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• W1701394088 abstract "To the Editor: In their recent study, Watson et al. report findings of a multicenter randomized clinical trial comparing incidence of delayed graft function in kidneys donated following cardiac death (DCD) after using pulsatile machine perfusion (MP) or conventional cold storage (CS) for preservation (1). Using a two-sided, single triangular test, sequential design, they stopped that trial after enrolment of 25% of the estimated, required sample size of 209 subjects for the equivalent fixed sample size study. Based on the presented data, the authors conclude that there is no difference between MP and CS preservation for DCD kidneys. We compliment the investigators on their efforts to address this important issue, but we are concerned with the design of this trial and the potential implications that this report may have. The authors justify their trial based on the fact that previous studies were severely underpowered. Group sequential methods were first developed in the 1970s for single-sided tests, and then modified in the 1990s to allow two-sided test (2). Simulation studies have shown that the advantage of the modified single test used in this study—to reach a two-sided conclusion with many fewer patients than a true two-sided test—comes at the expense of a considerable decrease in power to demonstrate inferiority (2, 3). In the present case, the power to detect a statistically significant difference in the primary endpoint between groups, at the time of study termination was at best 65%, for a two-sided McNemar test using the parameters defined by the authors (α= 0.05, sample size = 40 pairs, 20% difference between groups, 33% discordant pairs). Importantly, the power must be assumed to be even smaller for the secondary outcomes reported—such as patient survival—which suggested a trend but are barely interpretable given the limited number of events observed. Yet the authors use all these results to support the conclusion of similar outcomes between groups. In our opinion, the implications are different when stopping a clinical trial prematurely for early rejection of the null hypothesis, rather than stopping for failure to reject it. In the former case, the sequential design provides a decisive advantage of demonstrating early the benefit or harm of an intervention. The latter case, unless supported by a prudent statistical approach, is vulnerable to limitations and criticism, including, but not limited to the issue of study power for statistical inference. This situation obviously has the potential to result in repetitive studies, delays and more costs. Such a situation has de facto been created here, considering that a subgroup analysis of a different trial comparing MP versus CS showed a beneficial effect of MP with DCD (4). As stated in the accompanying editorial: ‘The primary question of whether MP reduces the incidence of DGF compared to CS in DCD donors is left completely unanswered’ (5). This is particularly of concern given that, among the available study designs to address a scientific question, the randomized control trial is the gold-standard for causal inference, but also the most labor-intensive and expensive. The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation." @default.
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• W1701394088 date "2011-05-01" @default.
• W1701394088 modified "2023-09-26" @default.
• W1701394088 title "Limited Statistical Power of the Two-Sided Single Triangular Test in Sequential Method Design" @default.
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• W1701394088 doi "https://doi.org/10.1111/j.1600-6143.2011.03501.x" @default.
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