A process for assessing the feasibility of a network meta-analysis: a case study of everolimus in combination with hormonal therapy versus chemotherapy for advanced breast cancer

A process for assessing the feasibility of a network meta-analysis: a case study of everolimus in combination with hormonal therapy versus chemotherapy for advanced breast cancer
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DOI:
10.1186/1741-7015-12-93
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发表时间:
2014-06-05
期刊:
影响因子:
9.3
通讯作者:
Schmid, Peter
Schmid, Peter
中科院分区:
医学1区
文献类型:
--
作者:
Cope, Shannon;Zhang, Jie;Schmid, Peter

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背景资料:本研究的目的是概述一个一般的过程进行有效的网络荟萃分析(NMA)的随机对照试验(RCT)的可行性评估,以综合直接和间接的证据,为特定疾病population.Methods的替代治疗:几个步骤,以评估NMA的可行性提出了基于现有的建议。接下来,一个案例研究被用来说明NMA的可行性评估过程,以比较依维莫司联合激素治疗与替代化疗在晚期乳腺癌女性无进展生存期方面的效果。结果:概述了评估NMA可行性的一般过程,其中包括明确的步骤,以可视化治疗和结局特征方面的异质性(A部分)以及研究和患者特征(B部分)。此外,还进行了一些步骤,以说明不同类型的直接比较在基线风险(C部分)和观察到的治疗效应(D部分)方面的差异,因为存在一种风险,即由于非预期、未报告或未测量的差异,确定的治疗效应修饰因子可能无法解释观察到的异质性或结果不一致性。根据可用的数据,建议采用替代方法:列出假设,进行荟萃回归分析,亚组分析,敏感性分析,或总结NMA不可行的原因。为评估国家市场评估的可行性而概述的程序提供了一个逐步的框架,有助于确保系统地探讨基本假设,对于特定的研究问题,汇集和间接比较RCT的治疗效果(和益处)是透明的。
Background: The aim of this study is to outline a general process for assessing the feasibility of performing a valid network meta-analysis (NMA) of randomized controlled trials (RCTs) to synthesize direct and indirect evidence for alternative treatments for a specific disease population.Methods: Several steps to assess the feasibility of an NMA are proposed based on existing recommendations. Next, a case study is used to illustrate this NMA feasibility assessment process in order to compare everolimus in combination with hormonal therapy to alternative chemotherapies in terms of progression-free survival for women with advanced breast cancer.Results: A general process for assessing the feasibility of an NMA is outlined that incorporates explicit steps to visualize the heterogeneity in terms of treatment and outcome characteristics (Part A) as well as the study and patient characteristics (Part B). Additionally, steps are performed to illustrate differences within and across different types of direct comparisons in terms of baseline risk (Part C) and observed treatment effects (Part D) since there is a risk that the treatment effect modifiers identified may not explain the observed heterogeneity or inconsistency in the results due to unexpected, unreported or unmeasured differences. Depending on the data available, alternative approaches are suggested: list assumptions, perform a meta-regression analysis, subgroup analysis, sensitivity analyses, or summarize why an NMA is not feasible.Conclusions: The process outlined to assess the feasibility of an NMA provides a stepwise framework that will help to ensure that the underlying assumptions are systematically explored and that the risks (and benefits) of pooling and indirectly comparing treatment effects from RCTs for a particular research question are transparent.