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Alan Girling University of Birmingham, UK

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1 Alan Girling University of Birmingham, UK A.J.Girling@bham.ac.uk
Optimality in stepped wedge cluster trials: When and Where to take measurements Introduction Alan Girling University of Birmingham, UK Funding support (AG) from the NIHR through: The NIHR Collaborations for Leadership in Applied Health Research and Care for West Midlands (CLAHRC WM). The HiSLAC study (NIHR ref 12/128/07) SCT/ICTMC Liverpool, May 2017

2 Standard Stepped Wedge Layout
Clusters  Time  1 0: Control (untreated) Cell 1: Treated Cell Aim: maximise the precision of the treatment effect estimate by changing the design in some way

3 Essential Constraints
Allow for Time Effects Otherwise get a “Before & After” Design Treatment implementation cannot be reversed If it can a Cross-Over Design is best

4 1. Optimising the layout in a ‘complete’ trial
Assume uniform sampling over time in each cluster Choose when to implement the treatment in each cluster. For example, Is better than ? And what is the best layout overall? Lawrie J, Carlin JB, Forbes AB. (2015) Optimal stepped wedge designs. Statistics & Probability Letters , 99: Girling, A. J., and Hemming, K. (2016) Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Statist. Med., 35: 2149–2166.

5 For ‘large studies’ the best design looks like:
Parallel Clusters 100R% Stepped-Wedge Clusters A ‘Hybrid’ combination of Parallel and Stepped Wedge clusters

6 2. Optimising the sampling rate in each cluster over time
In a standard SW design, some of the cells contribute almost nothing to the treatment effect estimate Better estimates can be got by re-allocating observations from less to more influential cells Optimal allocation depends on constraints E.g. Fixed total number of observations; Fixed number in each cluster…. Solution can be a sparse design

7 E.g. A Sparse Design with 6 groups of clusters
5 8 9 This is Optimal for fixed total number of observations unless this number, or the ICC, is ‘too large’. (unpubl)

8 The Way Ahead Exact Results Algorithmic Approaches
Useful designs (Optimal, or near-Optimal)

9 Speakers Jennifer Thompson (LSHTM) Jessica Kasza (Monash):
The optimal design of the stepped-wedge trial and a comparison to other trial designs Jessica Kasza (Monash): Information content of cluster-periods in stepped-wedge trials Richard Hooper (Queen Mary) Trimming the fat from stepped wedge trials: an algorithmic search for the trial design requiring the fewest participants


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