CONSORT-SPI 2018 Explanation and elaboration: Guidance for reporting social and psychological intervention trials.

Grant, S., Mayo-Wilson, E., Montgomery, P., Macdonald, G., Michie, S., Hopewell, S., . . . Yaffe, J. (2018). CONSORT-SPI 2018 Explanation and elaboration: Guidance for reporting social and psychological intervention trials. Trials,19, 406.

• The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomized controlled trials (RCTs) transparently. The authors have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioral and social scientists report these studies transparently. CONSORT-SPI 2018 extends nine items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with three 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.

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