Adding value to evidence-based clinical guidelines.

CLINICAL PRACTICE GUIDELINES (CPGS) ARE WIDELY viewed as a cornerstone of current efforts to improve the quality of clinical care. At their best, CPGs articulate clear goals of care, enumerate potentially beneficial therapeutic approaches, and may reduce undesirable variation in care while supporting rational clinical management of common conditions. Clinical recommendations are often supported by evidence from well-designed randomized trials when such information is available. The National Guideline Clearinghouse sponsored by the Agency for Healthcare Research and Quality listed about 650 CPGs in 1999 and more than 1650 active CPGs in July 2005. In the last several years, major evidence-based recommendations from CPGs have often been proposed as measures of quality of care. For example, McGlynn et al identified 439 disease-specific and preventive quality-of-care indicators, many of which reflect current care recommendations in CPGs. Others have proposed and federal law may soon mandate use of such quality measures to assess clinical performance for accountability purposes and for pay-forperformance initiatives. A wealth of evidence suggests that intensive management of diabetes, hypertension, dyslipidemias, and other chronic conditions is, on average, beneficial to broad groups of patients in terms of health outcomes. Most data are based on studies limited to a single clinical intervention, but several clinical trials that intensively managed multiple clinical domains also have shown unequivocal benefit. In one randomized trial of adults with type 2 diabetes, simultaneous intensive management of glucose levels, blood pressure, lipid levels, use of angiotensin-converting enzyme inhibitors, and use of aspirin led to a 53% reduction in major cardiovascular events over a 7.8-year period. However, in this issue of JAMA, Boyd and colleagues demonstrate that even the best evidence-based, disease-specific CPGs may lead to unintended consequences when used to help guide the care of elderly patients with multiple comorbid conditions. In reviewing national guidelines for 9 common chronic conditions, the authors note that 8 of the 9 CPGs failed to emphasize that benefits may vary significantly in relation to patient factors such as life expectancy. Five of these 9 CPGs failed to address the care of patients with multiple comorbid conditions, although comorbidity is common in elderly patients. About 83% of Medicare beneficiaries have at least 1 chronic condition, and about 68% of Medicare’s budget is devoted to the 23% of beneficiaries with 5 or more chronic conditions. Patients treated with multiple medications and multiple lifestyle interventions are at high risk of medical errors and nonadherance. Many patients described by Boyd et al would receive 10 or more distinct medications dosed at 3 to 5 times each day, along with more than a dozen nonpharmacological treatment recommendations. Such complex treatment regimens disrupt daily routines, impair social activities, and almost inevitably invite nonadherance. As shown by Boyd et al, medication costs may easily exceed $5000 per year. Even with forthcoming Part D Medicare coverage, out-ofpocket costs for many patients’ medication could be nearly $4000 per year. The cost of multiple physician visits is also high, especially if the patient does not have a primary care physician to optimize referrals and provide care for multiple conditions at each office visit. Patients’ willingness to follow complicated pharmacological regimens may further decline because of high-deductible health insurance. Patients may become increasingly intolerant of overly complex and expensive multidrug regimens and frequent clinic visits when initial costs are paid out of pocket. The implementation of multiple evidence-based clinical recommendations by physicians in office settings is limited both by patient preferences and by physician factors that are poorly understood. The evidence base on which CPGs rest is limited by the number, design, and quality of the underlying clinical trials. Clinical practice guidelines have been reported to be variably flawed in terms of conflict of interest, specialty turf battles, endorsement of new or relatively unproven pharmaceutical agents, and focus on a single condition compared with a broader clinical focus. There is much redundancy and significant variation in recommendations across multiple CPGs for single conditions, such as the 386 diabetes-related CPGs now listed as active at the National Guideline Clearinghouse. Evidence-