Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?
Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?
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DOI：
10.1016/s0140-6736(98)01085-x
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发表时间：
1998-08-22
期刊：
影响因子：
168.9
通讯作者：
Klassen, TP
中科院分区：
文献类型：
--
作者：
Moher, D;Pham, B;Klassen, TP
背景
随机试验的荟萃分析很少评估所纳入研究的质量。然而，越来越多的证据表明试验质量会影响干预效果的评估。我们研究了不同的质量评估方法是否会对随机对照试验（RCT）中评估的干预效果产生不同的估计。
方法
我们随机选取了11项荟萃分析，涉及127项关于循环系统和消化系统疾病、心理健康以及妊娠和分娩所使用干预措施效果的随机对照试验。我们利用原始研究发表的数据重复了所有的荟萃分析。通过成分法和量表法对所有127项临床试验的报告质量进行了评估。为了探究质量对定量结果的影响，我们检验了将质量评分纳入（敏感性分析和质量权重）的不同方法对荟萃分析结果的影响。
结果
试验质量较低。盲法评估的得分显著高于非盲法评估（平均2.74[标准差1.10]对2.55[1.20]）。低质量试验（得分小于或等于2）与高质量试验（得分>2）相比，效益估计值增加了34%（比值比[ROR]为0.66[95%置信区间0.52 - 0.83]）。与采用适当方法的试验相比，分配隐藏不充分的试验效益估计值也增加（37%；ROR = 0.63[0.45 - 0.88]）。所有试验的平均治疗效益为39%（比值比[OR]为0.61[0.57 - 0.65]），低质量试验为52%（OR为0.48[0.43 - 0.54]），高质量试验为29%（OR为0.71[0.65 - 0.77]）。将所有试验评分用作质量权重将效应降低至35%（OR为0.65[0.59 - 0.71]），并导致统计异质性最小。
解释
无论在试验质量评估中使用量表法还是成分法，将质量评估纳入荟萃分析的低方法学质量研究都可能改变对干预效益的解释。
Background Few meta-analyses of randomised trials assess the quality of the studies included. Yet there is increasing evidence that trial quality can affect estimates of intervention efficacy. We investigated whether different methods of quality assessment provide different estimates of intervention efficacy evaluated in randomised controlled trials (RCTs).Methods We randomly selected 11 meta-analyses that involved 127 RCTs on the efficacy of interventions used for circulatory and digestive diseases, mental health, and pregnancy and childbirth. We replicated all the meta-analyses using published data from the primary studies. The quality of reporting of all 127 clinical trials was assessed by means of component and scale approaches. To explore the effects of quality on the quantitative results, we examined the effects of different methods of incorporating quality scores (sensitivity analysis and quality weights) on the results of the meta-analyses,Findings The quality of trials was low. Masked assessments provided significantly higher scores than unmasked assessments (mean 2.74 [SD 1.10] vs 2.55 [1.20]). Low-quality trials (score less than or equal to 2), compared with high-quality trials (score >2), were associated with an increased estimate of benefit of 34% (ratio of odds ratios [ROR] 0.66 [95% CI 0.52-0.83]). Trials that used inadequate allocation concealment, compared with those that used adequate methods, were also associated with an increased estimate of benefit (37%; ROR = 0.63 [0.45-0.88]). The average treatment benefit was 39% (odds ratio [OR] 0.61 [0.57-0.65]) for all trials, 52% (OR 0.48 [0.43-0.54]) for low-quality trials, and 29% (OR 0.71 [0.65-0.77]) for high-quality trials. Use of all the trial scores as quality weights reduced the effects to 35% (OR 0.65 [0.59-0.71]) and resulted in the least statistical heterogeneity,Interpretation Studies of low methodological quality in which the estimate of quality is incorporated into the meta-analyses can alter the interpretation of the benefit of intervention, whether a scale or component approach is used in the assessment of trial quality.