Managing uncertainty within NICE technological appraisals: the nature and impact of the 'social features' of decision-making

Qualitative methods using a combination of non participatory observation,informal interviews and documentary analysis.
The study set out to explore and describe the various aspects of uncertainty faced by the NICE appraisal committee, the social mechanisms applied for coping with these and the influence of these processes on the outcomes of decisions. These aims were explored through an ethnographic study that was based on primary data collected using a prospective design to follow three distinctly different pharmaceutical products through the single technology appraisal process (STA) involving three different NICE technological appraisal committees This involved documentary analysis, observation of the open and closed sessions of the committee (9 observational sessions) and interviews (N=41) with committee members = 23, analysts from the NICE project teams =3, drug manufacturers representatives = 5, patient organisations =3, members of the assessment group = 4 and clinical experts = 3. Telephone interviews (N=26) were used in tandem with face-to-face interviews (N=15).These data were collected between 2012-2014.<p>The National Institute for Health and Clinical Excellence is emblematic of the 'neutral' and 'objective' approach of modern regulatory institutions. Through systematic appraisals of the cost-effectiveness of drugs for the NHS, it aims to overcome the inconsistencies of the previously discretionary decisions of medical professionals.

Cost-effectiveness recommendations ensure a more standardised access to medication across the NHS, as well as regulating the imperfections of the market in terms of over-priced medication. These regulatory roles have important ethical implications for access and resource use, yet the neutrality and objectivity referred to is not straightforward. The volume, contestability and complexity of information which is processed within these appraisals means that a number of decision mechanisms for coping with uncertainty are inevitably invoked. Uncertainty appears to be inherent in this decision making process.

The proposed study will investigate the nature of uncertainties faced within appraisal decisions, the social mechanisms applied in dealing with these, and the impact this has on decision outcomes. This ethnographic study will involve:

non-participant observation of committee meetings

Interviews with committee members, analysts from NICE’s project team, a range of representatives from the various interest groups, and experts involved in the process and documentary outputs from committee processes.</p>

本研究采用非参与式观察、非正式访谈与文献分析相结合的质性研究方法（qualitative methods）。本研究旨在探索并描述英国国家卫生与临床优化研究所（National Institute for Health and Clinical Excellence，NICE）技术评估委员会所面临的各类不确定性、用于应对此类不确定性的社会机制，以及上述流程对决策结果的影响。
本研究依托前瞻性设计（prospective design）收集的一手数据（primary data）开展民族志研究（ethnographic study），追踪三款截然不同的药品通过单一技术评估（Single Technology Appraisal，STA）流程的全过程，评估工作由三个独立的NICE技术评估委员会负责。本次研究涵盖文献分析、委员会开放与闭门会议观察（共9场观察）以及访谈（总样本量N=41）：其中委员会成员23名、NICE项目团队分析师3名、药品制造商代表5名、患者组织代表3名、评估小组成员4名以及临床专家3名。研究结合电话访谈（telephone interviews，N=26）与面对面访谈（face-to-face interviews，N=15）两种形式，数据采集时间为2012年至2014年。
英国国家卫生与临床优化研究所（National Institute for Health and Clinical Excellence，NICE）是现代监管机构“中立”与“客观”范式的标志性代表。通过针对英国国民保健署（National Health Service，NHS）所用药品的成本效益开展系统性评估，该机构旨在解决此前医疗专业人员决策缺乏统一标准的弊端。
成本效益相关建议可确保NHS范围内药物可及性更趋标准化，同时可对定价过高的药品市场乱象加以规范。上述监管职能对医疗可及性与资源使用具有重要的伦理意涵，但所谓的中立性与客观性实则并非易事。此类评估流程中需处理的信息体量庞大、争议性强且复杂度高，因此不可避免地需要调用多种决策机制以应对不确定性。不确定性似乎已内嵌于该决策流程之中。
本拟开展的研究将探索评估决策中面临的不确定性本质、用于应对此类不确定性的社会机制，以及该机制对决策结果产生的影响。本次民族志研究将包含以下内容：
1. 对委员会会议开展非参与式观察
2. 对委员会成员、NICE项目团队分析师、各类利益群体代表、流程参与专家以及委员会流程产生的书面成果开展访谈。