Regression to the Mean-Adjusted Sample-Size Determination for Cutoff-Selected Single-Arm Pre-Post Studies
阈值筛选单臂前后研究的均值回归调整样本量设计
Studies enrolling participants on the basis of an extreme baseline value are susceptible to regression to the mean (RTM), such that some observed pre-post change is expected even without treatment. Existing methods estimate and decompose RTM retrospectively. We extend this framework to prospective study design by deriving a closed-form sample-size method for continuous, cutoff-selected, single-arm pre-post studies. The method partitions anticipated total change into that…