Modeling for Health Care and Other Policy Decisions: Uses, Roles, and Validity

Abstract

The role of models to support recommendations on the cost-effective use of medical technologies and pharmaceuticals is controversial. At the heart of the controversy is the degree to which experimental or other empirical evidence should be required prior to model use. The controversy stems in part from a misconception that the role of models is to establish truth rather than to guide clinical and policy decisions. In other domains of public policy that involve human life and health, such as environmental protection and defense strategy, models are generally accepted as decision aids, and many models have been formally incorporated into regulatory processes and governmental decision making. We formulate an analytical framework for evaluating the role of models as aids to decision making. Implications for the implementation of Section 114 of the Food and Drug Administration Modernization Act (FDAMA) are derived from this framework.

Simulating Strategies for Improving Control of Hypertension Among Patients with Usual Source of Care in the United States: The Blood Pressure Control Model

“…Computer simulation modeling has been instrumental in developing clinical guidelines and policy in general, 14,[23][24][25][26] and for hypertension in particular. 27 Farley and colleagues 27 used mathematical modeling to project the potential mortality benefits of increasing hypertension control, while Turner and Schalkwyk 28 used computer simulation of BP variability to examine spurious identification of hypertension in clinical studies.…”

Estimating the value of novel interventions for Parkinson's disease: An early decision-making model with application to dopamine cell replacement

“…Using real life observations as the basis for modeling is also less restricting and enables hypothetical comparisons between standard therapy and a variety of alternative strategies. This is a particularly important feature in early decisionmaking modeling, where assumptions typically need to be varied and re-iterated as new data become available [9,33].…”

“…Early outcome modeling is important for a variety of reasons [7][8][9]. First, it provides initial guidance in priority settings and decision-making for the further development of interventions.…”

Using Agent-Based Modelling Approaches to Support the Development of Safety Policy for Systems of Systems

“…The informal role of models in policy making is well established [3]. Theoretical as well as empirical models are used by Government and other decision makers to set policies on a number of issues, ranging from health and the economy to the environment.…”