The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
J Clin Epidemiol. 2010 Mar;63(3):246-56. doi: 10.1016/j.jclinepi.2009.08.023. Epub 2009 Dec 11.
Conclusions based on meta-analyses of randomized trials carry a status of "truth." Methodological components may identify trials with systematic errors ("bias"). Trial sequential analysis (TSA) evaluates random errors in meta-analysis. We analyzed meta-analyses on laparoscopic vs. small-incision cholecystectomy regarding different outcome measures for the occurrence of type I errors.
Using TSA, we calculated the required information size (IS) and the trial sequential monitoring boundaries regarding complications in our Cochrane review with meta-analyses of cholecystectomy. For each outcome, we calculated a low risk of bias heterogeneity-adjusted IS. As a sensitivity analysis, we calculated an a priori heterogeneity-adjusted IS.
According to the trial sequential analyses based on a low risk of bias heterogeneity-adjusted IS definitive evidence may be reached by conducting one more randomized trial. Information may be required on 582 and 119 additional randomized patients to evaluate the effect on severe complications and serious adverse events (SAEs), respectively.
Our results provide incentives to conduct a new trial with a low risk of bias focusing on a new composite outcome measure of SAEs to obtain conclusive evidence on which operative method to recommend.
基于随机试验荟萃分析的结论具有“真实性”。方法学组成部分可识别出存在系统性错误（“偏倚”）的试验。试验序贯分析（TSA）评估荟萃分析中的随机误差。我们分析了腹腔镜与小切口胆囊切除术的荟萃分析，以评估不同的结局测量方法发生 I 型错误的情况。
使用 TSA，我们根据胆囊切除术荟萃分析的 Cochrane 综述，计算了并发症的所需信息大小（IS）和试验序贯监测边界。对于每个结局，我们计算了低偏倚异质性调整的 IS。作为敏感性分析，我们计算了预先确定的异质性调整的 IS。
根据基于低偏倚异质性调整的 IS 的试验序贯分析，通过进行一项额外的随机试验可能会获得确定性证据。需要对 582 名和 119 名额外的随机患者进行信息评估，以分别评估严重并发症和严重不良事件（SAE）的效果。
我们的结果提供了动力，建议进行一项新的低偏倚风险的试验，重点关注新的 SAE 复合结局测量，以获得推荐哪种手术方法的结论性证据。
