Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey
Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey
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DOI：
10.1136/bmj.i493
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发表时间：
2016-02-08
影响因子：
105.7
通讯作者：
Ioannidis, John P. A.
中科院分区：
文献类型：
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作者：
Hemkens, Lars G.;Contopoulos-Ioannidis, Despina G.;Ioannidis, John P. A.
目的评估常规收集健康数据的观察性研究（RCD；在试验可用之前发表）与针对同一临床问题的随机对照试验的后续证据之间估计的治疗效果对死亡率的差异。DesignMeta-epidemiological调查。数据来源pubmed检索至2014年11月。方法截至2010年，已发表的符合条件的RCD研究使用倾向评分来解决混杂偏差，并报告了干预措施对死亡率的比较效果。该分析仅包括在同一主题的任何试验发表之前进行的RCD研究。比较RCD研究和随机对照试验的治疗效果方向、置信区间和效果大小（优势比）。计算所有对RCD研究和试验的相对优势比（即试验的总优势比除以RCD研究估计值）和总相对优势比。摘要相对优势比大于1表明RCD研究给出了更有利的死亡率结果。结果纳入16项符合条件的RCD研究和36项后续发表的随机对照试验，研究相同的临床问题（17275例患者，835例死亡）。试验在相应的RCD研究后中位数三年发表。对于16个临床问题中的5个（31%），RCD研究和试验之间的治疗效果方向不同。9项（56%）RCD研究的置信区间未包括RCT效应估计。总体而言，RCD研究显示，与随后的试验相比，对死亡率的估计明显更有利31%(总相对优势比1.31（95%可信区间1.03 ~ 1.65;I-2=0%）。结论常规收集的健康数据的研究可能会在相同的临床问题上给出与随后的随机对照试验不同的答案，并且可能会大大高估治疗效果。需要谨慎，以防止错误的临床决策。
ObjectiveTo assess differences in estimated treatment effects for mortality between observational studies with routinely collected health data (RCD; that are published before trials are available) and subsequent evidence from randomized controlled trials on the same clinical question.DesignMeta-epidemiological survey.Data sourcesPubMed searched up to November 2014.MethodsEligible RCD studies were published up to 2010 that used propensity scores to address confounding bias and reported comparative effects of interventions for mortality. The analysis included only RCD studies conducted before any trial was published on the same topic. The direction of treatment effects, confidence intervals, and effect sizes (odds ratios) were compared between RCD studies and randomized controlled trials. The relative odds ratio (that is, the summary odds ratio of trial(s) divided by the RCD study estimate) and the summary relative odds ratio were calculated across all pairs of RCD studies and trials. A summary relative odds ratio greater than one indicates that RCD studies gave more favorable mortality results.ResultsThe evaluation included 16 eligible RCD studies, and 36 subsequent published randomized controlled trials investigating the same clinical questions (with 17 275 patients and 835 deaths). Trials were published a median of three years after the corresponding RCD study. For five (31%) of the 16 clinical questions, the direction of treatment effects differed between RCD studies and trials. Confidence intervals in nine (56%) RCD studies did not include the RCT effect estimate. Overall, RCD studies showed significantly more favorable mortality estimates by 31% than subsequent trials (summary relative odds ratio 1.31 (95% confidence interval 1.03 to 1.65; I-2=0%)).ConclusionsStudies of routinely collected health data could give different answers from subsequent randomized controlled trials on the same clinical questions, and may substantially overestimate treatment effects. Caution is needed to prevent misguided clinical decision making.