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Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.

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

Author information

1
Behavioral & Policy Sciences, RAND Corporation, 1776 Main Street, Santa Monica, CA, 90407-2138, USA. sgrant@rand.org.
2
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, 615 North Wolfe Street, E6036, Baltimore, MD, 21205, USA.
3
School of Social Policy, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
4
School for Policy Studies, 8 Priory Road, Bristol, BS8 1TZ, UK.
5
Department of Clinical, Educational and Health Psychology, Centre for Behaviour Change, University College London, London, WC1E 7HB, UK.
6
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD, UK.
7
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, K1H 8L6, Canada.

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.

KEYWORDS:

CONSORT; Randomised controlled trial; Reporting guideline; Reporting standards; Transparency

PMID:
30060763
PMCID:
PMC6066913
DOI:
10.1186/s13063-018-2735-z
[Indexed for MEDLINE]
Free PMC Article

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