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A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs.

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Area of Science:

  • Implementation Science
  • Clinical Trials Methodology
  • Health Services Research

Background:

  • Controlled implementation trials with few sites risk imbalance between case and control groups, threatening internal validity.
  • A stepped wedge design (SWD) staggers intervention implementation across sites over time.
  • Minimizing site characteristic imbalance is crucial for robust SWD internal validity.

Purpose of the Study:

  • To introduce and evaluate a novel randomization method, sequential balance, for controlling time trends in site allocation.
  • To enhance the internal validity of stepped wedge design (SWD) implementation trials.
  • To minimize potential confounding due to site characteristics in SWDs.

Main Methods:

  • A stepped wedge design (SWD) trial involving nine US Department of Veterans Affairs medical centers was used.
  • An expert panel identified eight facility-level characteristics relevant to implementation success.
  • A weighted sum of characteristics calculated imbalance scores for 1680 possible site assignments to find sequentially balanced schemes.

Main Results:

  • From 1680 possible site assignments, 34 with minimal imbalance scores were identified.
  • A random selection from these 34 assignments was used for randomization.
  • The mean imbalance score decreased from 3.10 to 0.99 after applying sequential balancing.

Conclusions:

  • Sequential balancing of site characteristics in SWDs strengthens internal validity.
  • This method minimizes potential confounding by controlling imbalances across time waves.
  • The proposed sequential balance method is effective for SWD implementation trials.