Reporting randomised trials of social and psychological interventions

The CONSORT-SPI 2018 Extension

on behalf of the CONSORT-SPI Group

Research output: Contribution to journalArticle

Abstract

Background: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. Methods: We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. Results: The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. Conclusions: Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

Original languageEnglish (US)
Article number407
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Jul 31 2018

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Randomized Controlled Trials
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Behavioral Sciences
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Social Sciences
Practice Guidelines
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Keywords

  • CONSORT
  • Randomised controlled trial
  • Reporting guideline
  • Reporting standards
  • Transparency

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Reporting randomised trials of social and psychological interventions : The CONSORT-SPI 2018 Extension. / on behalf of the CONSORT-SPI Group.

In: Trials, Vol. 19, No. 1, 407, 31.07.2018.

Research output: Contribution to journalArticle

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title = "Reporting randomised trials of social and psychological interventions: The CONSORT-SPI 2018 Extension",
abstract = "Background: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. Methods: We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. Results: The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. Conclusions: Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.",
keywords = "CONSORT, Randomised controlled trial, Reporting guideline, Reporting standards, Transparency",
author = "{on behalf of the CONSORT-SPI Group} and Paul Montgomery and Sean Grant and Mayo-Wilson, {Evan R} and Geraldine Macdonald and Susan Michie and Sally Hopewell and David Moher and {Lawrence Aber}, J. and Doug Altman and Kamaldeep Bhui and Andrew Booth and David Clark and Peter Craig and Manuel Eisner and Lawrence Sherman and Fraser, {Mark W.} and Frances Gardner and Larry Hedges and Steve Hollon and Robert Kaplan and Peter Kaufmann and Spyros Konstantopoulos and Kenneth McLeroy and Brian Mittman and Arthur Nezu and Edmund Sonuga-Barke and James Thomas and Gary VandenBos and Elizabeth Waters and Robert West and Joanne Yaffe",
year = "2018",
month = "7",
day = "31",
doi = "10.1186/s13063-018-2733-1",
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AU - on behalf of the CONSORT-SPI Group

AU - Montgomery, Paul

AU - Grant, Sean

AU - Mayo-Wilson, Evan R

AU - Macdonald, Geraldine

AU - Michie, Susan

AU - Hopewell, Sally

AU - Moher, David

AU - Lawrence Aber, J.

AU - Altman, Doug

AU - Bhui, Kamaldeep

AU - Booth, Andrew

AU - Clark, David

AU - Craig, Peter

AU - Eisner, Manuel

AU - Sherman, Lawrence

AU - Fraser, Mark W.

AU - Gardner, Frances

AU - Hedges, Larry

AU - Hollon, Steve

AU - Kaplan, Robert

AU - Kaufmann, Peter

AU - Konstantopoulos, Spyros

AU - McLeroy, Kenneth

AU - Mittman, Brian

AU - Nezu, Arthur

AU - Sonuga-Barke, Edmund

AU - Thomas, James

AU - VandenBos, Gary

AU - Waters, Elizabeth

AU - West, Robert

AU - Yaffe, Joanne

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N2 - Background: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. Methods: We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. Results: The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. Conclusions: Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

AB - Background: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. Methods: We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. Results: The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. Conclusions: Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

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KW - Randomised controlled trial

KW - Reporting guideline

KW - Reporting standards

KW - Transparency

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