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Dollars and sense in sepsis.

Over the past 2 yrs, the debate about health care has raged across the United States. Initially focusing on the issues of access and cost, nearly all participants in healthcare reform now acknowledge that cost represents the main concern. Costs continue to rise because of a multitude of factors ranging from the expense of new technologies to the aging of the population. These escalating costs drive access by either pricing individuals out of health care or forcing government purchasers to restrict access. Because critical care consumes nearly 0.5% of the national gross domestic product, intensivists must be involved in healthcare reform (1). Historically, physicians have only addressed concerns related to the risk/benefit ratio of an intervention. Now, we are all being asked to consider, either directly or indirectly, the concept of cost relative to benefit. Although the evolution of the concept of “comparative effectiveness” led to consternation about “rationing,” the notion of trying to systematically assess the value of an intervention is a crucial part of any effort to rigorously determine how to allocate scarce resources—irrespective of the means for that allocation, whether via a market or a government policy. Readers should note that cost-effectiveness is a means to an end. It does not represent an end in itself. The results of any specific assessment of a novel therapy’s cost-effectiveness are not meant to trump other ethical issues surrounding the determination of whether to adopt or fund a new intervention. Rather, costeffectiveness analyses (CEAs) are meant to inform the decision-making process (2). In turn, those practicing in the intensive care unit (ICU) must become familiar with the language of CEAs, as we will be asked to either comment on them or alter our care in response to them. CEAs can take many forms. In ICU studies, two general methods are utilized. Cost-minimization analysis represents an effort to determine which pathway or process requires the fewest resources (e.g., which option is cheaper) while maintaining similar overall outcomes (2). True CEA incorporates a more complicated set of variables. CEA aims to evaluate the total costs of an intervention relative to the benefits accrued. Costs are measured in some unit of currency (2). Benefits are often computed in some common denominator that allows one to compare alternate options. For CEA, the appropriate unit for evaluating benefit is the quality-adjusted life year (QALY); one incorporates how many lives are saved along with how long survivors live and the quality of those additional years of life (3). Measurement of QALYs is fraught with complication and nuance. As with all the medical literature, some CEAs are more methodologically rigorous than others. When reviewing a CEA, readers should use the same jaundiced eye and skepticism applied when examining a clinical study. In this issue of Critical Care Medicine, Jones and colleagues (4) present a thought-provoking CEA of an emergency-department-based early goal-directed therapy (EGDT) protocol for patients with severe sepsis. Clinical trial data suggest that EGDT results in improved mortality (5). However, the use of specific catheters to facilitate EGDT can prove costly. More survivors, furthermore, may mean more cost if patients destined to die are saved but in such a state that they consume vast resources. In a prospective sequential study consisting of 285 patients with severe sepsis or septic shock, they found that the use of EGDT was associated with a cost of $5397 per QALY gained (4). They also determined that the probability of cost-effectiveness was 98% at a willingness to pay $50,000 per QALY (4). The $50,000 per QALY threshold, which has come to represent the definition of “cost-effective,” is arbitrary, and it remains unclear if and how it should be revised. The authors conclude that EGDT is extremely cost-effective and should therefore be implemented. The results of this study demonstrate that EGDT is not only feasible but also economically viable. EGDT leads to more survivors and longer life expectancies compared to those not treated with EGDT. EGDT subjects also had longer ICU and hospital lengths of stay. The authors are to be commended for (1) utilizing data from a clinical study to serve as the foundation for their CEA and (2) building specific measures of resource use into their assessment of end points. An important additional strength of their study was the effort to account for all the costs related to the protocol. Their cost calculation includes those related to the initial education and the resources required for the successful execution of their protocol. Yet, how do we determine costs in medicine? Cost has very little correlation with the “charge” on a hospital bill. Many poorly done CEAs fail to make any effort to grapple with this concern; if the methods do not clearly articulate how charges were adjusted to costs, one should be very cautious of the study’s overall findings. Jones et al (4) state that they relied on a hospital work load accounting system that measures costs rather than charges. This methodology, however, remains somewhat opaque. Jones et al also commit an error common in CEAs. They conflate both fixed and variable costs. Fixed costs are those that remain no matter what happens to the patient. Variable costs represent those that can actually be “saved.” As one can imagine, most costs related to ICU care are fixed (6). As an example, although a bed day in an ICU may cost several thousand dollars, most of those costs are not recoverable if a patient is not filling the bed (6). Even if the bed is empty, someone has to pay for the hospital overhead, the nurse who is on duty even if there is no patient to treat, and the physician on call. Hence, CEA essentially represents a series of mathematical models. Despite the issues raised above, the core concern remains the quality of the inputs utilized *See also p. 1306.