TY - JOUR
T1 - Reporting randomised trials of social and psychological interventions
T2 - the CONSORT-SPI 2018 Extension
AU - on behalf of the CONSORT-SPI Group
AU - Montgomery, Paul
AU - Grant, Sean
AU - Mayo-Wilson, Evan
AU - Macdonald, Geraldine
AU - Michie, Susan
AU - Hopewell, Sally
AU - Moher, David
AU - Lawrence Aber, J.
AU - Altman, Doug
AU - Bhui, Kamaldeep
AU - Booth, Andrew
AU - Clark, David
AU - Craig, Peter
AU - Eisner, Manuel
AU - Sherman, Lawrence
AU - Fraser, Mark W.
AU - Gardner, Frances
AU - Hedges, Larry
AU - Hollon, Steve
AU - Kaplan, Robert
AU - Kaufmann, Peter
AU - Konstantopoulos, Spyros
AU - McLeroy, Kenneth
AU - Mittman, Brian
AU - Nezu, Arthur
AU - Sonuga-Barke, Edmund
AU - Thomas, James
AU - VandenBos, Gary
AU - Waters, Elizabeth
AU - West, Robert
AU - Yaffe, Joanne
PY - 2018/7/31
Y1 - 2018/7/31
N2 - 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.
AB - 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.
KW - CONSORT
KW - Randomised controlled trial
KW - Reporting guideline
KW - Reporting standards
KW - Transparency
UR - http://www.scopus.com/inward/record.url?scp=85050762292&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-2733-1
DO - 10.1186/s13063-018-2733-1
M3 - Article (Academic Journal)
C2 - 30060754
AN - SCOPUS:85050762292
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
M1 - 407
ER -