Division of Infectious Diseases, Department of Medicine, University of California, San Francisco, California, USA.
Transpl Infect Dis. 2022 Oct;24(5):e13888. doi: 10.1111/tid.13888.
Current clinical trials of new antibiotics facilitate bringing new drugs to market but often fail to provide useful information for clinical decision making.
Literature review of desirability of outcome ranking (DOOR) in antibiotic clinical trials and description how DOOR can fit into design, administration, and assessment of clinical trials.
DOOR is an approach that addresses many of the shortcomings of current trials by incorporating efficacy and safety into a single outcome to analyze the patient experience in its entirety. Application of partial credit, tiebreaker strategies including response adjusted for duration of antibiotic risk (RADAR), and DOOR for Management of Antimicrobial Therapy (DOOR MAT) provides additional nuance and granularity. To address pitfalls of DOOR, investigators must develop the DOOR a priori, ideally with input from and incorporation of patient voices, and should perform component analysis to ensure that imbalances in key components are detected.
Inclusion of DOOR in clinical trials will enrich our understanding of how new antibiotics might benefit patients who have had transplantation. Additional work to develop best practices for DOOR selection, analysis, and interpretation must continue, and incorporation of the patient perspective is essential.
当前新抗生素的临床试验有助于将新药推向市场，但往往无法为临床决策提供有用的信息。
对抗生素临床试验中结局排序的适宜性（DOOR）的文献回顾，并描述 DOOR 如何适用于临床试验的设计、管理和评估。
DOOR 是一种方法，通过将疗效和安全性纳入单一结局进行分析，从而解决了当前试验的许多缺点，全面分析了患者的体验。应用部分信用、决胜策略，包括反应调整抗生素风险持续时间（RADAR）和 DOOR 治疗抗菌药物管理（DOOR MAT），提供了更多的细微差别和粒度。为了解决 DOOR 的缺陷，研究人员必须预先制定 DOOR，理想情况下，需要来自患者的意见和投入，并应进行成分分析，以确保检测到关键成分的不平衡。
将 DOOR 纳入临床试验将丰富我们对新抗生素如何使接受过移植的患者受益的理解。必须继续开展有关 DOOR 选择、分析和解释的最佳实践的工作，并且必须纳入患者的观点。
