With interest we read the article by Major et al 1 on the effect of rifaximin ‘follow-on’ treatment to prevent recurrent Clostridium difficile infection (rCDI). Major et al point out the advantage of their study sample being composed of elderly patients who represent the frailties and comorbidities of the target population. The frailty of the sample is reflected by the, compared with other trials on new agents, higher mortality rate, which is considered to increase the generalisability of the results to daily clinical practice. A main statistical challenge when studying a frail patient population using a non-fatal endpoint is dealing with mortality.2 Patients who died without rCDI are no longer at risk of a recurrent infection. Thus, death is a competing risk of rCDI. In their analysis, Major et al first exclude patients who have died or have withdrawn from the study before end of follow-up by using generalised estimating equations to estimate the risk difference (RD) of rCDI. Second, they treat them equally as randomly censored by using a Kaplan-Meier estimator (K-M) to estimate the …

中文翻译：

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后续利福昔明用于预防艰难梭菌感染标准治疗后的复发：竞争风险分析提供了可能治疗效果的全貌

我们饶有兴趣地阅读了 Major 等人 1 撰写的关于利福昔明“后续”治疗预防复发性艰难梭菌感染 (rCDI) 效果的文章。Major 等人指出他们的研究样本由代表目标人群的虚弱和合并症的老年患者组成的优势。与其他新药试验相比，样本的脆弱性反映在更高的死亡率上，这被认为增加了结果对日常临床实践的普遍性。使用非致命终点研究体弱患者群体时，一个主要的统计挑战是处理死亡率。2 没有 rCDI 死亡的患者不再有复发感染的风险。因此，死亡是 rCDI 的竞争风险。在他们的分析中，Major 等人首先通过使用广义估计方程来估计 rCDI 的风险差异 (RD)，排除了在随访结束前已经死亡或退出研究的患者。其次，他们通过使用 Kaplan-Meier 估计量 (KM) 来估计......