Abstract
BackgroundThe 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.MethodsFollowing 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.ResultsCONSORT-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.ConclusionsThe 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.
Highlights
Item 2a: scientific background and explanation of rationale A structured introduction should describe theItem 2b: specific objectives or hypotheses The objectives summarise the research questions, including any hypotheses about the expected magnitude and direction of intervention effects [48, 50]
Several reviews have shown that Randomised controlled trial (RCT) of social and psychological interventions are often not reported with sufficient accuracy, comprehensiveness, and transparency to replicate these studies, assess their quality, and understand for whom and under what circumstances the evaluated intervention should be delivered [18,19,20,21,22]
We conducted an international online Delphi process between September 2013 and February 2014 to prioritise the list of potential items for the Consolidated Standards of Reporting Trials (CONSORT)-SPI 2018 checklist and flow diagram that were identified in the systematic review
Summary
Item 2a: scientific background and explanation of rationale A structured introduction should describe theItem 2b: specific objectives or hypotheses The objectives summarise the research questions, including any hypotheses about the expected magnitude and direction of intervention effects [48, 50]. 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. CONSORT-SPI 2018 explanation and elaboration The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help authors report randomised controlled trials (RCTs) [1]. It has improved the quality of reports in medicine [2,3,4,5], and has been officially endorsed by over 600 journals and prominent editorial groups [6]. Behavioural and social scientists may be prevented from reproducing or synthesising previous studies because trial protocols, outcome data, and the materials required to implement social and psychological interventions are often
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