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. and CONSORT-SPI Group, (2018) CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials. Trials, 19(1), 406. (doi:10.1186/s13063-018-2735-z)

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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.

Item Type:Articles
Additional Information:This project is funded by the UK Economic and Social Research Council (ES/K00087X/1).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Craig, Dr Peter
Authors: Grant, S., Mayo-Wilson, E., Montgomery, P., Macdonald, G., Michie, S., Hopewell, S., Moher, D., and CONSORT-SPI Group,
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO Unit
Journal Name:Trials
Publisher:BioMed Central
ISSN:1745-6215
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2018 The Authors
First Published:First published in Trials 19(1):406
Publisher Policy:Reproduced under a Creative Commons License

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