Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. Given that the CONSORT Statement has improved the reporting of RCTs in biomedicine, a similar high-quality guideline is needed for the behavioural and social sciences.
CONSORT-SPI 2018 is an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions. It was developed following best practices in developing reporting guideline extensions: a systematic review of existing reporting guidelines, an online Delphi process of 384 international participants, and a 3-day consensus meeting in March 2014 of 31 experts from core disciplines (e.g. public health, social work, education, criminology, psychology) and professional roles (e.g. trialists, funders, journal editors).
The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. An Explanation and Elaboration (E&E) document discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.
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|Explanation & Elaboration||n/a||Download|
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|Checklist for Cluster Extension||Download||Download|
|Checklist for Clusters Extension Abstract||Download||Download|
Montgomery, P., Grant, S., Mayo-Wilson, E., Macdonald, G., Michie, S., Hopewell, S., & Moher, D. (2018). Reporting randomised trials of social and psychological interventions: The CONSORT-SPI 2018 Extension. Trials, 19, 407. doi: 10.1186/s13063-018-2733-1
Grant, S., Mayo-Wilson, E., Montgomery, P., Macdonald, G., Michie, S., Hopewell, S., & Moher, D. (2018). CONSORT-SPI 2018 Explanation and Elaboration: Guidance for reporting social and psychological intervention trials. Trials, 19, 406. doi: 10.1186/s13063-018-2735-z
Grant, S., Mayo-Wilson, E., Melendez-Torres, G.J., & Montgomery, P. (2013). Reporting quality of social and psychological intervention trials: A systematic review of reporting guidelines and trial publications. PLOS One, 8(5), e65442. doi: 10.1371/journal.pone.0065442
Montgomery, P., Grant, S., Hopewell, S., Macdonald, G., Moher, D., Michie, S., & Mayo- Wilson, E. (2013). Protocol for CONSORT-SPI: An Extension for Social and Psychological Interventions. Implementation Science, 8, 99. doi:10.1186/1748-5908-8-99
Mayo-Wilson, E., Grant, S., Hopewell, S., Macdonald, G., Moher, D., & Montgomery, P. (2013). Developing a reporting guideline for social and psychological intervention trials. Trials, 14(1), 242. doi: 10.1186/1745-6215-14-242