these measures is most appropriate for regulatory analysis. We then describe and evaluate each approach in more detail. The subsequent sections of this chapter first briefly review the single-dimension measures common in statistical reporting systems and epidemiological studies, including case reporting of illness or injury, preventable deaths, and life years lost. This section also considers the contribution of mortality and longevity changes, relative to changes in HRQL, to overall estimates of effectiveness. Next we examine alternative HALY metrics, discuss their construction and theoretical roots, and methods for determining the relative values of specific health states. These metrics, survey instruments, and methods for eliciting preferences or values for particular health states are evaluated in terms of their practicality, reliability, and theoretical and empirical validity. In the following section we consider sources of health state values for regulatory analysis and review four commonly used generic HRQL survey instruments. The fifth section identifies data collection and research priorities as well as promising developments for improving the measurement of health effects for regulatory analysis. Last, we briefly summarize the Committee’s findings and conclusions based on the material presented in the chapter.

CRITERIA FOR SELECTING HALY METRICS FOR REGULATORY CEA

As introduced in the preceding chapters, regulatory analysts face a series of choices in determining how to structure the effectiveness measure in their analyses. First, they may choose between a single-dimension or integrated measure. Although single-dimension measures, such as lives saved, life years extended, or cases of illness or injury avoided provide important information of interest to decision makers, analyses of major regulations generally include more than one health effect of concern. Thus our focus is on developing criteria for selecting among the integrated measures that are the main focus of the report.

The first choice that analysts face in selecting an integrated measure is whether to rely on the most commonly used approach—the quality-adjusted life year (QALY)—or one of the other HALY approaches. HALY approaches, which rest on how length of life is combined with a value or preference for a given state of health, are discussed in detail later in this chapter. They vary primarily in the extent to which they are widely accepted, available, and used. Because the requirements for regulatory CEA are already in effect and analysts need tools that are ready for use, the Committee’s criteria for selecting among these HALY measures are largely practical ones. (The development and pursuit of a longer term research agenda are discussed separately at the end of this chapter.)

At this broadest conceptual level, the relevant performance characteris-



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