EUR-ASSESS project subgroup report on methodology - Methodological guidance for the conduct of health technology assessment

`Health technology assessment (HTA) is primarily concerned with the consequences (benefits and costs) of health care and health policy decisions. Because decision making is complex and outcomes are often uncertain, it is helpful to attempt to assess the consequences. The quality of decisions can be improved by a process that provides a consistent framework for identifying and assessing health technologies. Health technology assessment activities have grown in many sites and have developed to meet many different needs. HTA must be tailored to the needs of a particular situation to be useful. Factors such as the particularities of decisions and the decisionmaking process, political factors and influences, and cultural variability mean that there can never be one process or method of HTA applicable to all circumstances. On the other hand, the lack of a common framework has meant that those carrying out HTAs use different methods and that this difference makes it more difficult to understand and interpret HTAs and hinders use of results from other places. Effective communication and coordination of HTA efforts requires a degree of commonality in frameworks and methods. Therefore, the goal of the report of the EUR-ASSESS Subgroup on Methodology is to outline a set of key elements of a health technology assessment, to provide guidance for ensuring that these are carried out to a high standard, and to improve the standards of reporting what was done and how. This will allow for greater use of the results of HTAs conducted by different agencies and programs. It may also provide a basis for international collaboration in the conduct of HTAs. Having a standard set of principles and methods of HTA will also help identify those areas where results cannot be generalized across countries because they should be complemented by considerations such as costs, social values and local context. This is particularly true when assessing the broader impact and policy relevance of a health technology. Specifically, the report seeks to contribute to three aims: 1. To promote common elements in an assessment; 2. To promote common methods; and 3. To promote a common reporting structure. The focus of this report is on synthesis or secondary analysis. Synthesis is perhaps the core activity of health technology assessment and deserves more attention in consideration of methods. There is no shortage of guidance on methods to collect primary data, such as randomized controlled trials (RCTs). The report reflects the judgment of the subgroup members that improving synthesis activities in HTA agencies and programs is a very high priority. Most of the report summarizes the good ideas that others have developed and, in the main, does not set out to innovate. The members of the subgroup included both experts in methods and those actually carrying out assessments. In several meetings, the subgroup discussed areas needing a degree of improvement or standardization of methods. Based on this discussion, the subgroup developed an outline for a report. Members of the subgroup took responsibility for drafting defined areas of the report. The co-chairs of the subgroup collated these contributions and edited them to produce the final draft report.