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Challenges in Small Sample Size Cluster Trials for Medication Adherence: Insights From TAKE-IT-TOO.

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Designing cluster randomized controlled trials (CRTs) for medication adherence in pediatric kidney transplant recipients requires careful planning. The TAKE-IT-TOO pilot study explored methods to estimate sample size needs for future CRTs, finding repeated measures enhance efficiency.

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Area of Science:

  • Clinical Trials Methodology
  • Pediatric Nephrology
  • Health Services Research

Background:

  • Cluster randomized controlled trials (CRTs) are essential for evaluating interventions involving clinical teams.
  • CRTs often need larger sample sizes due to within-cluster correlation and between-cluster variability.
  • Accurate sample size estimation is critical for the successful design of CRTs.

Purpose of the Study:

  • To estimate the intraclass correlation (ICC) for designing a full-scale CRT to improve medication adherence in pediatric kidney transplant recipients.
  • To assess how different approaches to summarizing electronically measured adherence data impact ICC estimation and sample size requirements.
  • To evaluate the efficiency of using repeated adherence measures versus single summary measures in CRTs.

Main Methods:

  • The TAKE-IT-TOO pilot study randomized seven centers to either an adherence-promoting or healthy-living intervention.
  • Medication adherence was tracked using electronic pillboxes over a 4-week run-in and 10-week intervention period.
  • Generalized linear mixed models (GLMM) were used to calculate variance estimates and derive ICC values, comparing two adherence data summarization methods.

Main Results:

  • Using repeated adherence measures within participants improved statistical power compared to a single summary measure.
  • Estimating ICC precisely was challenging due to large standard errors around variance estimates.
  • A plausible range of ICC values and corresponding sample size requirements for future trials were identified.

Conclusions:

  • The TAKE-IT-TOO study highlights challenges in conducting CRTs in small populations, particularly in estimating ICC.
  • Repeated outcome measures are valuable for maximizing statistical efficiency in adherence research for pediatric kidney transplant recipients.
  • The findings provide guidance for designing future large-scale CRTs for medication adherence interventions in this population.