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

Background 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,...

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Vydáno v:Current controlled trials in cardiovascular medicine Ročník 19; číslo 1; s. 407 - 14
Hlavní autoři: Montgomery, Paul, Grant, Sean, Mayo-Wilson, Evan, Macdonald, Geraldine, Michie, Susan, Hopewell, Sally, Moher, David
Médium: Journal Article
Jazyk:angličtina
Vydáno: London BioMed Central 31.07.2018
Springer Nature B.V
BMC
Témata:
Behavior Therapy - standards
Biomedicine
Checklist - standards
Consensus
Consensus Development Conferences as Topic
CONSORT
Criminology
Data Accuracy
Delphi method
Delphi Technique
Endpoint Determination - standards
Health Sciences
Humans
Intervention
Medicine
Medicine & Public Health
Methodology
Outcome Assessment, Health Care - standards
Public health
Randomised controlled trial
Randomized Controlled Trials as Topic - standards
Report writing
Reporting guideline
Reporting standards
Research Design - standards
Scientists
Social Environment
Statistics for Life Sciences
Systematic review
Transparency
Treatment Outcome
CONSORT
Transparency
Reporting guideline
Reporting standards
Randomised controlled trial
ISSN:1745-6215, 1745-6215
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Shrnutí:Background 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. Methods 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. Results 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. Conclusions 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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ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-018-2733-1