Laparoscopic hernia repairs. The importance of cost as an outcome measurement at the century's end.

New innovations in surgery are frequently spontaneously and uncritically accepted by a few enthusiastic surgeons. Most surgeons, however, instinctively and bitterly reject the "innovative" new procedure, sometimes even after the initial phase of outcomes data collection has demonstrated some validity to the procedure. This rejection is partly caused by past experiences with techniques and technologies that subsequently failed to justify initial enthusiasm. Also, normal behavior may be to try to discredit things that entail additional work to learn or that challenge cherished concepts learned from mentors. If asked directly, most surgeons would probably declare that their choice of a new procedure was solely based on scientifically validated clinical outcomes reports, but many more factors have a role in the general acceptance of a new procedure, including: Objective Scientific trials Reported in peer-reviewed literature Industry-sponsored trials and "white papers" Institution-conducted studies for quality assurance or administrative purposes Subjective Industry marketing efforts Practice marketing by individual surgeons Public demand Surgical politics Regardless, outcomes testing as reported in the scientific literature or at annual societal meetings remains an important element in the assessment and eventual acceptance of new procedures. Also, this ability to accurately track outcomes has become critical for individual surgeons and surgical departments as a tool to improve the overall quality of care, a process often popularized by the terms continuous quality improvement and best practices. 15 The scientific study of outcomes is a complex field with a wide variety of testing instruments of greater or lesser accuracy, including: Clinical-based outcomes tools Case reports Retrospective series reports Case-matched comparative series reports Prospective series reports Cumulative (meta-)analysis of published reports Randomized prospective comparative trials Randomized, blinded, controlled, prospective trials Outcomes measurement tools Patient preference or satisfaction surveys Quality of life Disease-specific tools Validated tools (e.g., short form [SF]-36) Cost assessment Hospital charges Cost–benefit analysis National benchmarking (i.e., relative value scales) Each of these testing tools also has a certain surgical cachet that can dramatically affect the acceptance of results obtained using an instrument irrespective of the overall scientific validity of that test. The prime example of this is the reverence that surgeons accord to randomized prospective clinical trials. Another variable in reporting is the choice of the outcome to be measured. Traditionally, when applied to surgical procedures, surgeons have wanted to know the rate of perioperative mortality, surgical morbidities up to 30 days, surgical times, length of hospital stay, and long-term success rates whether measured as successful symptom control or long-term survival. Driven primarily by changes in medical reimbursement, two newer outcomes endpoints have assumed increasing importance over the past decade: (1) quality of life (QOL) and cost analysis. These inter-related measurements reflect the recent increase in the power of patient advocacy groups and of financial managers of medical care, including the government. 17,29,35 The measurement of QOL following medical intervention is not new but only recently has been applied to surgery. 10,41 Three methods for testing the effect of surgery on a patient's lifestyle exist. 9 The first method uses recovery of function as an indirect indicator of QOL. This method presupposes that an early discharge from the hospital, a return to normal activity, or a postoperative decrease in preoperative symptoms directly affects patients' QOL in a positive fashion. This method, although appealing to surgeons because it directly ties successful surgical intervention to patients' QOL, is less desirable from a scientific standpoint because it does not directly measure patents' perception of their well-being and oversimplifies the effect of surgery on a person's life (e.g., the psychological effect of postoperative pain or the social effect of the hospital bills). The other two methods of testing QOL as an outcomes issue are validated measurement tools specifically designed to assess the psychological effect of an intervention. These tools are designed specifically for a particular disease state, as in the gastroesophageal reflux disease assessment test, or are general measures of patients' overall well-being. The most widely known example of the latter is the SF-36 test (Medical Outcomes, Inc., Colorado Springs, CO). It is considered preferable to use a more general QOL testing tool on the assumption that the effect of the surgery on the patient's overall function should be of most concern. 41 The difference between a general QOL tool and a specific tool is somewhat like the assessment of a cancer therapy based on local control versus long-term survival. Cost outcomes, or cost–benefit analysis, are an equally relevant but much more controversial measurement of surgical results. 2 Controversy is created by the fact that this is a new way of looking at surgical outcomes and by the fears that results will be used for the economic credentialing of surgeons or denial of care to patients. 7,12 Regardless, procedural costs and their relation to the quality of care are important outcomes measurements that must be mastered and understood by all surgeons. Methods of cost-outcome analysis can range from simple reporting of hospital charges; to sophisticated probability based outcomes models; to highly complex, comprehensive analysis of the costs, the reimbursements, and the social implications of time off of work. 9 The latter type of study requires enormous population-based samples (and correspondingly large amounts of resources) to achieve statistical validity. Studies that look only at hospital charges are easy to generate but offer less meaningful information because charges vary among hospitals and regions and often have little correspondence to the actual cost of the procedure or the eventual reimbursement. Cost-outcomes models that are based on theoretic options and historical data are useful for program administration and the creation of practice guidelines. Such models, however, are less appealing to surgeons because of their generality, which fails to take into account individual and local variations. Cost-outcomes analysis is not only useful in determining the relative value of a new procedure or modification but also amenable to the continuous quality improvement process, participation in which is becoming increasingly demanded of all surgeons and hospitals. 11,39