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

Trials

, on behalf of the CONSORT-SPI Group¹  Sean Grant²  David Moher³  Susan Michie⁴  Evan Mayo-Wilson⁵  Sally Hopewell⁶  Geraldine Macdonald⁷  Paul Montgomery⁸ 

[1] ;Behavioral & Policy Sciences, RAND Corporation;Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute;Department of Clinical, Educational and Health Psychology, Centre for Behaviour Change, University College London;Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health;Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre;School for Policy Studies;School of Social Policy, University of Birmingham;

关键词: CONSORT;    Randomised controlled trial;    Reporting guideline;    Reporting standards;    Transparency;   

DOI  :  10.1186/s13063-018-2735-z

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown