Abstract
We propose a Bayesian nonparametric utility-based group sequential design for a randomized clinical trial to compare a gel sealant to standard care for resolving air leaks after pulmonary resection. Clinically, resolving air leaks in the days soon after surgery is highly important, since longer resolution time produces undesirable complications that require extended hospitalization. The problem of comparing treatments is complicated by the fact that the resolution time distributions are skewed and multi-modal, so using means is misleading. We address these challenges by assuming Bayesian nonparametric probability models for the resolution time distributions and basing the comparative test on weighted means. The weights are elicited as clinical utilities of the resolution times. The proposed design uses posterior expected utilities as group sequential test criteria. The procedure's frequentist properties are studied by extensive simulations.
Highlights
1.1 The motivating clinical trialIntraoperative air leaks (IALs) occur in 48 to 75% of patients after pulmonary resection (Serra-Mitjans and Belda-Sanchıs, 2005)
Air leaks are a severe problem in patients with emphysematous lungs or who have undergone extensive visceral pleural denuding procedures, such as pleurectomy decortication. This is a surgical procedure in which the lining surrounding one lung first is removed, and any tumor masses that are growing inside the chest cavity are removed
Because the study of Allen et al (2004) varied the application of Progel based on the size of the air bubbles seen in each patient, and the precise methodology of how this was done was not explained in sufficient detail to enable replication, the results of this trial are of limited use for a general comparison of Progel to standard care
Summary
Intraoperative air leaks (IALs) occur in 48 to 75% of patients after pulmonary resection (Serra-Mitjans and Belda-Sanchıs, 2005). Air leaks are a severe problem in patients with emphysematous lungs or who have undergone extensive visceral pleural denuding procedures, such as pleurectomy decortication. Because the study of Allen et al (2004) varied the application of Progel based on the size of the air bubbles seen in each patient, and the precise methodology of how this was done was not explained in sufficient detail to enable replication, the results of this trial are of limited use for a general comparison of Progel to standard care. The study of Klijian (2012) was retrospective and not randomized Given these limitations of existing data, the desire to obtain a prospective randomized comparison of Progel to standard care motivated the clinical trial described in this paper.
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