Unaccounted clustering assumptions still compromise inferences in cluster randomized trials in orthodontic research.

Abstract

Objective: This meta-epidemiological study aimed to determine whether optimal sample size calculation was applied in orthodontic cluster randomized trials (CRTs).

Methods: Orthodontic randomized clinical trials with a cluster design, published between January 1, 2017 to December 31, 2023, in leading orthodontic journals were sourced. Study selection was undertaken by two independent authors. The study characteristics and variables required for sample size calculation were also extracted by the authors. The design effect for each trial was calculated using an intra-cluster correlation coefficient of 0.1 and the number of teeth in each cluster to recalculate the sample size. Descriptive statistics for the study characteristics, summary values for the design effect, and sample sizes were provided.

Results: One-hundred and five CRTs were deemed eligible for inclusion. Of these, 100 reported sample size calculation. Nine CRTs (9.0%) did not report any effect measures for the sample size calculation, and a few did not report any power assumptions or significance levels or thresholds. Regarding the specific variables for the cluster design, only one CRT reported a design effect and adjusted the sample size accordingly. Recalculations indicated that the sample size of orthodontic CRTs should be increased by a median of 50% to maintain the same statistical power and significance level.

Conclusions: Sample size calculations in orthodontic cluster trials were suboptimal. Greater awareness of the cluster design and variables is required to calculate the sample size adequately, to reduce the practice of underpowered studies.