评估试验质量没有捷径：一个案例研究。
No short-cut in assessing trial quality: a case study.
作者信息
Hirji Karim F
机构信息
Department of Epidemiology and Biostatistics, Muhimbili University of Health and Allied Sciences, P O Box 65015, Dar es Salaam, Tanzania.
出版信息
Trials. 2009 Jan 7;10:1. doi: 10.1186/1745-6215-10-1.
BACKGROUND
Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment.
RESULTS
The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991) is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations.
CONCLUSION
A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.
背景
评估纳入试验的质量是系统评价的核心部分。有许多用于此目的的清单式工具。以1991年发表于《英国医学杂志》的伯克等人关于急性中耳炎抗生素治疗的试验为例，本文阐述了清单法在试验质量评估方面的一些局限性。
结果
九项相关系统评价中清单式评估的总体结论是，伯克等人（1991年）的试验质量良好。所有相关的荟萃分析都广泛使用其数据来形成治疗证据。另一方面，我的综合评估揭示了该试验在设计、实施、分析和报告方面存在一系列严重问题，而早期评估并未发现这些问题。
结论
基于清单或工具的方法，如果用作捷径，有时可能会将存在严重缺陷的试验评为高质量试验。清单至关重要，但需要通过深入审查进行补充，并且在可能的情况下，对试验方案、试验记录和原始数据进行审查。就这一特定试验而言，我发现的问题的范围和严重性表明，在将其纳入系统评价之前需要进行独立审计。
Zotero 插件