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 2  The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: No relationships to disclose

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. 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.Meta-epidemiology (literature review) 2.Consensus processes o Delphi panel of experts o Consensus meeting 3.Dissemination o Journal endorsement o 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 CONSORT-SPI 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 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 o Social and psychological mechanisms of action, multi-level problems, subjective outcomes, natural settings

NEW CONSORT-SPI Checklist: 1.Title and abstract 2.Background and objectives (modified) 3.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 groups)  Outcomes  Sample size  Randomization  Awareness of assignment  Analytical methods (missing data) 4.Results (modified):  Participant flow (approached, screened, eligible, attrition)  Recruitment  Baseline data/numbers (SES)  Outcomes and estimation (availability of trial data) 5.Discussion 6.Important information (modified to include other potential interests) 7.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: 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 Chris Bonell David Clark Frances Gardner Steve Hollon Jim McCambridge Laurence Moore Mark Petticrew Steve Pilling Lawrence Sherman James Thomas Elizabeth Waters David Weisburd Jo Yaffe

Consensus Meeting Participants Doug Altman Kamaldeep Bhui Andrew Booth Peter Craig Manuel Eisner Mark Fraser Larry Hedges Robert Kaplan Peter Kaufmann Spyros Konstantopoulos Kenneth McLeroy Brian Mittman Arthur Nezu Edmund Sonuga-Barke Gary VandenBos Robert West