The steppwed wedge cluster randomised trial workshop: Session 1 introduction

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This short introduction to the SW-CRT introduces the design and considers some settings where it may be particularly useful.

Daten & Analysen

Reconciling Scientific Rigour with
the Service Imperative
30/08/2016
Society for Clinical Trials Conference
Arlington, VA
May 17th 2015
Professor Richard Lilford

Collaborations for Leadership in
Applied Health Research Care
Hospital
Primary Care
Local Authority
Intervention
Development
Evaluation
£20m £10m

Step Wedge Design
• What?
• Why?
Today’s talk: trialsCluster

What is a Step Wedge Design?
Hemming, Lilford & Girling. Stat Med. 2015; 34(2): 181-96.
Cluster exposed to intervention
Cluster unexposed to intervention (control)
Time
1
2
3
4
5
6
Cluster
Many variations on a theme

What is the Counter-factual?
Two Types of Cluster Study:
Cross-sectional
Cohort

Why Consider a SWD, rather than
Parallel Cluster Trial?
1. Ethics
2. Acceptability
3. Logistics
• Sample size
• Interaction between
intervention effect and time
Co-exist
4. Scientific Reasons

Disadvantages of SWDs?
Always
Analytically
complex
Sometimes
Violation of
sequence
Increase trial
duration
Long gap
between
intervention &
outcome
Spurious
All cluster
studies

Step Wedge Trials vs.
Step Wedge Studies
Time
Cluster
1
2
3
4
5
6
7
8
But may be “instrumental variable”
Naturalistic SWD
= Instrumental variable approach

The End

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The steppwed wedge cluster randomised trial workshop: Session 1 introduction

1. Reconciling Scientific Rigour with the Service Imperative 30/08/2016 Society for Clinical Trials Conference Arlington, VA May 17th 2015 Professor Richard Lilford

2. Collaborations for Leadership in Applied Health Research Care Hospital Primary Care Local Authority Intervention Development Evaluation £20m £10m

3.

4. Step Wedge Design • What? • Why? Today’s talk: trialsCluster

5. What is a Step Wedge Design? Hemming, Lilford & Girling. Stat Med. 2015; 34(2): 181-96. Cluster exposed to intervention Cluster unexposed to intervention (control) Time 1 2 3 4 5 6 Cluster Many variations on a theme

6. What is the Counter-factual? Two Types of Cluster Study: Cross-sectional Cohort

7. Why Consider a SWD, rather than Parallel Cluster Trial? 1. Ethics 2. Acceptability 3. Logistics • Sample size • Interaction between intervention effect and time Co-exist 4. Scientific Reasons

8. Disadvantages of SWDs? Always Analytically complex Sometimes Violation of sequence Increase trial duration Long gap between intervention & outcome Spurious All cluster studies

9. Step Wedge Trials vs. Step Wedge Studies Time Cluster 1 2 3 4 5 6 7 8 But may be “instrumental variable” Naturalistic SWD = Instrumental variable approach