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评估随机对照试验的质量。当前问题与未来方向。

Assessing the quality of randomized controlled trials. Current issues and future directions.

作者信息

Moher D, Jadad A R, Tugwell P

机构信息

University of Ottawa.

出版信息

Int J Technol Assess Health Care. 1996 Spring;12(2):195-208. doi: 10.1017/s0266462300009570.

DOI:10.1017/s0266462300009570
PMID:8707495
Abstract

Assessing the quality of randomized controlled trials is a relatively new and important development. Three approaches have been developed: component, checklist, and scale assessment. Component approaches evaluate selected aspects of trials, such as masking. Checklists and scales involve lists of items thought to be integral to study quality. Scales, unlike the other methods, provide a summary numeric score of quality, which can be formally incorporated into a systematic review. Most scales to date have not been developed with sufficient rigor, however. Empirical evidence indicates that differences in scale development can lead to important differences in quality assessment. Several methods for including quality scores in systematic reviews have been proposed, but since little empirical evidence supports any given method, results must be interpreted cautiously. Future efforts may be best focused on gathering more empirical evidence to identify trial characteristics directly related to bias in the estimates of intervention effects and on improving the way in which trials are reported.

摘要

评估随机对照试验的质量是一个相对较新且重要的发展。已开发出三种方法:要素评估、清单评估和量表评估。要素评估方法评估试验的选定方面,如设盲。清单和量表涉及被认为是研究质量不可或缺的项目列表。与其他方法不同,量表提供质量的汇总数值分数,可正式纳入系统评价。然而,迄今为止大多数量表的开发都不够严谨。实证证据表明,量表开发的差异可能导致质量评估的重大差异。已经提出了几种将质量分数纳入系统评价的方法,但由于几乎没有实证证据支持任何特定方法,因此对结果的解释必须谨慎。未来的努力可能最好集中在收集更多实证证据,以确定与干预效果估计中的偏差直接相关的试验特征,以及改进试验报告的方式上。

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