Rawlins Michael D
Royal Society of Medicine.
Int J Technol Assess Health Care. 2014 Apr;30(2):233-8. doi: 10.1017/S0266462314000154. Epub 2014 Apr 28.
The evidence supporting the use of new, or established, interventions may be derived from either (or both) experimental or observational study designs. Although a rigorous examination of the evidence base for clinical and cost-effectiveness is essential, it is never sufficient, and those undertaking a health technology assessment (HTA) also have to exercise judgments.
The basis for this discussion is largely from the author's experience as chairman of the national Institute for Health and Clinical Excellence (NICE).
The judgments necessary for HTA to make are twofold. Scientific judgments relate to the interpretation of the science. Social value judgments are concerned with the ethical principles, preferences, culture, and aspirations of society.
How scientific and social value judgments might be most appropriately captured is a challenge for all HTA agencies. Although competent HTA bodies should be able to exercise scientific judgments they have no legitimacy to impose their own social values. These must ultimately be informed by the general public.
支持使用新的或已确立的干预措施的证据可能来自实验性或观察性研究设计(或两者皆有)。尽管对临床和成本效益的证据基础进行严格审查至关重要,但这永远是不够的,进行卫生技术评估(HTA)的人员还必须做出判断。
本次讨论的依据主要来自作者作为国家卫生与临床优化研究所(NICE)主席的经验。
HTA需要做出的判断有两个方面。科学判断涉及对科学的解释。社会价值判断涉及社会的伦理原则、偏好、文化和期望。
如何最恰当地把握科学和社会价值判断对所有HTA机构来说都是一项挑战。尽管有能力的HTA机构应该能够做出科学判断,但它们没有权力将自己的社会价值观强加于人。这些最终必须由公众来决定。