The average hazard (AH), recently introduced by Uno and Horiguchi, represents a novel summary metric of event time distributions, conceptualized as the general censoring-free average person-time incidence rate on a given time window, $[0,\tau].$ This metric is calculated as the ratio of the cumulative incidence probability at $\tau$ to the restricted mean survival time at $\tau$ and can be estimated through non-parametric methods. The AH's difference and ratio present viable alternatives to the traditional Cox's hazard ratio for quantifying the treatment effect on time-to-event outcomes in comparative clinical studies. While the methodology for evaluating the difference and ratio of AH in randomized clinical trials has been previously proposed, the application of the AH-based approach in general comparative effectiveness research (CER), where interventions are not randomly allocated, remains underdiscussed. This paper aims to introduce several approaches for applying the AH in general CER, thereby extending its utility beyond randomized trial settings to observational studies where treatment assignment is non-random.
翻译:平均风险(AH)是Uno和Horiguchi近期提出的新指标,用于概括事件时间分布特征。该指标被定义为给定时间窗$[0,\tau]$内无删失条件下的平均人时发病率,其计算方式为$\tau$时刻的累积发病概率与$\tau$时刻限制平均生存时间之比,并可通过非参数方法进行估计。在比较临床研究中,AH的差值比与比值比为量化治疗对时间-终点结局的影响提供了传统Cox风险比之外的有效替代方案。尽管随机临床试验中评估AH差值比与比值比的方法已有先例,但在干预措施非随机分配的一般比较效果研究(CER)中,基于AH方法的应用尚未得到充分探讨。本文旨在提出若干将AH应用于一般CER的途径,从而将其应用范围从随机试验场景拓展至治疗分配非随机的观察性研究领域。