目的:已经引入了对间接治疗比较(ITC)方法和报告的控制和治理,以最大程度地减少偏见,并确保医疗决策的科学可信度和透明度。这项研究的目的是强调ITC技术,这是进行客观和分析合理的分析的关键,并确定ITC的间接适用性,作为医疗保健干预措施的比较证据来源。
方法:从2010年1月至2023年8月对OvidMEDLINE®进行了搜索,以识别与ITC相关的公开文件(即,准则和最佳实践)。辅以各国际组织网站的手工搜索,监管机构,和欧洲的报销机构,北美,和亚太地区。审查了针对具体司法管辖区的国贸中心方法和报告建议。
结果:纳入了来自全球10个权威机构的68个指南用于合成。纳入的许多准则在过去五年中进行了更新,并通常将缺乏直接比较研究作为采用ITC的主要理由。大多数司法管辖区都赞成人口调整或锚定的ITC技术,而不是幼稚的比较。关于这些ITC的报告和列报的建议因当局而异;然而,关键要素之间有一些重叠。
结论:鉴于进行头对头随机对照试验的挑战,来自ITC的比较数据为临床有效性提供了有价值的见解。因此,世界各地出现了多个ITC指南。根据最新版本的指南,采用的ITC技术的适用性和后续可接受性取决于数据源,现有证据,以及收益/不确定性的大小。
OBJECTIVE: Controls and governance over the methodology and reporting of indirect treatment comparisons (ITCs) have been introduced to minimize bias and ensure scientific credibility and transparency in healthcare decision making. The objective of this study was to highlight ITC techniques that are key to conducting objective and analytically sound analyses and to ascertain circumstantial suitability of ITCs as a source of comparative evidence for healthcare interventions.
METHODS: Ovid MEDLINE was searched from January 2010 through August 2023 to identify publicly available ITC-related documents (ie,
guidelines and best practices) in the English language. This was supplemented with hand searches of websites of various international organizations, regulatory agencies, and reimbursement agencies of Europe, North America, and Asia-Pacific. The jurisdiction-specific ITC methodology and reporting recommendations were reviewed.
RESULTS: Sixty-eight
guidelines from 10 authorities worldwide were included for synthesis. Many of the included
guidelines were updated within the last 5 years and commonly cited the absence of direct comparative studies as primary justification for using ITCs. Most jurisdictions favored population-adjusted or anchored ITC techniques opposed to naive comparisons. Recommendations on the reporting and presentation of these ITCs varied across authorities; however, there was some overlap among the key elements.
CONCLUSIONS: Given the challenges of conducting head-to-head randomized controlled trials, comparative data from ITCs offer valuable insights into clinical-effectiveness. As such, multiple ITC
guidelines have emerged worldwide. According to the most recent versions of the
guidelines, the suitability and subsequent acceptability of the ITC technique used depends on the data sources, available evidence, and magnitude of benefit/uncertainty.