ArticleStatistical methods in medical research2025
Group sequential analysis of marked point processes: Plasma donation trials.
Article in Statistical methods in medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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2 authors.
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Abstract
Plasma donation plays a critical role in modern medicine by providing lifesaving treatments for patients with a wide range of conditions like bleeding disorders, immune deficiencies, and infections. Evaluation of devices used to collect blood plasma from donors is essential to ensure donor safety. We consider the design of plasma donation trials when the goal is to assess the safety of a new device on the response to transfusions compared to the standard device. A unique feature is that the number of donations per donor varies substantially so some individuals contribute more information and others less. The sample size formula is derived to ensure power requirements are met when analyses are based on generalized estimating equations and robust variance estimation. Strategies for interim monitoring based on group sequential designs using alpha spending functions are developed based on a robust covariance matrix for estimates of treatment effect over successive analyses. The design of a plasma donation study is illustrated where the focus is on assessing the safety of a new device with serious hypotensive adverse events as the primary outcome.
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