Poynard T
Service d'Hépato-Gastro-Entérologie, Hôpital Antoine Béclère, Clamart.
Presse Med. 1988 Feb 27;17(7):315-8.
A grid devised to evaluate the methodological quality of randomized therapeutic trials is presented. Fourteen items are analysed: description of the principal criterion of assessment, criteria of inclusion, number of subjects seen and excluded, number of subjects randomized to each group, number of subjects excluded who are alive or lost to follow-up and reasons for the fall-outs, blind character of the doctors, patients and persons responsible for the assessment criteria, calculation of the number of subjects required before starting the trial, method of randomization and its blind character, analysis and discussion of covariables, statistical tests used, taking into account of the fall-outs and power of the trials with non-significant results. This grid, used for the analysis of 527 randomized trials, showed that about one-half of them were of mediocre quality, the most frequent defects encountered being the multiplicity of assessment criteria, the lack of description of the subjects excluded, the absence of calculation of the number of subjects required before starting the trial and the small number of subjects in trials with non-significant results.
本文介绍了一种用于评估随机治疗性试验方法学质量的表格。分析了14个项目：主要评估标准的描述、纳入标准、观察和排除的受试者数量、随机分配到每组的受试者数量、排除的存活或失访受试者数量及其退出原因、医生、患者和负责评估标准人员的盲法特征、试验开始前所需受试者数量的计算、随机化方法及其盲法特征、协变量的分析和讨论、使用的统计检验、对退出情况的考虑以及无显著结果试验的效能。使用该表格对527项随机试验进行分析，结果显示约一半试验质量一般，最常见的缺陷是评估标准多样、未描述排除的受试者、试验开始前未计算所需受试者数量以及无显著结果试验中的受试者数量较少。
