"Estimating Treatment Effects with Observational Data: A New Approach to Using Hospital-level Variation in Treatment Intensity" Mark McClellan and Douglas Staiger ABSTRACT Estimating the effect of medical treatment on patient outcomes is one of the central problems in medical research. Traditionally, randomized controlled trials have been the only definitive method for establishing such treatment effects. However, in response to a variety of perceived problems with randomized controlled trials, ranging from their expense to their external validity, there has recently been an increased interest in estimating treatment effects using observational data (e.g. patient chart or claims data). The central problem with observational data, however, is that treatment is endogenous, i.e. is not randomly assigned across patients and is likely to be related to unmeasured patient characteristics which also influence outcomes. Two basic approaches have been taken to this endogeneity problem (see McClellan and Noguchi, 1998). One approach has been to collect detailed patient information (e.g. from charts) and control directly for risk factors other than treatment which may influence patient outcomes. This approach is inevitably limited because patient outcomes, such as mortality, may directly affect whether a patient receives treatment independent of patient risk factors. A second approach to the endogeneity problem has been to use instrumental variables (IV) estimation. In IV estimation one uses factors (instruments) that influence treatment decisions, but are unrelated to patient risk factors, to identify how treatment variation that is unrelated to risk factors is associated with patient outcomes. This approach is limited by the availability of suitable instruments, particularly in cases in which many treatments must be considered. In this paper we propose a method of estimating treatment effects which combines these two prior approaches. We estimate patient-level outcome equations, controlling for detailed patient risk factors, using hospital-level variation in treatment intensity as an instrument for the treatment variables. After controlling for the detailed risk factors, we argue that variation in treatment across hospitals is unlikely to be related to unobserved risk factors affecting patient outcomes (unlike the variation in treatment within hospitals). In contrast to previous IV approaches, our method provides suitable instruments for any treatment of interest, so long as there is variation across hospitals (for any reason) in treatment intensity. Recent work on weak instruments suggest that standard IV estimation methods will yield biased estimates of treatment effects in our approach (Staiger and Stock, 1996). Therefore, we develop an alternative IV estimator, closely related to the methodology developed in McClellan and Staiger (1998a,b), that does not suffer from this bias. We apply our method to estimating the effects of hospital treatment on survival following a heart attack. We use detailed medical chart review data and linked Medicare administrative records from the Cooperative Cardiovascular Project on over 180,000 elderly heart attack patients from 1994-1995. Treatments considered include whether the patient receives cardiac catheterization, angioplasty, bypass surgery, as well as the use of drugs such as aspirin, thrombolytics, or beta blockers.