Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2

Gordon Forbes, Kirsty Loudon, Shaun Treweek, Stephanie JC. Taylor, Sandra Eldridge

Research output: Contribution to journalArticle

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Abstract

Objective To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion. Study Design and Setting We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion. Results Seven teams took part in the study. Prior to the discussion within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved following the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, though some domains were more pragmatic than others. Conclusion PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully we recommend a discussion between those with detailed understanding of: what usual care is for the intervention, the trial’s design including operational and technical aspects, and the PRECIS-2 domains. For some cluster randomised trials greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and one at the cluster level.
Original languageEnglish
Pages (from-to)119-126
Number of pages8
JournalJournal of Clinical Epidemiology
Volume90
Early online date17 Jun 2017
DOIs
Publication statusPublished - Oct 2017

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Pragmatic Clinical Trials
Primary Health Care

Keywords

  • Randomized controlled trials
  • Clinical trial methodology
  • Pragmatic trial
  • primary care
  • Trial design

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Understanding the applicability of results from primary care trials : lessons learned from applying PRECIS-2. / Forbes, Gordon; Loudon, Kirsty; Treweek, Shaun; Taylor, Stephanie JC.; Eldridge, Sandra.

In: Journal of Clinical Epidemiology, Vol. 90, 10.2017, p. 119-126.

Research output: Contribution to journalArticle

Forbes, Gordon ; Loudon, Kirsty ; Treweek, Shaun ; Taylor, Stephanie JC. ; Eldridge, Sandra. / Understanding the applicability of results from primary care trials : lessons learned from applying PRECIS-2. In: Journal of Clinical Epidemiology. 2017 ; Vol. 90. pp. 119-126.
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title = "Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2",
abstract = "Objective To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion. Study Design and Setting We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion. Results Seven teams took part in the study. Prior to the discussion within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved following the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, though some domains were more pragmatic than others. Conclusion PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully we recommend a discussion between those with detailed understanding of: what usual care is for the intervention, the trial’s design including operational and technical aspects, and the PRECIS-2 domains. For some cluster randomised trials greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and one at the cluster level.",
keywords = "Randomized controlled trials, Clinical trial methodology, Pragmatic trial, primary care, Trial design",
author = "Gordon Forbes and Kirsty Loudon and Shaun Treweek and Taylor, {Stephanie JC.} and Sandra Eldridge",
note = "Funding statement Some of the work described was part of Chief Scientist Office (CSO) grant CZH/4/773 and UK Medical Research Council and the University of Dundee through the provision of a PhD stipend for Kirsty Loudon, the University of Stirling and from the Health Services Research Unit at the University of Aberdeen, Nursing Midwifery Allied Health Professionals Research Unit at the University of Stirling which are both core funded by the CSO of the Scottish Government Health Directories. Stephanie Taylor was (in part) supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health",
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AU - Eldridge, Sandra

N1 - Funding statement Some of the work described was part of Chief Scientist Office (CSO) grant CZH/4/773 and UK Medical Research Council and the University of Dundee through the provision of a PhD stipend for Kirsty Loudon, the University of Stirling and from the Health Services Research Unit at the University of Aberdeen, Nursing Midwifery Allied Health Professionals Research Unit at the University of Stirling which are both core funded by the CSO of the Scottish Government Health Directories. Stephanie Taylor was (in part) supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

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N2 - Objective To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion. Study Design and Setting We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion. Results Seven teams took part in the study. Prior to the discussion within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved following the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, though some domains were more pragmatic than others. Conclusion PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully we recommend a discussion between those with detailed understanding of: what usual care is for the intervention, the trial’s design including operational and technical aspects, and the PRECIS-2 domains. For some cluster randomised trials greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and one at the cluster level.

AB - Objective To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion. Study Design and Setting We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion. Results Seven teams took part in the study. Prior to the discussion within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved following the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, though some domains were more pragmatic than others. Conclusion PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully we recommend a discussion between those with detailed understanding of: what usual care is for the intervention, the trial’s design including operational and technical aspects, and the PRECIS-2 domains. For some cluster randomised trials greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and one at the cluster level.

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