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Published in: Trials 1/2018

Open Access 01-12-2018 | Methodology

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

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

Published in: Trials | Issue 1/2018

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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.
Appendix
Available only for authorised users
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Metadata
Title
CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials
Authors
Sean Grant
Evan Mayo-Wilson
Paul Montgomery
Geraldine Macdonald
Susan Michie
Sally Hopewell
David Moher
, on behalf of the CONSORT-SPI Group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2735-z

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