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Pragmatic Replication Trial of Health

Anna Sallis, Amanda Bunten, Annabelle Bonus, Andrew James, Tim Chadborn, Daniel Berry
BACKGROUND: The National Health Service Health Check (NHS HC) is a population level public health programme. It is a primary prevention initiative offering cardiovascular risk assessment and management for adults aged 40-74 years (every five years). It was designed to reduce the incidence of major vascular disease events by preventing or delaying the onset of diabetes, heart and kidney disease, stroke and vascular dementia . Effectiveness of the programme has been modelled on a national uptake of 75% however in 2012/13 uptake, nationally, was 49%...
March 24, 2016: BMC Family Practice
Anja Gysin-Maillart, Simon Schwab, Leila Soravia, Millie Megert, Konrad Michel
BACKGROUND: Attempted suicide is the main risk factor for suicide and repeated suicide attempts. However, the evidence for follow-up treatments reducing suicidal behavior in these patients is limited. The objective of the present study was to evaluate the efficacy of the Attempted Suicide Short Intervention Program (ASSIP) in reducing suicidal behavior. ASSIP is a novel brief therapy based on a patient-centered model of suicidal behavior, with an emphasis on early therapeutic alliance...
March 2016: PLoS Medicine
Lisa Ruth Hirschhorn, Katherine Semrau, Bhala Kodkany, Robyn Churchill, Atul Kapoor, Jonathan Spector, Steve Ringer, Rebecca Firestone, Vishwajeet Kumar, Atul Gawande
BACKGROUND: Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India...
August 14, 2015: Implementation Science: IS
Joana Cunha-Cruz, Peter Milgrom, R Michael Shirtcliff, Colleen E Huebner, Sharity Ludwig, Gary Allen, JoAnna Scott
BACKGROUND: Twice daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental associations. Not all parents, children, or adolescents follow this recommendation. This protocol describes the methods for the implementation and evaluation of a quality improvement health promotion program. OBJECTIVE: The objective of the study is to show a theory-informed, evidence-based program to improve twice daily toothbrushing and oral health-related quality of life that may reduce dental caries, dental treatment need, and costs...
May 22, 2015: JMIR Research Protocols
Stephen J Bartels, Sarah I Pratt, Kelly A Aschbrenner, Laura K Barre, John A Naslund, Rosemarie Wolfe, Haiyi Xie, Gregory J McHugo, Daniel E Jimenez, Ken Jue, James Feldman, Bruce L Bird
OBJECTIVE: Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population. METHOD: Persons with serious mental illness and a body mass index (BMI) >25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program, which included membership in a public fitness club and weekly meetings with a health promotion coach, or to fitness club membership alone...
April 2015: American Journal of Psychiatry
William G Elder, Niki Munk
BACKGROUND: Pragmatic clinical trials (PCTs) are increasingly recommended to evaluate interventions in real-world conditions. Although PCTs share a common approach of evaluating variables from actual clinical practice, multiple characteristics can differ. These differences affect interpretation of the trial. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) model was developed in 2009 by the CONSORT Work Group on Pragmatic Trials, published by Thorpe et al, to aid in trial design...
November 2014: Journal of the American Board of Family Medicine: JABFM
Amy O'Donnell, Paul Wallace, Eileen Kaner
BACKGROUND: Robust evidence supports the effectiveness of screening and brief alcohol interventions in primary healthcare. However, lack of understanding about their "active ingredients" and concerns over the extent to which current approaches remain faithful to their original theoretical roots has led some to demand a cautious approach to future roll-out pending further research. Against this background, this paper provides a timely overview of the development of the brief alcohol intervention evidence base to assess the extent to which it has achieved the four key levels of intervention research: efficacy, effectiveness, implementation, and demonstration...
2014: Frontiers in Psychiatry
R J Mash, H Rhode, M Zwarenstein, S Rollnick, C Lombard, K Steyn, N Levitt
AIM: To evaluate the effectiveness of group education, led by health promoters using a guiding style, for people with type 2 diabetes in public sector community health centres in Cape Town. METHODS: This was a pragmatic clustered randomized controlled trial with 17 randomly selected intervention and 17 control sites. A total of 860 patients with type 2 diabetes, regardless of therapy used, were recruited from the control sites and 710 were recruited from the intervention sites...
August 2014: Diabetic Medicine: a Journal of the British Diabetic Association
Mark A Hlatky, Roberta M Ray, Dale R Burwen, Karen L Margolis, Karen C Johnson, Anna Kucharska-Newton, JoAnn E Manson, Jennifer G Robinson, Monika M Safford, Matthew Allison, Themistocles L Assimes, Anthony A Bavry, Jeffrey Berger, Rhonda M Cooper-DeHoff, Susan R Heckbert, Wenjun Li, Simin Liu, Lisa W Martin, Marco V Perez, Hilary A Tindle, Wolfgang C Winkelmayer, Marcia L Stefanick
BACKGROUND: Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or clinical registry studies. The reliability of claims data for documenting outcomes is unknown. METHODS AND RESULTS: We linked records of Women's Health Initiative (WHI) participants aged ≥65 years to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction or coronary revascularization with WHI outcomes adjudicated by study physicians...
January 2014: Circulation. Cardiovascular Quality and Outcomes
Muhammad Amir Khan, Wajiha Javed, Maqsood Ahmed, John Walley, Haroon Jahangir Khan
BACKGROUND: Cardiovascular diseases (CVDs) are one of the leading causes of death and disability in the world. Over 80% of CVD deaths take place in low-and middle-income countries. One-third of the population aged above 40 years suffers from Hypertension (HTN) and this is largely unreported as there is no registry for CVDs. No guidelines are available for use in health care facilities, especially private health facilities where practice among GPs varies considerably. We aim to conduct a Cluster Randomized Controlled trial delivering a quality HTN-CVD care package at strengthened private health facilities as compared to current practice at private health facilities...
2013: BMC Cardiovascular Disorders
Debra P Ritzwoller, Russell E Glasgow, Anna Y Sukhanova, Gary G Bennett, Erica T Warner, Mary L Greaney, Sandy Askew, Julie Goldman, Karen M Emmons, Graham A Colditz
BACKGROUND: The U.S. Preventive Services Task Force has released new guidelines on obesity, urging primary care physicians to provide obese patients with intensive, multi-component behavioral interventions. However, there are few studies of weight loss in real world nonacademic primary care, and even fewer in largely racial/ethnic minority, low-income samples. OBJECTIVE: To evaluate the recruitment, intervention and replications costs of a 2-year, moderate intensity weight loss and blood pressure control intervention...
December 2013: Journal of General Internal Medicine
Martin Cartwright, Shashivadan P Hirani, Lorna Rixon, Michelle Beynon, Helen Doll, Peter Bower, Martin Bardsley, Adam Steventon, Martin Knapp, Catherine Henderson, Anne Rogers, Caroline Sanders, Ray Fitzpatrick, James Barlow, Stanton P Newman
OBJECTIVE: To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions. DESIGN: A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care...
February 26, 2013: BMJ: British Medical Journal
Lise Juul, Helle T Maindal, Vibeke Zoffmann, Morten Frydenberg, Annelli Sandbaek
BACKGROUND: Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant well-being, but experimental research is needed to develop and evaluate SDT-based interventions. The aims of this paper were to describe 1) the design of a trial assessing the effectiveness of a training course for practice-nurses in autonomy support on patient-perceived motivation, HbA1, cholesterol, and well-being among a diabetes population, 2) the actual intervention to a level of detail that allows its replication, and 3) the connection between SDT recommendations for health care-provider behaviour and the content of the training course...
November 24, 2011: BMC Family Practice
Lisa Cadmus, Marsha B Patrick, Matthew L Maciejewski, Tari Topolski, Basia Belza, Donald L Patrick
PURPOSE: To evaluate the effectiveness of a community-based aquatic exercise program for improved quality of life among persons with osteoarthritis. METHOD: Two hundred forty-nine adults with osteoarthritis were enrolled in a 20-wk randomized controlled trial of a preexisting community-based aquatic exercise program versus control. Intervention group participants (n = 125) were asked to attend at least two aquatic exercise sessions per week. Control group participants (n = 124) were asked to maintain their usual activity levels...
January 2010: Medicine and Science in Sports and Exercise
T Yates, M Davies, K Khunti
Type 2 diabetes is associated with many serious comorbidities and is one of the leading causes of mortality globally. Type 2 diabetes is preceded by a condition called prediabetes, which is characterised by elevated glucose concentrations resulting from peripheral and/or hepatic insulin resistance. Individuals with prediabetes have been the traditional target of diabetes prevention programmes; these have consistently shown that lifestyle modification can significantly reduce the risk of developing type 2 diabetes...
September 2009: Postgraduate Medical Journal
Filip Smit, Godelief Willemse, Peter Meulenbeek, Marc Koopmanschap, Anton van Balkom, Philip Spinhoven, Pim Cuijpers
BACKGROUND: Panic disorder affects many people, is associated with a formidable disease burden, and imposes costs on society. The annual influx of new cases of panic disorder is substantial. From the public health perspective it may therefore be a sound policy to reduce the influx of new cases, to maintain the quality of life in many people, and to avoid the economic costs associated with the full-blown disorder. For this purpose, prevention is needed. Here we present the first economic evaluation of such an intervention...
April 24, 2009: Cost Effectiveness and Resource Allocation: C/E
Ruth Harris, Jenifer Wilson-Barnett, Peter Griffiths
OBJECTIVES: To determine whether transfer to a nursing-led inpatient unit (NLIU) prior to discharge from hospital can improve clinical outcome and reduce length of stay and readmission rate for medically stable post-acute patients assessed as requiring inpatient care. METHOD: Retrospective secondary data analysis of individual patient data (n=471) from a programme of three, purposefully replicated, pragmatic randomized controlled trials. Patients were referred to the NLIU by their consultant (attending doctor/surgeon) for nursing-led subacute/post-acute care and randomly allocated to a treatment group for planned transfer to the NLIU for the remainder of their hospital stay or to a control group for traditional consultant-led care in acute wards...
April 2007: Journal of Evaluation in Clinical Practice
R Peveler, T Kendrick, M Buxton, L Longworth, D Baldwin, M Moore, J Chatwin, J Goddard, A Thornett, H Smith, M Campbell, C Thompson
OBJECTIVE: To determine the relative cost-effectiveness of three classes of antidepressants: tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and the modified TCA lofepramine, as first choice treatments for depression in primary care. DESIGN: Open, pragmatic, controlled trial with three randomised arms and one preference arm. Patients were followed up for 12 months. SETTING: UK primary care: 73 practices in urban and rural areas in England...
May 2005: Health Technology Assessment: HTA
B J Wilson, N Torrance, J Mollison, S Wordsworth, J R Gray, N E Haites, A Grant, M K Campbell, Z Miedyzbrodzka, A Clarke, M S Watson, A Douglas
OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of two complementary interventions, using familial breast cancer as a model condition. The primary care intervention consisted of providing computerised referral guidelines and related education to GPs. The nurse counsellor intervention evaluated genetic nurses as substitutes for specialist geneticists in the initial assessment and management of referred patients. DESIGN: The computerised referral guidelines study was a pragmatic, cluster randomised controlled trial (RCT) with general practices randomised to intervention or control groups...
February 2005: Health Technology Assessment: HTA
J Bond, A Atkinson, B A Gregson, D J Newell
This paper reviews the issues which arose in the design of a randomized controlled trial of three experimental National Health Service nursing homes. Problems associated with the implementation of the trial included ethical issues, choice of sample size and recruitment of subjects to the trial, choice and validity of measures of outcome, evaluation of outcomes and replicability of findings. The distinction between explanatory and pragmatic trials is shown to overcome some of these problems.
March 1989: Age and Ageing
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