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Learning Objectives Identify predictors of excessive risk perception in women with a distant history of DCIS. Explain the importance of educating women with a history of DCIS about reasonable assessments of their risk for future breast cancer. Introduction. Previous research has demonstrated that many women with ductal carcinoma in situ (DCIS) overestimate their risk for future breast cancer at the time of diagnosis and soon thereafter. This study aims to evaluate risk perceptions after 5 years. Patients and Methods. In a longitudinal cohort study, we mailed long-term follow-up surveys to 315 women who had previously responded to a survey 18 months after they were diagnosed with DCIS, excluding those who had experienced recurrence and those not treated at our institution. We evaluated risk perceptions with items used previously in the cohort. Results. One hundred ninety-three women (61%) responded. The median time since diagnosis was 5.9 years. We excluded 12 because of recurrence. Of the 181 remaining, 32% perceived at least a moderate 5-year risk for developing DCIS again, 43% perceived at least a moderate lifetime risk for developing DCIS again, 27% perceived at least a moderate 5-year risk for invasive breast cancer, 38% perceived at least a moderate lifetime risk for invasive breast cancer, and 24% perceived at least a moderate risk for DCIS spreading to other body parts. In a multivariate model, worse financial status and higher perceived risk in the previous survey were the only predictors of at least a moderate perception of risk for DCIS spreading. Conclusion. Women with a history of DCIS continue to harbor inaccurate perceptions of their risk for future breast cancer events even 5 years after diagnosis.

Myeloid colony-stimulating factors (CSFs) decrease the risk of febrile neutropenia (FN) from high-risk chemotherapy regimens administered to patients at 20% or greater risk of FN, but little is known about their use in clinical practice. We evaluated CSF use in a multiregional population-based cohort of lung and colorectal cancer patients (N = 1849). Only 17% (95% confidence interval [CI] = 8% to 26%) patients treated with high-risk chemotherapy regimens received CSFs, compared with 18% (95% CI = 16% to 20%) and 10% (95% CI = 8% to 12%) of patients treated with intermediate- (10%–20% risk of FN) and low-risk (

To determine the accuracy with which Medicare claims data measure disease-free survival in elderly Medicare beneficiaries with cancer, we performed a criterion validation study. We merged gold-standard clinical trial data of 45 elderly patients with node-positive breast cancer who were treated on the Cancer and Leukemia Group B (CALGB) adjuvant breast trial 9344 with Centers for Medicare and Medicaid Services (CMS) data files and compared the results of a CMS-based algorithm with the CALGB disease-free survival information to determine sensitivity and specificity. For 5-year disease-free survival, the sensitivity of the CMS-based algorithm was 100% (95% confidence interval [CI] = 81% to 100%), the specificity was 97% (95% CI = 83% to 100%), and the area under the receiver operator curve was 98[corrected]% (95% CI = 95[corrected]% to 100%). For 2-year disease-free survival, the test characteristics were less favorable: sensitivity was 83% (95% CI = 36% to 100%), specificity was 95% (95% CI = 83% to 100%), and area under the receiver operator curve was 89[corrected]% (95% CI = 72[corrected]% to 100%).

Objective. To evaluate measures that could use existing administrative data to assess the intensity of end-of-life cancer care. Methods. Benchmarking standards and statistical variation were evaluated using Medicare claims of 48,906 patients who died from cancer from 1991 through 1996 in 11 regions of the United States. We assessed accuracy by comparing administrative data to 150 medical records in one hospital and affiliated cancer treatment center. Results. Systems not providing overly aggressive care near the end of life would be ones in which less than 10% of patients receive chemotherapy in the last 14 days of life, less than 2% start a new chemotherapy regimen in the last 30 days of life, less than 4% have multiple hospitalizations or emergency room visits or are admitted to the intensive care unit (ICU) in the last month of life, and less than 17% die in an acute care institution. At least 55% of patients would receive hospice services before death from cancer, and less than 8% of those would be admitted to hospice within only 3 days of death. All measures were found to have accuracy ranging from 85 to 97% and 2- to 5-fold adjusted variability between the 5th and 95th percentiles of performance. Conclusions. The usefulness of these measures will depend on whether the concept of intensity of care near death can be further validated as an acceptable and important quality issue among patients, their families, health care providers, and other stakeholders in oncology.

BACKGROUND Ongoing clinical trials are addressing the accuracy and safety of sentinel node biopsy (SNB) in the treatment of breast cancer; however, SNB is already increasingly being used in clinical practice. This study examined the extent and time trends of the use of SNB in stage I and II breast cancer patients. METHODS Clinical data were collected from stage I and II (tumor size < or =5.0 cm) breast cancer patients (n = 3003) who were treated at five comprehensive cancer centers between July 1, 1997, and December 31, 2000. Axillary surgery was classified as SNB alone, SNB + axillary node dissection (AND), AND alone, or none. Patterns of use of axillary surgery were summarized as the percentage of patients receiving each surgery type. The statistical significance of time trends for the use of SNB alone was analyzed by logistic regression models. All statistical tests were two-sided. RESULTS Overall, SNB alone was used in 13% of patients, SNB + AND in 22%, AND alone in 59%, and no axillary surgery in 6%. Use of SNB alone was statistically significantly associated with breast-conserving surgery of both smaller (< or =2 cm) and larger tumors (2-5 cm) (P

BACKGROUND Many research subjects believe incorrectly that the primary purpose of clinical trials is to benefit the participants rather than to improve therapy for future patients. However, few data are available about how physicians view trials. METHODS We mailed surveys to a stratified random sample (n = 1120) of U.S. medical, pediatric, and other oncology specialists who were selected from the American Society of Clinical Oncology Membership Directory. Respondents were asked to select, from a list of options, their reasons for enrolling individual patients in trials and what they thought the main societal purposes of clinical trials are. We used logistic regression models to evaluate which demographic and clinical practice characteristics were associated with responses to these questions. All statistical tests were two-sided. RESULTS Of the 547 physicians (48.8%) who responded, 40.5% of the medical oncologists, 32.3% of the pediatric oncologists, and 62.6% of the other oncology subspecialists reported enrolling individual patients in clinical trials to improve future therapy. Most of the other respondents reported enrolling patients to ensure that they received state-of-the-art treatment. When asked about the main societal purpose of clinical trials, 72.7% of the medical oncologists, 59.4% of the pediatric oncologists, and 81.9% of the other oncology subspecialists cited improving future therapy; most of the other respondents cited ensuring state-of-the-art treatment for participants. In multivariable analysis, medical oncologists (odds ratio [OR] = 0.6, 95% confidence interval [CI] = 0.3 to 0.9) and pediatric oncologists (OR = 0.3, 95% CI = 0.2 to 0.5) were less likely than other oncologists to identify improving future therapy as the main societal purpose of clinical trials, whereas industry physicians (OR = 4.6, 95% CI = 1.1 to 20.5) chose this option more often than physicians who did not work for industry. CONCLUSIONS Many respondents viewed the main societal purpose of clinical trials as benefiting the participants rather than as creating generalizable knowledge to advance future therapy. This view, which was more prevalent among specialists such as pediatric oncologists that enrolled greater proportions of patients in trials, conflicts with established principles of research ethics.

BACKGROUND Substantial shortcomings in the quality of breast cancer (BC) care have been identified. While breast cancer is responsible for the largest share of cancer care spending, little is known about the value of care provided to US women with BC. METHODS For women aged 65 to 70 years diagnosed July 1997 through December 2005 with stage 0-III BC who were continuously enrolled in fee-for-service Medicare, we evaluated performance relative to 20 measures recommending for proven therapies and seven measures recommending against unnecessary therapies. Using health care service area as the unit of analysis, we characterized quality for recommended and unnecessary therapies, median per-patient cost in the year after diagnosis for Medicare parts A and B, and five-year overall survival. We analyzed the relationships between quality, cost, and survival. All statistical tests were two-sided. RESULTS We assessed the care provided to 15357 women and compiled quality, cost, and outcomes data for 99 regions. The median number of patients/region was 85 (interquartile range = 47-158); the five-year overall survival was 87.5%. Part B expenditure correlated positively with measures of recommended therapy (P = .027) and negatively with measures of unnecessary therapy (P = .004). Survival did not correlate with quality or cost. Regions demonstrating lower quality for both recommended and unnecessary therapy measures exhibited higher part A expenditure. CONCLUSIONS BC patients experience wide variation in quality, cost, and survival. Process measures that assess recommended and unnecessary therapies did not correlate with survival, but did shed light on spending for related and unrelated services. Additional efforts to identify factors that impact the relationships between quality, cost, and outcomes are needed.

The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking.We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and perceived (subjective) understanding of cancer clinical trials. The QuIC incorporates the basic elements of informed consent specified in federal regulations, assesses the therapeutic misconception (the belief that all aspects of a clinical trial are designed to directly benefit the subject), and employs the language and structure of the new National Cancer Institute template for informed consent documents. We modified the QuIC after receiving feedback from pilot tests with cancer research subjects, as well as validation from two independent expert panels. We then sent the QuIC to 287 adult cancer patients enrolled on phase I, II, or III clinical trials. Two hundred seven subjects (72%) completed the QuIC. To assess test-retest reliability, a random sample of 32 respondents was selected, of whom 17 (53%) completed the questionnaire a second time. The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective understanding and.77 for tests of subjective understanding. The current version of the QuIC, which consists of 20 questions for objective understanding and 14 questions for subjective understanding, was tested for time and ease of administration in a sample of nine adult cancer patients. The QuIC required an average of 7.2 minutes to complete.The QuIC is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.

"Outcomes research" is a commonly used term, but what does it really mean? In this review article, we 1) briefly review the historic background of outcomes research, paying particular attention to the social and political movements that helped shape the field; 2) present a conceptual framework to help classify the major areas of research and provide a working definition of outcomes research; and 3) review the oncology literature in the English language from 1966 through 1998 to examine temporal trends and characterize the body of work being presented to the practicing oncology community. We conclude that outcomes research is a broad concept, which, in its current usage, describes an array of distinct types of research. However, common themes are apparent when outcomes research is viewed in the context of its historic origins and is contrasted with other established disciplines, especially clinical trials. Our literature review shows that outcomes studies are increasing in absolute numbers, in relative proportion of the oncology literature, and in quality. We suggest that as different branches of investigation develop their own literature and methodology-in effect, outgrowing the generic label of outcomes research-they become identified by separate, more precise terms.

Background Adjuvant endocrine treatment with aromatase inhibitors improves disease-free survival compared with tamoxifen in postmenopausal women with estrogen receptor–positive breast cancer. This difference could be due to differences in tamoxifen metabolism because levels of endoxifen, the active tamoxifen metabolite, vary with the number of mutant alleles, including the *4 allele, of the gene encoding cytochrome P450 2D6 (CYP2D6).

In recent years, studies of "large databases" have yielded a number of interesting insights into patterns of cancer care. These databases, collected for administrative purposes, such as Medicare billing, have been mined as a source of populationbased data on the nonmedical determinants of treatment choice. Many of the findings have been unsettling. For example, recent large database studies have found that the proportion of women with breast cancer who receive mastectomy rather than breastconserving surgery is up to three times higher in the central United States than on both coasts (7,2), and that insurance status predicts for stage at diagnosis and survival, stage for stage, in breast cancer (5). These studies {1-3) have also confirmed what smaller case series have suggested for some time, that older cancer patients receive less aggressive treatment than younger patients. Although large database studies have proven to be extremely useful in demonstrating that nonmedical factors may be driving some of the variability in cancer care, they are much less helpful in identifying where the problem lies or even if there is a problem. Treatment choice is influenced by a number of factors: physician knowledge, physician bias, geographic access to specialized treatment facilities, financial access to care, comorbid conditions, and patient preferences. In contrast to the other determinants, patient preferences are rarely, if ever, evaluated in patterns of care studies. In some cases, there is little need to assess preferences. Threefold differences between mastectomy rates in Massachusetts and Minnesota are almost certainly not due to marked differences in the preferences between women in those two states. However, an assessment of patient preferences is essential in determining whether the less aggressive cancer treatment received by older Americans represents age discrimination or a response to patients' preferences. A previous study (4) has suggested that, although the primary determinant of cancer treatment for the elderly is physicians' recommendations, older patients may give greater weight to considerations of toxicity than younger patients. However, studies of actual decision making cannot disentangle patients' innate preferences about treatment outcomes from the manner in which physicians choose to present those outcomes. The report by Yellen et al. (5) in this issue of the Journal makes an important contribution to our understanding of the role of elderly patients' preferences in determining cancer treatment choice. Using structured vignettes to assess cancer patients' willingness to accept toxic therapy to enhance survival, Yellen et al. found that older patients were as willing to choose chemotherapy as were younger patients, but that older patients required a greater survival advantage before they would choose a toxic regimen over a less toxic alternative. One could argue that preferences expressed about hypothetical choices might differ from decisions patients would make if they faced the same choice in real life. However, the value of using scenarios in this setting is that it eliminates the confounding effect of physicians' biases. What are the implications of this work for the practicing oncologist? One might conclude that treatment should be recommended with equal enthusiasm to all patients regardless of age, but that special attention should be paid to the severity of expected toxic effects when presenting alternatives to older patients. However, an age-based approach to patient counseling should be accepted with caution. Perhaps the most striking feature of the data presented by Yellen et al. (5) is not the differences in preferences across age groups, but rather the wide variability in preferences within age groups. Examinations of patient preferences in a variety of diseases have repeatedly demonstrated that individuals differ widely in their values for different aspects of health (6). Factors such as age, socioeconomic status, religion, and health status explain relatively little of this variability (7). Individuals' goals in life and the sacrifices they are willing to make to attain them are highly personalized and cannot be intuited from a sociodemograph ic profile.