Biostatistics Department, Ramón y Cajal Hospital and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, CIBERESP, Madrid, Spain.
Respiratory Department, Hospital Ramón y Cajal, Medicine Department, Universidad de Alcala (IRYCIS), Madrid, Spain.
Chest. 2019 Apr;155(4):689-698. doi: 10.1016/j.chest.2018.10.016. Epub 2018 Oct 25.
It is unknown whether propensity score-adjusted observational studies produce results comparable to those of randomized controlled trials (RCTs) that address similar VTE treatment issues.
The PubMed and Web of Science databases were systematically searched for propensity score-adjusted observational studies, RCTs, and meta-analyses of RCTs that estimated all-cause mortality following VTE treatment. After identifying distinct clinical treatment issues evaluated in the eligible observational studies, a standardized algorithm was used to identify and match at least one RCT or RCT meta-analysis publication for paired study design analyses. Meta-analyses were used to summarize groups of studies. Treatment efficacy statistics (relative ORs) were compared between the paired observational and RCT studies, and the summary relative ORs for all study design pairs were also calculated.
The observational and RCT study pairs assessed seven clinical treatment issues. Overall, the observational study-RCT pairs did not exhibit significantly different mortality estimates (summary relative OR, 0.89; 95% CI, 0.32-1.46; I = 23%). However, two of the seven treatment issue study pairs (thrombolysis vs anticoagulation for pulmonary embolism; once- vs twice-daily enoxaparin for VTE) exhibited a significantly different treatment effect direction, and there was a substantial (nonsignificant) difference in the magnitude of the effect in another two of the study pairs (rivaroxaban vs vitamin K antagonists for VTE; home treatment vs hospitalization for DVT).
This systematic comparison across seven VTE treatment topics suggests that propensity score-adjusted observational studies and RCTs often exhibit similar all-cause mortality, although differences in the direction or the magnitude of estimated treatment effects may occasionally occur.
PROSPERO; CRD42018087819; URL: http://www.crd.york.ac.uk/PROSPERO.
目前尚不清楚经过倾向评分调整的观察性研究能否产生与解决类似静脉血栓栓塞症(VTE)治疗问题的随机对照试验(RCT)相似的结果。
系统检索了 PubMed 和 Web of Science 数据库,以获取经过倾向评分调整的观察性研究、RCT 以及评估 VTE 治疗后全因死亡率的 RCT 荟萃分析。在确定了合格的观察性研究中评估的不同临床治疗问题后,使用标准化算法确定并匹配至少一个 RCT 或 RCT 荟萃分析出版物,以进行配对研究设计分析。荟萃分析用于总结研究组。比较配对观察性研究和 RCT 研究之间的治疗效果统计数据(相对 OR),并计算所有研究设计配对的汇总相对 OR。
观察性和 RCT 研究配对评估了七个临床治疗问题。总体而言,观察性研究-RCT 配对并未表现出明显不同的死亡率估计值(汇总相对 OR,0.89;95%CI,0.32-1.46;I=23%)。然而,在七个治疗问题研究配对中有两个(肺栓塞溶栓治疗与抗凝治疗;VTE 患者每日一次与每日两次使用依诺肝素)的治疗效果方向明显不同,另外两个研究配对(VTE 患者使用利伐沙班与维生素 K 拮抗剂;DVT 患者家庭治疗与住院治疗)的效果大小也存在显著差异(无统计学意义)。
对七个 VTE 治疗主题的系统比较表明,经过倾向评分调整的观察性研究和 RCT 通常表现出相似的全因死亡率,尽管估计治疗效果的方向或幅度可能偶尔存在差异。
PROSPERO;CRD42018087819;网址:http://www.crd.york.ac.uk/PROSPERO。