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Efficient designs for three-sequence stepped wedge trials with continuous recruitment.

Richard Hooper1, Olivier Quintin1, Jessica Kasza2

  • 1Wolfson Institute of Population Health, Queen Mary University of London, London, UK.

Clinical Trials (London, England)
|May 22, 2024
PubMed
Summary
This summary is machine-generated.

Optimizing stepped wedge trial designs with continuous recruitment is crucial. Our study reveals that standard designs are often inefficient, and flexible, tailored approaches can significantly improve treatment effect estimation accuracy.

Keywords:
Stepped wedge trialcentrosymmetrycontinuous recruitmentdecaying intra-cluster correlationoptimal design

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Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Epidemiological Study Design

Background:

  • Stepped wedge trials with continuous recruitment typically use equally divided time periods.
  • This standard approach offers limited flexibility in optimizing design parameters.
  • Alternative designs can enhance the precision of treatment effect estimation.

Purpose of the Study:

  • To investigate optimal stepped wedge trial designs for continuous recruitment.
  • To minimize the variance of the treatment effect estimator.
  • To explore designs with a small number of intervention sequences.

Main Methods:

  • Analysis of three-sequence, centrosymmetric stepped wedge designs.
  • Modeling intra-cluster correlation with exponential decay.
  • Using generalized least squares estimation to derive variance expressions.
  • Numerical evaluation of variance for different design parameters.

Main Results:

  • A two-dimensional design space for three-sequence, centrosymmetric stepped wedge trials was identified.
  • Contour maps show broad regions of near-optimal designs.
  • The standard design with equally spaced periods and 1:1:1 allocation generally performs poorly.

Conclusions:

  • Simple, tailored designs can achieve near-optimal efficiency in stepped wedge trials.
  • Contour maps aid in selecting robustly efficient designs.
  • Prioritizing optimal design enhances the efficiency justification for stepped wedge trials.