CONSORT-SPI 2018 Explanation and Elaboration

Guidance for reporting social and psychological intervention trials

on behalf of the CONSORT-SPI Group

Research output: Contribution to journalArticle

Abstract

Background: The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently. Methods: Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram. Results: CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. Conclusions: The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website ( www.consort-statement.org ) are helpful resources for improving the reporting of social and psychological intervention RCTs.

Original languageEnglish (US)
Article number406
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Jul 31 2018

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Psychology
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Randomized Controlled Trials
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Keywords

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

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

CONSORT-SPI 2018 Explanation and Elaboration : Guidance for reporting social and psychological intervention trials. / on behalf of the CONSORT-SPI Group.

In: Trials, Vol. 19, No. 1, 406, 31.07.2018.

Research output: Contribution to journalArticle

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abstract = "Background: The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently. Methods: Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84{\%}) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram. Results: CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. Conclusions: The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website ( www.consort-statement.org ) are helpful resources for improving the reporting of social and psychological intervention RCTs.",
keywords = "CONSORT, Randomised controlled trial, Reporting guideline, Reporting standards, Transparency",
author = "{on behalf of the CONSORT-SPI Group} and Sean Grant and Mayo-Wilson, {Evan R} and Paul Montgomery 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",
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AU - Montgomery, Paul

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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KW - Reporting standards

KW - Transparency

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