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Purpose: Clinical trials demonstrated adjuvant aromatase inhibitor treatment is superior for decreasing breast cancer recurrence risk over adjuvant tamoxifen treatment as early as 2001. Yet clinical use for adjuvant treatment was not recommended by the American Society of Clinical Oncology until 2004. Aromatase inhibitor uptake after the first public presentation of randomized trial results but before the release of national guidelines is unclear. We evaluated diffusion of aromatase inhibitor dispensings for breast cancer treatment in integrated healthcare delivery systems across the United States., Methods: We collected automated data for 13,245 women enrolled at seven integrated healthcare delivery systems in the Cancer Research Network. All women were aged >55 and diagnosed with estrogen receptor positive, invasive breast cancer between 1996 and 2003. We used electronic pharmacy data to identify aromatase inhibitor and tamoxifen dispensings through 2004. We evaluated the proportions of women who received hormone dispensings in two ways: (1) at any point after diagnosis to capture all use, and (2) in the two-year period following diagnosis to approximate adjuvant use., Results: Over time, adjuvant aromatase inhibitor use increased whereas tamoxifen use decreased. Aromatase inhibitor dispensings within 2 years of diagnosis increased from 4.1% among women diagnosed in 2000 to 13% in 2001, 24% in 2002, and 40% in 2003. Tamoxifen use declined starting in 2001 at every system., Conclusion: Aromatase inhibitor use rose dramatically after 2001 while tamoxifen use decreased. It appears results from early clinical trials changed practice in these integrated healthcare systems before formal changes in national guidelines.

Because of recent studies showing strong prevention benefit and acceptable psychosocial outcomes, more women may be considering prophylactic mastectomy. A growing literature shows some positive psychosocial outcomes for women with bilateral prophylactic mastectomy, but less is known about women with contralateral prophylactic mastectomy. Several surveys have shown that a large majority of women with prophylactic mastectomy report satisfaction with their decisions to have the procedure when asked in a quantitative, closed-ended format. We sought to explore the nuances of women's satisfaction with the procedure using a qualitative, open-ended format. We included open-ended questions as part of a mailed survey on psychosocial outcomes of prophylactic mastectomy. The research team coded and analyzed these responses using qualitative methods. We used simple descriptive statistics to compare the demographics of the entire survey sample to those women who answered the open-ended questions; the responses to the open- and closed-ended satisfaction questions, and the responses of women with bilateral and contralateral prophylactic mastectomy. Seventy-one percent of women with prophylactic mastectomy responded to the survey and 48% provided open-ended responses about psychosocial outcomes. Women's open-ended responses regarding psychosocial outcomes could be coded into one of three general categories--positive, negative, and disparate. In the subgroup of women with both open- and closed-ended responses, over 70% of women providing negative and disparate comments to the open-ended question simultaneously indicated satisfaction on a closed-ended question. Negative and disparate open-ended responses were twice as common among women with bilateral prophylactic mastectomy (52%) than women with contralateral prophylactic mastectomy (26%). These findings suggest that even among women who report general satisfaction with their decision to have prophylactic mastectomy via closed-ended survey questions, lingering negative psychosocial outcomes can remain, particularly among women with bilateral prophylactic mastectomy. This dichotomy could be an important factor to discuss in counseling women considering the procedure.

Although prophylactic mastectomy significantly reduces the incidence and recurrence of breast cancer, little is known about women's information needs before the procedure. We surveyed 967 women, from 6 healthcare systems, with bilateral or contralateral prophylactic mastectomy performed between 1979 and 1999. There were 2 open-ended questions: "What one thing do you wish you had known before your prophylactic mastectomy" and "Is there anything else you would like to share with us?" Three researchers categorized responses, and informational needs were ascertained. Seventy-one percent (684 women) responded, of which 81% answered one or both open-ended questions. There were 386 comments (made by 293 women) that related to information needs; 79% of women had bilateral prophylactic mastectomy and 58% had contralateral prophylactic mastectomy. Most concerns (69%) were related to reconstruction: the longevity; look and feel of implants, pain, numbness, scarring, and reconstruction options. Many women wished they had seen photographs to better prepare them for the final result. Our findings suggest that information needs of many women undergoing prophylactic mastectomy, particularly those selecting bilateral prophylactic mastectomy, have not been sufficiently addressed. Clinicians and health educators should be aware of patient needs and must counsel women accordingly.

Background: Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (approximately 94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity., Objective: To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity., Design: Retrospective cohort study., Subjects: Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484)., Measurements: Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered "average-risk" if they had neither a family history of breast cancer nor a prior breast biopsy and "increased-risk" otherwise., Results: Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8-99.7%] and 97.1% (95% CI: 95.7-98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7-76.5%) and 57.1% (95% CI: 51.1-63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10-0.46)., Conclusions: Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.

Background: Bilateral prophylactic mastectomy in women with increased breast cancer risk dramatically reduces breast cancer occurrence but little is known about psychosocial outcomes., Methods: To examine long-term quality of life after bilateral prophylactic mastectomy, we mailed surveys to 195 women who had the procedure from 1979 to 1999 and to a random sample of 117 women at increased breast cancer risk who did not have the procedure. Measures were modeled on or drawn directly from validated instruments designed to assess quality of life, body image, sexuality, breast cancer concerns, depression, health perception, and demographic characteristics. We used logistic regression to examine associations between quality of life and other domains., Results: The response rate was 58%, with 106 women with and 62 women without prophylactic mastectomy returning complete surveys. Among women who underwent bilateral prophylactic mastectomy, 84% were satisfied with their decision to have the procedure; 61% reported high contentment with quality of life compared with an identical 61% of women who did not have the procedure (P = 1.0). Among all subjects, diminished contentment with quality of life was not associated with bilateral prophylactic mastectomy but with dissatisfaction with sex life (adjusted ratio [OR] = 2.5, 95% confidence interval [CI] = 1.0-6.2), possible depression (CES-D > 16, OR = 4.9, CI = 2.0-11.8), and poor or fair general health perception (OR = 8.3, 95% CI = 2.4-29.0)., Conclusions: The majority of women reported satisfaction with bilateral prophylactic mastectomy and experienced psychosocial outcomes similar to women with similarly elevated breast cancer risk who did not undergo prophylactic mastectomy. Bilateral prophylactic mastectomy appears to neither positively nor negatively impact long-term psychosocial outcomes.

Purpose: To understand psychosocial outcomes after prophylactic removal of the contralateral breast in women with unilateral breast cancer., Methods: We mailed surveys to women with contralateral prophylactic mastectomy after breast cancer diagnosis between 1979 and 1999 at six health care delivery systems, and to a smaller random sample of women with breast cancer without the procedure. Measures were modeled on instruments developed to assess contentment with quality of life, body image, sexual satisfaction, breast cancer concern, depression, and health perception. We examined associations between quality of life and the other domains using logistic regression., Results: The response rate was 72.6%. Among 519 women who underwent contralateral prophylactic mastectomy, 86.5% were satisfied with their decision; 76.3% reported high contentment with quality of life compared with 75.4% of 61 women who did not undergo the procedure (P = .88). Among all case subjects, less contentment with quality of life was not associated with contralateral prophylactic mastectomy or demographic characteristics, but was associated with poor or fair general health perception (odds ratio [OR], 7.0; 95% CI, 3.4 to 14.1); possible depression (OR, 5.4; 95% CI, 3.1 to 9.2); dissatisfaction with appearance when dressed (OR, 3.5; 95% CI, 2.0 to 6.0); self-consciousness about appearance (OR, 2.0; 95% CI, 1.1 to 3.7); and avoiding thoughts about breast cancer (modest: OR, 2.2; 95% CI, 1.1 to 4.5; highest: OR, 1.7; 95% CI, 0.9 to 3.2)., Conclusion: Most women undergoing contralateral prophylactic mastectomy report satisfaction with their decision and experience psychosocial outcomes similar to breast cancer survivors without the procedure.

Background: The efficacy of breast cancer screening in the community may differ from that suggested by the results of randomized trials, and no data have been available on efficacy among women who have different levels of breast cancer risk., Methods: We conducted a matched case-control study among women enrolled in six health plans in Washington, Oregon, California, Massachusetts, and Minnesota. We examined the efficacy of screening by mammography and/or clinical breast examination among women in two age cohorts (40-49 years and 50-65 years) and in two breast cancer risk levels (average and increased risk). Women who died from breast cancer from January 1, 1983, through December 31, 1998, (N = 1351; case subjects) were matched to control subjects (N = 2501) on age and risk level. Increased risk was defined as a family history of breast cancer or a breast biopsy noted in the medical records before the index date (defined as date of first suspicion of breast abnormalities in case subjects, with the same date used for matched control subjects). Data on screening, risk status, and other variables were abstracted from medical records. Conditional logistic regression was used to examine the association between breast cancer mortality and receipt of screening. All statistical tests were two-sided., Results: There were small, non-statistically significant associations between breast cancer mortality and receipt of screening during the 3 years prior to the index date for both the younger women [odds ratio (OR) = 0.92; 95% confidence interval (CI) = 0.76 to 1.13] and the older women (OR = 0.87; 95% CI = 0.68 to 1.12). The association among women at increased risk (OR = 0.74; 95% CI = 0.50 to 1.03) was stronger than that among women at average risk (OR = 0.96; 95% CI = 0.80 to 1.14), but the difference was not statistically significant (P = .17)., Conclusions: In this community-based study, screening history was not associated with breast cancer mortality. However, potential limitations of this study argue for a cautious interpretation of these findings.

Purpose: We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer., Methods: This retrospective cohort study comprised approximately 50,000 women who were diagnosed with unilateral breast cancer during 1979 to 1999. Using computerized data confirmed by chart review, we identified 1,072 women (1.9%) who had CPM. We obtained covariate information for these women and for a sample of 317 women who did not undergo CPM., Results: The median time from initial breast cancer diagnosis to the end of follow-up was 5.7 years. Contralateral breast cancer developed in 0.5% of women with CPM, metastatic disease developed in 10.5%, and subsequent breast cancer developed in 12.4%; 8.1% died from breast cancer. Contralateral breast cancer developed in 2.7% of women without CPM, and 11.7% died of breast cancer. After adjustment for initial breast cancer characteristics, treatment, and breast cancer risk factors, the hazard ratio (HR) for the occurrence of contralateral breast cancer after CPM was 0.03 (95% CI, 0.006 to 0.13). After adjustment for breast cancer characteristics and treatment, the HRs for the relationship of CPM with death from breast cancer, with death from other causes, and with all-cause mortality were 0.57 (95% CI, 0.45 to 0.72), 0.78 (95% CI, 0.57 to 1.06), and 0.60 (95% CI, 0.50 to 0.72), respectively., Conclusion: CPM seems to protect against the development of contralateral breast cancer, and although women who underwent CPM had relatively low all-cause mortality, CPM also was associated with decreased breast cancer mortality.

Background: Findings from several studies suggest that bilateral prophylactic mastectomy reduces breast cancer incidence by 90% or more, but the studies used highly selected patients from referral centers, and the comparison groups were not population based. We studied the efficacy of bilateral prophylactic mastectomy in women with elevated breast cancer risk cared for in community practices., Methods: We conducted a retrospective case-cohort study of women aged 18 to 80 years with 1 or more breast cancer risk factors (family history of breast cancer, history of atypical hyperplasia, or > or =1 breast biopsies with benign findings). Using computerized data and medical records, we identified 276 women with bilateral prophylactic mastectomy and a stratified random sample of 196 women representing an underlying cohort of 666 800 women with elevated breast cancer risk without prophylactic mastectomy, and then we determined who developed breast cancer., Results: Breast cancer developed in 1 woman (0.4%) after bilateral prophylactic mastectomy vs 26 800 women (4.0%) without prophylactic mastectomy. Stratifying by birth year, the hazard ratio for breast cancer occurrence after bilateral prophylactic mastectomy was 0.005 (95% confidence interval, 0.001-0.044). No woman with bilateral prophylactic mastectomy died of breast cancer vs a calculated 0.2% of women without prophylactic mastectomy., Conclusions: Bilateral prophylactic mastectomy reduced breast cancer incidence in women at elevated risk for breast cancer cared for in community-based practices. However, the absolute risk of breast cancer incidence and death in women who did not undergo the procedure in these settings was relatively low.

Background: Although most American women regularly receive screening clinical breast examination (CBE), little is known about CBE accuracy in community practice. We sought to estimate the rate of cancer detection (sensitivity) of screening CBE performed by community-based clinicians on women who ultimately died of breast cancer, as well as to identify factors associated with accurate detection., Subjects and Methods: We evaluated CBE accuracy among asymptomatic female health plan enrollees in five states (WA, OR, CA, MA, and MN) who received a CBE within 1 year of breast cancer diagnosis and who died of breast cancer within 15 years of diagnosis (N = 485). Sensitivity was estimated as the proportion whose exam was abnormal. Bivariate and logistic regression analyses identified patient characteristics associated with cancer detection., Results: An abnormality was noted on screening CBE in one of five women who ultimately succumbed to breast cancer (sensitivity = 21.6%; 95% confidence interval [CI] = 18.1% to 25.6%). The odds of a true-positive screening CBE (sensitivity) were decreased among women using estrogen (odds ratio [OR] = 0.23; 95% CI = 0.07 to 0.80), receiving a Pap smear during the same visit as CBE (OR = 0.45; 95% CI = 0.27 to 0.72), and with increasing chronic disease comorbidity (P(trend) = .08)., Conclusion: Screening CBE as performed in the community may be insufficiently sensitive to detect most lethal breast cancers. Low sensitivity of screening CBE in community practice may be partly attributable to its performance alongside time-consuming clinical tasks such as Pap smear screening or chronic illness care.

Background: Contralateral prophylactic mastectomy (CPM) is the removal of a nonaffected breast in a woman with unilateral breast cancer and is effective in reducing the risk of recurrences. Little is known about women's decision-making roles regarding CPM., Methods: Women aged 18-80 years with CPM performed at one of six health maintenance organizations between 1979 and 1999 were surveyed. We determined women's reported decision-making roles at the time of CPM, analyzed their trends over time, and explored the association between decision-making roles and psychosocial outcomes following CPM., Results: We received 562 responses (response rate = 73%); 431 completed items needed for this analysis. Most respondents were white, younger than 55 years at CPM, married, and had CPM within 10 years of completing the survey. Forty-five percent made the decision to undergo CPM alone, 37% considered their doctor's opinion, 15% shared the decision with their doctor and only 3% reported their doctor primarily made the decision. Women reporting active roles were more likely to be younger (P<.0008), college educated (P<.0001) and have CPM more recently (P = .002). Compared with those sharing the decision with their doctors, women with active roles were twice as likely to be satisfied 6 months following CPM (odds ratio [OR] = 2.2, 95% confidence interval [CI] = 1.1 to 4.2) and report current concern about breast cancer (OR = 1.9, 95% CI = 1.0 to 3.4)., Conclusions: Most women reported active or shared roles in decision making regarding CPM, particularly younger women, those with college education, and those with recent CPM. Women with active roles were more often satisfied in the short term but were also more likely to report current concern about breast cancer. Whether higher concern is related to insufficient input from clinicians should be explored. Prospective data are needed.

Understanding and eliminating health disparities requires accurate data on race/ethnicity. To assess the quality of race/ethnicity data, we compared medical record classifications to self-report of a study of prophylactic mastectomy. A total of 788 women had race/ethnicity from both sources; 69.9% were 55 years of age or older, 38.3% were at least college graduates, and 67.8% were married or living with someone. There were 817 race/thnicity classifications for the 788 women, of which 758 (92.3%) were identical in the medical record and self-report. Sensitivity and positive predictive value were high (86.7%-97.2%) for whites, Asians, and blacks and moderate (64.0% and 68.1%) for Latinas. However, only one of 18 Native Americans was correctly identified in her medical record. Our results indicate that even if the overall accuracy of medical record classifications for race/ethnicity is high, such a finding may obscure substantial inaccuracies in the recording for racial/ethnic minorities, especially Latinas and Native Americans.

Background: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort., Methods: Women aged 18-80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure., Results: We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055)., Conclusion: We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.

Clinical studies using medical record review should include careful training and quality assurance methods to enhance the reliability and validity of data obtained from the records. Because of time and budget constraints, comprehensive assessments of data quality and reliability, including masking of medical record abstractors, are not always possible. This paper describes the abstractor training and quality control methods and results of a masked medical record review study. The medical record review study was carried out within a larger multisite study of the effectiveness of screening mammography in preventing breast cancer mortality with an observation period within 1983 and 1993, with mortality follow-up through 1998. An eight-step program was developed to train medical record abstractors and monitor the quality of their work. A key follow-up component to the training protocol was a 5% reabstraction of medical records (n = 160), masked and reviewed by a second abstractor. High agreement was found between initial (unmasked) abstractors and masked abstractors for all key exposure variables (kappa ranged from 0.76 to 0.91), with no evidence of biased directionality by unmasked reviewers. Rigorous ongoing training programs for medical record abstractors provide assurance of good quality control in large multisite studies. Additionally, a masking study with a subsample of subjects may be a feasible and cost-effective alternative to the time- and cost-intensive methodological approach of masking all medical records.

The authors sought to examine the hypothesis that girls who were relatively tall during the prepubescent period (indicative of an affluent diet and good general health) were at increased risk of subsequent breast cancer. They conducted a case-control study of 214 long-term members who were diagnosed with breast cancer during 1973-1995 and who were age 12 years or younger when they first joined Kaiser Permanente and of 214 appropriately matched controls. Information was obtained from the medical records. While the authors observed the expected association of adult height with risk of breast cancer (height at age 15-18 years, tall-for-age vs. short-for-age: odds ratio = 2.2, 95% confidence interval: 1.1, 4.3), the association was no stronger earlier in life (height at age 9-11 years: odds ratio = 1.0, 95% confidence interval: 0.5, 1.8). The study does not support a relation between pubertal skeletal growth and adult risk of breast cancer. However, it is limited by the inclusion of few postmenopausal women.

We sought to assess the reliability of information regarding the maternal history of cancer by comparing the medical records of 214 women with breast cancer, ages 26-59 years and diagnosed in 1974-1995, and of their controls with the medical records of their mothers. Subjects were members of Kaiser Permanente, Northern California, selected for a study of early-life predictors of breast cancer. For any type of cancer identified in the mother's medical record, the proportion noted in the daughter's medical record at least 6 months before the daughter's diagnosis or reference date was 56% among cases and 32% among controls. The odds ratio for the association of maternal cancer history with breast cancer risk was 2.1 using the maternal record and 3.5 using the subject's record. For a maternal history of breast cancer, the proportion noted in the subject's record was 79% among cases and 57% among controls, and the odds ratios were 4.0 and 6.5, respectively. We believe that the case-control difference in missing information was attributable to higher utilization of breast cancer screening among cases. This study illustrates the need to assess the impact of screening differences on the ascertainment of information from the medical records.

We studied breast cancer incidence during the period 1973-1986 in Asian residents of three U.S. geographic areas. The rate in Asian-American women born in China or Japan and in their U.S.-born counterparts was about 50% and 75% that of U.S.-born whites, respectively, and was approximately twice the rate of women residing in Asia. Breast cancer incidence was nearly identical in U.S.- and foreign-born Filipino-Americans, but it was 40% that of U.S.-born whites.

Background: The effect of alcohol intake on mammographic densities and the possible interaction between these two factors in regard to the risk of breast cancer were assessed using information from the Breast Cancer Detection and Demonstration Project., Methods: Mammograms taken during the first year of screening for patients whose breast cancer was detected in the 5th year of follow-up (n = 266) and their matched controls (n = 301) were blindly assessed for the percent of mammographic densities, which were measured by planimetry., Results: Among controls, alcohol intake was weakly, positively associated with the percent of mammographic densities (Spearman rank correlation coefficient, 0.09), although the association may have been the result of chance (P = 0.12). After adjustment for confounding factors, the lifetime alcohol intake did not appear to modify the effect of the percent mammographic densities on the risk of breast cancer (P for the interaction, 0.09)., Conclusions: Longitudinal studies and larger case-control studies should be conducted to assess the relationship between diet and changes in mammographic densities further.