A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers

Kevin E. Thorpe*, Merrick Zwarenstein, Andrew D. Oxman, Shaun Treweek, Curt D. Furberg, Douglas G. Altman, Sean Tunis, Eduardo Bergel, Ian Harvey, David J. Magid, Kalipso Chalkidou

*Corresponding author for this work

Research output: Contribution to journalArticle

586 Citations (Scopus)

Abstract

Objective: To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose.

Study Design and Setting: Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?," whereas explanatory trials are focused on the question, "Can this intervention work under ideal conditions?" Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory.

Results: We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically.

Conclusion: We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.

Original languageEnglish
Pages (from-to)464-475
Number of pages12
JournalJournal of Clinical Epidemiology
Volume62
Issue number5
DOIs
Publication statusPublished - May 2009

Keywords

  • decision-making
  • pragmatic trial
  • randomized controlled trials
  • women
  • preeclampsia
  • clinical-research
  • trial design
  • low-dose aspirin
  • explanatory trial
  • clinical trial
  • clinical trial methodology

Cite this

Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... Chalkidou, K. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464-475. https://doi.org/10.1016/j.jclinepi.2008.12.011

A pragmatic-explanatory continuum indicator summary (PRECIS) : a tool to help trial designers. / Thorpe, Kevin E.; Zwarenstein, Merrick; Oxman, Andrew D.; Treweek, Shaun; Furberg, Curt D.; Altman, Douglas G.; Tunis, Sean; Bergel, Eduardo; Harvey, Ian; Magid, David J.; Chalkidou, Kalipso.

In: Journal of Clinical Epidemiology, Vol. 62, No. 5, 05.2009, p. 464-475.

Research output: Contribution to journalArticle

Thorpe, KE, Zwarenstein, M, Oxman, AD, Treweek, S, Furberg, CD, Altman, DG, Tunis, S, Bergel, E, Harvey, I, Magid, DJ & Chalkidou, K 2009, 'A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers', Journal of Clinical Epidemiology, vol. 62, no. 5, pp. 464-475. https://doi.org/10.1016/j.jclinepi.2008.12.011
Thorpe, Kevin E. ; Zwarenstein, Merrick ; Oxman, Andrew D. ; Treweek, Shaun ; Furberg, Curt D. ; Altman, Douglas G. ; Tunis, Sean ; Bergel, Eduardo ; Harvey, Ian ; Magid, David J. ; Chalkidou, Kalipso. / A pragmatic-explanatory continuum indicator summary (PRECIS) : a tool to help trial designers. In: Journal of Clinical Epidemiology. 2009 ; Vol. 62, No. 5. pp. 464-475.
@article{03da0c38168a47d2b621da99ec828812,
title = "A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers",
abstract = "Objective: To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose.Study Design and Setting: Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, {"}Does this intervention work under usual conditions?,{"} whereas explanatory trials are focused on the question, {"}Can this intervention work under ideal conditions?{"} Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory.Results: We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically.Conclusion: We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.",
keywords = "decision-making, pragmatic trial, randomized controlled trials, women, preeclampsia, clinical-research, trial design, low-dose aspirin, explanatory trial, clinical trial, clinical trial methodology",
author = "Thorpe, {Kevin E.} and Merrick Zwarenstein and Oxman, {Andrew D.} and Shaun Treweek and Furberg, {Curt D.} and Altman, {Douglas G.} and Sean Tunis and Eduardo Bergel and Ian Harvey and Magid, {David J.} and Kalipso Chalkidou",
year = "2009",
month = "5",
doi = "10.1016/j.jclinepi.2008.12.011",
language = "English",
volume = "62",
pages = "464--475",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier USA",
number = "5",

}

TY - JOUR

T1 - A pragmatic-explanatory continuum indicator summary (PRECIS)

T2 - a tool to help trial designers

AU - Thorpe, Kevin E.

AU - Zwarenstein, Merrick

AU - Oxman, Andrew D.

AU - Treweek, Shaun

AU - Furberg, Curt D.

AU - Altman, Douglas G.

AU - Tunis, Sean

AU - Bergel, Eduardo

AU - Harvey, Ian

AU - Magid, David J.

AU - Chalkidou, Kalipso

PY - 2009/5

Y1 - 2009/5

N2 - Objective: To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose.Study Design and Setting: Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?," whereas explanatory trials are focused on the question, "Can this intervention work under ideal conditions?" Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory.Results: We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically.Conclusion: We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.

AB - Objective: To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose.Study Design and Setting: Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?," whereas explanatory trials are focused on the question, "Can this intervention work under ideal conditions?" Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory.Results: We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically.Conclusion: We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.

KW - decision-making

KW - pragmatic trial

KW - randomized controlled trials

KW - women

KW - preeclampsia

KW - clinical-research

KW - trial design

KW - low-dose aspirin

KW - explanatory trial

KW - clinical trial

KW - clinical trial methodology

U2 - 10.1016/j.jclinepi.2008.12.011

DO - 10.1016/j.jclinepi.2008.12.011

M3 - Article

VL - 62

SP - 464

EP - 475

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

IS - 5

ER -