Reporting Guidelines for Trials of Social
and Psychological Interventions:
CONSORT-SPI
EVAN MAYO-WILSON, DPHIL
SEAN GRANT, MSC
PAUL MONTGOMERY, DPHIL
KENNETH R. MCLEROY, PHD
Presenter disclosure
Kenneth R. McLeroy, PhD
(1)The following personal financial relationships with
commercial interests relevant to this presentation
existed during the past 12 months:
No relationships to disclose
2
Why reporting standards?
• Systematic reviews of RCTs are an important standard for effectiveness
research
 Typically rely on (published) reports of research
 Numerous reviews suggest overall reporting quality is bad (Grant et al. 2013, Stevens et al.
et al. 2014)
• Issues with:
 Randomization
 Post hoc hypothesis testing
 Positive result bias
 Failure to publish bias and reporting of harms
 Misinterpretation of findings
• Transparency in research
History of reporting standards
• Current widely endorsed reporting standards
 CONSORT: RCTs
 TREND: Quasi experiments
 PRISMA: Systematic literature reviews
• Effects of reporting standards
 Completeness (Hopewell et al. 2010)
 Transparency
 Replicability
• EQUATOR Network
CONSORT
•
Methods of development:
1.
2.
Meta-epidemiology (literature review)
Consensus processes
o
o
3.
Dissemination
o
o
•
•
Delphi panel of experts
Consensus meeting
Journal endorsement
Use by authors/reviewers/editors
25-item checklist
Flow chart
(Moher et al. 2010)
Why the Extension for Social and
Psychological Interventions (SPI)
• Physical, mental and social outcomes
• Complex interventions with multiple, interacting components
• Outcomes at multiple levels
• Contextually dependent
• Hard-to-control environments
• May take on multiple forms while targeting same outcomes
• While technically suitable for RCTs, many of the issues many of the issues addressed
apply to other research designs.
Disciplines Covered by the CONSORTSPI Extension:
• Criminology
• Social Work
• Education
• Psychology
• Public Health
Procedures for Developing the SPI
Extension
• Phase I
 Literature review
• Phase II
 Delphi Process (384 from 32 countries) – Reviewed and endorsed existing
existing CONSORT items
 Identified additional items for inclusion
• Phase III
 31 attendees drawn from Delphi group
 14 new items identified
 Highlighted issues to discuss in Explanation and Elaboration document
document
o
Social and psychological mechanisms of action, multi-level problems, subjective
subjective outcomes, natural settings
NEW CONSORT-SPI Checklist:
1.
2.
3.
Title and abstract
Background and objectives (modified)
Methods (modified):
 Trial design (unit of assignment)
 Participants (eligibility criteria for setting)
 Intervention (level of intervention, delivery as planned, availability of intervention materials, providers assigned to





4.
5.
6.
7.




assigned to groups)
Outcomes
Sample size
Randomization
Awareness of assignment
Analytical methods (missing data)
Results (modified):
Participant flow (approached, screened, eligible, attrition)
Recruitment
Baseline data/numbers (SES)
Outcomes and estimation (availability of trial data)
Discussion
Important information (modified to include other potential interests)
Stakeholder involvement (new item)
Dissemination Process
• Discipline-specific versions
• Explanation and Elaboration (E&E) with examples of good
writing
• Journal endorsement
• Training and education
• Public feedback: http://tinyurl.com/CONSORT-study
Project Publications
• Mayo-Wilson et al. (2013). Developing a reporting guideline
for social and psychological intervention trials. Trials, 14,
242.
• Grant et al. (2013). Reporting quality of social and
psychological intervention trials: a systematic review of
reporting guidelines and trial publications. PLoS One, 8(5),
e65442
• Montgomery et al. (2013). Protocol for CONSORT-SPI: An
Extension for Social and Psychological Interventions.
Implementation Science, 8, 99.
Project Executive
• Paul Montgomery, University of Oxford
• Evan Mayo-Wilson, Johns Hopkins University
• Sean Grant, RAND
• Geraldine Macdonald, Queen’s University Belfast
• Sally Hopewell, University of Oxford
• Susan Michie, University College London
• David Moher, Ottawa Health Research Institute
International Advisory Group
• J Lawrence Aber
• Steve Pilling
• Chris Bonell
• Lawrence Sherman
• David Clark
• James Thomas
• Frances Gardner
• Elizabeth Waters
• Steve Hollon
• David Weisburd
• Jim McCambridge
• Jo Yaffe
• Laurence Moore
• Mark Petticrew
Consensus Meeting Participants
• Doug Altman
• Spyros Konstantopoulos
• Kamaldeep Bhui
• Kenneth McLeroy
• Andrew Booth
• Brian Mittman
• Peter Craig
• Arthur Nezu
• Manuel Eisner
• Edmund Sonuga-Barke
• Mark Fraser
• Gary VandenBos
• Larry Hedges
• Robert West
• Robert Kaplan
• Peter Kaufmann