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Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

Overview of attention for article published in Trials, July 2018
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Title
Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension
Published in
Trials, July 2018
DOI 10.1186/s13063-018-2733-1
Pubmed ID
Authors

Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, on behalf of the CONSORT-SPI Group

Abstract

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. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. 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. 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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Geographical breakdown

Country Count As %
Unknown 223 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 40 18%
Researcher 35 16%
Student > Master 24 11%
Student > Bachelor 17 8%
Professor 13 6%
Other 45 20%
Unknown 49 22%
Readers by discipline Count As %
Psychology 47 21%
Medicine and Dentistry 38 17%
Nursing and Health Professions 25 11%
Social Sciences 16 7%
Neuroscience 10 4%
Other 20 9%
Unknown 67 30%