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

There might be things in these reporting guidelines that can be used to criticise someone ME/CFS trials.

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https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2733-1

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

• Paul MontgomeryEmail authorView ORCID ID profile,
• Sean Grant,
• Evan Mayo-Wilson,
• Geraldine Macdonald,
• Susan Michie,
• Sally Hopewell,
• David Moher and
• on behalf of the CONSORT-SPI Group

Trials201819:407
https://doi.org/10.1186/s13063-018-2733-1

© The Author(s). 2018

• Received: 17 January 2018
• Accepted: 8 June 2018
• Published: 31 July 2018

Open Peer Review reports
Abstract
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.

Keywords

• CONSORT
• Randomised controlled trial
• Reporting guideline
• Reporting standards
• Transparency

 

See also:
CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials
https://www.s4me.info/threads/conso...l-and-psychological-intervention-trials.5239/