Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, CONSORT-SPI Group, J Lawrence Aber, Doug Altman, Kamaldeep Bhui, Andrew Booth, David Clark, Peter Craig, Manuel Eisner, Mark W Fraser, Frances Gardner, Sean Grant, Larry Hedges, Steve Hollon, Sally Hopewell, Robert Kaplan, Peter Kaufmann, Spyros Konstantopoulos, Geraldine Macdonald, Evan Mayo-Wilson, Kenneth McLeroy, Susan Michie, Brian Mittman, David Moher, Paul Montgomery, Arthur Nezu, Lawrence Sherman, Edmund Sonuga-Barke, James Thomas, Gary VandenBos, Elizabeth Waters, Robert West, Joanne Yaffe, Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, CONSORT-SPI Group, J Lawrence Aber, Doug Altman, Kamaldeep Bhui, Andrew Booth, David Clark, Peter Craig, Manuel Eisner, Mark W Fraser, Frances Gardner, Sean Grant, Larry Hedges, Steve Hollon, Sally Hopewell, Robert Kaplan, Peter Kaufmann, Spyros Konstantopoulos, Geraldine Macdonald, Evan Mayo-Wilson, Kenneth McLeroy, Susan Michie, Brian Mittman, David Moher, Paul Montgomery, Arthur Nezu, Lawrence Sherman, Edmund Sonuga-Barke, James Thomas, Gary VandenBos, Elizabeth Waters, Robert West, Joanne Yaffe

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.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was obtained from the Department Research Ethics Committee for the Department of Social and Intervention, University of Oxford (reference 2011-12_83).

Consent for publication

Not applicable.

Competing interests

SG’s spouse is a salaried-employee of Eli Lilly and Company, and owns stock. SG has accompanied his spouse on company-sponsored travel. SH and DM are members of the CONSORT Group. All other authors declare no competing interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of potential checklist items through CONSORT-SPI 2018 project
Fig. 2
Fig. 2
The CONSORT-SPI 2018 flow diagram

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