关于治疗肺癌的随机对照试验的质量,演变和临床影响. 对元分析的错失机会
A Nicolucci1, R Grilli, A A Alexanian
1Clinical Epidemiology Unit, Consorzio Mario Negri Sud, S Maria Imbaro (Chieti), Italy.
JAMA
|October 20, 1989
概括
肺癌试验的方法缺陷,包括处理撤回和样本大小,阻碍了进展. 尽管取得了一些改进,但质量不一致和缺乏明确的疗效数据限制了元分析对肺癌治疗研究的价值.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 随机对照试验 (RCT) 对于推进肺癌治疗至关重要.
- 以前的审查表明,已发表的肺癌试验存在方法上的局限性.
- 评估证据质量对于指导临床实践和未来研究至关重要.
研究的目的:
- 批判性地评估肺癌治疗中已发表的随机试验的方法质量.
- 在试验设计,执行和报告中确定特定关注的领域.
- 评估随着时间的推移,试验质量的演变及其对研究结果可靠性的影响.
主要方法:
- 150个已发表的肺癌治疗随机试验的系统审查和批判性评估.
- 评估方法方面,包括处理撤回,样本大小估计,随机化程序,并报告符合条件的非随机患者.
- 分析随着时间的推移,试验质量的趋势以及非小细胞肺癌和小细胞肺癌之间的差异.
主要成果:
- 大多数审查的试验中发现了重要的方法缺陷.
- 关键的关注领域包括撤回的处理不充分 (只有7/150个试验),未指定的样本大小计算 (只有9/150),不令人满意的随机盲定 (只有22/150),以及不准确的符合条件的非随机患者报告 (只有13/150).
- 虽然随着时间的推移观察到一些设计和报告的改进,但这种演变是不一致的,特别是在非小细胞肺癌中,尽管缺乏证明的疗效,但未经治疗的对照臂被放弃了.
结论:
- 肺癌随机试验的方法质量仍然是一个重大问题,限制了其结果的可靠性.
- 不一致的试验质量和在非小细胞肺癌中放弃未经治疗的对照组,凸显了建立有效治疗方法的挑战.
- 现有试验的异质性和方法上的局限性使得定量元分析不太可能对定义最佳肺癌护理具有建设性.
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