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

Whatever Georgia may achieve by expanding cancer screening and early detection could be compromised if the state fails to adequately address the next stages in the continuum of cancer care—diagnosis and treatment. Cancer diagnosis is the critical first step in ascertaining the tumor biology or characteristics and extent of disease, as well as in determining the optimal clinical strategy for combating the disease. Several aspects of the diagnostic process are fundamental to quality cancer care: (1) the timely gathering of appropriate diagnostic and surgical specimens for histological assessment, (2) clear, reliable, and standardized pathology reporting on surgical specimens, and (3) documenting the stage of disease before initiating treatment.

The Institute of Medicine (IOM) committee recommends that the Georgia Cancer Coalition (GCC) adopt 14 quality measures related to

cancer diagnosis (Box 5-1). The first five measures will help Georgia ensure that adequate diagnostic and surgical specimens are available for timely, pathologic assessment or evaluation of breast and colorectal cancers. The next five measures can be used by Georgia to track the quality of the pathology reports on cancer surgical specimens, which clinicians depend on to assess the extent of the cancer and to advise patients on treatment options. The final set of four measures will help the state ensure adequate treatment planning by monitoring whether health care providers document patients’ cancer stage before initiating chemotherapy or radiation treatment.

The 14 recommended quality measures pertaining to cancer diagnosis are discussed further below. For each measure discussed, there is a section providing a brief rationale for the selection of the measure, explanation of the evidence underlying the measure (the “consensus on care”) and a description of what is known about the gap between the evidence and current practice (“knowledge vs. practice”). Also provided near the end of the chapter is a brief section on the potential data sources for measures in

the diagnostic domain. The chapter concludes with summaries of each quality measure.

Two of the five recommended quality-of-cancer-care measures related to the adequacy of diagnostic and surgical specimens pertain to the use of biopsies in breast cancer diagnosis. During a breast biopsy, either a small sample of suspicious breast tissue (i.e., an incisional core biopsy) or an entire lump or suspicious area is removed (i.e., an excisional biopsy) for histological assessment. When the tissue sample is removed with a needle, the procedure is referred to as a needle biopsy or fine-needle aspiration. To track the timeliness of biopsy after a suspicious, abnormal mammogram and the use of needle biopsy before breast cancer surgery, the committee recommends that Georgia adopt the following measures:

• Measure 5-1—Timely breast cancer biopsy—the proportion of women who receive a biopsy within 14 days after first documentation of a category 4 or 5 abnormal mammogram.

• Measure 5-2—Use of needle biopsy in breast cancer diagnosis—the proportion of women who have a needle biopsy of the breast at least 1 day prior to breast cancer surgery.

The remaining three measures pertain to the collection and histological assessment or evaluation of surgical specimens taken from patients who undergo surgery for breast or colorectal cancer. To monitor the appropriate collection and histological assessment or evaluation of breast and colorectal cancer surgical specimens, the committee recommends that the GCC adopt the following measures:

• Measure 5-3—Tumor-free surgical margins in breast-conserving surgery for breast cancer—the proportion of patients undergoing breast-conserving surgery whose surgical margins are free of tumor after the last surgical procedure.

• Measure 5-4—Appropriate histological assessment of breast cancer—the proportion of Stage I and Stage II breast cancer cases with sentinel node biopsy or with histological assessment of 10 or more axillary lymph nodes.

• Measure 5-5—Appropriate histological assessment of colorectal cancer—the proportion of colorectal cancer surgery patients with documented histological assessment of 12 or more lymph nodes.

The rationale for the IOM committee’s decision to recommend each of these measures is discussed further below.

The first two recommended quality-of-cancer-care measures pertaining to the adequacy of diagnostic and surgical specimens are the timeliness of biopsy after a suspicious, abnormal mammogram and the use of needle biopsy before breast cancer surgery. A strong evidence base shows that screening mammography reduces breast cancer deaths by finding cancer at an early, treatable stage (USPSTF, 2002).¹ Mammography can only improve breast cancer outcomes, however, if follow-up of abnormal findings is timely and appropriate. Screening mammography findings should be documented according to the Breast Imaging and Reporting Data System (BI-RADS) (Box 5-2). Women with abnormalities that are suspicious or suggestive of malignancy—BI-RADS categories 4 and 5—should be followed up with a biopsy according to the National Comprehensive Cancer Network (NCCN) breast screening and diagnosis guidelines (ACR, 2003; NCCN, 2004c).

Timely breast cancer biopsy.

Consensus on care. There is no consensus on the ideal interval between finding a category 4 or 5 abnormal mammogram and the follow-up biopsy; however, the available evidence suggests that the interval should be brief (Olivotto et al., 2001). The Institute for Clinical Systems Improvement recommends that the biopsy be completed in less than 14 days after first documentation of a category 4 or 5 mammogram; RAND, Inc. recommends no more than 6 weeks (Gifford and Schmidt, 2000; ICSI, 2003). Delayed diagnosis of breast cancer is associated with later stage at diagnosis and poorer prognosis. A recent, multivariate analysis of 4,465 women with invasive breast cancer suggests that 6- to 12-month delays to diagnosis of asymptomatic breast cancer are associated with increased risk of lymph node metastases and larger tumor size (Olivotto et al., 2002).

Timeliness is a basic attribute of high-quality health care (IOM, 2001). The IOM committee feels strongly that women with suspicious or highly suggestive abnormal mammograms should not have to wait longer than 14 days for a biopsy. Delays in diagnosis are associated with substantial anxiety and distress for the patient (IOM, 2004).

Knowledge vs. practice. The proportion of women who have a needle biopsy before breast cancer surgery is not known. There are only limited

data on the extent of delays in follow-up biopsies after a suspicious mammogram. Studies assessing follow-up of all types of cancer screening indicate that about 25 percent of patients with a suspicious finding do not receive needed follow-up care (Yabroff et al., 2003). Racial and ethnic minorities, as well as uninsured and low-income persons, are especially at risk. A 2001 survey of medical directors of community health centers in 10 states found that about 40 percent of uninsured patients had difficulty getting specialty referrals, including referrals for follow-up of abnormal screening tests (Gusmano et al., 2002).

Use of needle biopsy in breast cancer diagnosis.

Consensus on care. NCCN recommends that breast tissue samples be obtained by needle biopsy if feasible (NCCN, 2004c). Needle biopsy is preferred because it is quick, accurate, and less invasive, and produces a better cosmetic outcome than alternative approaches do (Liberman, 2000; Morrow et al., 2001; Collins et al., 2004; Baxter et al., 2004; NCCN, 2004c). Needle biopsy techniques include core needle biopsy, vacuum-assisted biopsy, or fine-needle aspiration. The biopsy may be performed with or without image guidance depending on the location of the lesion, its visibility at ultrasound, equipment availability, and radiologist’s expertise. For about 10 to 20 percent of women, however, a needle biopsy is not technically feasible because of the location and nature of their breast lesion (NCCN, 2004c). Thus, a standard of 70 to 80 percent rather than 100 percent would be appropriate.

Knowledge vs. practice. Data on the use of needle biopsy before breast cancer surgery are not available.

Three of the recommended quality measures pertain to the collection and histological assessment or evaluation of surgical specimens taken from patients who undergo surgery for breast or colorectal cancer.

One measure is the proportion of breast cancer surgery patients whose surgical margins are free of tumor after the last surgical procedure. The histological assessment of surgical margins is fundamental to cancer diagnosis (Bland et al., 1999; Stocchi et al., 2001; Weir et al., 2002; Trocha and Giuliano, 2003; Le Voyer et al., 2003; Compton, 2003; Krag and Single, 2003; Fitzgibbons et al., 2004). The outer edge of the surgical specimen—referred to as the surgical margin—is considered free of tumor if there is no tumor at the line of resection. If the margin contains cancer or is too small to be fully analyzed, the extent of the patient’s cancer may be underestimated and undertreated.

The other two measures pertain to the histological assessment of lymph nodes in patients with breast cancer or colorectal cancer. Lymph node evaluation is central to determining the stage of cancer at diagnosis. About one-third of persons have metastases detected at the time of their first cancer diagnosis (Eyre et al., 2002). If a cancer spreads, the lymph nodes are usually affected. In breast cancer, the axillary (armpit) nodes are the main passageway that cancer cells use to spread to other parts of the body. In colorectal cancer, the regional lymph nodes are the main passageway.

Consensus on care.

Tumor free-breast cancer surgical margins. The goal of breast cancer surgery is to completely remove the tumor and to obtain clear surgical margins. There is extensive evidence that positive surgical margins are associated with significant morbidity and cost, including higher rates of local tumor recurrence and further surgical or medical treatment (Silverstein et al., 1999; Fredriksson et al., 2003; NCCN, 2004b). With lumpectomy, a positive margin often leads to additional surgery with either re-excision of additional tissue at the positive margin, or total mastectomy. If it is not possible to obtain a negative margin with re-excision, then mastectomy is usually required, although it may be appropriate to treat cases with a microscopic focally-positive margin with breast conservation by increasing the dose of a radiation therapy boost (NCCN, 2004b). NCCN guidelines indicate that while margins greater than 1 centimeter are “widely accepted” as negative, such margin width may be excessive causing a less acceptable cosmetic result. Margins less than 1 millimeter are considered inadequate. However, the NCCN guidelines state that data are insufficient to make definitive statements about margins between 1 and 10 mm.

Assessment of lymph nodes after breast cancer surgery. Histological assessment of axillary nodes is critical to diagnosing Stage I and II breast cancer and to determining the appropriate course of treatment (Weir et al., 2002; Fitzgibbons et al., 2004; NCCN, 2004b). In Stage I breast cancer, the tumor is less than 2 centimeters in diameter with no spread beyond the breast (axillary nodes are clear). In Stage II, the tumor is 2 to 5 centimeters in size or the tumor has spread to the axillary nodes (Box 5-3). Several studies suggest that examining an insufficient number of lymph nodes leads to poorer survival after breast cancer surgery (Bland et al., 1998; Bland et al., 1999; Weir et al., 2002; Krag and Single, 2003). If too few nodes are removed, the patient’s cancer may be understaged and thus undertreated. NCCN guidelines recommend two options: (1) dissection of 10 or more axillary lymph nodes for histological assessment or (2) sentinel node biopsy for patients with unicentric tumors smaller than 5 centimeters with no prior treatment or large excisions if an experienced sentinel lymph node team is available (NCCN, 2004b). Either procedure may be optional in patients who have particularly favorable tumors, patients for whom the selection of adjuvant systemic therapy is unlikely to be affected, elderly patients, and patients with serious comorbid conditions.

Assessment of lymph nodes after colorectal cancer surgery. Most colorectal cancer patients undergo surgical resection—an estimated 92 percent of colon cancer patients and 84 percent of rectal cancer patients (Compton, 2003). Diagnosing the extent of colorectal cancer requires histological assessment of the regional lymph nodes that are retrieved during surgery. There is an extensive literature showing that survival of colorectal

cancer increases with the number of recovered lymph nodes, regardless of the number of positive nodes that are found (Stocchi et al., 2001; Le Voyer et al., 2003; Compton, 2003). While there is no consensus on the specific number of nodes that should be analyzed, the range in the recommendations is small. For example, NCCN advises at least 14 nodes, while the College of American Pathologists (CAP) advises at least 12 nodes and urges that additional techniques such as visual enhancement be considered if fewer than 12 nodes are found (Compton, 2004a, NCCN, 2004f).

Knowledge vs. practice. It is difficult to discern from the available research whether shortcomings in pathology data are due to poor documentation

practices or poor surgical technique. Most research on the collection of breast cancer and colorectal cancer surgical specimens has focused on reporting practices rather than the adequacy of the specimens themselves. However, there is evidence that older women are less likely than younger women to undergo an axillary node dissection despite clinical guidelines to the contrary (Malin et al., 2002).

Numerous studies indicate that surgical and pathology reporting practices are of variable quality and, in fact, information on margins and the number and status of nodes is often missing from pathology reports (Weir et al., 2002; Imperato et al., 2002; Compton, 2003; White et al., 2003; Wilkinson et al., 2003; Wei et al., 2004). Stocchi et al. (2001) examined the surgery and pathology reports of 673 patients who were enrolled in a U.S. cooperative group clinical trial for Stage II or III rectal cancer. The researchers found that the operative and pathology notes were poorer than expected; 18 percent of patients had fewer than five lymph nodes examined and 68 percent had fewer than 12 nodes examined.

The IOM committee recommends five quality measures to monitor the adequacy of pathology reports on cancer surgical specimens. The first measure tracks pathology laboratories’ compliance with the American College of Surgeons’ Commission on Cancer reporting standards for breast, colorectal, lung, and prostate cancers.

• Measure 5-6—Pathology laboratories’ compliance with reporting standards for cancer surgical specimens—the proportion of pathology laboratories that report CAP data elements as required by the Commission on Cancer.

The remaining four measures track whether pathology reports include the key data elements currently mandated by the Commission on Cancer for breast, colorectal, lung, and prostate cancers:

• Measure 5-7—Adequacy of pathology reports on breast cancer surgical specimens—the proportion of pathology reports on invasive breast cancer surgical specimens that include CAP data elements as required by the Commission on Cancer.

• Measure 5-8—Adequacy of pathology reports on colorectal cancer surgical specimens—the proportion of pathology reports on colorectal cancer surgical specimens that include CAP data elements as required by the Commission on Cancer.

• Measure 5-9—Adequacy of pathology reports on lung cancer surgical specimens—the proportion of pathology reports on invasive lung cancer surgical specimens that include CAP data elements as required by the Commission on Cancer.

• Measure 5-10—Adequacy of pathology reports on prostate cancer surgical specimens—the proportion of pathology reports on prostate cancer surgical specimens that include CAP data elements as required by the Commission on Cancer.

The rationale for the IOM committee’s decision to recommend each of these measures is discussed further below.

Pathologists examine surgical specimens to identify the tumor size, histology, and other tumor characteristics—findings that are needed to properly stage the disease, to formulate treatment decisions, and to determine prognosis. The pathology report communicates these findings to the clinician. It is essential that the report is clear and comprehensive. Traditionally, pathologists have used an unstructured, narrative style to complete their reports. Research in the last decade has suggested, however, that standardized reporting templates yield more comprehensive and readable information than free-text pathology reports (Appleton et al., 1998; Cross et al., 1998; Branston et al., 2002). In response, CAP has developed a set of reporting templates, called checklists, for reporting pathology findings for cancer specimens (CAP, 2003). There is a specific checklist for each tumor site and type of surgical specimen. CAP recommends, but does not require, that its certified laboratories use the checklist.

As of 2004, the Commission on Cancer, a multidisciplinary program of the American College of Surgeons, has required that pathology laboratories at Commission on Cancer-certified cancer centers report the scientifically validated data elements in the CAP checklists for cancer-directed surgical specimens. The CAP checklist itself is optional. The mandatory data elements include the histologic type and grade, pathologic staging including distant metastasis, margins and lymph nodes, and other cancer-specific data items (Gal et al., 2004; Srigley et al., 2004; Fitzgibbons et al., 2004; Compton, 2004a).

Figure 5-1 illustrates the data elements required by the Commission on Cancer in a pathology report on a prostate cancer specimen. Only cancer-directed surgical resection specimens must meet the Commission on Cancer’s requirement to report the scientifically validated data elements in the CAP checklists; cytologic specimens, diagnostic biopsies, and palliative resections are exempt (Paxton, 2004). In 2005, the Commission on Cancer will begin auditing its certified pathology laboratories to ensure that they comply with

the mandate to report the scientifically validated data elements for surgical specimens.

Pathology laboratories’ compliance with reporting standards for cancer surgical specimens. The quality of pathology reporting in Georgia has not been studied. There are 39 Commission on Cancer-approved cancer programs in Georgia (Table 5-1). Presumably, once the Commission on Cancer reporting mandate is fully enforced, it will improve pathology reporting at these Georgia institutions. Numerous studies have documented generally poor compliance with guidelines on reporting cancer-related pathology findings (Weir et al., 2002; Malin et al., 2002; Imperato et al., 2002; IOM, 2003; Compton, 2003; White et al., 2003; Wilkinson et al., 2003; Wei et al., 2004). Recent evidence indicates that the quality of cancer-related pathology reporting has improved since the problems were first identified in the mid- to late-1980s.

Adequacy of pathology reports on breast cancer surgical specimens. Researchers assessed concordance with breast cancer pathology reporting guidelines in 1998 and 1999 at the Roswell Park Cancer Center, a National Cancer Institute-designated comprehensive cancer center. One hundred patient records were reviewed and most lacked at least one required data element. Only 77 percent of the breast surgery reports documented margin status (Wilkinson et al., 2003). An earlier study of breast pathology reporting by hospitals in New York state found wide variation in quality (Imperato et al., 2002). Overall, performance was less than 70 percent on 9 of 16 data elements, including tumor margin status. Distance to closest margin was reported in 69 percent of the cases, but the margin orientation was noted in only 25 percent. A large-scale national study of 7,097 women who underwent lumpectomy in 1994, found significant variation in the content of pathology reports (White et al., 2003). Substantial proportions of the reports were missing key pathologic data, including lymph node invasion (46 percent), ductal carcinoma in situ (43 percent), and macroscopic margin (27 percent). The researchers found that geographic location and type of cancer program were important predictors of compliance with reporting standards; women who were treated in the Midwest or by a community hospital were the most likely to have incomplete records.

Adequacy of pathology reports on colorectal cancer surgical specimens. Although data are limited, there are studies showing considerable variability in colorectal cancer pathology reporting including failure to document critical data. There is also evidence that the quality of colorectal cancer

pathology reports varies with a laboratory’s affiliation and hospital case volume. Wei et al. studied the pathology records of 438 North Carolina patients diagnosed with colorectal cancer between 1997 and 2000 (Wei et al., 2004). Compared with contract pathology labs and community hospitals, high-volume hospitals and teaching facilities were more likely to report recommended pathology data including macroscopic depth of penetration and margin status.

Adequacy of pathology reports on lung cancer surgical specimens. Surgical resection is the primary treatment for lung cancer (NCCN, 2004d). Few studies have been done on the quality of pathology reporting for lung cancer specimens. A 1991 CAP study of pathology reports of lung cancer resection specimens found poor documentation of some key data elements. Venous invasion was reported in only 22.6 percent of cases and regional lymph nodes were described in 74.7 percent of the reports (Gephardt and Baker, 1996).

Adequacy of pathology reports on prostate cancer specimens. Radical prostatectomy was the primary treatment for an estimated 41 percent of prostate cancer patients from 1995 to 2003 (Cooperberg et al., 2004). Little is known about the quality of pathology reports on prostate surgical specimens.

Cancer stage describes the extent and severity of an individual’s cancer. The stage of a cancer is determined by a number of diagnostic factors, including location of the primary tumor, tumor size, regional lymph node involvement, cell type and tumor grade, and presence or absence of distant metastasis (Greene et al., 2002). Cancer staging information is the most important indicator of a patient’s prognosis (Bland et al., 1999; Stocchi et al., 2001; Weir et al., 2002; Trocha and Giuliano, 2003; Le Voyer et al., 2003; Krag and Single, 2003; Compton, 2003; Fitzgibbons et al., 2004; Compton, 2004b). Information about the stage of a cancer patient’s cancer gives clinicians a roadmap for determining a patient’s treatment options. It also helps cancer patients understand the extent of their disease, their prognosis, and their treatment choices (Brierley et al., 2002; Compton, 2004b).

Cancer stage may be referred to as clinical or pathologic depending on the timing. Clinical stage is based on what has been learned about a patient’s cancer through, for example, physical exams, imaging tests, biopsies, and blood tests—up to the time of initial definitive treatment which is often surgery (NCI, 2005). Pathologic stage combines the clinical staging infor-

mation with surgical findings, incorporating data not only from before the initial definitive treatment but also from pathologic examination of resected primary and regional lymph nodes.

In addition to being important for the provision of treatment to individual patients, stage data are essential to building a sound infrastructure for cancer research, quality improvement, and population cancer control. Stage data are basic inputs to tumor registries; to evaluating screening and early detection programs, treatment interventions, and quality improvement efforts; to developing, implementing, and monitoring clinical guidelines; and to identifying patients who might benefit from a clinical trial; and to computing survival statistics (Chamberlain et al., 2000; Brierley et al., 2002; Woodward et al., 2003; Compton, 2004b). Clearly, clinical outcomes can be understood only in the context of the stage of the disease.

The IOM committee recommends that the GCC adopt four quality measures to help Georgia ensure that patients’ cancers are appropriately staged before chemotherapy or radiation treatment begins:

• Measure 5-11—Breast cancer stage determined before treatment—the proportion of new breast cancer cases with medical chart documentation of pathologic stage before chemotherapy or radiation treatment is initiated.

• Measure 5-12—Colorectal cancer stage determined before treatment—the proportion of new colorectal cancer cases with medical chart documentation of pathologic stage before chemotherapy or radiation treatment is initiated.

• Measure 5-13—Lung cancer stage determined before treatment—the proportion of new lung cancer cases with medical chart documentation of pathologic stage before chemotherapy or radiation treatment is initiated.

• Measure 5-14—Prostate cancer stage determined before treatment—the proportion of new prostate cancer cases with medical chart documentation of pathologic stage before chemotherapy or radiation treatment is initiated.

The rationale for the IOM committee’s decision to recommend these measures is discussed further below.

Every cancer patient’s treatment regimen should be tailored to his or her stage of disease. Most treatment guidelines cannot be followed until the tumor stage has been determined (ASCO, 2002; ACR, 2004; NCCN, 2004a). Chemotherapy and radiation treatment of most cancers, including breast, colorectal, lung, and prostate cancers, should not be initiated until

the pathologic stage has been determined and documented in the medical record (NCCN, 2004a).²

Little is known about the extent to which cancer treatment is initiated before the stage has been determined and documented. Likewise, little is known about the completeness of staging or its documentation. Nonetheless, a plethora of evidence documenting serious underreporting of pathology information suggests that many cancer patients are treated in advance of, or in the absence of, appropriate documentation of the stage of their disease (Weir et al., 2002; Imperato et al., 2002; White et al., 2003; Wilkinson et al., 2003; Wei et al., 2004; Compton, 2004b).

The data for 12 of the 14 measures pertaining to quality of cancer diagnosis must be abstracted from pathology reports and medical records (Table 5-2). Data for the remaining two measures—measures 5-1 (timely breast cancer diagnosis) and 5-2 (use of needle biopsy in breast cancer diagnosis)—can be drawn from the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset and might also be in a mammography registry (should Georgia develop one). Further information about the strengths and weakness of data sources is presented in Chapter 2, Concepts, Methods, and Data Sources, and Appendix A.

Accurate and timely diagnosis is basic to combating cancer and is the essential first step in quality care. If diagnostic practice is poor, treatment and outcomes are likely to be less than optimal. A substantial body of research has documented that the process of cancer diagnosis in the United States is often incomplete and inadequately documented. This situation probably exists in Georgia as well, although specific evidence is not currently available. If Georgia is to meaningfully improve cancer outcomes for its residents, it must address the conduct of cancer diagnosis statewide. This chapter has recommended 14 quality measures that GCC should use to gauge its progress in ensuring that cancer treatment in Georgia draws from comprehensive and clearly documented diagnostic and histological records.

The following section contains summary descriptions of the quality indicators presented in this chapter. These quality indicators were drawn from a variety of clinical practice setting organizations, federal programs, provider groups, and other sources. See Appendix A for descriptions of each of these organizations, including their classification schemes for grading clinical recommendations and characterizing evidence.

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