The hazards of scoring the quality of clinical trials for meta-analysis
The hazards of scoring the quality of clinical trials for meta-analysis
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DOI：
10.1001/jama.282.11.1054
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发表时间：
1999-09-15
影响因子：
120.7
通讯作者：
Egger, M
中科院分区：
文献类型：
--
作者：
Jüni, P;Witschi, A;Egger, M
背景尽管临床试验被广泛推荐进行某种类型的质量审查，目的探讨质量评价量表的类型是否影响Meta分析研究的结论。设计与设置对17项比较低分子肝素（LMWH）的临床试验进行Meta分析标准肝素预防术后血栓形成，使用25个不同的量表来识别高质量的试验。治疗效果与汇总评分之间的关联以及与3个关键领域的关联（治疗分配的隐藏，结局评估的盲法，主要结果测量高质量与低质量试验中LMWH与标准肝素治疗深静脉血栓形成的合并相对风险，由25个质量量表确定。高质量试验的范围为0.63（95%置信区间[CI]，0.44-0.90）至0.90（95% CI，0.67-1.21），低质量试验的范围为0.52（95% CI，0.24-1.09）至1.13（95% CI，0.70-1.82）。对于6个量表，高质量试验的相对风险接近于1，表明LMWH并不显著优于标准肝素上级，而低质量试验显示LMWH的保护作用更好（P
Context Although it is widely recommended that clinical trials undergo some type of quality review, the number and variety of quality assessment scales that exist make it unclear how to achieve the best assessment.Objective To determine whether the type of quality assessment scale used affects the conclusions of meta-analytic studies.Design and Setting Meta-analysis of 17 trials comparing low-molecular-weight heparin (LMWH) with standard heparin for prevention of postoperative thrombosis using 25 different scales to identify high-quality trials. The association between treatment effect and summary scores and the association with 3 key domains (concealment of treatment allocation, blinding of outcome assessment, and handling of withdrawals) were examined in regression models.Main Outcome Measure Pooled relative risks of deep vein thrombosis with LMWH vs standard heparin in high-quality vs low-quality trials as determined by 25 quality scales.Results Pooled relative risks from high-quality trials ranged from 0.63 (95% confidence interval [CI], 0.44-0.90) to 0.90 (95% CI, 0.67-1.21) vs 0.52 (95% CI, 0.24-1.09) to 1.13 (95% CI, 0.70-1.82) for low-quality trials. For 6 scales, relative risks of high-quality trials were close to unity, indicating that LMWH was not significantly superior to standard heparin, whereas low-quality trials showed better protection with LMWH (P