Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials
Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials
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DOI：
10.1001/jama.287.22.2973
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发表时间：
2002-06-12
影响因子：
120.7
通讯作者：
Lau, J
中科院分区：
文献类型：
--
作者：
Balk, EM;Bonis, PAL;Lau, J
试验质量的特定特征可能与随机研究中观察到的治疗效果的夸大或缩小有关。因此，在荟萃分析中经常使用试验质量评估。目的探讨随机对照试验（randomized controlled trials，RCTs）中质量指标与疗效大小的相关性（心血管疾病、传染病、儿科和外科）。纳入的荟萃分析纳入了至少6项RCT，检查了二分结局，并在比值比（OR）量表中证明了研究间显著的异质性。主要结局指标（总结OR）高质量与低质量研究，由每项质量指标确定，结果共纳入26项Meta分析的276项随机对照试验，采用24项质量指标进行分析。这些质量指标的高质量研究与低质量研究的相对OR范围为0.83 - 1.26;与治疗效果无统计学显著相关性。在4个医学领域，满足特定质量指标的研究比例差异很大。在仅限于特定医学领域的分析中，安慰剂对照、多中心研究、研究国家、护理人员设盲和统计方法在7种情况下与治疗效果显著相关。这些相对OR范围为0.40 - 1.74。然而，这些协会的方向是不一致的。结论个别质量措施是不可靠的治疗效果的强度跨研究和医疗领域。虽然在有相关证据的特定明确领域使用特定质量指标可能是适当的，但与治疗效果相关的结果不能推广到所有临床领域或荟萃分析。
Context Specific features of trial quality maybe associated with exaggeration or shrinking of the observed treatment effect in randomized studies. Therefore, assessment of trial quality is often used in meta-analysis. However, the degree to which specific quality measures are associated with treatment effects has not been well established across a broad range of clinical areas.Objective To determine if quality measures are associated with treatment effect size in randomized controlled trials (RCTs).Design Quality measures from published quality assessment scales were evaluated in RCTs included in meta-analyses from 4 medical areas (cardiovascular disease, infectious disease, pediatrics, and surgery). Included meta-analyses incorporated at least 6 RCTs, examined dichotomous outcomes, and demonstrated significant between-study heterogeneity in the odds ratio (OR) scale.Main Outcome Measures Relative ORs comparing overall treatment effect (summary OR) of high- vs low-quality studies, as determined by each quality measure, with relative ORs less than 1 indicating larger treatment effect in low-quality studies.Results Twenty-four quality measures were analyzed for 276 RCTs from 26 meta-analyses. Relative ORs of high- vs low-quality studies for these quality measures ranged from 0.83 to 1.26; none was statistically significantly associated with treatment effect. The proportion of studies fulfilling specific quality measures varied widely in the 4 medical areas. In analyses limited to specific medical areas, placebo control, multicenter studies, study country, caregiver blinding, and statistical methods were significantly associated with treatment effect on 7 occasions. These relative ORs ranged from 0.40 to 1.74. However, the directions of these associations were not consistent.Conclusions Individual quality measures are not reliably associated with the strength of treatment effect across studies and medical areas. Although use of specific quality measures may be appropriate in specific well-defined areas in which there is pertinent evidence, findings of associations with treatment effect cannot be generalized to all clinical areas or meta-analyses.