CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

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

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CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

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

Trials201819:406
https://doi.org/10.1186/s13063-018-2735-z

© The Author(s). 2018

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

Open Peer Review reports
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.

 

See also:
Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension
https://www.s4me.info/threads/repor...ventions-the-consort-spi-2018-extension.5240/