本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.6281

摘要内容如下：

重要性

许多癌症临床研究人员认为临床试验为患者提供了比常规临床护理更好的护理。然而，参与试验的临床获益（以下简称参与效应）的确切证据尚未出现。

目的

对证据进行系统回顾和荟萃分析，以检验与常规治疗相比，患者参与癌症试验是否与更大的生存获益相关。

数据源

通过PubMed和EMBASE（2000年1月1日至2022年8月31日）以及反向和正向引文检索发现研究。

研究选择

纳入的研究比较了试验参与者和常规护理患者的总生存率。

数据提取与合成

数据提取和方法学质量评估由2名独立的编码员使用Covidence软件完成。使用随机效应模型汇总数据，并根据试验参与者和常规护理患者之间的比较质量（即研究控制偏倚和混杂因素的程度）进行分析。

主要成果和措施

试验参与者与常规护理患者总生存率的风险比（HR）。

结果

纳入了39篇出版物，包括85个试验参与者和常规护理患者的比较。荟萃分析显示，当所有研究合并时，无论设计或质量如何，试验参与者的总体生存获益均具有统计学意义（HR，0.76[95%CI，0.69-0.82]）。然而，在符合入选标准的试验参与者和常规护理患者相匹配的研究亚组中，生存获益减少（HR，0.85[95%CI，0.75-0.97]），并且当仅合并高质量研究时，生存获益消失（HR，0.91[95%CI，0.80-1.05]）。当对潜在的发表偏倚（HR，0.94[95%CI，0.86-1.03]）进行估计调整时，它们也消失了。

结论和相关性

许多研究表明，癌症试验参与者的生存获益。然而，在使用解决重要偏倚和混杂来源的设计的研究中没有发现这些益处。高质量研究的汇总结果与参与试验本身的有益效果并不一致。

英文原文如下：

Abstracts

Importance  Many cancer clinical investigators view clinical trials as offering better care for patients than routine clinical care. However, definitive evidence of clinical benefit from trial participation (hereafter referred to as the participation effect) has yet to emerge.

Objective  To conduct a systematic review and meta-analysis of the evidence examining whether patient participation in cancer trials was associated with greater survival benefit compared with routine care.

Data Sources  Studies were found through PubMed and Embase (January 1, 2000, until August 31, 2022), as well as backward and forward citation searching.

Study Selection  Studies were included that compared overall survival of trial participants and routine care patients.

Data Extraction and Synthesis  Data extraction and methodological quality assessment were completed by 2 independent coders using Covidence software. Data were pooled using a random-effects model and analyzed based on the quality of the comparison between trial participants and routine care patients (ie, extent to which studies controlled for bias and confounders).

Main Outcomes and Measures  The hazard ratio (HR) for overall survival of trial participants vs routine care patients.

Results  Thirty-nine publications were included, comprising 85 comparisons of trial participants and routine care patients. The meta-analysis revealed a statistically significant overall survival benefit for trial participants (HR, 0.76 [95% CI, 0.69-0.82]) when all studies were pooled, regardless of design or quality. However, survival benefits diminished in study subsets that matched trial participants and routine care patients for eligibility criteria (HR, 0.85 [95% CI, 0.75-0.97]) and disappeared when only high-quality studies were pooled (HR, 0.91 [95% CI, 0.80-1.05]). They also disappeared when estimates were adjusted for potential publication bias (HR, 0.94 [95% CI, 0.86-1.03]).

Conclusions and Relevance  Many studies suggest a survival benefit for cancer trial participants. However, these benefits were not detected in studies using designs addressing important sources of bias and confounding. Pooled results of high-quality studies are not consistent with a beneficial effect of trial participation on its own.

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