Department of Healthcare Surveillance and Bioethics, Università Cattolica del Sacro Cuore, Rome, Italy.
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Int J Technol Assess Health Care. 2024 Nov 4;40(1):e39. doi: 10.1017/S0266462324000394.
Since its inception, Health Technology Assessment (HTA) has typically determined the value of a technology by collecting information derived from randomized clinical trials (RCTs), in line with the principles of evidence-based medicine (EBM). However, data from RCTs did not constitute the sole source of information, as other types of evidence (such as primary qualitative research) have often been utilized. Recent advances in both generating and collecting other types of evidence are broadening the landscape of evidence, adding complexity to the discussion of "robustness of evidence." What are the consequences of these recent developments for the methodology and conduct of HTA, the HTA community, and its ethical commitments? The aim of this article is to explore some ethical challenges that are emerging in the current evolving evidence landscape, particularly changes in evidence generation and collection (e.g., diversification of data sources), and shifting standards of evidence in the field of HTA (e.g., increasing acceptability of evidence that is thought of as lower quality). Our conclusion is that deciding how to best maintain trustworthiness is common to all these issues.
自成立以来,卫生技术评估(HTA)通常通过收集符合循证医学(EBM)原则的随机临床试验(RCT)得出的信息来确定技术的价值。然而,RCT 数据并不是唯一的信息来源,因为其他类型的证据(如原始定性研究)经常被使用。最近在生成和收集其他类型证据方面的进展拓宽了证据范围,使“证据稳健性”的讨论更加复杂。这些最新发展对 HTA 的方法学和实施、HTA 界及其道德承诺有何影响?本文的目的是探讨当前不断发展的证据环境中出现的一些伦理挑战,特别是证据生成和收集方面的变化(例如,数据源的多样化),以及 HTA 领域证据标准的变化(例如,越来越接受被认为质量较低的证据)。我们的结论是,决定如何最好地保持可信度是所有这些问题的共同问题。