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Development of a Flow Diagram Template
forStepped Wedge Cluster Randomised Trials
Catriona Keerie
Weir CJ, Gray H, Brady M
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Outline
What have we learnt?
The flow diagram template
Practical example
Back
ground
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Background
Flow diagrams are central to the reporting of clinical trials.
Gaps exist in current reporting guidelines for SW-CRTs.
Particular design features need to be incorporatedAdded level of complexity
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Challenge
To report the flow of a stepped-wedge cluster randomised trial (SW-CRT).
ClearUnambiguousTailoredCompliant with guidelines
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SW-CRTs – Reporting quality
• Increase in number of published SW-CRTs
• Variations in quality of reporting
Grayling et al. Trials (2017) 18:33 https://doi.org/10.1186/s13063-017-1783-0
Completed trials
n = 39
Included studiesn = 123
Systematic review (Grayling et al, 2017)
Flow diagram provided
n = 24 (61.5%)
Participants and clusters
n = 12
Participants n = 10
Clustersn = 2
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Current CONSORT Guidelines
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Flow Diagram for RCTs
Schulz KF, Altman DG, Moher D, for the CONSORT Group. BMJ 2010;340:c332.
Demonstrates participant flow
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Flow Diagram for Cluster RCTs
Campbell MK, Piaggio G, Elbourne DR, Altman DG; for the CONSORT Group. BMJ 2012;345:e5661.
Demonstrates cluster and
participant flow
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Common Ground
AnalysisFollow-upAllocationEnrolment
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Extending the guidelines - a practical example
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Stroke Oral healthCare pLan Evaluation (SOCLE):
Phase II Stepped-Wedge Cluster Randomised Controlled Trial
Brady M, Stott D, Weir C, Chalmers C, Pollock A, Sweeney P,
Donaldson C, Barr J, Barr M, Bowers N, Langhorne P.
Trial Registration: NCT01954212
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Study setting
DesignPilot study
Multi-centre - stroke care (n = 4)
AimsFeasibility of a full scale trial
Standard oral care vs. complex intervention
Primary outcomePatients – incidence of pneumonia
Does keeping your mouth and teeth clean avoid pneumonia?
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Outcome Measures
Patientsn = 325
Pneumonia
Plaque
Staffn = 112
Knowledge and attitudes
OHC assessments
OHC plans
Services
Specialist referrals
Access to equipment/
products
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SOCLE II Stepped Wedge Design
Usual Care Intervention Enhanced Care
Clu
ste
r
Time
13 months of outcome data per site
4 sites
Analysis totals
Usual Care Intervention Enhanced Care
Site flow – in detail
Site 1
Patients
Staff
Site 1
Usual Care
Intervention
Enhanced Care
Site 1 - Patients
Screened 440Consented 87
Usual Care 35Intervention 15Enhanced Care 40
Differences between phases
Site 1 - Staff
Consented 26
Usual CareK&A Q #1 25
InterventionK&A Q #2 23K&A Q #3 21
Enhanced CareK&A Q #4 22
Differences between phases
AnalysisFollow-upAllocationEnrolment
Allocation
Follow-up Analysis
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What have we learned?
• Ease of understanding• Small number of sites• Tailored• Adaptable
• Large number of sites• More complex designs• Standardisation