THE APPROPRIATENESS “GAP”
Appropriate surgical care is an essential feature of the overall effort to improve healthcare value. Assessing surgical appropriateness balances the risks and benefits of a procedure against its costs.1 The first component considers the inherent risks of surgery (eg, postoperative complications) relative to the expected health benefit. For example, a patient with advanced rectal cancer may have a high morbidity risk from multivisceral resection, but may benefit greatly from curative treatment. The second component of appropriateness considers the costs of a procedure from the societal perspective, which is usually done through cost-effectiveness research. These analyses compare the relative costs and outcomes of care, where gains in health are quantified using generic measures of disease burden such quality-adjusted life-years (QALYs) or other measures of estimated patient utility.2
Despite their extensive use, these conventional methods of assessing appropriateness are nonspecific and lack outcome measures that clearly indicate patient benefit. Traditional efforts to define appropriateness of surgical procedures have used decision algorithms that lump patients into a “one size fits all” care plan. Although these protocols may save money, they rarely incorporate patient nuance or preference into decision-making. As a result, the outcomes that may be most important to patients, such as functional status, pain, or alleviation of symptoms, are absent from the determination of whether a procedure is or is not appropriate.
Perhaps the greatest impediment to establishing effective surgical appropriateness criteria is the lack of data elucidating patient benefit after many procedures. Over the past decade, large-scale efforts to reduce the delivery of inappropriate care, such as the American Board of Internal Medicine Foundation's Choosing Wisely Campaign, have not achieved the desired results.3 Furthermore, specialty-specific appropriateness criteria can be outdated or nonexistent for many procedures.4 In surgery, the RAND/UCLA Appropriateness Method (RAM) has been proposed as the best available tool to guide surgical decision-making.5 This method uses expert panels to synthesize evidence and determine concrete indication, overuse, and underuse criteria for specific procedures. However, in situations where patient benefit is unclear, the RAM criteria are subject to differing interpretation leading to further variability in care across clinical settings.5 Even the best current appropriateness approaches (including the RAM criteria) do not incorporate patient values or perspectives in their algorithms.5
CLARIFYING THE PATIENT BENEFIT WITHIN THE APPROPRIATENESS PARADIGM
Many surgical leaders feel the need to expand the appropriateness paradigm beyond the “right operation, right provider, right place” to include the “right patient.”1,5 Patient-reported outcomes (PROs), which are standardized, patient-elicited measures of health, quality of life, or function, can be used for this purpose. PROs capture the benefits of surgery beyond clinical measures, and often represent outcomes that are most important to patients.6 For example, for patients undergoing knee and hip arthroplasty, traditional clinical outcomes such as implant failure rates, prosthetic infection, and surgical revision would imply that patients have excellent outcomes greater than 80% of the time. However, most arthroplasties are done for degenerative osteoarthritis, and when these procedures are evaluated for long-term pain and mobility, they produce an excellent outcome only 60% of the time.6 Traditional metrics do not capture the entire story, and what is deemed a “desirable” outcome may be made more accurate by adding PROs to the discussion. PROs can thus clarify the assessment of appropriateness by better defining patient benefit.
Patient-reported outcomes also augment shared decision-making and improve patients’ understanding and management of expectations after surgery.7 While their collection has not yet spread widely in general surgery, PROs are currently being used in specialties such as oncology and orthopedic surgery to inform shared patient–physician decision-making, monitor symptoms, and plan for adverse events.8 As treatment continues to shift towards more individualized and patient-centered care, it is crucial to include a truly patient-centered component in the surgical decision making process.
FROM PROMISE TO APPLICATION: PROs TO INFORM APPROPRIATE LOW-RISK ELECTIVE SURGERY
One area where PROs may best inform appropriateness is within low-risk elective surgery, where provider and patient discretion play a large role in decision-making. This is especially true for low-risk procedures aimed at improving functional status, disability, or quality of life. Without incorporating patients’ preferences and goals into data collection, current measures of appropriateness are misleading. For example, 1 recent study demonstrated that 17.7% of patients who underwent primary laparoscopic antireflux surgery experienced recurrent reflux requiring long-term medication use or additional surgery.9 However, measurement of recurrent reflux was defined as medical record evidence of persistent postoperative antireflux medication use or secondary surgery, and did not include symptoms reported by the patient. As a result, we gain no insight into the patients’ preoperative or postoperative symptomatology or quality of life, or if the patients themselves believed their operation to be beneficial. It is possible that many of the recurrent reflux patients from this study still achieved considerable symptomatic relief, despite persistent antireflux medication use or additional surgery. Conversely, it is possible much greater than 17.7% of patients experienced little to no symptom relief postoperatively, and therefore underwent a procedure that did not alleviate their symptoms. For reflux and other clinical indications like these, current outcome measures do not clearly identify patients who benefit from surgical care; PROs would clarify this knowledge gap.
Cholecystectomy is another low-risk surgery that would benefit from routine collection of PRO data. While patients likely expect that cholecystectomy for symptomatic gallstone disease will treat their symptoms, a review of 38 large studies showed that abdominal discomfort persisted in 33% of patients postoperatively and arose de novo in 14%.10 One study from the Netherlands found that 41% of patients undergoing laparoscopic surgery experienced persistent postoperative abdominal pain, and that these patients accounted for substantial increases in healthcare costs and sick leave.11 For this subset of patients, surgical treatment was ineffective at both the patient and system level, and this impact is magnified given the enormous number of cholecystectomies performed worldwide. PRO data for discretionary procedures could be used to benchmark appropriate care and to better predict patients who are likely and unlikely to benefit based on symptom constellation, comorbid conditions, and other patient factors.
FEASIBILITY AND CONCERNS FOR PRO COLLECTION AND INTEGRATION
Collection of PRO data in surgery has recently begun on a national level within the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP), and at the state level within the Michigan Surgical Quality Collaborative (MSQC). However, widespread PRO collection has proved challenging due to numerous administrative and logistical concerns. For example, within the MSQC, considerable manpower and costs were associated with a new PRO program establishing regular 30 and 90-day patient follow-up. Furthermore, this process required iterative refining of existing PROs and the addition of new measures to the collection process. Despite these difficulties, current efforts will guide more efficient future collection at other sites, and the lessons learned can be disseminated for others to use when initiating their own PRO collection program.
Also, the routine collection of PROs may not yet be warranted outside of low-risk elective surgery. Most would argue that operative management is appropriate in urgent and emergent scenarios where there is often a clear choice as to what is right by the patient. In these cases, what the patient wants versus what the patient needs may conflict, such as a patient who refuses to undergo operative management of a localized but highly dysplastic colonic lesion. In the event of urgent or life-saving procedures, PROs are unlikely to give us important information about the appropriateness of the treatment. However, PROs may provide insight into the long-term clinical outcomes that could alter current treatment protocols, particularly with regards to planning and management of postoperative rehabilitation.
Finally, concerns exist regarding the reliability of PROs, particularly when they oppose traditional clinical outcomes. Patients may experience illness in varying ways that reflect their culture, motivations, and experiences. Additionally, generic PROs (such as quality of life or satisfaction) may not be sensitive enough to provide valid information about a patient's postoperative function.12 Condition-specific measures must be identified and validated for different diseases or phases of recovery, which requires both time and resources. While measuring PROs presents its own challenges, surgeons are just beginning to understand how patients’ perspectives affect their health behaviors, clinical decision-making, adherence to treatment plans, and postoperative outcomes. Robust PRO collection will help elucidate these important relationships.
Patient-reported outcomes have the potential to enhance the validity and utility of surgical appropriateness criteria. Targeted collection of PROs after low-risk elective surgery will help optimize patient selection for these procedures, reduce the administrative and financial burden of their collection, and inform the integration of PROs into broader clinical practice. If collected in a standardized and reliable manner, PROs will play an integral role in providing patients with higher-quality, personalized treatment, while reducing costly and inappropriate surgical care.
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