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Background: Breast density tends to decrease when women stop taking hormone therapy (HT). Some women find HT cessation difficult to tolerate, possibly because of fluctuations in endogenous hormone levels and vasomotor symptoms. We hypothesized that women with dense breasts might have lower tolerance for short-term HT suspension than do women with fatty breasts., Methods: As part of the Radiologic Evaluation And breast Density (READ) trial, we randomly assigned 881 women aged 45-80 with a prior screening (index) mammogram to suspend HT for 1 or 2 months before their next screening (study) mammogram. We measured continuous breast density on index mammograms using computer-assisted thresholding. At study mammograms, women indicated tolerance for stopping HT from 1 (extremely difficult) to 7 (very easy). Using linear regression, we evaluated the association between index breast density and tolerance after cessation, adjusting for age, body mass index (BMI), HT type, randomization group, and vasomotor symptoms., Results: A higher percentage of breast density was associated with lower unadjusted mean tolerance scores (tolerance 4.27, 95% confidence interval [CI] 3.77-4.77 for women with > or =50% density, and 4.73, 95% CI 4.45-5.01 for women with <10% density, not a statistically significant difference). In adjusted analyses, neither percent breast density nor dense breast area was associated with tolerance for HT suspension., Conclusions: Although HT use affects breast density, tolerance for suspending HT is not associated with breast density. Women with dense breasts have the greatest potential for decreases in density after HT cessation; they should tolerate stopping HT as well as women with fatty breasts.

Objective: Some healthcare providers recommend hormone therapy (HT) cessation before mammography to improve performance. Our objective was to evaluate characteristics of women willing to consider HT cessation before screening mammography., Methods: We performed a randomized clinical trial, the Radiological Evaluation and Breast Density study, within an integrated health plan (2004-2007). Women aged 45 to 80 years who used HT at their most recent screening (index) mammogram, who were due for a screening (study) mammogram, and who were still using HT were invited to participate. Randomization groups were: (1) no, (2) 1-month, or (3) 2-month cessation. Women's willingness to participate was evaluated by age, race, ethnicity, education, hysterectomy, type of HT (unopposed estrogen and estrogen plus progestin), duration of HT use, body mass index, breast cancer risk, and breast density., Results: A total of 5,861 women were invited to participate; 2,999 refused. An additional 169 women agreed to participate but withdrew before data collection. Compared with women who participated (n = 1,535), nonparticipants (n = 3,168; 2,999 + 169; 54%) were older, were less educated, and had lower body mass index (all P < 0.05). Among nonparticipants, 1,876 (59.2%) were unwilling to stop HT. Among estrogen-plus-progestin users, women with a first-degree relative with a history of breast cancer had lower odds of refusal than women without a family history of breast cancer (adjusted odds ratio, 0.71; 95% CI, 0.54-0.93)., Conclusions: Most women were unwilling to stop HT, even for a short period, when the intent was to improve mammographic accuracy, and even when informed that they could restart HT at any time during the 2-month study. Some factors predicted willingness to stop HT; the magnitude of the differences may not be clinically meaningful.

Background: Without population-based evidence, some clinicians recommend short-term suspension of hormone therapy to improve the performance of mammography. Hormone therapy increases breast density, and abnormal screening mammograms are more common among women with denser breasts and among women using hormone therapy., Objective: To test whether 1 to 2 months of hormone therapy suspension before screening mammography decreases additional mammographic imaging (recall) in women age 45 to 80 years., Design: 3-group randomized, controlled trial., Setting: Integrated health plan in western Washington from 2004 to 2007., Patients: 1704 women age 45 to 80 years who used hormone therapy at their most recent screening (index) mammography, were due for screening (study) mammography, and were still using hormone therapy., Intervention: Block random assignment (by breast density and hormone therapy type) to no hormone therapy suspension (n = 567) or suspension for 1 month (n = 570) or 2 months (n = 567) before study mammography. One blinded expert radiologist interpreted all mammograms., Measurements: Recall was the primary outcome, and change in mammographic breast density (percentage and dense area) between the index and study mammograms was the secondary outcome., Results: Mammography recall rates were 11.3% (61 of 542 women in the no-suspension group), 12.3% (50 of 478 women in the 1-month suspension group), and 9.8% (44 of 451 women in the 2-month suspension group). No subgroups were identified in which brief suspension of hormone therapy resulted in decreased mammography recall. With suspension, decreases in percentage of breast density were orderly and statistically significant: 0.1% (no-suspension group), -0.9% (1-month suspension group), and -1.5% (2-month suspension group). Similar ordered decreases were observed for dense area. Women in the suspension groups experienced increased menopause symptoms., Limitations: Results can only be generalized to women age 45 to 80 years who have used hormone therapy for at least 1 year and will consider short-term suspension; most eligible women (61%) declined participation. Mammography recall was determined by 1 expert radiologist., Conclusion: Brief hormone therapy suspension was associated with small changes in breast density and did not affect recall rates. No evidence supports short-term hormone therapy suspension before mammography.

Objective: To obtain quality-of-life (QOL) valuations associated with mammography screening and breast cancer treatment that are suitable for use in cost-effectiveness analyses., Methods: Subjects comprised 131 women (age range 50-79 years) randomly sampled from a breast cancer screening program. In an in-person or telephone interview, women rated the QOL impact of 14 clinical scenarios (ranging from mammography to end-of-life care for breast cancer) using a visual analogue scale anchored by death (0) and perfect health/quality of life (100)., Results: Women rated the scenarios describing true negative results, false positive results, and routine screening mammography at 80 or above on a scale of 0-100, suggesting that they perceive these states as being close to perfect health. They rated adjuvant chemotherapy (39.7; range 10-90), palliation/end-of-life care (35.8; range 0-100), and recurrence at 1 year (33.0; range 0-95) the lowest, suggesting that these health states are perceived as compromised. Women rated receiving news of a breast cancer diagnosis (true positive) (45.7; range 5-100) and receiving delayed news of a breast cancer diagnosis (false negative) (48.5; range 5-100) as being comparable to undergoing mastectomy (48.3; range 10-100) and radiation therapy (46.2; range 5-100) for breast cancer., Conclusions: These data can be used to update cost analyses of mammography screening that wish to take into account the QOL impact of screening.

The objective of our study was to evaluate organized breast cancer screening implementation by measuring the association between screening program enrollment and late-stage disease. Our setting was a health plan using mailed mammography reminders to women ages > or = 40. We conducted yearly cross-sectional summaries of mammography experience and late-stage (regional or distant Surveillance Epidemiology and End Results Reporting (SEER) stage) breast cancer occurrence for all of the health-plan women ages > or = 40 (1986-1998). We estimated the odds of late-stage breast cancer among health-plan and surrounding community women because it was too early to compare changes in mortality. We also estimated the odds of late-stage disease (1995-1998) associated with program enrollment and mammography screening among health-plan women. We found that mammography-within-two-years increased within the health plan from 25.9% to 51.2% among women ages 40-49 and from 32.9% to 74.7% among women ages> or = 50. Health-plan late-stage rates were lower than those in the surrounding community [ages 40-49: odds ratio (OR), 0.87; 95% confidence interval (CI), 0.77-0.99; ages 50-79: OR, 0.86; 95% CI, 0.80-0.92] and declined parallel to the community. Among health-plan cancer cases, women ages > or = 43 who were enrolled in the screening program and who had at least one program mammogram were less likely to have late-stage disease compared with the women not enrolled in the program (OR, 0.31; 95% CI, 0.16-0.61) but the odds of late-stage was also reduced among program-enrolled women not receiving program mammograms (OR, 0.45; 95% CI, 0.21-0.95). We concluded that enrollment in organized screening is associated with increased likelihood of mammography and reduced odds of late-stage breast cancer. Addressing the concerns of un-enrolled women and those without mammograms offers an opportunity for further late-stage disease reduction.

Context: Initiation of hormone replacement therapy (HRT) has been shown to increase breast density. Evidence exists that increased breast density decreases mammographic sensitivity. The effects on breast density of discontinuing and continuing HRT have not been studied systematically., Objective: To examine the effects of initiation, discontinuation, and continued use of HRT on breast density in postmenopausal women., Design, Setting, and Participants: Observational cohort study of 5212 naturally postmenopausal women aged 40 to 96 years and enrolled in a large health maintenance organization in western Washington State who had 2 screening mammograms between 1996 and 1998., Main Outcome Measures: Breast density, assessed using the clinical radiologists' BI-RADS 4-point scale, compared among women who did not use HRT before either mammogram (nonusers); who used HRT before the first but not before the second mammogram (discontinuers); who used HRT before the second but not before the first mammogram (initiators); and who used HRT prior to both mammograms (continuing users)., Results: Relative to nonusers, women who initiated HRT were more likely to show increases in breast density (relative risk [RR], 2.57; 95% confidence interval [CI], 2.12-3.08), while women who discontinued HRT use were more likely to show decreases in density (RR, 1.81; 95% CI, 1.06-2.98) and women who continued to use HRT were more likely to show both increases in density (RR, 1.33; 95% CI, 1.13-1.55) and sustained high density (RR, 1.45; 95% CI, 1.33-1.58)., Conclusions: These results indicate that breast density changes associated with HRT are dynamic, increasing with initiation, and decreasing with discontinuation.

Objective: We conducted an analysis among 31 community radiologists to identify the average change in screening mammography interpretive accuracy afforded by independent double interpretation., Materials and Methods: We assessed interpretive accuracy using a stratified random sample of test mammograms that included 30 women with cancer and 83 without. Radiologists were unaware of clinical information and of each other's assessments. We describe accuracy for individual radiologists and for double interpretation, including average sensitivity, specificity, diagnostic likelihood ratios positive and negative, and area under the receiver operating characteristic (ROC) curve. We also assessed weighted and nonweighted kappa statistics among all 465 pairs of radiologists and 31,465 pairs of unique pairs. The assessment for double interpretations used the "highest" (i.e., most abnormal) assessment of the two radiologists. We calculated the difference between each radiologist's individual accuracy and the average accuracy across that radiologist's 30 double interpretations., Results: We found the following average accuracy statistics for individual radiologists: sensitivity, 79%; specificity, 81%; diagnostic likelihood ratio positive, 5.53; diagnostic likelihood ratio negative, 0.26; and area under the ROC curve, 0.85. The mean kappa statistic among radiologists for cancer cases increased with double interpretation from 0.59 to 0.70, and for noncancer cases from 0.30 to 0.34. Double interpretation resulted in an average increase in sensitivity of 7%, an average decrease in specificity of 11%, a decrease in diagnostic likelihood ratio positive of 2.35, a decrease in diagnostic likelihood ratio negative of 0.06, and an increase in area under the ROC curve of 0.02., Conclusion: Independent double interpretation does not increase accuracy as measured by the area under the ROC curve.

Background: Prospective randomized trials have demonstrated that motivational telephone calls increase adherence to screening mammography. To better understand the effects of motivational calls and to maximize adherence, we conducted a randomized trial among women aged 50-79 years., Methods: We created a stratified random sample of 5062 women due for mammograms within the Group Health Cooperative of Puget Sound, including 4099 women with prior mammography and 963 without it. We recruited and surveyed 3743 (74%) of the women before mailing a recommendation. After 2 months, 1765 (47%) of the 3743 women had not scheduled a mammogram and were randomly assigned to one of three intervention groups: a reminder post-card group (n = 590), a reminder telephone call group (n = 585), and a motivational telephone call addressing barriers group (n = 590). The telephone callers could schedule mammography. We used Cox proportional hazards models to estimate the hazard ratio (HR) and 95% confidence interval (CI) for documented mammography use by 1 year., Results: Women who received reminder calls were more likely to get mammograms (HR = 1.9; 95% CI = 1.6-2.4) than women who were mailed postcards. The motivational and reminder calls (average length, 8.5 and 3.1 minutes, respectively) had equivalent effects (HR = 0.97; 95% CI = 0.8-1.2). After we controlled for the intervention effect, women with prior mammography (n = 1277) were much more likely to get a mammogram (HR = 3.4; 95% CI = 2.7-4.3) than women without prior use (n = 488). Higher income, but not race or more education, was associated with higher adherence., Conclusions: Reminding women to schedule an appointment was as efficacious as addressing barriers. Simple intervention groups should be included as comparison groups in randomized trials so that we better understand more complex intervention effects.