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.

Details

Title
CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials
Author
Grant, Sean 1   VIAFID ORCID Logo  ; Mayo-Wilson, Evan 2 ; Montgomery, Paul 3 ; Macdonald, Geraldine 4 ; Michie, Susan 5 ; Hopewell, Sally 6 ; Moher, David 7 ; Aber, J. Lawrence; Altman, Doug; Bhui, Kamaldeep; Booth, Andrew; Clark, David; Craig, Peter; Eisner, Manuel; Fraser, Mark W.; Gardner, Frances; Hedges, Larry; Hollon, Steve; Kaplan, Robert; Kaufmann, Peter; Konstantopoulos, Spyros; McLeroy, Kenneth; Mittman, Brian; Nezu, Arthur; Sherman, Lawrence; Sonuga-Barke, Edmund; Thomas, James; VandenBos, Gary; Waters, Elizabeth; West, Robert; Yaffe, Joanne

1  Behavioral & Policy Sciences, RAND Corporation, Santa Monica, USA (GRID:grid.34474.30) (ISNI:0000 0004 0370 7685) 
2  Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311) 
3  School of Social Policy, University of Birmingham, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486) 
4  School for Policy Studies, Bristol, UK (GRID:grid.6572.6) 
5  University College London, Department of Clinical, Educational and Health Psychology, Centre for Behaviour Change, London, UK (GRID:grid.83440.3b) (ISNI:0000000121901201) 
6  University of Oxford, Botnar Research Centre, Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, Oxford, UK (GRID:grid.4991.5) (ISNI:0000 0004 1936 8948) 
7  Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000 0000 9606 5108) 
Pages
406
Publication year
2018
Publication date
Dec 2018
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-018-2735-z
ProQuest document ID
2795264800
Copyright
© The Author(s). 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.