidance on Clinical Trial Inspection (2011). The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences. ACTRN12615000630516, U1111-1171-1876. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Development and evaluation of a mobile AAC: a virtual therapist and speech assistant for people with communication disabilities.

    PubMed

    Wang, Erh-Hsuan; Zhou, Leming; Chen, Szu-Han Kay; Hill, Katya; Parmanto, Bambang

    2017-09-26

    The currently existing Augmentative and Alternative Communication (AAC) technologies have limitations to produce the best communication rehabilitation outcomes and therefore a better solution is needed. In this work, a mobile AAC app was developed based on results from research studies. Sophisticated AAC language programming, embedded training materials, and real-time communication performance reporting were integrated into the app. Two groups of study participants were recruited to participate a usability study and a preliminary feasibility study for the purpose of evaluating this mobile AAC app, respectively. A tablet-based AAC app was developed to support communication rehabilitation. User studies of the app were conducted and included able-bodied individuals and people with verbal communication disabilities. All study participants agreed that the app establishes a usable alternative treatment protocol for communication rehabilitation. The app's integrated features have great potential to maximize users' communication effectiveness, enhance language skills, and ultimately improve users' quality of life. Implications for rehabilitation We have developed and evaluated an integrated mobile AAC language-based app. This tablet-based app integrated AAC with embedded trainings and real-time performance report.

  13. Measuring participation in children with Gilles de la Tourette syndrome: a pilot study with ICF-CY.

    PubMed

    Meucci, Paolo; Leonardi, Matilde; Zibordi, Federica; Nardocci, Nardo

    2009-01-01

    Environmental factors (EF) have an important role on Tourette's symptoms and the same factors can be decisive on the impact that the disease has on people with Tourette syndrome (TS) daily life. The research was carried out by the Neurological Institute Carlo Besta IRCCS Foundation with the principal objective of describing the complete range of functional profiles of children with TS, to define the functioning and the difficulties in social participation. The research protocol was composed of the ICF-CY questionnaire, WHO-DAS II proxy version, the Vineland Adaptive Behavior Scale and the Kidscreen questionnaires - Quality of life (QoL) questionnaires for children and adolescents. The research protocol involved a multidisciplinary team (medical staff, psychologist, pedagogist). The children reported higher QoL's level than the QoL attributed by parents. The Vineland scores reflected considerable difficulties in socialisation. Through the EF analysis, this study highlights the facilitating role of the immediate family and health professionals. Beyond the clinical symptoms, this study points out that the therapeutic elements must be identified by a change of environment, and not only in a child's adaptation ability.

  14. Several submaximal exercise tests are reliable, valid and acceptable in people with chronic pain, fibromyalgia or chronic fatigue: a systematic review.

    PubMed

    Ratter, Julia; Radlinger, Lorenz; Lucas, Cees

    2014-09-01

    Are submaximal and maximal exercise tests reliable, valid and acceptable in people with chronic pain, fibromyalgia and fatigue disorders? Systematic review of studies of the psychometric properties of exercise tests. People older than 18 years with chronic pain, fibromyalgia and chronic fatigue disorders. Studies of the measurement properties of tests of physical capacity in people with chronic pain, fibromyalgia or chronic fatigue disorders were included. Studies were required to report: reliability coefficients (intraclass correlation coefficient, alpha reliability coefficient, limits of agreements and Bland-Altman plots); validity coefficients (intraclass correlation coefficient, Spearman's correlation, Kendal T coefficient, Pearson's correlation); or dropout rates. Fourteen studies were eligible: none had low risk of bias, 10 had unclear risk of bias and four had high risk of bias. The included studies evaluated: Åstrand test; modified Åstrand test; Lean body mass-based Åstrand test; submaximal bicycle ergometer test following another protocol other than Åstrand test; 2-km walk test; 5-minute, 6-minute and 10-minute walk tests; shuttle walk test; and modified symptom-limited Bruce treadmill test. None of the studies assessed maximal exercise tests. Where they had been tested, reliability and validity were generally high. Dropout rates were generally acceptable. The 2-km walk test was not recommended in fibromyalgia. Moderate evidence was found for reliability, validity and acceptability of submaximal exercise tests in patients with chronic pain, fibromyalgia or chronic fatigue. There is no evidence about maximal exercise tests in patients with chronic pain, fibromyalgia and chronic fatigue. Copyright © 2014. Published by Elsevier B.V.

  15. Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD 'QbTest Utility for Optimising Treatment in ADHD' (QUOTA): a feasibility randomised controlled trial.

    PubMed

    Hall, Charlotte L; James, Marilyn; Brown, Sue; Martin, Jennifer L; Brown, Nikki; Selby, Kim; Clarke, Julie; Vijayan, Hena; Guo, Boliang; Sayal, Kapil; Hollis, Chris; Groom, Madeleine J

    2018-02-15

    Attention-deficit hyperactivity disorder (ADHD) is characterised by symptoms of inattention, hyperactivity and impulsivity. To improve outcomes, the National Institute for Health and Care Excellence ADHD guidelines recommend regular monitoring of symptoms when children commence medication. However, research suggests that routine monitoring rarely happens, and clinicians often rely on subjective information such as reports from parents and teachers to ascertain improvement. These sources can be unreliable and difficult to obtain. The addition of an objective test of attention and activity (QbTest) may improve the objectivity, reliability and speed of clinical decision-making and so reduce the time to identify the optimal medication dose. This study aims to assess the feasibility and acceptability of a QbTest medication management protocol delivered in routine healthcare services for children with ADHD. This multisite feasibility randomised controlled trial (RCT) will recruit 60 young people (aged 6-17 years old), diagnosed with ADHD, and starting stimulant medication who are seen by Child and Adolescent Mental Health Services or Community Paediatric services. Participants will be randomised into one of two arms. In the experimental arm (QbTest protocol), the participant will complete a QbTest at baseline (prior to medication initiation), and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later). In the control arm, participants will receive treatment as usual, with at least two follow-up consultations. Measures of parent-, teacher- and clinician-rated symptoms and global functioning will be completed at each time point. Health economic measures will be completed. Clinicians will record treatment decision-making. Acceptability and feasibility of the protocol will be assessed alongside outcome measure completion rates. Qualitative interviews will be conducted. The findings will be used to inform the development of a fully powered RCT. The results will be submitted for publication in peer-reviewed journals. The study has ethical approval. NCT03368573; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  16. A Review on Locomotor Training after Spinal Cord Injury: Reorganization of Spinal Neuronal Circuits and Recovery of Motor Function

    PubMed Central

    2016-01-01

    Locomotor training is a classic rehabilitation approach utilized with the aim of improving sensorimotor function and walking ability in people with spinal cord injury (SCI). Recent studies have provided strong evidence that locomotor training of persons with clinically complete, motor complete, or motor incomplete SCI induces functional reorganization of spinal neuronal networks at multisegmental levels at rest and during assisted stepping. This neuronal reorganization coincides with improvements in motor function and decreased muscle cocontractions. In this review, we will discuss the manner in which spinal neuronal circuits are impaired and the evidence surrounding plasticity of neuronal activity after locomotor training in people with SCI. We conclude that we need to better understand the physiological changes underlying locomotor training, use physiological signals to probe recovery over the course of training, and utilize established and contemporary interventions simultaneously in larger scale research studies. Furthermore, the focus of our research questions needs to change from feasibility and efficacy to the following: what are the physiological mechanisms that make it work and for whom? The aforementioned will enable the scientific and clinical community to develop more effective rehabilitation protocols maximizing sensorimotor function recovery in people with SCI. PMID:27293901

  17. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

    PubMed Central

    Agot, Kawango

    2017-01-01

    Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54) PMID:28274904

  18. Revisiting the ALA/N (alpha-lipoic acid/low-dose naltrexone) protocol for people with metastatic and nonmetastatic pancreatic cancer: a report of 3 new cases.

    PubMed

    Berkson, Burton M; Rubin, Daniel M; Berkson, Arthur J

    2009-12-01

    The authors, in a previous article, described the long-term survival of a man with pancreatic cancer and metastases to the liver, treated with intravenous alpha-lipoic acid and oral low-dose naltrexone (ALA/N) without any adverse effects. He is alive and well 78 months after initial presentation. Three additional pancreatic cancer case studies are presented in this article. At the time of this writing, the first patient, GB, is alive and well 39 months after presenting with adenocarcinoma of the pancreas with metastases to the liver. The second patient, JK, who presented to the clinic with the same diagnosis was treated with the ALA/N protocol and after 5 months of therapy, PET scan demonstrated no evidence of disease. The third patient, RC, in addition to his pancreatic cancer with liver and retroperitoneal metastases, has a history of B-cell lymphoma and prostate adenocarcinoma. After 4 months of the ALA/N protocol his PET scan demonstrated no signs of cancer. In this article, the authors discuss the poly activity of ALA: as an agent that reduces oxidative stress, its ability to stabilize NF(k)B, its ability to stimulate pro-oxidant apoptosic activity, and its discriminative ability to discourage the proliferation of malignant cells. In addition, the ability of lowdose naltrexone to modulate an endogenous immune response is discussed. This is the second article published on the ALA/N protocol and the authors believe the protocol warrants clinical trial.

  19. Does Real World Use of Liraglutide Match its Use in the LEADER Cardiovascular Outcome Trial? Study Protocol.

    PubMed

    Hinton, William; Feher, Michael; Munro, Neil; de Lusignan, Simon

    2018-06-01

    Liraglutide is an injectable therapy to treat type 2 diabetes (T2DM), belonging to the glucagon-like peptide-1 receptor agonist class of drugs. The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial established that liraglutide demonstrated glucose-lowering benefits and improved cardiovascular outcomes in those individuals with T2DM at high cardiovascular risk. The aim of this study is to report the prevalence and characteristics of people treated with liraglutide compared with the LEADER trial. In addition, the remaining portion of the T2DM population will be examined to determine the prevalence of those who meet the inclusion criteria for the LEADER trial but who are not treated with this medication. This is a cross-sectional analysis of routinely collected primary care data on all people with T2DM included in the Royal College of General Practitioners (RCGP) Research and Surveillance Center (RSC) network database. People with T2DM will be identified from the dataset using a well-established ontological process. Read and other clinical codes will be used to identify people prescribed liraglutide and those at high cardiovascular risk. We will use descriptive statistics to report the characteristics of people with T2DM prescribed liraglutide compared with those of the LEADER trial and the proportion of the wider T2DM cohort that matches the LEADER inclusion criteria. In terms of ethical considerations, this study used pseudonymized data, and was classed as an "Audit of current practice". The results of the study will be submitted for publication in a peer-reviewed journal to report the applicability of the results of the LEADER trial to real-world clinical practice. Novo Nordisk Limited.

  20. Yoga Training Has Positive Effects on Postural Balance and Its Influence on Activities of Daily Living in People with Multiple Sclerosis: A Pilot Study.

    PubMed

    de Oliveira, Gerson; Tavares, Maria da Consolação Cunha Gomes Fernandes; de Faria Oliveira, Jane Domingues; Rodrigues, Marcos Rojo; Santaella, Danilo Forghieri

    2016-01-01

    There is a little evidence about the influence of yoga as a complementary therapy for postural balance and its influence on activities of daily living in multiple sclerosis (MS) patients. To evaluate the influence of a six-month yoga program on postural balance and subjective impact of postural balance impairment on activities of daily living in people with MS. Randomized controlled pilot study. Protocol developed at the Adaptive Physical Activity Study Department, College of Physical Education, State University of Campinas, Brazil. A total of 12 (11 women) yoga naive people with MS randomly divided into two groups as follows: Control (C-waiting list, n = 6) and Yoga (Y-Yoga training, n = 6). Yoga group practiced postures, breathing exercises, meditation, and relaxation on weekly 60-min classes for a six-month period. The following evaluations were performed at study entry (baseline), and after six months (six months): Berg Balance Scale (BBS), Expanded Disability Status Scale (EDSS), and self-reported postural balance quality and influence of postural balance on activities of daily living. There was a significant improvement in BBS score from baseline to six months only in the Yoga group, especially in subjects with higher EDSS score, with increased quality of self-reported postural balance, and decreased influence of postural balance impairment on activities of daily living. In conclusion, a six-month yoga training is beneficial for people with MS, since it improves postural balance and decreases the influence of postural balance impairment on activities of daily living. A greater sample size is necessary to increase generalization, but it seems that yoga could be included as a feasible complementary therapy for people with MS. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. A randomized controlled trial of an enhanced interdisciplinary community based group program for people with Parkinson's disease: study rationale and protocol.

    PubMed

    Peters, Catherine; Currin, Michelle; Tyson, Sara; Rogers, Anthea; Healy, Susan; McPhail, Steven; Brauer, Sandra G; Heathcote, Katharine; Comans, Tracy

    2012-01-09

    Parkinson's disease (PD) is a progressive, chronic neurodegenerative disorder for which there is no known cure. Physical exercise programs may be used to assist with the physical management of PD. Several studies have demonstrated that community based physical therapy programs are effective in reducing physical aspects of disability among people with PD. While multidisciplinary therapy interventions may have the potential to reduce disability and improve the quality of life of people with PD, there is very limited clinical trial evidence to support or refute the use of a community based multidisciplinary or interdisciplinary programs for people with PD. A two group randomized trial is being undertaken within a community rehabilitation service in Brisbane, Australia. Community dwelling adults with a diagnosis of Idiopathic Parkinson's disease are being recruited. Eligible participants are randomly allocated to a standard exercise rehabilitation group program or an intervention group which incorporates physical, cognitive and speech activities in a multi-tasking framework. Outcomes will be measured at 6-week intervals for a period of six months. Primary outcome measures are the Montreal Cognitive Assessment (MoCA) and the Timed Up and Go (TUG) cognitive test. Secondary outcomes include changes in health related quality of life, communication, social participation, mobility, strength and balance, and carer burden measures. This study will determine the immediate and long-term effectiveness of a unique multifocal, interdisciplinary, dual-tasking approach to the management of PD as compared to an exercise only program. We anticipate that the results of this study will have implications for the development of cost effective evidence based best practice for the treatment of people with PD living in the community.

  2. Efficacy of a web- and text messaging-based intervention to reduce problem drinking in young people: study protocol of a cluster-randomised controlled trial.

    PubMed

    Haug, Severin; Kowatsch, Tobias; Castro, Raquel Paz; Filler, Andreas; Schaub, Michael P

    2014-08-07

    Problem drinking, particularly risky single-occasion drinking is widespread among adolescents and young adults in most Western countries. Mobile phone text messaging allows a proactive and cost-effective delivery of short messages at any time and place and allows the delivery of individualised information at times when young people typically drink alcohol. The main objective of the planned study is to test the efficacy of a combined web- and text messaging-based intervention to reduce problem drinking in young people with heterogeneous educational level. A two-arm cluster-randomised controlled trial with one follow-up assessment after 6 months will be conducted to test the efficacy of the intervention in comparison to assessment only. The fully-automated intervention program will provide an online feedback based on the social norms approach as well as individually tailored mobile phone text messages to stimulate (1) positive outcome expectations to drink within low-risk limits, (2) self-efficacy to resist alcohol and (3) planning processes to translate intentions to resist alcohol into action. Program participants will receive up to two weekly text messages over a time period of 3 months. Study participants will be 934 students from approximately 93 upper secondary and vocational schools in Switzerland. Main outcome criterion will be risky single-occasion drinking in the past 30 days preceding the follow-up assessment. This is the first study testing the efficacy of a combined web- and text messaging-based intervention to reduce problem drinking in young people. Given that this intervention approach proves to be effective, it could be easily implemented in various settings, and it could reach large numbers of young people in a cost-effective way. Current Controlled Trials ISRCTN59944705.

  3. Examining Expertise Using Interviews and Verbal Protocols

    ERIC Educational Resources Information Center

    van de Wiel, Margje W. J.

    2017-01-01

    To understand expertise and expertise development, interactions between knowledge, cognitive processing and task characteristics must be examined in people at different levels of training, experience, and performance. Interviewing is widely used in the initial exploration of domain expertise. Work and cognitive task analysis chart the knowledge,…

  4. Navigating the Unfamiliar in a Quest towards Culturally Responsive Pedagogy in the Classroom

    ERIC Educational Resources Information Center

    Baskerville, Delia

    2009-01-01

    This paper examines a New Zealand "Pakeha" (European) teacher's professional development experience working with "Maori" (indigenous people of New Zealand), and their protocols and practices. A "Maori kaumatua" (male leader) experienced in theatre direction, acting, and psychiatric nursing led "Maori"…

  5. Protocol: A grounded theory of 'recovery'-perspectives of adolescent users of mental health services.

    PubMed

    Palmquist, Lucianne; Patterson, Sue; O'Donovan, Analise; Bradley, Graham

    2017-07-20

    Policies internationally endorse the recovery paradigm as the appropriate foundation for youth mental health services. However, given that this paradigm is grounded in the views of adults with severe mental illness, applicability to youth services and relevance to young people is uncertain, particularly as little is known about young people's views. A comprehensive understanding of the experiences and expectations of young people is critical to developing youth mental health services that are acceptable, accessible, effective and relevant. To inform development of policy and youth services, the study described in this protocol aims to develop a comprehensive account of the experiences and expectations of 12-17 year olds as they encounter mental disorders and transition through specialist mental health services. Data will be analysed to model recovery from the adolescents' perspective. This grounded theory study will use quantitative and qualitative data collected in interviews with 12-17 year olds engaged with specialist Child/Youth Mental Health Service in Queensland, Australia. Interviews will explore adolescents' expectations and experiences of mental disorder, and of services, as they transition through specialist mental health services, including the meaning of their experiences and ideas of 'recovery' and how their experiences and expectations are shaped. Data collection and analysis will use grounded theory methods. Adolescents' experiences will be presented as a mid-range theory. The research will provide tangible recommendations for youth-focused mental health policy and practice. Findings will be disseminated within academic literature and beyond to participants, health professionals, mental health advocacy groups and policy and decision makers via publications, research summaries, conferences and workshops targeting different audiences. Ethical and research governance approvals have been obtained from relevant Human Research Ethics committees and all sites involved. © 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.

  6. Protocol for a qualitative study on promoting dietary change and positive food choices for poor people with low income who experience cardiovascular disease in Pakistan

    PubMed Central

    Barolia, Rubina Iqbal; Clark, Alexander M; Higginbottom, Gina M A

    2013-01-01

    Introduction There is a misconception that cardiovascular disease (CVD) is the burden of wealthy nations, but, in fact, it is the leading cause of death and disability-adjusted life worldwide. Healthy diets are an essential factor in the prevention of CVD. However, promoting healthy diet is challenging, particularly for people with low-socioeconomic status (SES), because poverty is linked with many risk behaviours such as smoking, unhealthy eating and obesity. Multiple factors, cultural values and beliefs interact and make healthy eating very challenging. The effects of these factors in the context of low-SES populations with CVD are largely unknown. To address this gap, this study will examine the factors that affect decisions about consuming healthy diet in Pakistanis with low SES who suffer from CVD. Methods and analysis A qualitative method of interpretive description will be used. 25 participants will be selected from two cardiac rehabilitation (CR) centres in Karachi, Pakistan. Face-to-face interviews using a critical realist framework will be used to understand individual and contextual factors in the food choices of people with low SES and CVD. ATLAS.ti qualitative data analysis software will be used to identify themes and patterns in the interview data. Ethics and discussion Ethical approvals were received from the Ethics Review board of University of Alberta, Canada and Aga Khan University, Karachi Pakistan. The findings will generate new knowledge about which and how factors influence the food choices of Pakistanis with CVD and low SES to provide an insight into the development of an operational framework for designing interventions for prevention of CVD. For knowledge-translation purposes, we will publish the findings in highly accessed, peer-reviewed scientific and health policy journals at the national and international level. This research protocol received IRDC (International Development Research Centre) doctoral award from International Development Research Centre, Ottawa, Canada. PMID:24309173

  7. Well-being, health and fitness of children who use wheelchairs: feasibility study protocol to develop child-centred 'keep-fit' exercise interventions.

    PubMed

    O'Brien, Thomas D; Noyes, Jane; Spencer, Llinos Haf; Kubis, Hans-Peter; Edwards, Rhiannon T; Bray, Nathan; Whitaker, Rhiannon

    2015-02-01

    To undertake the pre-clinical and modelling phases of the Medical Research Council complex intervention framework to underpin development of child-centred 'keep-fit', exercise and physical activity interventions for children and young people who use wheelchairs. Children who use wheelchairs face many barriers to participation in physical activity, which compromises fitness, obesity, well-being and health. 'Keep-fit' programmes that are child-centred and engaging are urgently required to enhance participation of disabled children and their families as part of a healthy lifestyle. Nurses will likely be important in promoting and monitoring 'keep-fit' intervention(s) when implemented in the community. Mixed-method (including economic analysis) feasibility study to capture child and family preferences and keep-fit needs and to determine outcome measures for a 'keep-fit' intervention. The study comprises three stages. Stage 1 includes a mixed-method systematic review of effectiveness, cost effectiveness and key stakeholder views and experiences of keep-fit interventions, followed by qualitative interviews with children, young people and their parents to explore preferences and motivations for physical activity. Stage 2 will identify standardized outcome measures and test their application with children who use wheelchairs to obtain baseline fitness data. Options for an exercise-based keep-fit intervention will then be designed based on Stage 1 and 2 findings. In stage 3, we will present intervention options for feedback and further refinement to children and parents/carers in focus groups. (Project funded October 2012). At completion, this study will lead to the design of the intervention and a protocol to test its efficacy. © 2014 John Wiley & Sons Ltd.

  8. Comparison of error-based and errorless learning for people with severe traumatic brain injury: study protocol for a randomized control trial.

    PubMed

    Ownsworth, Tamara; Fleming, Jennifer; Tate, Robyn; Shum, David H K; Griffin, Janelle; Schmidt, Julia; Lane-Brown, Amanda; Kendall, Melissa; Chevignard, Mathilde

    2013-11-05

    Poor skills generalization poses a major barrier to successful outcomes of rehabilitation after traumatic brain injury (TBI). Error-based learning (EBL) is a relatively new intervention approach that aims to promote skills generalization by teaching people internal self-regulation skills, or how to anticipate, monitor and correct their own errors. This paper describes the protocol of a study that aims to compare the efficacy of EBL and errorless learning (ELL) for improving error self-regulation, behavioral competency, awareness of deficits and long-term outcomes after TBI. This randomized, controlled trial (RCT) has two arms (EBL and ELL); each arm entails 8 × 2 h training sessions conducted within the participants' homes. The first four sessions involve a meal preparation activity, and the final four sessions incorporate a multitasking errand activity. Based on a sample size estimate, 135 participants with severe TBI will be randomized into either the EBL or ELL condition. The primary outcome measure assesses error self-regulation skills on a task related to but distinct from training. Secondary outcomes include measures of self-monitoring and self-regulation, behavioral competency, awareness of deficits, role participation and supportive care needs. Assessments will be conducted at pre-intervention, post-intervention, and at 6-months post-intervention. This study seeks to determine the efficacy and long-term impact of EBL for training internal self-regulation strategies following severe TBI. In doing so, the study will advance theoretical understanding of the role of errors in task learning and skills generalization. EBL has the potential to reduce the length and costs of rehabilitation and lifestyle support because the techniques could enhance generalization success and lifelong application of strategies after TBI. ACTRN12613000585729.

  9. Understanding the role of contrasting urban contexts in healthy aging: an international cohort study using wearable sensor devices (the CURHA study protocol).

    PubMed

    Kestens, Yan; Chaix, Basile; Gerber, Philippe; Desprès, Michel; Gauvin, Lise; Klein, Olivier; Klein, Sylvain; Köppen, Bernhard; Lord, Sébastien; Naud, Alexandre; Payette, Hélène; Richard, Lucie; Rondier, Pierre; Shareck, Martine; Sueur, Cédric; Thierry, Benoit; Vallée, Julie; Wasfi, Rania

    2016-05-05

    Given the challenges of aging populations, calls have been issued for more sustainable urban re-development and implementation of local solutions to address global environmental and healthy aging issues. However, few studies have considered older adults' daily mobility to better understand how local built and social environments may contribute to healthy aging. Meanwhile, wearable sensors and interactive map-based applications offer novel means for gathering information on people's mobility, levels of physical activity, or social network structure. Combining such data with classical questionnaires on well-being, physical activity, perceived environments and qualitative assessment of experience of places opens new opportunities to assess the complex interplay between individuals and environments. In line with current gaps and novel analytical capabilities, this research proposes an international research agenda to collect and analyse detailed data on daily mobility, social networks and health outcomes among older adults using interactive web-based questionnaires and wearable sensors. Our study resorts to a battery of innovative data collection methods including use of a novel multisensor device for collection of location and physical activity, interactive map-based questionnaires on regular destinations and social networks, and qualitative assessment of experience of places. This rich data will allow advanced quantitative and qualitative analyses in the aim to disentangle the complex people-environment interactions linking urban local contexts to healthy aging, with a focus on active living, social networks and participation, and well-being. This project will generate evidence about what characteristics of urban environments relate to active mobility, social participation, and well-being, three important dimensions of healthy aging. It also sets the basis for an international research agenda on built environment and healthy aging based on a shared and comprehensive data collection protocol.

  10. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

    PubMed

    Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

    2018-04-19

    Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Orientation and mobility training for adults with low vision: a new standardized approach

    PubMed Central

    Ballemans, Judith; Kempen, Gertrudis IJM

    2013-01-01

    Background: Orientation and mobility training aims to facilitate independent functioning and participation in the community of people with low vision. Objective: (1) To gain insight into current practice regarding orientation and mobility training, and (2) to develop a theory-driven standardized version of this training to teach people with low vision how to orientate and be safe in terms of mobility. Study of current practice: Insight into current practice and its strengths and weaknesses was obtained via reviewing the literature, observing orientation and mobility training sessions (n = 5) and interviewing Dutch mobility trainers (n = 18). Current practice was mainly characterized by an individual, face-to-face orientation and mobility training session concerning three components: crystallizing client’s needs, providing information and training skills. A weakness was the lack of a (structured) protocol based on evidence or theory. New theory-driven training: A new training protocol comprising two face-to-face sessions and one telephone follow-up was developed. Its content is partly based on the components of current practice, yet techniques from theoretical frameworks (e.g. social-cognitive theory and self-management) are incorporated. Discussion: A standardized, tailor-made orientation and mobility training for using the identification cane is available. The new theory-driven standardized training is generally applicable for teaching the use of every low-vision device. Its acceptability and effectiveness are currently being evaluated in a randomized controlled trial. PMID:22734105

  12. Impact of home modification services on ability in everyday life for people ageing with disabilities.

    PubMed

    Petersson, Ingela; Lilja, Margareta; Hammel, Joy; Kottorp, Anders

    2008-04-01

    To examine the impact of home modifications on self-rated ability in everyday life from various aspects for people ageing with disabilities. The study sample was recruited from an agency providing home modification services in Sweden and comprised 73 subjects whose referrals had been approved and who were scheduled to receive home modifications (intervention group) and 41 subjects waiting for their applications to be assessed for approval (comparison group). The subjects rated their ability in everyday life using the Client-Clinician Assessment Protocol Part I on 2 occasions: at baseline and follow-up. The Client-Clinician Assessment Protocol Part I provides data on the clients' self-rated independence, difficulty and safety in everyday life. The data were first subjected to Rasch analysis in order to convert the raw scores into interval measures. Further analyses to investigate changes in self-rated ability were conducted with parametric statistics. Subjects who had received home modifications reported a statistically significant improvement in their self-rated ability in everyday life compared with those in the comparison group. Subjects who had received home modifications reported less difficulty and increased safety, especially in tasks related to self-care in the bathroom and transfers, such as getting in and out of the home. Home modifications have a positive impact on self-rated ability in everyday life, especially on decreasing the level of difficulty and increasing safety.

  13. Interventions for improving adherence to iron chelation therapy in people with sickle cell disease or thalassaemia

    PubMed Central

    Fortin, Patricia M; Madgwick, Karen V; Trivella, Marialena; Hopewell, Sally; Doree, Carolyn; Estcourt, Lise J

    2016-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows: To identify and assess the effectiveness of interventions to improve adherence to iron chelation therapy compared to standard care in people with SCD or thalassaemia including: identifying and assessing the effectiveness of different types of interventions (psychological and psychosocial, educational, medication interventions, or multi-component interventions);identifying and assessing the effectiveness of interventions specific to different age groups (children, adolescents, adults). PMID:27713668

  14. Status epilepticus and cluster seizures.

    PubMed

    Patterson, Edward Ned E

    2014-11-01

    Status epilepticus (SE) is a medical emergency for companion animals, with significant associated morbidity and mortality. Therapy in companion animals and people has been largely with sedatives and anesthetics, many of which have gamma-aminobutyric acid receptor-mediated mechanisms. Early aggressive treatment includes staged first-line therapy with benzodiazepines, and second- and third-line protocols when needed. Recently, intravenous levetiracetam has also been used in for SE in dogs and people, and there are other human intravenous drug preparations that may hold promise for future use in companion animals. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    PubMed

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

  16. Understanding influences on the uptake of pulmonary rehabilitation in the East of England: an Inclusive Design/mixed-methods study protocol.

    PubMed

    Liu, Yuanyuan; Dickerson, Terry; Early, Frances; Fuld, Jonathan; Clarkson, P John

    2018-04-24

    1.2 million people in the UK have chronic obstructive pulmonary disease (COPD) that causes breathlessness, difficulty with daily activities, infections and hospitalisation. Pulmonary rehabilitation (PR), a programme of supervised exercise and education, is recommended for patients with COPD. However, only 1 in 10 of those who need it receive PR. Also, the UK National COPD Audit Programme concluded that the COPD treatment might not be accessible to people with disabilities. This paper applies an Inclusive Design approach to community-based PR service provisions. It aims to inform improvements to the PR service by identifying barriers to the uptake of PR in the COPD care journey in relation to patients' capabilities that can affect their access to PR. The protocol includes four steps. Step 1 will involve interviews with healthcare professionals and patients to gather insight into their experiences and produce a hierarchical task analysis of the COPD care journeys. Step 2 will estimate the service exclusion: the demand of every task on patients' capabilities will be rated by predefined scales, and the proportion of the population excluded from the service will be estimated by an exclusion calculator. Step 3 will identify the challenges of the PR service; a framework analysis will guide the data analysis of the interviews and care journey. Step 4 will propose recommendations to help patients manage their COPD care informed by the challenges identified in step 3 and refine recommendations through interviews and focus groups. The Cambridge Central Research Ethics Committee gave the study protocol a positive ethical opinion (17/EE/0136). Study results will be disseminated through peer-reviewed journals, conferences and the British Lung Foundation networks. They will also be fed into a Research for Patient Benefit project on increasing the referral and uptake of PR. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Pain in dementia: prevalence and associated factors: protocol of a multidisciplinary study.

    PubMed

    van Kooten, Janine; Delwel, Suzanne; Binnekade, Tarik T; Smalbrugge, Martin; van der Wouden, Johannes C; Perez, Roberto S G M; Rhebergen, Didi; Zuurmond, Wouter W A; Stek, Max L; Lobbezoo, Frank; Hertogh, Cees M P M; Scherder, Erik J A

    2015-03-21

    Pain is a common problem in people with dementia, however the exact prevalence of pain in dementia subtypes, e.g. Alzheimer's Disease (AD), Vascular Dementia (VaD), Frontotemporal Dementia (FTD) and dementia with Lewy Bodies (DLB), is unknown, as is the relation between pain and the different subtypes of dementia. In this study, the prevalence of pain in people with dementia will be investigated per dementia subtype and the relationship between the various subtypes of dementia and the presence of specific types of pain (i.e. musculoskeletal pain, neuropathic pain and orofacial pain) will be examined. Secondly, associations between various types of pain, cognitive functioning, neuropsychiatric symptoms and quality of life in people with dementia will be examined. A third purpose is to study the value of the assessment of autonomic responses in assessing pain in people with dementia. Finally, the effect of feedback to the attending physician on the presence of pain, based on examination by investigators with backgrounds in neuropsychology, geriatric dentistry and elderly care medicine, will be evaluated. A cross-sectional, partially longitudinal observational study in 400 participants with dementia, aged 60 years and older. Participants will be recruited from an outpatient memory clinic and dementia special care units. All participants will be examined by an elderly care medicine trainee, a dentist with experience in geriatric dentistry, and a neuropsychologist. The primary outcome is presence of pain. Secondary outcomes will include oral health, autonomic responses to pain stimulus, vital sensibility and gnostic sensibility, musculoskeletal examination, cognitive functioning, neuropsychiatric symptoms, and quality of life. This study will help to enhance our knowledge regarding the prevalence of different types of pain in different dementia subtypes i.e. AD, VaD, FTD and DLB. This study also aims to contribute to a better understanding of oral health status in people with dementia, the use of autonomic responses in the assessment of pain in people with dementia and the relationships between pain and cognitive symptoms, neuropsychiatric symptoms and quality of life in people with various dementia subtypes and in different stages of the disease.

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

    PubMed

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

    2018-02-12

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

  19. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial.

    PubMed

    Sternberg, Cora N; Castellano, Daniel; Daugaard, Gedske; Géczi, Lajos; Hotte, Sebastien J; Mainwaring, Paul N; Saad, Fred; Souza, Ciro; Tay, Miah H; Garrido, José M Tello; Galli, Luca; Londhe, Anil; De Porre, Peter; Goon, Betty; Lee, Emma; McGowan, Tracy; Naini, Vahid; Todd, Mary B; Molina, Arturo; George, Daniel J

    2014-10-01

    In the final analysis of the phase 3 COU-AA-301 study, abiraterone acetate plus prednisone significantly prolonged overall survival compared with prednisone alone in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy. Here, we present the final analysis of an early-access protocol trial that was initiated after completion of COU-AA-301 to enable worldwide preapproval access to abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy. We did a multicentre, open-label, early-access protocol trial in 23 countries. We enrolled patients who had metastatic castration-resistant prostate cancer progressing after taxane chemotherapy. Participants received oral doses of abiraterone acetate (1000 mg daily) and prednisone (5 mg twice a day) in 28-day cycles until disease progression, development of sustained side-effects, or abiraterone acetate becoming available in the respective country. The primary outcome was the number of adverse events arising during study treatment and within 30 days of discontinuation. Efficacy measures (time to prostate-specific antigen [PSA] progression and time to clinical progression) were gathered to guide treatment decisions. We included in our analysis all patients who received at least one dose of abiraterone acetate. This study is registered with ClinicalTrials.gov, number NCT01217697. Between Nov 17, 2010, and Sept 30, 2013, 2314 patients were enrolled into the early-access protocol trial. Median follow-up was 5·7 months (IQR 3·5-10·6). 952 (41%) patients had a grade 3 or 4 treatment-related adverse event, and grade 3 or 4 serious adverse events were recorded in 585 (25%) people. The most common grade 3 and 4 adverse events were hepatotoxicity (188 [8%]), hypertension (99 [4%]), cardiac disorders (52 [2%]), osteoporosis (31 [1%]), hypokalaemia (28 [1%]), and fluid retention or oedema (23 [1%]). 172 (7%) patients discontinued the study because of adverse events (64 [3%] were drug-related), as assessed by the investigator, and 171 (7%) people died. The funder assessed causes of death, which were due to disease progression (85 [4%]), an unrelated adverse experience (72 [3%]), and unknown reasons (14 [1%]). Of the 86 deaths not attributable to disease progression, 18 (<1%) were caused by a drug-related adverse event, as assessed by the investigator. Median time to PSA progression was 8·5 months (95% CI 8·3-9·7) and median time to clinical progression was 12·7 months (11·8-13·8). No new safety signals or unexpected adverse events were found in this early-access protocol trial to assess abiraterone acetate for patients with metastatic castration-resistant prostate cancer who progressed after chemotherapy. Future work is needed to ascertain the most effective regimen of abiraterone acetate to optimise patients' outcomes. Janssen Research & Development. Copyright © 2014 Elsevier Ltd. All rights reserved.

  20. Virtual reality and cognitive rehabilitation: a review of current outcome research.

    PubMed

    Larson, Eric B; Feigon, Maia; Gagliardo, Pablo; Dvorkin, Assaf Y

    2014-01-01

    Recent advancement in the technology of virtual reality (VR) has allowed improved applications for cognitive rehabilitation. The aim of this review is to facilitate comparisons of therapeutic efficacy of different VR interventions. A systematic approach for the review of VR cognitive rehabilitation outcome research addressed the nature of each sample, treatment apparatus, experimental treatment protocol, control treatment protocol, statistical analysis and results. Using this approach, studies that provide valid evidence of efficacy of VR applications are summarized. Applications that have not yet undergone controlled outcome study but which have promise are introduced. Seventeen studies conducted over the past eight years are reviewed. The few randomized controlled trials that have been completed show that some applications are effective in treating cognitive deficits in people with neurological diagnoses although further study is needed. Innovations requiring further study include the use of enriched virtual environments that provide haptic sensory input in addition to visual and auditory inputs and the use of commercially available gaming systems to provide tele-rehabilitation services. Recommendations are offered to improve efficacy of rehabilitation, to improve scientific rigor of rehabilitation research and to broaden access to the evidence-based treatments that this research has identified.

  1. Mobile Phone and Tablet Apps to Support Young People's Management of Their Physical Long-Term Conditions: A Systematic Review Protocol.

    PubMed

    Majeed-Ariss, Rabiya; Hall, Andrew G; McDonagh, Janet; Fallon, Deborah; Swallow, Veronica

    2015-04-07

    The prevalence of long-term or chronic conditions that limit activity and reduce quality of life in young people aged 10-24 years is rising. This group has distinct health care needs and requires tailored support strategies to facilitate increasing personal responsibility for the management of their condition wherever possible, as they mature. Mobile phone and tablet mobile technologies featuring software program apps are already well used by young people for social networking or gaming. They have also been utilized in health care to support personal condition management, using condition-specific and patient-tailored software. Such apps have much potential, and there is an emerging body of literature on their use in a health context making this review timely. The objective of this paper is to develop a systematic review protocol focused on identifying and assessing the effectiveness of mobile phone and tablet apps that support young people's management of their chronic conditions. The search strategy will include a combination of standardized indexed search terms and free-text terms related to the key concepts of young people; long-term conditions and mobile technology. Peer-reviewed journal articles published from 2003 that meet the inclusion and exclusion criteria will be identified through searching the generated hits from 5 bibliographical databases. Two independent reviewers will screen the titles and abstracts to determine which articles focus on testing interventions identified as a mobile phone or tablet apps, and that have been designed and delivered to support the management of long-term conditions in young people aged 10-24 years. Data extraction and quality assessment tools will be used to facilitate consistent analysis and synthesis. It is anticipated that several studies will meet the selection criteria but that these are likely to be heterogeneous in terms of study design, reported outcomes, follow-up times, participants' age, and health condition. Sub-group analyses will be undertaken and where possible meta-analyses will take place. This review will synthesize available knowledge surrounding tablet and mobile phone apps that support management of long term physical health conditions in young people. The findings will be synthesized to determine which elements of the technologies were most effective for this population. This systematic review aims to synthesize existing literature in order to generate findings that will facilitate the development of an app intervention. The review will form the first phase of development and evaluation of a complex intervention as recommended by the United Kingdom Medical Research Council. The knowledge gained from the review will be verified in subsequent phases, which will include primary qualitative work with health professionals and young people with long term conditions as research participants. Young people living with long-term conditions will be involved as co-researchers and consumer advisors in all subsequent phases to develop and evaluate an app to support the management of long-term physical health conditions. PROSPERO International prospective register of systematic reviews: CRD42014015418; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014015418#.VRqCpTpnL8E (Archived by Webcite at http://www.webcitation.org/6XREcWqQY).

  2. Where Young People See Science: Everyday Activities Connected to Science

    ERIC Educational Resources Information Center

    Zimmerman, Heather Toomey; Bell, Philip

    2014-01-01

    This project analyses the prevalence and social construction of science in the everyday activities of multicultural, multilingual children in one urban community. Using cross-setting ethnographic fieldwork (i.e. home, museum, school, community), we developed an ecologically grounded interview protocol and analytical scheme for gauging students'…

  3. Heterogeneity among Violence-Exposed Women: Applying Person-Oriented Research Methods

    ERIC Educational Resources Information Center

    Nurius, Paula S.; Macy, Rebecca J.

    2008-01-01

    Variability of experience and outcomes among violence-exposed people pose considerable challenges toward developing effective prevention and treatment protocols. To address these needs, the authors present an approach to research and a class of methodologies referred to as person oriented. Person-oriented tools support assessment of meaningful…

  4. “They treated me like crap and I know it was because I was Native”: The healthcare experiences of Aboriginal Peoples living in Vancouver’s inner city

    PubMed Central

    Goodman, Ashley; Fleming, Kim; Markwick, Nicole; Morrison, Tracey; Lagimodiere, Louise; Kerr, Thomas

    2017-01-01

    There is growing evidence that Aboriginal peoples often experience healthcare inequalities due to racism. However, research exploring the healthcare experiences of Aboriginal peoples who use illicit substances is limited, and research rarely accounts for how multiple accounts of stigma intersect and contribute to the experiences of marginalized populations. Our research aimed to explore the healthcare experiences of Aboriginal peoples who use illicit drugs and or illicit alcohol (APWUID/A) living in Vancouver’s inner city. Using Indigenous methodologies, a community research team comprised of APWUID/A led the study design, data collection and analysis. Peer-facilitated talking circles explored community members’ experiences accessing healthcare services and patient-provider encounters. Using an intersectionality framework, our research demonstrated how healthcare inequalities among Aboriginal peoples are perpetuated by systemic racism and discrimination. Stigmatizing racial stereotypes were perceived to negatively influence individual attitudes and clinical practice. Participants’ experiences of medical dismissal often resulted in disengagement from care or delay in care. The findings suggest healthcare providers must understand the structural and historical forces that influence racial disparities in healthcare and personal attitudes in clinical practice. Adequate clinical protocols for pain management within the context of illicit substance use are urgently needed. The valuation of Aboriginal peoples and cultures within healthcare is paramount to addressing the health gap between Aboriginal and non-Aboriginal Canadians. PMID:28214449

  5. A randomised controlled feasibility trial of family and social network intervention for young people who misuse alcohol and drugs: study protocol (Y-SBNT).

    PubMed

    Watson, Judith; Back, Donna; Toner, Paul; Lloyd, Charlie; Day, Ed; Brady, Louca-Mai; Templeton, Lorna; Ambegaokar, Sangeeta; Parrott, Steve; Torgerson, David; Cocks, Kim; Gilvarry, Eilish; McArdle, Paul; Copello, Alex

    2015-01-01

    A growing body of research has identified family interventions to be effective in treating young people's substance use problems. However, despite this evidence, take-up of family-based approaches in the UK has been low. Key factors for this appear to include the resource-intensive nature of most family interventions which challenges implementation and delivery in many service settings and the cultural adaptation of approaches developed in the USA to a UK setting. This study aims to demonstrate the feasibility of recruiting young people to a specifically developed family- and wider social network-based intervention by testing an adapted version of adult social behaviour and network therapy (SBNT). A pragmatic, randomised controlled, open feasibility trial delivered in two services for young people in the UK. Potential participants are aged 12-18 years referred for drug or alcohol problems to either service. The main purpose of this study is to demonstrate the feasibility of recruiting young people to a specifically developed family and social network-based intervention. The feasibility and acceptability of this intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews. The feasibility of training staff from existing services to deliver this intervention will be explored. Using this opportunity to compare the effectiveness of the intervention against treatment as usual, Timeline Follow-Back interviews will document the proportion of days on which the main problem substance was used in the preceding 90-day period at each assessment point. The economic component will examine the feasibility of conducting a full incremental cost-effectiveness analysis of the two treatments. The study will also explore and develop models of patient and public involvement which support the involvement of young people in a study of this nature. An earlier phase of work adapted social behaviour and network therapy (adult approach) to produce a purpose-designed youth version supported by a therapy manual and associated resources. This was achieved by consultation with young people with experience of services and professionals working in services for young people. This feasibility trial alongside ongoing consultations with young people will offer a meaningful understanding of processes of delivery and implementation. ISRCTN93446265; Date ISRCTN assigned 31/05/2013.

  6. Construction and validation of the Scale Sources of Information about AIDS (SSIA).

    PubMed

    Chaves, Claudia; Pereira, Anabela; Duarte, João; Martins, Rosa; Nelas, Paula; Ferreira, Manuela

    2014-11-01

    To characterize sources of information students of higher education turn to for clarification about AIDS. Cross-sectional, non-experimental research, with the features of descriptive, correlational and explanatory studies. The data collection protocol includes personal and academic data and the sources of information about AIDS scale. 2002 students participated, 60.7% girls (X=21.76; years ± 4.43 SD), of the first and last years of higher education in the North and Centre of Portugal. Students rely mainly on reading informational materials for information about AIDS. Approximately 37% have good information on AIDS with young people up to the age of 25 and attending courses in field of health having higher scores. Changes are needed in health education models in the area of HIV/AIDS, since these are not showing a satisfactory level of efficiency. On the other hand, it is important to motivate young people to change their behaviours. Although many young people have knowledge, they do not change their risk behaviours. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  7. The effect of abdominal resistance training and energy restricted diet on lateral abdominal muscles thickness of overweight and obese women.

    PubMed

    Noormohammadpour, Pardis; Kordi, Ramin; Dehghani, Saeed; Rostami, Mohsen

    2012-07-01

    The role of transabdominal muscles (external oblique, internal oblique and transversus abdominis) on core stability has been shown previously. Energy restricted diet and abdominal resistance training are commonly used by overweight and obese people to reduce their weight. In this study we investigated the impact of 12 weeks concurrent energy restricted diet and abdominal resistance training on the thickness of the lateral abdominal muscles of 19 obese and overweight women employing ultrasonography in resting and drawing-in maneuvers. The results showed significant increase of the muscle thicknesses during drawing-in maneuver after 12 weeks intervention. Based on our findings, it can be concluded that 12 weeks concurrent abdominal resistance training and energy restricted diet in addition to weight loss lead to improvement of transabdominal muscles thickness in obese and overweight people. Considering the role of these muscles in core stability, using this therapeutic protocol in obese people, particularly in those who have weakness of these muscles might be helpful. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Pressure injuries in people with darker skin tones: A literature review.

    PubMed

    Oozageer Gunowa, Neesha; Hutchinson, Marie; Brooke, Joanne; Jackson, Debra

    2017-09-08

    In this article, we aimed to explore the literature to ascertain what research evidence exists in relation to the identification of pressure injuries in people with dark skin tones. Pressure injuries development has been widely researched and documented; however, much of this work does not address ethnicity or race and assumes Caucasian-ness. Thus, the perceptions of people with dark skin tones and the influence of skin pigmentation on identification and management of pressure injuries is under examined. Literature review. A comprehensive electronic database search was undertaken of PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane and British Nursing Index (BNI) between 1990-July 2016. Alongside the electronic data, journals, books, papers from conferences, relevant national and international organisations and reference lists were also used to help source key studies. A search of the literature revealed 11 relevant articles. The foci of studies included the following: risk of sustaining a pressure injuries based on skin tones, identification of pressure injuries amongst people with dark skin tones, pressure injuries and place of care and socio-economic impact on pressure injuries development. Overall, findings indicate that people with darker skin tones are more likely to develop higher stage pressure injuries. Reasons for this are not fully elucidated; however, it may be associated with current skin assessment protocols being less effective for people who have darker skin tones resulting in early damage arising from pressure not being recognised. From the literature reviewed, it can be seen that there is a lack of guidance and evidence, and people with darker skin tones are more likely in comparison with people presenting as Caucasian to develop higher stage pressure injuries. The current literature suggests a need for researchers and clinicians to consider skin tone variances rather than ethnicity when exploring comprehensive skin assessment. © 2017 John Wiley & Sons Ltd.

  9. A European study investigating patterns of transition from home care towards institutional dementia care: the protocol of a RightTimePlaceCare study

    PubMed Central

    2012-01-01

    Background Health care policies in many countries aim to enable people with dementia to live in their own homes as long as possible. However, at some point during the disease the needs of a significant number of people with dementia cannot be appropriately met at home and institutional care is required. Evidence as to best practice strategies enabling people with dementia to live at home as long as possible and also identifying the right time to trigger admission to a long-term nursing care facility is therefore urgently required. The current paper presents the rationale and methods of a study generating primary data for best-practice development in the transition from home towards institutional nursing care for people with dementia and their informal caregivers. The study has two main objectives: 1) investigate country-specific factors influencing institutionalization and 2) investigate the circumstances of people with dementia and their informal caregivers in eight European countries. Additionally, data for economic evaluation purposes are being collected. Methods/design This paper describes a prospective study, conducted in eight European countries (Estonia, Finland, France, Germany, Netherlands, Sweden, Spain, United Kingdom). A baseline assessment and follow-up measurement after 3 months will be performed. Two groups of people with dementia and their informal caregivers will be included: 1) newly admitted to institutional long-term nursing care facilities; and 2) receiving professional long-term home care, and being at risk for institutionalization. Data will be collected on outcomes for people with dementia (e.g. quality of life, quality of care), informal caregivers (e.g. caregiver burden, quality of life) and costs (e.g. resource utilization). Statistical analyses consist of descriptive and multivariate regression techniques and cross-country comparisons. Discussion The current study, which is part of a large European project 'RightTimePlaceCare', generates primary data on outcomes and costs of long-term nursing care for people with dementia and their informal caregivers, specifically focusing on the transition from home towards institutional care. Together with data collected in three other work packages, knowledge gathered in this study will be used to inform and empower patients, professionals, policy and related decision makers to manage and improve health and social dementia care services. PMID:22269343

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

    PubMed Central

    2012-01-01

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

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed

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

    2009-11-11

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

  13. Prognostic value of baseline absolute lymphocyte concentration and neutrophil/lymphocyte ratio in dogs with newly diagnosed multi-centric lymphoma.

    PubMed

    Mutz, M; Boudreaux, B; Kearney, M; Stroda, K; Gaunt, S; Shiomitsu, K

    2015-12-01

    Canine multi-centric B-cell lymphoma shares similarities with diffuse large B-cell (Non-Hodgkin's) lymphoma (NHL) in people. In people with NHL, lymphopenia at diagnosis and first relapse and neutrophil/lymphocyte ratio (N:L) > 3.5 are negative prognostic factors for survival. The objective of this study was to determine if lymphocyte concentration at diagnosis and first relapse and N:L were prognostic for survival in dogs with newly diagnosed multi-centric lymphoma. Medical records of 77 dogs with multi-centric lymphoma treated with a CHOP-based chemotherapy protocol were retrospectively evaluated. Absolute lymphocyte concentration and N:L ratio at presentation of dogs pre-treated with steroids was not significantly different from dogs who had not received steroids. On multivariate analysis, only immunophenotype remained significant for progression-free survival (PFS), whereas no variables remained significant for ST. A prospective study of these haematologic variables is warranted to assess their true significance. © 2013 John Wiley & Sons Ltd.

  14. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study.

    PubMed

    Vitale, M; Masulli, M; Rivellese, A A; Bonora, E; Cappellini, F; Nicolucci, A; Squatrito, S; Antenucci, D; Barrea, A; Bianchi, C; Bianchini, F; Fontana, L; Fornengo, P; Giorgino, F; Gnasso, A; Mannucci, E; Mazzotti, A; Nappo, R; Palena, A P; Pata, P; Perriello, G; Potenziani, S; Radin, R; Ricci, L; Romeo, F; Santini, C; Scarponi, M; Serra, R; Timi, A; Turco, A A; Vedovato, M; Zavaroni, D; Grioni, S; Riccardi, G; Vaccaro, O

    2018-03-01

    Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. We studied 2573 men and women aged 50-75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes.

  15. Establishment of a definitive protocol for the diagnosis and management of body packers (drug mules).

    PubMed

    Mandava, Nageswara; Chang, Richard S; Wang, John H; Bertocchi, Michael; Yrad, Jonathan; Allamaneni, Shyam; Aboian, Edouard; Lall, Malini H; Mariano, Rosalind; Richards, Neil

    2011-02-01

    'Mules' or body packers are people who transport illegal drugs by packet ingestion into the gastrointestinal tract. These people are otherwise healthy and their management should maintain minimal morbidity. In this study, experience with body packers is presented and an algorithm for conservative and surgical management is provided. The clinical patient database for all body packer admissions at Mary Immaculate Hospital of the Caritas Health Care Inc. from 1993 to 2005 was interrogated. 56 patients (4.5%) required admission out of a total of 1250 subjects confirmed to be body packers and apprehended by United State Customs officials at JFK International Airport, New York. The retrieved patient data were analysed retrospectively. 70% of the body packers were men, with a male to female ratio of 2.8 to 1. The mean age was 33 years and 52% were from Columbia. Heroin was the most common illegally transported substance (73%). 25 patients (45%) required surgical intervention, whereas 31 patients (55%) were successfully managed conservatively. Indications for intervention included: bowel obstruction, packet rupture/toxicity, and delayed progression of packet transit on conservative management. Multiple intraoperative manoeuvres were used to remove the foreign bodies: gastrotomy, enterotomy and colotomy. Wound infection was the most common complication and is associated with distal enterotomy and colotomy. Men were more likely to present as body packers than women. Proximal enterotomies are preferred and multiple enterotomies should be avoided. A confirmatory radiological study is needed to demonstrate complete clearance of packets. A systematic protocol for the management of body packers results in minimal morbidity and no mortality.

  16. A Closed Mars Analog Simulation: The Approach of Crew 5 At the Mars Desert Research Station

    NASA Technical Reports Server (NTRS)

    Clancey, William J.; Koga, Dennis (Technical Monitor)

    2002-01-01

    For twelve days in April 2002 we performed a closed simulation in the Mars Desert Research Station, isolated from other people, as on Mars, while performing systematic surface exploration and life support chores. Email provided our only means of contact; no phone or radio conversations were possible. All mission-related messages were mediated by a remote mission support team. This protocol enabled a systematic and controlled study of crew activities, scheduling, and use of space. The analysis presented here focuses on two questions: Where did the time go-why did people feel rushed and unable to complete their work? How can we measure and model productivity, to compare habitat designs, schedules, roles, and tools? Analysis suggests that a simple scheduling change-having lunch and dinner earlier, plus eliminating afternoon meetings-increased the available productive time by 41%.

  17. [Psychiatry and NS euthanasia. Facts, transgenerational effects and work with the relatives in Carinthia/Austria].

    PubMed

    Oberlerchner, H; Stromberger, H

    2015-01-01

    This article describes the current state of research concerning the fate of mentally ill people in the psychiatric hospital of Klagenfurt am Wörthersee during the era of National Socialism (NS). Sterilization based on the "Erbgesundheitsgesetz" (genetic health law) deportation to the Castle of Hartheim near Linz, transport to Klagenfurt and killing in the departments of the hospital are documented. This knowledge is to be given to the relatives. Encouraged by diverse public work activities relatives of victims of NS euthanasia sought contact with the department to discover the fate of relatives. Touching meetings with the relatives took place. Since January 2011 the contacting relatives, their motives and the meetings have been protocolled and in this study an attempt is made to give an initial characterization of these people. This approach of a reconstructive biographical work together with relatives of the victims is presented as a proactive duty of psychiatric institutions.

  18. Buddhist religious practices and blood pressure among elderly in rural Uttaradit Province, northern Thailand.

    PubMed

    Stewart, Onwilasini; Yamarat, Khemika; Neeser, Karl J; Lertmaharit, Somrat; Holroyd, Eleanor

    2014-03-01

    The purpose of this study was to test the relationship between Buddhist religious practices and blood pressure. A cross-sectional survey of Buddhist religious practices and blood pressure was conducted with 160 Buddhist elderly in rural Uttaradit, northern Thailand. After controlling for the variables of gender, status, education, salary, underlying hypertension, exercise, salt intake, and taking antihypertensive medications, it was found that lower systolic and diastolic blood pressure is associated with the Buddhist religious practice of temple attendance. The Buddhist older people who regularly attended a temple every Buddhist Holy day (which occurs once a week) were found to have systolic and diastolic blood pressure readings lower than people who did not attend as regularly. It is recommended that nurses advocate for temple attendance in the care protocols for older Buddhist hypertensive patients both in Thailand and internationally. © 2013 Wiley Publishing Asia Pty Ltd.

  19. [Autism after an earthquake: the experience of L'Aquila (Central Italy) as a basis for an operative guideline].

    PubMed

    Valenti, Marco; Di Giovanni, Chiara; Mariano, Melania; Pino, Maria Chiara; Sconci, Vittorio; Mazza, Monica

    2016-01-01

    People with autism, their families, and their specialised caregivers are a social group at high health risk after a disruptive earthquake. They need emergency assistance and immediate structured support according to definite protocols and quality standards. We recommend to establish national guidelines for taking-in-charge people with autism after an earthquake. The adaptive behaviour of participants with autism declined dramatically in the first months after the earthquake in all the dimensions examined (i.e., communication, daily living, socialisation, and motor skills). After relatively stable conditions returned and with immediate and intensive post-disaster intervention, children and adolescents with autism showed a trend towards partial recovery of adaptive functioning. As to the impact on services, this study indicates the need for supporting exposed caregivers at high risk of burnout over the first two years after the disaster and for an immediate reorganisation of person-tailored services.

  20. Access to timely formal dementia care in Europe: protocol of the Actifcare (ACcess to Timely Formal Care) study.

    PubMed

    Kerpershoek, Liselot; de Vugt, Marjolein; Wolfs, Claire; Jelley, Hannah; Orrell, Martin; Woods, Bob; Stephan, Astrid; Bieber, Anja; Meyer, Gabriele; Engedal, Knut; Selbaek, Geir; Handels, Ron; Wimo, Anders; Hopper, Louise; Irving, Kate; Marques, Maria; Gonçalves-Pereira, Manuel; Portolani, Elisa; Zanetti, Orazio; Verhey, Frans

    2016-08-23

    Previous findings indicate that people with dementia and their informal carers experience difficulties accessing and using formal care services due to a mismatch between needs and service use. This mismatch causes overall dissatisfaction and is a waste of the scarce financial care resources. This article presents the background and methods of the Actifcare (ACcess to Timely Formal Care) project. This is a European study aiming at best-practice development in finding timely access to formal care for community-dwelling people with dementia and their informal carers. There are five main objectives: 1) Explore predisposing and enabling factors associated with the use of formal care, 2) Explore the association between the use of formal care, needs and quality of life and 3) Compare these across European countries, 4) Understand the costs and consequences of formal care services utilization in people with unmet needs, 5) Determine the major costs and quality of life drivers and their relationship with formal care services across European countries. In a longitudinal cohort study conducted in eight European countries approximately 450 people with dementia and informal carers will be assessed three times in 1 year (baseline, 6 and 12 months). In this year we will closely monitor the process of finding access to formal care. Data on service use, quality of life and needs will be collected. The results of Actifcare are expected to reveal best-practices in organizing formal care. Knowledge about enabling and predisposing factors regarding access to care services, as well as its costs and consequences, can advance the state of the art in health systems research into pathways to dementia care, in order to benefit people with dementia and their informal carers.

  1. Social relations and healthcare utilisation among middle-aged and older people: study protocol for an implementation and register-based study in Denmark.

    PubMed

    Mikkelsen, Anne Sophie Bech; Lund, Rikke; Kristiansen, Maria

    2017-11-15

    While previous research establishes an association between social relations, health and use of healthcare services among older people, how to implement this knowledge in real-life settings has received much less attention. This study will explore the relationship between social relations, health and use of healthcare services in a Danish mid-life population sample. In addition, the study will explore individual and contextual factors affecting the implementation of a group-based life story intervention aimed at establishing and strengthening social relations among older people at nursing homes in Denmark. A combined quantitative register-based approach and a qualitative implementation approach will be applied in this study. First, we will quantitatively analyse the relationship between social relations, health status and use of healthcare services among middle-aged people in Denmark by linking survey data on social relations, loneliness, self-perceived health and disease status from the Copenhagen Aging and Midlife Biobank (CAMB) (n = 7191) with national registries through the Public Health Database on use of healthcare services and demographic and socioeconomic factors. Second, we will qualitatively analyse individual and contextual factors affecting the implementation process of the group-based life story intervention based on semi-structured interviews (n = 16), observations and field notes with and among intervention stakeholders, i.e., participants and group leaders facilitating the intervention. The results of this study are expected to improve knowledge about mechanisms through which social relations are associated with health status and use of healthcare services and to inform the implementation of future interventions targeting social relations among older people at nursing homes. The study has been registered and approved by the Danish Data Protection Agency. Seperate approvals have been attained for the qualitative data (Approval No. SUND-2016-08), and for the quantitative data in the CAMB database which has also received approval from the local ethical committee (approval No.H-A-2008-126 and No. 2013-41-1814, respectively).

  2. A cross-sectional study on person-centred communication in the care of older people: the COMHOME study protocol.

    PubMed

    Hafskjold, Linda; Sundler, Annelie J; Holmström, Inger K; Sundling, Vibeke; van Dulmen, Sandra; Eide, Hilde

    2015-04-15

    This paper presents an international cross-sectional study on person-centred communication with older people receiving healthcare (COMHOME). Person-centred care relies on effective communication, but few studies have explored this with a specific focus on older people. The main aim of the COMHOME study is to generate knowledge on person-centred communication with older people (>65 years) in home healthcare services, radiographic and optometric practice. This study will explore the communication between care providers and older persons in home care services. Home healthcare visits will be audiorecorded (n=500) in Norway, the Netherlands and Sweden. Analyses will be performed with the Verona Coding Definitions for Emotional Sequences (VR-CoDES), the Roter Interaction Analysis System (RIAS) and qualitative methods. The content of the communication, communicative challenging situations as well as empathy, power distance, decision-making, preservation of dignity and respect will be explored. In Norway, an additional 100 encounters, 50 in optometric practice (video recorded) and 50 in radiographic practice (audiorecorded), will be analysed. Furthermore, healthcare providers' self-reported communication skills, empathy, mindfulness and emotional intelligence in relation to observed person-centred communication skills will be assessed using well-established standardised instruments. Depending on national legislation, approval of either the central ethical committees (eg, nation or university), the national data protection officials or the local ethical committees (eg, units of home healthcare) was obtained. Study findings will be disseminated widely through peer-reviewed publications and conference presentations. The research findings will add knowledge to improve services provided to this vulnerable group of patients. Additionally, the findings will underpin a training programme for healthcare students and care providers focusing on communication with older people. 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.

  3. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

    PubMed

    Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

    2013-07-02

    People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. ISRCTN62019087.

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

    PubMed

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

    2018-04-17

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

  5. A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial.

    PubMed

    Gulliver, Amelia; Banfield, Michelle; Reynolds, Julia; Miller, Sarah; Galati, Connie; Morse, Alyssa R

    2017-12-07

    There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. The program will be delivered over a period of approximately 4 months, commencing June 2017. If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers. ©Amelia Gulliver, Michelle Banfield, Julia Reynolds, Sarah Miller, Connie Galati, Alyssa R Morse. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.12.2017.

  6. A Study Protocol for Applying User Participation and Co-Learning—Lessons Learned from the eBalance Project

    PubMed Central

    Åberg, Anna Cristina; Halvorsen, Kjartan; From, Ingrid; Bruhn, Åsa Bergman; Oestreicher, Lars; Melander-Wikman, Anita

    2017-01-01

    The eBalance project is based on the idea that serious exergames—i.e., computer gaming systems with an interface that requires physical exertion to play—that are well adapted to users, can become a substantial part of a solution to recognized problems of insufficient engagement in fall-prevention exercise and the high levels of fall-related injuries among older people. This project is carried out as a collaboration between eight older people who have an interest in balance training and met the inclusion criteria of independence in personal activities of daily living, access to and basic knowledge of a computer, four staff working with the rehabilitation of older adults, and an interdisciplinary group of six research coordinators covering the areas of geriatric care and rehabilitation, as well as information technology and computer science. This paper describes the study protocol of the project’s initial phase which aims to develop a working partnership with potential users of fall-prevention exergames, including its conceptual underpinnings. The qualitative methodology was inspired by an ethnographical approach implying combining methods that allowed the design to evolve through the study based on the participants’ reflections. A participatory and appreciative action and reflection (PAAR) approach, accompanied by inquiries inspired by the Normalization Process Theory (NPT) was used in interactive workshops, including exergame testing, and between workshop activities. Data were collected through audio recordings, photos, and different types of written documentation. The findings provide a description of the methodology thus developed and applied. They display a methodology that can be useful for the design and development of care service and innovations for older persons where user participation is in focus. PMID:28489067

  7. Sugar-sweetened beverage consumption, correlates and interventions among Australian Aboriginal and Torres Strait Islander communities: a scoping review protocol.

    PubMed

    Avery, Jodie C; Bowden, Jacqueline A; Dono, Joanne; Gibson, Odette R; Brownbill, Aimee; Keech, Wendy; Roder, David; Miller, Caroline L

    2017-07-31

    Aboriginal and Torres Strait Islander communities of Australia experience poorer health outcomes in the areas of overweight and obesity, diabetes and cardiovascular disease. Contributing to this burden of disease in the Australian community generally and in Aboriginal and Torres Strait Islander communities, is the consumption of sugar-sweetened beverages (SSBs). We have described a protocol for a review to systematically scope articles that document use of SSBs and interventions to reduce their consumption with Aboriginal and Torres Strait Islander people. These results will inform future work that investigates interventions aimed at reducing harm associated with SSB consumption. This scoping review draws on a methodology that uses a six-step approach to search databases including PubMed, SCOPUS, CINAHL, Informit (including Informit: Indigenous Peoples), Joanna Briggs Institute EBP Database and Mura, between January 1980 and February 2017. Two reviewers will be engaged to search for and screen studies independently, using formulated selection criteria, for inclusion in our review. We will include primary research studies, systematic reviews including meta-analysis or meta-synthesis, reports and unpublished grey literature. Results will be entered into a table identifying study details and characteristics, summarised using a Preferred Reporting Items for Systematic Reviews and Meta-Analysis chart and then critically analysed. This review will not require ethics committee review. Results will be disseminated at appropriate scientific meetings, as well as through the Aboriginal and Torres Strait Islander community. © 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.

  8. A Study Protocol for Applying User Participation and Co-Learning-Lessons Learned from the eBalance Project.

    PubMed

    Åberg, Anna Cristina; Halvorsen, Kjartan; From, Ingrid; Bruhn, Åsa Bergman; Oestreicher, Lars; Melander-Wikman, Anita

    2017-05-10

    The eBalance project is based on the idea that serious exergames-i.e., computer gaming systems with an interface that requires physical exertion to play-that are well adapted to users, can become a substantial part of a solution to recognized problems of insufficient engagement in fall-prevention exercise and the high levels of fall-related injuries among older people. This project is carried out as a collaboration between eight older people who have an interest in balance training and met the inclusion criteria of independence in personal activities of daily living, access to and basic knowledge of a computer, four staff working with the rehabilitation of older adults, and an interdisciplinary group of six research coordinators covering the areas of geriatric care and rehabilitation, as well as information technology and computer science. This paper describes the study protocol of the project's initial phase which aims to develop a working partnership with potential users of fall-prevention exergames, including its conceptual underpinnings. The qualitative methodology was inspired by an ethnographical approach implying combining methods that allowed the design to evolve through the study based on the participants' reflections. A participatory and appreciative action and reflection (PAAR) approach, accompanied by inquiries inspired by the Normalization Process Theory (NPT) was used in interactive workshops, including exergame testing, and between workshop activities. Data were collected through audio recordings, photos, and different types of written documentation. The findings provide a description of the methodology thus developed and applied. They display a methodology that can be useful for the design and development of care service and innovations for older persons where user participation is in focus.

  9. Advances in Remote Respiratory Assessments for People with Chronic Obstructive Pulmonary Disease: A Systematic Review.

    PubMed

    Baroi, Sidney; McNamara, Renae J; McKenzie, David K; Gandevia, Simon; Brodie, Matthew A

    2018-06-01

    Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality. Advances in remote technologies and telemedicine provide new ways to monitor respiratory function and improve chronic disease management. However, telemedicine does not always include remote respiratory assessments, and the current state of knowledge for people with COPD has not been evaluated. Systematically review the use of remote respiratory assessments in people with COPD, including the following questions: What devices have been used? Can acute exacerbations of chronic obstructive pulmonary disease (AECOPD) be predicted by using remote devices? Do remote respiratory assessments improve health-related outcomes? The review protocol was registered (PROSPERO 2016:CRD42016049333). MEDLINE, EMBASE, and COMPENDEX databases were searched for studies that included remote respiratory assessments in people with COPD. A narrative synthesis was then conducted by two reviewers according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Fifteen studies met the inclusion criteria. Forced expiratory volume assessed daily by using a spirometer was the most common modality. Other measurements included resting respiratory rate, respiratory sounds, and end-tidal carbon dioxide level. Remote assessments had high user satisfaction. Benefits included early detection of AECOPD, improved health-related outcomes, and the ability to replace hospital care with a virtual ward. Remote respiratory assessments are feasible and when combined with sufficient organizational backup can improve health-related outcomes in some but not all cohorts. Future research should focus on the early detection, intervention, and rehabilitation for AECOPD in high-risk people who have limited access to best care and investigate continuous as well as intermittent monitoring.

  10. Validation of asthma recording in the Clinical Practice Research Datalink (CPRD)

    PubMed Central

    Morales, Daniel R; Mullerova, Hana; Smeeth, Liam; Douglas, Ian J; Quint, Jennifer K

    2017-01-01

    Objectives The optimal method of identifying people with asthma from electronic health records in primary care is not known. The aim of this study is to determine the positive predictive value (PPV) of different algorithms using clinical codes and prescription data to identify people with asthma in the United Kingdom Clinical Practice Research Datalink (CPRD). Methods 684 participants registered with a general practitioner (GP) practice contributing to CPRD between 1 December 2013 and 30 November 2015 were selected according to one of eight predefined potential asthma identification algorithms. A questionnaire was sent to the GPs to confirm asthma status and provide additional information to support an asthma diagnosis. Two study physicians independently reviewed and adjudicated the questionnaires and additional information to form a gold standard for asthma diagnosis. The PPV was calculated for each algorithm. Results 684 questionnaires were sent, of which 494 (72%) were returned and 475 (69%) were complete and analysed. All five algorithms including a specific Read code indicating asthma or non-specific Read code accompanied by additional conditions performed well. The PPV for asthma diagnosis using only a specific asthma code was 86.4% (95% CI 77.4% to 95.4%). Extra information on asthma medication prescription (PPV 83.3%), evidence of reversibility testing (PPV 86.0%) or a combination of all three selection criteria (PPV 86.4%) did not result in a higher PPV. The algorithm using non-specific asthma codes, information on reversibility testing and respiratory medication use scored highest (PPV 90.7%, 95% CI (82.8% to 98.7%), but had a much lower identifiable population. Algorithms based on asthma symptom codes had low PPVs (43.1% to 57.8%)%). Conclusions People with asthma can be accurately identified from UK primary care records using specific Read codes. The inclusion of spirometry or asthma medications in the algorithm did not clearly improve accuracy. Ethics and dissemination The protocol for this research was approved by the Independent Scientific Advisory Committee (ISAC) for MHRA Database Research (protocol number15_257) and the approved protocol was made available to the journal and reviewers during peer review. Generic ethical approval for observational research using the CPRD with approval from ISAC has been granted by a Health Research Authority Research Ethics Committee (East Midlands—Derby, REC reference number 05/MRE04/87). The results will be submitted for publication and will be disseminated through research conferences and peer-reviewed journals. PMID:28801439

  11. Autologous Stem Cells in Achilles Tendinopathy (ASCAT): protocol for a phase IIA, single-centre, proof-of-concept study

    PubMed Central

    Goldberg, Andrew J; Zaidi, Razi; Brooking, Deirdre; Kim, Louise; Korda, Michelle; Masci, Lorenzo; Green, Ruth; O’Donnell, Paul; Smith, Roger

    2018-01-01

    Introduction Achilles tendinopathy (AT) is a cause of pain and disability affecting both athletes and sedentary individuals. More than 150 000 people in the UK every year suffer from AT. While there is much preclinical work on the use of stem cells in tendon pathology, there is a scarcity of clinical data looking at the use of mesenchymal stem cells to treat tendon disease and there does not appear to be any studies of the use of autologous cultured mesenchymal stem cells (MSCs) for AT. Our hypothesis is that autologous culture expanded MSCs implanted into an area of mid-portion AT will lead to improved pain-free mechanical function. The current paper presents the protocol for a phase IIa clinical study. Methods and analysis The presented protocol is for a non-commercial, single-arm, open-label, phase IIa proof-of-concept study. The study will recruit 10 participants and will follow them up for 6 months. Included will be patients aged 18–70 years with chronic mid-portion AT who have failed at least 6 months of non-operative management. Participants will have a bone marrow aspirate collected from the posterior iliac crest under either local or general anaesthetic. MSCs will be isolated and expanded from the bone marrow. Four to 6 weeks after the harvest, participants will undergo implantation of the culture expanded MSCs under local anaesthetic and ultrasound guidance. The primary outcome will be safety as defined by the incidence rate of serious adverse reaction. The secondary outcomes will be efficacy as measured by patient-reported outcome measures and radiological outcome using ultrasound techniques. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Harrow; reference 13/LO/1670). Trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02064062. PMID:29764889

  12. Challenges in Patient Recruitment, Implementation, and Fidelity in a Mobile Telehealth Study.

    PubMed

    Baron, Justine; Hirani, Shashivadan; Newman, Stanton

    2016-05-01

    Mobile telehealth (MTH) evaluations in diabetes have been conducted, but few report details and issues related to recruitment, implementation (intervention delivery), fidelity, and context. These have important implications on the interpretation of the findings and effectiveness of the intervention. This article reports these data from an MTH study and describes the challenges experienced in running an intervention such as this in an active clinical environment. We conducted a mixed-methods MTH study that included a 9-month randomized controlled trial in people with poorly controlled diabetes. Detailed recruitment data were recorded during the study. Data on contacts between MTH participants and the MTH team were collected and used to report on intervention delivery and fidelity. Meeting and field notes, as well as communications between research team members during the study, were used to report on the contextual factors that affected recruitment, implementation, and fidelity. The recruited sample size represented 6% of the total clinic population (n = 1,360) and 10.7% of the number of potentially eligible people at the clinic (n = 802) identified at the beginning of the study. Contextual factors related to patients, healthcare providers, the institution, or the recruitment protocol contributed to influence access to study participants and the number of participants randomized (n = 81). Technical and device-related aspects of the MTH intervention were delivered successfully, but the expected education and clinical feedback by the MTH nurse were not delivered according to the protocol. Although 92.5% of introductory calls were made by the MTH nurses, only 13.3% of expected educational calls were performed. Changes to the MTH nursing staff affected intervention participants differently and contributed to the low fidelity of intervention delivery. The current article presents data on the influence of contextual factors on the conduct of this MTH study and underlines the need for these processes to be assessed and reported adequately in future MTH research.

  13. A protocol for eliciting nonmaterial values through a cultural ecosystem services frame.

    PubMed

    Gould, Rachelle K; Klain, Sarah C; Ardoin, Nicole M; Satterfield, Terre; Woodside, Ulalia; Hannahs, Neil; Daily, Gretchen C; Chan, Kai M

    2015-04-01

    Stakeholders' nonmaterial desires, needs, and values often critically influence the success of conservation projects. These considerations are challenging to articulate and characterize, resulting in their limited uptake in management and policy. We devised an interview protocol designed to enhance understanding of cultural ecosystem services (CES). The protocol begins with discussion of ecosystem-related activities (e.g., recreation, hunting) and management and then addresses CES, prompting for values encompassing concepts identified in the Millennium Ecosystem Assessment (2005) and explored in other CES research. We piloted the protocol in Hawaii and British Columbia. In each location, we interviewed 30 individuals from diverse backgrounds. We analyzed results from the 2 locations to determine the effectiveness of the interview protocol in elucidating nonmaterial values. The qualitative and spatial components of the protocol helped characterize cultural, social, and ethical values associated with ecosystems in multiple ways. Maps and situational, or vignette-like, questions helped respondents articulate difficult-to-discuss values. Open-ended prompts allowed respondents to express a diversity of ecosystem-related values and proved sufficiently flexible for interviewees to communicate values for which the protocol did not explicitly probe. Finally, the results suggest that certain values, those mentioned frequently throughout the interview, are particularly salient for particular populations. The protocol can provide efficient, contextual, and place-based data on the importance of particular ecosystem attributes for human well-being. Qualitative data are complementary to quantitative and spatial assessments in the comprehensive representation of people's values pertaining to ecosystems, and this protocol may assist in incorporating values frequently overlooked in decision making processes. © 2014 The Authors. Conservation Biology published by Wiley Periodicals, Inc. on behalf of Society for Conservation Biology.

  14. Effectiveness of influenza vaccination for preventing influenza-related complications in people with asthma: a systematic review protocol

    PubMed Central

    Vasileiou, Eleftheria; Sheikh, Aziz; Butler, Chris; von Wissmann, Beatrix; McMenamin, Jim; Ritchie, Lewis; Tian, Lilly; Simpson, Colin

    2016-01-01

    Introduction Influenza vaccination is administered annually as a preventive measure against influenza infection and influenza-related complications in high-risk individuals, such as those with asthma. However, the effectiveness of influenza vaccination in people with asthma against influenza-related complications is still not well established. Methods and analysis We will search the following databases: MEDLINE (Ovid), EMBASE (Ovid), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Cochrane Database of Systematic Reviews (CDSR), Web of Science Core Collection, Science direct, WHO Library Information System (WHOLIS), Global Health Library and Chinese databases (CNKI, Wanfang and ChongQing VIP) from Jan 1970 to Jan 2016 for observational and experimental studies on effectiveness of influenza vaccine in people with asthma. The identification of studies will be complemented with the searching of the reference lists and citations, and contacting influenza vaccine manufacturers to identify unpublished or ongoing studies. Two reviewers will extract data and appraise the quality of each study independently. Separate meta-analyses will be undertaken for observational and experimental evidence using fixed-effect or random-effects models, as appropriate. Ethics and dissemination Formal ethical approval is not required, as primary data will not be collected. The review will be disseminated in peer-reviewed publications and conference presentations. PMID:27026658

  15. A Lightweight Continuous Authentication Protocol for the Internet of Things.

    PubMed

    Chuang, Yo-Hsuan; Lo, Nai-Wei; Yang, Cheng-Ying; Tang, Ssu-Wei

    2018-04-05

    Modern societies are moving toward an information-oriented environment. To gather and utilize information around people's modern life, tiny devices with all kinds of sensing devices and various sizes of gateways need to be deployed and connected with each other through the Internet or proxy-based wireless sensor networks (WSNs). Within this kind of Internet of Things (IoT) environment, how to authenticate each other between two communicating devices is a fundamental security issue. As a lot of IoT devices are powered by batteries and they need to transmit sensed data periodically, it is necessary for IoT devices to adopt a lightweight authentication protocol to reduce their energy consumption when a device wants to authenticate and transmit data to its targeted peer. In this paper, a lightweight continuous authentication protocol for sensing devices and gateway devices in general IoT environments is introduced. The concept of valid authentication time period is proposed to enhance robustness of authentication between IoT devices. To construct the proposed lightweight continuous authentication protocol, token technique and dynamic features of IoT devices are adopted in order to reach the design goals: the reduction of time consumption for consecutive authentications and energy saving for authenticating devices through by reducing the computation complexity during session establishment of continuous authentication. Security analysis is conducted to evaluate security strength of the proposed protocol. In addition, performance analysis has shown the proposed protocol is a strong competitor among existing protocols for device-to-device authentication in IoT environments.

  16. Improving access to high-quality primary care for socioeconomically disadvantaged older people in rural areas: a mixed method study protocol.

    PubMed

    Ford, John A; Jones, Andrew P; Wong, Geoff; Clark, Allan B; Porter, Tom; Shakespeare, Tom; Swart, Ann Marie; Steel, Nicholas

    2015-09-18

    The UK has an ageing population, especially in rural areas, where deprivation is high among older people. Previous research has identified this group as at high risk of poor access to healthcare. The aim of this study is to generate a theory of how socioeconomically disadvantaged older people from rural areas access primary care, to develop an intervention based on this theory and test it in a feasibility trial. On the basis of the MRC Framework for Developing and Evaluating Complex Interventions, three methods will be used to generate the theory. First, a realist review will elucidate the patient pathway based on existing literature. Second, an analysis of the English Longitudinal Study of Ageing will be completed using structural equation modelling. Third, 15 semistructured interviews will be undertaken with patients and four focus groups with health professionals. A triangulation protocol will be used to allow each of these methods to inform and be informed by each other, and to integrate data into one overall realist theory. Based on this theory, an intervention will be developed in discussion with stakeholders to ensure that the intervention is feasible and practical. The intervention will be tested within a feasibility trial, the design of which will depend on the intervention. Lessons from the feasibility trial will be used to refine the intervention and gather the information needed for a definitive trial. Ethics approval from the regional ethics committee has been granted for the focus groups with health professionals and interviews with patients. Ethics approval will be sought for the feasibility trial after the intervention has been designed. Findings will be disseminated to the key stakeholders involved in intervention development, to researchers, clinicians and health planners through peer-reviewed journal articles and conference publications, and locally through a dissemination event. 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.

  17. A study protocol of a randomised controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome.

    PubMed

    Shields, Nora; Taylor, Nicholas F; Fernhall, Bo

    2010-03-25

    Muscle strength is important for young people with Down syndrome as they make the transition to adulthood, because their workplace activities typically emphasise physical rather than cognitive skills. Muscle strength is reduced up to 50% in people with Down syndrome compared to their peers without disability. Progressive resistance training improves muscle strength and endurance in people with Down syndrome. However, there is no evidence on whether it has an effect on work task performance or physical activity levels. The aim of this study is to investigate if a student-led community-based progressive resistance training programme can improve these outcomes in adolescents and young adults with Down syndrome. A randomised controlled trial will compare progressive resistance training with a control group undertaking a social programme. Seventy adolescents and young adults with Down syndrome aged 14-22 years and mild to moderate intellectual disability will be randomly allocated to the intervention or control group using a concealed method. The intervention group will complete a 10-week, twice a week, student-led progressive resistance training programme at a local community gymnasium. The student mentors will be undergraduate physiotherapy students. The control group will complete an arts/social programme with a student mentor once a week for 90 minutes also for 10 weeks to control for the social aspect of the intervention. Work task performance (box stacking, pail carry), muscle strength (1 repetition maximum for chest and leg press) and physical activity (frequency, duration, intensity over 7-days) will be assessed at baseline (Week 0), following the intervention (Week 11), and at 3 months post intervention (Week 24) by an assessor blind to group allocation. Data will be analysed using ANCOVA with baseline measures as covariates. This paper outlines the study protocol for a randomised controlled trial on the effects of progressive resistance training on work task performance and physical activity for adolescents and young adults with Down syndrome. The intervention addresses the impairment of muscle weakness which may improve work task performance and help to increase physical activity levels. Australian New Zealand Clinical Trials Registry ACTRN12609000938202.

  18. Effective knowledge translation approaches and practices in Indigenous health research: a systematic review protocol.

    PubMed

    Morton Ninomiya, Melody E; Atkinson, Donna; Brascoupé, Simon; Firestone, Michelle; Robinson, Nicole; Reading, Jeff; Ziegler, Carolyn P; Maddox, Raglan; Smylie, Janet K

    2017-02-20

    Effective knowledge translation (KT) is critical to implementing program and policy changes that require shared understandings of knowledge systems, assumptions, and practices. Within mainstream research institutions and funding agencies, systemic and insidious inequities, privileges, and power relationships inhibit Indigenous peoples' control, input, and benefits over research. This systematic review will examine literature on KT initiatives in Indigenous health research to help identify wise and promising Indigenous KT practices and language in Canada and abroad. Indexed databases including Aboriginal Health Abstract Database, Bibliography of Native North Americans, CINAHL, Circumpolar Health Bibliographic Database, Dissertation Abstracts, First Nations Periodical Index, Medline, National Indigenous Studies Portal, ProQuest Conference Papers Index, PsycInfo, Social Services Abstracts, Social Work Abstracts, and Web of Science will be searched. A comprehensive list of non-indexed and grey literature sources will also be searched. For inclusion, documents must be published in English; linked to Indigenous health and wellbeing; focused on Indigenous people; document KT goals, activities, and rationale; and include an evaluation of their KT strategy. Identified quantitative, qualitative, and mixed methods' studies that meet the inclusion criteria will then be appraised using a quality appraisal tool for research with Indigenous people. Studies that score 6 or higher on the quality appraisal tool will be included for analysis. This unique systematic review involves robust Indigenous community engagement strategies throughout the life of the project, starting with the development of the review protocol. The review is being guided by senior Indigenous researchers who will purposefully include literature sources characterized by Indigenous authorship, community engagement, and representation; screen and appraise sources that meet Indigenous health research principles; and discuss the project with the Indigenous Elders to further explore the hazards, wisdom, and processes of sharing knowledge in research contexts. The overall aim of this review is to provide the evidence and basis for recommendations on wise practices for KT terminology and research that improves Indigenous health and wellbeing and/or access to services, programs, or policies that will lead to improved health and wellbeing. PROSPERO CRD42016049787 .

  19. No effects of functional exercise therapy on walking biomechanics in patients with knee osteoarthritis: exploratory outcome analyses from a randomised trial.

    PubMed

    Henriksen, Marius; Klokker, Louise; Bartholdy, Cecilie; Schjoedt-Jorgensen, Tanja; Bandak, Elisabeth; Bliddal, Henning

    2016-01-01

    To assess the effects of a functional and individualised exercise programme on gait biomechanics during walking in people with knee OA. Sixty participants were randomised to 12 weeks of facility-based functional and individualised neuromuscular exercise therapy (ET), 3 sessions per week supervised by trained physical therapists, or a no attention control group (CG). Three-dimensional gait analyses were used, from which a comprehensive list of conventional gait variables were extracted (totally 52 kinematic, kinetic and spatiotemporal variables). According to the protocol, the analyses were based on the 'Per-Protocol' population (defined as participants following the protocol with complete and valid gait analyses). Analysis of covariance adjusting for the level at baseline was used to determine differences between groups (95% CIs) in the changes from baseline at follow-up. The per-protocol population included 46 participants (24 ET/22 CG). There were no group differences in the analysed gait variables, except for a significant group difference in the second peak knee flexor moment and second peak vertical ground reaction force. While plausible we have limited confidence in the findings due to multiple statistical tests and lack of biomechanical logics. Therefore we conclude that a 12-week supervised individualised neuromuscular exercise programme has no effects on gait biomechanics. Future studies should focus on exercise programmes specifically designed to alter gait patterns, or include other measures of mobility, such as walking on stairs or inclined surfaces. ClinicalTrials.gov: NCT01545258.

  20. The effects of a mindfulness-based lifestyle programme for adults with Parkinson's disease: protocol for a mixed methods, randomised two-group control study.

    PubMed

    Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

    2013-10-10

    Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11/2662-2011001553. This is the first research of its kind in Australia involving a comprehensive, lifestyle-based programme for people with PD and has the potential to involve a broader range of providers than standard care. The findings will be disseminated through peer reviewed journals, primary care conferences in Australia as well as abroad and through the Parkinson's community. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820.

  1. The effects of a mindfulness-based lifestyle programme for adults with Parkinson’s disease: protocol for a mixed methods, randomised two-group control study

    PubMed Central

    Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

    2013-01-01

    Introduction Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. Methods A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Analysis Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. Ethics This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11/2662–2011001553. Dissemination This is the first research of its kind in Australia involving a comprehensive, lifestyle-based programme for people with PD and has the potential to involve a broader range of providers than standard care. The findings will be disseminated through peer reviewed journals, primary care conferences in Australia as well as abroad and through the Parkinson's community. Registration details Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820. PMID:24114370

  2. Brain-computer interface (BCI) evaluation in people with amyotrophic lateral sclerosis.

    PubMed

    McCane, Lynn M; Sellers, Eric W; McFarland, Dennis J; Mak, Joseph N; Carmack, C Steve; Zeitlin, Debra; Wolpaw, Jonathan R; Vaughan, Theresa M

    2014-06-01

    Brain-computer interfaces (BCIs) might restore communication to people severely disabled by amyotrophic lateral sclerosis (ALS) or other disorders. We sought to: 1) define a protocol for determining whether a person with ALS can use a visual P300-based BCI; 2) determine what proportion of this population can use the BCI; and 3) identify factors affecting BCI performance. Twenty-five individuals with ALS completed an evaluation protocol using a standard 6 × 6 matrix and parameters selected by stepwise linear discrimination. With an 8-channel EEG montage, the subjects fell into two groups in BCI accuracy (chance accuracy 3%). Seventeen averaged 92 (± 3)% (range 71-100%), which is adequate for communication (G70 group). Eight averaged 12 (± 6)% (range 0-36%), inadequate for communication (L40 subject group). Performance did not correlate with disability: 11/17 (65%) of G70 subjects were severely disabled (i.e. ALSFRS-R < 5). All L40 subjects had visual impairments (e.g. nystagmus, diplopia, ptosis). P300 was larger and more anterior in G70 subjects. A 16-channel montage did not significantly improve accuracy. In conclusion, most people severely disabled by ALS could use a visual P300-based BCI for communication. In those who could not, visual impairment was the principal obstacle. For these individuals, auditory P300-based BCIs might be effective.

  3. HIV Futures 8: Protocol for a Repeated Cross-sectional and Longitudinal Survey of People Living with HIV in Australia.

    PubMed

    Power, Jennifer; Brown, Graham; Lyons, Anthony; Thorpe, Rachel; Dowsett, Gary W; Lucke, Jayne

    2017-01-01

    More than 27,000 Australians currently live with HIV. Most of these people have access to quality clinical care and antiretroviral treatment (ART) and can expect good general health. However, HIV-related stigma is a problem and many people living with HIV experience poorer than average mental health. Issues of aging are also of increasing concern. This paper describes the methods and sample for the HIV Futures 8 study, a national survey of people living with HIV in Australia that aimed to identify factors that support health and well-being among this population. HIV Futures 8 forms part of a series of cross-sectional surveys (The "HIV Futures" studies) that have been repeated periodically since 1997. In the most recent survey, participants were able to opt into a prospective longitudinal study. HIV Futures 8 was open to people aged over 17 who were living with HIV. Data were collected in 2015/2016 using a self-complete survey that contained approximately 250 items related to physical and mental health, use of ART, HIV exposure and testing, financial security, social connectedness, relationships, life satisfaction, resilience, stigma, use of health and support services, and health literacy. To enable comparison of cross-sectional data over time, questionnaire items were consistent with those used in previous HIV Futures surveys. In HIV Futures 8, participants were invited to volunteer coded information that will allow longitudinal follow-up when participants complete subsequent HIV Futures surveys. The survey was advertised through the networks of HIV organizations, on social media and through HIV clinics and services. HIV Futures 8 was completed by 895 participants. This represents approximately 3.8% of the total number of people living with diagnosed HIV in Australia in 2014. Findings from HIV Futures 8 will contribute important insights into the complexity of factors that support physical and mental well-being among people living with HIV. The findings will also assist HIV services to align with broader public health goals related to increasing ART use and improving quality of life among people living with HIV.

  4. Effectiveness of interventions to directly support food and drink intake in people with dementia: systematic review and meta-analysis.

    PubMed

    Abdelhamid, Asmaa; Bunn, Diane; Copley, Maddie; Cowap, Vicky; Dickinson, Angela; Gray, Lucy; Howe, Amanda; Killett, Anne; Lee, Jin; Li, Francesca; Poland, Fiona; Potter, John; Richardson, Kate; Smithard, David; Fox, Chris; Hooper, Lee

    2016-01-22

    Eating and drinking difficulties are recognised sources of ill health in people with dementia. In the EDWINA (Eating and Drinking Well IN dementiA) systematic review we aimed to assess effectiveness of interventions to directly improve, maintain or facilitate oral food and drink intake, nutrition and hydration status, in people with cognitive impairment or dementia (across all settings, levels of care and support, types and degrees of dementia). Interventions included oral nutrition supplementation, food modification, dysphagia management, eating assistance and supporting the social element of eating and drinking. We comprehensively searched 13 databases for relevant intervention studies. The review was conducted with service user input in accordance with Cochrane Collaboration's guidelines. We duplicated assessment of inclusion, data extraction, and validity assessment, tabulating data, carrying out random effects meta-analysis and narrative synthesis. Forty-three controlled interventions were included, disappointingly none were judged at low risk of bias. Oral nutritional supplementation studies suggested small positive short term but unclear long term effects on nutritional status. Food modification or dysphagia management studies were smaller and of low quality, providing little evidence of an improved nutritional status. Eating assistance studies provided inconsistent evidence, but studies with a strong social element around eating/drinking, although small and of low quality provided consistent suggestion of improvements in aspects of quality of life. There were few data to address stakeholders' questions. We found no definitive evidence on effectiveness, or lack of effectiveness, of specific interventions but studies were small and short term. People with cognitive impairment and their carers have to tackle eating problems despite this lack of evidence, so promising interventions are listed. The need remains for high quality trials tailored for people with cognitive impairment assessing robust outcomes. The systematic review protocol was registered (CRD42014007611) and is published, with the full MEDLINE search strategy, on Prospero.

  5. Acceptance and usability of a home-based monitoring tool of health indicators in children of people with dementia: a Proof of Principle (POP) study.

    PubMed

    Boessen, April Bcg; Vermeulen, Joan; de Witte, Luc P

    2017-01-01

    Large-scale cohort studies are needed to confirm the relation between dementia and its possible risk factors. The inclusion of people with dementia in research is a challenge, however, children of people with dementia are at risk and are highly motivated to participate in dementia research. For technologies to support home-based data collection during large-scale studies, participants should be able and willing to use technology for a longer period of time. This study investigated acceptance and usability of iVitality, a research platform for home-based monitoring of dementia health indicators, in 151 children of people with dementia and investigated which frequency of measurements is acceptable for them. Participants were randomized to fortnightly or monthly measurements. At baseline and after 3 months, participants completed an online questionnaire regarding the acceptance (Technology Acceptance Model; 38 items) and usability (Post-Study System Usability Questionnaire; 24 items) of iVitality. Items were rated from 1 (I totally disagree) to 7 (I totally agree). Participants were also invited to take part in an online focus group (OFG) after 3 months of follow-up. Descriptive statistics and both two-sample/independent and paired t -tests were used to analyze the online questionnaires and a directed content analysis was used to analyze the OFGs. Children of people with dementia accept iVitality after long-term use and evaluate iVitality as a user-friendly, useful, and trusted technology, despite some suggestions for improvement. Overall, mean scores on acceptance and usability were higher than 5 (I somewhat agree), although the acceptance subscales "social influence" and "time" were rated somewhat lower. No significant differences in acceptance and usability were found between both protocol groups. Over time, "affect" significantly increased among participants measuring blood pressure fortnightly. iVitality has the potential to be used in large-scale studies for home-based monitoring of health indicators related to the development of dementia.

  6. Implementation of an evidence-based intervention to improve the wellbeing of people with dementia and their carers: study protocol for 'Care of People with dementia in their Environments (COPE)' in the Australian context.

    PubMed

    Clemson, Lindy; Laver, Kate; Jeon, Yun-Hee; Comans, Tracy A; Scanlan, Justin; Rahja, Miia; Culph, Jennifer; Low, Lee-Fay; Day, Sally; Cations, Monica; Crotty, Maria; Kurrle, Susan; Piersol, Catherine; Gitlin, Laura N

    2018-05-09

    There are effective non-pharmacological treatment programs that reduce functional disability and changed behaviours in people with dementia. However, these programs (such as the Care of People with dementia in their Environments (COPE) program) are not widely available. The primary aim of this study is to determine the strategies and processes that enable the COPE program to be implemented into existing dementia care services in Australia. This study uses a mixed methods approach to test an implementation strategy. The COPE intervention (up to ten consultations with an occupational therapist and up to two consultations with a nurse) will be implemented using a number of strategies including planning (such as developing and building relationships with dementia care community service providers), educating (training nurses and occupational therapists in how to apply the intervention), restructuring (organisations establishing referral systems; therapist commitment to provide COPE to five clients following training) and quality management (coaching, support, reminders and fidelity checks). Qualitative and quantitative data will contribute to understanding how COPE is adopted and implemented. Feasibility, fidelity, acceptability, uptake and service delivery contexts will be explored and a cost/benefit evaluation conducted. Client outcomes of activity engagement and caregiver wellbeing will be assessed in a pragmatic pre-post evaluation. While interventions that promote independence and wellbeing are effective and highly valued by people with dementia and their carers, access to such programs is limited. Barriers to translation that have been previously identified are addressed in this study, including limited training opportunities and a lack of confidence in clinicians working with complex symptoms of dementia. A strength of the study is that it involves implementation within different types of existing services, such as government and private providers, so the study will provide useful guidance for further future rollout. 16 February 2017; ACTRN12617000238370 .

  7. On the Effective Evaluation of TCP

    NASA Technical Reports Server (NTRS)

    Allman, Mark; Falk, Aaron

    2000-01-01

    Understanding the performance of the Internet's Transmission Control Protocol (TCP) is important because it is the dominant protocol used in the Internet today. Various testing methods exist to evaluate TCP performance, however all have pitfalls an that need to be understood prior to obtaining useful results. Simulating TCP is difficult because of the wide range of variables, environments, and implementations available. Testing TCP modifications in the global Internet may not be the answer either: testing new protocols on real networks endangers other people's traffic and, if not done correctly, may also yield inaccurate or misleading results. In order for TCP research to be independently evaluated in the Internet research community there is a set of questions that researchers should try to answer. This paper attempts to list some of those questions and make recommendations as to how TCP testing can be structured to be provide useful answers.

  8. An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes - the MID-Frail study: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. Methods/Design The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. Discussion The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. Trial registration ClinicalTrials.gov: NCT01654341. PMID:24456998

  9. An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial.

    PubMed

    Rodríguez-Mañas, Leocadio; Bayer, Antony J; Kelly, Mark; Zeyfang, Andrej; Izquierdo, Mikel; Laosa, Olga; Hardman, Timothy C; Sinclair, Alan J; Moreira, Severina; Cook, Justin

    2014-01-24

    Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. ClinicalTrials.gov: NCT01654341.

  10. 78 FR 8030 - Misuse of Internet Protocol (IP) Captioned Telephone Service; Telecommunications Relay Services...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    ... Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554... . To request materials in accessible formats for people with disabilities (Braille, large print..., 127 F.3d 90, 94 (DC Cir. 1997) (``an interpretive rule can construe an agency's substantive regulation...

  11. A School-Based Suicide Risk Assessment Protocol

    ERIC Educational Resources Information Center

    Boccio, Dana E.

    2015-01-01

    Suicide remains the third leading cause of death among young people in the United States. Considering that youth who contemplate suicide generally exhibit warning signs before engaging in lethal self-harm, school-based mental health professionals can play a vital role in identifying students who are at risk for suicidal behavior. Nevertheless, the…

  12. Education Experiences and Training for People Living with HIV

    ERIC Educational Resources Information Center

    Coleman, Gary

    2017-01-01

    Prior to the development of new medications, the effects of the HIV/AIDS epidemic have taken many lives. Despite the introduction of protocols that can prolong and stabilize their lives, many patients do not conform to treatment requirements due to a lack of health literacy. This three-article dissertation examined relevant literature in Article…

  13. The School-to-Prison Pipeline: Disproportionate Impact on Vulnerable Children and Adolescents

    ERIC Educational Resources Information Center

    Mallett, Christopher A.

    2017-01-01

    This conceptual article synthesizes the empirical research on punitive environmental norms of schools and the disproportionate effects on certain child and adolescent groups, particularly within urban schools. This involvement has come to be known as the school-to-prison pipeline. The young people affected by harsh school discipline protocols and…

  14. Role of optimization in the human dynamics of task execution

    NASA Astrophysics Data System (ADS)

    Cajueiro, Daniel O.; Maldonado, Wilfredo L.

    2008-03-01

    In order to explain the empirical evidence that the dynamics of human activity may not be well modeled by Poisson processes, a model based on queuing processes was built in the literature [A. L. Barabasi, Nature (London) 435, 207 (2005)]. The main assumption behind that model is that people execute their tasks based on a protocol that first executes the high priority item. In this context, the purpose of this paper is to analyze the validity of that hypothesis assuming that people are rational agents that make their decisions in order to minimize the cost of keeping nonexecuted tasks on the list. Therefore, we build and analytically solve a dynamic programming model with two priority types of tasks and show that the validity of this hypothesis depends strongly on the structure of the instantaneous costs that a person has to face if a given task is kept on the list for more than one period. Moreover, one interesting finding is that in one of the situations the protocol used to execute the tasks generates complex one-dimensional dynamics.

  15. Culture and self in South Africa: individualism-collectivism predictions.

    PubMed

    Eaton, L; Louw, J

    2000-04-01

    People from collectivist cultures may have more concrete and interdependent self-concepts than do people from individualist cultures (G. Hofstede, 1980). African cultures are considered collectivist (H. C. Triandis, 1989), but research on self-concept and culture has neglected this continent. The authors attempted a partial replication in an African context of cross-cultural findings on the abstract-concrete and independent-interdependent dimensions of self-construal (referred to as the abstract-specific and the autonomous-social dimensions, respectively, by E. Rhee, J. S. Uleman, H. K. Lee, & R. J. Roman, 1995). University students in South Africa took the 20 Statements Test (M. Kuhn & T. S. McPartland, 1954; Rhee et al.); home languages were rough indicators of cultural identity. The authors used 3 coding schemes to analyze the content of 78 protocols from African-language speakers and 77 protocols from English speakers. In accord with predictions from individualism-collectivism theory, the African-language speakers produced more interdependent and concrete self-descriptions than did the English speakers. Additional findings concerned the orthogonality of the 2 dimensions and the nature and assessment of the social self-concept.

  16. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial.

    PubMed

    Tiedemann, Anne; Rissel, Chris; Howard, Kirsten; Tong, Allison; Merom, Dafna; Smith, Stuart; Wickham, James; Bauman, Adrian; Lord, Stephen R; Vogler, Constance; Lindley, Richard I; Simpson, Judy M; Allman-Farinelli, Margaret; Sherrington, Catherine

    2016-05-10

    Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years. This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach. Protocol has been approved by the Human Research Ethics Committee at The University of Sydney, Australia (number 2015/517). Results will be disseminated via peer-reviewed journal articles, international conference presentations and participants' newsletters. ACTRN12615001190594. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  17. Integrated Environment for Ubiquitous Healthcare and Mobile IPv6 Networks

    NASA Astrophysics Data System (ADS)

    Cagalaban, Giovanni; Kim, Seoksoo

    The development of Internet technologies based on the IPv6 protocol will allow real-time monitoring of people with health deficiencies and improve the independence of elderly people. This paper proposed a ubiquitous healthcare system for the personalized healthcare services with the support of mobile IPv6 networks. Specifically, this paper discusses the integration of ubiquitous healthcare and wireless networks and its functional requirements. This allow an integrated environment where heterogeneous devices such a mobile devices and body sensors can continuously monitor patient status and communicate remotely with healthcare servers, physicians, and family members to effectively deliver healthcare services.

  18. Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

    PubMed

    Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

    2017-03-08

    Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54). ©Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles M Cleland, Peter Cherutich, James N Kiarie, Alfred Osoti, Connie L Celum, Jared M Baeten, Ruth Nduati, John Kinuthia, Timothy B Hallett, Ramzi Alsallaq, Ann E Kurth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2017.

  19. The Quik Fix study: a randomised controlled trial of brief interventions for young people with alcohol-related injuries and illnesses accessing emergency department and crisis support care.

    PubMed

    Hides, Leanne; Kavanagh, David J; Daglish, Mark; Cotton, Susan; Connor, Jason P; Barendregt, Jan J; Young, Ross McD; Sanders, Davina; White, Angela; Mergard, Lance

    2014-08-08

    Alcohol is a major preventable cause of injury, disability and death in young people. Large numbers of young people with alcohol-related injuries and medical conditions present to hospital emergency departments (EDs). Access to brief, efficacious, accessible and cost effective treatment is an international health priority within this age group. While there is growing evidence for the efficacy of brief motivational interviewing (MI) for reducing alcohol use in young people, there is significant scope to increase its impact, and determine if it is the most efficacious and cost effective type of brief intervention available. The efficacy of personality-targeted interventions (PIs) for alcohol misuse delivered individually to young people is yet to be determined or compared to MI, despite growing evidence for school-based PIs. This study protocol describes a randomized controlled trial comparing the efficacy and cost-effectiveness of telephone-delivered MI, PI and an Assessment Feedback/Information (AF/I) only control for reducing alcohol use and related harm in young people. Participants will be 390 young people aged 16 to 25 years presenting to a crisis support service or ED with alcohol-related injuries and illnesses (including severe alcohol intoxication). This single blinded superiority trial randomized young people to (i) 2 sessions of MI; (ii) 2 sessions of a new PI or (iii) a 1 session AF/I only control. Participants are reassessed at 1, 3, 6 and 12 months on the primary outcomes of alcohol use and related problems and secondary outcomes of mental health symptoms, functioning, severity of problematic alcohol use, alcohol injuries, alcohol-related knowledge, coping self-efficacy to resist using alcohol, and cost effectiveness. This study will identify the most efficacious and cost-effective telephone-delivered brief intervention for reducing alcohol misuse and related problems in young people presenting to crisis support services or EDs. We expect efficacy will be greatest for PI, followed by MI, and then AF/I at 1, 3, 6 and 12 months on the primary and secondary outcome variables. Telephone-delivered brief interventions could provide a youth-friendly, accessible, efficacious, cost-effective and easily disseminated treatment for addressing the significant public health issue of alcohol misuse and related harm in young people. This trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000108718.

  20. Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Santiago, Chile: a cluster randomized controlled trial. a study protocol [ISRCTN 02694183

    PubMed Central

    2011-01-01

    Background Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment. CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. Less is known about subclinical vitamin B12 deficiency and concurrent neuroconduction and cognitive impairment. A Programme of Complementary Feeding for the Older Population (PACAM) in Chile delivers 2 complementary fortified foods that provide approximately 1.4 μg/day of vitamin B12 (2.4 μg/day elderly RDA). The aim of the present study is to assess whether supplementation with vitamin B12 will improve neuroconduction and cognitive function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of clinical deficiency. Methods We designed a cluster double-blind placebo-controlled trial involving community dwelling people aged 70-79 living in Santiago, Chile. We randomized 15 clusters (health centers) involving 300 people (20 per cluster). Each cluster will be randomly assigned to one of three arms: a) a 1 mg vitamin B12 pill taken daily and a routine PACAM food; b) a placebo pill and the milk-PACAM food fortified to provide 1 mg of vitamin B12; c) the routine PACAM food and a placebo pill. The study has been designed as an 18 month follow up period. The primary outcomes assessed at baseline, 4, 9 and 18 months will be: serum levels of vitamin B12, neuroconduction and cognitive function. Conclusions In view of the high prevalence of vitamin B12 deficiency in later life, the present study has potential public health interest because since it will measure the impact of the existing program of complementary feeding as compared to two options that provide higher vitamin B12 intakes that might potentially may contribute in preserving neurophysiologic and cognitive function and thus improve quality of life for older people in Chile. Trial registration ISRCTN: ISRCTN02694183 PMID:21952034

  1. The prevention access and risk taking in young people (PARTY) project protocol: A cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice

    PubMed Central

    2012-01-01

    Background There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. Main outcomes: clinicians’ detection of risk-taking and emotional distress, young people’s intention to change and reduction of risk taking. Secondary outcomes: pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. Methods PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff’s self-perceived competency in young people’s care and clinicians’ detection and response to risk taking behaviours and emotional distress in 14–24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation. Discussion The PARTY trial is the first to examine the effectiveness and efficiency of a psychosocial risk screening and counselling intervention for young people attending primary care. It will provide important data on health risk profiles of young people attending general practice and on the effects of the intervention on engagement with primary care and health outcomes over 12 months. Trial registration ISRCTN16059206 PMID:22672481

  2. Study protocol for a randomised trial of nicotine-free cigarettes as an adjunct to usual NRT-based cessation practice, in people who wish to stop smoking

    PubMed Central

    2011-01-01

    Background Current smoking cessation treatments focus on addressing the pharmacological dependence of smokers on nicotine. However, new strategies are needed that address both nicotine dependence and the psychological dependence on cigarettes as the source of nicotine. Evidence from a number of small smoking cessation studies suggests that the use of cigarettes with reduced nicotine content, in combination with nicotine replacement therapy (NRT), may help reduce withdrawal symptoms and increase quit rates. This paper describes the protocol for a large randomised-controlled trial to test the effect of using nicotine-free cigarettes together with NRT on long-term quit rates. Methods/design This single-blind, randomised trial aims to recruit 1,410 participants through the national telephone-based Quitline service in New Zealand. Participants in the treatment arm will be asked to stop smoking nicotine-containing cigarettes on their chosen Quit day and smoke ad libitum nicotine-free (Quest 3) cigarettes for six weeks. At the same time people in this group will be asked to start using NRT patches, gum and/or lozenges (as recommended by Quitline) for eight weeks. Participants in the control arm will be asked to stop smoking completely on their chosen Quit day and start using NRT patches, gum and/or lozenges (as recommended by Quitline) for eight weeks. Data collection will occur at baseline, three and six weeks, and three and six months after Quit day. The primary outcome is the proportion of participants who self-report seven-day point prevalence abstinence at six months since Quit date. Discussion Smoking prevalence in New Zealand has changed little in recent years (particularly in Māori, the indigenous people of New Zealand) and additional options for smokers who want to quit are needed. Although a variety of methods are available to help, many are expensive, have side effects, and despite their use most quit attempts still fail. This trial will test the balance of benefits and risks of a new strategy for people to overcome nicotine dependence. Since smoking is the leading cause of lost healthy life years in New Zealand, if proven effective this strategy is likely to have substantial public health benefits. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12608000410358 PMID:21232155

  3. Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

    PubMed Central

    2012-01-01

    Background Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed. Methods A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional support. (2) Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3) Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4) Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. Discussion This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12609000469213 PMID:23035666

  4. Central and peripheral hemodynamic responses to passive limb movement: the role of arousal

    PubMed Central

    Venturelli, Massimo; Amann, M.; McDaniel, J.; Trinity, J. D.; Fjeldstad, A. S.

    2012-01-01

    The exact role of arousal in central and peripheral hemodynamic responses to passive limb movement in humans is unclear but has been proposed as a potential contributor. Thus, we used a human model with no lower limb afferent feedback to determine the role of arousal on the hemodynamic response to passive leg movement. In nine people with a spinal cord injury, we compared central and peripheral hemodynamic and ventilatory responses to one-leg passive knee extension with and without visual feedback (M+VF and M-VF, respectively) as well as in a third trial with no movement or visual feedback but the perception of movement (F). Ventilation (V̇e), heart rate, stroke volume, cardiac output, mean arterial pressure, and leg blood flow (LBF) were evaluated during the three protocols. V̇e increased rapidly from baseline in M+VF (55 ± 11%), M-VF (63 ± 13%), and F (48 ± 12%) trials. Central hemodynamics (heart rate, stroke volume, cardiac output, and mean arterial pressure) were unchanged in all trials. LBF increased from baseline by 126 ± 18 ml/min in the M+VF protocol and 109 ± 23 ml/min in the M-VF protocol but was unchanged in the F protocol. Therefore, with the use of model that is devoid of afferent feedback from the legs, the results of this study reveal that, although arousal is invoked by passive movement or the thought of passive movement, as evidenced by the increase in V̇e, there is no central or peripheral hemodynamic impact of this increased neural activity. Additionally, this study revealed that a central hemodynamic response is not an obligatory component of movement-induced LBF. PMID:22003056

  5. Inertial Sensors to Assess Gait Quality in Patients with Neurological Disorders: A Systematic Review of Technical and Analytical Challenges

    PubMed Central

    Vienne, Aliénor; Barrois, Rémi P.; Buffat, Stéphane; Ricard, Damien; Vidal, Pierre-Paul

    2017-01-01

    Gait disorders are major causes of falls in patients with neurological diseases. Understanding these disorders allows prevention and better insights into underlying diseases. InertiaLocoGraphy (ILG) –the quantification of gait by using inertial measurement units (IMUs) –shows great potential to address this public health challenge, but protocols vary widely and normative values of gait parameters are still unavailable. This systematic review critically compares ILG protocols, questions features extracted from inertial signals and proposes a semeiological analysis of clinimetric characteristics for use in neurological clinical routine. For this systematic review, PubMed, Cochrane and EMBASE were searched for articles assessing gait quality by using IMUs that were published from January 1, 2014 to August 31, 2016. ILG was used to assess gait in a wide range of neurological disorders – including Parkinson disease, mild cognitive impairment, Alzheimer disease, cerebral palsy, and cerebellar atrophy – as well as in the faller or frail older population and in people presenting rheumatological pathologies. However, results have not yet been driving changes in clinical practice. One reason could be that studies mainly aimed at comparing pathological gait to healthy gait, but there is stronger need for semiological descriptions of gait perturbation, severity or prognostic assessment. Furthermore, protocols used to assess gait using IMUs are too many. Likely, outcomes are highly heterogeneous and difficult to compare across large panels of studies. Therefore, homogenization is needed to foster the use of ILG to assess gait quality in neurological routine practice. The pros and cons of each protocol are emphasized so that a compromise can be reached. As well, analysis of seven complementary clinical criteria (springiness, sturdiness, smoothness, steadiness, stability, symmetry, synchronization) is advocated. PMID:28572784

  6. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV) results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community), participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may contribute to a functional decline following discharge from formal rehabilitation. Best practice guidelines recommend a prolonged period of rehabilitation, however this is expensive and therefore not undertaken in most publicly funded centres. An effective, cost-effective, and preference-sensitive therapy using basic technology to assist programme delivery may improve patient autonomy as they leave formal rehabilitation and return home. Trial registration ACTRN12612000464864 PMID:23216861

  7. Validity of Current Treatment Protocols to Overcome Hypochondriasis

    PubMed Central

    Srivastava, Meher Narain

    2017-01-01

    Hypochondriasis has been difficult to define and its classification amongst diseases has been blurred since, time immemorial. Though decades have been passed since its discovery and known to the people that the disorder is of the mind itself, the treatment options are still limited for the disorder and therefore, in dire need of exploration and analysis. Hypochondriasis, also sometimes referred to as health anxiety, is much more common in general health ward than previously accounted for. Thus, an efficient way of its management needs to be formulated and this review article helps to shed out light on the current treatment protocol available for hypochondriasis and their efficacy for the same. The treatment modules for hypochondriasis are unfortunately few and limited. None of the review articles have evaluated the efficacy of the tried treatment interventions and through this review article we want to highlight the same. A Medline search of the relevant publications and the references of the studies were incorporated to obtain the data. PMID:28274027

  8. A Design to Investigate the Feasibility and Effects of Partnered Ballroom Dancing on People With Parkinson Disease: Randomized Controlled Trial Protocol

    PubMed Central

    Roberts, Lisa; Pickering, Ruth; Roberts, Helen Clare; Wiles, Rose; Kunkel, Dorit; Hulbert, Sophia; Robison, Judy; Fitton, Carolyn

    2014-01-01

    Background Self-help and physical leisure activities has become increasingly important in the maintenance of safe and functional mobility among an increasingly elderly population. Preventing the cycle of deterioration, falling, inactivity, dependency, and secondary complications in people with Parkinson disease (PD) is a priority. Research has shown that people with PD are interested in dance and although the few existing trials are small, initial proof of principle trials from the United States have demonstrated beneficial effects on balance control, gait, and activity levels. To our knowledge, there has been no research into long-term effects, cost effectiveness, the influence on spinal posture and turning, or the personal insights of dance participants. Objective The purpose of this study was to determine the methodological feasibility of conducting a definitive phase III trial to evaluate the benefits of dance in people with PD. We will build on the proof of principle trials by addressing gaps in knowledge, focusing on areas of greatest methodological uncertainty; the choice of dances and intensity of the program; for the main trial, the availability of partners, the suitability of the currently envisaged primary outcomes, balance and spinal posture; and the key costs of delivering and participating in a dance program to inform economic evaluation. Methods Fifty participants (mild-to-moderate condition) will be randomized to the control (usual care) or experimental (dance plus usual care) groups at a ratio of 15:35. Dance will be taught by professional teachers in a dance center in the South of England. Each participant in the experimental group will dance with his or her spouse, a friend, or a partner from a bank of volunteers. A blinded assessor will complete clinical measures and self-reported ability at baseline, and at 3 and 6 months after randomization. A qualitative study of a subgroup of participants and partners will examine user’s views about the appropriateness and acceptability of the intervention, assessment protocol, and general trial procedures. Procedures for an economic evaluation of dance for health care will be developed for the main trial. Results Recruitment began in January 2013 and the last participant is expected to complete the trial follow-up in June 2014. Conclusions Findings from our study may provide novel insights into the way people with PD become involved in dance, their views and opinions, and the suitability of our primary and secondary outcomes. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 63088686; http://www.controlled-trials.com/ISRCTN63088686/63088686 (Archived by WebCite at http://www.webcitation.org/6QYyjehP7). PMID:25051989

  9. A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol.

    PubMed

    Coote, Susan; Gallagher, Stephen; Msetfi, Rachel; Larkin, Aidan; Newell, John; Motl, Robert W; Hayes, Sara

    2014-12-21

    Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effect of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS. People with a diagnosis of MS who walk independently, score of 0-3 on the Patient Determined Disease Steps, who have not experienced an MS relapse or change in their MS medication in the last 12 weeks and who are physically inactive will be randomised to one of two study conditions. The experimental group will undergo a 10-week exercise plus SCT-based behavioural change intervention. The control group will undergo a 10-week exercise plus education intervention to control for contact. Participants will be assessed at weeks 1, 12, 24 and 36. The primary outcome will be walking mobility. Secondary outcomes will include: aerobic capacity, lower extremity muscle strength, participant adherence to the exercise programme, self-report exercise intensity, self-report enjoyment of exercise, exercise self-efficacy, outcome expectations for exercise, goal-setting for exercise, perceived benefits and barriers to exercise, perceptions of social support, physical and psychological impact of MS and fatigue. A qualitative evaluation of Step it Up will be completed among participants post-intervention. This randomised controlled trial will examine the effectiveness of an exercise plus SCT-based behaviour change intervention on walking mobility among people with MS. To this end, Step it Up will serve to inform future directions of research and clinical practice with regard to sustainable exercise interventions for people with MS. ClinicalTrials.gov, NCT02301442.

  10. The Effectiveness of Aromatherapy for Depressive Symptoms: A Systematic Review.

    PubMed

    Sánchez-Vidaña, Dalinda Isabel; Ngai, Shirley Pui-Ching; He, Wanjia; Chow, Jason Ka-Wing; Lau, Benson Wui-Man; Tsang, Hector Wing-Hong

    2017-01-01

    Background . Depression is one of the greatest health concerns affecting 350 million people globally. Aromatherapy is a popular CAM intervention chosen by people with depression. Due to the growing popularity of aromatherapy for alleviating depressive symptoms, in-depth evaluation of the evidence-based clinical efficacy of aromatherapy is urgently needed. Purpose . This systematic review aims to provide an analysis of the clinical evidence on the efficacy of aromatherapy for depressive symptoms on any type of patients. Methods . A systematic database search was carried out using predefined search terms in 5 databases: AMED, CINHAL, CCRCT, MEDLINE, and PsycINFO. Outcome measures included scales measuring depressive symptoms levels. Results . Twelve randomized controlled trials were included and two administration methods for the aromatherapy intervention including inhaled aromatherapy (5 studies) and massage aromatherapy (7 studies) were identified. Seven studies showed improvement in depressive symptoms. Limitations . The quality of half of the studies included is low, and the administration protocols among the studies varied considerably. Different assessment tools were also employed among the studies. Conclusions . Aromatherapy showed potential to be used as an effective therapeutic option for the relief of depressive symptoms in a wide variety of subjects. Particularly, aromatherapy massage showed to have more beneficial effects than inhalation aromatherapy.

  11. Ethnicity and cardiovascular health inequalities in people with severe mental illnesses: protocol for the E-CHASM study.

    PubMed

    Das-Munshi, J; Ashworth, M; Gaughran, F; Hull, S; Morgan, C; Nazroo, J; Roberts, A; Rose, D; Schofield, P; Stewart, R; Thornicroft, G; Prince, M J

    2016-04-01

    People with severe mental illnesses (SMI) experience a 17- to 20-year reduction in life expectancy. One-third of deaths are due to cardiovascular disease. This study will establish the relationship of SMI with cardiovascular disease in ethnic minority groups (Indian, Pakistani, Bangladeshi, black Caribbean, black African and Irish), in the UK. E-CHASM is a mixed methods study utilising data from 1.25 million electronic patient records. Secondary analysis of routine patient records will establish if differences in cause-specific mortality, cardiovascular disease prevalence and disparities in accessing healthcare for ethnic minority people living with SMI exist. A nested qualitative study will be used to assess barriers to accessing healthcare, both from the perspectives of service users and providers. In primary care, 993,116 individuals, aged 18+, provided data from 186/189 (98 %) practices in four inner-city boroughs (local government areas) in London. Prevalence of SMI according to primary care records, ranged from 1.3-1.7 %, across boroughs. The primary care sample included Bangladeshi [n = 94,643 (10 %)], Indian [n = 6086 (6 %)], Pakistani [n = 35,596 (4 %)], black Caribbean [n = 45,013 (5 %)], black African [n = 75,454 (8 %)] and Irish people [n = 13,745 (1 %)]. In the secondary care database, 12,432 individuals with SMI over 2007-2013 contributed information; prevalent diagnoses were schizophrenia [n = 6805 (55 %)], schizoaffective disorders [n = 1438 (12 %)] and bipolar affective disorder [n = 4112 (33 %)]. Largest ethnic minority groups in this sample were black Caribbean [1432 (12 %)] and black African (1393 (11 %)). There is a dearth of research examining cardiovascular disease in minority ethnic groups with severe mental illnesses. The E-CHASM study will address this knowledge gap.

  12. Treatment effects of massage therapy in depressed people: a meta-analysis.

    PubMed

    Hou, Wen-Hsuan; Chiang, Pai-Tsung; Hsu, Tun-Yen; Chiu, Su-Ying; Yen, Yung-Chieh

    2010-07-01

    To systematically investigate the treatment effects of massage therapy in depressed people by incorporating data from recent studies. A meta-analysis of randomized controlled trials (RCTs) of massage therapy in depressed people was conducted using published studies from PubMed, EMBASE, PsycINFO, and CINAHL electronic database from inception until July 2008. The terms used for the search were derived from medical subheading term (MeSH) massage combined with MeSH depression. Hand searching was also checked for bibliographies of relevant articles. Retrieval articles were constrained to RCTs/clinical trials and human subjects. No language restrictions were imposed. We included 17 studies containing 786 persons from 246 retrieved references. Trials with other intervention, combined therapy, and massage on infants or pregnant women were excluded. Two reviewers independently performed initial screen and assessed quality indicators by Jadad scale. Data were extracted on publication year, participant characteristics, and outcomes by another single reviewer. All trials showed positive effect of massage therapy on depressed people. Seventeen RCTs were of moderate quality, with a mean quality score of 6.4 (SD = 0.85). The pooled standardized mean difference in fixed- and random-effects models were 0.76 (95% CI, 0.61-0.91) and 0.73 (95% CI, 0.52-0.93), respectively. Both indicated significant effectiveness in the treatment group compared with the control group. The variance between these studies revealed possible heterogeneity (tau(2) = 0.06, Cochran chi-squared(16) = 25.77, P = .06). Massage therapy is significantly associated with alleviated depressive symptoms. However, standardized protocols of massage therapy, various depression rating scales, and target populations in further studies are suggested. (c) Copyright 2010 Physicians Postgraduate Press, Inc.

  13. Age discrimination in healthcare institutions perceived by seniors and students.

    PubMed

    Dobrowolska, Beata; Jędrzejkiewicz, Bernadeta; Pilewska-Kozak, Anna; Zarzycka, Danuta; Ślusarska, Barbara; Deluga, Alina; Kościołek, Aneta; Palese, Alvisa

    2017-01-01

    Old age-based discrimination is observed as the most tolerated prejudice in society and has also been witnessed in healthcare institutions. The aim of this study is to explore age-based discrimination in healthcare institutions as perceived by seniors and students of Medicine and Nursing. A multi-method study design, by involving a triangulation design. Participants and research context: A purposeful sample of individuals aged 65+ (n = 80) and medical and nursing students (n = 100) in the eastern region of Poland. Ethical considerations: Ethical approval of the research protocol was received from the Ethics Committee at the Medical University of Lublin. 'Old age' was perceived by groups of participants based on three themes: (a) positive, (b) negative and (c) neutral connotations. The negative connotations predominated. The beginning of old age was defined by the metric of age and described by showing the complexity of the ageing process involving subjective, objective and societal aspects. Experience of age discrimination in healthcare institutions was reported by 24 (30%) seniors and witnessed by 47 (47%) students surveyed and for both groups occurred mainly at the hospital level and by physicians. Only 48 students (48%) declared a willingness to work with the older people in the future, and barriers were reported at the personal and professional levels, and also in some visions of older people. The conceptualization of old age as reported by seniors and students mainly carried negative connotations, reflecting the profoundly based stereotypes within society regarding the older people. Seniors have reported being exposed to ageism and have witnessed ageism episodes in HCIs; also, students have faced ageism episodes during their clinical education. There is a need for ethical education within medical and nursing courses to shape positive attitudes towards the older people. A positive vision of ageing should be promoted not only among young people but also among adults and older people to avoid self-stereotyping of older people and seeing old age from negative perspective.

  14. Effectiveness and usability of Scanning Wizard software: a tool for enhancing switch scanning.

    PubMed

    Koester, Heidi Horstmann; Simpson, Richard C

    2017-11-24

    Scanning Wizard software helps scanning users improve the setup of their switch and scanning system. This study evaluated Scanning Wizard's effectiveness and usability. Ten people who use switch scanning and ten practitioners used Scanning Wizard in the initial session. Usability was high, based on survey responses averaging over 4.5 out of 5, and qualitative feedback was very positive. Five switch users were able to complete the multi-week protocol, using settings on their own scanning system that were recommended from the Scanning Wizard session. Using these revised settings, text entry rates improved by an average of 71%, ranging from 29% to 172% improvement. Results suggest that Scanning Wizard is a useful tool for improving the configuration of scanning systems for people who use switch scanning to communicate. Implications for Rehabilitation Some individuals with severe physical impairments use switch scanning for spoken and written communication. Scanning Wizard software helps scanning users improve the setup of their switch and scanning system. This study demonstrated high usability of Scanning Wizard (with 10 switch userpractitioner teams) and increased text entry rate by an average of 71% (for five switch users). Results suggest that Scanning Wizard is a useful tool for improving the configuration of scanning systems for people who use switch scanning to communicate.

  15. Integrating cardiovascular diseases, hypertension, and diabetes with HIV services: a systematic review.

    PubMed

    Haldane, Victoria; Legido-Quigley, Helena; Chuah, Fiona Leh Hoon; Sigfrid, Louise; Murphy, Georgina; Ong, Suan Ee; Cervero-Liceras, Francisco; Watt, Nicola; Balabanova, Dina; Hogarth, Sue; Maimaris, Will; Buse, Kent; McKee, Martin; Piot, Peter; Perel, Pablo

    2018-01-01

    Non-communicable diseases (NCDs), including cardiovascular diseases (CVD), hypertension and diabetes together with HIV infection are among the major public health concerns worldwide. Health services for HIV and NCDs require health systems that provide for people's chronic care needs, which present an opportunity to coordinate efforts and create synergies between programs to benefit people living with HIV and/or AIDS and NCDs. This review included studies that reported service integration for HIV and/or AIDS with coronary heart diseases, chronic CVD, cerebrovascular diseases (stroke), hypertension or diabetes. We searched multiple databases from inception until October 2015. Articles were screened independently by two reviewers and assessed for risk of bias. 11,057 records were identified with 7,616 after duplicate removal. After screening titles and abstracts, 14 papers addressing 17 distinct interventions met the inclusion criteria. We categorized integration models by diseases (HIV with diabetes, HIV with hypertension and diabetes, HIV with CVD and finally HIV with hypertension and CVD and diabetes). Models also looked at integration from micro (patient focused integration) to macro (system level integrations). Most reported integration of hypertension and diabetes with HIV and AIDS services and described multidisciplinary collaboration, shared protocols, and incorporating screening activities into community campaigns. Integration took place exclusively at the meso-level, with no micro- or macro-level integrations described. Most were descriptive studies, with one cohort study reporting evaluative outcomes. Several innovative initiatives were identified and studies showed that CVD and HIV service integration is feasible. Integration should build on existing protocols and use the community as a locus for advocacy and health services, while promoting multidisciplinary teams, including greater involvement of pharmacists. There is a need for robust and well-designed studies at all levels - particularly macro-level studies, research looking at long-term outcomes of integration, and research in a more diverse range of countries.

  16. Noise-Enhanced Eversion Force Sense in Ankles With or Without Functional Instability.

    PubMed

    Ross, Scott E; Linens, Shelley W; Wright, Cynthia J; Arnold, Brent L

    2015-08-01

    Force sense impairments are associated with functional ankle instability. Stochastic resonance stimulation (SRS) may have implications for correcting these force sense deficits. To determine if SRS improved force sense. Case-control study. Research laboratory. Twelve people with functional ankle instability (age = 23 ± 3 years, height = 174 ± 8 cm, mass = 69 ± 10 kg) and 12 people with stable ankles (age = 22 ± 2 years, height = 170 ± 7 cm, mass = 64 ± 10 kg). The eversion force sense protocol required participants to reproduce a targeted muscle tension (10% of maximum voluntary isometric contraction). This protocol was assessed under SRSon and SRSoff (control) conditions. During SRSon, random subsensory mechanical noise was applied to the lower leg at a customized optimal intensity for each participant. Constant error, absolute error, and variable error measures quantified accuracy, overall performance, and consistency of force reproduction, respectively. With SRS, we observed main effects for force sense absolute error (SRSoff = 1.01 ± 0.67 N, SRSon = 0.69 ± 0.42 N) and variable error (SRSoff = 1.11 ± 0.64 N, SRSon = 0.78 ± 0.56 N) (P < .05). No other main effects or treatment-by-group interactions were found (P > .05). Although SRS reduced the overall magnitude (absolute error) and variability (variable error) of force sense errors, it had no effect on the directionality (constant error). Clinically, SRS may enhance muscle tension ability, which could have treatment implications for ankle stability.

  17. The effects of actors vocal exercises for relaxation on fluency: A preliminary study.

    PubMed

    Monteagudo, Emily; Sawyer, Jean; Sivek-Eskra, Alyssa

    2017-12-01

    To determine the efficacy of treatment based on Kristin Linklater's technique for vocal preparation for performance for use with people who stutter. A protocol for a treatment for stuttering involving breathing exercises, relaxation techniques, and focus on awareness was designed by the first author from Linklater's published exercises in her book Freeing the Natural Voice (2006). Four adults who stutter participated in a 12-week, single-case reversal design study. Treatment efficacy was determined by baseline and post-treatment measures on the OASES, self-report naturalness, tension and severity scale, and percentage of stuttering-like disfluency (SLD). Qualitative measures included a daily tension and practice log, a program completion questionnaire, and accounts from the clinicians administering the treatment protocol. Three of four participants scored lower on the OASES post-treatment, suggesting that the impact of stuttering on their daily lives had decreased. All four experienced a reduction in the number of SLD counted throughout treatment sessions compared to baseline data. A treatment for stuttering based on Linklater's work including regulation of breathing, relaxation, and awareness of breath may be effective in improving fluency and decreasing the impact of stuttering and warrants further study. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. A systematic review of evidence for fitness-to-drive among people with the mental health conditions of schizophrenia, stress/anxiety disorder, depression, personality disorder and obsessive compulsive disorder.

    PubMed

    Unsworth, Carolyn A; Baker, Anne M; So, Man H; Harries, Priscilla; O'Neill, Desmond

    2017-08-31

    Limited evidence exists regarding fitness-to-drive for people with the mental health conditions of schizophrenia, stress/anxiety disorder, depression, personality disorder and obsessive compulsive disorder (herein simply referred to as 'mental health conditions'). The aim of this paper was to systematically search and classify all published studies regarding driving for this population, and then critically appraise papers addressing assessment of fitness-to-drive where the focus was not on the impact of medication on driving. A systematic search of three databases (CINAHL, PSYCHINFO, EMBASE) was completed from inception to May 2016 to identify all articles on driving and mental health conditions. Papers meeting the eligibility criteria of including data relating to assessment of fitness-to-drive were critically appraised using the American Academy of Neurology and Centre for Evidence-Based Medicine protocols. A total of 58 articles met the inclusion criteria of driving among people with mental health conditions studied, and of these, 16 contained data and an explicit focus on assessment of fitness-to-drive. Assessment of fitness-to-drive was reported in three ways: 1) factors impacting on the ability to drive safely among people with mental health conditions, 2) capability and perception of health professionals assessing fitness-to-drive of people with mental health conditions, and 3) crash rates. The level of evidence of the published studies was low due to the absence of controls, and the inability to pool data from different diagnostic groups. Evidence supporting fitness-to-drive is conflicting. There is a relatively small literature in the area of driving with mental health conditions, and the overall quality of studies examining fitness-to-drive is low. Large-scale longitudinal studies with age-matched controls are urgently needed in order to determine the effects of different conditions on fitness-to-drive.

  19. Test-retest reliability, smallest real difference and concurrent validity of six different balance tests on young people with mild to moderate intellectual disability.

    PubMed

    Blomqvist, Sven; Wester, Anita; Sundelin, Gunnevi; Rehn, Börje

    2012-12-01

    Some studies have reported that people with intellectual disability may have reduced balance ability compared with the population in general. However, none of these studies involved adolescents, and the reliability and validity of balance tests in this population are not known. The purpose of this study was to examine the reliability of six different balance tests and to investigate their concurrent validity. Test-retest reliability assessment. All subjects were recruited from a special school for people with intellectual disability in Bollnäs, Sweden. Eighty-nine adolescents (35 females and 54 males) with mild to moderate intellectual disability with a mean age of 18 years (range 16 to 20 years). All subjects followed the same test protocol on two occasions within an 11-day period. Balance test performances. Intraclass correlation coefficients greater than 0.80 were achieved for four of the balance tests: Extended Timed Up and Go Test, Modified Functional Reach Test, One-leg Stance Test and Force Platform Test. The smallest real differences ranged from 12% to 40%; less than 20% is considered to be low. Concurrent validity among these balance tests varied between no and low correlation. The results indicate that these tests could be used to evaluate changes in balance ability over time in people with mild to moderate intellectual disability. The low concurrent validity illustrates the importance of knowing more about the influence of various sensory subsystems that are significant for balance among adolescents with intellectual disability. Copyright © 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  20. Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background The provision of appropriate medical and nursing care for people with dementia is a major challenge for the healthcare system in Germany. New models of healthcare provision need to be developed, tested and implemented on the population level. Trials in which collaborative care for dementia in the primary care setting were studied have demonstrated its effectiveness. These studies have been conducted in different healthcare systems, however, so it is unclear whether these results extend to the specific context of the German healthcare system. The objective of this population-based intervention trial in the primary care setting is to test the efficacy and efficiency of implementing a subsidiary support system on a population level for persons with dementia who live at home. Methods and study design The study was designed to assemble a general physician-based epidemiological cohort of people above the age of 70 who live at home (DelpHi cohort). These people are screened for eligibility to participate in a trial of dementia care management (DelpHi trial). The trial is a cluster-randomised, controlled intervention trial with two arms (intervention and control) designed to test the efficacy and efficiency of implementing a subsidiary support system for persons with dementia who live at home. This subsidiary support system is initiated and coordinated by a dementia care manager: a nurse with dementia-specific qualifications who delivers the intervention according to a systematic, detailed protocol. The primary outcome is quality of life and healthcare for patients with dementia and their caregivers. This is a multidimensional outcome with a focus on four dimensions: (1) quality of life, (2) caregiver burden, (3) behavioural and psychological symptoms of dementia and (4) pharmacotherapy with an antidementia drug and prevention or suspension of potentially inappropriate medication. Secondary outcomes include the assessment of dementia syndromes, activities of daily living, social support health status, utilisation of health care resources and medication. Discussion The results will provide evidence for specific needs in ambulatory care for persons with dementia and will show effective ways to meet those needs. Qualification requirements will be evaluated, and the results will help to modify existing guidelines and treatment paths. Trial registration NCT01401582 PMID:22575023

  1. Potential Projective Material on the Rorschach: Comparing Comprehensive System Protocols to Their Modeled R-Optimized Administration Counterparts.

    PubMed

    Pianowski, Giselle; Meyer, Gregory J; Villemor-Amaral, Anna Elisa de

    2016-01-01

    Exner ( 1989 ) and Weiner ( 2003 ) identified 3 types of Rorschach codes that are most likely to contain personally relevant projective material: Distortions, Movement, and Embellishments. We examine how often these types of codes occur in normative data and whether their frequency changes for the 1st, 2nd, 3rd, 4th, or last response to a card. We also examine the impact on these variables of the Rorschach Performance Assessment System's (R-PAS) statistical modeling procedures that convert the distribution of responses (R) from Comprehensive System (CS) administered protocols to match the distribution of R found in protocols obtained using R-optimized administration guidelines. In 2 normative reference databases, the results indicated that about 40% of responses (M = 39.25) have 1 type of code, 15% have 2 types, and 1.5% have all 3 types, with frequencies not changing by response number. In addition, there were no mean differences in the original CS and R-optimized modeled records (M Cohen's d = -0.04 in both databases). When considered alongside findings showing minimal differences between the protocols of people randomly assigned to CS or R-optimized administration, the data suggest R-optimized administration should not alter the extent to which potential projective material is present in a Rorschach protocol.

  2. Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol

    PubMed Central

    Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

    2014-01-01

    Introduction A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. Methods and analysis We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. Ethics and dissemination The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. Trial registration number UKCRN Study ID: 15939. PMID:25146718

  3. Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol.

    PubMed

    Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

    2014-08-21

    A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. UKCRN Study ID: 15939. 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.

  4. Integrating Psychological Theory Into the Design of an Online Intervention for Sexual Health: The Sexunzipped Website

    PubMed Central

    2012-01-01

    Background The Internet can provide a confidential and convenient medium for sexual health promotion for young people. Objective This paper describes the development of an interactive, theory-based website (Sexunzipped) aimed at increasing safe sexual behavior of young people, as well as an outline of the evaluation protocol. Methods The website focuses on safer sex, relationships, and sexual pleasure. An overview of the site is provided, including a description of the theoretical constructs which form the basis of the site development. An integrated behavioral model was chosen as the guiding theory for the Sexunzipped intervention. A randomized trial design will be used to evaluate the site quantitatively. Results The content of the site is described in detail with examples of the main content types: information pages, quizzes, and decision-making activities. We describe the protocol for quantitative evaluation of the website using a randomized trial design and discuss the principal challenges involved in developing the site, including the challenge of balancing the requirements of theory with young people’s views on website content and design. Conclusions Considerations for future interventions are discussed. Developing an online behavior-change intervention is costly and time consuming. Given the large public health potential, the cost involved in developing online interventions, and the need for attractive design, future interventions may benefit from collaborating with established sites that already have a user base, a brand, and a strong Internet presence. It is vital to involve users in decisions about intervention content, design, and features, paying attention to aspects that will attract and retain users’ interest. A central challenge in developing effective Internet-based interventions for young people is to find effective ways to operationalize theory in ways that address the views and perspectives of young people. PMID:23612122

  5. How do older people describe their sensory experiences of the natural world? A systematic review of the qualitative evidence.

    PubMed

    Orr, Noreen; Wagstaffe, Alexandra; Briscoe, Simon; Garside, Ruth

    2016-06-01

    Despite the increased scholarly interest in the senses and sensory experiences, the topic of older people's sensory engagement with nature is currently under researched. This paper reviews and synthesises qualitative research evidence about how older people, including those living with dementia, describe their sensory engagement with the natural world. Ten databases were searched from 1990 to September 2014: MEDLINE (Ovid), MEDLINE-in-Process (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), GreenFILE (EBSCO), ProQuest Sociology, ASSIA (ProQuest), International Bibliography of the Social Sciences (ProQuest); HMIC (Ovid); Social Policy and Practice (Ovid). Forward and backward citation chasing of included articles was conducted; 20 organizations were contacted to identify unpublished reports. Screening was undertaken independently by two reviewers. Twenty seven studies were included. Thematic analysis revealed that descriptions of sensory experiences are encompassed within six themes: descriptions from 'the window'; sensory descriptions that emphasise vision; descriptions of 'being in nature'; descriptions of 'doing in nature'; barriers to sensory engagement; and meanings of being and doing in nature. Older people derive considerable pleasure and enjoyment from viewing nature, being and doing in nature which, in turn has a positive impact on their wellbeing and quality of life. Future research could usefully explore how sensory engagement with nature could be used to stimulate reminiscences of places and people, and evoke past sensory experiences to enrich everyday life and maintain a sense of self. The protocol was registered with PROSPERO ( CRD42015020736 ).

  6. A View from the Clouds

    ERIC Educational Resources Information Center

    Chudnov, Daniel

    2010-01-01

    Cloud computing is definitely a thing now, but it's not new and it's not even novel. Back when people were first learning about the Internet in the 1990s, every diagram that one saw showing how the Internet worked had a big cloud in the middle. That cloud represented the diverse links, routers, gateways, and protocols that passed traffic around in…

  7. Creating a "SIS-A" Annual Review Protocol to Determine the Need for Reassessment

    ERIC Educational Resources Information Center

    Thompson, James R.; Shogren, Karrie A.; Seo, Hyojeong; Wehmeyer, Michael L.; Lang, Kyle M.

    2016-01-01

    The Supports Intensity Scale-Adult Version ("SIS-A") has been widely adopted throughout North America and the world since its publication a little over a decade ago. Many organizations and jurisdictions operate under regulations that require an annual assessment of people who receive services and supports that are financed through public…

  8. A Review of Verb Network Strengthening Treatment: Theory, Methods, Results, and Clinical Implications

    ERIC Educational Resources Information Center

    Edmonds, Lisa A.

    2016-01-01

    This article examines Verb Network Strengthening Treatment (VNeST), a relatively new treatment approach for anomia in people with aphasia. The VNeST protocol aims to promote generalization to increased lexical retrieval of untrained words across a hierarchy of linguistic tasks, including single-word naming of nouns and verbs, sentence production,…

  9. Assessment of factors possibly contributing to the susceptibility of sickle trait erythrocytes to mild hypoxia. I., Design considerations and research protocol.

    DOT National Transportation Integrated Search

    1978-08-01

    This report continues a review (see FAA-AM-76-15) of the evidence for mixed dominance of the Hbs beta gene in people with the sickle cell trait. These individuals, whose erythrocytes contain a mixture of hemoglobins (HbA/HbS), are healthy and have a ...

  10. Update: What Nurses Need to Know about Human Trafficking.

    PubMed

    Washburn, Joy

    Nurses are key people who interact with victims of human trafficking in healthcare and other settings. This article provides a current overview of human trafficking, explains legal definitions, elements for protocols in healthcare settings when trafficking is suspected, nursing roles and responses, interview tools, resources, public health recommendations, and nursing education approaches to address human trafficking.

  11. How I Learned to Design and Conduct Semi-Structured Interviews: An Ongoing and Continuous Journey

    ERIC Educational Resources Information Center

    Rabionet, Silvia E.

    2011-01-01

    Qualitative interviewing is a flexible and powerful tool to capture the voices and the ways people make meaning of their experience Learning to conduct semi-structure interviews requires the following six stages: (a) selecting the type of interview; (b) establishing ethical guidelines, (c) crafting the interview protocol; (d) conducting and…

  12. Technology: Technology and Common Sense

    ERIC Educational Resources Information Center

    Van Horn, Royal

    2004-01-01

    The absence of common sense in the world of technology continues to amaze the author. Things that seem so logical to just aren nott for many people. The installation of Voice-over IP (VoIP, with IP standing for Internet Protocol) in many school districts is a good example. Schools have always had trouble with telephones. Many districts don't even…

  13. A Failure to Communicate

    ERIC Educational Resources Information Center

    Fredette, Michelle

    2011-01-01

    In April, Asia officially ran out of Internet Protocol (IP) version 4 addresses--the computer equivalent of running out of telephone numbers. Over the next couple of years, the rest of the world will also run dry. Yet, unlike the Y2K bug that had some people convinced the sky would fall, this particular problem is generating little more than tired…

  14. A randomised controlled trial of benefit finding in caregivers: The Building Resources in Caregivers Study Protocol

    PubMed Central

    Brand, Charles; O’Connell, Brenda H

    2015-01-01

    Caregivers may engage in benefit finding, that is, an increase in perceived positive growth, as a cognitive strategy for coping with stress. The Building Resources in Caregivers study will compare effects of a brief benefit finding writing intervention with a control intervention. Caregivers of people with mental and physical disabilities will be randomised into either a benefit-writing group or a neutral writing group. Caregivers will complete measures relating to themselves and care-recipients (e.g. sociodemographics and illness type) and psychometric measures of benefit finding, distress and quality of life at three time points. Additionally, qualitative commentary on participation experiences will be gathered. PMID:28070362

  15. The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial.

    PubMed

    Skingley, Ann; Clift, Stephen M; Coulton, Simon P; Rodriguez, John

    2011-02-28

    The growth in numbers of older people represents a considerable cost to health and social care services in the United Kingdom. There is an acknowledged need to address issues of social exclusion and both the physical and mental health of this age group. In recent years there has been much interest in the potential contribution of the arts to the health of communities and individuals. There is some evidence that participative singing may be of benefit to older people, however studies to date are limited in number and have lacked rigour. There is therefore a need to build on this knowledge base to provide more quantifiable evidence of both effectiveness and cost effectiveness of singing as a health intervention for this population group. The proposed study is a pragmatic randomised controlled trial with two parallel arms. The primary hypothesis is that singing groups for older people improve both physical and mental aspects of quality of life when compared to usual activities. Potential participants will be volunteers over 60 years living in the community and recruited through publicity. Eligible and consenting participants will be randomized to either a singing group or a control group. Singing groups will take part in a twelve week planned programme of singing and control groups will continue with usual activities. The primary outcome measure will be the York SF-12, a health related quality of life measure which will be administered at baseline, three and six months after baseline. The study will evaluate both effectiveness and cost-effectiveness. This study proposes to add to the existing body of evidence on the value of singing for older people by using a rigorous methodological design, which includes a power calculation, a standardised intervention and assessment of cost-effectiveness. It should be regarded as a stage in a progressive programme of studies in this area. If group singing is found to be effective and cost-effective it may offer an alternative means to maintaining the health of people in later life. ISRCTN62404401.

  16. Transforming primary healthcare by including the stakeholders involved in delivering care to people living in poverty: EQUIhealThY study protocol.

    PubMed

    Loignon, Christine; Hudon, Catherine; Boudreault-Fournier, Alexandrine; Dupéré, Sophie; Macaulay, Ann C; Pluye, Pierre; Gaboury, Isabelle; Haggerty, Jeannie L; Fortin, Martin; Goulet, Émilie; Lambert, Mireille; Pelissier-Simard, Luce; Boyer, Sophie; de Laat, Marianne; Lemire, Francine; Champagne, Louise; Lemieux, Martin

    2013-03-11

    Ensuring access to timely and appropriate primary healthcare for people living in poverty is an issue facing all countries, even those with universal healthcare systems. The transformation of healthcare practices and organization could be improved by involving key stakeholders from the community and the healthcare system in the development of research interventions. The aim of this project is to stimulate changes in healthcare organizations and practices by encouraging collaboration between care teams and people living in poverty. Our objectives are twofold: 1) to identify actions required to promote the adoption of professional practices oriented toward social competence in primary care teams; and 2) to examine factors that would encourage the inclusion of people living in poverty in the process of developing social competence in healthcare organizations. This study will use a participatory action research design applied in healthcare organizations. Participatory research is an increasingly recognized approach that is helpful for involving the people for whom the research results are intended. Our research team consists of 19 non-academic researchers, 11 academic researchers and six partners. A steering committee composed of academic researchers and stakeholders will have a decision-making role at each step, including knowledge dissemination and recommendations for new interventions. In this project we will adopt a multiphase approach and will use a variety of methods, including photovoice, group discussions and interviews. The proposed study will be one of only a few using participatory research in primary care to foster changes aimed at enhancing quality and access to care for people living in poverty. To our knowledge this will be the first study to use photovoice in healthcare organizations to promote new interventions. Our project includes partners who are targeted for practice changes and improvements in delivering primary care to persons living in poverty. By involving knowledge users, including service recipients, our study is more likely to produce a transformation of professional practices and encourage healthcare organizations to take into account the needs of persons living in poverty.

  17. Transforming primary healthcare by including the stakeholders involved in delivering care to people living in poverty: EQUIhealThY study protocol

    PubMed Central

    2013-01-01

    Background Ensuring access to timely and appropriate primary healthcare for people living in poverty is an issue facing all countries, even those with universal healthcare systems. The transformation of healthcare practices and organization could be improved by involving key stakeholders from the community and the healthcare system in the development of research interventions. The aim of this project is to stimulate changes in healthcare organizations and practices by encouraging collaboration between care teams and people living in poverty. Our objectives are twofold: 1) to identify actions required to promote the adoption of professional practices oriented toward social competence in primary care teams; and 2) to examine factors that would encourage the inclusion of people living in poverty in the process of developing social competence in healthcare organizations. Methods/design This study will use a participatory action research design applied in healthcare organizations. Participatory research is an increasingly recognized approach that is helpful for involving the people for whom the research results are intended. Our research team consists of 19 non-academic researchers, 11 academic researchers and six partners. A steering committee composed of academic researchers and stakeholders will have a decision-making role at each step, including knowledge dissemination and recommendations for new interventions. In this project we will adopt a multiphase approach and will use a variety of methods, including photovoice, group discussions and interviews. Discussion The proposed study will be one of only a few using participatory research in primary care to foster changes aimed at enhancing quality and access to care for people living in poverty. To our knowledge this will be the first study to use photovoice in healthcare organizations to promote new interventions. Our project includes partners who are targeted for practice changes and improvements in delivering primary care to persons living in poverty. By involving knowledge users, including service recipients, our study is more likely to produce a transformation of professional practices and encourage healthcare organizations to take into account the needs of persons living in poverty. PMID:23497400

  18. How well do services for young people with long term conditions deliver features proposed to improve transition?

    PubMed

    Colver, A; Pearse, R; Watson, R M; Fay, M; Rapley, T; Mann, K D; Le Couteur, A; Parr, J R; McConachie, H

    2018-05-08

    For young people with long-term conditions, transition from child to adult-oriented health services is a critical period which, if not managed well, may lead to poor outcomes. There are features of transition services which guidance and research suggest improve outcomes. We studied nine such features, calling them 'proposed beneficial features': age-banded clinic; meet adult team before transfer; promotion of health self-efficacy; written transition plan; appropriate parent involvement; key worker; coordinated team; holistic life-skills training; transition manager for clinical team. We aimed to describe the extent to which service providers offer these nine features, and to compare this with young people's reported experience of them. A longitudinal, mixed methods study followed 374 young people as their care moved from child to adult health services. Participants had type 1 diabetes, cerebral palsy or autism spectrum disorder with additional mental health difficulties. Data are reported from the first two visits, one year apart. Three hundred four (81.3%) of the young people took part in the second visit (128 with diabetes, 91 with autism, 85 with cerebral palsy). Overall, the nine proposed beneficial features of transition services were poorly provided. Fewer than half of services stated they provided an age-banded clinic, written transition plan, transition manager for clinical team, a protocol for promotion of health self-efficacy, or holistic life-skills training. To varying degrees, young people reported that they had not experienced the features which services said they provided. For instance, the agreement for written transition plan, holistic life-skills training and key worker, was 30, 43 and 49% respectively. Agreement was better for appropriate parent involvement, age-banded clinic, promotion of health self-efficacy and coordinated team at 77, 77, 80 and 69% respectively. Variation in the meaning of the features as experienced by young people and families was evident from qualitative interviews and observations. UK services provide only some of the nine proposed beneficial features for supporting healthcare transition of young people with long term conditions. Observational studies or trials which examine the influence of features of transition services on outcomes should ensure that the experiences of young people and families are captured, and not rely on service specifications.

  19. The effects of prolonged wear of textured shoe insoles on gait, foot sensation and proprioception in people with multiple sclerosis: study protocol for a randomised controlled trial.

    PubMed

    Hatton, Anna L; Dixon, John; Rome, Keith; Brauer, Sandra G; Williams, Katrina; Kerr, Graham

    2016-04-21

    Many people with multiple sclerosis experience problems with walking, which can make daily activities difficult and often leads to falls. Foot sensation plays an important role in keeping the body balanced whilst walking; however, people with multiple sclerosis often have poor sensation on the soles of their feet. Wearing a specially designed shoe insole, which enhances plantar sensory information, could help people with multiple sclerosis to walk better. This study will explore whether long-term wear of a textured insole can improve walking in people with multiple sclerosis. A prospective randomised controlled trial with two parallel groups will be conducted aiming to recruit 176 people with multiple sclerosis living in the community (Brisbane, Australia). Adults with a clinical diagnosis of multiple sclerosis, Disease Steps score 1-4, who are ambulant over 100 m and who meet specific inclusion criteria will be recruited. Participants will be randomised to a smooth control insole (n = 88) or textured insole (n = 88) group. The allocated insole will be worn for 12-weeks within participants' own footwear, with self-report wear diaries and falls calendars being completed over this period. Blinded assessors will conduct two baseline assessments and one post-intervention assessment. Gait tasks will be completed barefoot, wearing standardised footwear only, and wearing standardised footwear with smooth and textured insoles. The primary outcome measure will be mediolateral base of support when walking over even and uneven surfaces. Secondary measures include spatiotemporal gait parameters (stride length, stride time variability, double-limb support time, velocity), gait kinematics (hip, knee, and ankle joint angles, toe clearance, trunk inclination, arm swing, mediolateral pelvis/head displacement), foot sensation (light touch-pressure, vibration, two-point discrimination) and proprioception (ankle joint position sense). Group allocation will be concealed and all analyses will be based on an intention-to-treat principle. This study will explore the effects of wearing textured insoles over 12-weeks on gait, foot sensation and proprioception in people with multiple sclerosis. The study has the potential to identify a new, evidence-based footwear intervention which has the capacity to enhance mobility and independent living in people with multiple sclerosis. Australian New Zealand Clinical Trials Registry ACTRN12615000421538 . Registered 4 May 2015.

  20. Early detection of health problems in potentially frail community-dwelling older people by general practices--project [G]OLD: design of a longitudinal, quasi-experimental study.

    PubMed

    Stijnen, Mandy M N; Duimel-Peeters, Inge G P; Jansen, Maria W J; Vrijhoef, Hubertus J M

    2013-01-18

    Due to the ageing of the population, the number of frail older people who suffer from multiple, complex health complaints increases and this ultimately threatens their ability to function independently. Many interventions for frail older people attempt to prevent or delay functional decline, but they show contradicting results. Recent studies emphasise the importance of embedding these interventions into existing primary care systems and tailoring care to older people's needs and wishes. This article presents the design of an evaluation study, aiming to investigate the effects and feasibility of the early detection of health problems among community-dwelling older people and their subsequent referral to appropriate care and/or well-being facilities by general practices. A longitudinal, quasi-experimental study is designed comparing 13 intervention practices with 11 control practices. General practices select eligible community-dwelling older people (≥ 75 years). Practice nurses from intervention practices (1) visit older people at home for a comprehensive assessment of their health and well-being; (2) discuss results with the GP; (3) formulate - if required - a care and treatment plan together with the patient; (4) refer patient to care and/or well-being facilities; and (5) monitor and coordinate care and follow-up. Control practices provide usual care and match the intervention practices on the presence of different primary care professionals within the practice. Primary outcome measures are health-related quality of life and disability. Additionally, attitude towards ageing, care satisfaction, health care utilisation, nursing home admission and mortality are measured. Some outcomes are assessed by means of a postal questionnaire (at baseline and after 6, 12, and 18 months follow-up), others through continuous registration over the 18-month period. A profound process evaluation will provide insight into barriers and facilitators for implementing the intervention protocol within general practices from both the patient and caregiver perspective. The proposed approach requires redesigning care delivery within general practices for accomplishing appropriate care for older people. A quasi-experimental design is chosen to closely resemble a real-life situation, which is desirable for future implementation after this innovation proves to be successful. Results of the effect and process evaluation will become available in 2013. The Netherlands National Trial Register NTR2737.

  1. Investigation of alcohol-related social norms among youth aged 14–17 years in Perth, Western Australia: protocol for a respondent-driven sampling study

    PubMed Central

    Hildebrand, Janina; Maycock, Bruce; Howat, Peter; Burns, Sharyn; Allsop, Steve; Dhaliwal, Satvinder; Lobo, Roanna

    2013-01-01

    Introduction Alcohol use among young people is a major public health concern in Australia and internationally. Research elucidating social norms influencing alcohol use supports the desire to conform to peers. However, there is a lack of evidence on how social norms are transmitted from the community to young people and between family members and peers, as previous studies are limited to mainly school and university environments. This article describes the proposed process to investigate common alcohol-related norms held by 14-year-olds to 17-year-olds in Perth, Western Australia, and to clarify the process and pathways through which proalcohol norms are transmitted to adolescents. Methods and analysis This cross-sectional quantitative study will use respondent-driven sampling (RDS) to recruit a sample of 672 adolescents from sporting groups, youth programmes and the community in Perth. Data will be collected with a previously developed and validated multidimensional online survey instrument. A variety of strategies will be explored to aid participation including face-to-face recruitment and survey administration, web-based RDS and a ‘mature minor’ consent assessment protocol. Data analysis will include descriptive statistics of demographic characteristics, as well as social network and dyadic analyses, to explore the connections between shared understanding of norms and behaviours among individuals and how these translate into reported practices. Ethics and dissemination This research is expected to extend our understanding of normative development pathways to inform future interventions, and will be widely disseminated through conference presentations, peer-reviewed papers, media channels and community seminars. A study reference group of key health industry stakeholders will be established to encourage integration of study findings into policy and practice, and results will guide the development of community interventions. The Curtin University Human Research Ethics Committee has granted approval for this research. PMID:24154519

  2. Effects of a nutrition plus exercise programme on physical function in sarcopenic obese elderly people: study protocol for a randomised controlled trial.

    PubMed

    Shen, Shan-Shan; Chu, Jiao-Jiao; Cheng, Lei; Zeng, Xing-Kun; He, Ting; Xu, Li-Yu; Li, Jiang-Ru; Chen, Xu-Jiao

    2016-09-30

    With a rapidly ageing population, sarcopenic obesity, defined as decreased muscle mass and function combined with increased body fat, is a complex health problem. Although sarcopenic obesity contributes to a decline in physical function and exacerbates frailty in older adults, evidence from clinical trials about the effect of exercise and nutrition on this complex syndrome in Chinese older adults is lacking. We devised a study protocol for a single-blind randomised controlled trial. Sarcopenia is described as age-related decline in muscle mass plus low muscle strength and/or low physical performance. Obesity is defined as a percentage of body fat above the 60th centile. Ninety-two eligible participants will be randomly assigned to a control group, nutrition group, exercise group and nutrition plus exercise group to receive an 8-week intervention and 12-week follow-up. The primary outcomes will be the change in short physical performance battery scores, grip strength and 6 m usual gait speed. The secondary outcomes will include basic activities of daily living scores, instrumental activity daily living scores, body composition and body anthropometric indexes. For all main analyses, the principle of intention-to-treat will be used. This study was approved by the medical ethics committee of Zhejiang Hospital on 25 November 2015. The study will present data targeting the clinical effects of nutrition and exercise on physical function and body composition in a Chinese older population with sarcopenic obesity. The results will help to provide important clinical evidence of the role of complex non-pharmaceutical interventions for sarcopenic obese older people. The findings of this study will be submitted to peer-reviewed medical journals for publication and presented at relevant academic conferences. ChiCTR-IOR-15007501; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  3. Unwelcome visitors: is EMS ready for fire ants and killer bees.

    PubMed

    Bledsoe, Bryan E

    2007-08-01

    Fire ants and AHBs are aggressive social insects that readily attack when they perceive a threat. Rarely, each can cause fatal allergic reactions. However, AHBs can overwhelm and kill even healthy, nonallergic people. Such encounters are relatively rare, yet increasing in frequency. As a rule, fire ants can't overwhelm a healthy, mobile person, and even hundreds of stings are rarely fatal. AHBs, however, pose a greater threat to EMS and fire personnel when encountered. Every EMS agency in areas where AHBs are located (or predicted to migrate) should develop protocols for AHB attacks. Such a response should assure adequate personnel and, above all, rescuer safety. The protocol should be periodically practiced and reviewed.

  4. Comprehensive systematic review summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

    PubMed

    Rae-Grant, Alexander; Day, Gregory S; Marrie, Ruth Ann; Rabinstein, Alejandro; Cree, Bruce A C; Gronseth, Gary S; Haboubi, Michael; Halper, June; Hosey, Jonathan P; Jones, David E; Lisak, Robert; Pelletier, Daniel; Potrebic, Sonja; Sitcov, Cynthia; Sommers, Rick; Stachowiak, Julie; Getchius, Thomas S D; Merillat, Shannon A; Pringsheim, Tamara

    2018-04-24

    To review evidence on starting, switching, and stopping disease-modifying therapies (DMTs) for multiple sclerosis (MS) in clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and progressive MS forms. Relevant, peer-reviewed research articles, systematic reviews, and abstracts were identified (MEDLINE, CENTRAL, EMBASE searched from inception to November 2016). Studies were rated using the therapeutic classification scheme. Prior published Cochrane reviews were also used. Twenty Cochrane reviews and an additional 73 full-text articles were selected for data extraction through an updated systematic review (completed November 2016). For people with RRMS, many DMTs are superior to placebo (annualized relapses rates [ARRs], new disease activity [new MRI T2 lesion burden], and in-study disease progression) (see summary and full text publications). For people with RRMS who experienced a relapse on interferon-β (IFN-β) or glatiramer acetate, alemtuzumab is more effective than IFN-β-1a 44 μg subcutaneous 3 times per week in reducing the ARR. For people with primary progressive MS, ocrelizumab is probably more effective than placebo (in-study disease progression). DMTs for MS have varying adverse effects. In people with CIS, glatiramer acetate and IFN-β-1a subcutaneous 3 times per week are more effective than placebo in decreasing risk of conversion to MS. Cladribine, immunoglobulins, IFN-β-1a 30 μg intramuscular weekly, IFN-β-1b subcutaneous alternate day, and teriflunomide are probably more effective than placebo in decreasing risk of conversion to MS. Suggestions for future research include studies considering comparative effectiveness, usefulness of high-efficacy treatment vs stepped-care protocols, and research into predictive biomarkers. © 2018 American Academy of Neurology.

  5. Reproducibility of a peripheral quantitative computed tomography scan protocol to measure the material properties of the second metatarsal.

    PubMed

    Chaplais, Elodie; Greene, David; Hood, Anita; Telfer, Scott; du Toit, Verona; Singh-Grewal, Davinder; Burns, Joshua; Rome, Keith; Schiferl, Daniel J; Hendry, Gordon J

    2014-07-19

    Peripheral quantitative computed tomography (pQCT) is an established technology that allows for the measurement of the material properties of bone. Alterations to bone architecture are associated with an increased risk of fracture. Further pQCT research is necessary to identify regions of interest that are prone to fracture risk in people with chronic diseases. The second metatarsal is a common site for the development of insufficiency fractures, and as such the aim of this study was to assess the reproducibility of a novel scanning protocol of the second metatarsal using pQCT. Eleven embalmed cadaveric leg specimens were scanned six times; three times with and without repositioning. Each foot was positioned on a custom-designed acrylic foot plate to permit unimpeded scans of the region of interest. Sixty-six scans were obtained at 15% (distal) and 50% (mid shaft) of the second metatarsal. Voxel size and scan speed were reduced to 0.40 mm and 25 mm.sec(-1). The reference line was positioned at the most distal portion of the 2(nd) metatarsal. Repeated measurements of six key variables related to bone properties were subject to reproducibility testing. Data were log transformed and reproducibility of scans were assessed using intraclass correlation coefficients (ICC) and coefficients of variation (CV%). Reproducibility of the measurements without repositioning were estimated as: trabecular area (ICC 0.95; CV% 2.4), trabecular density (ICC 0.98; CV% 3.0), Strength Strain Index (SSI) - distal (ICC 0.99; CV% 5.6), cortical area (ICC 1.0; CV% 1.5), cortical density (ICC 0.99; CV% 0.1), SSI - mid shaft (ICC 1.0; CV% 2.4). Reproducibility of the measurements after repositioning were estimated as: trabecular area (ICC 0.96; CV% 2.4), trabecular density (ICC 0.98; CV% 2.8), SSI - distal (ICC 1.0; CV% 3.5), cortical area (ICC 0.99; CV%2.4), cortical density (ICC 0.98; CV% 0.8), SSI - mid shaft (ICC 0.99; CV% 3.2). The scanning protocol generated excellent reproducibility for key bone properties measured at the distal and mid-shaft regions of the 2(nd) metatarsal. This protocol extends the capabilities of pQCT to evaluate bone quality in people who may be at an increased risk of metatarsal insufficiency fractures.

  6. Reproducibility of a peripheral quantitative computed tomography scan protocol to measure the material properties of the second metatarsal

    PubMed Central

    2014-01-01

    Background Peripheral quantitative computed tomography (pQCT) is an established technology that allows for the measurement of the material properties of bone. Alterations to bone architecture are associated with an increased risk of fracture. Further pQCT research is necessary to identify regions of interest that are prone to fracture risk in people with chronic diseases. The second metatarsal is a common site for the development of insufficiency fractures, and as such the aim of this study was to assess the reproducibility of a novel scanning protocol of the second metatarsal using pQCT. Methods Eleven embalmed cadaveric leg specimens were scanned six times; three times with and without repositioning. Each foot was positioned on a custom-designed acrylic foot plate to permit unimpeded scans of the region of interest. Sixty-six scans were obtained at 15% (distal) and 50% (mid shaft) of the second metatarsal. Voxel size and scan speed were reduced to 0.40 mm and 25 mm.sec-1. The reference line was positioned at the most distal portion of the 2nd metatarsal. Repeated measurements of six key variables related to bone properties were subject to reproducibility testing. Data were log transformed and reproducibility of scans were assessed using intraclass correlation coefficients (ICC) and coefficients of variation (CV%). Results Reproducibility of the measurements without repositioning were estimated as: trabecular area (ICC 0.95; CV% 2.4), trabecular density (ICC 0.98; CV% 3.0), Strength Strain Index (SSI) - distal (ICC 0.99; CV% 5.6), cortical area (ICC 1.0; CV% 1.5), cortical density (ICC 0.99; CV% 0.1), SSI – mid shaft (ICC 1.0; CV% 2.4). Reproducibility of the measurements after repositioning were estimated as: trabecular area (ICC 0.96; CV% 2.4), trabecular density (ICC 0.98; CV% 2.8), SSI - distal (ICC 1.0; CV% 3.5), cortical area (ICC 0.99; CV%2.4), cortical density (ICC 0.98; CV% 0.8), SSI – mid shaft (ICC 0.99; CV% 3.2). Conclusions The scanning protocol generated excellent reproducibility for key bone properties measured at the distal and mid-shaft regions of the 2nd metatarsal. This protocol extends the capabilities of pQCT to evaluate bone quality in people who may be at an increased risk of metatarsal insufficiency fractures. PMID:25037451

  7. A scoping review of crisis teams managing dementia in older people.

    PubMed

    Streater, Amy; Coleston-Shields, Donna Maria; Yates, Jennifer; Stanyon, Miriam; Orrell, Martin

    2017-01-01

    Research on crisis teams for older adults with dementia is limited. This scoping review aimed to 1) conduct a systematic literature review reporting on the effectiveness of crisis interventions for older people with dementia and 2) conduct a scoping survey with dementia crisis teams mapping services across England to understand operational procedures and identify what is currently occurring in practice. For the systematic literature review, included studies were graded using the Critical Appraisal Skills Programme checklist. For the scoping survey, Trusts across England were contacted and relevant services were identified that work with people with dementia experiencing a mental health crisis. The systematic literature review demonstrated limited evidence in support of crisis teams reducing the rate of hospital admissions, and despite the increase in number of studies, methodological limitations remain. For the scoping review, only half (51.8%) of the teams had a care pathway to manage crises and the primary need for referral was behavioral or psychological factors. Evidence in the literature for the effectiveness of crisis teams for older adults with dementia remains limited. Being mainly cohort designs can make it difficult to evaluate the effectiveness of the intervention. In practice, it appears that the pathway for care managing crisis for people with dementia varies widely across services in England. There was a wide range of names given to the provision of teams managing crisis for people with dementia, which may reflect the differences in the setup and procedures of the service. To provide evidence on crisis intervention teams, a comprehensive protocol is required to deliver a standardized care pathway and measurable intervention as part of a large-scale evaluation of effectiveness.

  8. A scoping review of crisis teams managing dementia in older people

    PubMed Central

    Streater, Amy; Coleston-Shields, Donna Maria; Yates, Jennifer; Stanyon, Miriam; Orrell, Martin

    2017-01-01

    Background Research on crisis teams for older adults with dementia is limited. This scoping review aimed to 1) conduct a systematic literature review reporting on the effectiveness of crisis interventions for older people with dementia and 2) conduct a scoping survey with dementia crisis teams mapping services across England to understand operational procedures and identify what is currently occurring in practice. Methods For the systematic literature review, included studies were graded using the Critical Appraisal Skills Programme checklist. For the scoping survey, Trusts across England were contacted and relevant services were identified that work with people with dementia experiencing a mental health crisis. Results The systematic literature review demonstrated limited evidence in support of crisis teams reducing the rate of hospital admissions, and despite the increase in number of studies, methodological limitations remain. For the scoping review, only half (51.8%) of the teams had a care pathway to manage crises and the primary need for referral was behavioral or psychological factors. Conclusion Evidence in the literature for the effectiveness of crisis teams for older adults with dementia remains limited. Being mainly cohort designs can make it difficult to evaluate the effectiveness of the intervention. In practice, it appears that the pathway for care managing crisis for people with dementia varies widely across services in England. There was a wide range of names given to the provision of teams managing crisis for people with dementia, which may reflect the differences in the setup and procedures of the service. To provide evidence on crisis intervention teams, a comprehensive protocol is required to deliver a standardized care pathway and measurable intervention as part of a large-scale evaluation of effectiveness. PMID:29042760

  9. The impact of staff initiated referral and intervention protocols on symptoms of depression in people with mild intellectual disability.

    PubMed

    McGillivray, Jane A; Kershaw, Mavis M

    2013-02-01

    It has been estimated that people with ID experience the same and possibly higher levels of depression than the general population. Referral to a General Medical Practitioner (GP) for primary care is recommended practice for people with depression and cognitive behavioural (CB) therapy is now an accepted evidence based intervention. A growing body of literature indicates that people with ID and depression may benefit from CB strategies. The aim of the current study was to compare (i) CB group intervention strategies with referral to a GP; (ii) CB group intervention strategies only; and (iii) referral to a GP only on symptoms of depression among people with mild ID. Staff from six participating agencies received training in (a) how to identify and screen individuals with mild ID for depressive symptoms and risk factors for depression, and (b) supportive referral of identified individuals to GPs for mental health services. In addition, staff from four of the agencies undertook (c) training on how to deliver group CB intervention strategies. Eighty-two participants were allocated to one of the three intervention groups. Depressive symptoms and negative automatic thoughts were assessed prior to the intervention, at the conclusion of the intervention, and at eight months follow-up. Compared to GP referral alone, those participants who received CB strategies both with and without GP referral displayed significant reductions in depressive symptoms. The use of CB strategies only also resulted in a significant reduction in frequency of negative automatic thoughts. The findings of this study support routine screening of individuals with mild ID for depression and the delivery of group CB intervention programmes by trained staff within community-based disability agencies. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. OCD? Not Me! Protocol for the development and evaluation of a web-based self-guided treatment for youth with obsessive-compulsive disorder.

    PubMed

    Rees, Clare S; Anderson, Rebecca A; Finlay-Jones, Amy

    2015-04-29

    OCD? Not Me! is a novel, web-based, self-guided intervention designed to treat obsessive-compulsive disorder (OCD) in young people aged 12-18, using the principles of exposure and response prevention. The current paper presents the protocol for the development of the programme and for an open trial that will evaluate the effectiveness of this programme for OCD in young people, and associated distress and symptom accommodation in their parents and caregivers. We will measure the impact of the OCD? Not Me! programme on OCD symptoms using the Children's Florida Obsessive Compulsive Inventory (C-FOCI), and both the self-report and parent report of the Children's Obsessional Compulsive Inventory-Revised (ChOCI-R). The impact of the programme on OCD-related functional impairment will be measured using the parent report of the Child Obsessive-Compulsive Impact Scale-Revised (COIS-R). Secondary outcome measures include the Rosenberg Self-Esteem Scale and the Youth Quality of Life-Short Form (YQoL-SF). The 21-item Depression Anxiety Stress Scales (DASS-21) will be used to measure the impact of the programme on parent/caregiver distress, while the Family Accommodation Scale (FAS) will be used to measure change in family accommodation of OCD symptoms. Multilevel mixed effects linear regression will be used to analyse the impact of the intervention on the outcome measures. This study has been approved by the Curtin University Human Research Ethics Committee. The results of the study will be reported in international peer-reviewed journals. Australian New Zealand Clinical Trials Registry: ACTRN12613000152729. 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.

  11. Protocol: A grounded theory of ‘recovery’—perspectives of adolescent users of mental health services

    PubMed Central

    Palmquist, Lucianne; Patterson, Sue; O'Donovan, Analise; Bradley, Graham

    2017-01-01

    Introduction Policies internationally endorse the recovery paradigm as the appropriate foundation for youth mental health services. However, given that this paradigm is grounded in the views of adults with severe mental illness, applicability to youth services and relevance to young people is uncertain, particularly as little is known about young people’s views. A comprehensive understanding of the experiences and expectations of young people is critical to developing youth mental health services that are acceptable, accessible, effective and relevant. Aim To inform development of policy and youth services, the study described in this protocol aims to develop a comprehensive account of the experiences and expectations of 12–17 year olds as they encounter mental disorders and transition through specialist mental health services. Data will be analysed to model recovery from the adolescents’ perspective. Method and analysis This grounded theory study will use quantitative and qualitative data collected in interviews with 12–17 year olds engaged with specialist Child/Youth Mental Health Service in Queensland, Australia. Interviews will explore adolescents’ expectations and experiences of mental disorder, and of services, as they transition through specialist mental health services, including the meaning of their experiences and ideas of ‘recovery’ and how their experiences and expectations are shaped. Data collection and analysis will use grounded theory methods. Ethics and dissemination Adolescents’ experiences will be presented as a mid-range theory. The research will provide tangible recommendations for youth-focused mental health policy and practice. Findings will be disseminated within academic literature and beyond to participants, health professionals, mental health advocacy groups and policy and decision makers via publications, research summaries, conferences and workshops targeting different audiences. Ethical and research governance approvals have been obtained from relevant Human Research Ethics committees and all sites involved. PMID:28729312

  12. OCD? Not Me! Protocol for the development and evaluation of a web-based self-guided treatment for youth with obsessive-compulsive disorder

    PubMed Central

    Rees, Clare S; Anderson, Rebecca A

    2015-01-01

    Background OCD? Not Me! is a novel, web-based, self-guided intervention designed to treat obsessive-compulsive disorder (OCD) in young people aged 12–18, using the principles of exposure and response prevention. The current paper presents the protocol for the development of the programme and for an open trial that will evaluate the effectiveness of this programme for OCD in young people, and associated distress and symptom accommodation in their parents and caregivers. Methods We will measure the impact of the OCD? Not Me! programme on OCD symptoms using the Children's Florida Obsessive Compulsive Inventory (C-FOCI), and both the self-report and parent report of the Children's Obsessional Compulsive Inventory—Revised (ChOCI-R). The impact of the programme on OCD-related functional impairment will be measured using the parent report of the Child Obsessive-Compulsive Impact Scale—Revised (COIS-R). Secondary outcome measures include the Rosenberg Self-Esteem Scale and the Youth Quality of Life—Short Form (YQoL-SF). The 21-item Depression Anxiety Stress Scales (DASS-21) will be used to measure the impact of the programme on parent/caregiver distress, while the Family Accommodation Scale (FAS) will be used to measure change in family accommodation of OCD symptoms. Multilevel mixed effects linear regression will be used to analyse the impact of the intervention on the outcome measures. Ethics and dissemination This study has been approved by the Curtin University Human Research Ethics Committee. The results of the study will be reported in international peer-reviewed journals. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12613000152729. PMID:25926148

  13. Comparison of fracture rates between indigenous and non-indigenous populations: a systematic review protocol.

    PubMed

    Brennan-Olsen, Sharon L; Quirk, Shae E; Leslie, William D; Toombs, Maree; Holloway, Kara L; Hosking, Sarah M; Pasco, Julie A; Doolan, Brianna J; Page, Richard S; Williams, Lana J

    2016-08-26

    Over recent years, there has been concerted effort to 'close the gap' in the disproportionately reduced life expectancy and increased morbidity experienced by indigenous compared to non-indigenous persons. Specific to musculoskeletal health, some data suggest that indigenous peoples have a higher risk of sustaining a fracture compared to non-indigenous peoples. This creates an imperative to identify factors that could explain differences in fracture rates. This protocol presents our aim to conduct a systematic review, first, to determine whether differences in fracture rates exist for indigenous versus non-indigenous persons and, second, to identify any risk factors that might explain these differences. We will conduct a systematic search of PubMed, OVID, MEDLINE, CINAHL and EMBASE to identify articles that compare all-cause fracture rates at any skeletal site between indigenous and non-indigenous persons of any age. Eligibility of studies will be determined by 2 independent reviewers. Studies will be assessed for methodological quality using a previously published process. We will conduct a meta-analysis and use established statistical methods to identify and control for heterogeneity where appropriate. Should heterogeneity prevents numerical syntheses, we will undertake a best-evidence analysis to determine the level of evidence for differences in fracture between indigenous and non-indigenous persons. This systematic review will use published data; thus, ethical permissions are not required. In addition to peer-reviewed publication, findings will be presented at (inter)national conferences, disseminated electronically and in print, and will be made available to key country-specific decision-makers with authority for indigenous health. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  14. Development of a patient decision aid for people with refractory angina: protocol for a three-phase pilot study

    PubMed Central

    2014-01-01

    Background Refractory angina is a severe chronic disease, defined as angina which cannot be controlled by usual treatments for heart disease. This disease is frightening, debilitating, and difficult to manage. Many people suffering refractory have inadequate pain relief, continually revisit emergency departments for help, undergo repeated cardiac investigations, and struggle with obtaining appropriate care. There is no clear framework to help people understand the risks and benefits of available treatment options in Canada. Some treatments for refractory angina are invasive, while others are not covered by provincial health insurance plans. Effective care for refractory angina sufferers in Canada is critically underdeveloped; it is important that healthcare professionals and refractory angina sufferers alike understand the treatment options and their implications. This proposal builds on the recent Canadian practice guidelines for the management of refractory angina. We propose to develop a decision support tool in order to help people suffering from refractory angina make well-informed decisions about their healthcare and reduce their uncertainty about treatment options. Methods This project will be conducted in three phases: a) development of the support tool with input from clinical experts, the Canadian refractory angina guidelines, and people living with refractory angina, b) pilot testing of the usability of the tool, and c) formal preliminary evaluation of the effectiveness of the support tool to help people make informed decisions about treatment options. Discussion A decision support tool for refractory angina is needed and the available data suggest that by developing such a tool, we may be able to help refractory angina sufferers better understand their condition and the effectiveness of available treatment options (in their respective clinical settings) as well as their implications (e.g. risks vs. benefits). By virtue of this tool, we may also be able to facilitate identification and inclusion of patients’ values and preferences in the decision making process. This is particularly important as refractory angina is an intractable condition, necessitating that the selected course of treatment be lifelong. This study will yield a much needed patient decision aid for people living with refractory angina and pilot data to support a subsequent effectiveness study. PMID:24920518

  15. Effectiveness of interventions to indirectly support food and drink intake in people with dementia: Eating and Drinking Well IN dementiA (EDWINA) systematic review.

    PubMed

    Bunn, Diane K; Abdelhamid, Asmaa; Copley, Maddie; Cowap, Vicky; Dickinson, Angela; Howe, Amanda; Killett, Anne; Poland, Fiona; Potter, John F; Richardson, Kate; Smithard, David; Fox, Chris; Hooper, Lee

    2016-05-04

    Risks and prevalence of malnutrition and dehydration are high in older people but even higher in older people with dementia. In the EDWINA (Eating and Drinking Well IN dementiA) systematic review we aimed to assess effectiveness of interventions aiming to improve, maintain or facilitate food/drink intake indirectly, through food service or dining environment modification, education, exercise or behavioural interventions in people with cognitive impairment or dementia (across all settings, levels of care and support, types and degrees of dementia). We comprehensively searched Medline and twelve further databases, plus bibliographies, for intervention studies with ≥3 cognitively impaired adult participants (any type/stage). The review was conducted with service user input in accordance with Cochrane Collaboration's guidelines. We duplicated assessment of inclusion, data extraction, and validity assessment, tabulating data. Meta-analysis (statistical pooling) was not appropriate so data were tabulated and synthesised narratively. We included 56 interventions (reported in 51 studies). Studies were small and there were no clearly effective, or clearly ineffective, interventions. Promising interventions included: eating meals with care-givers, family style meals, soothing mealtime music, constantly accessible snacks and longer mealtimes, education and support for formal and informal care-givers, spaced retrieval and Montessori activities, facilitated breakfast clubs, multisensory exercise and multicomponent interventions. We found no definitive evidence on effectiveness, or lack of effectiveness, of specific interventions but studies were small and short term. A variety of promising indirect interventions need to be tested in large, high-quality RCTs, and may be approaches that people with dementia and their formal or informal care-givers would wish to try. The systematic review protocol was registered (CRD42014007611) and is published, with the full MEDLINE search strategy, on Prospero (http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014007611).

  16. Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

    PubMed

    Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

    2013-03-09

    Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand. ClinicalTrials.gov: NCT01635582.

  17. HIV patient retention: the implementation of a North Carolina clinic-based protocol.

    PubMed

    Keller, Jennifer; Heine, Amy; LeViere, Anna Finestone; Donovan, Jenna; Wilkin, Aimee; Sullivan, Kristen; Quinlivan, Evelyn Byrd

    2017-05-01

    Decreased visit attendance leads to poor health outcomes, decreased viral suppression, and higher mortality rates for persons living with HIV. Retention in care is an important factor in improving health status for people living with HIV but continues to be a challenge in clinical settings. This paper details the development and implementation of the NC-LINK Retention Protocol, a clinic-based protocol to locate and reengage out-of-care patients, as part of overall clinic retention efforts. The protocol was implemented as one of four interventions of the NC-LINK Systems and Linkages Project, a multi-site initiative funded by the HIV/AIDS Bureau and the Special Projects of National Significance. Lists of out-of-care patients who had not received HIV medical care in over nine months and did not have a future appointment were created each month. Patient navigators, case managers, and other staff then followed a standardized protocol to locate and reengage these patients in care. A total of 452 patients were identified for reengagement services. Of those, 194 (43%) returned to care, 108 (24%) had another definitive outcome (incarcerated, deceased, or relocated) and 150 (33%) were referred for additional follow-up to locate and reengage in care. In summary, 67% of patients were located through the efforts of the clinic staff. The results of this intervention indicate that it is possible to successfully integrate a protocol into the existing infrastructure of a clinic and reengage a majority of out-of-care patients into medical care.

  18. Effects of electrical stimulation-induced gluteal versus gluteal and hamstring muscles activation on sitting pressure distribution in persons with a spinal cord injury.

    PubMed

    Smit, C A J; Haverkamp, G L G; de Groot, S; Stolwijk-Swuste, J M; Janssen, T W J

    2012-08-01

    Ten participants underwent two electrical stimulation (ES) protocols applied using a custom-made electrode garment with built-in electrodes. Interface pressure was measured using a force-sensitive area. In one protocol, both the gluteal and hamstring (g+h) muscles were activated, in the other gluteal (g) muscles only. To study and compare the effects of electrically induced activation of g+h muscles versus g muscles only on sitting pressure distribution in individuals with a spinal cord injury (SCI). Ischial tuberosities interface pressure (ITs pressure) and pressure gradient. In all participants, both protocols of g and g+h ES-induced activation caused a significant decrease in IT pressure. IT pressure after g+h muscles activation was reduced significantly by 34.5% compared with rest pressure, whereas a significant reduction of 10.2% after activation of g muscles only was found. Pressure gradient reduced significantly only after stimulation of g+h muscles (49.3%). g+h muscles activation showed a decrease in pressure relief (Δ IT) over time compared with g muscles only. Both protocols of surface ES-induced of g and g+h activation gave pressure relief from the ITs. Activation of both g+h muscles in SCI resulted in better IT pressure reduction in sitting individuals with a SCI than activation of g muscles only. ES might be a promising method in preventing pressure ulcers (PUs) on the ITs in people with SCI. Further research needs to show which pressure reduction is sufficient in preventing PUs.

  19. OPERANT CONDITIONING OF A SPINAL REFLEX CAN IMPROVE LOCOMOTION AFTER SPINAL CORD INJURY IN HUMANS

    PubMed Central

    Thompson, Aiko K.; Pomerantz, Ferne; Wolpaw, Jonathan R.

    2013-01-01

    Operant conditioning protocols can modify the activity of specific spinal cord pathways and can thereby affect behaviors that use these pathways. To explore the therapeutic application of these protocols, we studied the impact of down-conditioning the soleus H-reflex in people with impaired locomotion caused by chronic incomplete spinal cord injury. After a baseline period in which soleus H-reflex size was measured and locomotion was assessed, subjects completed either 30 H-reflex down-conditioning sessions (DC subjects) or 30 sessions in which the H-reflex was simply measured (Unconditioned (UC) subjects), and locomotion was reassessed. Over the 30 sessions, the soleus H-reflex decreased in two-thirds of the DC subjects (a success rate similar to that in normal subjects) and remained smaller several months later. In these subjects, locomotion became faster and more symmetrical, and the modulation of EMG activity across the step-cycle increased bilaterally. Furthermore, beginning about halfway through the conditioning sessions, all of these subjects commented spontaneously that they were walking faster and farther in their daily lives, and several noted less clonus, easier stepping, and/or other improvements. The H-reflex did not decrease in the other DC subjects or in any of the UC subjects; and their locomotion did not improve. These results suggest that reflex conditioning protocols can enhance recovery of function after incomplete spinal cord injuries and possibly in other disorders as well. Because they are able to target specific spinal pathways, these protocols could be designed to address each individual’s particular deficits, and might thereby complement other rehabilitation methods. PMID:23392666

  20. Te Ira Tangata: a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm.

    PubMed

    Hatcher, Simon; Coupe, Nicole; Durie, Mason; Elder, Hinemoa; Tapsell, Rees; Wikiriwhi, Karen; Parag, Varsha

    2011-05-11

    Maori, the indigenous people of New Zealand, who present to hospital after intentionally harming themselves, do so at a higher rate than non-Maori. There have been no previous treatment trials in Maori who self harm and previous reviews of interventions in other populations have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and sending regular postcards after the self harm attempt may be an effective treatment. There is also a small literature on sense of belonging in self harm and the importance of culture. This protocol describes a pragmatic trial of a package of measures which include problem solving therapy, postcards, patient support, cultural assessment, improved access to primary care and a risk management strategy in Maori who present to hospital after self harm using a novel design. We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a representative cohort of patients. The main outcome will be the number of Maori scoring below nine on the Beck Hopelessness Scale. Secondary outcomes will be hospital repetition at one year; self reported self harm; anxiety; depression; quality of life; social function; and hospital use at three months and one year. A strength of the study is that it is a pragmatic trial which aims to recruit Maori using a Maori clinical team and protocol. It does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. This study is the first randomised control trial to explicitly use cultural assessment and management. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000952246.

  1. Te Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm

    PubMed Central

    2011-01-01

    Background Maori, the indigenous people of New Zealand, who present to hospital after intentionally harming themselves, do so at a higher rate than non-Maori. There have been no previous treatment trials in Maori who self harm and previous reviews of interventions in other populations have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and sending regular postcards after the self harm attempt may be an effective treatment. There is also a small literature on sense of belonging in self harm and the importance of culture. This protocol describes a pragmatic trial of a package of measures which include problem solving therapy, postcards, patient support, cultural assessment, improved access to primary care and a risk management strategy in Maori who present to hospital after self harm using a novel design. Methods We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a representative cohort of patients. The main outcome will be the number of Maori scoring below nine on the Beck Hopelessness Scale. Secondary outcomes will be hospital repetition at one year; self reported self harm; anxiety; depression; quality of life; social function; and hospital use at three months and one year. Discussion A strength of the study is that it is a pragmatic trial which aims to recruit Maori using a Maori clinical team and protocol. It does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. This study is the first randomised control trial to explicitly use cultural assessment and management. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000952246 PMID:21569300

  2. SABE Colombia: Survey on Health, Well-Being, and Aging in Colombia—Study Design and Protocol

    PubMed Central

    Corchuelo, Jairo; Curcio, Carmen-Lucia; Calzada, Maria-Teresa; Mendez, Fabian

    2016-01-01

    Objective. To describe the design of the SABE Colombia study. The major health study of the old people in Latin America and the Caribbean (LAC) is the Survey on Health, Well-Being, and Aging in LAC, SABE (from initials in Spanish: SAlud, Bienestar & Envejecimiento). Methods. The SABE Colombia is a population-based cross-sectional study on health, aging, and well-being of elderly individuals aged at least 60 years focusing attention on social determinants of health inequities. Methods and design were similar to original LAC SABE. The total sample size of the study at the urban and rural research sites (244 municipalities) was 23.694 elderly Colombians representative of the total population. The study had three components: (1) a questionnaire covering active aging determinants including anthropometry, blood pressure measurement, physical function, and biochemical and hematological measures; (2) a subsample survey among family caregivers; (3) a qualitative study with gender and cultural perspectives of quality of life to understand different dimensions of people meanings. Conclusions. The SABE Colombia is a comprehensive, multidisciplinary study of the elderly with respect to active aging determinants. The results of this study are intended to inform public policies aimed at tackling health inequalities for the aging society in Colombia. PMID:27956896

  3. Effectiveness of influenza vaccination for preventing influenza-related complications in people with asthma: a systematic review protocol.

    PubMed

    Vasileiou, Eleftheria; Sheikh, Aziz; Butler, Chris; von Wissmann, Beatrix; McMenamin, Jim; Ritchie, Lewis; Tian, Lilly; Simpson, Colin

    2016-03-29

    Influenza vaccination is administered annually as a preventive measure against influenza infection and influenza-related complications in high-risk individuals, such as those with asthma. However, the effectiveness of influenza vaccination in people with asthma against influenza-related complications is still not well established. We will search the following databases: MEDLINE (Ovid), EMBASE (Ovid), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Cochrane Database of Systematic Reviews (CDSR), Web of Science Core Collection, Science direct, WHO Library Information System (WHOLIS), Global Health Library and Chinese databases (CNKI, Wanfang and ChongQing VIP) from Jan 1970 to Jan 2016 for observational and experimental studies on effectiveness of influenza vaccine in people with asthma. The identification of studies will be complemented with the searching of the reference lists and citations, and contacting influenza vaccine manufacturers to identify unpublished or ongoing studies. Two reviewers will extract data and appraise the quality of each study independently. Separate meta-analyses will be undertaken for observational and experimental evidence using fixed-effect or random-effects models, as appropriate. Formal ethical approval is not required, as primary data will not be collected. The review will be disseminated in peer-reviewed publications and conference presentations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial.

    PubMed

    Levinger, Pazit; Dunn, Jeremy; Bifera, Nancy; Butson, Michael; Elias, George; Hill, Keith D

    2017-08-18

    The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined. This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA. The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial. Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.

  5. Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services

    PubMed Central

    2013-01-01

    Background Young people with complex health needs have impairments that can limit their ability to carry out day-to-day activities. As well as coping with other developmental transitions, these young people must negotiate the transfer of their clinical care from child to adult services. The process of transition may not be smooth and both health and social outcomes may suffer. Increasingly, policy-makers have recognised the need to ensure a smoother transition between children’s and adult services, with processes that are holistic, individualised, and person-centred; however, there is little outcome data to support proposed models of care. This study aims to identify the features of transitional care that are potentially effective and efficient for young people with complex health needs making their transition. Methods/Design Longitudinal cohort study. 450 young people aged 14 years to 18 years 11 months (with autism spectrum disorder and an additional mental health problem, cerebral palsy or diabetes) will be followed through their transition from child to adult services and will contribute data at baseline, 12, 24 and 36 months. We will collect data on: health and wellbeing outcomes (participation, quality of life, satisfaction with services, generic health status (EQ-5D-Y) and condition specific measure of disease control or management); exposure to proposed beneficial features of services (such as having a key worker, appropriate involvement of parents); socio-economic characteristics of the sample; use of condition-related health and personal social services; preferences for the characteristics of transitional care. We will us regression techniques to explore how outcomes vary by exposure to service features and by characteristics of the young people. These data will populate a decision-analytic model comparing the costs and benefits of potential alternative ways of organising transition services. In order to better understand mechanisms and aid interpretation, we will undertake qualitative work with 15 young people, including interviews, non-participant observation and diary collection. Discussion This study will evaluate the effect of service components of transitional care, rather than evaluation of specific models that may be unsustainable or not generalisable. It has been developed in response to numerous national and international calls for such evaluation. PMID:23875722

  6. [Indigenous peoples, HIV and public policy in Latin America: an exploration of the current situations of epidemiological prevalence, prevention, care and timely treatment].

    PubMed

    Ponce, Patricia; Muñoz, Rubén; Stival, Matías

    2017-01-01

    This article aims to describe and analyze the situations of epidemiological prevalence, prevention, care and treatment of HIV in indigenous populations of Latin America. In order to do so, 304 published materials - including declarations, public policy and health program protocols, case studies and literature reviews with local, national and regional scopes - were identified, classified and analyzed. The differential social vulnerability to HIV infection and the inequity in health care access among indigenous populations can be attributed to the juxtaposition of factors such as structural violence, gender, racism, and discrimination due health condition (living with HIV) as well as the subordinated position of indigenous peoples in societies stratified not only socially and economically but also ethnically and culturally. The few studies done in the region on epidemiological prevalence, morbidity and mortality that are disaggregated by ethnicity reveal alarming data highlighting the need for further information on the epidemic in this population so as to address its repercussions in terms of prevention, care and timely follow-up.

  7. Dementia and Traffic Accidents: A Danish Register-Based Cohort Study.

    PubMed

    Petersen, Jindong Ding; Siersma, Volkert; Nielsen, Connie Thurøe; Vass, Mikkel; Waldorff, Frans Boch

    2016-09-27

    As a consequence of a rapid growth of an ageing population, more people with dementia are expected on the roads. Little is known about whether these people are at increased risk of road traffic-related accidents. Our study aims to investigate the risk of road traffic-related accidents for people aged 65 years or older with a diagnosis of dementia in Denmark. We will conduct a nationwide population-based cohort study consisting of Danish people aged 65 or older living in Denmark as of January 1, 2008. The cohort is followed for 7 years (2008-2014). Individual's personal data are available in Danish registers and can be linked using a unique personal identification number. A person is identified with dementia if the person meets at least one of the following criteria: (1) a diagnosis of the disease in the Danish National Patient Register or in the Danish Psychiatric Central Research Register, and/or (2) at least one dementia diagnosis-related drug prescription registration in the Danish National Prescription Registry. Police-, hospital-, and emergency room-reported road traffic-related accidents occurred within the study follow-up are defined as the study outcome. Cox proportional hazard regression models are used for the main analysis. Our study protocol has 3 phases including data collection, data analysis, and reporting. The first phase of register-based data collection of 853,228 individual's personal information was completed in August, 2016. The next phase is data analysis, which is expected to be finished before December 2016, and thereafter writing publications based on the findings. The study started in January 2016 and will end in December 2018. This study covers the entire elderly population of Denmark, and thereby will avoid selection bias due to nonparticipation and loss to follow-up. Furthermore, this ensures that the study results are reliable and generalizable. However, underreporting of traffic-related accidents may occur, which will limit estimation of absolute risks.

  8. Dementia and Traffic Accidents: A Danish Register-Based Cohort Study

    PubMed Central

    Siersma, Volkert; Nielsen, Connie Thurøe; Vass, Mikkel; Waldorff, Frans Boch

    2016-01-01

    Background As a consequence of a rapid growth of an ageing population, more people with dementia are expected on the roads. Little is known about whether these people are at increased risk of road traffic-related accidents. Objective Our study aims to investigate the risk of road traffic-related accidents for people aged 65 years or older with a diagnosis of dementia in Denmark. Methods We will conduct a nationwide population-based cohort study consisting of Danish people aged 65 or older living in Denmark as of January 1, 2008. The cohort is followed for 7 years (2008-2014). Individual’s personal data are available in Danish registers and can be linked using a unique personal identification number. A person is identified with dementia if the person meets at least one of the following criteria: (1) a diagnosis of the disease in the Danish National Patient Register or in the Danish Psychiatric Central Research Register, and/or (2) at least one dementia diagnosis-related drug prescription registration in the Danish National Prescription Registry. Police-, hospital-, and emergency room-reported road traffic-related accidents occurred within the study follow-up are defined as the study outcome. Cox proportional hazard regression models are used for the main analysis. Results Our study protocol has 3 phases including data collection, data analysis, and reporting. The first phase of register-based data collection of 853,228 individual’s personal information was completed in August, 2016. The next phase is data analysis, which is expected to be finished before December 2016, and thereafter writing publications based on the findings. The study started in January 2016 and will end in December 2018. Discussion This study covers the entire elderly population of Denmark, and thereby will avoid selection bias due to nonparticipation and loss to follow-up. Furthermore, this ensures that the study results are reliable and generalizable. However, underreporting of traffic-related accidents may occur, which will limit estimation of absolute risks. PMID:27678553

  9. A factorial-design cluster randomised controlled trial investigating the cost-effectiveness of a nutrition supplement and an exercise programme on pneumonia incidence, walking capacity and body mass index in older people living in Santiago, Chile: the CENEX study protocol

    PubMed Central

    Dangour, Alan D; Albala, Cecilia; Aedo, Cristian; Elbourne, Diana; Grundy, Emily; Walker, Damian; Uauy, Ricardo

    2007-01-01

    Background Chile is currently undergoing a period of rapid demographic transition which has led to an increase in the proportion of older people in the population; the proportion aged 60 years and over, for example, increased from 8% of the population in 1980 to 12% in 2005. In an effort to promote healthy ageing and preserve function, the government of Chile has formulated a package of actions into the Programme of Complementary Feeding for the Older Population (PACAM) which has been providing a nutritional supplement to older people since 1998. PACAM distributes micronutrient fortified foods to individuals aged 70 years and over registered at Primary Health Centres and enrolled in the programme. The recommended serving size (50 g/day) of these supplements provides 50% of daily micronutrient requirements and 20% of daily energy requirements of older people. No information is currently available on the cost-effectiveness of the supplementation programme. Aim The aim of the CENEX cluster randomised controlled trial is to evaluate the cost-effectiveness of an ongoing nutrition supplementation programme, and a specially designed physical exercise intervention for older people of low to medium socio-economic status living in Santiago, Chile. Methods The study has been conceptualised as a public health programme effectiveness study and has been designed as a 24-month factorial cluster-randomised controlled trial conducted among 2800 individuals aged 65.0–67.9 years at baseline attending 28 health centres in Santiago. The main outcomes are incidence of pneumonia, walking capacity and change in body mass index over 24 months of intervention. Costing data (user and provider), collected at all levels, will enable the determination of the cost-effectiveness of the two interventions individually and in combination. The study is supported by the Ministry of Health in Chile, which is keen to expand and improve its national programme of nutrition for older people based on sound science-base and evidence for cost-effectiveness. Trial registration ISRCTN48153354 PMID:17615064

  10. Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol

    PubMed Central

    Underwood, Sonia M.; Matz, Rebecca L.; Posey, Lynmarie A.; Carmel, Justin H.; Caballero, Marcos D.; Fata-Hartley, Cori L.; Ebert-May, Diane; Jardeleza, Sarah E.; Cooper, Melanie M.

    2016-01-01

    Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of “three-dimensional learning” is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not. PMID:27606671

  11. Characterizing College Science Assessments: The Three-Dimensional Learning Assessment Protocol.

    PubMed

    Laverty, James T; Underwood, Sonia M; Matz, Rebecca L; Posey, Lynmarie A; Carmel, Justin H; Caballero, Marcos D; Fata-Hartley, Cori L; Ebert-May, Diane; Jardeleza, Sarah E; Cooper, Melanie M

    2016-01-01

    Many calls to improve science education in college and university settings have focused on improving instructor pedagogy. Meanwhile, science education at the K-12 level is undergoing significant changes as a result of the emphasis on scientific and engineering practices, crosscutting concepts, and disciplinary core ideas. This framework of "three-dimensional learning" is based on the literature about how people learn science and how we can help students put their knowledge to use. Recently, similar changes are underway in higher education by incorporating three-dimensional learning into college science courses. As these transformations move forward, it will become important to assess three-dimensional learning both to align assessments with the learning environment, and to assess the extent of the transformations. In this paper we introduce the Three-Dimensional Learning Assessment Protocol (3D-LAP), which is designed to characterize and support the development of assessment tasks in biology, chemistry, and physics that align with transformation efforts. We describe the development process used by our interdisciplinary team, discuss the validity and reliability of the protocol, and provide evidence that the protocol can distinguish between assessments that have the potential to elicit evidence of three-dimensional learning and those that do not.

  12. Health-related quality of life of young people and adults with primary or recurrent episodes of genital herpes: a mixed methods systematic review protocol.

    PubMed

    Bennett, Clare; Rebafka, Anne; Carrier, Judith; Edwards, Deborah; Jones, Jonathan

    2018-05-01

    The review questions are:The specific objectives are:This mixed methods review seeks to develop an aggregated synthesis of quantitative and qualitative data on the HRQOL implications of genital herpes for the individual in order to derive conclusions and recommendations for clinical practice and policy decision making.

  13. Open-Source Data Collection Techniques for Weapons Transfer Information

    DTIC Science & Technology

    2012-03-01

    IR Infrared ISO International Organization for Standardization ITAR International Traffic in Arms Regulations NER Named Entity Recognition NLP ...Control Protocol UAE United Arab Emirates URI Uniform Resource Identifier URL Uniform Resource Locator USSR Union of Soviet Socialist Republics UTF...KOREA, DEMOCRATIC PEOPLE’S REPUBLIC OF North Korea KOREA, REPUBLIC OF South Korea LIBYAN ARAB JAMAHIRIYA Libya RUSSIAN FEDERATION Russia Table 3

  14. A Systematic Review of Factors Linked to Poor Academic Performance of Disadvantaged Students in Science and Maths in Schools

    ERIC Educational Resources Information Center

    Banerjee, Pallavi Amitava

    2016-01-01

    Socio-economic hardships put children in an underprivileged position. This systematic review was conducted to identify factors linked to underachievement of disadvantaged pupils in school science and maths. What could be done as evidence-based practice to make the lives of these young people better? The protocol from preferred reporting items for…

  15. Live chat alternative security protocol

    NASA Astrophysics Data System (ADS)

    Rahman, J. P. R.; Nugraha, E.; Febriany, A.

    2018-05-01

    Indonesia is one of the largest e-commerce markets in Southeast Asia, as many as 5 million people do transactions in e-commerce, therefore more and more people use live chat service to communicate with customer service. In live chat, the customer service often asks customers’ data such as, full name, address, e-mail, transaction id, which aims to verify the purchase of the product. One of the risks that will happen is sniffing which will lead to the theft of confidential information that will cause huge losses to the customer. The anticipation that will be done is build an alternative security protocol for user interaction in live chat by using a cryptographic algorithm that is useful for protecting confidential messages. Live chat requires confidentiality and data integration with encryption and hash functions. The used algorithm are Rijndael 256 bits, RSA, and SHA256. To increase the complexity, the Rijndael algorithm will be modified in the S-box and ShiftRow sections based on the shannon principle rule, the results show that all pass the Randomness test, but the modification in Shiftrow indicates a better avalanche effect. Therefore the message will be difficult to be stolen or changed.

  16. Does Indigenous health research have impact? A systematic review of reviews.

    PubMed

    Kinchin, Irina; Mccalman, Janya; Bainbridge, Roxanne; Tsey, Komla; Lui, Felecia Watkin

    2017-03-21

    Aboriginal and Torres Strait Islander Australians (hereafter respectfully Indigenous Australians) claim that they have been over-researched without corresponding research benefit. This claim raises two questions. The first, which has been covered to some extent in the literature, is about what type(s) of research are likely to achieve benefits for Indigenous people. The second is how researchers report the impact of their research for Indigenous people. This systematic review of Indigenous health reviews addresses the second enquiry. Fourteen electronic databases were systematically searched for Indigenous health reviews which met eligibility criteria. Two reviewers assessed their characteristics and methodological rigour using an a priori protocol. Three research hypotheses were stated and tested: (1) reviews address Indigenous health priority needs; (2) reviews adopt best practice guidelines on research conduct and reporting in respect to methodological transparency and rigour, as well as acceptability and appropriateness of research implementation to Indigenous people; and (3) reviews explicitly report the incremental impacts of the included studies and translation of research. We argue that if review authors explicitly address each of these three hypotheses, then the impact of research for Indigenous peoples' health would be explicated. Seventy-six reviews were included; comprising 55 journal articles and 21 Australian Government commissioned evidence review reports. While reviews are gaining prominence and recognition in Indigenous health research and increasing in number, breadth and complexity, there is little reporting of the impact of health research for Indigenous people. This finding raises questions about the relevance of these reviews for Indigenous people, their impact on policy and practice and how reviews have been commissioned, reported and evaluated. The findings of our study serve two main purposes. First, we have identified knowledge and methodological gaps in documenting Indigenous health research impact that can be addressed by researchers and policy makers. Second, the findings provide the justification for developing a framework allowing researchers and funding bodies to structure future Indigenous health research to improve the reporting and assessment of impact over time.

  17. Adapting Human Videofluoroscopic Swallow Study Methods to Detect and Characterize Dysphagia in Murine Disease Models

    PubMed Central

    Lever, Teresa E.; Braun, Sabrina M.; Brooks, Ryan T.; Harris, Rebecca A.; Littrell, Loren L.; Neff, Ryan M.; Hinkel, Cameron J.; Allen, Mitchell J.; Ulsas, Mollie A.

    2015-01-01

    This study adapted human videofluoroscopic swallowing study (VFSS) methods for use with murine disease models for the purpose of facilitating translational dysphagia research. Successful outcomes are dependent upon three critical components: test chambers that permit self-feeding while standing unrestrained in a confined space, recipes that mask the aversive taste/odor of commercially-available oral contrast agents, and a step-by-step test protocol that permits quantification of swallow physiology. Elimination of one or more of these components will have a detrimental impact on the study results. Moreover, the energy level capability of the fluoroscopy system will determine which swallow parameters can be investigated. Most research centers have high energy fluoroscopes designed for use with people and larger animals, which results in exceptionally poor image quality when testing mice and other small rodents. Despite this limitation, we have identified seven VFSS parameters that are consistently quantifiable in mice when using a high energy fluoroscope in combination with the new murine VFSS protocol. We recently obtained a low energy fluoroscopy system with exceptionally high imaging resolution and magnification capabilities that was designed for use with mice and other small rodents. Preliminary work using this new system, in combination with the new murine VFSS protocol, has identified 13 swallow parameters that are consistently quantifiable in mice, which is nearly double the number obtained using conventional (i.e., high energy) fluoroscopes. Identification of additional swallow parameters is expected as we optimize the capabilities of this new system. Results thus far demonstrate the utility of using a low energy fluoroscopy system to detect and quantify subtle changes in swallow physiology that may otherwise be overlooked when using high energy fluoroscopes to investigate murine disease models. PMID:25866882

  18. Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

    PubMed

    Gaus, Wilhelm; Muche, Rainer

    2013-05-01

    Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice.

    PubMed

    Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

    2018-01-01

    Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided.

  20. Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice

    PubMed Central

    Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

    2018-01-01

    Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided. PMID:29740326

  1. Application of zero-inflated poisson mixed models in prognostic factors of hepatitis C.

    PubMed

    Akbarzadeh Baghban, Alireza; Pourhoseingholi, Asma; Zayeri, Farid; Jafari, Ali Akbar; Alavian, Seyed Moayed

    2013-01-01

    In recent years, hepatitis C virus (HCV) infection represents a major public health problem. Evaluation of risk factors is one of the solutions which help protect people from the infection. This study aims to employ zero-inflated Poisson mixed models to evaluate prognostic factors of hepatitis C. The data was collected from a longitudinal study during 2005-2010. First, mixed Poisson regression (PR) model was fitted to the data. Then, a mixed zero-inflated Poisson model was fitted with compound Poisson random effects. For evaluating the performance of the proposed mixed model, standard errors of estimators were compared. The results obtained from mixed PR showed that genotype 3 and treatment protocol were statistically significant. Results of zero-inflated Poisson mixed model showed that age, sex, genotypes 2 and 3, the treatment protocol, and having risk factors had significant effects on viral load of HCV patients. Of these two models, the estimators of zero-inflated Poisson mixed model had the minimum standard errors. The results showed that a mixed zero-inflated Poisson model was the almost best fit. The proposed model can capture serial dependence, additional overdispersion, and excess zeros in the longitudinal count data.

  2. The role of premorbid adjustment in schizophrenia: Focus on cognitive remediation outcome.

    PubMed

    Buonocore, Mariachiara; Bosinelli, Francesca; Bechi, Margherita; Spangaro, Marco; Piantanida, Marco; Cocchi, Federica; Bianchi, Laura; Guglielmino, Carmelo; Mastromatteo, Antonella Rita; Cavallaro, Roberto; Bosia, Marta

    2018-02-19

    Premorbid adjustment has been associated with several outcomes in schizophrenia and has been proposed as an index of cognitive reserve. This study aims to comprehensively analyse the relation between premorbid adjustment and clinical, neurocognitive, socio-cognitive and functional assessments, as well as to investigate the effect of premorbid adjustment on cognitive improvements after a cognitive remediation therapy protocol. Seventy-nine clinically stabilised outpatients with schizophrenia underwent a combined intervention consisting of cognitive remediation therapy added to standard rehabilitation therapy. All patients were assessed at baseline for psychopathology, premorbid adjustment, intellectual level, cognition and functioning. Cognitive evaluations were also repeated after the intervention. At baseline, significant correlations were observed between premorbid adjustment and working memory. The global cognitive improvement after treatment was significantly predicted by age and premorbid adjustment. This study confirms the association between premorbid adjustment and cognitive impairment and is the first to highlight the possible role of premorbid adjustment on the capacity to recover from cognitive deficits through a cognitive remediation therapy protocol. The data suggest that cognitive remediation may be particularly effective for people in the early course and that the assessment of premorbid adjustment could be of value to design individualised interventions.

  3. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to assess the effectiveness of a 12 week exercise intervention (the HOPE programme) designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT), measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL), EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life measure and the geriatric depression scale (GDS), measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS), record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881 PMID:21651805

  4. Prescribing prophylaxis to patients who have been exposed to HIV.

    PubMed

    Bagley, Sue

    2012-03-01

    Emergency nurse practitioners should be prepared to prescribe post-exposure prophylaxis for sexual exposure (PEPSE) to people who may have been exposed to HIV, even where the number of such presentations is small. As this article makes clear, nurse prescribers require a sound knowledge of the drugs recommended in PEPSE protocols, and of their side effects, to relieve patients' anxiety and inform them about safe sexual practice. The article offers a case study and reflection to show that patients, particularly those who may have been exposed to HIV, who have been given the information they want are more likely to complete their courses of treatment.

  5. Is the test of senior friendly/child resistant packaging ethical?

    PubMed

    Bix, Laura; de la Fuente, Javier; Pimple, Kenneth D; Kou, Eric

    2009-12-01

    Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the 'senior friendliness' of CR designs that are used throughout the world disallow people with 'overt or obvious' disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision.

  6. The INTERPRET-DD study of diabetes and depression: a protocol.

    PubMed

    Lloyd, C E; Sartorius, N; Cimino, L C; Alvarez, A; Guinzbourg de Braude, M; Rabbani, G; Uddin Ahmed, H; Papelbaum, M; Regina de Freitas, S; Ji, L; Yu, X; Gaebel, W; Müssig, K; Chaturvedi, S K; Srikanta, S S; Burti, L; Bulgari, V; Musau, A; Ndetei, D; Heinze, G; Romo Nava, F; Taj, R; Khan, A; Kokoszka, A; Papasz-Siemieniuk, A; Starostina, E G; Bobrov, A E; Lecic-Tosevski, D; Lalic, N M; Udomratn, P; Tangwongchai, S; Bahendeka, S; Basangwa, D; Mankovsky, B

    2015-07-01

    People with diabetes are at an increased risk of developing depression and other psychological disorders. However, little is known about the prevalence, correlates or care pathways in countries other than the UK and the USA. A new study, the International Prevalence and Treatment of Diabetes and Depression Study (INTERPRET-DD) aims to address this dearth of knowledge and identify optimal pathways to care across the globe. INTERPRET-DD is a 2-year longitudinal study, taking place in 16 countries' diabetes outpatients' facilities, investigating the recognition and management of depressive disorders in people with Type 2 diabetes. Clinical interviews are used to diagnose depression, with clinical and other data obtained from medical records and through patient interviews. Pathways to care and the impact of treatment for previously unrecognized (undocumented) depression on clinical outcomes and emotional well-being are being investigated. Initial evidence indicates that a range of pathways to care exist, with few of them based on available recommendations for treatment. Pilot data indicates that the instruments we are using to measure both the symptoms and clinical diagnosis of depression are acceptable in our study population and easy to use. Our study will increase the understanding of the impact of comorbid diabetes and depression and identify the most appropriate (country-specific) pathways via which patients receive their care. It addresses an important public health problem and leads to recommendations for best practice relevant to the different participating centres with regard to the identification and treatment of people with comorbid diabetes and depression. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  7. Implementation of a baby doll therapy protocol for people with dementia: Innovative practice.

    PubMed

    Braden, Barbara A; Gaspar, Phyllis M

    2015-09-01

    Dementia is exhibited by both emotional and physical states such as agitation. Chemical restraints, often used for agitated behaviors, are not always effective and produce untoward effects. Baby doll therapy is a nonpharmacologic therapy that can affect agitated behavior in dementia patients, yet a protocol for the therapy did not exist. An implementation protocol for doll therapy for those with dementia was developed and implemented with 16 residents in a dementia care center. Outcomes were measurements of the impact of the dolls on six areas of the resident's behavior and their reactions to the doll. Participants had an increase in level of happiness, activity/liveliness, interaction with staff and others, and ease of giving care. There was also a reduction in the level of anxiety. The increase in happiness was a statistically significant outcome. Baby doll therapy is an effective nonpharmacological approach for improving the well-being of patients with moderate to severe dementia. © The Author(s) 2014.

  8. [Seasonality and nutritional status of indigenous peoples: the case of Wari' in Rondônia State, Brazil].

    PubMed

    Leite, Maurício Soares; Santos, Ricardo Ventura; Coimbra, Carlos E A

    2007-11-01

    Despite the importance of nutritional status and eating practices among Brazilian indigenous populations, the subject has received little research attention. This study examines the Wari' community in Rondônia State, in the southwest Amazon. Two anthropometric surveys, six months apart, were carried out to characterize the group's nutritional status and investigate possible seasonal variations (n = 279 and 266; age range, 0-87 years). Prevalence rates of low height for age (61.7%) and weight for age (51.7%) in Wari' under-5 children were among the highest reported in the literature on indigenous populations in Brazil. Overweight and obesity were not common in the population, regardless of age. According to the anthropometric data, nutritional conditions are generally worse during the rainy season, when undernutrition increases in children, and both male and female adults lose weight. Seasonality is an important factor when defining nutritional surveillance protocols and discussing the nutritional status of indigenous peoples.

  9. The Quik Fix study: a randomised controlled trial of brief interventions for young people with alcohol-related injuries and illnesses accessing emergency department and crisis support care

    PubMed Central

    2014-01-01

    Background Alcohol is a major preventable cause of injury, disability and death in young people. Large numbers of young people with alcohol-related injuries and medical conditions present to hospital emergency departments (EDs). Access to brief, efficacious, accessible and cost effective treatment is an international health priority within this age group. While there is growing evidence for the efficacy of brief motivational interviewing (MI) for reducing alcohol use in young people, there is significant scope to increase its impact, and determine if it is the most efficacious and cost effective type of brief intervention available. The efficacy of personality-targeted interventions (PIs) for alcohol misuse delivered individually to young people is yet to be determined or compared to MI, despite growing evidence for school-based PIs. This study protocol describes a randomized controlled trial comparing the efficacy and cost-effectiveness of telephone-delivered MI, PI and an Assessment Feedback/Information (AF/I) only control for reducing alcohol use and related harm in young people. Methods/design Participants will be 390 young people aged 16 to 25 years presenting to a crisis support service or ED with alcohol-related injuries and illnesses (including severe alcohol intoxication). This single blinded superiority trial randomized young people to (i) 2 sessions of MI; (ii) 2 sessions of a new PI or (iii) a 1 session AF/I only control. Participants are reassessed at 1, 3, 6 and 12 months on the primary outcomes of alcohol use and related problems and secondary outcomes of mental health symptoms, functioning, severity of problematic alcohol use, alcohol injuries, alcohol-related knowledge, coping self-efficacy to resist using alcohol, and cost effectiveness. Discussion This study will identify the most efficacious and cost-effective telephone-delivered brief intervention for reducing alcohol misuse and related problems in young people presenting to crisis support services or EDs. We expect efficacy will be greatest for PI, followed by MI, and then AF/I at 1, 3, 6 and 12 months on the primary and secondary outcome variables. Telephone-delivered brief interventions could provide a youth-friendly, accessible, efficacious, cost-effective and easily disseminated treatment for addressing the significant public health issue of alcohol misuse and related harm in young people. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000108718. PMID:25103779

  10. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

    PubMed Central

    2013-01-01

    Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. Discussion This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. Trial registration ISRCTN62019087 PMID:23819476

  11. A busy day has minimal effect on factors associated with falls in older people: An ecological randomised crossover trial.

    PubMed

    Sturnieks, Daina L; Yak, Sin Lin; Ratanapongleka, Mayna; Lord, Stephen R; Menant, Jasmine C

    2018-06-01

    Fatigue is a common complaint in older people. Laboratory-induced muscle fatigue has been found to affect physical functions in older populations but these protocols are rigorous and are unlikely to accurately reflect daily activities. This study used an ecological approach to determine the effects of a busy day on self-reported fatigue and fall-related measures of physical and cognitive function in older people. Fifty community-dwelling adult volunteers, aged 60-88 (mean 73) years participated in this randomised crossover trial. Participants undertook assessments of balance, strength, gait, mobility, cognitive function and self-reported fatigue, before and after a planned rest day and a planned busy day (randomly allocated) at least one week apart. Participants wore an activity monitor on both the rest and busy days. On average, participants undertook twice as many steps and 2.5 times more minutes of activity on the busy, compared with the rest day. Participants had a significant increase in self-reported fatigue on the afternoon of the busy day and no change on the rest day. Repeated measures ANOVAs found no significant day (rest/busy) × time (am/pm) interaction effects, except for the timed up and go test of mobility, resulting from relatively improved mobility performance over the rest day, compared with the busy day. This study showed few effects of a busy day on physical and cognitive performance tests associated with falls in older people. Copyright © 2018 Elsevier Inc. All rights reserved.

  12. Reasoning About Cultural and Genetic Transmission: Developmental and Cross-Cultural Evidence From Peru, Fiji, and the United States on How People Make Inferences About Trait Transmission.

    PubMed

    Moya, Cristina; Boyd, Robert; Henrich, Joseph

    2015-10-01

    Using samples from three diverse populations, we test evolutionary hypotheses regarding how people reason about the inheritance of various traits. First, we provide a framework for differentiat-ing the outputs of mechanisms that evolved for reasoning about variation within and between (a) biological taxa and (b) culturally evolved ethnic categories from (c) a broader set of beliefs and categories that are the outputs of structured learning mechanisms. Second, we describe the results of a modified "switched-at-birth" vignette study that we administered among children and adults in Puno (Peru), Yasawa (Fiji), and adults in the United States. This protocol permits us to study perceptions of prenatal and social transmission pathways for various traits and to differentiate the latter into vertical (i.e., parental) versus horizontal (i.e., peer) cultural influence. These lines of evidence suggest that people use all three mechanisms to reason about the distribution of traits in the population. Participants at all three sites develop expectations that morphological traits are under prenatal influence, and that belief traits are more culturally influenced. On the other hand, each population holds culturally specific beliefs about the degree of social influence on non-morphological traits and about the degree of vertical transmission-with only participants in the United States expecting parents to have much social influence over their children. We reinterpret people's differentiation of trait transmission pathways in light of humans' evolutionary history as a cultural species. Copyright © 2015 Cognitive Science Society, Inc.

  13. Metformin for Clozapine Associated Obesity: A Systematic Review and Meta-Analysis.

    PubMed

    Siskind, Dan J; Leung, Janni; Russell, Anthony W; Wysoczanski, Daniel; Kisely, Steve

    2016-01-01

    Although clozapine is the gold-standard for treatment refractory schizophrenia, it has the worst metabolic profile of all antipsychotics. This is partly mediated by clozapine's impact on glucagon-like peptide (GLP-1). There is an absence of robust evidence for effective treatments for clozapine associated weight gain and metabolic syndrome. Metformin, with its role in increasing GLP-1 may aid weight loss among people on clozapine. We conducted a systematic-review and meta-analysis of metformin versus placebo for change in weight and metabolic syndrome for people on clozapine without diabetes mellitus. We searched the Cochrane Schizophrenia Group's trial register, Pubmed and Embase, as well as the following Chinese databases: the Chinese Biomedical Literature Service System and China Knowledge Resource Integrated Database. This was supplemented by hand searches of key papers. Eight studies, of which three were from Chinese databases, with 478 participants were included. We found that metformin was superior to placebo in terms of weight loss (-3.12kg, 95%CI -4.88kg to -1.37kg) and BMI (-1.18kg/m2, 95%CI -1.76kg/m2 to -0.61kg/m2). Metformin significantly improved three of the five components of metabolic syndrome; waist circumference, fasting glucose and triglycerides. Sensitivity analysis on study quality and duration did not greatly impact results. Metformin led to clinically meaningful weight loss among people on clozapine, and may reduce the rates of metabolic syndrome. Inclusion of metformin into the treatment protocols of people on clozapine, as tolerated, should be considered. PROSPERO registration number: CRD42015029723.

  14. Effect of spinal orthoses and postural taping on balance, gait and quality of life in older people with thoracic hyperkyphosis: protocol for a systematic review and meta-analysis.

    PubMed

    Aboutorabi, Atefeh; Arazpour, Mokhtar; Ahmadi Bani, Monireh; Keshtkar, Abbas Ali

    2018-01-31

    Thoracic hyperkyphosis is one of the most common spinal disorders in older people, creating impairment, postural instability, gait disorders and a reduced quality of life. The use of spinal orthoses and/or postural taping may be feasible conservative interventions, but their efficacy is uncertain. The aim of this review is therefore to investigate the effectiveness of spinal orthoses and taping on the balance and gait of older people with hyperkyphosis. We will include randomised controlled trials and clinical trial studies which assess the efficacy of spinal orthoses and taping using the WHO International Classification of Functioning, Disability and Health (ICF) outcome measures in older people with hyperkyphosis of the thoracic spine. A search will be performed in PubMed, SCOPUS, ISI Web of Knowledge, CENTRAL, EMBASE, CINAHL, AMED, PEDro, REHAB DATA and RECAL databases with no restriction of language. Two independent reviewers will perform the study selection and data extraction. Quality assessment will be implemented using modified Down and Black checklists. Publication bias and data synthesis will be assessed by funnel plots, Begg's and Egger's tests, and plots using STATA software V.12.1 version. No ethical issues are predicted. These findings will be published in a peer reviewed journal and presented at national and international conferences. CRD42016045880. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Assessment of exposure to Leptospira serovars in veterinary staff and dog owners in contact with infected dogs.

    PubMed

    Barmettler, Reto; Schweighauser, Ariane; Bigler, Susanne; Grooters, Amy M; Francey, Thierry

    2011-01-15

    To assess patterns of seroreactivity to Leptospira serovars in veterinary professional staff and dog owners exposed to dogs with acute leptospirosis and to contrast these patterns in people with those observed in dogs. Cross-sectional study. Human subjects consisted of 91 people (50 veterinarians, 19 technical staff, 9 administrative personnel, and 13 dog owners) exposed to dogs with leptospirosis. Canine subjects consisted of 52 dogs with naturally occurring leptospirosis admitted to the University of Bern Vetsuisse Faculty Small Animal Clinic in 2007 and 2008. People were tested for seroreactivity to regionally prevalent Leptospira serovars by use of a complement fixation test. A questionnaire designed to identify risk factors associated with seropositivity was used to collect demographic information from each study participant. Dogs were tested for seroreactivity to Leptospira serovars by use of a microscopic agglutination test. On the basis of microscopic agglutination test results, infected dogs were seropositive for antibodies against Leptospira serovars as follows (in descending order): Bratislava (43/52 [83%]), Australis (43/52 [83%]), Grippotyphosa (18/52 [35%]), Pomona (12/52 [23%]), Autumnalis (6/52 [12%]), Icterohemorrhagiae (4/52 [8%]), Tarassovi (2/52 [4%]), and Canicola (1/52 [2%]). All 91 people were seronegative for antibodies against Leptospira serovars. Therefore, statistical evaluation of risk factors and comparison of patterns of seroreactivity to Leptospira serovars between human and canine subjects were limited to theoretical risks. Seroreactivity to Leptospira serovars among veterinary staff adhering to standard hygiene protocols and pet owners exposed to dogs with acute leptospirosis was uncommon.

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

    PubMed

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

    2017-07-17

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

  17. Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER - Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial.

    PubMed

    McClurg, Doreen; Goodman, Kirsteen; Hagen, Suzanne; Harris, Fional; Treweek, Sean; Emmanuel, Anton; Norton, Christine; Coggrave, Maureen; Doran, Selina; Norrie, John; Donnan, Peter; Mason, Helen; Manoukian, Sarkis

    2017-03-29

    Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50-80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain. This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles. This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS. ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.

  18. Screening of hearing in elderly people: assessment of accuracy and reproducibility of the whispered voice test.

    PubMed

    Labanca, Ludimila; Guimarães, Fernando Sales; Costa-Guarisco, Letícia Pimenta; Couto, Erica de Araújo Brandão; Gonçalves, Denise Utsch

    2017-11-01

    Given the high prevalence of presbycusis and its detrimental effect on quality of life, screening tests can be useful tools for detecting hearing loss in primary care settings. This study therefore aimed to determine the accuracy and reproducibility of the whispered voice test as a screening method for detecting hearing impairment in older people. This cross-sectional study was carried out with 210 older adults aged between 60 and 97 years who underwent the whispered voice test employing ten different phrases and using audiometry as a reference test. Sensitivity, specificity and positive and negative predictive values were calculated and accuracy was measured by calculating the area under the ROC curve. The test was repeated on 20% of the ears by a second examiner to assess inter-examiner reproducibility (IER). The words and phrases that showed the highest area under the curve (AUC) and IER values were: "shoe" (AUC = 0.918; IER = 0.877), "window" (AUC = 0.917; IER = 0.869), "it looks like it's going to rain" (AUC = 0.911; IER = 0.810), and "the bus is late" (AUC = 0.900; IER = 0.810), demonstrating that the whispered voice test is a useful screening tool for detecting hearing loss among older people. It is proposed that these words and phrases should be incorporated into the whispered voice test protocol.

  19. Reply to Commentary: "Are HIV-Infected Candidates for Participation in Risky Cure-Related Studies Otherwise Healthy?"

    PubMed

    Dubé, Karine; Sylla, Laurie; Dee, Lynda

    2018-02-01

    We respond to Eyal et al.'s commentary focusing on how people living with HIV participating in HIV cure-related studies are defined. We argue that the types of participants enrolled in research cannot be dissociated from the study interventions, the types of anticipated risks, and the background standard of care. As the field of HIV cure research advances, more nuance and granularity will be needed to define research criteria and acceptable risk/benefit ratios for cure study participants, as well as specific tiered protocol designs that serve to protect various participant populations from untoward risks, especially in very early phase research with interventions known to have potentially serious toxicities. We highlight key lessons from the ACTIVATE study involving a latency-reversing agent, Panobinostat, for HIV cure study design involving "otherwise healthy volunteers".

  20. Implementing AORN recommended practices for prevention of deep vein thrombosis.

    PubMed

    Van Wicklin, Sharon A

    2011-11-01

    One to two people per 1,000 are affected by deep vein thrombosis (DVT) or pulmonary embolism in the United States each year. AORN published its new "Recommended practices for prevention of deep vein thrombosis" to guide perioperative RNs in establishing organization-wide protocols for DVT prevention. Strategies for successful implementation of the recommended practices include taking a multidisciplinary approach to protocol development, providing education and guidance for performing preoperative patient assessments and administering DVT prophylaxis, and having appropriate resources and the facility's policy and procedure for DVT prevention readily available in the practice setting. Hospital and ambulatory patient scenarios have been included as examples of appropriate execution of the recommended practices. Copyright © 2011 AORN, Inc. Published by Elsevier Inc. All rights reserved.

  1. A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

    PubMed Central

    Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

    2006-01-01

    Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

  2. The Effectiveness of Aromatherapy for Depressive Symptoms: A Systematic Review

    PubMed Central

    Ngai, Shirley Pui-Ching; He, Wanjia; Chow, Jason Ka-Wing; Tsang, Hector Wing-Hong

    2017-01-01

    Background. Depression is one of the greatest health concerns affecting 350 million people globally. Aromatherapy is a popular CAM intervention chosen by people with depression. Due to the growing popularity of aromatherapy for alleviating depressive symptoms, in-depth evaluation of the evidence-based clinical efficacy of aromatherapy is urgently needed. Purpose. This systematic review aims to provide an analysis of the clinical evidence on the efficacy of aromatherapy for depressive symptoms on any type of patients. Methods. A systematic database search was carried out using predefined search terms in 5 databases: AMED, CINHAL, CCRCT, MEDLINE, and PsycINFO. Outcome measures included scales measuring depressive symptoms levels. Results. Twelve randomized controlled trials were included and two administration methods for the aromatherapy intervention including inhaled aromatherapy (5 studies) and massage aromatherapy (7 studies) were identified. Seven studies showed improvement in depressive symptoms. Limitations. The quality of half of the studies included is low, and the administration protocols among the studies varied considerably. Different assessment tools were also employed among the studies. Conclusions. Aromatherapy showed potential to be used as an effective therapeutic option for the relief of depressive symptoms in a wide variety of subjects. Particularly, aromatherapy massage showed to have more beneficial effects than inhalation aromatherapy. PMID:28133489

  3. Educational interventions for general practitioners to identify and manage depression as a suicide risk factor in young people: a systematic review and meta-analysis protocol.

    PubMed

    Tait, Lynda; Michail, Maria

    2014-12-15

    Suicide is a major public health problem and globally is the second leading cause of death in young adults. Globally, there are 164,000 suicides per year in young people under 25 years. Depression is a strong risk factor for suicide. Evidence shows that 45% of those completing suicide, including young adults, contact their general practitioner rather than a mental health professional in the month before their death. Further evidence indicates that risk factors or early warning signs of suicide in young people go undetected and untreated by general practitioners. Healthcare-based suicide prevention interventions targeted at general practitioners are designed to increase identification of at-risk young people. The rationale of this type of intervention is that early identification and improved clinical management of at-risk individuals will reduce morbidity and mortality. This systematic review will synthesise evidence on the effectiveness of education interventions for general practitioners in identifying and managing depression as a suicide risk factor in young people. We shall conduct a systematic review and meta-analysis following the Cochrane Handbook for Systematic Reviews of Interventions guidelines and conform to the reporting guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement recommendations. Electronic databases will be systematically searched for randomised controlled trials and quasi-experimental studies investigating the effectiveness of interventions for general practitioners in identifying and managing depression as a suicide risk factor in young people in comparison to any other intervention, no intervention, usual care or waiting list. Grey literature will be searched by screening trial registers. Only studies published in English will be included. No date restrictions will be applied. Two authors will independently screen titles and abstracts of potential studies. The primary outcome is identification and management of depression. Secondary outcomes are suicidal ideation, suicide attempts, deliberate self-harm, knowledge of suicide risk factors and suicide-related behaviours, attitudes towards suicide risk and suicide-related behaviours, confidence in dealing with suicide risk factors and suicide-related behaviour. Our study will inform the development of future education interventions and provide feasibility and acceptability evidence, to help general practitioners identify and manage suicidal behaviour in young people. PROSPERO registration number: CRD42014009110.

  4. Transition to adult mental health services for young people with attention deficit hyperactivity disorder in Italy: Parents' and clinicians' experiences.

    PubMed

    Reale, Laura; Frassica, Simona; Gollner, Astrid; Bonati, Maurizio

    2015-01-01

    The aim of this study was to describe the experiences of parents and clinicians in relation to the transition from child and adolescent neuropsychiatric services (CANPS) to adult services for people with attention deficit hyperactivity disorder (ADHD) in Italy. Parents of people with ADHD who reached the transition boundary for CANPS were sampled from the A.I.F.A. association (Italian Association of ADHD Families). We thematically analyzed informative and qualitative questionnaires completed by parents and clinicians. Parents' (n = 24) and clinicians' (n = 27) experiences differed slightly on challenges and unmet needs, whereas clinicians agreed on the variables required for an optimal transition process. Poor transition and multiple barriers to such care were identified. Specifically, far fewer people received services, especially public health services, after reaching the age of 18, and perceived barriers included problems with user access, limited transition protocols, poor service coordination, and possible lack of ADHD-related knowledge on the part of adult practitioners. Care continuity in mental healthcare remains a need to be prioritized and better defined also for ADHD patients (and their parents). Parents' and clinicians' experiences are more likely to be positive if transition management is characterized by a gradual preparation, a period of parallel care, and commonly acknowledged, clear information on available services and how to access them. Identifying the needs and barriers of the people representing the different roles (clinicians, parents, and users) involved in the transition to adult mental health services is of particular importance in designing effective, shared transfer planning procedures.

  5. Qualitative study investigating the commissioning process for older people's services provided by third sector organisations: SOPRANO study protocol.

    PubMed

    Sands, Gina; Chadborn, Neil; Craig, Chris; Gladman, John

    2016-05-18

    The commissioning of third sector services for older people may influence the quality, availability and coordination of services for older people. The SOPRANO study aims to understand the relationships between and processes of commissioning bodies and third sector organisations providing health and social care services for older people. This qualitative study will be based in the East Midlands region of England. An initial scoping survey of commissioners will give an overview of services to maintain the health and well-being of older people in the community that are commissioned. Following this, semistructured interviews will be conducted with 4 sample groups: health and social care commissioners, service provider managers, service provider case workers and older service users. A sample size of 10-15 participants in each of the 4 groups is expected to be sufficient to reach data saturation, resulting in a final expected sample size of 40-60 participants. Informed consent will be gained from all participants, and those unable to provide informed consent will be excluded. The interview data will be analysed by 2 researchers using framework content analysis. Approval for the study has been gained from the University of Nottingham School of Medicine ethical review board, and the relevant approvals have been gained from the National Health Service (NHS) research and development departments for interviewing NHS staff. Early engagement with a wide range of stakeholders will ensure that the research findings are extensively disseminated to relevant stakeholders (including commissioners and third sector providers) in an accessible format using the extensive communication networks available to the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care CLAHRCs (applied health research organisations covering all of England). The study will also be disseminated through academic routes such as conference presentations and journal papers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. Acceptance and usability of a home-based monitoring tool of health indicators in children of people with dementia: a Proof of Principle (POP) study

    PubMed Central

    Boessen, April BCG; Vermeulen, Joan; de Witte, Luc P

    2017-01-01

    Background Large-scale cohort studies are needed to confirm the relation between dementia and its possible risk factors. The inclusion of people with dementia in research is a challenge, however, children of people with dementia are at risk and are highly motivated to participate in dementia research. For technologies to support home-based data collection during large-scale studies, participants should be able and willing to use technology for a longer period of time. Objective This study investigated acceptance and usability of iVitality, a research platform for home-based monitoring of dementia health indicators, in 151 children of people with dementia and investigated which frequency of measurements is acceptable for them. Methods Participants were randomized to fortnightly or monthly measurements. At baseline and after 3 months, participants completed an online questionnaire regarding the acceptance (Technology Acceptance Model; 38 items) and usability (Post-Study System Usability Questionnaire; 24 items) of iVitality. Items were rated from 1 (I totally disagree) to 7 (I totally agree). Participants were also invited to take part in an online focus group (OFG) after 3 months of follow-up. Descriptive statistics and both two-sample/independent and paired t-tests were used to analyze the online questionnaires and a directed content analysis was used to analyze the OFGs. Results Children of people with dementia accept iVitality after long-term use and evaluate iVitality as a user-friendly, useful, and trusted technology, despite some suggestions for improvement. Overall, mean scores on acceptance and usability were higher than 5 (I somewhat agree), although the acceptance subscales “social influence” and “time” were rated somewhat lower. No significant differences in acceptance and usability were found between both protocol groups. Over time, “affect” significantly increased among participants measuring blood pressure fortnightly. Conclusion iVitality has the potential to be used in large-scale studies for home-based monitoring of health indicators related to the development of dementia. PMID:28814839

  7. Facilitators and barriers to the delivery of school-based smoking prevention interventions for children and young people: a protocol for a systematic review of qualitative studies.

    PubMed

    Dobbie, Fiona; Angus, Kathryn; Littlecott, Hannah; Allum, Karen; Wells, Valerie; Amos, Amanda; Haw, Sally; Bauld, Linda

    2018-04-06

    Despite a decline in child and adult smoking prevalence, young people who smoke (even occasionally) can rapidly become addicted to nicotine, with most adult smokers initiating smoking before they are 18. Schools have long been a popular setting to deliver youth smoking prevention interventions, but evidence of the effectiveness of school-based prevention programmes is mixed, and outcomes vary by the type of programme delivered. Existing systematic reviews that explore the factors contributing to the success or failure of school-based smoking prevention programmes often exclude qualitative studies, due to a focus on intervention effectiveness which qualitative research cannot answer. Instead, qualitative research is focussed on the experiences and perceptions of those involved in the programmes. This systematic review will address this gap by updating a 2009 review to examine qualitative studies. The aim is to generate deeper insight to help target resources which have the potential to save lives by preventing smoking initiation among children and young people. This systematic review will be searching the following databases: the Cochrane Library, MEDLINE, EMBASE, PsycINFO, HMIC, ERIC, ASSIA, Web of Science and CINAHL. In order to identify additional references, we will consult the reference lists of a sample of systematic reviews and search relevant organizational websites in order to identify appropriate grey literature. The search strategy will include key words and database-specific subject headings relating to smoking, children and young people, health promotion and school. Authors will independently screen, assess data quality and extract data for synthesis. Study findings will be synthesised thematically using 'best-fit framework syntheses'. This allows for an existing set of themes to be used as a starting point to map or code included studies. These themes are then adapted as coding takes place to accommodate new emerging themes. This review will focus on qualitative studies that seek to examine the barriers and facilitators to the delivery of school-based smoking prevention programmes in order to inform the design of future theory-based interventions in schools to prevent children and young people from smoking. PROSPERO CRD42014015483.

  8. The effect of Nintendo® Wii® on balance in people with multiple sclerosis: a pilot randomized control study.

    PubMed

    Brichetto, Giampaolo; Spallarossa, Patricio; de Carvalho, Maria L Lopes; Battaglia, Mario A

    2013-08-01

    Improvement of sensory strategies is a relevant part of balance rehabilitation in multiple sclerosis (MS). This study aimed to Assess the effectiveness of visual-feedback exercises in improving balance in MS. We divided 36 patients into Wii and control-treated groups that underwent balance rehabilitation. Outcomes were obtained for Berg Balance Scale (BBS), Modified Fatigue Impact Scale, and sway area under conditions of opened and closed eyes. BBS showed a statistically significant improvement (from 49.6 to 54.6 points, p < 0.05) in the Wii group. Interactive visual-feedback exercises such as Wii could be more effective than the current standard protocol in improving balance disorders in MS.

  9. The Use of "Literary Fiction" to Promote Mentalizing Ability.

    PubMed

    Pino, Maria Chiara; Mazza, Monica

    2016-01-01

    Empathy is a multidimensional process that incorporates both mentalizing and emotional sharing dimensions. Empathic competencies are important for creating interpersonal relationships with other people and developing adequate social behaviour. The lack of these social components also leads to isolation and exclusion in healthy populations. However, few studies have investigated how to improve these social skills. In a recent study, Kidd and Castano (2013) found that reading literary fiction increases mentalizing ability and may change how people think about other people's emotions and mental states. The aim of our study was to evaluate the effects of reading literary fiction, compared to nonfiction and science fiction, on empathic abilities. Compared to previous studies, we used a larger variety of empathy measures and utilized a pre and post-test design. In all, 214 healthy participants were randomly assigned to read a book representative of one of three literary genres (literary fiction, nonfiction, science fiction). Participants were assessed before and after the reading phase using mentalizing and emotional sharing tests, according to Zaki and Ochsner' s (2012) model. Comparisons of sociodemographic, mentalizing, and emotional sharing variables across conditions were conducted using ANOVA. Our results showed that after the reading phase, the literary fiction group showed improvement in mentalizing abilities, but there was no discernible effect on emotional sharing abilities. Our study showed that the reading processes can promote mentalizing abilities. These results may set important goals for future low-cost rehabilitation protocols for several disorders in which the mentalizing deficit is considered central to the disease, such as Autism Spectrum Disorders and Schizophrenia.

  10. Impact of a 10-Week Individualized Exercise Program on Physical Function and Fatigue of People with Multiple Sclerosis

    PubMed Central

    Elgelid, Staffan; Bolger, Shannon; Parsons, Caroline; Quashnoc, Rachel; Raymor, Johanna

    2011-01-01

    Research has found that people with multiple sclerosis (MS) who engage in exercise programs experience improvements in physical and psychological health, resulting in enhanced quality of life. These studies have involved structured exercise protocols, but few have examined the effects of an individualized exercise program allowing for peer socialization. The purpose of this study was to investigate the effects of a 10-week individualized exercise program offering opportunities to socialize with peers on fatigue and physical functioning in people with MS. Thirteen individuals with a physician diagnosis of MS were enrolled in a 10-week exercise program at Nazareth College in Rochester, New York. Eleven participants (9 female, 2 male; mean ± SD age, 55.0 ± 7.06 years) completed the study. The following qualitative and quantitative measures were used for evaluation before and after the exercise program: Multiple Sclerosis Quality of Life–54 (MSQOL-54), Activities-specific Balance Confidence (ABC) scale, Modified Fatigue Impact Scale (MFIS), Timed Up and Go (TUG) test, Timed 10-Meter Walk (T10MW) test, functional reach test, and single-leg stance (SLS) test. Statistically significant differences were found for the TUG (P = .005), T10MW (P = .014), and MFIS physical functioning subscore (P = .039). The results showed significant increases in gait speed and mobility as well as decreased impact of fatigue on physical functioning after the 10-week exercise program. PMID:24453715

  11. Quality of relationships as predictors of outcomes in people with dementia: a systematic review protocol.

    PubMed

    Edwards, Hannah B; Savović, Jelena; Whiting, Penny; Leach, Verity; Richards, Alison; Cullum, Sarah; Cheston, Richard

    2016-04-04

    Serious adverse outcomes for people with dementia include institutionalisation, hospitalisation, death, development of behavioural and psychiatric symptoms, and reduced quality of life. The quality of the relationship between the person with dementia and their informal/family carer is thought to affect the risk of these outcomes. However, little is known about which aspects of relationship quality are important, or how they affect outcomes for people with dementia. This will be a systematic review of the literature. Electronic databases MEDLINE, EMBASE, Web of Science, PsycInfo, the Cochrane Database, ALOIS and OpenGrey will be searched from inception. 2 independent reviewers will screen results for eligibility with standardised criteria. Data will be extracted for relevant studies, and information on the associations between relationship quality and dementia outcomes will be synthesised. Meta-analysis will be performed if possible to calculate pooled effect sizes. Narrative synthesis will be performed if study heterogeneity rules out meta-analysis. Ethical review is not necessary as this review summarises data from previous studies. Results will be disseminated via peer-reviewed publication. Results will also be disseminated to a patient and public involvement group and an expert panel for their views on the findings and implications for future work. CRD42015020518. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Developing a dementia-specific preference-­based quality of life measure (AD-5D) in Australia: a valuation study protocol

    PubMed Central

    Comans, Tracy A; Nguyen, Kim-Huong; Mulhern, Brendan; Corlis, Megan; Li, Li; Welch, Alyssa; Kurrle, Susan E; Rowen, Donna; Moyle, Wendy; Kularatna, Sanjeewa; Ratcliffe, Julie

    2018-01-01

    Introduction Generic instruments for assessing health-related quality of life may lack the sensitivity to detect changes in health specific to certain conditions, such as dementia. The Quality of Life in Alzheimer’s Disease (QOL-AD) is a widely used and well-validated condition-specific instrument for assessing health-related quality of life for people living with dementia, but it does not enable the calculation of quality-adjusted life years, the basis of cost utility analysis. This study will generate a preference-based scoring algorithm for a health state classification system -the Alzheimer’s Disease Five Dimensions (AD-5D) derived from the QOL-AD. Methods and analysis Discrete choice experiments with duration (DCETTO) and best–worst scaling health state valuation tasks will be administered to a representative sample of 2000 members of the Australian general population via an online survey and to 250 dementia dyads (250 people with dementia and their carers) via face-to-face interview. A multinomial (conditional) logistic framework will be used to analyse responses and produce the utility algorithm for the AD-5D. Ethics and dissemination The algorithms developed will enable prospective and retrospective economic evaluation of any treatment or intervention targeting people with dementia where the QOL-AD has been administered and will be available online. Results will be disseminated through journals that publish health economics articles and through professional conferences. This study has ethical approval. PMID:29358437

  13. Effectiveness of an oral health educational program on community-dwelling older people with xerostomia.

    PubMed

    Ohara, Yuki; Yoshida, Naomi; Kono, Yoko; Hirano, Hirohiko; Yoshida, Hideyo; Mataki, Shiro; Sugimoto, Kumiko

    2015-04-01

    The purpose of the present study was to evaluate the changes in oral health and function through an oral health educational program for the independent older people with xerostomia. Community-dwelling older people with xerostomia aged over 65 years who participated in a preliminary comprehensive health survey in 2011 were recruited for the educational program. A total of 47 participants were randomly assigned into two groups, the intervention group (n = 26) and the control group (n = 21). The intervention group attended a 90-min oral health education program every 2 weeks for 3 months. The program consisted of oral hygiene instruction, facial and tongue muscle exercise, and salivary gland massage. The control group was provided only general information about oral health. The assessments of oral function, such as oral diadochokinesis of articulation, swallowing, taste threshold and salivary flow rate, were carried out before and after 3 months with or without intervention. A total of 38 participants (21 of intervention group and 17 of control group) completed the study protocol. In the intervention group, resting salivation significantly improved after the program. The second and third cumulated Repetitive Saliva Swallowing Test times significantly improved in the intervention group. The threshold for bitterness significantly lowered in the intervention group, whereas the sour threshold significantly heightened in the control group after 3 months (P < 0.05). The present study suggests that the educational program targeting oral function improvement is effective among the independent older population. © 2014 Japan Geriatrics Society.

  14. Can cognitive enhancers reduce the risk of falls in older people with Mild Cognitive Impairment? A protocol for a randomised controlled double blind trial

    PubMed Central

    2009-01-01

    Background Older adults with cognitive problems have a higher risk of falls, at least twice that of cognitively normal older adults. The consequences of falls in this population are very serious: fallers with cognitive problems suffer more injuries due to falls and are approximately five times more likely to be admitted to institutional care. Although the mechanisms of increased fall risk in cognitively impaired people are not completely understood, it is known that impaired cognitive abilities can reduce attentional resource allocation while walking. Since cognitive enhancers, such as cholinesterase inhibitors, improve attention and executive function, we hypothesise that cognitive enhancers may reduce fall risk in elderly people in the early stages of cognitive decline by improving their gait and balance performance due to an enhancement in attention and executive function. Method/Design Double blinded randomized controlled trial with 6 months follow-up in 140 older individuals with Mild Cognitive Impairment (MCI). Participants will be randomized to the intervention group, receiving donepezil, and to the control group, receiving placebo. A block randomization by four and stratification based on fall history will be performed. Primary outcomes are improvements in gait velocity and reduction in gait variability. Secondary outcomes are changes in the balance confidence, balance sway, attention, executive function, and number of falls. Discussion By characterizing and understanding the effects of cognitive enhancers on fall risk in older adults with cognitive impairments, we will be able to pave the way for a new approach to fall prevention in this population. This RCT study will provide, for the first time, information regarding the effect of a medication designed to augment cognitive functioning have on the risk of falls in older adults with Mild Cognitive Impairment. We expect a significant reduction in the risk of falls in this vulnerable population as a function of the reduced gait variability achieved by treatment with cognitive enhancers. This study may contribute to a new approach to prevent and treat fall risk in seniors in early stages of dementia. Trial Registration The protocol for this study is registered with the Clinical Trials Registry, identifier number: NCT00934531 http://www.clinicaltrials.gov PMID:19674471

  15. Training Endogenous Task Shifting Using Music Therapy: A Feasibility Study.

    PubMed

    Lynch, Colleen; LaGasse, A Blythe

    2016-01-01

    People with acquired brain injury (ABI) are highly susceptible to disturbances in executive functioning (EF), and these effects are pervasive. Research studies using music therapy for cognitive improvement in this population are limited. The purpose of this study was to determine the feasibility of a Musical Executive Function Training (MEFT) intervention to address task-shifting skills in adults with ABI and to obtain preliminary evidence of intervention effect on task shifting. Fourteen participants were randomly assigned to one of three groups: a music therapy intervention group (MTG), a singing group (SG), or the no-intervention control group (CG). The SG and MTG met for one hour a day for five days. Feasibility measures included participant completion rates and intervention fidelity. Potential benefits were measured using the Trail Making Test and the Paced Auditory Serial Addition Task as a pre- and posttest measure. Participant completion rates and interventionist fidelity to the protocol supported feasibility. One-way ANOVA of the pre- and posttest group differences revealed a trend toward improvement in the MTG over the SG. Feasibility and effect size data support a larger trial of the MEFT protocol. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. Probiotics for preventing urinary tract infection in people with neuropathic bladder.

    PubMed

    Toh, Swee-Ling; Boswell-Ruys, Claire L; Lee, Bon San B; Simpson, Judy M; Clezy, Kate R

    2017-09-08

    Neuropathic or neurogenic bladder describes a process of dysfunctional voiding as the result of injury in the brain, spinal cord or nerves innervating the bladder. People with neuropathic bladder, such as from spinal cord injury (SCI), are at significant risk of morbidity from urinary tract infections (UTI). Effective methods to prevent UTI in people with SCI have been sought for many years. Probiotics (micro-organisms that exert beneficial health effects in the host) have been recommended for bacterial interference of the urological tract to reduce colonisation by uropathogen and to manage the dual problems of infection and antibiotic resistance. This review looked at the benefits and harms of probiotics in preventing symptomatic UTI in people with neuropathic bladder compared with placebo, no therapy, or non-antibiotic prophylaxis (cranberry juice, methenamine hippurate, topical oestrogen). We searched the Cochrane Kidney and Transplant Specialised Register up to 10 March 2017 through contact with the Information Specialist using search terms relevant to this review. Studies in the Specialised Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov. All randomised controlled trials (RCTs), quasi-RCTs and cross-over RCTs looking at the use of probiotics for the prophylaxis of UTI in people with neuropathic bladders was considered for inclusion. Men, women and children of all ages with neuropathic bladders from neurological injury such as suprapontine, supra sacral and sacral aetiologies was included. All bladder management types, including reflex voiding, time voiding, indwelling and intermittent catheterization were eligible for this review.Studies comparing probiotics to placebo, no treatment or other non-antibiotic prophylaxis was included. Studies comparing probiotics with antibiotics or in combination with antibiotics were excluded. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) and 95% CI were planned for continuous outcomes. This review includes a total of three studies (one cross-over and two parallel RCTs) which involved 110 participants. All three studies looked at intravesical instillation of a low virulent Escherichia coli (E. coli) strain in reducing the risk of symptomatic UTI in participants with neuropathic bladder, predominantly from SCI. Two studies used the E. coli 83972 strain and one study used the E. coli HU2117 strain.We did not find any RCTs involving other probiotics or other routes of administration for preventing UTI in people with neuropathic bladder.There was consistency in definition of symptomatic UTI in all three studies. Symptoms that all studies considered were relevant to diagnose UTI were adequately defined. All three studies defined microbiological diagnosis of symptomatic UTI.Asymptomatic bacteriuria was not considered an outcome measure in any of the included studies; however it was defined in two studies to establish successful inoculation.It is uncertain if the risk of symptomatic UTI is reduced with bladder inoculation using E. coli because the certainty of the evidence is very low (3 studies, 110 participants: RR 0.32, 95% CI 0.08 to 1.19; I 2 = 82%).Two studies reported adverse events. One study reported one episode of autonomic dysreflexia. One study reported three symptomatic UTI occurring in two patients, and two studies mentioned the absence of septicaemia and pyelonephritis. Intravesical instillation was reported as "generally safe". One study reported high attrition rates in participants due to the need to adhere to strict instillation protocols.The overall quality of the studies was poor. All three studies had high risk of attrition bias due to failure of an intention-to-treat analysis which undermines the randomisation process and weakened the results of the studies. All three studies also had high risk of reporting bias. In this review, there were no studies identified addressing oral probiotics in preventing UTI in people with neuropathic bladder. It is uncertain if the risk of symptomatic UTI is reduced in people with neuropathic bladders via intravesical instillation of non-pathogenic E. coli as data were derived from small studies with high risk of bias.Although very minimal levels of harm was reported with this procedure, due to variable success rates, the need for strict adherence to instillation protocols together with high attrition rates in these studies, it is doubtful bladder instillation will be a widely accepted intervention in its current form.It is recommended that further appropriately powered RCTs with more robust methodological reporting be carried out.

  17. An Australian Brain Bank: a critical investment with a high return!

    PubMed Central

    Garrick, T.; Dedova, I.; Hunt, C.; Miller, R.; Sundqvist, N.; Harper, C.

    2012-01-01

    Research into neuropsychiatric disorders, including alcohol-related problems, is limited in part by the lack of appropriate animal models. However, the development of new technologies in pathology and molecular biology means that many more questions can be addressed using appropriately stored human brain tissues. The New South Wales Tissue Resource Centre (TRC) in the University of Sydney (Australia) is a human brain bank that can provide tissues to the neuroscience research community studying alcohol-related brain disorders, schizophrenia, depression and bipolar disorders. Carefully standardised operational protocols and integrated information systems means that the TRC can provide high quality, accurately characterised, tissues for research. A recent initiative, the pre-mortem donor program called “Using our Brains”, encourages individuals without neuropsychiatric illness to register as control donors, a critical group for all research. Community support for this program is strong with over 2,000 people registering their interest. Discussed herein are the protocols pertaining to this multifaceted facility and the benefits of investment, both scientific and financial, to neuroscience researchers and the community at large. PMID:18543078

  18. An Australian Brain Bank: a critical investment with a high return!

    PubMed

    Sheedy, D; Garrick, T; Dedova, I; Hunt, C; Miller, R; Sundqvist, N; Harper, C

    2008-09-01

    Research into neuropsychiatric disorders, including alcohol-related problems, is limited in part by the lack of appropriate animal models. However, the development of new technologies in pathology and molecular biology means that many more questions can be addressed using appropriately stored human brain tissues. The New South Wales Tissue Resource Centre (TRC) in the University of Sydney (Australia) is a human brain bank that can provide tissues to the neuroscience research community studying alcohol-related brain disorders, schizophrenia, depression and bipolar disorders. Carefully standardised operational protocols and integrated information systems means that the TRC can provide high quality, accurately characterised, tissues for research. A recent initiative, the pre-mortem donor program called "Using our Brains", encourages individuals without neuropsychiatric illness to register as control donors, a critical group for all research. Community support for this program is strong with over 2,000 people registering their interest. Discussed herein are the protocols pertaining to this multifaceted facility and the benefits of investment, both scientific and financial, to neuroscience researchers and the community at large.

  19. Affirmative LGBT psychotherapy: Outcomes of a therapist training protocol.

    PubMed

    Pepping, Christopher A; Lyons, Anthony; Morris, Eric M J

    2018-03-01

    Lesbian, gay, bisexual, and transgender (LGBT) people seek psychotherapy at high rates, and the importance of providing culturally appropriate and LGBT-affirmative psychotherapy has been widely acknowledged. Despite this, remarkably little research has investigated the effects of therapist training in LGBT-affirmative psychotherapy. Here we examined the effectiveness of a training protocol for LGBT-affirmative psychotherapy with 96 mental health professionals, ranging in therapeutic experience from <1 year to 37 years (M = 6.54 years). Across all outcomes, therapists reported increased knowledge and skills related to working with LGBT clients following the training. Therapists also displayed reductions in homo-negativity and trans-negativity. Therapists' characteristics did not influence the extent to which they benefited from training. Specifically, years of clinical experience, therapist religiosity, and therapist psychological flexibility were unrelated to changes in attitudes, knowledge, and skills. The results of this study clearly suggest that providing training in LGBT-affirmative psychotherapy can enhance therapists' attitudes, knowledge, and skills. Of particular importance is that the benefits associated with such training appear to hold regardless of therapists' characteristics. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  20. Gencrypt: one-way cryptographic hashes to detect overlapping individuals across samples

    PubMed Central

    Turchin, Michael C.; Hirschhorn, Joel N.

    2012-01-01

    Summary: Meta-analysis across genome-wide association studies is a common approach for discovering genetic associations. However, in some meta-analysis efforts, individual-level data cannot be broadly shared by study investigators due to privacy and Institutional Review Board concerns. In such cases, researchers cannot confirm that each study represents a unique group of people, leading to potentially inflated test statistics and false positives. To resolve this problem, we created a software tool, Gencrypt, which utilizes a security protocol known as one-way cryptographic hashes to allow overlapping participants to be identified without sharing individual-level data. Availability: Gencrypt is freely available under the GNU general public license v3 at http://www.broadinstitute.org/software/gencrypt/ Contact: joelh@broadinstitute.org Supplementary information: Supplementary data are available at Bioinformatics online. PMID:22302573

  1. Heterogeneity among violence-exposed women: applying person-oriented research methods.

    PubMed

    Nurius, Paula S; Macy, Rebecca J

    2008-03-01

    Variability of experience and outcomes among violence-exposed people pose considerable challenges toward developing effective prevention and treatment protocols. To address these needs, the authors present an approach to research and a class of methodologies referred to as person oriented. Person-oriented tools support assessment of meaningful patterns among people that distinguish one group from another, subgroups for whom different interventions are indicated. The authors review the conceptual base of person-oriented methods, outline their distinction from more familiar variable-oriented methods, present descriptions of selected methods as well as empirical applications of person-oriented methods germane to violence exposure, and conclude with discussion of implications for future research and translation between research and practice. The authors focus on violence against women as a population, drawing on stress and coping theory as a theoretical framework. However, person-oriented methods hold utility for investigating diversity among violence-exposed people's experiences and needs across populations and theoretical foundations.

  2. Extended brief intervention to address alcohol misuse in people with mild to moderate intellectual disabilities living in the community (EBI-ID): study protocol for a randomised controlled trial.

    PubMed

    Kouimtsidis, Christos; Fodor-Wynne, Lucy; Scior, Katrina; Hunter, Rachael; Baio, Gianluca; Pezzoni, Vittoria; Hassiotis, Angela

    2015-03-25

    There is some evidence that people with intellectual disabilities who live in the community are exposed to the same risks of alcohol use as the rest of the population. Various interventions have been evaluated in the general population to tackle hazardous or harmful drinking and alcohol dependence, but the literature evaluating interventions is very limited regarding intellectual disabilities. The National Institute for Health and Clinical Excellence recommends that brief and extended brief interventions be used to help young persons and adults who have screened as positive for hazardous and harmful drinking. The objective of this trial is to investigate the feasibility of adapting and delivering an extended brief intervention (EBI) to persons with mild/moderate intellectual disability who live in the community and whose level of drinking is harmful or hazardous. The study has three stages, which include the adaptation of the Extended Brief Intervention (EBI) for people with intellectual disability, a single blind, randomised controlled trial of an individual Extended Brief Intervention to test the feasibility of the intervention, and a qualitative study that will assess the perceived acceptability and usefulness of the intervention. Fifty participants in total will be recruited from community intellectual disability services and social care or third sector organisations. The main outcome is a reduction in alcohol consumption measured by the Alcohol Use Disorders Identification Test. Alcohol misuse is a relatively under-researched mental health problem in people with intellectual disabilities. Therefore, the study addresses both diagnostic issues and the delivery of a simple first stage intervention, which is available to the population of average intelligence and young persons in particular. The findings from the study will guide the preparation of a large-scale study to test whether this treatment is clinically and cost-effective in this population. ISRCTN58783633 (19 December 2013).

  3. Research protocol for the Picture Talk Project: a qualitative study on research and consent with remote Australian Aboriginal communities

    PubMed Central

    Fitzpatrick, Emily F M; Carter, Maureen; Oscar, June; Lawford, Tom; Martiniuk, Alexandra L C; D’Antoine, Heather A; Elliott, Elizabeth J

    2017-01-01

    Introduction Research with Indigenous populations is not always designed with cultural sensitivity. Few publications evaluate or describe in detail seeking consent for research with Indigenous participants. When potential participants are not engaged in a culturally respectful manner, participation rates and research quality can be adversely affected. It is unethical to proceed with research without truly informed consent. Methods and analysis We describe a culturally appropriate research protocol that is invited by Aboriginal communities of the Fitzroy Valley in Western Australia. The Picture Talk Project is a research partnership with local Aboriginal leaders who are also chief investigators. We will interview Aboriginal leaders about research, community engagement and the consent process and hold focus groups with Aboriginal community members about individual consent. Cultural protocols will be applied to recruit and conduct research with participants. Transcripts will be analysed using NVivo10 qualitative software and themes synthesised to highlight the key issues raised by the community about the research process. This protocol will guide future research with the Aboriginal communities of the Fitzroy Valley and may inform the approach to research with other Indigenous communities of Australia or the world. It must be noted that no community is the same and all research requires local consultation and input. To conduct culturally sensitive research, respected local people from the community who have knowledge of cultural protocol and language are engaged to guide each step of the research process from the project design to the delivery of results. Ethics and dissemination Ethics approval was granted by the University of Sydney Human Research Ethics Committee (No. 2012/348, reference:14760), the Western Australia Country Health Service Ethics Committee (No. 2012:15), the Western Australian Aboriginal Health Ethics Committee and reviewed by the Kimberley Aboriginal Health Planning Forum Research Sub-Committee (No. 2012–008). Results will be disseminated through peer review articles, a local Fitzroy Valley report and conference presentations. PMID:29288181

  4. Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol.

    PubMed

    Claborn, Kasey; Becker, Sara; Ramsey, Susan; Rich, Josiah; Friedmann, Peter D

    2017-03-14

    People living with HIV (PLWH) with a substance use disorder (SUD) tend to receive inadequate medical care in part because of a siloed healthcare system in which HIV and substance use services are delivered separately. Ideal treatment requires an interdisciplinary, team-based coordinated care approach, but many structural and systemic barriers impede the integration of HIV and SUD services. The current protocol describes the development and preliminary evaluation of a care coordination intervention (CCI), consisting of a tablet-based mobile platform for HIV and SUD treatment providers, an interagency communication protocol, and a training protocol. We hypothesize that HIV and SUD treatment providers will find the CCI to be acceptable, and that after receipt of the CCI, providers will: exhibit higher retention in dual care among patients, report increased frequency and quality of communication, and report increased rates of relational coordination. A three phase approach is used to refine and evaluate the CCI. Phase 1 consists of in-depth qualitative interviews with 8 key stakeholders as well as clinical audits of participating HIV and SUD treatment agencies. Phase 2 contains functionality testing of the mobile platform with frontline HIV and SUD treatment providers, followed by refinement of the CCI. Phase 3 consists of a pre-, post-test trial with 30 SUD and 30 HIV treatment providers. Data will be collected at the provider, organization, and patient levels. Providers will complete assessments at baseline, immediately post-training, and at 1-, 3-, and 6-months post-training. Organizational data will be collected at baseline, 1-, 3-, and 6-months post training, while patient data will be collected at baseline and 6-months post training. This study will develop and evaluate a CCI consisting of a tablet-based mobile platform for treatment providers, an interagency communication protocol, and a training protocol as a means of improving the integration of care for PLWH who have a SUD. Results have the potential to advance the field by bridging gaps in a fragmented healthcare system, and improving treatment efficiency, work flow, and communication among interdisciplinary providers from different treatment settings. NCT02906215.

  5. Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol.

    PubMed

    Li, Sophie H; Sandler, Carolina X; Casson, Sally M; Cassar, Joanne; Bogg, Tina; Lloyd, Andrew R; Barry, Benjamin K

    2017-05-10

    Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2%-2.6% of the world's population. Although there is level 1 evidence of the benefit of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for some people with CFS, uptake of these interventions is low or at best untimely. This can be partly attributed to poor clinician awareness and knowledge of CFS and related CBT and GET interventions. This trial aims to evaluate the effect of participation in an online education programme, compared with a wait-list control group, on allied health professionals' knowledge about evidence-based CFS interventions and their levels of confidence to engage in the dissemination of these interventions. A randomised controlled trial consisting of 180 consenting allied health professionals will be conducted. Participants will be randomised into an intervention group (n=90) that will receive access to the online education programme, or a wait-list control group (n=90). The primary outcomes will be: 1) knowledge and clinical reasoning skills regarding CFS and its management, measured at baseline, postintervention and follow-up, and 2) self-reported confidence in knowledge and clinical reasoning skills related to CFS. Secondary outcomes include retention of knowledge and satisfaction with the online education programme. The influence of the education programme on clinical practice behaviour, and self-reported success in the management of people with CFS, will also be assessed in a cohort study design with participants from the intervention and control groups combined. The study protocol has been approved by the Human Research Ethics Committee at The University of New South Wales (approval number HC16419). Results will be disseminated via peer-reviewed journal articles and presentations at scientific conferences and meetings. ACTRN12616000296437. © 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.

  6. Innovative public–private partnership to target subsidised antimalarials: a study protocol for a cluster randomised controlled trial to evaluate a community intervention in Western Kenya

    PubMed Central

    Laktabai, Jeremiah; Lesser, Adriane; Platt, Alyssa; Maffioli, Elisa; Mohanan, Manoj; Menya, Diana; Prudhomme O'Meara, Wendy; Turner, Elizabeth L

    2017-01-01

    Introduction There are concerns of inappropriate use of subsidised antimalarials due to the large number of fevers treated in the informal sector with minimal access to diagnostic testing. Targeting antimalarial subsidies to confirmed malaria cases can lead to appropriate, effective therapy. There is evidence that community health volunteers (CHVs) can be trained to safely and correctly use rapid diagnostic tests (RDTs). This study seeks to evaluate the public health impact of targeted antimalarial subsidies delivered through a partnership between CHVs and the private retail sector. Methods and analysis We are conducting a stratified cluster-randomised controlled trial in Western Kenya where 32 community units were randomly assigned to the intervention or control (usual care) arm. In the intervention arm, CHVs offer free RDT testing to febrile individuals and, conditional on a positive test result, a voucher to purchase a WHO-qualified artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector. Study outcomes in individuals with a febrile illness in the previous 4 weeks will be ascertained through population-based cross-sectional household surveys at four time points: baseline, 6, 12 and 18 months postbaseline. The primary outcome is the proportion of fevers that receives a malaria test from any source (CHV or health facility). The main secondary outcome is the proportion of ACTs used by people with a malaria-positive test. Other secondary outcomes include: the proportion of ACTs used by people without a test and adherence to test results. Ethics and dissemination The protocol has been approved by the National Institutes of Health, the Moi University School of Medicine Institutional Research and Ethics Committee and the Duke University Medical Center Institutional Review Board. Findings will be reported on clinicalstrials.gov, in peer-reviewed publications and through stakeholder meetings including those with the Kenyan Ministry of Health. Trial registration number Pre-results, NCT02461628. PMID:28320794

  7. Feasibility of ballistic strength training in sub-acute stroke: A randomized, controlled, assessor-blinded pilot study.

    PubMed

    Hendrey, Genevieve; Clark, Ross A; Holland, Anne E; Mentiplay, Benjamin F; Davis, Carly; Windfeld-Lund, Cristie; Raymond, Melissa J; Williams, Gavin

    2018-05-30

    To establish the feasibility and effectiveness of a six week ballistic strength training protocol in people with stroke. Randomized, controlled, assessor-blinded study. Sub-acute inpatient rehabilitation. Consecutively admitted inpatients with a primary diagnosis of first ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14m were screened for eligibility to recruit 30 participants for randomization. Participants were randomized to standard therapy or ballistic strength training three times per week for six weeks. The primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power and quality of life. Thirty participants (11% of those screened) with mean age of 50 (SD 18) years were randomized. The median number of sessions attended was 15/18 and 17/18 for the ballistic and control groups respectively. Earlier than expected discharge home (n=4) and illness (n=7) were the most common reasons for non-attendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (p<0.05) between-group changes favoring the ballistic group for comfortable gait velocity (mean difference (MD) 0.31m/s, 95% confidence interval CI: 0.08 to 0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3 to 13) and peak propulsive velocity (MD 64cm/s, 95% CI: 17 to 112). Ballistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial. Copyright © 2018. Published by Elsevier Inc.

  8. A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of dignity therapy for older people in care homes: study protocol.

    PubMed

    Hall, Sue; Chochinov, Harvey; Harding, Richard; Murray, Scott; Richardson, Alison; Higginson, Irene J

    2009-03-24

    Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable. Current Controlled Clinical Trials: ISRCTN37589515.

  9. The Science Management Observation Protocol: Using Structured Observations to Improve Teachers' Management of Inquiry-Based Classrooms

    ERIC Educational Resources Information Center

    Sampson, Victor

    2004-01-01

    With the publication of the National Science Education Standards and the Benchmarks for Science Literacy, people now have a thorough idea of what an inquiry-based teacher is, and what he or she needs to do within a classroom in order to be successful. However, one major barrier in learning how to become an effective inquiry-based science teacher…

  10. Managing Chronic Pain in Adults with or in Recovery from Substance Use Disorders. Treatment Improvement Protocol (TIP) Series 54

    ERIC Educational Resources Information Center

    Substance Abuse and Mental Health Services Administration, 2012

    2012-01-01

    Chronic noncancer pain (CNCP) is common in the general population as well as in people who have a substance use disorder (SUD) (Exhibit 1-1). Chronic pain is not harmless; it has physiological, social, and psychological dimensions that can seriously harm health, functioning, and well-being. As a multidimensional condition with both objective and…

  11. The Use of Melatonin to Treat Sleep Disorder in Adults with Intellectual Disabilities in Community Settings -- the Evaluation of Three Cases Using Actigraphy

    ERIC Educational Resources Information Center

    Dodd, A.; Hare, D. J.; Arshad, P.

    2008-01-01

    Background: Sleep disorders are known to be very prevalent in adults with intellectual disabilities (ID) but to date there has been limited objective assessment of either sleep disorders or of interventions such as the use of melatonin. Methodology: A protocol-driven assessment and intervention procedure was followed with three people with…

  12. Team Faces Tough Odds to Implement New Phone Network | Poster

    Cancer.gov

    It was a Saturday, in the final stretch of winter in late February, and the temperature peaked to a pleasant 66 degrees. Many people were outside enjoying the spring-like weather; however, the Voice over Internet Protocol (VoIP) Deployment Team was hard at work at Industry Lane. The team of 10 was installing the new voice-only network, including deploying 145 phones, switching

  13. Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS).

    PubMed

    Lincoln, Nadina B; das Nair, Roshan; Bradshaw, Lucy; Constantinescu, Cris S; Drummond, Avril E R; Erven, Alexandra; Evans, Amy L; Fitzsimmons, Deborah; Montgomery, Alan A; Morgan, Miriam

    2015-12-08

    People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established. This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme. The study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis. ISRCTN09697576 . Registered 14 August 2014.

  14. Internet protocol television for personalized home-based health information: design-based research on a diabetes education system.

    PubMed

    Gray, Kathleen Mary; Clarke, Ken; Alzougool, Basil; Hines, Carolyn; Tidhar, Gil; Frukhtman, Feodor

    2014-03-10

    The use of Internet protocol television (IPTV) as a channel for consumer health information is a relatively under-explored area of medical Internet research. IPTV may afford new opportunities for health care service providers to provide health information and for consumers, patients, and caretakers to access health information. The technologies of Web 2.0 add a new and even less explored dimension to IPTV's potential. Our research explored an application of Web 2.0 integrated with IPTV for personalized home-based health information in diabetes education, particularly for people with diabetes who are not strong computer and Internet users, and thus may miss out on Web-based resources. We wanted to establish whether this system could enable diabetes educators to deliver personalized health information directly to people with diabetes in their homes; and whether this system could encourage people with diabetes who make little use of Web-based health information to build their health literacy via the interface of a home television screen and remote control. This project was undertaken as design-based research in two stages. Stage 1 comprised a feasibility study into the technical work required to integrate an existing Web 2.0 platform with an existing IPTV system, populated with content and implemented for user trials in a laboratory setting. Stage 2 comprised an evaluation of the system by consumers and providers of diabetes information. The project succeeded in developing a Web 2.0 IPTV system for people with diabetes and low literacies and their diabetes educators. The performance of the system in the laboratory setting gave them the confidence to engage seriously in thinking about the actual and potential features and benefits of a more widely-implemented system. In their feedback they pointed out a range of critical usability and usefulness issues related to Web 2.0 affordances and learning fundamentals. They also described their experiences with the system in terms that bode well for its educational potential, and they suggested many constructive improvements to the system. The integration of Web 2.0 and IPTV merits further technical development, business modeling, and health services and health outcomes research, as a solution to extend the reach and scale of home-based health care.

  15. Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

    PubMed

    Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

    2017-09-29

    Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting. This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12614001268639 : (4/12/14).

  16. Effectiveness of aerobic exercise for adults living with HIV: systematic review and meta-analysis using the Cochrane Collaboration protocol.

    PubMed

    O'Brien, Kelly K; Tynan, Anne-Marie; Nixon, Stephanie A; Glazier, Richard H

    2016-04-26

    People with HIV are living longer with the health-related consequences of HIV, multi-morbidity, and aging. Exercise is a key strategy that may improve or sustain health for people living with HIV. Our aim was to examine the safety and effectiveness of aerobic exercise interventions on immunological, virological, cardiorespiratory, strength, weight, body composition, and psychological outcomes in adults living with HIV. We conducted a systematic review using the Cochrane Collaboration protocol. We searched databases up to April 2013. We included randomized controlled trials comparing aerobic exercise with no exercise or another intervention performed at least three times per week for at least four weeks among adults living with HIV. Two reviewers independently determined study eligibility. Data were extracted from studies that met inclusion criteria using standardized forms. We assessed risk of bias using the Cochrane Collaboration's tool for assessing risk of bias. Outcomes were analyzed as continuous and meta-analyses conducted using random effects models with Review Manager (RevMan) computer software. Twenty-four studies met inclusion criteria (n = 936 participants at study completion); the majority of participants were men (73 %) and the majority were taking antiretroviral therapy (19/24 included studies). The exercise intervention included aerobic exercise alone (11 studies) or a combination of aerobic and resistive exercise (13 studies) ranging from 5 to 52 weeks. Fifty-eight meta-analyses were performed. Main results indicated statistically significant improvements in selected outcomes of cardiorespiratory status (maximum oxygen consumption, exercise time), strength (chest press, knee flexion), body composition (lean body mass, percent body fat, leg muscle area), depression symptoms, and quality of life (SF-36 questionnaire) among exercisers compared with non-exercisers. No significant differences in change in CD4 count and viral load were found. Performing aerobic exercise or a combination of aerobic and resistive exercise at least three times per week for at least five weeks is safe and can lead to improvements in cardiorespiratory fitness, strength, body composition and quality of life for adults with HIV. Aerobic exercise is safe and beneficial for adults living with HIV who are medically stable.

  17. Protein Supplementation to Augment the Effects of High Intensity Resistance Training in Untrained Middle-Aged Males: The Randomized Controlled PUSH Trial.

    PubMed

    Wittke, Andreas; von Stengel, Simon; Hettchen, Michael; Fröhlich, Michael; Giessing, Jürgen; Lell, Michael; Scharf, Michael; Bebenek, Michael; Kohl, Matthias; Kemmler, Wolfgang

    2017-01-01

    High intensity (resistance exercise) training (HIT) defined as a "single set resistance exercise to muscular failure" is an efficient exercise method that allows people with low time budgets to realize an adequate training stimulus. Although there is an ongoing discussion, recent meta-analysis suggests the significant superiority of multiple set (MST) methods for body composition and strength parameters. The aim of this study is to determine whether additional protein supplementation may increase the effect of a HIT-protocol on body composition and strength to an equal MST-level. One hundred and twenty untrained males 30-50 years old were randomly allocated to three groups: (a) HIT, (b) HIT and protein supplementation (HIT&P), and (c) waiting-control (CG) and (after cross-over) high volume/high-intensity-training (HVHIT). HIT was defined as "single set to failure protocol" while HVHIT consistently applied two equal sets. Protein supplementation provided an overall intake of 1.5-1.7 g/kg/d/body mass. Primary study endpoint was lean body mass (LBM). LBM significantly improved in all exercise groups ( p ≤ 0.043); however only HIT&P and HVHIT differ significantly from control ( p ≤ 0.002). HIT diverges significantly from HIT&P ( p = 0.017) and nonsignificantly from HVHIT ( p = 0.059), while no differences were observed for HIT&P versus HVHIT ( p = 0.691). In conclusion, moderate to high protein supplementation significantly increases the effects of a HIT-protocol on LBM in middle-aged untrained males.

  18. An analysis of moderate sedation protocols used in dental specialty programs: a retrospective observational study.

    PubMed

    Setty, Madhavi; Montagnese, Thomas A; Baur, Dale; Aminoshariae, Anita; Mickel, Andre

    2014-09-01

    Pain and anxiety control is critical in dental practice. Moderate sedation is a useful adjunct in managing a variety of conditions that make it difficult or impossible for some people to undergo certain dental procedures. The purpose of this study was to analyze the sedation protocols used in 3 dental specialty programs at the Case Western Reserve University School of Dental Medicine, Cleveland, OH. A retrospective analysis was performed using dental school records of patients receiving moderate sedation in the graduate endodontic, periodontic, and oral surgery programs from January 1, 2010, to December 31, 2012. Information was gathered and the data compiled regarding the reasons for sedation, age, sex, pertinent medical conditions, American Society of Anesthesiologists physical status classifications, routes of administration, drugs, dosages, failures, complications, and other information that was recorded. The reasons for the use of moderate sedation were anxiety (54%), local anesthesia failures (15%), fear of needles (15%), severe gag reflex (8%), and claustrophobia with the rubber dam (8%). The most common medical conditions were hypertension (17%), asthma (15%), and bipolar disorder (8%). Most patients were classified as American Society of Anesthesiologists class II. More women (63.1%) were treated than men (36.9%). The mean age was 45 years. Monitoring and drugs varied among the programs. The most common tooth treated in the endodontic program was the mandibular molar. There are differences in the moderate sedation protocols used in the endodontic, periodontic, and oral surgery programs regarding monitoring, drugs used, and record keeping. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. Experimental Research Examining How People Can Cope with Uncertainty Through Soft Haptic Sensations.

    PubMed

    van Horen, Femke; Mussweiler, Thomas

    2015-09-16

    Human beings are constantly surrounded by uncertainty and change. The question arises how people cope with such uncertainty. To date, most research has focused on the cognitive strategies people adopt to deal with uncertainty. However, especially when uncertainty is due to unpredictable societal events (e.g., economical crises, political revolutions, terrorism threats) of which one is unable to judge the impact on one's future live, cognitive strategies (like seeking additional information) is likely to fail to combat uncertainty. Instead, the current paper discusses a method demonstrating that people might deal with uncertainty experientially through soft haptic sensations. More specifically, because touching something soft creates a feeling of comfort and security, people prefer objects with softer as compared to harder properties when feeling uncertain. Seeking for softness is a highly efficient and effective tool to deal with uncertainty as our hands are available at all times. This protocol describes a set of methods demonstrating 1) how environmental (un)certainty can be situationally activated with an experiential priming procedure, 2) that the quality of the softness experience (what type of softness and how it is experienced) matters and 3) how uncertainty can be reduced using different methods.

  20. Chair rise transfer detection and analysis using a pendant sensor: an algorithm for fall risk assessment in older people.

    PubMed

    Zhang, Wei; Regterschot, G Ruben H; Wahle, Fabian; Geraedts, Hilde; Baldus, Heribert; Zijlstra, Wiebren

    2014-01-01

    Falls result in substantial disability, morbidity, and mortality among older people. Early detection of fall risks and timely intervention can prevent falls and injuries due to falls. Simple field tests, such as repeated chair rise, are used in clinical assessment of fall risks in older people. Development of on-body sensors introduces potential beneficial alternatives for traditional clinical methods. In this article, we present a pendant sensor based chair rise detection and analysis algorithm for fall risk assessment in older people. The recall and the precision of the transfer detection were 85% and 87% in standard protocol, and 61% and 89% in daily life activities. Estimation errors of chair rise performance indicators: duration, maximum acceleration, peak power and maximum jerk were tested in over 800 transfers. Median estimation error in transfer peak power ranged from 1.9% to 4.6% in various tests. Among all the performance indicators, maximum acceleration had the lowest median estimation error of 0% and duration had the highest median estimation error of 24% over all tests. The developed algorithm might be feasible for continuous fall risk assessment in older people.

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