Department of Medicine, University of Toronto and Ministry of Health and Long-Term Care, Toronto, Ontario, Canada.
Int J Technol Assess Health Care. 2011 Apr;27(2):159-68. doi: 10.1017/S0266462311000018.
For non-drug technologies, there is often residual uncertainty following systematic review, mainly due to inadequate evidence of efficacy. The unwillingness to make decisions in the presence of uncertainty may lead to passive diffusion and intuitive decision making with or without public pressure. This may affect health system sustainability. There is increasing interest in post-market evaluation through processes that include coverage with evidence development (CED) to address residual uncertainty regarding effectiveness and cost-effectiveness. Global experience of CED has been slow to develop despite their potential contribution to decision making.
Ontario's field evaluation program to better inform decision making represents a collaboration between physicians, policy decision makers and academic centers. We report results of the first ten CEDs from this program to assess whether they achieved their objective of influencing policy by addressing residual uncertainty following systematic review.
Since 2003, nineteen field evaluation studies to resolve residual uncertainty following systematic review have been completed, ten of which met the criteria of CED and are the focus of this report. There was more than one patient subgroup or intervention in three of the CEDs. This provided the basis for evaluating thirteen outcomes. In each case, the CED addressed the uncertainty and led to a decision based on the systematic review and CED result. The CEDs led to adoption of the technology in six instances, modified adoption in three instances and withdrawal in four instances.
CED makes an important contribution to translating evidence to decision making. Methodologies are needed to increase the scope and reduce timelines for CEDs, such as the use of linked comprehensive and robust data sets and collaborative studies with other jurisdictions. CED before making long-term funding decisions, especially where there is uncertainty of effectiveness, safety or cost-effectiveness, should be increasingly funded by health systems.
对于非药物技术，系统评价后往往仍存在不确定性，主要是因为疗效证据不足。面对不确定性不愿做出决策可能导致在没有或有公众压力的情况下被动扩散和直观决策。这可能会影响卫生系统的可持续性。人们越来越感兴趣通过包括证据开发覆盖（CED）在内的后市场评估过程来解决有效性和成本效益方面的剩余不确定性。尽管 CED 有可能对决策做出贡献，但它们在全球的发展仍然缓慢。
安大略省的实地评估计划旨在更好地为决策提供信息，该计划代表了医生、政策决策者和学术中心之间的合作。我们报告了该计划的前十个 CED 的结果，以评估它们是否通过解决系统评价后剩余的不确定性来实现影响政策的目标。
自 2003 年以来，已经完成了 19 项旨在解决系统评价后剩余不确定性的实地评估研究，其中 10 项符合 CED 的标准，是本报告的重点。在三个 CED 中，有一个以上的患者亚组或干预措施。这为评估十三个结果提供了基础。在每种情况下，CED 都解决了不确定性，并根据系统评价和 CED 结果做出了决策。CED 导致在六种情况下采用了该技术，在三种情况下修改了采用，在四种情况下撤回了该技术。
CED 为将证据转化为决策做出了重要贡献。需要制定方法来扩大 CED 的范围并缩短其时间线，例如使用链接的综合和强大数据集以及与其他司法管辖区的合作研究。CED 应在卫生系统中越来越多地得到资助，特别是在有效性、安全性或成本效益方面存在不确定性的情况下，应在做出长期供资决策之前进行。
