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

doi:10.1016/j.jclinepi.2017.06.007

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

Health Services Research Unit (HSRU)

Queen Mary University of London

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

7 Downloads (Pure)

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 language	English
Pages (from-to)	119-126
Number of pages	8
Journal	Journal of Clinical Epidemiology
Volume	90
Early online date	17 Jun 2017
DOIs	https://doi.org/10.1016/j.jclinepi.2017.06.007
Publication status	Published - Oct 2017

Bibliographical 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

Keywords

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

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© 2017. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Accepted author manuscript, 415 KBLicence: CC BY-NC-ND

Cite this

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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{\textquoteright}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{\textquoteright}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",

year = "2017",

month = oct,

doi = "10.1016/j.jclinepi.2017.06.007",

language = "English",

volume = "90",

pages = "119--126",

journal = "Journal of Clinical Epidemiology",

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T1 - Understanding the applicability of results from primary care trials

T2 - lessons learned from applying PRECIS-2

AU - Forbes, Gordon

AU - Loudon, Kirsty

AU - Treweek, Shaun

AU - Taylor, Stephanie JC.

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

PY - 2017/10

Y1 - 2017/10

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.

KW - Randomized controlled trials

KW - Clinical trial methodology

KW - Pragmatic trial

KW - primary care

KW - Trial design

U2 - 10.1016/j.jclinepi.2017.06.007

DO - 10.1016/j.jclinepi.2017.06.007

M3 - Article

SN - 0895-4356

VL - 90

SP - 119

EP - 126

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

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

Abstract

Bibliographical note

Keywords

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Cite this