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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