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脊髓性肌萎缩症中匹配调整间接比较的批判性评价。

A Critical Appraisal of Matching-Adjusted Indirect Comparisons in Spinal Muscular Atrophy.

机构信息

Biogen, 225 Binney Street, Cambridge, MA, 02142, USA.

Maple Health Group, 1740 Broadway, 15th Floor, New York, NY, 10019, USA.

出版信息

Adv Ther. 2023 Jul;40(7):2985-3005. doi: 10.1007/s12325-023-02520-2. Epub 2023 Jun 5.

Abstract

In the absence of head-to-head trials, indirect treatment comparisons (ITCs) are often used to compare the efficacy of different therapies to support decision-making. Matching-adjusted indirect comparison (MAIC), a type of ITC, is increasingly used to compare treatment efficacy when individual patient data are available from one trial and only aggregate data are available from the other trial. This paper examines the conduct and reporting of MAICs to compare treatments for spinal muscular atrophy (SMA), a rare neuromuscular disease. A literature search identified three studies comparing approved treatments for SMA including nusinersen, risdiplam, and onasemnogene abeparvovec. The quality of the MAICs was assessed on the basis of the following principles consolidated from published MAIC best practices: (1) justification for the use of MAIC is clearly stated, (2) the included trials with respect to study population and design are comparable, (3) all known confounders and effect modifiers are identified a priori and accounted for in the analysis, (4) outcomes should be similar in definition and assessment, (5) baseline characteristics are reported before and after adjustment, along with weights, and (6) key details of a MAIC are reported. In the three MAIC publications in SMA to date, the quality of analysis and reporting varied greatly. Various sources of bias in the MAICs were identified, including lack of control for key confounders and effect modifiers, inconsistency in outcome definitions across trials, imbalances in important baseline characteristics after weighting, and lack of reporting key elements. These findings highlight the importance of evaluating MAICs according to best practices when assessing the conduct and reporting of MAICs.

摘要

在缺乏头对头试验的情况下,间接治疗比较(ITC)常用于比较不同疗法的疗效,以支持决策。当可以从一项试验中获得个体患者数据,而仅从另一项试验中获得汇总数据时,常使用匹配调整间接比较(MAIC)作为 ITC 的一种类型来比较治疗效果。本文检查了用于比较脊髓性肌萎缩症(SMA)治疗的 MAIC 的实施和报告,SMA 是一种罕见的神经肌肉疾病。文献检索确定了三项比较 SMA 获批治疗的研究,包括 nusinersen、risdiplam 和 onasemnogene abeparvovec。基于从已发表的 MAIC 最佳实践中综合的以下原则,评估了 MAIC 的质量:(1)明确说明使用 MAIC 的理由;(2)纳入的试验在研究人群和设计方面具有可比性;(3)预先确定并在分析中考虑所有已知混杂因素和效应修饰剂;(4)结果在定义和评估方面应相似;(5)报告调整前后的基线特征,以及权重;(6)报告 MAIC 的关键细节。迄今为止,在 SMA 的三项 MAIC 出版物中,分析和报告的质量差异很大。确定了 MAIC 中的各种偏倚来源,包括缺乏对关键混杂因素和效应修饰剂的控制、试验间结果定义不一致、加权后重要基线特征的不平衡以及缺乏报告关键要素。这些发现强调了在评估 MAIC 时,根据最佳实践评估 MAIC 的实施和报告的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ec7/10271880/ad24acf6ef5b/12325_2023_2520_Fig1_HTML.jpg

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