NICE technology appraisals: working with multiple levels of uncertainty and the potential for bias.

NICE technology appraisals: working with multiple levels of uncertainty and the potential for bias.
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DOI:
10.1007/s11019-011-9376-2
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发表时间:
2013-05
期刊:
Medicine, health care, and philosophy
影响因子:
--
通讯作者:
Calnan M
Calnan M
中科院分区:
其他
文献类型:
--
作者:
Brown P;Calnan M

文献摘要

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英国国家健康与临床卓越研究所(NICE)的关键角色之一是技术评估。这主要涉及评估在国家卫生服务体系内使用的药品和其他技术的成本效益。基于对揭示评估性质的关键文件的内容分析,本文提请注意评估过程中潜藏的多层不确定性和复杂性,以及通常为解决这些问题而建立的社会机制。认知假设、有限理性和更明确的管理知识的关系形式被应用于此目的。这些发现是在文献的背景下讨论的,这些文献强调了监管的内在社会过程。开发了一个框架,该框架假定各种形式的不确定性以及对这些不确定性的反应,作为监管偏见的潜在渠道--需要进一步研究。NICE的权威本身受到监管制度内其他行为者的监管,特别是制药业,这使其面临监管俘虏的威胁。根据Lehoux的结论,技术评估需要一种更透明和更具反映性的格式。这将使NICE能够以一种更强大、更具防御性的形式进行决策,并使NICE能够在威胁到这一点的压力中保持其合法性。
One of the key roles of the English National Institute for Health and Clinical Excellence (NICE) is technology appraisal. This essentially involves evaluating the cost effectiveness of pharmaceutical products and other technologies for use within the National Health Service. Based on a content analysis of key documents which shed light on the nature of appraisals, this paper draws attention to the multiple layers of uncertainty and complexity which are latent within the appraisal process, and the often socially constructed mechanisms for tackling these. Epistemic assumptions, bounded rationality and more explicitly relational forms of managing knowledge are applied to this end. These findings are discussed in the context of the literature highlighting the inherently social process of regulation. A framework is developed which posits the various forms of uncertainty, and responses to these, as potential conduits of regulatory bias—in need of further research. That NICE’s authority is itself regulated by other actors within the regulatory regime, particularly the pharmaceutical industry, exposes it to the threat of regulatory capture. Following Lehoux, it is concluded that a more transparent and reflexive format for technological appraisals is necessary. This would enable a more robust, defensible form of decision-making and moreover enable NICE to preserve its legitimacy in the midst of pressures which threaten this.