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Ensuring Quality Cancer Care (1999)

Chapter: 4 Defining and Assessing Quality Cancer Care

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Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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4
Defining And Assessing Quality Cancer Care

This chapter provides an overview of how quality of care is defined and measured, why quality assessment is important, and how quality information is collected. Evidence of quality problems is then summarized for two common cancers for which an evidence base exists: breast and prostate cancer.

Defining Quality of Care

The quality of health care can be precisely defined and accurately measured, but there are many different perspectives of quality to consider. Patients tend to evaluate care in terms of its responsiveness to their individual needs and may expect and value access to, and choice of services, doctors, and treatments that maximize their ability to work and enjoy life. Physicians may view quality in terms of their ability to exercise their medical judgment to optimize outcomes for patients. From a health plan's point of view, quality might mean efficiency, appropriate use of diagnostic and therapeutic technologies, and maintenance of high levels of patient satisfaction with care. From a public health perspective, quality might be reflected in high levels of access to primary care, effective prevention, and in low morbidity and mortality rates. A challenge to assessing quality is balancing these sometimes divergent perspectives (MeGlynn, 1997).

The Institute of Medicine (IOM) has defined quality as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge (IOM, 1990). In practical terms, poor quality can mean too much care (e.g., unnecessary tests, medications, or procedures, with associated risks and side effects); too little care (e.g., not receiving a lifesaving surgical procedure); or the wrong care (e.g., medicines that should not be given together, poor surgical techniques) (IOM, 1999). Good quality means providing patients with appropriate services in a technically competent manner, with good communication, shared decision making, and cultural sensitivity.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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Why Measure Quality of Cancer Care?

There are several reasons for measuring the quality of care:

  • To help consumers and purchasers make informed choices about health care (e.g., selecting health care coverage that balances likely health care effectiveness and costs).
  • To help clinicians and patients make informed treatment and referral decisions (e.g., evaluating mortality and quality of life trade-offs when deciding between two alternative treatments for cancer, comparing the relative success of two hospitals for a high-risk surgical procedure).
  • To help clinicians and health plans improve their care (e.g., assessing levels of cancer screening or monitoring surgical complication rates).
  • To determine the impact of new policies and systems (e.g., evaluating the consequences of increasing Medicare enrollment in health maintenance organizations [HMOs]).
  • To provide clinical input to financial decision-making processes (e.g., determining services to be included in an insurer's benefit package).
  • To guide public policy decisions (e.g., resource allocation decisions pertaining to the Medicaid or Medicare programs).

How is Quality Measured?

Quality assessment is the measurement of quality by expert judgment (implicit review) or by systematic reference to objective standards (explicit review). Quality may be evaluated at any level of the health care system: for physicians and other health care professionals; for hospitals, clinics, rehabilitation centers, and other institutions; for health plans; and for communities.

Different approaches to assessing quality have different strengths and weaknesses, and some approaches work better in one setting than another. An example of implicit review is having a clinician review the medical records of a patient and expressing a judgment on whether the care was good or bad. The clinician may base an opinion on years of experience and understanding of the clinical situation for which care was provided. However, the same rating may not be given on another day, and different colleagues might give a different rating.

Explicit review provides a more systematic approach and can be based on one or more of three dimensions: structure, process, and outcomes (Donabedian, 1980). ''Structural quality'' refers to health system characteristics, "process quality" refers to what the provider does, and "outcome" refers to patients' health. Although producing good outcomes is the ultimate goal of the health care system, for a variety of technical reasons, using outcome measures to assess quality is not generally the most effective approach (discussed below). Instead, process measures are used.

Structural Quality

Structural quality refers to characteristics of the health care system that affect its ability to meet the needs of individual patients or communities. These characteristics include clinician characteristics (e.g., board certification, average years of experience, distribution of specialties), organizational characteristics (e.g., staffing patterns, reimbursement method), patient character-

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

istics (e.g., insurance type, illness profile), and community characteristics (e.g., per capita hospital beds, transportation system, environmental risks). Structural measures specifically related to cancer quality could include the availability of a multidisciplinary cancer center, a bone marrow transplant unit, or psychological support services.

Structural characteristics are often necessary to provide good care, but they are usually insufficient to ensure excellent quality. The best structural measures are those that can be shown to have a positive influence on the provision of care (process quality) and on patients' health (outcomes), although this relationship has not been found for most measures (Brook et al., 1990).

Measures of structural quality have long been the key component in accreditation procedures. Various independent organizations accredit hospitals or health plans based on a set of criteria that generally focus on structural measures such as appropriate capacity for the covered patient population. In recent years, accreditation organizations have also been incorporating process and outcome measures into their accreditation procedures.

Process Quality

Process quality refers to what providers do for patients and how well they do it, both technically and interpersonally. Technical process refers to whether the right choices are made in diagnosing and treating the patient, and whether care is provided in an effective and skillful manner. Whether care is effective can be judged according to evidence from good studies (e.g., clinical trials) that show a link between a particular process and better outcomes. Quality is often measured according to appropriateness criteria or professional standards, but these may or may not conform to available evidence of effectiveness. The quality of evidence is itself rated according to aspects of the study's design and conduct. Reported "levels" of evidence are often used to evaluate the strength of clinical recommendations (see Box 4.1).

An intervention or service (e.g., laboratory test, procedure, medication) is considered appropriate if the expected health benefits (e.g., increased life expectancy, pain relief, decreased anxiety, improved functional capacity) exceed the expected health risks (e.g., mortality, morbidity, anxiety anticipating the intervention, pain caused by the intervention, inaccurate diagnoses) by a wide enough margin to make the intervention or service worthwhile (Brook et al., 1986). Some also distinguish a subset of appropriate care that they term necessary or crucial care. They consider care necessary if there is a reasonable chance of a nontrivial benefit to the patient and if it would be improper not to provide care. In their view, such care is important enough that it might be considered ethically unacceptable not to offer it (Kahan et al., 1994; Laouri et al., 1997). Criteria of appropriateness can be used to measure the overuse of care, which occurs when expected risks exceed expected benefits (which is a problem because of treatment complications and wasted resources), and the underuse of care, which occurs when people are not receiving care that is expected to improve their health.

A good example of the use of process measures can be found in the 1988 General Accounting Office (GAO) assessment of the use of seven "breakthrough" cancer treatments in the United States from 1975 to 1985 (e.g., adjuvant chemotherapy for breast cancer) (USGAO, 1988). All of the treatments had been proven to extend patients' survival in controlled experiments, and for many, the evidence had been available for several years. Data for 1985 show considerable variation in use of these innovative therapies (Table 4.1). The results illustrate the

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

problem of a slow rate of diffusion of innovation of cancer care, but optimal levels of use of each intervention are not known. One factor that might account for some of the underuse is possible underreporting of treatments in the Surveillance, Epidemiology, and End Results Program (SEER) cancer registry data (see description of SEER Program below).

BOX 4.1 Levels of Evidence Applied to Clinical Research

The "hierarchy of evidence" applied to clinical research (i.e., when the question is whether a given treatment is effective in patients with a specific type of cancer) is well established and agreed upon. The following version is taken from the Well-respected U.S. Preventive Services Task Force, proceeding from the most reliable to the least reliable type of evidence (i.e., from grade I to grade III):

I

Evidence obtained from at least one properly randomized controlled trial.

II-1

Evidence obtained from well-designed controlled trials without randomization.

II-2

Evidence obtained from well-designed cohort or case-control (epidemiologic) studies.

II-3

Evidence obtained from multiple time series. with or without the intervention—dramatic results in uncontrolled experiments (e.g., the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III

Opinions of respected authorities, based on clinical experience, descriptive studies and case repeals, or repeals of expert committees.

SOURCE: U.S. Department of Health and Human Services, 1996.

TABLE 4.1

Selected Results from 1988 GAO Report

Innovative Therapy

Percentage of Eligible Patients Treated, 1985a

Adjuvant chemotherapy for breast cancer (premenopausal node-positive)

63

Adjuvant chemotherapy for node-positive colon cancer

6

Adjuvant radiation therapy for rectum cancer

40

Chemotherapy for limited small-cell lung cancer

75

Chemotherapy for non-seminoma testicular cancer

50

Chemotherapy for Stage IIIB or IV Hodgkin's disease

90

Chemotherapy for diffuse intermediate or high grade non-Hodgkin's lymphoma

80b

a "Treated" includes the SEER treatment data fields of "given" and "planned.''

b Ten percent decrease from 1979 to 1985.

SOURCE: USGAO, 1988.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

Another way to measure process quality is to determine whether care meets evidence-based professional standards. This assessment can be done by creating a list of quality indicators describing a process of care that should (or should not) occur for a particular type of patient or clinical circumstance. Quality indicators are based on standards of care, which are found in the research literature and in statements of professional medical organizations or determined by an expert panel. The performance of physicians and health plans is assessed by calculating rates of adherence to the indicators for a sample of patients (see Chapter 6 for a discussion of quality assurance programs). Current performance can be compared to a physician's or plan's prior performance, to the performance of other physicians and plans, or to benchmarks of performance. Indicators can cover a specific condition (e.g., patients diagnosed with colon cancer who do not have metastatic disease should be offered a wide resection with anastomosis within six weeks of diagnosis), or they can be generic, covering general aspects of care regardless of condition (e.g., patients prescribed a medication should be asked about allergies to medications).

Interpersonal quality refers to whether the clinician provides care in a humane manner consistent with the patient's preferences. It includes such topics as whether the clinician supplied sufficient information for the patient to make informed choices and involved the patient in decision making. It is generally assessed using patient survey data.

Good process measures are based on research studies and supported by professional consensus. They are also flexible with respect to patient preferences. Some patients may not want what most people would consider proper care. Indicators can be constructed so that they are scored favorably if care was offered but declined. However, there has to be some recognition that a perfect score on indicators is not necessarily a feasible or even a desirable goal. For example, although chemotherapy is highly recommended after surgical resection for colon cancer involving the lymph nodes, some patients might decline treatment because they do not wish to experience its associated toxicities. Therefore, 100 percent adherence may not be a reasonable target for an indicator specifying adjuvant chemotherapy for these patients. Furthermore, such a target might also create incentives to ignore patient preferences in making treatment decisions. An alternative approach would be for an indicator to specify that chemotherapy was offered or recommended.

The best process measures are those for which there is evidence from research that better process leads to better outcomes. For example, adjuvant chemotherapy has been shown in several randomized controlled trials to improve survival after surgery for Duke's C colon cancer (NIH, 1990a); performing routine mammography identifies breast cancer at an earlier stage when it is more curable (Kerlikowske et al., 1995); perioperative chemotherapy and radiation therapy have been shown to increase survival for patients with rectal cancer (Krook et al., 1991; Moertel, 1994). Unfortunately, research has not covered all aspects of standard medical practice related to cancer (or other types of disease), so in these cases, expert consensus is used to decide which processes are important measures of quality. If there is not strong consensus supporting the value or superiority of a clinical practice, it generally is not used as a quality measure.

Several studies outside of oncology have tied process measures to outcomes. In a study of five hospitals in Los Angeles County, mortality rates were examined for patients who had coronary angiography and for whom a revascularization procedure was deemed "necessary" by explicit criteria. Those who received necessary revascularization within one year had a mortality of 9 percent, compared to 16 percent for those who did not. Those receiving "necessary" revascularization also had less chest pain at follow-up (Kravitz et al., 1995).

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

Other research also demonstrates the link between process and outcome. In a study of Medicare enrollees hospitalized with congestive heart failure, heart attack, pneumonia, and stroke in 1981-1982 and 1985-1986, better process quality of care was significantly associated with lower mortality rates 30 days after hospitalization. Patients who went to hospitals in the lowest 25th percentile on a set of process-of-care measures had a 39 percent increased likelihood of dying within 30 days after hospital admission compared to patients who went to hospitals in the highest 25th percentile, after adjustment for patient sickness at admission (Kahn et al., 1990).

Outcomes

Measurement of health-related outcomes is probably the most intuitively appealing approach to quality monitoring. "Outcomes" refers to the results of a health care delivery process. The three main types of outcomes are (1) clinical status, (2) functional status, and (3) consumer satisfaction. These outcomes, however, depend on myriad factors besides medical care, including characteristics of the patient and the disease process. Outcomes are thus valid measures of quality only to the extent that they have been associated with prior medical processes in well-designed studies.

Clinical Status

Clinical status is considered with the biological outcomes of disease, for example, how organ systems are functioning. Physicians have traditionally used clinical status to determine treatment success or failure. Cancer research, for example, has long used the outcome of five-year overall survival or five-year progression-free survival.

Other clinical measures might include postoperative wound infections or catheter infections. Proxy measures (sometimes called surrogate end points or intermediate outcomes) are also used. They do not measure the outcome of concern directly, but they do provide evidence or likelihood of a good outcome. For example, response rate (decrease in tumor size) is used to assess the impact of therapy, but the goal of therapy may be prolonged life. When used as a measure of quality or as an indicator of impact of therapy, it is important for there to be evidence that the proxy measures are really serving as a proxy. In other words, the effect of the intervention on the proxy should be concordant with the effect on the cancer itself (Schatzkin et al., 1996).

Functional Status

Measures of functional status assess how disease affects an individual's ability to participate in physical, mental, and social activities. They also cover the ability to meet the regular responsibilities of one's roles in society (e.g., parent, bank teller, volunteer). Health-related quality of life is similar to functional status but includes the person's sense of well-being as well as factors external to the individual such as social support.

Functional status assessment is based on the premise that many aspects of health are important to patients and will influence their treatment decisions. Such assessment could help

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

someone choose between a treatment that would give many more years of life with major incapacitation and a treatment that would give fewer years of life with full function. For example, treatment success or failure for prostate cancer has historically been assessed by the clinical outcome of whether the patient died from prostate cancer. However, functional status measures would incorporate other treatment outcomes, such as the patient's urinary, sexual, and bowel function (Litwin et al., 1995). Functional status assessment often includes the degree to which disease limits one's ability to participate fully in activities of daily living. Depending on the type of cancer and phase of illness, such activities could include going to work or caring for children. In patients with more advanced disease, however, assessment of whether they are able to go to the market for groceries or to bathe or dress themselves may be more relevant.

Performance status is a measure of functional status often used in oncology clinical trials. The Karnofsky Performance Status (Karnofsky and Burchenal, 1949) is a rating of patients' functional status that has been used in clinical trials since 1949 (Grieco and Long, 1984). The rating is performed by a physician or nurse. It has been found to be a strong predictor of survival in some patient populations, most notably patients with lung cancer. However, it covers only one aspect of quality of life—physical performance—and, although significantly correlated with quality of life, accounts for less than 50 percent of the variability in patients' own ratings of their quality of life. Although clinician-rated measures have value, the field is moving more toward the use of patients' assessments of functional status and quality of life (Reifel and Gantz, in press), which are preferable models for quality assessment. Examples of patient-based measures include the Cancer Rehabilitation Evaluation System (CARES) (Ganz et al., 1992b; Schag and Heinrich, 1990), the Functional Living Index-Cancer (FLIC) (Schipper et al., 1984), and the Breast Cancer Chemotherapy Questionnaire (BCQ) (Levine et al., 1988).

Consumer Satisfaction

Consumer satisfaction refers to patients' feelings about the care they receive and is generally measured by patient surveys. There is a relationship between satisfaction and adherence to treatment regimens. Patients who are satisfied are more likely to take their antibiotics properly (Bartlett et al., 1984), to follow treatment recommendations (Hsieh and Kagle, 1991), and to return for follow-up visits (Deyo and Inui, 1980). Thus, the physician has an incentive to please his or her patients as part of the treatment—so that they will be more likely to follow the physician's advice. Furthermore, dissatisfaction with care can lead patients to switch clinicians and health care institutions (Reichheld, 1996; Rubin et al., 1993; Young et al., 1985).

Although consumers are the best source to evaluate their interpersonal care, one limitation of satisfaction ratings is that consumers cannot always tell if the care was appropriate or technically good (Aharony and Strasser 1993); research has not shown a consistent relationship between consumer satisfaction and technical quality of care (Cleary and McNeil, 1988; Davies and Ware, 1988; Hayward et al., 1993). A kind and caring physician may provide care that is technically poor (Aharony and Strasser, 1993). Also, consumer satisfaction may vary with expectations. For example, patients who have a history of poor access to health care may be so appreciative when they actually see a physician that they may report high satisfaction regardless of how well care was delivered. Therefore, it is best not to rely on satisfaction ratings to measure technical quality.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

Clinical and functional status can be measured for more than one purpose. They are described here in the context of quality of care, in which outcomes are compared between two institutions as a sign of whether one institution is delivering better care (with the presumption that better care leads to better outcomes). However, these measures are also used clinically to track a patient's progress and in clinical trials to measure the efficacy or effectiveness of a new drug or intervention. The same measures can sometimes be used for both purposes, but certain measures are better suited for one purpose or the other. Five-year survival rates, for example, are a standard measure used in studies of new cancer treatments. However, when measuring quality of care for purposes of accountability or quality improvement, outcomes with a shorter time horizon than five years are generally needed. If two institutions are compared using five-year survival rates for colon cancer, one institution might have higher survival rates than the other. However, in the interim, there might have been a change in staff or a revamping of procedures that improved or weakened the quality of care at the hospitals, thereby making the comparison historically, but not practically, valuable.

Attributes of Good Outcomes Measurement

Outcomes measurement has become increasingly popular in the past few years, perhaps because outcomes are the most direct measure of the health of a population. For example, outcomes can be used to assess the quality of care that a health system provides to its cancer patients: outcomes can measure the survival and quality of life of women diagnosed with breast cancer and whether they are satisfied with their care. Their interpretation, however, must be tempered by the fact that many factors other than medical care influence outcomes.

Mortality trends are the principal yardstick used to measure overall progress against cancer because they capture the total effects of prevention, early detection, and treatment. The most recent assessment of mortality trends is encouraging—U.S. cancer mortality rates fell in the early 1990s for the first time since statistics have been collected (Wingo et al., 1998). It is difficult to estimate precisely the relative importance of factors contributing to this decline, but much of it stems from reduced smoking (among men) and other improvements in prevention (Cole and Rodu, 1996). Worthwhile advances in treatment may not be easily detected in overall mortality rates. Site-and stage-specific survival rates are better measures of treatment effects when adjusted for patient characteristics (e.g., prognostic factors such as age and extent of other illnesses).

The best outcome measures have certain key features or are used in a particular manner. First, they should be risk adjusted (or case-mix adjusted), in other words, adjusted for factors that influence outcomes but are beyond the health care system's control (e.g., age, socioeconomic status, comorbidities). Without such adjustment, it is impossible to determine how much of the improvement or worsening of outcomes is due to the care delivered (or not delivered) by the health care system. A radiation oncologist who receives referrals of patients with multiple medical problems is likely to have worse outcomes than one who takes only patients with early-stage disease and few comorbidities, even though the former may be a better radiation oncologist. To make comparisons in such a system, adjustments are needed for how ill the patients are. Risk adjustment is complex, and the factors to use in risk adjustment must be selected carefully to allow for accurate interpretation of the outcomes (Iezzoni, 1996).

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

Outcomes are only useful in quality assessment when the specific processes of care that relate to them are known. Then, if the outcomes are not as good as they should be, it is clear what aspects of care have to be addressed to try to improve them. In other words, if you do not know how an outcome relates to processes of care, you will not know what to do to improve the outcome when you find that it is poor at a particular hospital.

It also helps to measure outcomes from different perspectives. For example, palliative chemotherapy for metastatic cancer may decrease a patient's tumor burden and potentially prolong life, but it might also cause severe fatigue and weight loss, so the patient's clinical status might improve while functional status declines.

It is also important to use outcomes that can be reasonably related to the health care sys-tem-and the particular part of the system—that one is assessing. It is not reasonable to hold a provider or plan accountable for an outcome, unless the outcome is a direct result of the way care is provided. Sometimes, however, a single outcome may be influenced by many factors over many years, of which health care is only a part. Outcomes for lung cancer, for example, may reflect the quality of care provided over many years, including the quality of smoking prevention and cessation counseling for adolescents and adults. Outcomes for breast cancer may in part depend on the quality of screening and early detection. Given the frequency with which most patients change clinicians or health plans, it could be difficult to relate the quality of any one clinician or plan to some outcomes. Similarly, if one is trying to use outcomes to assess the quality of surgeons treating a sarcoma at various hospitals, it is important to distinguish whether the outcomes are related to the skill of the surgeon, competence of the surgical team, or organizational characteristics of the hospital. One might also want to consider the skill of the medical oncologist prescribing neoadjuvant chemotherapy. For breast cancer, treatment may depend upon an oncologist, a surgeon, and a radiation oncologist. It can be difficult to distribute responsibility among them.

In addition, outcomes should be measured on samples that are large enough to detect differences in quality. Adverse outcomes are often uncommon events, so large samples are needed to detect clinically meaningful differences between hospitals. To detect a difference of 2 percentage points in the rate of catheter infections between two hospitals (e.g., 5 percent for one and 7 percent for the other), each hospital would have to have at least 1,900 catheterized patients.

In summary, many challenges are inherent in using outcomes to measure quality of care. If these are not addressed, it is difficult to determine whether different outcomes observed among the patients of three physicians are attributable to the physicians themselves. Process measures have their own challenges (e.g., one must make sure that there is a proven link between the process and a desired outcome), but such measures can be quite effective in showing whether providers are doing what they should so that their patients have the best chance of achieving good outcomes. There has been more experience using process measures than outcomes measures to assess quality, and many quality assessment systems depend primarily or exclusively on process measures. However, interest in improving outcomes measurement is increasing, so that outcomes might be used along with process measures to provide more useful assessments of health care quality.

In conclusion, to assess quality of care, measures of structure, process, or outcome can be used. If outcomes measures are used, care must be taken to account for differences that might simply reflect differences in other factors, such as patient selection or case mix. If structure or process measures are used, they should be associated with the desired outcomes. In addition, to make inferences about quality, a measure must be compared to a standard.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

Variations In Care

Simply comparing variations in the structure or process of care does not provide an evaluation of the quality of care, although it may point to potential quality problems that merit further inquiry. In one such study of variation, five-year survival rates during 1983-1991 varied markedly for several cancer sites. For women with breast cancer, for example, five-year survival ranged from 71.0 percent in Iowa to 79.9 percent in Hawaii (Farrow et al., 1996) (Table 4.2). These differences persisted after adjusting for age and stage. For all cancers other than ovary and bladder, one or more regions were found whose survival rates differed significantly from the overall mean. These differences persisted and were even more pronounced when the analysis was limited to patients less than 70 years of age with local-stage surgically treated disease. However, other important case-mix adjusters, such as the presence of comorbid illnesses, were not included in the model, so interpretation of these results is difficult. Thus, it is not clear whether these regional variations in survival from breast cancer reflect differences in patient populations, regional differences in quality of care, or other factors.

TABLE 4.2

Five-Year Survival Comparisons Across Nine SEER Sites, Non-Hispanic Whites, 1983-1991

Cancer Site

Range of Relative Risk of Death for All Patients Across Sites (adjusted for sex, age, and stage)

Range of Relative Risk of Death—Local Disease, Age <70 (adjusted for surgical treatment)

Range of 5-Year Survival All Patients Across Sites for All (unadjusted)

Stomach

0.89-1.21

0.69-1.32

10.0-14.9

Colon

0.90-1.10

0.87-1.15

47.1-53.3

Rectum

0.91-1.09

0.76-1.17

45.6-52.4

Lung

0.93-1.12

0.74-1.19

10.5-16.1

Breast

0.82-1.11

0.64-1.34

71.0-79.9

Uterus

0.81-1.21

0.84-1.26

73.2-84.0

Ovary

0.91-1.08

0.82-1.16

34.1-39.2

Prostate

0.84-1.12

0.70-1.20

51.9-64.0

Bladder

0.91-1.15

0.84-1.16

58.4-64.2

 

SOURCE: Farrow et al., 1996.

How is Quality-Of-Care Information Collected?

Data for quality assessment can come from several sources. First, administrative records are widely available, and although they are limited in clinical detail, they can be used to show intensity or patterns of utilization. For example, they can be used to determine whether a patient with large-cell non-Hodgkin's lymphoma (NHL) received at least six months of chemotherapy and whether the patient had a white blood cell count performed before receiving chemotherapy. Second, medical records can provide greater clinical detail, the recorded medical history, the results of laboratory tests, and the treatment plan. For example, the medical record can show

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

whether the patient with NHL was neutropenic, whether proper components of the physical examination were performed, and whether chemotherapy was administered appropriately. Third, patient surveys can provide additional useful information. Patients can report on what happened during a clinical encounter and thereby provide information relevant to the processes of care. They can also rate their satisfaction with care and provide information on outcomes such as functional status. It is generally more expensive and time-consuming to collect information from medical records and from patients than from administrative data.

Cancer registries are also a potential source of information. They collect information on type of cancer, histology, stage at diagnosis, patient age, and initial course of treatment (whether the patient received surgery, chemotherapy, and radiation therapy that would normally be prescribed as part of the initial treatment plan). Registries exist at the regional, state, national, and international levels.

There are two main national registries: the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute (NCI) and the National Cancer Data Base (NCDB) (Swan et al., 1998). The SEER program was established as a result of the National Cancer Act of 1971 to assemble, analyze, and distribute information on the prevention, diagnosis, and treatment of cancer. Cancer is the only chronic disease (aside from HIV/AIDS) for which a national surveillance program exists. The program routinely collects information from designated population-based cancer registries in different parts of the country. The different areas have been chosen for their capacity to maintain a cancer reporting system as well as for their ability to report epidemiologically significant population subgroups. Currently, 14 percent of the U.S. population is represented by the nine geographic areas that make up the SEER program's database. Goals of the SEER program include the following:

  • compiling (with the help of the National Center for Health Statistics) estimates of cancer incidence and mortality in the United States;
  • discovering trends and unusual changes in specific cancers based on their geographic, demographic, and social characteristics;
  • providing information about trends in therapy, changes in the extent of disease (stage at diagnosis), and changes in patient survival; and
  • promoting studies that identify the factors that can be controlled through intervention strategies.

Health service researchers have linked SEER to Medicare administrative files to evaluate patterns of care, the use of health services, and the costs of treatment (Potosky et al., 1993; Edwards, personal communication to Maria Hewitt, November 1998). Many locations outside of the SEER program's area maintain cancer registries. The National Program of Cancer Registries of the Centers for Disease Control and Prevention (CDC) is bolstering states' capabilities to monitor cancer trends (CDC, 1998).

The National Cancer Data Base is a joint project of the Commission on Cancer (COC) of the American College of Surgeons (ACoS) and the American Cancer Society (ACS) to facilitate community, hospital, state, and national assessment of care of patients with cancer (Menck et al., 1997). It began in 1989, and 1,600 hospitals currently report data on 600,000 new cases annually to the NCDB (an estimated 58 percent of new cancer cases) (NCDB, 1998; Swan et al., 1998). NCDB collects information on patient characteristics, tumor characteristics, first course of treat-

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
×

ment, and follow-up. Participating hospitals submit all cases seen at their hospital for a particular data year. The system appears to have a bias toward hospitals with a computerized cancer registry, and it does not provide comprehensive outpatient data. After 1996, hospitals with ACoS accreditation (about 1,450 hospitals) were required to participate; it is estimated that in the year 2000, 1,750 hospitals caring for 80 percent of U.S. cancer cases will be participating. The NCDB provides comparisons of cancer management patterns and outcomes to national norms at the hospital, community, and state levels. The NCDB can also be used to track how well the results of major clinical trials are incorporated into clinical practice. There have been questions about quality control of the data collected by individual hospital registries, and NCDB is working to improve the quality.

The NCDB and the SEER program, when compared in 1992, provided similar patient descriptors (e.g., age, race, gender), cancer characteristics (e.g., stage), and types of surgical treatment for breast, colon, lung, and prostate cancer (Mettlin et al., 1997a). The two registries had similar distributions of cancer cases, by clinical characteristics.

Registries represent an exceptionally valuable opportunity to conduct quality assessment on a broad level. They could go further in collecting data on explicit process measures, intermediate outcomes, and treatment information, as well as characteristics needed to risk-adjust the outcomes. They would also be more useful for quality assessment if they were able to reduce the time lag between provision of care and availability of data. This information could be used both to provide detailed information on quality of care and to tie the processes of care to the outcomes. These data would also be useful in quality improvement.

There are a number of other ongoing data collection initiatives assessing the quality of cancer care:

  • The American College of Radiology (ACR) conducts ongoing Patterns of Care Studies for a variety of cancers. Since 1971, ACR has collected information periodically from a national sample of radiation oncology facilities (Kramer and Herring, 1976). Patterns of Care data have been collected in 1972-1974, 1977, 1979, 1984, 1989, and 1994. Data collected at each of these periods have included structure and process information; some years have also included patient outcomes measures. For example, 1989 assessed only structure and process measures, whereas 1994, which has not yet been made publicly available, included outcomes assessments as well.
  • The National Comprehensive Cancer Network (NCCN) has developed an outcomes database that pools information across NCI-designated comprehensive cancer center participants. In 1997, NCCN began the creation of a uniform outcomes reporting system (Weeks, 1997); results of this effort are pending.
  • The American Urological Association is developing a Documented Outcomes Collection System (DOCS) to assess patient outcomes for a selected number of conditions and may collect information related to prostate cancer outcomes in the future.

Evidence of Cancer Care Quality Problems

Efforts to measure quality of cancer care in the United States are in the early stages. National organizations conducting quality assessment have focused primarily on prevention and

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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screening, although they are now moving more toward assessing the quality of diagnosis and management. Research studies on quality of cancer care have been limited, with most research concentrating on cancers with comparatively higher prevalence and more evidence supporting clinical practice. In this section, the evidence of cancer care quality problems is assessed for breast and prostate cancer.

Breast Cancer

Breast cancer is the most commonly diagnosed non-skin cancer among American women, and it is estimated that one in eight women will develop breast cancer in her lifetime (Ries et al., 1998). In 1999, 176,300 new breast cancer diagnoses are expected (ACS, 1999). Although lung cancer has surpassed breast cancer as the leading cause of cancer deaths in women, breast cancer still accounts for 43,300 deaths annually (ACS, 1999). Breast cancer remains a common illness with significant morbidity and mortality.

Among oncologic conditions, breast cancer has one of the most extensive scientific literatures to support a strong association between processes of care and outcomes. Unlike many malignancies, effective interventions exist for breast cancer that decrease mortality and improve quality of life. In addition, evidence from the literature suggests that all phases of the continuum of care have an important effect on breast cancer outcomes, including early detection, diagnostic evaluation, and treatment. This extensive clinical literature, with many well-designed randomized controlled trials, provides a firm grounding for the development of process measures in breast cancer. However, even in breast cancer, not every aspect of the continuum of care has been studied to determine its effect on outcomes. Thus, even for this heavily studied disease, some of the presumed associations between process and outcomes reflect consensus within the medical community and expert opinion and are not based upon reliable evidence.

Screening And Diagnostic Evaluation

Although there has been controversy over the age at which one should begin screening for breast cancer, data from multiple randomized trials and several meta-analyses provide evidence that screening with mammography results in diagnosis at an earlier stage and in better outcomes. Early detection of breast cancer through screening mammography has been shown to reduce mortality by 20 to 39 percent for women ages 50 years and older (Nyström et al., 1993; Roberts et al., 1990; Shapiro et al., 1988). Also, results for women age 40 to 50 have shown a trend toward reduced mortality ranging from 13 to 23 percent (Kerlikowske et al., 1995; Tabar et al., 1995). Although the associated benefits and risks are controversial, many professional and public health organizations, including both the American Cancer Society and the National Cancer Institute, currently recommend screening mammography beginning at age 40 (Eastman, 1997; Mettlin and Smart, 1994).

For screening mammography to be effective, abnormalities identified at screening must be evaluated appropriately. Mammography is one of the most technically challenging radiological procedures, and ensuring the quality of the image is difficult. Furthermore, according to radiological experts, mammograms are the most difficult radiographic images to read (USGAO,

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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1998a, b). Although certain mammographic images (e.g. a spiculated mass) are characteristic of cancer, no criteria allow the radiologist to absolutely differentiate benign from malignant lesions (Osuch, 1996; Talamonti and Morrow, 1996). Given this significant overlap in the appearance of benign and malignant lesions on mammography, other tests are necessary to rule out a malignancy. Ultrasound may be useful to differentiate cysts from solid masses; however, a biopsy to obtain a pathologic diagnosis is often the only way to determine whether a lesion is benign or malignant. Any persistent breast mass that is not determined to be a simple cyst either by aspiration of clear fluid or by ultrasound characteristics should have a pathologic diagnosis, either through fine needle aspiration or excisional biopsy. Biopsy is the gold standard. Fine needle aspiration can falsely identify from less than 1 percent to 35 percent of cancers as negative, but accuracy improves when it is used in conjunction with clinical exam and simultaneous mammography in a procedure referred to as triple diagnosis (Kaufman et al., 1994).

Studies of screening mammography suggest significant variation in both the technical quality of radiographic images and their interpretation. A series of evaluations by the Food and Drug Administration (FDA) in 1985, 1988, and 1992 suggested widespread variation in mammographic image quality (Houn and Finder, 1997). Although improvement was noted overall, with 86 percent of images being acceptable in 1992 compared to only 64 percent in 1985, a significant problem in image quality remained, which was felt to be attributable to differences in technique (Segal, 1994). At the urging of the FDA, the American College of Radiology developed a voluntary accrediting process for mammography facilities in 1987 to attempt to correct this problem (Houn and Finder, 1997).

Concern about the quality of mammography led Congress to pass the Mammography Quality Standards Act in 1992, which established minimum national quality standards for mammography facilities (USGAO, 1998a, b). During the first three years of FDA inspections, compliance with national standards and x-ray quality improved. Before the act took effect, 11 percent of facilities tested were unable to pass image quality tests; in 1996, the nationwide figure was 2 percent (USGAO, 1998a, b).

The FDA has established federal qualification requirements for physicians who interpret mammograms, but each facility uses its own data to monitor physicians' performance on interpretation (USGAO, 1998a, b). Wide variation in diagnostic accuracy has been observed. According to a recent study, radiologists' ability to identify breast cancer from a screening mammogram (with biopsy as the gold standard) ranged from 47 to 100 percent, with a mean of 79 percent, and their ability to correctly rule out breast cancer varied from 36 to 99 percent. This study involved 108 radiologists practicing in 50 participating facilities randomly sampled from 4,611 ACR-accredited mammography centers (Beam et al., 1996).

The quality of the breast biopsy procedure is important so that the clinicians who make treatment recommendations to women with a breast lesion or with breast cancer have accurate information. Multiple steps in the process of breast biopsy are critical to ensuring that results are accurate, including the biopsy procedure itself (which may be a fine needle aspiration, a stereo-tactic core biopsy, an open biopsy, or a needle localization procedure followed by a biopsy), the tissue preparation, the cytopathology interpretation, the assessment of estrogen receptor and progesterone receptor status, and the pathology report that communicates all of the findings. A few studies have addressed the quality of some of these steps. A single community-based study in New Hampshire assessed the degree of diagnostic agreement among general pathologists reading an investigator-defined set of breast tissue specimens obtained via core and excisional biopsies

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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(Wells et al., 1998). They found overall high agreement among the pathologists for assignment to diagnostic category (kappa coefficient = 0.71) and very high agreement for differentiation of benign versus malignant breast disease (kappa coefficient = 0.95.) Other studies have found that the adequacy of specimens obtained from fine needle aspiration and stereotactic core biopsy varies widely, as do their reported sensitivity and specificity (Acheson et al., 1997; Hayes et al., 1996; Stolier, 1997). Yet no published studies have explored the issues that affect the quality of these procedures as performed in the diverse clinical facilities across the United States.

The pathology report is the critical link between pathologist and clinician. Deficits in the pathology report may represent problems with communication or deficiencies in the pathologic evaluation itself. Several studies suggest that variation exists in the quality of pathology reports for breast cancer specimens that warrants further evaluation. In the mid to late 1980s, three reports, although conducted in different populations, suggested serious underreporting of pathology information. Less than one-quarter of biopsies, for example, had documentation of lymph node dissection (Table 4.3).

TABLE 4.3

Quality Process Deficiencies in Initial Breast Cancer Care in the 1980s

Variable (stage)

Illinois—All Ages, 1988

Virginia—Age >65, 1985-1889

NCDB—All ages, 1988

No tumor size (I and II)

Not reported

24%

23%

No estrogen receptors

11%

Not reported

Not reported

No lymph node dissection

9%

24%

18%

 

SOURCE: Hand et al., 1991; Hillner et al., 1996; Osteen et al., 1992.

More recent data appear to show gains in some aspects of pathology reporting; however, room for improvement remains. In 1995, the College of American Pathology in its Q-Probes Study reviewed 20 breast biopsy specimens and the corresponding pathology reports from 434 voluntarily participating surgical pathology laboratories in the United States, Canada, and Australia (Nakleh et al., 1997):

  • In 92 percent of malignant cases the margin status was reported (necessary to determine if all of the malignancy was removed by the procedure), and 77 percent of reports contained the lesion size.
  • Approximately 75 percent documented whether estrogen and progesterone receptor status had been evaluated.

A single-institution study of needle localization breast biopsy reported even lower rates of documentation for this important information in the pathology report (Howe et al., 1995). Only 33 percent of reports in this study commented on the margins of the lesion, and estrogen receptor status was determined for only 68 percent of the cases. Such deficits in pathology reports have been the target of quality improvement projects. Hammond and Flinner (1997) reduced the number of incomplete breast cancer pathology reports in a large urban pathology practice in Salt Lake

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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City from 57 of 356 in 1990 to only 2 of 190 in 1995, after instituting a template for the report that included all essential information.

These studies identify multiple steps during the diagnostic evaluation of breast cancer at which the quality of care may be affected by the quality of the procedure. Poor quality at any step could significantly impact the overall quality of care provided. Although having information on every step in the continuum of care would provide a comprehensive assessment of the quality of care, this generally is not practical. Acquiring such comprehensive data on quality would be intrusive, time-consuming, and expensive. Nevertheless, considering all of the steps necessary to a multistep process such as the diagnosis of breast cancer can be extremely valuable in trying to determine the reasons for a quality problem that has been identified (e.g., too many women diagnosed with late-stage breast cancer, a high rate of local recurrence after breast conserving surgery).

Treatment

Extensive evidence is available for process-outcomes links in the treatment of breast cancer from randomized controlled trials and meta-analyses of these trials. Surgery has been the primary treatment for localized breast cancer since Halsted popularized the radical mastectomy in 1894 (Halsted, 1894). More recently, randomized controlled trials have demonstrated equivalent survival with a modified radical mastectomy or with breast conserving surgery followed by radiation therapy (Fisher et al., 1985; Sarrazin et al., 1984; Veronesi et al., 1981). In addition, having a choice of surgery appears important to a woman's subsequent quality of life; studies have not demonstrated any difference in overall quality of life between women who received breast conserving surgery and those treated with modified radical mastectomy as long as they were offered a choice of primary therapy (Ganz et al., 1992a; Kiebert et al., 1991). The most recent National Institutes of Health Consensus Conference statement for the treatment of early-stage breast cancer specifies breast conserving surgery as the preferred mode of therapy for the majority of women with Stage I and II breast cancer (NIH, 1990). Compared to modified radical mastectomy, breast conserving surgery has fewer short-term complications, but may require a similar length of convalescence because of the recommended six weeks of postsurgery radiation therapy. It is not a less costly treatment.

Strong process-outcomes links also exist for treating women with local or regional breast cancer with chemotherapy or hormone therapy or both in addition to surgery and radiation. Systemic treatment with chemotherapy or hormone therapy after all identifiable cancer has been removed surgically is termed adjuvant therapy. The goal of adjuvant therapy is to decrease future recurrences and thereby improve survival. However, the issue of adjuvant therapy in breast cancer raises another important consideration: When, despite strong evidence in the literature for a process-outcomes link, is the impact on outcome so small that the process should not be considered requisite for quality care? Adjuvant systemic therapy with either chemotherapy or hormone therapy has been demonstrated in randomized controlled clinical trials to improve survival in all women with breast cancer, although the benefit in women with very favorable prognoses is extremely small (EBCT, 1992, 1998). In addition, a small but significant improvement in both overall and disease-free survival is obtained from combined treatment with chemotherapy and tamoxifen (hormone therapy), compared with tamoxifen alone, in women with estrogen receptor-

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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positive tumors, regardless of the patient's age (Fisher et al., 1997). These studies demonstrate improved breast cancer outcomes with chemotherapy, tamoxifen, and perhaps both treatments together in all patients. However, given that the absolute benefit is extremely small in patients with a good prognosis (2 percent improvement in 10-year survival for low-risk patients), the benefits may not outweigh the risks of adjuvant treatment in these patients (Osborne et al., 1996). So although most experts would agree that all women with involved lymph nodes, large tumors, and even moderate-size tumors should receive adjuvant therapy, whether it is essential to offer treatment to women with extremely small tumors has not yet been clearly established. Thus, despite clear evidence of process-outcomes links for adjuvant therapy in breast cancer, the determination of whether all patients should be treated remains an issue of expert judgment and consensus. If adjuvant chemotherapy is administered, the quality of treatment can be evaluated by assessing whether an adequate dose of chemotherapy is given (Bonadonna, 1985).

Relatively few studies examine the full spectrum of cancer care. Hillner evaluated multiple dimensions of care for 983 nonelderly women diagnosed between 1989-1991 with early breast cancer and insured by Virginia Blue Cross/Blue Shield (BC/BS) according to a 12-point scorecard with target values set according to expert opinion (Table 4.4). Some procedures appeared to be overused (e.g., perioperative bone scans), while others were underused (e.g., breast conserving surgery, visit to medical oncologist to discuss adjuvant therapy). Claims for at least one cycle of chemotherapy were found for 83 percent of premenopausal, node-positive women.

Variations in Rates of Breast Conserving Surgery. Many studies have compared the proportion of women who receive breast conserving surgery (BCS) instead of mastectomy. The decision about which type of breast surgery to undergo depends on the size of the primary tumor, the skill and preferences of the surgeon, and the preferences of the patient. The proportion of women who would choose breast conserving surgery if they were presented with enough information to make an informed choice is not known. Since there is no benchmark for what percentage of women should receive breast conserving surgery, whether any identified variation in the rates of conservative surgery is associated with the quality of care cannot be ascertained. However, widespread differences in the percentage of women who receive the two types of surgery would suggest that some women are not able to completely exercise their choice.

The proportion of women who receive breast conserving surgery versus mastectomy as the primary surgical treatment for early breast cancer varies dramatically by region of the country, according to studies conducted in the 1980s after the results of randomized controlled trials demonstrating the equivalency of the two procedures were published. The proportion of all women 65 and older with early breast cancer who received breast conserving surgery ranged from 4 percent in Kentucky to 21 percent in Massachusetts in 1986 according to Medicare data (Nattinger et al., 1992). Across the nine areas with SEER registries, Seattle appeared to have the highest rates of breast conserving surgery in 1983-1989 with 34 percent of women with Stage I and II disease receiving BCS (Farrow et al., 1992; Lazovich et al., 1991; Samet et al., 1994). The national overall rates of breast conserving surgery among Medicare patients with nonmetastatic disease changed little between 1986 and 1990 (from 14.1 to 15.0 percent) (Nattinger et al., 1996). Although patient age, the sociodemographic characteristics of communities, hospital characteristics, and the availability of radiation therapy appear to affect the proportion of women who undergo breast conserving surgery, marked geographic variation in the use of the procedure persists even after adjusting for these characteristics (Farrow et al., 1992; Lazovich et al., 1991; Nattinger

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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et al., 1992; Samet et al., 1994). Although the proportion of women who would undergo breast conserving surgery if all eligible women were offered the procedure is not known, the wide regional variations could indicate variation in the quality of breast cancer care (i.e., women not offered choice of procedure by their provider).

TABLE 4.4

Target and Observed Care in 1989-1991 in Virginia BC/BS Women Age <65

Issue

Expert Target (%)a

BC/BS Cohort (%)a

Evaluation

Initial biopsy prior to total mastectomyb

>95

92

Treatment

Axillary node dissection

>90

88c

Breast conserving surgery for local disease

50

33

Local breast radiation following lumpectomy

>95

86

Staging

Perioperative (within 30 days) bone scan

<10

34

Perioperative (within 30 days) abdominal CT scan

<10

12

Adjuvant Chemotherapy

If premenopausal and >1 axillary node (+), receive chemotherapy,

>90

83

If postmenopausal and >1 axillary node (+), receive chemotherapyd

50

52

Referral

 

 

At least one visit to a medical oncologist to discuss adjuvant therapy

>80

56

If mastectomy, at least one visit to a plastic surgeon to discuss reconstructive surgery

>60

27

Follow-Up

 

 

Mammography within the first 18 months postoperatively

>95

79

Bone or CT scans for suspicious symptoms per year

<15

18-35

NOTE: CT = computed tomography.

a BC/BS cohort used local and regional summary staging.

b Biopsy could be aspiration cytology, core biopsy, or excisional biopsy prior to total mastectomy. A two-step surgical procedure is not implied.

c Based on axillary nodes reported to registry of those patients with summary staging; 11% of women with breast cancer were excluded since no staging data were reported.

d Chemotherapy only. Use of hormonal therapy could not be assessed.

SOURCE: Hillner et al., 1997.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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A recent study by Guadagnoli et al. (1998b) using data collected from medical records and a patient survey reported much higher rates of breast conserving surgery but still substantial regional variation when comparing women treated in 18 hospitals in 1993-1995 in Massachusetts and 30 hospitals in Minnesota in 1993. Although the hospitals participating in Massachusetts were selected randomly (20 were originally selected but two refused to participate), those from Minnesota were part of a consortium formed by the Healthcare Education and Research Foundation and included about 60 percent of patients hospitalized in Minnesota. Overall, 64 percent of women in Massachusetts and 38 percent of women in Minnesota with Stage I and II breast cancer received breast conserving surgery. However, after excluding patients with contraindications to breast conserving surgery (e.g., prior BCS, tumor multifocal, tumor centrally located), the proportions of eligible women receiving breast conserving surgery increased to 74 and 48 percent, for Massachusetts and Minnesota, respectively. Importantly, 27 percent of women in Minnesota and 15 percent in Massachusetts who underwent mastectomy, even though they were eligible for breast conserving surgery, reported that their surgeon had not discussed BCS with them. This suggests that a significant proportion of the variation in rates of breast conserving surgery reflects the fact that women have not been given an informed choice of procedure.

Data compiled by Wennberg et al. (1996) in the Dartmouth Atlas of Health Care using 1992-1993 Medicare claims show that widespread variation in the proportion of women offered breast conserving surgery remains. Without stratifying on stage in this predominantly 65 and older population, the proportion of inpatient cancer surgery that was a breast conserving procedure ranged from 1.4 to 48.0 percent by Medicare hospital referral region. In light of the data from Guadagnoli et al. (1998b) that up to one-quarter of women who undergo mastectomy have not been provided information about BCS, the persistent widespread regional variation in the performance of breast conserving surgery would appear to indicate that many women are not being offered a choice.

Other studies also have found significant variation in the use of breast conserving surgery according to hospital characteristics (Nattinger et al., 1992, 1996). A study by Nattinger et al. (1996) found that 55 percent of breast conserving surgeries performed on Medicare patients occurred in only 10 percent of the hospitals submitting claims in 1986 to 1990. Increased use of BCS was associated with larger hospital size, the presence of a radiation facility, the presence of a cancer program, being a teaching hospital, not-for-profit status, and the volume of breast cancer surgeries performed at the hospital. The study by Guadagnoli et al. (1998b) also found a positive association between breast conserving surgery and the teaching status of the hospital. The odds of breast conserving surgery were 2.4 times higher for patients treated at teaching hospitals in Massachusetts, and 1.5 times in Minnesota, compared with patients treated at nonteaching facilities (Guadagnoli et al., 1998b). Interestingly, in contrast to the Nattinger et al. (1996) study, Guadagnoli et al. found no relation between BCS and hospital size or presence of a radiation facility, perhaps indicating that these factors are no longer significant once higher rates of breast conserving surgery have been achieved overall in the community.

These studies suggest that many women are not offered a choice in the type of breast surgery and that steps have to be taken to increase the implementation of recommendations to promote informed decision making. Further research is needed to determine what proportion of patients are aware that breast conserving surgery is available, whether they are given a fully informed choice of surgery, and which procedure they ultimately receive. To evaluate this aspect

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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of quality of care, information would have to be obtained by patient self-report since this level of detail is not contained in cancer registries, claims, or medical records.

Receipt of Radiation, Adjuvant Chemotherapy, or Hormone Therapy Following Breast Conserving Surgery. Women who undergo breast conserving surgery should receive radiation therapy after surgery. Rates of radiation therapy after BCS suggest that in some parts of the United States, many women are not receiving needed radiation. In the nine SEER registry areas, the percentage of women receiving radiation therapy after breast conserving surgery in 1985-1986 had increased from 1983 to 1984, but still varied greatly (Farrow et al., 1992). Though Iowa had the greatest increase in the use of radiation therapy during this period, it still had the lowest use of all nine areas, with only 60 percent of women in 1985-1986 receiving radiation. Seattle had the highest use, with 81 percent in 1985-1986 receiving radiation therapy after breast conserving surgery. Although some women may refuse radiation therapy, one would hope that an informed discussion of the treatment options would lead many women who do not wish to receive radiation to choose mastectomy as their primary treatment. Thus, one might expect that only a small number of women would opt for breast conserving surgery without radiation.

A limitation of this study, and other studies that rely on cancer registry data, is that the validity of the data on treatment collected by the cancer registries has not been systematically evaluated. Thus, the low rates of radiation therapy after breast conserving surgery reported in this study may reflect incomplete data and not poor quality of care.

Alternatively, the low rates of radiation therapy after breast conserving surgery reported by Farrow et al. (1992) may reflect the practice in the 1980s but may not accurately describe the current quality of care in the United States. Two recently published studies of breast cancer care in selected populations suggest that the quality of care may have improved, at least for some women. Hillner et al. (1997) used 1989-1991 data from the Virginia Cancer Registry to evaluate the quality of care for 918 Virginia women age 64 or younger with Stage I-III breast cancer who had Blue Cross/Blue Shield health insurance. In this patient population, 82 percent of women who underwent breast conserving surgery received radiation therapy. In addition, 83 percent of women 50 and younger (who were assumed to be premenopausal) with node-positive disease received adjuvant chemotherapy. The authors were unable to assess the use of adjuvant hormone therapy through the claims data.

Guadagnoli et al. (1998a) compared the care received at 18 hospitals in Massachusetts by women diagnosed in 1993-1995 with Stage I or II breast cancer, with the care received at 30 hospitals in Minnesota by women diagnosed in 1993. In contrast to previous studies that relied on administrative data, these authors collected data about breast cancer treatment from medical records, patient surveys, and physician surveys. Among women treated at these institutions from 1993 to 1995, 84 percent in Massachusetts and 86 percent in Minnesota received radiation therapy after breast conserving surgery. In addition, 97 and 94 percent, respectively, of premenopausal women with node-positive breast cancer received adjuvant chemotherapy. By contrast, only 63 percent of postmenopausal women in Massachusetts and 59 percent in Minnesota who had positive lymph nodes and positive estrogen receptor status received adjuvant hormone therapy.

Another study (Young et al., 1996) used cancer registry data to examine the treatment of local breast cancer in Pennsylvania during 1986-1990, the time between that reported by Farrow et al. (1992) and by Hillner et al. (1997) and Guadagnoli et al. (1998a, b). This Study found that 82 percent of women received radiation therapy after breast conserving surgery. Of note, there

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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was substantial variation in the use of radiation therapy depending on the patient's type of insurance: 45 percent of Medicaid beneficiaries received radiation therapy, compared with 78 percent of Blue Cross/Blue Shield subscribers and 88 percent of Medicare enrollees.

An earlier study by Johnson et al. (1994), which looked only at the use of adjuvant therapy in women with Stage I and II breast cancer diagnosed in 1983-1989, also found high adherence to National Cancer Institute Consensus Conference guidelines among community hospitals participating in the Community Clinical Oncology Program (CCOP). The CCOP was initiated by the NCI in 1983 to increase community participation in clinical research (Kaluzny et al., 1995). In this study, the proportion of women with node-positive breast cancer receiving adjuvant hormone or chemotherapy was highest in 1988 after NCI released a clinical alert advising physicians of the potential benefits in women with node-negative disease. The proportion of women with node-negative breast cancer treated with adjuvant therapy increased from 26 percent in the quarter before the clinical alert to 54 percent in the quarter following its release. During the same period, the proportion of women with node-positive breast cancer treated with adjuvant therapy increased from 81 to 90 percent. A year after the NCI clinical alert, the percentage of node-negative patients treated remained elevated above baseline at 46 percent, while the percentage of node-positive women treated with adjuvant therapy had fallen back to the baseline rate of 79 percent. It is not known if the clinical alert had a transient spillover effect on the treatment of node-positive disease. The proportion of women receiving adjuvant therapy in this study approaches a level one would expect if all women who could benefit from adjuvant therapy were being offered treatment. These data are limited in their generalizability, however, because the facilities that chose to participate in the NCI's CCOP are more likely to have an interest in cancer treatment and more likely to adhere to NCI guidelines than the average facility in the community. Notwithstanding, these data—and those reported by Hillner et al. (1997) and Guadagnoli et al. (1998a)—demonstrate high levels of adherence to treatment standards for adjuvant therapy in breast cancer in selected patient populations, with the notable exception of the low use of hormone therapy in postmenopausal patients.

The higher rates of radiation therapy reported by Hillner et al. (1997), Guadagnoli et al. (1998a), and Young et al. (1996) compared with the earlier study of Farrow et al. (1992), may reflect a general improvement in the quality of breast cancer care in the United States. However, given the selected patient populations in the Hillner et al. (1997), Guadagnoli et al. (1998a), and Young et al. (1996) studies, these data must be interpreted cautiously, especially when attempting to generalize from these results to the entire U.S. population. The Hillner et al. (1997) study includes only women younger than 65 with private fee-for-service health insurance. Also, although the Guadagnoli et al. (1998a) study is not limited to a privately insured population, it is limited to patients treated at hospitals that agreed to participate and therefore may be providing a higher standard of care. The Young et al. (1996) study compared women with Blue Cross/Blue Shield, Medicare, and Medicaid and found that women with Medicaid received much poorer quality care. Nevertheless, these studies suggest that at least some women in the United States had access to high-quality breast cancer care by 1995. However, even among these women there is cause for concern since only 60 percent of postmenopausal women with node-positive, estrogen receptor-positive cancers received adjuvant hormone therapy.

One study conducted in 1988-1989 suggests that the dose of adjuvant therapy for women with breast cancer is inappropriately low. Schleifer et al. (1991) audited the care of 107 women with breast cancer by 29 oncologists at three university-affiliated practices. Adjuvant therapy over six months was retrospectively reviewed and patients were prospectively interviewed. More than

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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one-half (52 percent) of patients had at least one unjustified dose reduction. The total dose intensity for women whose doses were reduced was not reported. Older women and treatment in a ''clinic'' versus academic or private practice were associated with nonadherence to the treatment schedule.

Other studies using breast cancer process measures suggest that the proportion of women receiving standard treatment decreases with age, although the results of the published literature are not concordant. Several studies using cancer registry data to assess care for Medicare patients have shown that elderly women do not receive the recommended treatments for breast cancer as often as younger women, even when controlling for comorbid illness. Using New Mexico Cancer Registry data from 1984 to 1986, Goodwin et al. (1993) found that while only 43 percent of women age 85 and older, and 84 percent of women age 75 to 84, received definitive treatment for localized breast cancer compared with 92 percent of women age 65 to 74 (Goodwin et al., 1993). Definitive breast cancer treatment was defined as lumpectomy or excisional biopsy followed by radiation therapy or mastectomy. Age remained significant even when controlling for women's access to transportation, physical activity levels, income, social support, ability to perform activities of daily living, mental status, and the presence of other medical illnesses. In a comparable population of women in Virginia in 1985-1989, also using cancer registry data, Hillner et al. (1996) found that although the reported number of women age 65 to 69 receiving radiation therapy after breast conserving surgery was inappropriately low at 66 percent, only 7 percent of women age 85 and older had received radiation therapy (Hillner et al., 1996). In addition, although adjuvant therapy is recommended for all patients with node-positive disease, only 44 percent of patients with positive lymph nodes received any adjuvant therapy and only 33 percent received hormone therapy. Several studies, using data on treatment collected by the SEER cancer registries, have also noted that the use of radiation therapy in women who have undergone breast conserving surgery is lower than expected and declines with age (Ballard-Barbash et al., 1996; Farrow et al., 1992; Lazovich et al., 1991). Ballard-Barbash et al. (1996) found that whereas 76 percent of women age 65-69 received radiation therapy after breast conserving surgery for Stage I or II cancer, 68 percent of 70 to 74-year-olds, 56 percent of 75-to 79-year-olds, and 24 percent of women 80 years or older were given radiation treatment (Ballard-Barbash et al., 1996). They found that although controlling for differences in comorbidity was associated with a decrease in the frequency of radiation therapy after breast conserving surgery across all age groups, the decline with age persisted.

An earlier study, using data obtained directly from the medical record in seven southern California hospitals in 1980 through 1982, also found that rates of appropriate breast cancer treatment declined with age (Greenfield et al., 1987). Greenfield et al. (1987) reviewed patients' medical records to determine whether they had received diagnostic testing, staging evaluation, and treatment that was consistent with stage-specific consensus recommendations at the time (e.g., radiation therapy after breast conserving surgery; adjuvant chemotherapy for premenopausal women with node-positive breast cancer; adjuvant hormone therapy for postmenopausal women with node-positive estrogen receptor-positive tumors). Although the proportion of women receiving the recommended diagnostic and staging evaluations did not vary with age, the proportion receiving the recommended treatment did. According to the authors, 83 percent of women age 50 to 69 received the recommended breast cancer treatment compared with 67 percent of women age 70 and older. This difference remained significant when controlling for comorbidity, stage of breast cancer, and hospital at which treatment occurred.

In contrast, in a study of postmenopausal women age 50 and older with Stage I and II breast cancer treated in 1993 at 30 hospitals in Minnesota, using data collected through patient

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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self-report, survey of the treating physician, and the medical record, Guadagnoli et al. (1997) found that 92 percent of women with node-positive breast cancer received some form of adjuvant therapy. Although the likelihood of women with node-positive breast cancer receiving adjuvant therapy did appear to decline slightly with age, this was not statistically significant. The use of adjuvant therapy did decline in women with node-negative breast cancer, and this was true for both chemotherapy and hormone therapy: 73 percent of women 50 to 59 years old with node-negative breast cancer received adjuvant therapy compared with 67 percent of women age 60 to 69, 56 percent of women age 70 to 79, and 36 percent of women age 80 and older. However, these age-associated differences were not significant after adjusting for marital status, education, income, HMO membership, tumor size, lymphatic invasion, estrogen receptor status, grade, type of primary surgery, history of breast and other cancer, and severity of comorbid disease. The use of adjuvant hormone therapy in node-negative disease also declined to 34 percent in women age 80 and older from only 52 percent in the other age groups. Since the authors did not stratify on tumor size or estrogen receptor status, it cannot be determined if the subset of women with node-negative disease, but larger tumors, were more likely to receive adjuvant therapy, which would suggest that care was being provided in a manner consistent with the scientific evidence and medical consensus of the time.

This last study by Guadagnoli et al. (1997) reports appropriately high rates of adjuvant therapy and thus contradicts the other studies, which suggest that problems exist with the quality of care provided for elderly women with breast cancer in the United States (Ballard-Barbash et al., 1996; Farrow et al., 1992; Goodwin et al., 1993; Greenfield et al., 1987; Hillner et al., 1996; Lazovich et al., 1991). Of note, the Guadagnoli et al. (1997) study uses multiple data sources, including patient self-report, physician report, and the medical record, to obtain information about treatment. All of the authors who report poorer adherence to standard treatment in elderly patients, with the exception of Greenfield et al. (1987), used cancer registry data, which again raises the issue of the reliability of cancer registry data on processes of care. Another possible explanation for the higher rates of adjuvant therapy in the elderly in the study by Guadagnoli et al. (1997) is that the quality of care has improved over time; they report data from 1993, whereas the other studies include data from 1980-1986. Perhaps with the dissemination of the results of clinical trials performed in the 1980s, the use of adjuvant therapy and radiation therapy in the elderly after breast conserving surgery has increased appropriately. Alternatively, there may be regional variations in the quality of care that explain discrepancies in the results of these studies. Minnesota may have better-quality care for breast cancer than the rest of the United States. In any case, given the preponderance of data suggesting that compliance with standard therapy for breast cancer in older women in the United States is low, even in the face of an isolated study showing excellent quality of care in 30 hospitals in Minnesota, these results highlight potential problems in the quality of breast cancer care that warrant further investigation.

Evidence from the late 1980s suggests that some hospitals were providing poorer quality breast cancer care than others. In a study conducted in 1988 by Hand et al. (1991), the interquartile range (25th to 75th percentile) for hospitals in Illinois that did not provide radiation therapy after breast conserving surgery was 17 to 75 percent (Hand et al., 1991). For those not providing adjuvant therapy the interquartile range was 30 to 56 percent, and for those not performing an estrogen receptor test on the pathologic specimen it was 4 to 14 percent.

In conclusion, studies of processes of care that have compared rates of radiation therapy after breast conserving surgery and adjuvant therapy for locally advanced breast cancer suggest

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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that problems do exist with the quality of care received by many women in the United States. Many women (perhaps as many as 40 percent) do not appear to be receiving indicated radiation therapy after breast conserving surgery. In addition, older women are less likely to receive radiation therapy after breast conserving surgery. Rates of radiation therapy after breast conserving surgery also vary across hospitals, suggesting that some hospitals are providing poorer-quality breast cancer care than others. Of equal concern, many women do not appear to be receiving adjuvant chemotherapy (perhaps as many as 60 percent). These findings must be interpreted with caution, however, since many of the data reported are from the 1980s and are based on cancer registry data, whose accuracy is not known.

Variations in Compliance with American College of Radiology Quality Standards. While many women who undergo breast conserving surgery do not get indicated postoperative radiation therapy, potential quality problems still exist for the women who do get radiation therapy. The 1988 breast cancer Patterns of Care study performed by the American College of Radiology suggests widespread variation in compliance with standards of quality established by the ACR, with academic centers demonstrating the greatest compliance, followed by hospital facilities, and freestanding facilities having the poorest adherence (Kutchner et al., 1996). For example, immobilization of breast cancer patients receiving radiation therapy, in order to obtain consistent irradiation of the desired target, varied from 80 percent at academic centers, to 73 percent in hospital facilities, to only 51 percent in free-standing facilities. Similarly, the use of techniques to decrease the divergence of the radiation beam into lung tissue (in order to decrease pulmonary toxicity) ranged from 93 percent at academic centers to 77 percent at hospital facilities and 67 percent at free-standing facilities. A problem identified in an earlier 1983 Patterns of Care study was the misuse of axillary radiation; 53 percent of axillary node-negative women received radiation therapy. More recent data are needed to assess the state of compliance with radiology quality standards.

Follow-Up Care

Women should have a mammogram within 18 months following definitive surgery for breast cancer. According to one study of care provided to 936 privately insured, nonelderly women diagnosed from 1989 to 1991 in Virginia, only 79 percent had received a mammogram in the first 18 months (see Table 4.4).

The use of bone scans and imaging to search for liver metastases has been shown to have a low yield in clinical Stage I and II disease in numerous studies. Despite good evidence that their use does not improve clinical outcomes or quality of life (GIVIO, 1994), they are commonly done as a standard part of initial evaluation and often in subsequent follow-up care. In the Virginia study, 34 percent of women had a bone scan and 21 percent a computed tomography scan within 36 months of definitive surgery (Hillner et al., 1997).

The intensity of follow-up care appears to vary by site of care. During the same period, Simon et al. (1996) tracked 222 women treated and followed at one university hospital for three years. In the first year, patients treated with radiation or followed by medical oncology had the most frequent visits and intensity of testing. Wide variation in practice that was not explained by patient or provider characteristics was noted.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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Breast Cancer Summary

Studies of breast cancer quality of care have compared process and outcome measures to a standard across regions of United States. Rates of radiation therapy after breast conserving surgery and adjuvant therapy for locally advanced disease are lower than expected and suggest that problems may exist with the quality of care received by many women with breast cancer in the United States. Many women do not appear to be receiving indicated radiation therapy after breast conserving surgery, and in areas of the United States it appears that the percentage of women who do not receive radiation is very high. In addition, older women are less likely to receive radiation therapy after breast conserving surgery. Equally concerning, many women do not appear to be receiving adjuvant chemotherapy. Although these findings must be interpreted with caution since many of the data are from breast cancer cases diagnosed in the 1980s and collected primarily by cancer registries, they suggest that serious problems exist with the quality of care provided to women with breast cancer in the United States. To determine the quality of current practice, reliable process and outcome measures have to be applied to a national sample of newly diagnosed breast cancer patients and the results must be reported quickly.

Prostate Cancer

Prostate cancer is the most commonly diagnosed non-skin cancer in men. In 1999, 179,300 cases are expected to be diagnosed, and 37,000 men are expected to die from this disease (ACS, 1999). The number of new cases diagnosed has increased in recent years as a result of adoption of prostate-specific antigen (PSA) testing (Potosky et al., 1995), largely reflecting an increase in early detection rather than a true increase in incidence.

The risk of prostate cancer increases with age, with the average age at diagnosis about 65 years and the median age about 72; it is relatively rare in men younger than 50. Five-year survival rates are very high: nearly 90 percent of men diagnosed with prostate cancer will survive at least five years (ACS, 1998).

Assessing quality of care for prostate cancer detection and treatment is especially difficult. Definitive evidence supporting the efficacy of early detection for prostate cancer awaits the results of two clinical trials. NCI's Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial is examining the efficacy of early detection of prostate and other cancers, and the Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized trial that is addressing the efficacy of primary treatment of early-stage prostate cancer by surgery, compared to conservative management. There is currently no professional consensus regarding whether routine screening for prostate cancer should be performed (Table 4.5). Without essential information about the efficacy of early detection, there is no standard against which to assess the quality of screening or primary treatment. The prevalence of adverse effects of treatment (complications) may provide some information about quality of care. Presently, there is some limited evidence of variation in the results of treatment from facility to facility, but very little is known about the reasons for this variation.

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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TABLE 4.5

Prostate Cancer Screening Recommendations

Organization

Recommendation

American Cancer Society

Offer annual PSA testing to men over age 50 who have at least a 10-year life expectancy. Counsel certain high-risk groups (those with a family history including two or more first-degree relatives and African-American men) to begin testing at earlier ages (e.g., 45) (von Eschenbach et al., 1997)

American Urological Association

Offer the PSA test to men over age 50 who present for evaluation of prostatic disease symptoms after counseling them on the risks and benefits of the test. For men at high risk (positive family history, African American) the recommended age is 40 (Correa, 1998)

National Cancer Institute's PDQ

Evidence is insufficient to establish whether improvements in survival are associated with prostate cancer screening by DRE, TRUS, or PSA testing

U.S. Preventive Services Task Force (1996)

Routine screening is not recommended because of insufficient evidence regarding efficacy. Men who request screening should be given information about the risks and benefits of early detection and treatment

Veterans Administration

Discuss the risks and benefits of prostate cancer screening, including PSA testing, with men over age 50; however, no specific recommendation for routine screening is indicated (Wilson and Kizer, 1998)

NOTE: DRE = digital rectal exam; PSA = prostate-specific antigen; TRUS = transrectal ultrasound.

Measuring outcomes also has limitations in prostate cancer since the illness often progresses very slowly, so that long follow-up times are necessary to show differences in survival or disease progression. Differences in rates of recurrence or survival may be a result of treatment, but if treatment is not proven to be efficacious, then observed differences in outcomes across providers may simply reflect differences in patient selection.

Diagnostic Evaluation

Clinical staging is done using all information available prior to primary treatment, including digital rectal examination (DRE), imaging, and biopsy results (American Joint Committee on Cancer, 1997). Clinical staging of prostate cancer may be reported using one of two systems: modified American staging, or TNM (tumor-node-metastasis), or American Joint Committee on Cancer staging. Current methods for clinical staging may result in a substantial proportion of cases being understaged (up to 59 percent), with a smaller proportion being over-staged (about 5 percent) (Bostwick et al., 1994). Men with regional or metastatic prostate cancer should not have radical prostatectomy (see below for further discussion of appropriate care for advanced disease), and there is the potential for inappropriate surgery if the cancer is under-

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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staged. Inappropriate surgery can have significant effects on quality of life because the potential side effects of radical prostatectomy include permanent urinary and sexual dysfunction.

Numerous studies have illustrated the prognostic usefulness of pretreatment PSA, clinical stage, and Gleason score in predicting posttreatment outcomes such as risk of recurrence (American Joint Committee on Cancer, 1997; Pisansky et al., 1997). Partin et al. (1993) have developed tabulated estimates for risk of the tumor spreading (called extracapsular extension) using the Gleason score (indicating tumor differentiation) and PSA. The goal of this approach is to attempt to improve the prediction of pathological stage for patient counseling and treatment planning. Estimates from their original tables have been improved by pooling data from patients across multiple facilities (Partin et al., 1997), but concerns about patient representativeness may limit the use of these tables as decision aids for physicians.

In addition to PSA, Gleason score, stage, and patient comorbidity can provide independent prognostic information about treatment outcomes. Experts in urology and radiation oncology at academic treatment centers around the United States agree about the importance of comorbidity assessment as part of the pretreatment workup, but there is considerable variation in the methods used for such assessment (Schuster et al., 1998). Suggested information to be used includes: Karnofsky performance status; patient self-reported activity levels; obesity; and history of cardiac disease, vascular disease, pulmonary disease, hypertension, diabetes, and surgeries. Pretreatment urinary, bowel, and sexual functioning have most commonly been assessed by patients' verbal reports. Some physicians have reported using the American Urological Association symptom score to assess obstruction; formal assessment of potency, voiding symptoms, or continence is rarely performed on a routine basis.

Although there is evidence in the literature that PSA, stage, Gleason score, and patient comorbidity provide useful prognostic information when treating patients, there is no evidence indicating whether performing these assessments prior to initiating treatment improves patient outcomes. Given the absence of process-outcomes links for the pretreatment evaluation, developing process measures for this aspect of prostate cancer care would have to be based completely on expert opinion. At present, there are no specific guidelines for the staging, workup, or pre-treatment assessment of patient comorbidity.

Choice of Treatment Modality

The modality used for primary treatment of prostate cancer varies depending on stage of disease, age or life expectancy, and patient preference. Treatment of localized prostate cancer (T1 or T2) can include surgery (radical prostatectomy), radiation therapy (external beam, brachytherapy, or conformal radiation therapy), or expectant management (watchful waiting). However, surgical treatment is not recommended for patients whose life expectancy is less than 10 years because the risks of surgery outweigh the survival benefit (Talcott, 1996). In addition, conformal radiation therapy is still being studied for efficacy and side effects (compared to standard external beam radiation therapy), but it has not yet been widely adopted as standard practice among radiation oncologists. Definitive evidence is lacking about the comparative efficacy of alternative treatment modalities for treating early-stage prostate cancer. The information used to make such decisions may have varying accuracy depending on its source: for example, clinicians' assess-

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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ments of posttreatment complications have been found to greatly underestimate the rate reported by patients themselves (Litwin et al., 1998). This finding may suggest that a potentially important area for quality assessment is differences across providers in the patient counseling process.

A specific recommendation from the American Urological Association's (AUA's) clinical guidelines on the management of clinically localized prostate cancer is that all alternative treatment modalities (radical prostatectomy, radiation therapy external beam, interstitial treatment—and expectant management) should be presented to every patient (Middleton et al., 1995). Thus, a potential quality indicator could include whether these recommendations are followed by urologists.

Complications Associated With Primary Treatment Of Prostate Cancer

Estimates of complications resulting from primary treatment of prostate cancer vary widely across facilities even when stratifying by treatment modality: surgery, external beam radiation, or brachytherapy (interstitial radiation treatment or seed implants) (Middleton et al., 1995). After radical prostatectomy, rates of stress incontinence range from less than 10 to 50 percent and impotence rates range from 25 to 100 percent across series reports. Complications following external beam radiation included proctitis, with rates ranging from less than 10 percent to more than 50 percent; cystitis, ranging from 0 to 80 percent; and impotence, ranging from less than 10 percent to nearly 40 percent. Similarly, complication rates reported for brachytherapy range from 0 to 75 percent for proctitis, less than 10 percent to 90 percent for cystitis, and less than 10 percent to 75 percent for impotence.

While these widely varying complication rates may reflect differences in quality of care, it is difficult to draw conclusions based on this type of information (Wasson et al., 1993). First, there may be differences in the way the data were collected, which could account for variations in rates of complications. Second, there may be systematic differences in patient case mix (disease severity and comorbidities) across facilities, and these differences must be accounted for before comparing outcomes across institutions. Even if series reports could be adjusted for case mix, there is usually little information available to link differences in results to differences in the technical process of care. Finally, these series report data from only a small number of providers, often large academic clinics. The results for such providers may not represent those of other institutions or clinics.

Effectiveness of Radiation Equipment In Treating Localized Prostate Cancer

An early American College of Radiology Patterns of Care study examined the association between types of radiation equipment (a structure measure) and localized prostate cancer treatment outcomes (Hanks et al., 1985). Facilities that used cobalt units were found to have higher stage-adjusted rates of disease recurrence than facilities that used linear accelerators or betatrons. The use of cobalt equipment was also correlated with other structural indicators: these facilities had lower percentages of patients who were staged, had lower staff-patient ratios, and were more

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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likely to have parttime therapists, compared to national averages. From these results, the authors recommended that facilities using cobalt units should upgrade their treatment equipment, give palliative treatment only, or close. While this study helped to show that cobalt units were not as good as other types, the evidence available when the care was provided did not indicate that cobalt use was inappropriate. Therefore, this study was quite valuable in showing how to improve care, but it is not evidence of poor quality. Quality has to be judged by the level of knowledge and standards in place at the time care was delivered.

Treatment of Advanced Prostate Cancer

Treatment for advanced prostate cancer is palliative. Data from randomized controlled trials demonstrate a survival benefit as well as relief from bone pain by treatment with androgen ablation (the elimination of sources of male hormone such as testosterone), which can include orchiectomy alone, monotherapy with a luteinizing hormone-releasing hormone (LHRH) analogue, or "maximal androgen blockade" with either orchiectomy or an LHRH analogue and anti-androgen therapy (Garnick, 1996). When prostate cancer progresses on androgen ablation therapy, treatment is less effective; however, various drugs (ketoconazole or aminoglutethimide, estramustine, suramin, mitoxantrone with prednisone or steroids) can improve pain control and quality of life (Garnick, 1996). Because patients with prostate cancer that has metastasized to the bone often suffer excruciating pain, a primary focus in the care of patients with metastatic prostate cancer is control of their pain, with either narcotics, radiation therapy, or chemotherapy. So, although advanced prostate cancer is not curable, multiple treatment options exist and there is evidence in the scientific literature that they improve quality of life and, in some cases, prolong survival. Thus, there is sufficient evidence for process-outcomes links in advanced prostate cancer that process measures could be developed to evaluate the quality of care.

Prostate Cancer Summary

Prostate cancer provides a particular challenge for quality-of-care assessment: methods for early detection are available, but there is not yet definitive information about whether early detection improves survival. There are a number of treatment modalities for early-stage disease, but there is not definitive information about the efficacy of early treatment. The results of the PLCO trial will better inform decisions about whether routine screening for prostate cancer should be performed and for whom; and the results of the PIVOT trial will provide information about the efficacy of primary treatment of localized prostate cancer by surgery.

One candidate indicator for prostate cancer quality assessment is to identify whether information about alternative treatment modalities was presented to patients, as recommended by the AUA's practice guidelines (Middleton et al., 1995). A second candidate indicator may be to assess the rates of surgical treatment among men with life expectancies less than 10 years, using age 70 to represent a proxy for 10-year remaining life expectancy for the average patient (a high rate of surgical treatment in men with a life expectancy of less than 10 years would be an indicator of poor quality).

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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At present, available performance measures do not include quality indicators for prostate cancer treatment (e.g., measures of the National Committee on Quality Assurance and Foundation for Accountability). Investigators at RAND are developing candidate quality indicators based on a structured review of the literature, key informant interviews of prostate cancer experts, and focus groups with patients as part of a RAND study funded by the Bing Foundation. The next phase of this research will be to test the reliability and validity of these candidate measures in evaluating the quality of care, as well as exploring potential process-outcomes links.

Key Findings

Good indicators of quality are based on evidence from rigorous research, which is not available for most aspects of cancer care. For those aspects of care that have been evaluated, the quality of health care can be precisely defined and accurately measured. Measures of structure, process, and outcomes can all be used to assess quality. An outcomes indicator that is often used to evaluate cancer care has been five-year survival, but more timely and practical measures are becoming available to more precisely assess factors related to health care that can affect outcomes. Process measures can serve as good quality indicators when research has proved that a given process leads to better outcomes. Examples of good process measures for breast cancer include

  • use of screening mammography,
  • use of radiation therapy following breast conserving surgery, and
  • use of adjuvant therapy among women with local or regional breast cancer.

In other cases, research suggests that one process does not have an advantage over another in terms of outcomes, so patient preferences should dictate the course of care. For many women with breast cancer, for example, optimal care involves presenting information on alternative treatments and supporting an informed choice.

Sometimes, research suggests that providing a service does not have a favorable impact on outcomes, indicating that the service should not be provided. Most elderly men with prostate cancer, for example, would not likely benefit from radical prostatectomy if their life expectancy is less than 10 years. High rates of surgery among very old men could indicate that surgery is being performed too often when there is no expected benefit (and there is potential harm from surgery).

Two national databases are available with which to assess the quality of cancer care, but each has limitations in the context of evaluating quality of care. The SEER cancer registry has been valuable when linked to Medicare and other insurance administrative files to assess quality of care for the elderly and other insured populations. It is also useful in identifying cases for in-depth studies of quality-related issues. The SEER registry, however, covers only 14 percent of the U.S. population and thus may not adequately represent the diversity of systems of care. Finding ways to capture measures of process of care, treatment information, and intermediate outcomes and improving the timeliness of reporting would enhance the registry's use in quality assessment. The National Cancer Data Base now includes information on more than one-half of all newly diagnosed cases of cancer and many of the demographic, clinical, and health system

Suggested Citation:"4 Defining and Assessing Quality Cancer Care." Institute of Medicine and . 1999. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press. doi: 10.17226/6467.
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data elements needed to assess quality of care. The NCDB does not, however, include important aspects of care that take place in outpatient settings. The NCDB has not yet been widely used to assess quality of care but, if enhanced, would have great potential for doing so.

It is difficult to evaluate the quality of breast and prostate cancer care from the available evidence because

  • many studies have relied on data from the 1980s, and the care evaluated does not represent current practice;
  • many studies are difficult to interpret since dissimilar groups of patients are compared (e.g., insufficient controls for important clinical characteristics such as comorbidity);
  • studies are confined to a small group of patients, in one or a few institutions, states, or health plans, making it difficult to generalize to all cancer patients; and
  • studies are often based on data from cancer registries, which may not accurately represent some aspects of care (e.g., certain treatments may be underreported).

National studies of recently diagnosed individuals with cancer are necessary, using information sources with sufficient detail to allow appropriate comparisons. Ways must be found to produce information from these studies quickly, while they are still relevant to contemporaneous conditions.

Although the available evidence has limitations, it is suggestive of quality problems in cancer care. For women with breast cancer, many do not appear to be receiving indicated radiation therapy after breast conserving surgery. Of equal concern, many women with appropriate indications do not appear to be receiving adjuvant chemotherapy. Both treatments are known to improve outcomes. Furthermore, there is evidence of poor quality in essential aspects of the diagnostic process that is likely to compromise outcomes (e.g., inadequate biopsies, poor reporting of pathology studies). Evidence also suggests that a significant number of women with breast cancer and men with prostate cancer are not receiving information about the full range of treatment options available to them.

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We all want to believe that when people get cancer, they will receive medical care of the highest quality. Even as new scientific breakthroughs are announced, though, many cancer patients may be getting the wrong care, too little care, or too much care, in the form of unnecessary procedures.

How close is American medicine to the ideal of quality cancer care for every person with cancer? Ensuring Quality Cancer Care provides a comprehensive picture of how cancer care is delivered in our nation, from early detection to end-of-life issues. The National Cancer Policy Board defines quality care and recommends how to monitor, measure, and extend quality care to all people with cancer. Approaches to accountability in health care are reviewed.

What keeps people from getting care? The book explains how lack of medical coverage, social and economic status, patient beliefs, physician decision-making, and other factors can stand between the patient and the best possible care. The board explores how cancer care is shaped by the current focus on evidence-based medicine, the widespread adoption of managed care, where services are provided, and who provides care. Specific shortfalls in the care of breast and prostate cancer are identified. A status report on health services research is included.

Ensuring Quality Cancer Care offers wide-ranging data and information in clear context. As the baby boomers approach the years when most cancer occurs, this timely volume will be of special interest to health policy makers, public and private healthcare purchasers, medical professionals, patient advocates, researchers, and people with cancer.

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