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

Grant, S; Mayo-Wilson, E; Montgomery, P; Macdonald, G; Michie, S; Hopewell, S; Moher, D; ... Yaffe, J; + view all (2018) CONSORT-SPI 2018 Explanation and Elaboration: Guidance for reporting social and psychological intervention trials. Trials , 19 , Article 406. 10.1186/s13063-018-2735-z. Green open access

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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.

Type: Article
Title: CONSORT-SPI 2018 Explanation and Elaboration: Guidance for reporting social and psychological intervention trials
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-018-2735-z
Publisher version: https://doi.org/10.1186/s13063-018-2735-z
Language: English
Additional information: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: CONSORT, Randomised controlled trial, Reporting guideline, Reporting standards, Transparency
URI: http://discovery.ucl.ac.uk/id/eprint/10054169
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