Beyond Outcomes—The Appropriateness of Surgical Care

Quality improvement efforts in surgery have made significant progress in the past several decades. The surgical time-out, in which the operating team pauses and confirms patient identity and the surgical site, and briefing/debriefing checklists have resulted in safer surgery.¹ Quality evaluation programs such as the National Surgical Quality Improvement Program have led to real clinical improvements.² Progress to date has focused on enhancing care for patients who actually have operations. Many patients, however, do not receive operations that have been proven effective and would improve their health. In addition, many of the patients who do have operations cannot expect much gain from them, based on any evidence. In the balance of too many patients having surgical procedures they do not need, and too many not being offered operations they do need, lies the problem of inappropriate care.

For example, gastric bypass is a highly cost-effective treatment for morbid obesity, but many patients who would benefit never have the procedure. In contrast, coronary artery bypass graft and cesarean delivery have limited benefit and substantial risk for certain patients, but each year thousands of such patients undergo these procedures. An appropriate procedure is one in which the health benefits outweigh the health risks by a wide enough margin to make it worth performing. Failing to question the appropriateness of surgical procedures is not only unfair to patients; it results in excess costs and forgone savings that are not affordable. To realize the full benefits of surgery for the public's health, the indications for surgical procedures need to be better defined and disseminated, appropriateness evaluated, and policies that maximize appropriateness formulated.

The use of surgery in the United States varies substantially by race. Rates of resection for lung, rectal, and breast cancer are lower among black patients than among white patients, even when adjusted for cancer stage and preference.^{3 - 4} Cardiovascular disease is more prevalent among black individuals, but black patients are less likely to undergo coronary revascularization.⁵ Black patients also receive fewer renal transplants and undergo fewer peripheral revascularization procedures⁶ than white patients with equivalent disease. Although differential access to care explains some of these differences, surgeon knowledge and attitudes also may be involved.⁶

Addressing racial variation in surgery is possible. For example, differences in liver transplantation rates between black patients and white patients largely ended after adoption of the Model for End Stage Liver Disease criteria for liver allocation.⁷ Implementation of a patient tracking system at urban hospitals in New York was associated with greater parity in completion of breast cancer treatment.⁸ Other approaches, such as patient decision aids, clinician reminders, and clinician education, have been effective for nonsurgical conditions but need further study in surgery. The application of appropriateness criteria also may provide a foundation to reduce variations by race.

Patients may undergo unnecessary surgery or not receive effective surgery as a result of where they live. For instance, a patient with breast cancer who has a mastectomy in Atlanta is 5 times as likely to undergo breast reconstruction as a patient who has a mastectomy in Iowa.⁹ Could breast cancer patients' personal perspectives about reconstruction explain a 5-fold difference? Patient factors such as personal preference and empowerment to obtain desired treatments may play a role. Surgeon, hospital, and system factors, however, including prevailing professional norms about when surgery is indicated and competitive pressures to operate, also contribute to geographic practice variations.

One approach to reducing unwarranted variations is dissemination of appropriateness criteria. In the development of appropriateness criteria, expert panels rate potential indications for surgery in terms of benefits and risks and develop explicit criteria for surgery using the Delphi method. However, such guidelines exist for a minority of operations and generally have not incorporated data on the comparative effectiveness of alternate procedures for the same condition.

In many cases, whether a patient should have an operation depends largely on the patient's own preferences, because the decision about the procedure is highly personal (eg, lumpectomy vs mastectomy) or the evidence about the procedure is limited (eg, surgery for spinal stenosis). Patients making such preference-sensitive decisions often have large gaps in knowledge about the benefits and risks of surgery and frequently undergo procedures that are inconsistent with their treatment goals and preferences.¹⁰

Randomized controlled trials have shown that patients who engage in shared decision making are more knowledgeable, make decisions that are more consistent with their preferences, have more reasonable expectations, and participate more in decisions.¹⁰ Such patients are also more likely to choose a nonsurgical treatment in some cases or to choose a different type of surgery.¹⁰ Understanding the role of decision quality on treatment choice could help reduce unwarranted practice variations. Because so many procedures lack rigorous evidence to support their use, many surgical decisions are preference sensitive and would benefit from decision support.

Efforts to concentrate on the underuse and overuse in surgery face obstacles. Appropriateness research requires clinical data, making it more complicated, time-consuming, expensive, and subject to privacy regulation than studies using administrative data. Administrative data sets lack the clinical detail needed to determine the broader denominator of patients who are not treated and often do not measure race or important social characteristics. Studies of preferences can be even more challenging because they require patient-reported data or measurement of how much patients value different health states, and few validated measures of patient preferences or decision quality exist. Even when appropriateness criteria exist, implementation is seldom straightforward. In some cases, patients may choose treatments that are inconsistent with appropriateness criteria but consistent with their personal preferences. How should appropriateness evaluations handle such cases? For these and other reasons, development of appropriateness criteria and comparative effectiveness data that can be acted on will likely take many years.

Despite substantial barriers, improving the appropriateness of surgical care must be a priority. Recent legislation providing $1.1 billion for comparative effectiveness research reflects a new willingness to question which treatments are used, rather than only improving the treatments chosen. Increasing demand for patient-centered care suggests that patients want to know whether an operation is right for them, from both a clinical and personal perspective.

Addressing overuse and underuse will require investment in research and implementation. Funding agencies should prioritize studies of preferences, development of appropriateness criteria, enrollment of more patients into clinical trials and registries, and interventions to reduce unwarranted practice variations. A substantial portion of comparative effectiveness research funding should be used to understand patients' and clinicians' use of comparative effectiveness data and to develop shared decision-making interventions. To evaluate such interventions, validated measures of patient preferences and decision quality will be necessary. Systems for implementation that cut across specialties and disciplines are needed, such that use of appropriateness criteria is accurate, fair, a minimal burden, and meaningful for improving care of the surgical patient.

Delivery of appropriate surgical care will depend on more than better evidence. Payers, accreditation bodies, and regulatory agencies should base their quality evaluations on accepted appropriateness criteria in addition to processes or outcomes of surgical interventions. The medical community has an important opportunity and a responsibility to reconsider current health care financing arrangements to better align incentives with appropriateness.