Incorporating considerations of cost-effectiveness, affordability, and resource implications in guideline development: article 6 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

INTRODUCTION: 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.

METHODS: 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.

RESULTS AND DISCUSSION: 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.