CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

Sean Grant, Evan Mayo-Wilson, Paul Montgomery, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, , on behalf of the 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, Sean Grant, Evan Mayo-Wilson, Paul Montgomery, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, , on behalf of the 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: 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.

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). Informed consent was obtained from all participants.

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
The CONSORT-SPI 2018 flow diagram

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Source: PubMed

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