6
Cancer Care Quality Assurance

Individuals with cancer (or at risk of cancer) have relatively few direct or indirect ("surrogate") indicators of quality available to help them choose doctors, hospitals, and health plans or to evaluate the merits of alternative courses of treatment. This situation is changing as the science of measuring health care quality matures and begins to focus on consumer-oriented indicators for the treatment of chronic diseases. No national comprehensive quality monitoring system exists in the United States, but there is a patchwork of federal and private efforts to assess quality, each with different purposes, perspectives, and audiences. Much of the recent impetus for quality assessment stems from the desire of large employers, business groups, and government programs to purchase managed care products for employees on the basis of quality, as well as cost.

An important aspect of quality is accountability, which can be applied to many aspects of health care. Providers can, for example, be held accountable for professional competence, legal and ethical conduct, financial performance, accessibility of services, public health promotion, and community benefit (Emanual and Emanual, 1996). There have also been calls to hold managed care organizations and other insurers publicly accountable for the "reasonableness" of their decisions by making rationales for limit-setting decisions (e.g., decisions regarding coverage for new technologies) explicit and publicly available (Daniels and Sabin, 1997; 1998a). Many parties may wish to hold providers accountable, and "accountors" may at the same time be "accountees" (Darby, 1998). A hospital, for example, may require physicians to adhere to clinical practice guidelines, while the hospitals themselves, in turn, are subject to oversight from government regulators and professional groups. At least three types of forces exert pressure on the health care system to foster accountability (although the degree to which they influence the system is quite variable) (Darby, 1998; Donaldson, 1998):

  1. The public sector relies on the regulatory, oversight, and purchasing actions of government at the federal, state, and local levels to ensure quality. Government health agencies also conduct disease surveillance to monitor public health and develop tools to assess quality, often in partnership with the private sector. The courts are often the final arbitrators in disputes about possible medical negligence and the appropriateness of care.


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--> 6 Cancer Care Quality Assurance Individuals with cancer (or at risk of cancer) have relatively few direct or indirect ("surrogate") indicators of quality available to help them choose doctors, hospitals, and health plans or to evaluate the merits of alternative courses of treatment. This situation is changing as the science of measuring health care quality matures and begins to focus on consumer-oriented indicators for the treatment of chronic diseases. No national comprehensive quality monitoring system exists in the United States, but there is a patchwork of federal and private efforts to assess quality, each with different purposes, perspectives, and audiences. Much of the recent impetus for quality assessment stems from the desire of large employers, business groups, and government programs to purchase managed care products for employees on the basis of quality, as well as cost. An important aspect of quality is accountability, which can be applied to many aspects of health care. Providers can, for example, be held accountable for professional competence, legal and ethical conduct, financial performance, accessibility of services, public health promotion, and community benefit (Emanual and Emanual, 1996). There have also been calls to hold managed care organizations and other insurers publicly accountable for the "reasonableness" of their decisions by making rationales for limit-setting decisions (e.g., decisions regarding coverage for new technologies) explicit and publicly available (Daniels and Sabin, 1997; 1998a). Many parties may wish to hold providers accountable, and "accountors" may at the same time be "accountees" (Darby, 1998). A hospital, for example, may require physicians to adhere to clinical practice guidelines, while the hospitals themselves, in turn, are subject to oversight from government regulators and professional groups. At least three types of forces exert pressure on the health care system to foster accountability (although the degree to which they influence the system is quite variable) (Darby, 1998; Donaldson, 1998): The public sector relies on the regulatory, oversight, and purchasing actions of government at the federal, state, and local levels to ensure quality. Government health agencies also conduct disease surveillance to monitor public health and develop tools to assess quality, often in partnership with the private sector. The courts are often the final arbitrators in disputes about possible medical negligence and the appropriateness of care.

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--> The market relies on the use of quality data by health care purchasers and consumers in choosing plans and providers. The underlying assumption is that quality is a market force on a par or nearly so—with cost. The professional community relies on the actions of private-sector accreditation groups, trade associations and health plans, hospitals, and other providers to ensure quality. The profession assumes leadership for policing itself and demonstrating quality to outside parties. Although these categories are convenient for describing the forces at work, they are not entirely independent, and in fact, the number of public and private collaborative efforts is increasing. For instance, the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry (1998) recommended that two complementary bodies be formed on health care quality one lodged in the public sector to promote interagency coordination among federal agencies (Quality Interagency Coordination Health Care Task Force), and the other in the private sector to improve health care quality measurement and reporting (National Forum for Health Care Quality Measurement and Reporting). The goals of the Quality Forum are to (http://www.uhfnyc.org/intro/qfpc.htm): ensure system-wide capacity to evaluate and report on the quality of care, promote and inform consumer choice and further consumer understanding and use of quality measures, enable providers to use data to improve performance, allow meaningful quality comparisons of health care providers and plans, promote competition on the quality of health care services, use broad representation to marshal market forces for quality, and reduce the burdens on providers and health plans by enabling them to collect consistent data that avoids duplication. This chapter first considers the individual consumer's point of view in describing the strengths and weaknesses of the tools and information available to help understand accountability in cancer care and the quality of such care. Next, the forces that affect accountability are described, using the three categories listed above. Finally, some of the specific activities that are in place to try to measure and improve the quality of health care (and cancer care, specifically) are described. Quality Assurance: an Individual Consumer Perspective Choosing Insurers Most people are healthy when they first select a health plan or source of care and so do not focus specifically on the quality of cancer care. Then too, even if consumers wanted to comparison shop for a health plan on the basis of quality, many have no real choice of health plan. Most individuals under age 65 are insured through their employer, and less than half of employees (41 percent) who are offered insurance at work can choose among two or more plans (Long and Marquis, 1998). Furthermore, most new cases of cancer occur among those age 65 and older

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--> who receive care within Medicare's fee-for-service (FFS) system, where consumer-oriented quality measures are generally less available. Consumer-oriented quality initiatives have focused largely on helping people choose among managed care plans. For those with the opportunity to opt into managed care or switch plans, there is a wealth of information that, over time, is beginning to address meaningful issues for those with chronic illnesses such as cancer (see descriptions of the National Committee for Quality Assurance [NCQA] and the Foundation for Accountability [FACCT] later in this chapter). A new generation of consumer surveys about health plans is now available that go beyond simple ratings of satisfaction (Cleary et al., 1997). Consumers are asked to report on specific experiences in obtaining health care, for example, difficulty in obtaining referrals. If a plan is large enough, cancer-specific ratings or at least the experience of individuals with chronic illness or functional limitations—could be provided to those making health plan choices. Here too, standardized measures are being developed to allow managed care and FFS comparisons (http://www.ahcpr.gov/qual/cahpfact.htm). The Health Care Financing Administration (HCFA) has posted on the internet (www.medicare.gov) some results of these consumer satisfaction ratings for Medicare beneficiaries in health plans, along with comparative plan ratings on indicators such as mammography use. HCFA plans to survey those who have disenrolled from health plans to provide information to beneficiaries on why people leave health plans (Medicine & Health, 1999). Most individuals with a new diagnosis of cancer find themselves in an insurance system that they must live with, at least in the short term. At this point, many people have little flexibility in terms of their insurance plan, although they are usually able to choose among physicians within their plan and among institutions covered by their insurer. Choosing Physicians and Hospitals In choosing a physician, one basic piece of information is whether the physician is certified by a cancer specialty board, which requires completion of an approved training program and passing a rigorous written and oral exam about cancer care. Other potential indicators of physician quality of relevance to consumers might include: history of disciplinary action, hospital admitting privileges, volume of cancer patients treated, number and credentials of support staff, and the personality and demeanor of the provider and staff. Not all of this information is readily available, and as described in Chapter 5, good evidence is lacking to support the link between these indicators and outcomes of care. There are, for example, very few studies of the effects of physician specialization on outcomes of care, so although board certification has some intuitive appeal as a quality measure, the effect of certification on outcomes of care is virtually unknown. For hospitals, there are several indicators of the range of services available (e.g., research programs), structure (e.g., size as indicated by annual hospital discharges), and to a limited extent, the quality of cancer-related services (e.g., appropriate use of diagnostic tests): The American College of Surgeons' Commission on Cancer (see below) has standards for approving hospitals. The National Cancer Institute (NCI) designates cancer centers for support of cancer research, and these centers are affiliated with a wide range of small and large hospitals. Treatment at participating hospitals means patients could have access to clinical trials (see Chapter 3).

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--> The Joint Commission on Accreditation of Heathcare Organizations (JCAHO) is the lead organization in accrediting hospitals in the United States. JCAHO has recently instituted an outcomes-based performance system that includes specific oncology measures and may, over the coming years, improve the relevance of JCAHO certification to individuals with cancer (see below). Although various organizations collect information related to the quality of hospital-based cancer care, the consumer usually can find out only whether or not a hospital is approved or accredited. The overwhelming majority of hospitals that voluntarily submit to an inspection or review are approved or accredited, but the details of hospital performance on various indicators are not yet publicly available. Even if the information were available, it would be difficult for consumers to evaluate a particular hospital's quality because there are few established links between hospital attributes and quality (see Chapter 5). Standards can, however, help to ensure that hospitals meet minimum infection control, safety, and security standards. If a hospital fails to meet the criteria set forth by professional groups, consumers are justified in searching out more detail about potential problems before agreeing to use the facility. The news media and the popular press may also be sources of consumer information about the quality of health plans and hospitals. A few widely circulated magazines have sponsored national surveys of consumers regarding their satisfaction with care, and of providers regarding their assessments of the quality of sites of care, that they have used to rank services on the basis of quality. Consumer Reports has, for example, evaluated managed health care plans, and each year U.S. News & Worm Report ranks hospitals, including hospital-based cancer centers (Box 6.1), a feature that has been very popular with consumers and has been used by the high-ranking centers in marketing (Memorial Sloan-Kettering Cancer Center, 1998). While the U.S. News & Worm Report ranking includes indicators for which there is some evidence linking them to good health outcomes (i.e., volume of services, nurse to patient bed ratio), the ranking system itself has not been validated externally and the methodology has been criticized (Teasley, 1996). BOX 6.1 U.S. News and World Report Annual Ranking of Cancer Centers With a circulation of more than 2 million, the U.S. News & World Report annual ranking of hospital-based cancer programs is perhaps the most widely read source of information on the quality of cancer care. In 1997, 998 hospital-based cancer care programs were ranked according to measures of structure, process, and outcome: reputation score among board-certified oncologists; severity-adjusted cancer mortality rate; membership in the Council of Teaching Hospitals; availability of cancer-related technology; number of cancer discharges; and nurse to patient bed ratio. The authors of the ranking system concluded that there are a few extremely ''good'' hospitals, many hospitals providing "competent" care, and a few hospitals at the bottom of the curve. SOURCE: Comarow, 1997; Ehrlich et al., 1997.

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--> Choosing Treatment Options Most consumers do not have the scientific background to evaluate their treatment options, but they can still participate intelligently in decisions about their care. Specifically, they can seek independent second opinions; use information resources such as the patient-oriented version of the NCI's Physician Data Query (PDQ) system, which can be accessed by computer and describes (in nontechnical language) treatment options by type of cancer. Information is also available through telephone services operated by both NCI and the American Cancer Society (ACS) (Murphy et al., 1997); enter systems of care that employ a comprehensive approach to cancer treatment and management. (Programs that emphasize patient education, adherence to evidence-based protocols, and use of multidisciplinary teams of providers have been shown to contribute to greater patient satisfaction and better health outcomes (Wagner et al., 1996); and make use of an array of available consumer-oriented products that enable individuals with cancer to electronically access health educational materials, communicate with their providers and with individuals with cancer, and make more fully informed treatment decisions (CancerDesk, 1999; Gustafson et al., 1993). Use of Quality Information by Consumers There is evidence that the available quality information is not viewed by many consumers as relevant to their decision making (Hibbard and Jewett, 1997b). In one national survey, three-quarters of Americans said that they would opt to see a surgeon they know rather than one they do not, even if the alternative had much higher quality ratings. Also, although many Americans perceive great differences in the quality of care among health plans, hospitals, and doctors, relatively few are now using quality data to make health care choices (Kaiser Family Foundation, 1996). In many cases, consumer-oriented information is just not available for all of the decisions that a person with cancer may have to make—selecting a doctor, choosing among treatments, or finding a home health service, rehabilitation program, or hospice. The type of information needed about the quality of cancer care services can vary greatly by individual. The services important to the high-risk patient or person who has not yet been diagnosed are quite different from those important to a long-term cancer survivor. Barriers to the use of quality information include the complexity of the task of evaluating health care quality, difficulties in understanding such information (e.g., high rates of functional illiteracy, non-English speakers), a lack of familiarity among the public with the workings of the health care system (e.g., most Americans do not understand the concept of managed care) and the way in which the organization of care might influence quality, and importantly, a paucity of user-friendly information (Hibbard et al., 1997b). If large numbers of consumers do not use quality information directly, decisions at the intermediary level may offer important guidance to consumers (Hibbard et al., 1997c). Having a "thumbs-up" or "thumbs-down" rating from an influential group such as the American Association of Retired Persons (AARP) might be more useful for some consumers than detailed quality report cards. Awareness of quality issues in cancer care will likely increase as cancer advocacy groups

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--> promote measurement of aspects of care of particular relevance to individuals with cancer and disseminate information to raise awareness of quality issues. The National Coalition for Cancer Survivorship has, for example, published "principles of excellence" in cancer care (Box 6.2). BOX 6.2 National Coalition for Cancer Survivorship: Imperatives for Quality Cancer Care Principle 1 People with cancer have the right to a system of universal health care. This access should not be precluded because of preexisting conditions, genetic or other risk factors, or employment status. Principle 2 Quality cancer care should be available in a health care system whose standards and guidelines are developed in consideration of treating the whole person with cancer. Health care plans must regard the cancer patient as an autonomous individual who has the right to be involved in decisions about his or her care. Principle 3 Standards of cancer care should be driven by the quality of care, not only by the cost of care, and should include participation in clinical trials and quality-of-life considerations. Principle 4 All people diagnosed with cancer should have access to and coverage for services provided by a multidisciplinary team of care providers across the full continuum of care. Health care plans should be held accountable for timely referral to appropriate specialists when symptoms of cancer or its recurrence may be present. Principle 5 People with cancer should be provided a range of benefits by all health care plans that include primary and secondary prevention; early detection; initial treatment; supportive therapies to manage pain, nausea, fatigue, and infections; long-term follow-up; psychosocial services; palliative care; hospice care; and bereavement counseling. Principle 6 People with histories of cancer have the right to continued medical follow-up with basic standards of care that include the specific needs of long-term survivors.

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--> Principle 7 Long-term survivors should have access to specialized follow-up clinics that focus on health promotion, disease prevention, rehabilitation, and identification of physiologic and psychosocial problems. Communication with the primary care physician must be maintained. Principle 8 Systematic long-term follow-up should generate data that contribute to improvements in cancer therapies and decreases in morbidity. Principle 9 The responsibility for appropriate long-term medical care must be shared by cancer survivors, their families, the oncology team, and primary care providers. Principle 10 The provision of psychosocial services must be safeguarded and promoted. Persons diagnosed with cancer should receive psychosocial assessments at critical junctures along the continuum of cancer care to determine the availability of needed support and their ability to seek information and advocate on their own behalf. Principle 11 Psychosocial research is integral to comprehensive cancer care, and as such, psychosocial outcome measures should be included in all future clinical trials. The importance of this research and its application and transfer to oncology care plans should be recognized and encouraged. Principle 12 Cancer survivors, health care providers, and other key constituency groups must work together to increase public awareness; educate consumers, professionals, and public policy makers; develop guidelines and disseminate information; advocate for increased research funding; and articulate for and promote survivors' rights. SOURCE: NCCS, 1995. Quality Assurance: a Market Approach Although individual consumers may not yet wield much clout in the health care marketplace, large private-sector purchasers are already doing so. Most nonelderly Americans recieve their health care insurance through an employer, and employers choose health care plans for their employees on the basis of price, benefits, quality, and service. A common metric for quality is

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--> essential if health plans are to compete on the basis of value. Information on the quality of care provided in managed care plans is sometimes made available to employers, consumers, and other purchasers in the form of report cards, using a standardized format to make comparisons possible across health plans. Most employers currently make health care purchasing decisions on the basis of price, not quality (Darby, 1998). When quality enters the decision-making process, some evidence suggests that employers are more likely to consider consumer satisfaction and accreditation status than clinical performance measures (Hibbard et al., 1997a). Some very large employers (e.g., Digital, Xerox) have been addressing quality of care concerns for years, and employers are increasingly banding together increasingly to form large coalitions to gain purchasing clout and to push for uniform quality assessment among health plans. Purchasers may use quality information to identify high-value plans with which to contract, to steer employees into higher-performing plans, or as leverage when establishing rates for premiums (Darby, 1998). The Pacific Business Group on Health (PBGH), for example, is a nonprofit coalition of large health care purchasers in California and Arizona representing, as of 1996, 2.5 million insured individuals employed by 33 private-and public-sector organizations. PBGH collects and analyzes health plan performance data to produce report cards for consumers; promotes shared treatment decision making between providers and consumers; and collects, analyzes, and reports plan-level consumer satisfaction ratings (Castles et al., 1999; President's Advisory Commission, 1998). PBGH is also developing several disease-specific quality assessment programs, including one for breast cancer. PBGH was the first purchasing coalition to impose a condition on contracting plans whereby it would withhold 2 percent of the premium until the plans achieved specific goals for improving customer satisfaction and quality of care. The Alliance, a health insurance purchasing cooperative in Denver, subsequently adopted a similar approach (Darby, 1998). An informal group of large employer organizations including PBGH, called the Leapfrog group, is promoting "evidence-based hospital referral," the channeling of patients to certain hospitals for selected conditions and procedures (e.g., coronary angioplasty, bypass surgery) for which clear evidence exists that a higher volume of procedures or teaching status is associated with better outcomes. The PBGH is asking California HMOs with whom it has contracts to use new performance standards for physician groups, hospital precertification, and enrollee education to advance "evidence-based hospital referral" (Bodenheimer, 1999). Quality Assurance: the Public-Sector Approach Oversight through accreditation and licensing is one of the oldest systems of quality assurance employed by the federal government (e.g., accrediting hospitals providing care for Medicare beneficiaries) and states (e.g., licensing physicians). Although traditionally focused on regulation and oversight to ensure at least a minimal level of acceptable quality, government bodies are increasingly turning to market-based approaches. State-sponsored initiatives in Minnesota, Maryland, and Pennsylvania, for example, publish reports that allow consumers to compare health plans on various aspects of quality (Darby, 1998).

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--> Health Care Financing Administration Many of the federal health care accountability systems are housed within the Health Care Financing Administration (HCFA), the principal payer for health care. HCFA has two main quality-of-care strategies: (1) As part of its certification activities, it requires fee-for-service providers, HCFA-contracting health maintenance organizations (HMOs), and clinical laboratories to meet Medicare standards; (2) it undertakes quality improvement initiatives in cooperation with its peer review organization (PRO) programs. On the regulatory front, HCFA is revising its rules to certify Medicare providers in four areas: home health, hospital care, hospice care, and end-stage renal disease, placing more emphasis on clinical performance and patients' experience with care. The proposed home care rule, for example, would require Medicare home health agencies to use a standard system called the Outcomes and Assessment Information Set (OASIS) to measure quality and patient satisfaction with care (Darby, 1998). HMOs contracting with HCFA must now report clinical performance data (i.e., Health Plan Employer Data and Information Set [HEDIS] data) and information on patients' experience and satisfaction with plans (i.e., results from a new Consumer Assessment of Health Plans Survey). HCFA is also implementing the Quality Improvement System for Managed Care to require participating health plans to show improvement in the health care they provide. Minimum service levels for improvement measures such as mammography will be set, along with targets specific to a geographic region. Initially, the focus will be on preventive and acute care services. A similar system is being developed for fee-for-service care (Voelker, 1997). Relatively few Medicare beneficiaries are enrolled in managed care plans (13 percent as of 1997), and efforts are underway to gather performance information from providers in the FFS environment. Medicare beneficiaries are beginning to have more choices in type of health coverage beyond fee-for-service and HMOs. With the Medicare+Choice program, beneficiaries will be able to select new insurance options including preferred provider organizations (PPOs) and medical savings accounts. Many believe that HCFA will lead the effort to converge on a single set of quality measures applicable across delivery systems (Darby, 1998). In 1992, HCFA established the Health Care Quality Improvement Program, which promotes partnerships between PROs and hospitals, health plans, and physicians to improve quality. Each state has a PRO that evaluates whether care given to Medicare patients is reasonable, necessary, and provided in the most appropriate setting. Funding for PROs in 1997 was $183 million. HCFA maintains a quality-of-care surveillance system to provide information to PROs about Medicare health care utilization, patterns, and trends to help PROs target their quality improvement activities. Among the indices tracked are rates of radical prostatectomy among men 70 years or older (see examples of PRO activities in Box 6.3). As of 1998, more than 700 quality improvement projects were underway, some of which were national in scope and disease specific. The Cardiovascular Cooperative Project, for example, is a national, data-based effort to improve care for Medicare patients hospitalized for heart attacks (President's Advisory Commission, 1998). PROs appear to have been effective in improving the care of patients with acute myocardial infarction, according to a recent quasi-experimental assessment (Marciniak, 1997). HCFA is also actively involved in the development of clinical performance measures to assess quality. As part of HCFA's Outcomes Project, for example, it is identifying multiple domains of processes and outcomes of care for breast cancer, collecting and summarizing the ex-

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--> isting evidence supporting performance measures in each of these domains, and identifying multiple sources of performance data (Katherine Kahn and Marge Pearson, RAND, personal communication to Mark Schuster, 1998). BOX 6.3 HCFA's Peer Review Organizations—Examples of Cancer Care Quality Monitoring Radical Prostatectomy (RP) in Men 70 and Older. RP should generally not be used for men 70 and older, given the risks and benefits of the procedure. The PRO overseeing Medicare quality assurance in Kentucky and Indiana identified five "outlier" hospitals in each state with high rates of RP for older men (20-22 percent of prostate cancer admissions among elderly males). Provider education and monitoring of RP led to significant declines in RP in outlier hospitals, and in Kentucky, the rate of RP among older men was reduced to statewide norms (ML Daffron, personal communication to Maria Hewitt, February 18, 1998). Breast Conserving Surgery. The PRO overseeing Medicare quality in Delaware found that rates of breast conserving surgery (BCS) rose from 16 to 80 percent from 1993-1994 to 1996-1997 among Medicare beneficiaries with Stage I or II breast cancer. Among women eligible for BCS for whom mastectomy was performed, documentation of patient choice of mastectomy rose from 50 to 72 percent of cases (Cochran, 1997). Cancer Pain Management. The Minnesota PRO evaluated hospital adherence to the Agency for Health Care Policy and Research and American Pain Society guidelines on pain management. According to a review of 271 charts of patients admitted for specific cancers (e.g., metastasis to bone and spinal cord, liver, intestine, peritoneum), hospitals excelled at documenting some form of a patient's initial self-assessment of pain (93 percent of patients). Most hospitals, however, did not utilize effective means of communicating pain intensity (26 percent of patients). Pain reassessment was found to be inconsistent among hospitals. The PRO is planning interventions to improve compliance with pain management guidelines (Stratis Health, 1997). Determinants of Use of Adjuvant Cancer Therapy. The Colorado PRO matched cancer registry data with Medicare A and B claims data to assess factors associated with the use of adjuvant therapy for Stage I or II breast cancer and Stage III colon cancer. Underuse of adjuvant therapy was found among those age 65 and older, particularly for chemotherapy following Stage III colon cancer. The principle factor associated with failure to use adjuvant therapies was advancing age, which did not appear to be explained by comorbidities (Byers et al., 1998). Satisfaction with Breast Cancer Treatment. The Colorado PRO conducted focus groups among minority and non-minority group women and a telephone survey of women age 65 and older regarding their care for breast cancer. Women's satisfaction with cancer care was high, but areas in which doctors could provide more information to their patients were in the discussion of what to expect from surgery and the potential physical and emotional outcomes of surgery (Crane et al., 1997). SOURCES: Byers et al., 1998; Cochran, 1997; Crane et al., 1997; Daffron, 1998; Stratis Health, 1997.

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--> Most state Medicaid agencies monitor utilization, outcomes, consumer satisfaction, and disenrollment, through either chart review or client survey. Some have engaged in collaborative quality improvement initiatives with health plans, providers, public health agencies, and community organizations in areas such as pediatric immunization and prenatal care. Medicaid agencies are also beginning to incorporate quality-based performance indicators and specifications into their contracting strategies. Some use quality information to assess potential contractors, whereas others (e.g., Massachusetts) hold contractors accountable for measurable service improvements that are spelled out in a set of contractual terms and purchasing specifications (e.g., provision of member satisfaction data, clinical indicator data from HEDIS, and voluntary disenrollment rates) (Darby, 1998). Public Health Monitoring Another set of important quality assurance activities involves public health monitoring. Here, cancer registries, surveillance systems, and national survey data are used to monitor the epidemiology of cancer, the prevalence of risk factors, and the use of preventive health services. The adequacy of the nation's public health programs and services is, in part, judged by whether or not public health goals are met—for example, those established as part of the Centers for Disease Control and Prevention's (CDC's) Healthy People 2000 initiative, which highlights cancer as a priority area. The cancer objectives call for decreases in site-specific death rates (e.g., breast, colorectal); improved primary preventive health practices (e.g., reducing cigarette smoking, reducing dietary fat intake); improved early cancer detection (e.g., increased use of breast, colorectal, and cervical cancer screening); and ensuring that cancer screening and diagnostic tests meet quality standards (i.e., Pap tests, mammograms). As of 1997, progress had been made for 12 of the 17 cancer objectives, but in many cases the improvements have been slight (NCHS, 1997). State public health agencies are building links with local health plans and providers to monitor public health goals. Plans for the Missouri Health Indicator Set, for example, include integrating public health records on births, deaths, hospital discharges, and cancer (Darby, 1998). Some States (e.g., New York, Pennsylvania) track hospital admissions and outcomes associated with certain procedures in an effort to monitor quality. New York, for example, has since the late 1980s collected standardized clinical data for coronary artery bypass surgery (CABS) patients, producing and publishing risk-adjusted mortality rates for hospitals and surgeons, and using these data to facilitate quality improvement efforts. The program has led to declines in statewide mortality (Chassin et al., 1996, 1998; Hannan et al., 1994). Agency for Health Care Policy and Research The Agency for Health Care Policy and Research (AHCPR) is the lead agency within the federal Department of Health and Human Services (DHHS) charged with supporting research on health care quality, cost, financing, and access (see Chapter 7). AHCPR has developed a number of practice guidelines (e.g., a 1994 practice guideline on cancer pain, which will be updated in 1999). Although no longer developing new practice guidelines, AHCPR in collaboration with the American Medical Association and the American Association of Health Plans has developed a national

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--> plemented site-specific guidelines for staging, medical management, nursing, and rehabilitation. Community practice for breast, rectal, and small-cell lung cancer was evaluated in 1985-1986 after the program had been fully implemented. There was no evidence of diffusion of guideline principles to the majority of practicing physicians, even those who were involved in their development (Table 6.6). TABLE 6.6 Conformance to Accepted Standards of Care Cancer Standard (%) Conformance (%) Breast Clinical staging 100 33 Medical oncology consultation if node-positive 100 73 Radiation oncology consultation 100 27 Rectal Staging 100 67 Radiation therapy consultation 100 27 Small-Cell Lung Cancer Radiation oncology consultation 100 50   SOURCE: Ford et al., 1987. Some CHOPs developed more intense programs to encourage compliance that included tumor boards, educational efforts, peer pressure, and administrative action. The CHOPs that were able to ensure staging did so by requiring completion of forms before specimens were submitted to pathology or denying privileges if forms were not completed. As the authors note, these measures were successful but did not require guidelines. The authors conclude that for clinical practice guidelines, ''leadership and organizational commitment appear to be the necessary ingredients.'' Even though the guidelines were developed locally, it is likely that the program failed to change provider behavior because there was no plan for implementation and no system to hold providers accountable for change (Katterhagen, 1996). ASCO Guideline on Use of Hematopoietic Growth Factors. Hematopoietic growth factors are effective when administered to prevent or treat neutropenia (an abnormally small number of a type of blood cell), which may occur following chemotherapy, but they do not improve outcomes for those with febrile neutropenia (fever associated with neutropenia). The growth factors are expensive to use ($200 to $300 per dose), but there is little harm to patients if they are administered inappropriately. Their administration can be a significant source of income to a physician. Guidelines issued by ASCO in 1994 on the use of hematopoietic growth factors led to some reduction in their inappropriate use, but serious overuse of these substances persisted. This finding was based on physicians' self-reported use of hematopoietic growth factors on surveys conducted before, and shortly after, the 1994 guideline was issued and again following the publication of a guideline update in 1996. Response rates to the surveys were roughly 60 percent. Inappropriate

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--> use of hematopoietic growth factors was sharply reduced in one managed care organization by the institution of a simple accountability system. Before administering growth factors, physicians had to call the administrator and report the indication for its use (J.E. Katterhagen, personal communication to Thomas Smith, 1998). AHCPR Cancer Pain Management Guidelines. Recent studies suggest that as many as one in four cancer patients is given inadequate pain relief (Rischer and Childress, 1996). Adherence to the 1994 AHCPR guideline on cancer pain management, following its widespread dissemination, was assessed in seven acute care hospitals in Utah in 1995 and again in 1996 (Rischer and Childress, 1996). On most process measures, care improved, but outcomes (e.g., pain scores) were not assessed (Table 6.7). A limitation of this study is the absence of a concurrent control group that was not exposed to the guideline dissemination intervention. Without such a group, one cannot attribute improvements to the guidelines. The program to improve pain management according to the AHCPR guideline has been implemented throughout Utah. TABLE 6.7 Compliance with Core Guidelines Guideline Prea Postb p Value Opioids Prescribed 99 100 1.000 Initial Pain Assessment Rating Scale Used 64 79 .090 Ongoing Pain Assessment Pain rating scale repeated at regular intervals 27 74 <.001 Efficacy reported 83 97 .011 Analgesic Use Pain medicines on regular schedule 70 91 .003 Bowel Treatment Plan Laxatives ordered 66 69 .857 Education of Family or Patient Education about cancer pain 6 34 <.001 Written education 16 26 .238 Patient Satisfaction Evaluated (not actual patient satisfaction) 24 97 <.001 NOTE: Ten patients were assessed at each of seven hospitals; n = 70. a Pre = before guideline was issued. b Post = after guideline was issued. SOURCE: Rischer and Childress, 1996. American Urologic Association Early Prostate Cancer Guideline. The American Urologic Association recommended in 1995 that patients with localized prostate cancer be offered surgery, radiation, or surveillance as treatment options. To assess compliance with the guideline in the

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--> military health system (i.e., those covered by CHAMPUS), men who had received radical prostatectomy before and after the guideline was published were asked in a survey to report whether or not they had been offered treatment options. The guideline was mailed to each practitioner within the system. The average number of treatments offered increased following publication of the guideline (Thompson et al., 1995). A limitation of this study is that it included only men undergoing radical prostatectomy, not all men with prostate cancer. Evidence on The Impact of Guidelines in Canada and Europe Canada. Adherence to breast cancer guidelines in British Columbia as assessed in 1991 was very high for radiation therapy, with 95 percent of women receiving radiation therapy following breast conserving surgery. However, only 77 percent of women received adjuvant chemotherapy when indicated, and 68 percent received tamoxifen when indicated (Olivotto, 1997). Adherence to guidelines was higher at cancer centers than among community oncologists. Improvements in disease-free and overall survival coincided with implementation of the guidelines, but other factors such as the regionalization of cancer care services and the presence of strong opinion leaders may account for good outcomes. Italy. In an effort to improve community-based cancer care in Italy, guidelines on the treatment of breast, colorectal, and ovarian cancer were sent to practitioners in 1977. The effects of the educational program were evaluated in 1987 (Grilli et al., 1991). The familiarity of practitioners with the breast cancer guidelines was poor: roughly one-half knew of the breast cancer guideline, one-third knew of the colon cancer guidelines, and one-quarter knew of the ovarian cancer guidelines (estimates are weighted averages of respondents to a survey of providers). Compliance with the recommendations of the guidelines was poor in several areas as shown by chart audit. For women with breast cancer, for example, only 37 percent had full staging, and only 61 percent had a bilateral mammogram at the time of surgery (Table 6.8). Better compliance was observed among physicians with high-volume practices. The authors note that the results were "disappointing" and that efforts to improve cancer care with a "guidelines diffusion" approach appear to have had a negligible effect on cancer treatment. France. Cancer care guidelines developed and disseminated through a regional cancer center in Lyon, France, appear to have succeeded in improving cancer care. Guidelines on breast and colon cancer were developed by a task force in 1993 and then reviewed by all practitioners in the region. In 1994, the guidelines were widely available via different media—paper, computer disk, and on-line at the cancer center. A comparison of randomly selected patients with breast and colon cancer treated in 1993 and 1995 showed marked improvements in care. From 1993 to 1995, adherence to the recommended overall treatment sequence increased from 19 to 54 percent for breast cancer and from 50 to 70 percent for colon cancer (Table 6.9). The guidelines were reviewed again in 1995 and disseminated to a wider network of hospitals and providers through continuing education meetings and mailed reminders to physicians. Compliance measured from 1994 to 1996 also improved (Ray-Coquard et al., 1998). The success of the guideline program was attributed in part to the local development of the guidelines, their wide dissemination, and

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--> the reliance on peer pressure to change practice behavior (Ray-Coquard et al., 1997). The studies lacked a concurrent control group that was not exposed to the guideline intervention, so it is unclear whether improvements were due to the guideline program or to a generally increased awareness in the medical community. Scotland. As part of its national health plan, Scotland has initiated comprehensive efforts to improve cancer care. On a national basis, it has limited reimbursement for cancer services to practitioners who agree to use evidence-based guidelines and submit their results to external scrutiny. Full results of the first three years of this program will be available in 1999 (Smith et al., 1998). Effects of Local Guideline Implementation on Costs Whether implementing guidelines increases or decreases costs depends on the medical interventions involved. Guidelines aimed at currently overused services will likely reduce some spending, whereas those aimed at underused services could increase spending. Some guidelines might shift spending from inappropriate to more appropriate care, leading to better value but not necessarily lower costs (IOM, 1992). Although the intention of guidelines is usually to improve care, an added benefit may be increased efficiency and cost savings. There are several anecdotal accounts of cost savings associated with local implementation of practice guidelines, often with attendant improvements in care: Implementing surgical care guidelines for patients with gynecologic cancer in one surgical practice improved clinical outcomes, decreased hospital length of stay, decreased costs, and kept patient satisfaction high. A team approach to guideline development and accountability systems accounted for the program's success (Morris et al., 1997). Implementing surgical care guidelines for patients undergoing radical prostatectomy in hospital practice decreased length of stay, while maintaining high scores on patient satisfaction and quality of life (Litwin et al., 1996). Implementing clinical pathways and treatment protocols in one cancer group practice led to greater efficiency (increases in number of patient encounters, decreases in costs) and increased participation in clinical research (Feinberg and Feinberg, 1998). Implementing a clinical practice guideline for endoscopic sinus surgery at an academic medical center led to improved short-term outcomes (i.e., fewer unplanned admissions) and lower costs (Stewart et al., 1997). Implementing critical pathways for cancer care within a managed care organization reduced length of stay and costs for patients treated for respiratory cancer and for those undergoing chest procedures and bowel surgery (Patton and Katterhagen, 1997). In summary, several organizations have developed oncology practice guidelines to promote treatment that conforms to the best medical evidence available. Guidelines for many aspects of cancer care are not available, in part because the evidence base upon which to judge best practice does not exist. The oncology guidelines that have been put into practice have not been uniformly successful in changing physician behavior or clinical outcomes. Aspects of guideline development and

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--> implementation affect success, and the most successful guidelines are those with internal development, specific educational interventions, patient-specific reminders at the time of consultation, and a system to hold providers accountable for adherence. Studies of the impact of oncology guidelines have often not included a concurrent control group that was not exposed to the guideline intervention, which makes it difficult to attribute change to guideline implementation. TABLE 6.8 Compliance with National Guidelines in Italy as Measured by Chart Audit, 1987 Recommendation Compliance (%) Breast Cancer Gold standard: 100% Bilateral mammography 61 Clinical stage 37 Pathological stage 60 Evaluation of axillary lymph nodes 89 Avoidance of radical mastectomy if T < 2.0 cm 84 Radiotherapy after quadrantectomy 65 Adjuvant chemotherapy started at <4 weeks 52 Polychemotherapy if <50, + lymph nodes 71 Chemotherapy delivered at full dosage 86 Colon Cancer CEA levels and liver ultrasound 40 TNM staging 78 Search for intra-abdominal metastasis 67 Information on resection borders 48 Evaluation of regional lymph nodes 66 Miles resection in lower rectal cancer 68 Radiotherapy in rectal and rectosigmoid cancer 11 No adjuvant chemotherapy in colon cancer 79 If chemotherapy, 5-FU-containing regimen 90 Ovarian Cancer Full information on tumor grading 30 Staging including abdominal echography 75 Histologic type according to standard classifications 89 Chest x-ray 97 Evaluation of residual tumor 45 Disease stage according to standard classification 85 Alkylating agent as part of chemotherapy for early disease 18 Cisplatin-containing regimens for advanced disease 34 Monitoring of toxicity while on chemotherapy 91 Monitoring of nephrotoxicity while on chemotherapy 84 NOTE: CEA = carcinoembryonic antigen; 5-FU = 5-fluorouracil; TNM = tumor-node-mestastasis. SOURCE: Grilli et al., 1991.

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--> TABLE 6.9 Compliance Rates of Medical Decisions with Guidelines, Lyon, France   Compliant with Clinical Practice Guidelines (%) Type of Procedure 1993 1995 p Value Breast Cancer Initial evaluation 75 86 .09 Surgery 96 92 .26 Chemotherapy 71 85 .01 Radiotherapy 72 93 <.001 Hormonal therapy 83 94 .01 Follow-up 31 80 <.001 Overall treatment sequence 19 54 <.001 Colon Cancer Initial evaluation 100 100   Surgery 100 99 .56 Chemotherapy 56 78 .02 Follow-up 62 54 .69 Overall treatment sequence 50 70 .009   SOURCE: Ray-Coquard et al., 1998. Key Findings Information about quality cancer care is becoming more available to individuals with cancer (or at risk for cancer), but it is not yet easily accessible to or understandable for consumers. A number of potential quality indicators can be listed, but most have not been evaluated to assess their ultimate value to consumers. It is unclear, for example, how the following indicators affect an individual's experience of care or health care outcomes: a physician's board certification, a hospital's approval status determined by the American College of Surgeons' Commission on Cancer, and a health plan's accreditation status and HEDIS scores. By the time a diagnosis of cancer is made and individuals have a clear reason to seek quality cancer care, it is often too late to switch health plans. Even if they could, however, many individuals do not have access to alternative plans. Individuals may use available quality indicators to choose doctors and hospitals within their plans, and perhaps to choose alternative courses of treatment, but evidence suggests that individual consumers can exert only a modest market pressure for quality improvement through access to better information about the quality of cancer care. Quality assurance systems are often not apparent to consumers, but they have the potential to greatly affect care. Some large employer groups are beginning to hold health plans to

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--> quality performance goals. HCFA is requiring health plans, hospitals, and other providers to produce standardized quality reports, and state Medicaid programs are beginning to include quality provisions in their contracts with providers. The development of better standards and performance measures for cancer care could provide a way for large employers or groups of purchasers to exert influence on the quality of cancer and other health care. A variety of mechanisms are being used to improve health care from the inside: total quality improvement initiatives, disease management programs, and implementation of clinical practice guidelines all have the potential to improve care. The experience with oncology practice guidelines has been mixed, with some examples of success but others of ineffectiveness in changing provider behavior or outcomes. Many guideline efforts have failed because of limitations in the way they were developed or implemented. There are numerous health care accountability systems in place, but they fail to constitute a coordinated system for ensuring quality health care in general, and they do not yet embody a comprehensive, organized effort for cancer care. Given the diversity of the U.S. health care system, such fragmentation is not unexpected, but it could be remedied through a combination of public regulation and cooperation between public-and private-sector purchasers of care. Although much of the impetus for quality accountability has come from the private and professional sectors, government-sponsored programs have promoted public health accountability by maintaining cancer surveillance systems and monitoring the use of cancer screening tests among the U.S. population. The elderly are disproportionately affected by cancer, and cancer care quality indicators have in some areas been integrated into programs designed to ensure appropriate treatment for Medicare beneficiaries. The Agency for Health Care Policy and Research has assumed an important convening role in tracking clinical practice guidelines and supporting the basic health services research needed to form the basis of future guidelines. Comprehensive improvements in health care quality and in the ability of consumers to make health care decisions that are fully informed on the basis of quality will likely occur only through collaborative efforts of the public and private sectors (President's Advisory Commission, 1998). As large health care purchasers, both sectors have a stake in improving the quality of care, and both sectors have knowledge and experience concerning quality measurement and reporting. Each sector has unique strengths. Private-sector organizations have the capacity to act quickly in response to rapid changes in the health care system. The public sector can provide established channels and safeguards to ensure representative action and open proceedings. Such an approach has recently been recommended by the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, and some initial steps have being taken to implement a public-private collaborative effort (President's Advisory Commission, 1998). A concerted public-private collaboration on the development and reporting of performance standards for cancer and other care could provide a framework for changing incentives in the system so that they aim at publicly accountable measures of quality. References The Advisory Board. 1998. The Oncology Roundtable. The Advisory Board Company, Washington D.C. American College of Surgeons. 1999. National Cancer Data Base: Future plans . http://www.facs.org

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