Bowen James M, Patterson Lisa L, O'Reilly Daria, Hopkins Robert B, Blackhouse Gord, Burke Natasha, Xie Feng, Tarride Jean-Eric, Goeree Ron
Programs for Assessment of Technology in Health Research Institute, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
J Am Coll Radiol. 2009 May;6(5):324-31. doi: 10.1016/j.jacr.2009.01.023.
Randomized controlled trials may lack generalizability and cannot always provide sufficient information for policymakers to make decisions regarding the use of new technologies entering into a health care system. Information related to other aspects of health technologies, in addition to clinical endpoints, such as economic, patient-related, and organizational issues, may be needed before making policy decisions. To address generalizability issues related to a health care technology, primary data collection conducted within a health care system may be required. A process for primary data collection to inform health policy in Ontario regarding health care technologies was initiated in 2003. Following recommendations from the Ontario Health Technology Advisory Committee, conditionally funded field evaluations for promising technologies with insufficient information are initiated. The conduct of these field evaluations occurs in 3 stages. The translation of the policy problem to research questions that can be answered through the design of a practical clinical trial is the first stage, followed by implementation, data collection, quality control, and quality assurance activities. After the completion of the field evaluation data collection and analysis, the results of the study are presented to the committee to respond to its request. Technologies evaluated by this process include drug-eluting stents, the endovascular repair of abdominal aortic aneurysms, and multifaceted interventions in diabetes care. This process, developed in Ontario for the evaluation of health technologies, has been a successful collaborative effort between practitioners, academia, government, health policymakers, and industry that has permitted an evidence-based framework for the approval and funding of technologies within the health care system.
随机对照试验可能缺乏普遍性，并且无法始终为政策制定者提供足够的信息，以便他们就进入医疗保健系统的新技术的使用做出决策。在做出政策决策之前，除了临床终点之外，可能还需要与健康技术的其他方面相关的信息，例如经济、患者相关和组织问题。为了解决与医疗保健技术相关的普遍性问题，可能需要在医疗保健系统内进行原始数据收集。2003年启动了一项在安大略省收集原始数据以告知卫生政策有关医疗保健技术的过程。根据安大略省卫生技术咨询委员会的建议，对信息不足的有前景的技术进行有条件资助的现场评估。这些现场评估分三个阶段进行。将政策问题转化为可以通过实际临床试验设计来回答的研究问题是第一阶段，随后是实施、数据收集、质量控制和质量保证活动。在完成现场评估数据收集和分析后，将研究结果提交给委员会以回应其请求。通过该过程评估的技术包括药物洗脱支架、腹主动脉瘤的血管内修复以及糖尿病护理中的多方面干预措施。这个在安大略省开发的用于评估健康技术的过程，是从业者、学术界、政府、卫生政策制定者和行业之间成功的合作努力，它为医疗保健系统内技术的批准和资助提供了一个基于证据的框架。
