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Ensuring Statistical Power in Step-Wedge Designs with Unequal Cluster Sizes
Phase II of the TEC4Home project is a randomized trial of the effectiveness of Home Health Monitoring in patients with COPD. Patients will be recruited from 22 hospitals across BC with hospitals randomized using a step-wedge design. If the randomization is unconstrained, large variability across hospitals in the number of patients enrolled increases the risk that the trial will be underpowered. I will discuss the heuristics underlying this problem and potential solutions.
- Complex study designs involve complex power calculations.
- The risk that the realized power (achieved in the actual study) will be lower than the (pre-study) target power should be considered when designing a randomization plan.