CONSORT-SPI 2018 Explanation and Elaboration: Guidance for reporting social and psychological intervention trials
Year: 2024
Type: article
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.
DOI: 10.17615/w9f2-ce75
Authors: Michie, S., Altman, D., Moher, D., Grant, S., Clark, D., McLeroy, K., Kaplan, R., Eisner, M., Montgomery, P., Bhui, K., Hedges, L., Kaufmann, P., Craig, P., Fraser, M.W., Yaffe, J., West, R., Sonuga-Barke, E., Sherman, L., Macdonald, G., Konstantopoulos, S., Hollon, S., Aber, J.L., Hopewell, S., Gardner, F., CONSORT-SPI Group, Booth, A., Mittman, B., Waters, E., VandenBos, G., Nezu, A., Mayo-Wilson, E., Thomas, J.
Language: English
Subfield: Statistics, Probability and Uncertainty
Field: Decision Sciences
Domain: Social Sciences
Open Access status: green
Funders: Kaiser Permanente, Vanderbilt University, Northwestern University, Michigan State University, Johns Hopkins University, Drexel University, Queen Mary University of London, Ottawa Hospital Research Institute, York University, University College London, University of Oxford, University of Glasgow, University of Bristol, National Institutes of Health, College of Engineering, Michigan State University, University of California, Los Angeles, University of North Carolina at Chapel Hill, Medical Research Council, Economic and Social Research Council, Menzies Centre for Australian Studies, King's College London, University of London
OpenAlex ID: W4400024098