Dhalla Irfan A, Garner Sarah, Chalkidou Kalipso, Littlejohns Peter
Medicine and Health Policy, Management and Evaluation, University of Toronto, Keenan Research Centre of Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada.
Int J Technol Assess Health Care. 2009 Jul;25(3):272-80. doi: 10.1017/S026646230999002X.
The concept of using public funds to pay for healthcare interventions only when provided in the context of ongoing research is receiving increasing attention worldwide. Nevertheless, these decisions are often controversial and implementation can be problematic.
The aim of this study was to investigate the views of United Kingdom stakeholders on the current arrangements for implementing "only in research" (OIR) decisions and to investigate how improvements might be made.
After an internal review of previous OIR decisions issued by the National Institute for Health and Clinical Excellence (NICE), deliberations by NICE's Citizens Council, and an international workshop convened by NICE and the United States Agency for Healthcare Research and Quality, thirteen key stakeholders and experts from academia, industry, government, and the National Health Service (NHS) were interviewed using a semistructured interview guide. Interview transcripts were subjected to a framework-based analysis using computer-assisted qualitative data analysis software.
All interviewees endorsed the use of the OIR option. There was a high degree of consensus for several suggestions regarding how the use of the OIR option might be improved. For example, there was universal agreement that a formal process should be established to prioritize research needs arising from OIR decisions and that funds for publicly funded research projects should be channeled in a manner that would better motivate healthcare providers to participate in OIR-related research.
The findings of this study suggest several potential modifications of the OIR pathway in the United Kingdom and may also be helpful to health technology assessment agencies in other countries that already use or are considering using an OIR-like option to reduce the uncertainty inherent in health technology assessment.
仅在正在进行的研究背景下使用公共资金支付医疗干预措施的概念在全球范围内受到越来越多的关注。然而，这些决定往往存在争议，实施起来可能会有问题。
本研究旨在调查英国利益相关者对实施“仅在研究中”（OIR）决定的当前安排的看法，并探讨如何进行改进。
在对国家卫生与临床优化研究所（NICE）发布的先前OIR决定进行内部审查、NICE公民理事会进行审议以及由NICE和美国医疗保健研究与质量局召开国际研讨会之后，使用半结构化访谈指南对来自学术界、行业、政府和国民保健服务（NHS）的13名关键利益相关者和专家进行了访谈。访谈记录使用计算机辅助定性数据分析软件进行基于框架的分析。
所有受访者都认可使用OIR选项。对于如何改进OIR选项的使用，有几项建议达成了高度共识。例如，大家普遍认为应该建立一个正式程序，对OIR决定产生的研究需求进行优先排序，并且公共资助研究项目的资金应以更好地激励医疗服务提供者参与与OIR相关研究的方式进行分配。
本研究结果表明英国的OIR途径可能需要进行一些潜在的修改，对于其他已经使用或正在考虑使用类似OIR选项的国家的卫生技术评估机构也可能有帮助，以减少卫生技术评估中固有的不确定性。
