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

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

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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  1. [108]Cybulski L Mayo-Wilson E Grant S Improving transparency and reproducibility through registration: the status of intervention trials published in clinical psychology journals J Consult Clin Psychol 2016 84 9 753 767 10.1037/ccp0000115 27281372 · DOI

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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
Venue
Trials
Published
2018-07-31
Volume
19
Issue
1
Pages
406-406
ISSN
1745-6215 (ISSN-L)
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
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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