Proc Am Thorac Soc. 2012 Dec;9(5):251-5. doi: 10.1513/pats.201208-059ST.
Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are based on the best available research evidence. This is the sixth of a series of 14 articles prepared to advise guideline developers for respiratory and other diseases on how to achieve this goal. In this article, we focused on integrating cost and resource information in guideline development and formulating recommendations focusing on four key questions.
We addressed the following specific questions. (1) When is it important to incorporate costs, and/or resource implications, and/or cost-effectiveness, and/or affordability considerations in guidelines? (2) Which costs and which resource use should be considered in guidelines? (3)What sources of evidence should be used to estimate costs, resource use, and cost-effectiveness? (4) How can cost-effectiveness, resource implications, and affordability be taken into account explicitly? Our work was based on a prior review on this topic and our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions.
Many authorities suggest that there is a need to include explicit consideration of costs, resource use, and affordability during guideline development. Where drug use is at issue, "explicit consideration" may need to involve only noting whether the price (easily determined and usually the main component of "acquisition cost") of a drug is high or low. Complex interventions such as rehabilitation services are to a greater degree setting- and system-dependent. Resources used, and the costs of those resources, will vary among systems, and formal identification by a guideline group of the resource requirements of a complex intervention is essential. A clinical guideline usually contains multiple recommendations, and in some cases there are hundreds. Defining costs and resource use for all of them-especially for multiple settings-is unlikely to be feasible. At present, disaggregated resource utilization accompanied by some cost information seems to be the most promising approach. The method for assigning values to costs, including external or indirect cost (such as time off work), can have a significant impact on the outcome of any economic evaluation. The perspective that the guideline assumes should be made explicit. Standards for evidence for clinical data are usually good-quality trials reporting a relevant endpoint that should be summarized in a systematic review. Like others, we are therefore proposing that the ideal sources of evidence for cost and resource utilization data for guideline development are systematic reviews of randomized controlled trials that report resource utilization, with direct comparisons between the interventions of interest.
专业协会与世界各地的许多其他组织一样，已经认识到需要使用严格的流程来确保医疗保健建议基于最佳现有研究证据。这是为呼吸和其他疾病的指南制定者提供建议的 14 篇系列文章中的第六篇，旨在指导他们如何实现这一目标。在本文中，我们专注于在指南制定中整合成本和资源信息，并针对四个关键问题制定建议。
我们解决了以下具体问题。（1）何时需要在指南中纳入成本、资源影响、成本效益和负担能力考虑因素？（2）指南应考虑哪些成本和资源使用？（3）应使用哪些证据来源来估算成本、资源使用和成本效益？（4）如何明确考虑成本效益、资源影响和负担能力？我们的工作基于对该主题的先前审查，我们的结论基于现有证据、对指南制定者正在做的事情的考虑以及研讨会讨论。
许多权威人士认为，在指南制定过程中需要明确考虑成本、资源使用和负担能力。在涉及药物使用的情况下，“明确考虑”可能只需要注意药物的价格（容易确定，通常是“获得成本”的主要组成部分）是高还是低。康复服务等复杂干预措施在更大程度上取决于环境和系统。资源的使用及其成本将因系统而异，指南小组对复杂干预措施的资源需求进行正式确定至关重要。临床指南通常包含多个建议，在某些情况下，可能有数百个。为所有这些建议——尤其是为多个环境——定义成本和资源使用情况不太可能可行。目前，对资源利用情况进行分类并提供一些成本信息似乎是最有前途的方法。为成本赋值的方法，包括外部或间接成本（例如，停工时间），可能会对任何经济评估的结果产生重大影响。指南所采用的视角应明确。临床数据证据的标准通常是报告相关终点的高质量试验，应在系统综述中进行总结。像其他人一样，我们因此建议，用于指南制定的成本和资源利用数据的理想证据来源是报告资源利用的随机对照试验的系统评价，同时直接比较感兴趣的干预措施。
