Cited by 348Meta-analysis and systematic reviewsHealth Policy Implementation ScienceDelphi Technique in Research

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

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, on behalf of the CONSORT-SPI Group, Grant, Sean, Mayo-Wilson, Evan, Montgomery, Paul, Macdonald, Geraldine, Michie, Susan, Hopewell, Sally, Moher, David·2018·Trials

DOI 10.1186/s13063-018-2735-zPMC PMC6066913

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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.

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Additional file 5 of Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators
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Additional file 7 of Efficacy of supervised immersive virtual reality-based training for the treatment of chronic fatigue in post-COVID syndrome: study protocol for a double-blind randomized controlled trial (IFATICO Trial)
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Additional file 2 of Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators
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Authors: O. B. O. T. C.-S. G., Grant, S., Mayo-Wilson, E., Montgomery, P., Macdonald, G., Michie, S., Hopewell, S., & Moher, D.
Affiliations: RAND Corporation (US)
University of Bristol (GB)
University of Oxford (GB)
Ottawa Hospital Research Institute (CA)
Corresponding author: Grant, Sean
ORCID: Grant, Sean
Montgomery, Paul
Macdonald, Geraldine
Michie, Susan
Hopewell, Sally
Moher, David
Venue: Trials
Publisher: Springer Science and Business Media LLC
Published: 2018-07-31
Volume: 19
Issue: 1
Pages: 406-406
ISSN: 1745-6215 (ISSN-L)
DOI: 10.1186/s13063-018-2735-z
PMC: PMC6066913
OpenAlex: W2884377688
Cited by: 348
References: 125
Citations by year: 2026: 29 · 2025: 50 · 2024: 62 · 2023: 46 · 2022: 58 · 2021: 51 · 2020: 32 · 2019: 15 · 2018: 5
FWCI: 19.61
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
Locations: Trials (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, other-oa)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
Apollo (University of Cambridge) (submittedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
UCL Discovery (University College London) (submittedVersion)
Research Portal (King's College London) (submittedVersion)
University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
Bristol Research (University of Bristol) (submittedVersion, cc-by)
Explore Bristol Research (submittedVersion, cc-by)
Apollo (cc-by)
Funders: Economic and Social Research Council (ES/K00087X/1)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords: reporting guidelines, behavioral interventions, randomized controlled trials, stakeholder engagement, CONSORT flow diagram, reporting checklist
MeSH terms: Data Accuracy, Behavior Therapy, Delphi Technique, Humans, Research Design, Social Environment, Randomized Controlled Trials as Topic, Treatment Outcome, Outcome Assessment, Health Care, Endpoint Determination, Consensus, Checklist

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

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