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Originally published as JCO Early Release 10.1200/JCO.2005.03.3365 on January 9 2006

Journal of Clinical Oncology, Vol 24, No 4 (February 1), 2006: pp. 626-634
© 2006 American Society of Clinical Oncology.

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Results of the National Initiative for Cancer Care Quality: How Can We Improve the Quality of Cancer Care in the United States?

Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstein, John Adams, Ezekiel J. Emanuel, Katherine L. Kahn

From the RAND Corporation, Santa Monica; Department of Medicine, University of California Los Angeles, Los Angeles, CA; Department of Health Policy and Management, Harvard School of Public Health; Section on Health Policy, Division of General Medicine, Brigham and Women's Hospital, Boston, MA; and the Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD.

Address reprint requests to Jennifer L. Malin, MD, Amgen, One Amgen Center Dr, MS 28-3-A, Thousand Oaks, CA 91320; e-mail: jmalin{at}amgen.com


    ABSTRACT
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
PURPOSE: In 1999, the National Cancer Policy Board called attention to the quality of cancer care in the United States and recommended establishing a quality monitoring system with the capability of regularly reporting on the quality of care for patients with cancer.

METHODS: Using data from a patient survey 4 years after diagnosis and review of medical records, we determined the percentage of stage I to III breast cancer and stage II to III colorectal cancer survivors in five metropolitan statistical areas (MSAs) across the United States who received recommended care specified by a comprehensive set of explicit quality measures.

RESULTS: Two thousand three hundred sixty-six (63%) of 3,775 eligible patients responded to the survey, and 85% consented to have their medical records reviewed. Our final analytic sample (n = 1,765) included 47% of the eligible patients. Patients with breast and colorectal cancer received 86% of recommended care (95% CI, 86% to 87%) and 78% of recommended care (95% CI, 77% to 79%), respectively. Adherence to quality measures was less than 85% for 18 of the 36 breast cancer measures, and significant variation across MSAs was observed for seven quality measures. The percent adherence was less than 85% for 14 of the 25 colorectal cancer measures, and one quality measure demonstrated statistically significant variation across the MSAs.

CONCLUSION: Initial management of patients with breast and colorectal cancer in the United States seemed consistent with evidence-based practice; however, substantial variation in adherence to some quality measures point to significant opportunities for improvement.


    INTRODUCTION
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
Despite considerable progress in its prevention and treatment, cancer remains a leading cause of morbidity and mortality in the United States.1 Although the Institute of Medicine has called attention to problems with the quality of care in the United States2-4 and additional reports have confirmed that the problems are widespread,5-7 few reports have focused on the quality of care for patients with a diagnosis of cancer. In its 1999 report Ensuring the Quality of Cancer Care, the Institute of Medicine's National Cancer Policy Board (NCPB) concluded, "Based on the best available evidence, some individuals with cancer do not receive care known to be effective for their condition. The magnitude of the problem is not known, but the National Cancer Policy Board believes it is substantial."8 To address these concerns and the paucity of data on the quality of care for patients with cancer, the NCPB recommended establishing a quality monitoring system with capability of routine reporting of results.

Motivated by the NCPB report, a number of initiatives are underway to begin to measure and improve the quality of care of patients with cancer. Examples include the joint effort of the National Cancer Institute and the National Quality Forum to identify and evaluate quality measures for cancer care9; the American Society of Clinical Oncology Quality Oncology Practice Initiative10; the Oncology Demonstration Project sponsored by the Centers for Medicare and Medicaid Services11; and the National Initiative for Cancer Care Quality (NICCQ), which is led by American Society of Clinical Oncology in collaboration with multiple oncology professional societies, patient advocates, and researchers.12 In this report, we present the findings of the NICCQ, an in-depth study of the quality of care for patients with a new diagnosis of breast cancer or colorectal cancer in five different sites across the United States.


    METHODS
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
Eligibility Criteria
Patients were considered eligible if they had a new diagnosis of stage I to III breast cancer or stage II to III colorectal cancer during 1998 and were registered in an American College of Surgeons (ACoS) –approved hospital cancer registry located in one of the following five metropolitan statistical areas (MSAs): Atlanta, GA; Cleveland, OH; Houston, TX; Kansas City, KS; and Los Angeles, CA. To be eligible, participants had to be 21 to 80 years old at diagnosis, English speaking, and alive when contacted to participate in this study approximately 4 years after diagnosis. Twenty-seven percent of colorectal cancer patients and 9% of breast cancer patients were found to be deceased when identified by participating ACoS hospital cancer registries and, thus, not eligible for our analytic sample. Males with breast cancer were excluded.

Hospital Registry Sampling and Recruitment
To achieve a sample size of approximately 400 patients with either breast or colorectal cancer from each MSA, we recruited all available ACoS-approved hospital cancer registries in four MSAs, and from Los Angeles, a probability sample of registries was selected from one of three strata defined by the number of breast and colorectal patients in 1998 (< 125, 125 to 250, and > 250 breast and colorectal cancer patients per year). We invited the participation of the hospital cancer registries by contacting the chair of each hospital's Cancer Committee and the ACoS Cancer Liaison and then convened a meeting in each MSA to explain the study. The study was approved by the institutional review boards at each of the participating institutions, RAND Corporation (Santa Monica, CA), and Harvard University (Cambridge, MA).

Patient Sampling and Recruitment
We used de-identified National Cancer Data Base (NCDB) data to select a sample of eligible patients from each participating hospital cancer registry (eight hospital registries that had not yet reported their 1998 data to the NCDB did their own patient selection using our sampling protocol). We sampled breast cancer patients from high-volume hospital registries to avoid over-representing patients from these facilities and selected all breast cancer patients from the remaining facilities. Because of the differing incidence of breast and colorectal cancer patients meeting our eligibility criteria, we selected all eligible patients with colorectal cancer.

Patient contact information was obtained from the local hospital cancer registries. Before contacting a patient, the physician of record was notified by mail of our intent to contact the patient for a research study. Unless a physician indicated that a patient should not be contacted, 2 weeks later the patient was mailed a letter explaining the study and a postage-paid postcard allowing the patient to opt out without further contact.

Development of Quality Measures and Data Collection Instruments
The NICCQ project team developed measures of the process of care within a set of domains representing important aspects of the care provided to patients with a cancer diagnosis ( Table 1). After reviewing existing quality indicators,10 guidelines,11-14 and review articles,15-17 as well as randomized trials and other controlled studies of breast and colorectal cancer treatment identified through MEDLINE searches, we developed explicit quality measures to evaluate the initial management of breast and colorectal cancer patients. These measures specified eligible events—clinical care situations that should cause a clinician to recommend a particular diagnostic test, treatment, or other intervention based on the available medical science or general consensus among clinical experts. Proposed measures were reviewed to ensure clinical validity by an expert panel comprising clinical experts in breast and colorectal cancer, health services researchers, oncology nurses, and patient advocates. Our final set of quality measures included 36 breast cancer and 25 colorectal cancer quality measures. Examples of the quality measures are listed in Table 1, and the full set is presented in the Appendix.


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Table 1. Examples of NICCQ Quality Measures

 
After selecting the measures, we developed both a patient survey and a medical record abstraction instrument to collect the specific data elements necessary for each quality measure. The survey included questions regarding patients' initial therapy and experiences, symptoms related to cancer or its treatment, and current quality of life. In addition, patients were asked to provide the names and addresses of all physicians who had provided their medical care since their diagnosis. Data obtained from the medical record included detailed information about the tumor characteristics, staging, referrals and decision making, initial cancer treatment, adjunctive medications, and comorbid conditions. To be eligible for an individual measure, the patient's medical records had to contain the records for the specialist generally responsible for providing the care. In addition, if the quality measure relied on information that is typically documented in a specific document (eg, pathology report), the patient's medical record had to contain this document for the patient to be eligible for inclusion in the measure. For example, to be eligible for the measure of "IF a patient is treated with chemotherapy, THEN body-surface area should be documented," a patient's medical record would need to contain the records of the medical oncologist and the chemotherapy flow sheet.

Data Collection
For each patient, full data collection required completion of a survey, consent for medical record review, a list of all physicians the patient had seen since diagnosis, and abstraction of relevant medical records. Two weeks after the initial invitation to patients, those who did not opt out were mailed a questionnaire, a medical record consent form, and a $10 incentive. After three follow-up mailings, we attempted to contact nonresponders to complete the survey by telephone.

We requested photocopies of consenting patients' ambulatory medical records from all cancer providers and primary care physicians as well as the inpatient record for colorectal cancer patients. Trained nurses abstracted all available records using a computer-based medical record abstraction instrument. When abstraction revealed cancer providers not reported by the patients, we requested those physicians' medical records and abstracted them as well.

Statistical Analyses
We calculated the mean percent adherence for breast cancer and colorectal cancer quality measures for each of the following five clinical domains (overall and stratified by MSA): (1) Diagnostic Evaluation, (2) Surgery, (3) Adjuvant Therapy, (4) Management of Treatment Toxicity, and (5) Post-Treatment Surveillance; we also calculated the mean percent adherence for the following eight components of care: (1) Testing, (2) Pathology, (3) Documentation, (4) Referral, (5) Timing, (6) Receipt of Treatment, (7) Technical Quality, and (8) Respect for Patient Preferences. This method weights individual quality measures in the domain-level scores on the basis of prevalence of eligibility, determined by the number of times that patients were eligible for measures within a domain, which we refer to as the number of eligible events. In addition, we selected all measures with adherence less than 85% to compare the MSA-specific adherence because these measures are the most likely candidates for quality improvement interventions. We used {chi}2 tests to compare the individual quality measures and the domain-level quality scores across MSAs. Analyses were conducted using SAS statistical software version 9.0 (SAS Institute, Inc, Cary, NC).

We adjusted for both hospital and patient nonresponse for the following hospital characteristics using ACoS data and patient characteristics using NCDB data: hospital ownership; oncology surgeon on staff; dummy variables for the individual participating hospitals; patient age, sex, race, education, insurance, employment, country of origin, and primary language; cancer type and stage; and cancer treatment. Although we report weighted results because we believe they are most representative, weighting did not affect the direction or statistical significance of any reported results.


    RESULTS
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
Recruitment of Cohort
Of the 94 hospital cancer registries we invited to participate in NICCQ, 65 registries (69%) agreed. Among 3,775 eligible patients, 2,366 responded to the survey (63%); and, of these patients, 2,002 (85%) consented to have their medical records reviewed. We obtained at least one medical record for 98% of consenting patients, and the records of 88% of consenting patients (n = 1,765) were adequate for abstraction. Our final analytic sample included 47% of the eligible patients. The characteristics of the analytic cohort are listed in Table 2.


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Table 2. Characteristics of Analytic Cohort

 
Quality of Care
Among the patients with breast cancer (n = 1,287), there were 20,291 eligible events specified by 36 quality measures ( Table 3). On average, patients received 86% of recommended care (95% CI, 86% to 87%). Among the domains of care assessed, Diagnostic Evaluation had the greatest number of eligible events (n = 9,887), and Management of Treatment Toxicity had the fewest (n = 378). Adherence to recommended care within domains ranged from 73% (95% CI, 69% to 78%) for Management of Treatment Toxicity to 94% (95% CI, 92% to 95%) for Post-Treatment Surveillance. Adherence to recommended care across the different components of care ranged from 13% (95% CI, 7% to 21%) for Referral to 60% (95% CI, 57% to 62%) for Documentation to 96% (95% CI, 95% to 97%) and 97% (95% CI, 96% to 97%) for Receipt of Treatment and Testing, respectively.


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Table 3. Quality of Care for Initial Treatment of Breast Cancer (n = 1287) and Colorectal Cancer (n = 478) by Domain and Component of Care

 
Among the patients with colorectal cancer, there were 4,538 eligible events based on the 25 colorectal cancer measures ( Table 3). On average, patients received 78% of recommended care (95% CI, 77% to 79%). Again, the greatest number of eligible events was in Diagnostic Evaluation (n = 1,635). The domain of Post-Treatment Surveillance had the smallest number of eligible events (n = 478). Domain-specific adherence ranged from 50% (95% CI, 46% to 55%) for Post-Treatment Surveillance to 93% (95% CI, 91% to 95%) for Surgery. Adherence to recommended care across the different components of care ranged from 57% (95% CI, 53% to 62%) for Respect for patient references and 59% (95% CI, 50% to 68%) for Referral to 93% (95% CI, 91% to 94%) for Pathology.

Variation in Quality of Care Across NICCQ MSAs
The overall mean adherence to the 36 breast quality measures ranged from 82% to 87% across the five MSAs (P < .001, Table 4), but no MSA seemed to consistently provide better quality of care across all domains. Within domains, the greatest variation across MSAs was observed for Surgery (80% to 90%, P < .001). Significant variation across MSAs was also observed for the domains of Diagnostic Evaluation (P < .01) and Adjuvant Therapy (P < .05). In colorectal cancer, where we had a smaller sample size, the variation across MSAs was not statistically significant.


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Table 4. Quality of Care for Initial Treatment of Breast and Colorectal Cancer: Variation Across MSAs

 
Adherence to quality measures was less than 85% for 18 of the 36 breast cancer measures, and there was significant variation in the percent adherence across MSAs for seven of the quality measures ( Table 5). As much as a two-fold difference in adherence was observed for some measures across MSAs. For example, among patients treated with chemotherapy, the planned dose was consistent with published regimens for 58% of patients; however, this ranged from 29% to 74%, when weighted for hospital and patient nonresponse (P < .001). Notably, six of the measures with less than 85% adherence pertained to documentation of key clinical factors believed to be essential to providing appropriate cancer care, such as components of disease stage and patient's body-surface area.


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Table 5. Variation by MSA for Breast Cancer Quality Measures With Less Than 85% Adherence

 
The percent adherence was less than 85% for 14 of the 25 colorectal cancer measures; however, only one quality measure demonstrated statistically significant variation across the MSAs ( Table 6). In patients with stage II or III rectal cancer, we found that only 66% received radiation therapy as recommended; this varied by MSA from 58% to 92% (P = .05).


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Table 6. Variation by MSA for Colorectal Cancer Quality Measures with Less than 85% Adherence

 

    DISCUSSION
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
Our results suggest that patients with breast cancer receive 86% of recommended care, whereas patients with colorectal cancer receive 78% of recommended care. Adherence to several quality measures approached 100%, demonstrating that excellent quality of care is achievable. Yet, despite high adherence to many measures of the quality of cancer care, we observed less than 85% adherence for almost half of the quality measures, and for many of these measures, there was substantial variability in quality across the five metropolitan areas.

How do we put these results in context? Our results can be compared with a growing literature that addresses the quality of care of patients with chronic medical conditions, as well as prior studies that describe the patterns of care for patients with cancer. For example, two recent national studies, using methodology similar to that of NICCQ, suggest that the quality of care for cancer may be better than that observed for other chronic medical conditions. In one study, 73% of Medicare beneficiaries received health care services specified by one of 24 quality measures addressing heart disease, stroke, and pneumonia.5 Another recent study of the general population in 12 metropolitan areas of the United States concluded that participants received approximately 55% of recommended care for a wide variety of medical conditions.6 In contrast, the NICCQ results suggest that higher percentages of patients with breast and colorectal cancer receive recommended care.

Compared with prior studies of cancer care summarized by the NCPB, our results show strikingly higher adherence to processes of care believed to be essential for improving the outcomes of patients with breast and colorectal cancer. There are several possible explanations for this difference. In contrast to most prior studies, NICCQ used explicit quality measures with clinically detailed eligibility criteria.18,19 When simple utilization rates (eg, receipt of tamoxifen in nonmetastatic breast cancer patients) are used to estimate receipt of recommended care, quality of care may seem artificially low because many patients included in the analysis may not really be eligible for the specified care (eg, patients whose tumors do not express the estrogen or progesterone receptor). Furthermore, few studies have used the comprehensive data collection methods applied in NICCQ.20,21 NICCQ used patient self-report data along with data abstracted from multiple outpatient medical records (an average of 3.6 records per patient). The NCPB based its conclusions about the state of cancer care in the United States primarily on studies of existing administrative records, insurance claims, and cancer registry data. Such data frequently lack the clinical detail necessary to determine whether a patient is truly eligible for a particular intervention8,20,22 and may under-report the treatments provided, especially when delivered in the ambulatory setting.23-25 In fact, the few studies that used analogous methods to NICCQ to evaluate the quality of cancer care have reported better than 80% adherence.6,25-27

If the quality of care for cancer is indeed higher than for other medical conditions, what factors might contribute to the difference? It may be that the urgency of a new diagnosis of cancer focuses the attention of patients and providers on assuring treatment in a way that chronic diseases, especially silent ones such as hypertension or diabetes, cannot. Differences in the configuration of treatment teams, reimbursement for services, training, and public attention may also play a role.

This study assessed performance on a wide variety of quality metrics derived from the clinical literature. All of the measures underwent review and refinement by a multidisciplinary expert panel comprising clinical experts in breast and colorectal cancer, health services researchers, oncology nurses, and patient advocates. Many measures were linked by scientific evidence with improved patient outcomes. For example, randomized trials have demonstrated improved survival with 5 years of tamoxifen therapy in women with hormone receptor–positive breast cancer. In other instances, the measures focused on operational issues that clinical experts viewed as necessary to the delivery of high-quality care. For example, documentation of patient body-surface area in the medical record of the medical oncologist delivering chemotherapy is necessary for the physician to determine the appropriate dose and for the nursing or pharmacy staff to verify the prescribed dose to ensure patient safety.

Given adherence rates of less than 85% on almost half of the quality measures, our results suggest many opportunities to improve the quality of cancer care. Of concern, we found that, although most patients seemed to be receiving adjuvant chemotherapy when indicated, patients were often not prescribed a dose of the chemotherapy that was consistent with published regimens, and many began therapy more than 8 weeks after surgery. In addition to focusing on improving the quality of adjuvant chemotherapy delivery, our results suggest that quality improvement efforts should target management of treatment toxicity; advising patients about treatment options, especially when patient preference is a key factor in the decision-making process (ie, type of breast surgery and breast reconstruction after mastectomy); and improving documentation of key information regarding patients' cancer and treatment that may be needed by many other clinicians involved in the patients' care.

Our findings should be viewed in light of several limitations of our study design. First, our study was limited to patients with stage I to III breast cancer and stage II to III colorectal cancer. The quality of care for patients with other types of cancer and stages of disease may be different. Second, our quality measures reflect the weight of both scientific evidence and expert opinion. Variability in the strength of evidence underpinning individual measures could affect the pattern of performance we found. Third, we were unable to include patients who could not complete a survey in English or who died before study enrollment, two groups for whom the quality of care may be lower. The omission of patients who died within the first few years of diagnosis may be of particular concern because premature death could be an outcome of poor quality of care. If patients who die receive care that that is of lower quality than that received by survivors, then our results may overestimate the quality of care of colorectal cancer patients because 27% of patients reported by the registries were deceased when identified by NICCQ. However, only 9% of breast cancer patients were deceased 4 years after diagnosis, so the exclusion of decedents from our sampling frame is not likely to have had a large effect on our estimate of the quality of breast cancer care. Fourth, nonparticipation of hospitals and patients may also limit the generalizability of our results. Our final sample included 47% of eligible patients, which is comparable to other studies that have obtained survey and consent to review medical records from population-based samples.6 We used nonresponse weights to account for the different distribution of race/ethnicity and age in our final sample, and our results did not change substantively. Nevertheless, our results could still be biased if nonresponders were less likely to get appropriate care. Finally, although this study included data from both patient self report and abstraction from the medical records of all the physicians providing cancer care to patients, recall bias and missing documentation may have led to under-reporting of care that was actually provided. Despite these limitations, we believe that our results provide a useful benchmark for other efforts to evaluate the quality of cancer care.

To our knowledge, this the first report of a comprehensive evaluation of the quality of care for patients with cancer. Although our results imply that the quality of initial management of patients with breast and colorectal cancer in the United States is often consistent with evidence-based practice, care is still not perfect. Viewed from the perspective of the patient with breast or colorectal cancer, a person with a new diagnosis of cancer has approximately a one in five chance of failing to receive elements of cancer care consistent with the best evidence in the literature and expert-defined standards of clinical practice. Important opportunities to improve care exist. Our results may provide guidance for professional societies and clinicians involved in cancer care on how best to improve the care of patients with cancer.


    Appendix
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
The appendix is included in the full-text version of this article, available online at www.jco.org. It is not included in the PDF (via Adobe® Acrobat Reader®) version.


Appendix
NICCQ breast cancer quality measures
    Data gathering: pathology, evaluation, and staging
    Pathology reporting
    BR-1A1: IF a patient has stage I to III breast cancer and had a breast tumor removed, THEN the pathology report should state the tumor size.
    BR-1A2: IF a patient has stage I to III breast cancer and had a breast tumor removed, THEN the pathology report should state that the margins were inked.
    BR-1A3: IF a patient has stage I to III breast cancer and had a breast tumor removed, THEN the pathology report should state the status of the margins.
    BR-1A4: IF a patient has stage I to III breast cancer and had a breast tumor removed, THEN a pathology report should state the histologic grade of the tumor.
    BR-1A5: IF a patient has a diagnosis of stage I to III breast cancer and had a breast tumor removed, THEN the hormone receptor status of the tumor should be checked and reported. (continued on following page)


Appendix (continued)

    BR-1A6: IF a patient with a new diagnosis of stage I to III breast cancer undergoes an axillary lymph node dissection, THEN the pathology report should state:
    1. The number of lymph nodes evaluated AND
    2. The number of positive lymph nodes.
    Diagnostic evaluation
    BR-1B1: IF a patient with a new diagnosis of stage I to III breast cancer and meets all of the following criteria:
    1. Age < 70 years AND
    2. Tumor size > 1 cm AND
    3. No evidence of metastatic disease within 3 months of diagnosis AND
    4. There is no documentation in the medical record that axillary lymph node sampling would not change treatment, THEN the patient should have axillary lymph node sampling (either sentinel lymph node biopsy or lymph node dissection).
    BR-1B2: IF a patient has a sentinel node biopsy that is positive, THEN the patient should undergo axillary lymph node dissection.
    BR-1B3: IF a patient has an axillary lymph node dissection, THEN the patient should have at least 6 lymph nodes removed.
    Staging
    BR-1C2: IF a patient newly diagnosed with stage I to III breast cancer is not referred to another oncology specialist (eg, medical oncologist or radiation oncologist), THEN the medical record of the surgeon performing the last cancer surgery should document all of the following:
    1. Tumor size and lymph node status or AJCC stage or TNM stage AND
    2. Hormone receptor status.
    BR-1C3: IF a patient newly diagnosed with stage I to III breast cancer is seen in consultation by a medical oncologist after last breast surgery, THEN the medical record of the medical oncologist should document all of the following:
    1. Tumor size and lymph node status or AJCC stage or TNM stage AND
    2. Hormone receptor status (ie, positive, negative, not performed).
    BR-1C4: IF a patient newly diagnosed with stage I to III breast cancer is seen in consultation by a radiation oncologist after completion of the staging evaluation, THEN the medical record of the radiation oncologist should document at least one of the following:
    1. AJCC stage OR
    2. TNM stage OR
    3. Tumor size and lymph node status.
    Initial management
    Surgery
    BR-2A4: IF a patient has a new diagnosis of stage I to III breast cancer, THEN the patient should receive one of the following surgical treatments:
    1. BCS (radiation after lumpectomy is covered in a separate measure) OR
    2. Mastectomy.
    BR-2A5: IF a patient with a new diagnosis of stage I to III breast cancer undergoes surgical treatment with BCS (ie, does not undergo mastectomy), THEN the pathology report for the last cancer (final surgical excision) surgery should state that the surgical margins are clear or only focally involved with breast cancer.
    Systemic adjuvant therapy
    BR-2B1: IF a patient newly diagnosed with stage I to III breast cancer meets all of the following criteria:
    1. ER+ or PR+ breast cancer AND
    2. Tumor size ≥ 1 cm or involved axillary lymph nodes AND
    3. Was not taking tamoxifen WITHIN 6 MONTHS before diagnosis, THEN the patient should be started on tamoxifen 20 mg/d.
    BR-2B2b: IF a patient with stage I to III breast cancer initiates treatment with tamoxifen and there is no evidence of disease progression, THEN the patient should receive 5 years of tamoxifen 20 mg/d.
    BR-2B3: IF a patient newly diagnosed with stage II to III breast cancer is < 50 years old AND the tumor is > 2 cm or the tumor involves the lymph nodes, THEN the patient should receive chemotherapy with a regimen listed in the associated table or was in a clinical trial.
    BR-2B4: IF a patient is newly diagnosed with stage I to III breast cancer and the tumor is ≥ 1 cm or involves the lymph nodes, THEN a physician should have a discussion with the patient regarding possible treatment with chemotherapy.
    BR-2B5: IF a patient newly diagnosed with stage II to III breast cancer is < 50 years old and the tumor is > 2 cm or the tumor involves the lymph nodes, THEN the patient should start adjuvant chemotherapy within 8 weeks of the last therapeutic surgery.
    G-2B1: IF a patient is treated with chemotherapy, THEN the planned dose (dose per cycle x number of cycles) should be documented in the medical oncology or integrated record.
    G-2B2: IF a patient is treated with chemotherapy, THEN the planned dose (dose per cycle x number of cycles) should fall within a range that is consistent with published regimens.
    G-2B3: IF a patient is treated with chemotherapy, THEN body-surface area should be documented.
    Radiation therapy
    BR-2C1: IF a patient with a diagnosis of stage I to III breast cancer is treated with radiation therapy, THEN the radiation therapy medical record should document all of the following:
    1. The total radiation dose
    2. The radiation dose per fraction or number of fractions given
    3. The site.
    BR-2C2a: IF a patient with a diagnosis of stage I to III breast cancer has BCS, THEN the patient should receive local radiation therapy.
    BR-2C2b: IF a patient with a diagnosis of stage I to III breast cancer has BCS and the patient received radiation therapy (ie, passed BR-2C2a-Ta) AND DID NOT receive brachytherapy, THEN the patient should receive local radiation therapy 45 to 50.4 Gy to the whole breast. (continued on following page)


Appendix (continued)

    BR-2C3a: IF a patient with invasive breast cancer who undergoes a mastectomy has any of the following:
    1. Positive margins on the surgical specimen OR
    2. Tumor size > 5 cm OR
    3. 4 or more involved lymph nodes OR
    4. A T4 lesion, THEN the patient should receive radiotherapy.
    BR-2C3b: IF a patient with invasive breast cancer who undergoes a mastectomy has any of the following:
    1. Positive margins on the surgical specimen OR
    2. Tumor size > 5 cm OR
    3. 4 or more involved lymph nodes OR
    4. A T4 lesion
    AND the patient received radiotherapy, THEN the patient should receive radiotherapy 45 to 50.4 Gy to the chest wall.
    BR-2C5: IF a patient begins radiation therapy treatments and does not meet one of the following exclusion criteria:
    1. Hospitalized during treatment OR
    2. Grade 4 toxicity, THEN the planned radiation therapy should be completed.
    Management of treatment toxicity
    G-3A2: IF a patient ever receives highly emetogenic chemotherapy, THEN the patient should receive potent antiemetic therapy (eg, 5HT blockade).
    BR-3B2: IF a patient who is postmenopausal taking tamoxifen has vaginal bleeding, THEN the patient should have had at least one of the following evaluations:
    1. Endometrial biopsy
    2. Pelvic transvaginal ultrasound.
    Referrals
    BR-4-1: IF a patient with stage I to III breast cancer undergoes BCS (ie, does not have a mastectomy) and did not receive radiation therapy, THEN the patient should have a consultation with a radiation oncologist.
    BR-4-2: IF a patient with invasive breast cancer:
    A. Undergoes a mastectomy AND
    B. Has any of the following:
    1. Positive margins on the surgical specimen OR
    2. Tumor size > 5 cm OR
    3. 4 or more involved lymph nodes OR
    4. A T4 lesion, THEN the patient should have a consultation with a radiation oncologist.
    Respect for patient preferences and inclusion in decision making
    BR-5-2: IF a patient has a new diagnosis of stage I to III breast cancer and does not undergo axillary lymph node sampling, THEN the patient should be informed about the option of a surgical check or removal of lymph nodes under the arm (ie, sentinel-node biopsy or axillary dissection).
    BR-5-4: IF a patient with stage I to III breast cancer undergoes mastectomy as first therapeutic procedure, THEN before undergoing mastectomy, the patient should be informed about the option to have either BCS followed by radiation therapy or mastectomy.
    BR-5-5-I: IF a patient with stage I to III breast cancer undergoes mastectomy, THEN before undergoing mastectomy, the patient should be informed about the option of breast reconstruction after mastectomy.
    Surveillance
    BR-7-2: IF a patient has been diagnosed with stage I to III breast cancer and has not had bilateral mastectomies, THEN the patient should have a mammogram in the last 12 months.
NICCQ colorectal cancer quality measures
    Data gathering: pathology, evaluation, and staging
    Pathology reporting
    CO-1A1: IF a patient has a malignant tumor of the colon or rectum excised, THEN the pathology report should state the depth of invasion of the tumor.
    CO-1A4: IF a patient has a malignant tumor of the colon or rectum excised, THEN the pathology report should state whether or not the tumor involves lymph nodes.
    CO-1A5: IF a patient has a malignant rectal tumor excised, THEN the pathology report should state the presence or absence of lymphovascular invasion.
    CO-1A6: IF a patient has a malignant rectal tumor excised, THEN the pathology report should comment on the presence or absence of microscopic tumor cells at the resection margin.
    Diagnostic evaluation
    CO-1B1: IF a patient has a malignant rectal tumor excised, THEN a medical record should state the distance from the anal verge.
    CO-1B3: IF a patient has a malignant rectal tumor and undergoes transrectal ultrasound, THEN the transrectal ultrasound should occur before radiotherapy.
    CO-1B3: IF a patient has a malignant rectal tumor and undergoes transrectal ultrasound, THEN the ultrasound report should state the depth of invasion of the tumor.
    CO-1B8: IF a patient has surgical excision of a malignant colorectal tumor, THEN the patient should have colonoscopy or barium enema to assess for the presence of synchronous tumors or polyps between 6 months before and 16 weeks after the surgical excision.
    Staging
    CO-1C2: IF a patient has malignant tumor of the colon or rectal cancer and has the malignant tumor excised and is seen in consultation by a medical oncologist, THEN the medical oncologist's medical records should document at least one of the following:
    1. AJCC stage or TNM stage OR
    2. Nodal status and, if lymph nodes negative, the depth of invasion.(continued on following page)


Appendix (continued)

    CO-1C4: IF a patient has a malignant tumor of the colon or rectum surgically excised and is seen in consultation by a radiation oncologist, THEN the radiation oncologist's medical record§ should document at least one of the following:
    1. AJCC stage or TNM stage OR
    2. Nodal status and, if lymph nodes negative, the depth of invasion size and lymph node status.
    Initial management
    Surgery
    CO-2A3: IF a patient has resection of a malignant tumor of the colon (but not rectum) and not a T4 lesion OR a documented intraoperative complication that led to premature termination of the operation, THEN the last pathology report associated with the resection should note that the margins of the operative specimen should be free of tumor.
    CO-2A8: IF a patient has a malignant tumor of the colon or rectum excised, THEN there should be evidence that a lymphadenectomy was performed.
    CO-2A9: IF a patient has primary rectal cancer and does not have a T4 tumor OR a documented intraoperative complication that led to premature termination of the operation, THEN the surgical pathology report should document that the radial margin of the surgical specimen is free of tumor.
    CO-2A10: IF the patient receives a diverting ileostomy or colostomy, THEN the patient should receive enterostomy care and management instructions before discharge or receive a home healthcare follow-up.
    Systemic adjuvant therapy
    Combined CO-2B1a and CO-2B1b: IF a patient has stage II colon cancer features that increase the risk of recurrence (obstruction, perforation, or T4 lesions) or stage III colon cancer, THEN the patient should receive adjuvant chemotherapy with a regimen listed in Table A or was in a clinical trial.
    CO-2B2: IF a patient has resection of a malignant tumor for stage II colon cancer with high risk for recurrence (obstruction, perforation, or T4 lesions) or stage III colon cancer and received chemotherapy, THEN the patient should start adjuvant chemotherapy within 8 weeks of surgical resection.
    CO-2B3a: IF a patient has a stage II or III rectal cancer, THEN the patient should have received neoadjuvant chemotherapy or adjuvant chemotherapy with a regimen listed in the associated table or was in a clinical trial.
    CO-2B3: IF a patient has a stage II or III rectal cancer and received chemotherapy, THEN the patient should start chemotherapy within 8 weeks of first positive biopsy OR within 8 weeks of surgical resection.
    G-2B1: IF a patient is treated with chemotherapy, THEN the planned dose (dose per cycle x number of cycles) should be documented in the medical oncology or integrated record.
    G-2B2: IF a patient is treated with chemotherapy, THEN the planned dose (dose per cycle x number of cycles) should fall within a range that is consistent with published regimens.
    G-2B3: IF a patient is treated with chemotherapy, THEN body-surface area should be documented.
    Radiation therapy
    CO-2C1a: IF a patient has stage II or III rectal cancer, THEN the patient should receive radiation therapy either before definitive surgical excision OR after definitive surgical excision.
    CO-2C1b: IF a patient has stage II or III rectal cancer and received radiation therapy, THEN the patient should receive radiation (25 Gy total dose or greater) therapy either before definitive surgical excision OR after definitive surgical excision.
    Referrals and coordination of care
    CO-4-1: IF a patient has stage II or III rectal cancer, THEN the patient should have a consultation with a radiation oncologist.
    Surveillance
    CO-7-2: IF the patient has resection of stage II or III colon or rectal cancer, THEN the patient should be counseled about the need to have first-degree relatives undergo colorectal cancer screening.

Abbreviations: NICCQ, National Initiative for Cancer Care Quality; AJCC, American Joint Committee on Cancer; ER, estrogen receptor; PR, progesterone receptor; BCS, breast-conserving surgery; 5HT, 5-hydroxytryptamine-3. Measure includes data abstracted from patients' medical records. Measure includes data obtained from a patient survey approximately 4 years after diagnosis. The associated table of chemotherapy regimens appropriate for adjuvant therapy of breast cancer in 1998 included all published variations of doxorubicin and cyclophosphamide (AC), including those with the addition of a taxane (AC -> T, ATC); cyclophosphamide, doxorubicin, fluorouracil (CAF, FAC); fluorouracil, epirubicin, cyclophosphamide (FEC); cyclophosphamide, methotrexate, fluorouracil (CMF); and doxorubicin, cyclophosphamide, methotrexate, fluorouracil (A -> CMF). Patients were asked about tamoxifen used approximately 4 years after diagnosis. The associated table of chemotherapy regimens appropriate for adjuvant therapy of colorectal cancer in 1998 included all published variations of fluorouracil and leucovorin or levamisole.


    Authors' Disclosures of Potential Conflicts of Interest
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 
Althoguh all authors completed the disclosure declaration, the following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Authors Employment Leadership Consultant Stock Honoraria Research Funds Testimony Other

Jennifer L. Malin Amgen (N/R) Amgen (B); Genetech (B) ASCO (A) ASCO (B)
Eric C. Schneider ASCO (A) ASCO (B)
Arnold M. Epstein ASCO (A) ASCO (B)
John Adams ASCO (B)
Ezekiel J. Emanuel ASCO (A)
Katherine L. Kahn ASCO (A) ASCO (B)

Dollar Amount Codes (A) < $10,000 (B) $10,000-99,999 (C) ≥ $100,000 (N/R) Not Required


    Author Contributions
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 Appendix
 Authors' Disclosures of...
 Author Contributions
 REFERENCES
 

Conception and design: Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstein, John Adams, Ezekiel J. Emanuel, Katherine L. Kahn

Financial support: Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstein, Katherine L. Kahn

Collection and assembly of data: Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstei, Katherine L. Kahn

Data analysis and interpretation: Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstein, John Adams, Ezekiel J. Emanuel, Katherine L. Kahn

Manuscript writing: Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstein, John Adams, Katherine L. Kahn

Final approval of manuscript: Jennifer L. Malin, Eric C. Schneider, Arnold M. Epstein, John Adams, Ezekiel J. Emanuel, Katherine L. Kahn

 


    Acknowledgment
 
We thank Joseph Bailes and Deborah Kamin, along with the following members of the America Society of Clinical Oncology's Quality Task Force for their leadership and thoughtful suggestions throughout the study: Chandra Belani, Charles Bennett, Al Benson, Susan Braun, Nancy Davidson, Lawrence Einhorn, Arlene Forastiere, Becky Garcia, Michael Goldstein, Craig Henderson, Bruce Hillner, Patricia Jassak, Margaret Kemeny, Nancy Kemeny, Patricia Legant, Bernard Levin, William McGivney, Monica Morrow, Linda Mulvihill, Catherine Park, David Pfister, Lori Pierce, Arnold Potosky, Mack Roach, Christopher Rose, Carolyn Runowicz, Lowell Schnipper, Deborah Schrag, Joseph Simone, Thomas Smith, Glenn Steele, Ellen Stovall, Jane Weeks, William Wood, and Rodger Winn. We also acknowledge Carol Cosenza, Floyd J. Fowler Jr, and Matt Jans of the Center for Survey Research for contributions to the patient survey design and fieldwork. In addition, we also acknowledge the following individuals for their important contributions to the National Initiative for Cancer Care Quality: Chantal Avila, Robin Beckman, Matt Cioffi, Carol Edwards, Fuan-Ye Kung, Lorraine Scampini, and Jie Zheng for statistical programming; Jeff Adams, Marc Chow, Chris Collopy, Christy Herring, Nancee Inouye, and Mayde Rosen for project administration and management; Clifford Ko, Peggy Wallace, and Ann Zisser for assistance with the development and implementation of the medical record abstraction tool; and Peggy Wallace for assistance with specification of the quality measures. Finally, we express our gratitude to the patients and the cancer registrars and staff at all of the participating hospitals and medical practices, without whom this study would not have been possible.


    NOTES
 
Supported by a grant from the American Society of Clinical Oncology. J.L.M. was supported by a CI-10 Damon Runyon-Lilly Clinical Investigator Award from the Damon Runyon Cancer Research Foundation. The authors have received honoraria for presenting research results at conferences sponsored by the American Society of Clinical Oncology and the American College of Surgeons.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO), Orlando, FL, May 18-21, 2002; the 39th Annual Meeting of ASCO, Chicago, IL, May 31-June 3, 2003; the 40th Annual Meeting of ASCO, New Orleans, LA, June 5-8, 2004; and the 41st Annual Meeting of ASCO, Orlando, FL, May 13-17, 2005.

The assertions and opinions expressed in this article are solely those of the authors and are not necessarily those of the American Society of Clinical Oncology or its representatives.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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 ABSTRACT
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 METHODS
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 DISCUSSION
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 Authors' Disclosures of...
 Author Contributions
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5. Jencks SF, Huff ED, Cuerdon T: Change in the quality of care delivered to Medicare beneficiaries, 1998-1999 to 2000-2001. JAMA 289:305-312, 2003[Abstract/Free Full Text]

6. McGlynn EA, Asch SM, Adams J, et al: The quality of health care delivered to adults in the United States. N Engl J Med 348:2635-2645, 2003[Abstract/Free Full Text]

7. Agency for Healthcare Research and Quality: National Healthcare Quality Report: AHRQ Publication No. 04-RG003. http://www.ahrq.gov/qual/nhqr03/nhqrsum03.htm

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12. Schneider EC, Epstein AM, Malin JL, et al: Developing a system to assess the quality of cancer care: ASCO's national initiative on cancer care quality. J Clin Oncol 22:2985-2991, 2004[Free Full Text]

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Submitted June 30, 2005; accepted November 7, 2005.




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