Research Center for Clinical Bioethics and Medical Humanities, Università Cattolica del Sacro Cuore, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2023 Dec;27(23):11202-11210. doi: 10.26355/eurrev_202312_34560.
"Evidence" is a key term in medicine and health services research, including Health Technology Assessment (HTA). Randomized clinical trials (RCTs) have undoubtedly dominated the scene of generating evidence for a long period of time, becoming the hallmark of evidence-based medicine (EBM). However, due to a number of misunderstandings, the lay audience and some researchers have sometimes placed too much trust in RCTs compared to other methods of investigation. One of the principal misunderstandings is to consider RCTs findings as isolated and self-apparent pieces of information. In other words, what has been essentially lacking was the awareness of the value-context of the evidence and, in particular, the value- and theory-ladenness (normativity) of scientific knowledge. This paper aims to emphasize the normativity that exists in the production of scientific knowledge, and in particular in the conduct of RCTs as well as in the performance of HTA. The work is based on some lessons learned from Philosophy of Science and the European project "VALIDATE" (VALues In Doing Assessments of healthcare TEchnologies"). VALIDATE was a three-year EU Erasmus+ strategic partnerships project (2018-2021), in which training in the field of HTA was further optimized by using insights from political science and ethics (in accordance with the recent definition of HTA). Our analysis may reveal useful insights for addressing some challenges that HTA is going to face in the future.
“证据”是医学和卫生服务研究中的一个关键术语，包括卫生技术评估（HTA）。随机临床试验（RCT）无疑在很长一段时间内主导了证据生成领域，成为循证医学（EBM）的标志。然而，由于一些误解，外行人有时会过分信任 RCT，而不是其他研究方法。其中一个主要的误解是将 RCT 的发现视为孤立的、自明的信息。换句话说，人们基本上没有意识到证据的价值背景，特别是科学知识的价值和理论内涵（规范性）。本文旨在强调科学知识生产中存在的规范性，特别是在 RCT 的进行以及 HTA 的实施中。这项工作基于从科学哲学和欧洲项目“VALIDATE”（评估医疗保健技术的价值观）中吸取的一些经验教训。VALIDATE 是一个为期三年的欧盟伊拉斯谟+战略伙伴关系项目（2018-2021 年），通过利用政治学和伦理学的见解（根据 HTA 的最新定义）进一步优化了 HTA 领域的培训。我们的分析可能会为解决 HTA 在未来面临的一些挑战提供有用的见解。
