CONSORTSPI Evan MayoWilson 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 ID: 805718
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Slide1
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
Slide2Presenter 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
Slide3Why 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 testingPositive result biasFailure to publish bias and reporting of harmsMisinterpretation of findings Transparency in research
Slide4History of reporting standardsCurrent widely endorsed reporting standards
CONSORT: RCTs
TREND:
Quasi
experiments
PRISMA:
Systematic
literature reviews Effects of reporting standards
Completeness
(Hopewell et al. 2010)TransparencyReplicability EQUATOR Network
Slide5CONSORTMethods of development:
Meta-epidemiology (literature review)
Consensus processes
Delphi panel of experts
Consensus meeting
Dissemination
Journal endorsement
Use by authors/reviewers/editors25-item checklistFlow chart
(
Moher
et al. 2010)
Slide6Why 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.
Slide7Disciplines Covered by the CONSORT-SPI Extension:
Criminology
Social Work
Education
Psychology
Public Health
Slide8Procedures 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 group14 new items identified
Highlighted issues to discuss in Explanation and Elaboration document
Social and psychological mechanisms of action, multi-level problems, subjective outcomes, natural settings
Slide9NEW CONSORT-SPI Checklist:
Title and abstract
Background and objectives
(modified)
Methods
(modified
)
:
T
rial design
(unit of assignment)Participants (eligibility criteria for setting)I
ntervention
(level of intervention, delivery as planned, availability of intervention materials, providers assigned to groups)
O
utcomes
S
ample size
Randomization
A
wareness of assignment
A
nalytical methods
(missing data)
Results
(modified
)
:
P
articipant flow
(approached, screened, eligible, attrition)
R
ecruitment
B
aseline data/numbers
(SES)
O
utcomes and estimation
(availability of trial data)
Discussion
Important
i
nformation
(modified to include other potential interests)
Stakeholder involvement
(new item)
Slide10Dissemination ProcessDiscipline-specific versionsExplanation and Elaboration (E&E) with examples of good writing
Journal endorsement
Training and education
Public feedback
: http://tinyurl.com/CONSORT-study
Slide11Project 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.
Slide12Project ExecutivePaul Montgomery, University of OxfordEvan Mayo-Wilson, Johns Hopkins UniversitySean Grant, RAND
Geraldine Macdonald, Queen
’
s University Belfast
Sally Hopewell, University of OxfordSusan Michie, University College LondonDavid Moher, Ottawa Health Research Institute
Slide13International Advisory GroupJ Lawrence AberChris Bonell
David Clark
Frances Gardner
Steve
HollonJim McCambridgeLaurence MooreMark Petticrew
Steve Pilling
Lawrence Sherman
James ThomasElizabeth WatersDavid WeisburdJo Yaffe
Slide14Consensus Meeting Participants Doug AltmanKamaldeep
Bhui
Andrew Booth
Peter Craig Manuel EisnerMark FraserLarry HedgesRobert KaplanPeter KaufmannSpyros Konstantopoulos
Kenneth McLeroy
Brian Mittman Arthur NezuEdmund Sonuga-BarkeGary VandenBos Robert West