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CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials
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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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“The reporting of this psychological trial is in line with the Consolidated Standards of Reporting Trials (CONSORT) guidelines [36].”
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“The study follows the CONSORT guidelines for RCTs on social and psychological interventions (CONSORT-SPI 2018) [54].”
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Self-citationAdditional file 1 of Six practical recommendations for improved implementation outcomes reporting
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Metadata
- 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
- Venue
- Trials
- Published
- 2018-07-31
- Volume
- 19
- Issue
- 1
- Pages
- 406-406
- ISSN
- 1745-6215 (ISSN-L)
- 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
- 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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