Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia (2005)

Shortly after 1998, leading members of Georgia’s government, medical community, and public-spirited citizenry began considering ways in which some of Georgia’s almost $5 billion, 25-year settlement from the tobacco industry’s Master Settlement Agreement with the 50 states could be used to benefit Georgia residents. Given tobacco’s role in causing cancer, they decided to create an entity and program with the mission of making Georgia a national leader in cancer prevention, treatment, and research (GCC, 2001, 2003). This new entity—called the Georgia Cancer Coalition, Inc. (GCC)—and the state of Georgia subsequently began implementing a far-reaching state cancer initiative that includes five strategic goals: (1) preventing cancer and detecting existing cancers earlier; (2) improving access to quality care for all state residents with cancer; (3) saving more lives in the future; (4) training future cancer researchers and caregivers; and (5) turning the eradication of cancer into economic growth for Georgia (GCC, 2001).

In conjunction with this effort, GCC contracted with the Institute of Medicine (IOM) to identify a set of measures that could be used to gauge Georgia’s progress in improving the quality of its cancer services and in reducing cancer-related morbidity and mortality (Toal, 2003). The measure set should be pertinent to the mission and goals of GCC, in a form that is reasonable to implement, and drawn from established clinical guidelines or quality measures already in use. The current availability of the data necessary to develop the measures was not a principal concern because GCC intended to invest simultaneously in creating a state-of-the-art information infrastructure.

The IOM Committee on Assessing Improvements in Cancer Care in Georgia was established in the fall of 2003. Its assigned mission was to develop a set of quality-of-cancer-care measures that could be used by states—Georgia in particular—to assess progress in improving cancer-related services and in reducing cancer morbidity and mortality; to address economic, geographic, racial, and ethnic disparities in cancer care; to inform the governor, state legislature, and executive branch of GCC’s progress; to contribute to quality improvement initiatives and health education; and to educate the state’s health care community and the general public about cancer.

As described below, the committee first developed a conceptual framework for its review of potential quality measures for Georgia’s cancer initiative. After deliberating and considering scientific and other evidence, the committee decided to recommend 52 quality-of-cancer-care measures spanning the domains of cancer prevention, early detection, diagnosis, and treatment services. In addition, the committee recommended that Georgia take steps to capture cancer patients’ experiences as indicators of quality, as well as to understand and seek to reduce economic, geographic, and racial or ethnic disparities in the cancer burden and quality of cancer care. The committee believes that evaluating patients’ experiences will be as critical to assessing the quality of cancer care as deploying the 52 recommended quality indicators. It also believes that cancer outcomes will not meaningfully improve for Georgia unless disparities in the quality of cancer care are remedied.

The IOM committee began by establishing some basic definitions and concepts, including what constituted good quality health care, how to define quality measures, and what principles and criteria the committee should use to select quality measures for cancer care. The committee decided to recommend a rather slim set of quality-of-cancer-care measures, noting that in the future, as Georgia’s quality monitoring system matures, GCC can expand the scope and types of measures it employs.

To define good quality health care, the committee built on the classic work on quality of care of Avedis Donabedian and others (Donabedian, 1980; IOM, 1998, 1999a, 2000a,b, 2001a,b; Asch et al., 2000; McGlynn, 2002, 2003a,b; McGlynn and Malin, 2002; McGlynn et al., 2003). Accordingly, it defined good quality health care as patient-centered care that makes desired health outcomes more likely and more consistent with current professional knowledge (IOM, 1990, 2001a). In other words, good quality care means “doing the right thing, at the right time, in the right way, for the right person—and having the best possible results” (AHRQ, 2001). The

committee also agreed that there are three types of quality problems in health care—underuse, overuse, and misuse (IOM, 1998). Because patient-centeredness is fundamental to high-quality health care (IOM, 2001a), the committee also took the view that measuring patients’ perspectives, experiences, and preferences regarding the structure, process, and outcomes of cancer care is fundamental to measuring quality.

Using the excellent work of Donabedian and the IOM Roundtable on Health Care Quality as background, the committee devised a scoring evaluation and an informative staff-prepared one-page description for the review of potential quality measures as noted below. The committee limited its review to measures that might be used to track progress in controlling four types of cancer that together account for more than half of the cancer cases and deaths in Georgia—namely, breast, colorectal, prostate, and lung cancers. Because earlier IOM reports (IOM, 1999a) have pointed to a “wide gulf” between what is known about cancer care and what is actually experienced by many Americans, the committee further narrowed its review to focus on clinical indicators of quality, that is, measures useful in assessing the quality of preventive, diagnostic, and therapeutic patient care, rather than potential community-based, public health measures.

In deciding which quality-of-cancer-care measures should emerge from the evaluation process, the committee was guided by the principles and selection criteria of the National Quality Forum’s Strategic Framework Board, which were reflected in the scoring evaluation (McGlynn, 2002). Each measure should relate directly to one of the first two strategic goals of GCC, either preventing cancer and detecting existing cancers earlier, or improving access to quality care for all Georgians with cancer. Each measure should have a clear and compelling rationale and should avoid imposing an undue burden on those providing data (with the understanding that critical improvements to Georgia’s cancer information infrastructure may be necessary). Each measure should be actionable so that Georgia providers and other stakeholders can use it for making decisions or taking steps to improve the state’s cancer care, and each measure should help GCC lead the improvement of cancer care in Georgia. Additional criteria the committee used as ideals to guide its decisions about whether to accept or reject specific quality-of-cancer-care measures were each measure’s importance, scientific acceptability, and feasibility/utility (NQF, 2003). Finally, the committee weighed the strength of the evidence for each measure, using the hierarchy of evidence developed by the U.S. Preventive Services Task Force—with randomized clinical trials (Grade I evidence) at the top, followed by well-designed, controlled trials without randomization, cohort, or case control studies (Grade II evidence), and expert opinion, descriptive studies, and case reports (Grade III evidence).

The 52 quality-of-cancer-care measures recommended for Georgia by the committee are discussed below. The state should regularly revisit the measure set to consider potential new measures, make adjustments to existing measures, and retire measures if they prove to be ineffective or no longer relevant. As can be seen in Table ES-1, the recommended measures are organized in terms of their relationship to specific elements of the cancer control continuum:

• Measures related to preventing cancer. The objective of cancer prevention is to avoid the development of cancer (e.g., via the use of interventions that eliminate or reduce exposures to the causes of cancer, including tobacco, environmental carcinogens, and lifestyle factors). Ten of the recommended quality measures pertain to cancer prevention.

• Measures related to detecting cancer early. The objective of early detection is to allow the cancer to be treated at a localized stage when prospects for success are greatest (e.g., via the use of screening tests to identify premalignant disease or cancer in persons without signs or symptoms of cancer). In the case of colorectal cancer, colonoscopy screening can also prevent the development of cancer. Five of the recommended quality-of-cancer-care measures pertain to early detection.

• Measures related to diagnosing cancer. The objective of cancer diagnosis is to confirm the presence or absence of cancer and to ascertain the stage of disease. Fourteen of the measures recommended for Georgia are related to cancer diagnosis.

• Measures related to treating cancer. The objective of cancer treatment is to cure cancer or improve the patient’s quality of life through the provision and coordination of the basic treatment modalities—i.e., surgery, chemotherapy and/or hormonal therapy, and radiation—as well as psychosocial support, rehabilitation, and symptom management and palliative care. Twenty-three of the recommended quality measures pertain to cancer treatment.

For most cancers, including lung cancer, the search for effective primary treatments continues, and the most effective means of control is prevention (Alberg and Samet, 2003). The committee recommends that Georgia adopt 10 quality measures related to cancer prevention: two measures of smoking rates, two measures of the delivery of smoking cessation interventions, one measure of obesity trends, and five measures of cancer incidence rates.

Smoking rates and interventions. Cigarette smoking accounts for at least 30 percent of cancer-related deaths and a staggering 87 percent of lung cancer deaths in Georgia (ACS, 2004). Thus, the application of evidence-based, effective means to discourage individuals from taking up smoking and to help current smokers quit smoking could help prevent a substantial portion of cancer cases (IOM, 2003a).

The first two recommended measures related to cancer prevention are smoking rates among adults and smoking rates among adolescents in high school. Because many of the health risks associated with smoking are reduced after quitting (U.S. DHHS, 1989), two additional quality measures recommended by the committee pertain to the delivery of recommended smoking cessation interventions. One is the percentage of smokers aged 18 and older advised by a health professional to quit smoking in the past year. The other recommended measure is the percentage of adult smokers whose health professional recommended or discussed medication to help them quit smoking in the past year.

Trend in obesity. The fifth quality measure related to cancer prevention is the adult obesity rate. Obesity, defined as a body mass index of 30 or more,¹ is a major risk factor for breast, colorectal, and other types of cancer (Vainio and Bianchini, 2002; Key et al., 2004). One way to help prevent such cancers, therefore, is by reducing obesity (Friedenreich, 2001).

Cancer incidence rates.² Cancer incidence rates are the ultimate indicators of success in preventing cancer. With sustained and effective cancer prevention efforts, Georgia should eventually experience declining cancer incidence rates. For that reason, the committee recommends that the state track five measures of cancer incidence: the incidence of all cancers combined (all sites) and the incidence of breast, colorectal, lung, and prostate cancer, respectively.

Five quality-of-cancer-care measures are recommended by the committee in the realm of early detection: two measures that track the use of cancer screening interventions and three that track the stage at which cancer is diagnosed.

Use of cancer screening interventions. The first recommended measure related to early detection is the proportion of women aged 52 to 69 with

one or more mammograms in the past 2 years. Numerous randomized clinical trials have yielded strong evidence that routine mammography screening reduces the risk of death from breast cancer by as much as 35 percent (USPSTF, 2002a; Fletcher and Elmore, 2003; NCI, 2004). The evidence supporting regular mammography is strongest for women aged 50 to 69 (USPSTF, 2002a). Although monitoring should begin at age 50, the measure starts at age 52 because it will be applied retrospectively and should allow for the full 2 years to receive recommended screening.

The second recommended measure is the proportion of adults aged 52 to 80 who have been screened for colorectal cancer (i.e., received either a fecal occult blood test within the past year, flexible sigmoidoscopy within the past 5 years, colonoscopy within the past 10 years, or double-contrast barium enema within the past 5 years). The United States Prevention Services Task Force (USPSTF) and most other guidelines recommend that starting at age 50, all people should be periodically screened for colorectal cancer using one of the available options (USPSTF, 2002b; Winawer et al., 2003; IOM, 2003a).

Cancer stage at diagnosis. Two of the recommended quality measures related to early detection track breast cancer stage at diagnosis. One is the proportion of new breast cancer cases in Georgia diagnosed at a treatable early stage (in situ or localized), and the other is the incidence of advanced-stage breast cancer (regional or distant stage) among females aged 40 and older. If Georgia significantly increases routine mammography screening, women diagnosed with breast cancer will be more likely to be diagnosed with treatable, early-stage disease (USPSTF, 2002a; IOM, 2003a), and the incidence of advanced-stage breast cancer in the state will decline.

The last measure related to early detection is the incidence of advanced-stage colorectal cancer. If Georgia improves the rate of routine colorectal cancer screening, the incidence of advanced-stage colorectal cancer will decline (USPSTF, 2002b; IOM, 2003a).

Fourteen quality measures recommended by the committee are related to diagnosing cancer: five measures of the adequacy of diagnostic and surgical specimens; five of the adequacy of pathology reports on surgical specimens; and four of the staging of patients’ cancers prior to chemotherapy or radiation treatment.

Adequacy of diagnostic and surgical specimens. The first of the five recommended quality measures pertaining to the adequacy of diagnostic and surgical specimens is the proportion of women who receive a biopsy within 14 days of the first documentation of a category 4 or 5 abnormal mammogram. The National Comprehensive Cancer Network recommends a

follow-up biopsy of suspicious or highly suggestive abnormal mammograms (NCCN, 2004c). The IOM committee believes strongly that, under such circumstances, women should not have to wait longer than 14 days for a biopsy of the mammogram abnormality.

The second recommended quality measure is the proportion of women who have a needle biopsy of the breast at least 1 day before breast cancer surgery. Needle biopsy is preferred to alternative diagnostic approaches because it is quick, accurate, and less invasive and also yields a better cosmetic outcome (Liberman, 2000; Collins et al., 2004; Baxter et al., 2004; NCCN, 2004c).

The third recommended quality measure is the proportion of breast cancer surgery patients whose surgical margins are free of tumor after the last surgery. The goal of breast cancer surgery is to completely remove the tumor and to obtain clear surgical margins. There is extensive evidence that surgical margins that are not clear are associated with higher rates of breast cancer recurrence (Silverstein et al., 1999; Fredriksson et al., 2003; NCCN, 2004b).

The final two measures related to the adequacy of diagnostic and surgical specimens track the adequacy of histological assessment of lymph nodes for patients who undergo surgery for cancer: first, the proportion of Stage I and Stage II breast cancer cases with sentinel node biopsy or histological assessment of 10 or more axillary lymph nodes; and second, the proportion of colorectal cancer surgery patients with documented histological assessment of 12 or more lymph nodes. There is extensive literature showing that survival of colorectal cancer increases with the number of recovered lymph nodes, regardless of how many nodes are positive (Stocchi et al., 2001; Le Voyer et al., 2003; Compton, 2003).

Adequacy of pathology reports on surgical specimens. Pathologists’ findings are critical to proper cancer staging, treatment decisions, and the evaluation of a patient’s prognosis. Thus, five of the recommended quality measures related to cancer diagnosis pertain to the adequacy of pathology reports on surgical specimens from patients with breast, colorectal, lung, or prostate cancer. One measure is the proportion of pathology laboratories that report College of American Pathologists (CAP) data elements as required by the American College of Surgeons’ Commission on Cancer. Pathology reports on cancer specimens examined in Commission on Cancer-certified laboratories must contain the scientifically validated elements from reporting checklists developed by CAP (Commission on Cancer, 2003; Gal et al., 2004; Srigley et al., 2004; Compton, 2004; Fitzgibbons et al., 2004). The four other measures are the proportion of pathology reports on surgical specimens from patients with the four major types of cancer—breast, colorectal, lung, and prostate cancer—that include the CAP data elements required by the Commission on Cancer.

Documentation of cancer pathologic stage before chemotherapy or

radiation treatment begins. Chemotherapy and radiation treatment of most cancers should not be initiated until the pathologic stage of the cancer has been determined and documented in the medical record. Documenting the stage of cancer is essential to the provision of good quality cancer care (Compton, 2003). Thus, four of the quality-of-cancer-care measures recommended by the committee for Georgia pertain to the documentation of cancer stage. The measures are the proportion of breast, colorectal, lung, and prostate cancer cases, respectively, with medical chart documentation of pathologic tumor stage before chemotherapy or radiation is initiated.

If Georgia is to significantly improve cancer outcomes for its residents, it must aim for the delivery of evidence-based cancer treatment statewide. As shown in Table ES-1, the committee recommends that Georgia adopt 23 quality measures to gauge the state’s progress in improving cancer treatment. Four of these measures pertain to the receipt of appropriate primary therapy for cancer; four to appropriate adjuvant therapy for cancer; two to appropriate follow-up care for cancer; four to the minimization of cancer patients’ suffering; and nine to cancer survival and mortality rates.

Receipt of appropriate primary therapy. One of the recommended measures related to primary therapy for cancer is the proportion of cancer patients in treatment in Georgia who participate in clinical trials. National Cancer Comprehensive Network guidelines strongly encourage cancer patients to participate in clinical trials (NCCN, 2004a). Furthermore, expanding participation in cancer clinical trials is a principal, strategic goal of GCC (GCC, 2003).

The other three recommended quality measures related to primary therapy for cancer track whether prostate cancer patients receive evidence-based care. Although evidence on the comparative efficacy of the alternative treatments for prostate cancer is scarce (Potosky et al., 2000), evidence supporting the optimal delivery of recommended treatments is well established. The committee selected the three recommended quality measures related to therapy for prostate cancer taking that evidence into account.

Receipt of appropriate adjuvant therapy. Noting that adjuvant therapies that are critical to the survival of breast and colorectal cancer patients are frequently underused, the committee recommends that Georgia adopt four quality indicators to monitor cancer patients’ receipt of appropriate adjuvant therapy (Du et al., 1999; Nattinger et al., 2000; Gilligan et al., 2002; Hahn et al., 2003). The available data on the benefit of adjuvant therapy for lung and prostate cancer are too limited or inconclusive to support recommending measures in these areas.

The first three recommended quality measures pertain to adjuvant

therapy for breast cancer. One measure is the proportion of selected women who receive adjuvant radiation within 8 weeks of breast-conserving surgery for invasive breast cancer. An established, high-level evidence base shows that adjuvant radiation after breast-conserving surgery markedly reduces the risk of recurrence in the same breast compared with surgery alone (Early Breast Cancer Trialists’ Collaborative Group, 2000).

The second recommended quality measure is the proportion of selected women who receive adjuvant hormonal therapy for invasive breast cancer. Considerable evidence shows that adjuvant hormonal therapy—tamoxifen in particular—reduces the risk of tumor recurrence and significantly improves survival for women with early-stage hormone receptor positive breast cancer (Early Breast Cancer Trialists’ Collaborative Group, 1998; Adjuvant therapy, 2000; Baum et al., 2002; Winer et al., 2002; Goldhirsch et al., 2003).

The third recommended measure is the proportion of selected breast cancer patients who receive adjuvant combination chemotherapy. An extensive body of research based on randomized trials shows that combination chemotherapy substantially increases relapse-free survival and survival overall for women under age 71 with operable breast cancer (Adjuvant therapy, 2000; Cole et al., 2001). There are insufficient data to either support or discourage adjuvant chemotherapy for women over age 70.

The fourth recommended quality measure related to adjuvant therapy is the proportion of selected colon cancer patients who receive adjuvant chemotherapy after surgery. Numerous randomized trials have shown that adjuvant chemotherapy substantially increases disease-free and overall survival of patients with Stage III colon cancer (Moertel et al., 1995; IMPACT Investigators, 1995; Wolmark et al., 1999; Potosky et al., 2002).

Receipt of appropriate follow-up care. The committee recommends that Georgia adopt two quality indicators to monitor appropriate follow-up of individuals treated for cancer. The first recommended measure is the proportion of women with breast cancer who receive a follow-up mammogram by 19 months after their diagnosis. The measure focuses on the 19 months after a breast cancer diagnosis to allow for a 12-month follow-up period after a 7-month therapeutic period. The second recommended measure is the proportion of patients treated for Stage I to Stage III colorectal cancer who receive a follow-up colonoscopy within a year of their surgery. Insufficient evidence or consensus exists to support recommendations for measures of follow-up after treatment for lung or prostate cancer.

Minimization of suffering. The committee recommends that Georgia use four quality indicators related to the minimization of cancer patients’ suffering. One measure is the proportion of cancer patients with documented pain assessment. Severe pain is often characteristic of cancer patients’ experience during the course of treatment and afterwards, as well as in the later

stages of terminal disease (Goudas et al., 2001; Allard et al., 2001; IOM, 2003b). Several studies indicate that the most important predictor of inadequate pain relief is a discrepancy between the patient’s and the physician’s assessment of the severity of pain (Jacox et al., 1994; Reifel, 2000). Consequently, numerous clinical guidelines advise that patients be directly queried regarding their level of pain (Jacox et al., 1994; WHO, 1996; ONS, 2002; National Consensus Project for Quality Palliative Care, 2004; JCAHO, 2004; NCCN, 2004d). The second recommended measure is the prevalence of pain among cancer patients. Although there are no definitive estimates of the prevalence of pain among cancer patients, a measure of prevalence across varied care settings and in different subgroups should provide information about the adequacy of pain management (Symptom management, 2002).

In addition, the committee recommends that Georgia use two measures to monitor the use of hospice services at the end of life. Hospice is a home-based or inpatient program of palliative and supportive care services that provides physical, psychological, social, and spiritual care—and it is the gold standard of care for dying persons, their families, and other loved ones (ASCO, 1998; NCCN, 2004e). One of the recommended quality measures, therefore, is the incidence of cancer deaths in hospice. Most patients are referred to hospice too late to fully benefit from hospice care, and some dying cancer patients are not referred at all (MedPAC, 2002; NCCN, 2004e). The other recommended measure is the proportion of cancer patients who have a hospice length of stay of at least 7 days. The median length of hospice stay for adult cancer patients was 15.4 days in 2000, but a substantial proportion of cancer patients receive hospice care just days before death (AHRQ, 2003).

Cancer survival³and mortality rates.⁴ If Georgia succeeds in narrowing the gap between what is known about effective cancer treatment and what is practiced in health care settings, the state will eventually see improved cancer survival rates and reduced cancer mortality rates. For that reason, the committee recommends that Georgia track 5- and 10-year relative cancer survival rates for each of the state’s four most common cancers: breast, colorectal, lung, and prostate cancer. The committee also recommends that Georgia track mortality rates caused by each of these four cancers, along with the mortality rate for all types of cancer.

The IOM committee believes that evaluating patients’ experiences is critical to assessing the quality of cancer care. Responsiveness to patient-centered needs, preferences, and outcomes is a fundamental attribute of quality of care (IOM, 2001a; AHRQ, 2003). The committee also believes that cancer outcomes will not meaningfully improve for Georgians unless an effort is made to reduce the gross disparities in the behaviors and environmental conditions that lead to cancer, as well as in the incidence, diagnosis, treatment, and outcomes of cancer (IOM, 1999b, 2003c; Landis et al., 2004; Jemal et al., 2004).

For these reasons, the committee recommends that Georgia expand and enhance its cancer information systems to include (1) a patient survey program to collect data pertaining to cancer patients’ experiences that can be used to assess the quality of cancer care, and (2) a system for the collection and analysis of high-quality data that yield insights into how best to address racial, ethnic, and socioeconomic disparities in the cancer burden and quality of cancer care. Georgia’s use of patient surveys to capture cancer patients’ experiences is likely to be groundbreaking. GCC will face numerous and complex survey design decisions and should obtain expert advice. Guidance on sampling design and potential topics for patient surveys are provided in Chapter 7, along with advice about improving the collection of cancer-related data that can be used to understand and reduce disparities. Socioeconomic data will be essential to better understanding racial and ethnic disparities. Georgia should consider using currently available software to geocode its cancer registry records as each new cancer case is entered into the state’s surveillance database.

GCC now faces the challenge of implementing the quality-of-cancer-care measures. Precisely how this should best be done is well beyond the scope of this report, but implementation is a very important undertaking. In the final chapter of the IOM report, the committee offers advice on important principles of implementation for this first-of-a-kind state cancer care quality program. The IOM committee urges GCC to remember that the purpose of monitoring the quality of cancer care is not only to evaluate progress but also to motivate change. Implementation should begin with a blueprint for a cancer surveillance, monitoring, and evaluation organizational unit. The unit must be managed by the highest level of GCC with the assurance of long-term, sustainable funding. The monitoring system itself should be transparent and public, and it should build on Georgia’s existing measurement and reporting systems.

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