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Background Most breast biopsies will be negative for cancer. Benign breast biopsy can cause changes in the breast tissue, but whether such changes affect the interpretive performance of future screening mammography is not known. Methods We prospectively evaluated whether self-reported benign breast biopsy was associated with reduced subsequent screening mammography performance using examination data from the mammography registries of the Breast Cancer Surveillance Consortium from January 2, 1996, through December 31, 2005. A positive interpretation was defined as a recommendation for any additional evaluation. Cancer was defined as any invasive breast cancer or ductal carcinoma in situ diagnosed within 1 year of mammography screening. Measures of mammography performance (sensitivity, specificity, and positive predictive value 1 [PPV1]) were compared both at woman level and breast level in the presence and absence of self-reported benign biopsy history. Referral to biopsy was considered a positive interpretation to calculate positive predictive value 2 (PPV2). Multivariable analysis of a correct interpretation on each performance measure was conducted after adjusting for registry, year of examination, patient characteristics, months since last mammogram, and availability of comparison film. Accuracy of the mammogram interpretation was measured using area under the receiver operating characteristic curve (AUC). All statistical tests were two-sided. Results A total of 2007381 screening mammograms were identified among 799613 women, of which 14.6% mammograms were associated with self-reported previous breast biopsy. Multivariable adjusted models for mammography performance showed reduced specificity (odds ratio [OR] = 0.74, 95% confidence interval [CI] = 0.73 to 0.75, P < .001), PPV2 (OR = 0.85, 95% CI = 0.79 to 0.92, P < .001), and AUC (AUC 0.892 vs 0.925, P < .001) among women with self-reported benign biopsy. There was no difference in sensitivity or PPV1 in the same adjusted models, although unadjusted differences in both were found. Specificity was lowest among women with documented fine needle aspiration--the least invasive biopsy technique (OR = 0.58, 95% CI = 0.55 to 0.61, P < .001). Repeating the analysis among women with documented biopsy history, unilateral biopsy history, or restricted to invasive cancers did not change the results. Conclusions Self-reported benign breast biopsy history was associated with statistically significantly reduced mammography performance. The difference in performance was likely because of tissue characteristics rather than the biopsy itself. J Natl Cancer Inst 2010;102:1040-1051 DOI: 10.1093/jnci/djq233

Background Interpretive performance of screening mammography varies substantially by facility, but performance of diagnostic interpretation has not been studied. Methods Facilities performing diagnostic mammography within three registries of the Breast Cancer Surveillance Consortium were surveyed about their structure, organization, and interpretive processes. Performance measurements (false-positive rate, sensitivity, and likelihood of cancer among women referred for biopsy [positive predictive value of biopsy recommendation {PPV2}]) from January 1, 1998, through December 31, 2005, were prospectively measured. Logistic regression and receiver operating characteristic (ROC) curve analyses, adjusted for patient and radiologist characteristics, were used to assess the association between facility characteristics and interpretive performance. All statistical tests were two-sided. Results Forty-five of the 53 facilities completed a facility survey (85% response rate), and 32 of the 45 facilities performed diagnostic mammography. The analyses included 28100 diagnostic mammograms performed as an evaluation of a breast problem, and data were available for 118 radiologists who interpreted diagnostic mammograms at the facilities. Performance measurements demonstrated statistically significant interpretive variability among facilities (sensitivity, P = .006; false-positive rate, P < .001; and PPV2, P < .001) in unadjusted analyses. However, after adjustment for patient and radiologist characteristics, only false-positive rate variation remained statistically significant and facility traits associated with performance measures changed (false-positive rate = 6.5%, 95% confidence interval [CI] = 5.5% to 7.4%; sensitivity = 73.5%, 95% CI = 67.1% to 79.9%; and PPV2 = 33.8%, 95% CI = 29.1% to 38.5%). Facilities reporting that concern about malpractice had moderately or greatly increased diagnostic examination recommendations at the facility had a higher false-positive rate (odds ratio [OR] = 1.48, 95% CI = 1.09 to 2.01) and a nonstatistically significantly higher sensitivity (OR = 1.74, 95% CI = 0.94 to 3.23). Facilities offering specialized interventional services had a non-statistically significantly higher false-positive rate (OR = 1.97, 95% CI = 0.94 to 4.1). No characteristics were associated with overall accuracy by ROC curve analyses. Conclusions Variation in diagnostic mammography interpretation exists across facilities. Failure to adjust for patient characteristics when comparing facility performance could lead to erroneous conclusions. Malpractice concerns are associated with interpretive performance.

Background: Black-white disparities exist in receipt of recommended medical care, including colorectal cancer treatment. This retrospective cohort study examines the degree to which health systems (e.g., physician, hospital) factors explain black-white disparities in colon cancer care. Methods: Data from the Surveillance, Epidemiology, and End Results program; Medicare claims; the American Medical Association Masterfile; and hospital surveys were linked to examine chemotherapy receipt after stage III colon cancer resection among 5294 elderly ([greater than or equal to] 66 years of age) black and white Medicare-insured patients. Logistic regression analysis was used to identify factors associated with black--white differences in chemotherapy use. All statistical tests were two-sided. Results: Black and white patients were equally likely to consult with a medical oncologist, but among patients who had such a consultation, black patients were less likely than white patients (59.3% versus 70.4%, difference = 10.9%, 95% confidence interval [CI] = 5.1% to 16.4%, P

Background: Invasive cervical cancer is highly preventable, yet it continues to occur, even among women who have access to cancer screening and treatment services. To reduce cervical cancer among such women, reasons for its occurrence must be better understood. We examined factors associated with the diagnosis of cervical cancer among women enrolled in health plans. Methods: We identified all cases of invasive cervical cancer (n = 833) diagnosed from January 1, 1995, through December 31, 2000, among women who were long-term members of seven prepaid comprehensive health plans and reviewed each woman's medical records for the 3 years prior to her cancer diagnosis. Women were classified into one of three categories based on Pap test histories 4-36 months before diagnosis: failure to screen with a Pap test, failure in detection by a Pap test, or failure in follow-up of an abnormal test result. Results: The majority of cases (n = 464; 56%) were in women who had no Pap tests during the period 4-36 months prior to diagnosis. Of the remaining cases, 263 (32%) were attributed to Pap test detection failure and 106 (13%) to follow-up failure. Being older (odds ratio [OR] = 6.48, 95% confidence interval [CI] = 3.89 to 10.79) or living in an area of higher poverty (OR = 1.72, 95% CI = 1.11 to 2.67) or having a lower education level (OR= 1.52; 95% CI = 1.07 to 2.16) was associated with the likelihood of being assigned to the failure to screen category versus either of the other two categories. A total of 375 (81%) of the 464 patients who had not had Pap screening had had at least one outpatient visit 4-36 months prior to cancer diagnosis. The cancer diagnostic process was triggered by a routine screening examination in 44% of patients, whereas 53% of the patients presented with symptoms consistent with cervical cancer; the remaining 3% were identified fortuitously during the course of receiving noncervical care. Conclusions: To reduce the incidence of invasive cervical cancer among women with access to screening and treatment, Pap screening adherence should be increased. In addition, strategies to improve the accuracy of Pap screening could afford earlier detection of cervical cancer.

Background: Radiologists differ in their ability to interpret screening mammograms accurately. We investigated the relationship of radiologist characteristics to actual performance from 1996 to 2001. Methods: Screening mammograms (n = 469 512) interpreted by 124 radiologists were linked to cancer outcome data. The radiologists completed a survey that included questions on demographics, malpractice concerns, years of experience interpreting mammograms, and the number of mammograms read annually. We used receiver operating characteristics (ROC) analysis to analyze variables associated with sensitivity, specificity, and the combination of the two, adjusting for patient variables that affect performance. All P values are two-sided. Results: Within 1 year of the mammogram, 2402 breast cancers were identified. Relative to low annual interpretive volume ([less than or equal to] 1000 mammograms), greater interpretive volume was associated with higher sensitivity (P = .001; odds ratio [OR] for moderate volume [1001-2000] = 1.68, 95% CI = 1.18 to 2.39; OR for high volume [>2000] = 1.89, 95% CI = 1.36 to 2.63). Specificity decreased with volume (OR for 1001-2000 = 0.65, 95% CI = 0.52 to 0.83; OR for more than 2000 = 0.76, 95% CI = 0.60 to 0.96), compared with 1000 or less (P = .002). Greater number of years of experience interpreting mammograms was associated with lower sensitivity (P = .001), but higher specificity (P = .003). ROC analysis using the ordinal BI-RADS interpretation showed an association between accuracy and both previous mammographic history (P = .012) and breast density (P

Background: Mammography screening may reduce breast cancer mortality by detecting cancers at an earlier stage. However, certain questions remain, including the ideal interval between mammograms. Methods: We conducted an observational study using information collected by seven mammography registries across the United States to investigate whether women diagnosed with breast cancer after having screening mammograms separated by a 2-year interval (n = 2440) are more likely to be diagnosed with late-stage disease (positive lymph nodes or metastases) than women diagnosed with breast cancer after having screening mammograms separated by a 1-year interval (n = 5400). Analyses were stratified by age and breast density to clarify whether groups that have the poorest mammography sensitivity (i.e., women under age 50 years and those with mammographically dense breasts) would benefit most from annual screening. The subjects were women diagnosed with breast cancer between 1996 and 2001 who were 40-89 years old at their index mammographic examination (i.e., the most recent screen at or before breast cancer diagnosis). Data were analyzed by logistic regression, adjusting for race, ethnicity, family history of breast cancer, and mammography registry. Results: Among women age 40-49 years at the index mammogram, those with a 2-year screening interval were more likely to have late-stage disease at diagnosis than those with a 1-year screening interval (28% versus 21%; odds ratio [OR] = 1.35, 95% confidence interval [CI] = 1.01 to 1.81). There was no increase in late-stage disease for women 50 years or older with a 2-year versus a 1-year screening interval (women age 50-59 years at index mammogram: OR = 0.97, 95% CI = 0.75 to 1.25; women age 60-69 years at index mammogram: OR = 0.99, 95% CI = 0.72 to 1.35; women age 70 years or older at index mammogram: OR = 0.88, 95% CI = 0.64 to 1.19). There was no indication that women with dense breasts would benefit more from a 1-year versus 2-year screening interval than women with fatty breasts. Conclusion: These findings may be useful for policy decisions about appropriate screening intervals and for use in statistical models that estimate the costs and benefits of mammography by age and screening interval.

Background: Mammography screening increases the detection of early-stage breast cancers. Therefore, implementing screening should reduce the percentage of women who are diagnosed with late-stage disease. However, despite high national mammography screening rates, late-stage breast cancers still occur, possibly because of failures in screening implementation. Methods: Using data from seven health care plans that included 1.5 million women aged 50 years or older, we conducted retrospective reviews of chart and automated data for 3 years before 1995-1999 diagnoses of late-stage (metastatic and/or tumor size [greater than or equal to] 3 cm; case subjects, n = 1347) and early-stage breast cancers (control subjects, n = 1347). We categorized the earliest screening mammogram during the period 13-36 months before diagnosis as none (absence of screening), negative (absence of detection), or positive (potential breakdown in follow-up). We compared the proportion of case and control subjects in each category, of screening implementation and estimated the likelihood (odds ratio [OR] with 95% confidence intervals [CIs]) of late-stage breast cancer. We also evaluated demographic characteristics associated with absence of screening in women with late-stage disease. All statistical tests were two-sided. Results: Absence of screening, absence of detection, and potential breakdown in follow-up were distributed differently among case (52.1%, 39.5%, and 8.4%, respectively) and control subjects (34.4%, 56.9%, and 8.8%, respectively) (P = .03). Among all women, the odds of having late-stage cancer were higher among women with an absence of screening (OR = 2.17, 95% CI = 1.84 to 2.56; P

Background: Younger women (40-49 years) have lower mammographic sensitivity (i.e., greater proportion of cancers detected after a negative mammogram) than older women ([greater than or equal to] 50 years). We explored the effect of tumor growth rate, breast density, mammographic image quality, and breast cancer risk factors on mammographic sensitivity in younger and older women. Methods: We studied 576 women (n = 73 aged 40-49 years and n = 503 aged 50 years or older) who were diagnosed with invasive breast cancer between 1988 and 1993. Interval cancers were defined as those diagnosed within 12 or 24 months after a negative screening mammogram and before a subsequent mammogram. Tumor growth rate was assessed by mitotic figure count and Ki-67 positivity. The main outcome measures were percentage of women with interval cancer (1 - mammographic sensitivity) by age, odds ratio (OR) of interval cancer by age, and excess odds (i.e., the percentage of the odds ratio for age that was explained by individual covariates). Results: Interval cancers occurred in 27.7% of younger women and 13.9% of older women within 12 months (OR = 2.36, 95% confidence interval [CI] = 1.14 to 4.77) and in 52.1% of younger women and 24.7% of older women within 24 months (OR = 3.58, 95% CI = 2.15 to 5.97). Greater breast density explained 67.6% of the decreased mammographic sensitivity in younger women at 12 months, whereas rapid tumor growth explained 30.6% and breast density explained 37.6% of the decreased sensitivity in younger women at 24 months. Conclusions: Breast density largely explained decreased mammographic sensitivity at 12 months, whereas rapid tumor growth contributed to decreased mammographic sensitivity at 24 months. A 12-month versus a 24-month mammography screening interval may therefore reduce the adverse impact of faster growing tumors on mammographic sensitivity in younger women. [J Natl Cancer Inst 2004;96:1432-40]

Background: With the large number of women having mammography--an estimated 28.4 million U.S. women aged 40 years and older in 1998--the percentage of cancers detected as ductal carcinoma in situ (DCIS), which has an uncertain prognosis, has increased. We pooled data from seven regional mammography registries to determine the percentage of mammographicaily detected cancers that are DCIS and the rate of DCIS per 1000 mammograms. Methods: We analyzed data on 653 833 mammograms from 540738 women between 40 and 84 years of age who underwent screening mammography at facilities participating in the National Cancer Institute's Breast Cancer Surveillance Consortium (BCSC) throughout 1996 and 1997. Mammography results were linked to population-based cancer and pathology registries. We calculated the percentage of screen-detected breast cancers that were DCIS, the rate of screen-detected DCIS per 1000 mammograms by age and by previous mammography status, and the sensitivity of screening mammography. Statistical tests were two-sided. Results: A total of 3266 cases of breast cancer were identified, 591 DCIS and 2675 invasive breast cancer. The percentage of screen-detected breast cancers that were DCIS decreased with age (from 28.2% [95% confidence interval (CI) = 23.9% to 32.5%] for women aged 40-49 years to 16.0% [95% CI = 13.3% to 18.7%] for women aged 70-84 years). However, the rate of screen-detected DCIS cases per 1000 mammograms increased with age (from 0.56 [95% CI = 0.41 to 0.70] for women aged 40-49 years to 1.07 [95 % CI = 0.87 to 1.27] for women aged 70-84 years). Sensitivity of screening mammography in all age groups combined was higher for detecting DCIS (86.0% [95% CI = 83.2% to 88.8%]) than it was for detecting invasive breast cancer (75.1% [95 % CI = 73.5 % to 76.8%]). Conclusions: Overall, approximately 1 in every 1300 screening mammography examinations leads to a diagnosis of DCIS. Given uncertainty about the natural history of DCIS, the clinical significance of screen-detected DCIS needs further investigation.

Background: The performance of diagnostic mammography for women with signs or symptoms of breast cancer has not been well studied. We evaluated whether age, breast density, self-reported breast lump, and previous mammography influence the performance of diagnostic mammography. Methods: From January 1996 through March 1998, prospective diagnostic mammography data from women aged 25-89 years with no previous breast cancer were linked to cancer outcomes data in six mammography registries participating in the Breast Cancer Surveillance Consortium. We used the final mammographic assessment at the end of the imaging work-up to determine abnormal mammographic examination rate, positive predictive value (PPV), sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve. We used age, breast density, prior mammogram, and self-reported breast lump jointly as predictors of performance. All statistical tests were two-sided. Results: Of 41427 diagnostic mammograms, 6279 (15.2%) were judged abnormal. The overall PPV was 21.8%, sensitivity was 85.8%, and specificity was 87.7%. Multivariate analysis showed that sensitivity and specificity generally declined as breast density increased (P = .007 and P

Background: Although it is recommended that women with a family history of breast cancer begin screening mammography at a younger age than average-risk women, few studies have evaluated the performance of mammography in this group. Objective: To compare the performance of screening mammography in women with a first-degree family history of breast cancer and women of similar age without such history. Design: Cross-sectional. Setting: Mammography registries in California (n = 1), New Hampshire (n = 1), New Mexico (n = 1), Vermont (n = 1), Washington State (n = 2), and Colorado (n = 1). Participants: 389 533 women 30 to 69 years of age who were referred for screening mammography from April 1985 to November 1997. Measurements: Risk factors for breast cancer; results of first screening examination captured for a woman by a registry; and any invasive cancer or ductal carcinoma in situ identified by linkage to a pathology database, the Surveillance, Epidemiology, and End Results program, or a state tumor registry. Results: The number of cancer cases per 1000 examinations increased with age and was higher in women with a family history of breast cancer than in those without (3.2 vs. 1.6 for ages 30 to 39 years, 4.7 vs. 2.7 for ages 40 to 49 years, 6.6 vs. 4.6 for ages 50 to 59 years, and 9.3 vs. 6.9 for ages 60 to 69 years). The sensitivity of mammography increased significantly with age (P = 0.001 [chi-square test for trend]) in women with a family history and in those without (63.2% [95% CI, 41.5% to 84.8%] vs. 69.5% [CI, 57.7% to 81.2%] for ages 30 to 39 years, 70.2% [CI, 61.0% to 79.5%] vs. 77.5% [CI, 73.3% to 81.8%] for ages 40 to 49 years, 81.3% [CI, 73.3% to 89.3%] vs. 80.2% [CI, 76.5% to 83.9%] for ages 50 to 59 years, and 83.8% [CI, 76.8% to 90.9%] vs. 87.7% [CI, 84.8% to 90.7%] for ages 60 to 69 years). Sensitivity was similar for each decade of age regardless of family history. The positive predictive value of mammography was higher in women with a family history than in those without (3.7% vs. 2.9%; P = 0.001). Conclusions: Cancer detection rates in women who had a first-degree relative with a history of breast cancer were similar to those in women a decade older without such a history. The sensitivity of screening mammography was influenced primarily by age.

Background: Mammography is less effective for women aged 40-49 years than for older women, which has led to a call for research to improve the performance of screening mammography for younger women. One factor that may influence the performance of mammography is breast density. Younger women have greater mammographic breast density on average, and increased breast density increases the likelihood of false-negative and false-positive mammograms. We investigated whether breast density varies according to time in a woman's menstrual cycle. Methods: Premenopausal women aged 40-49 years who were not on exogenous hormones and who had a screening mammogram at a large health maintenance organization during 1996 were studied (n = 2591). Time in the menstrual cycle was based on the woman's self-reported last menstrual bleeding and usual cycle length. Results: A smaller proportion of women had 'extremely dense' breasts during the follicular phase of their menstrual cycle (24% for week 1 and 23% for week 2) than during the luteal phase (28% for both weeks 3 and 4) (two-sided P = .04 for the difference in breast density between the phases, adjusted for body mass index). The relationship was stronger for women whose body mass index was less than or equal to the median (two-sided P [is less than] .01), the group who have the greatest breast density. Conclusions/Implications: These findings are consistent with previous evidence suggesting that scheduling a woman's mammogram during the follicular phase (first and second week) of her menstrual cycle instead of during the luteal phase (third and fourth week) may improve the accuracy of mammography for premenopausal women in their forties. Breast tissue is less radiographically dense in the follicular phase than in the luteal phase. [J Natl Cancer Inst 1998;90:906-10]

Background: Enrollment in health maintenance organizations (HMOs) has increased rapidly during the past 10 years, reflecting a growing emphasis on health care cost containment. To determine whether there is a difference in the treatment and outcome for female patients with breast cancer enrolled in HMOs versus a fee-for-service setting, we compared the 10-year survival and initial treatment of patients with breast cancer enrolled in both types of plans. Methods: With the use of tumor registries covering the greater San Francisco-Oakland and Seattle-Puget Sound areas, respectively, we obtained information on the treatment and outcome for 13 358 female patients with breast cancer, aged 65 years and older, diagnosed between 1985 and 1992. We linked registry information with Medicare data and data from the two large HMOs included in the study. We compared the survival and treatment differences between HMO and fee-for-service care after adjusting for tumor stage, comorbidity, and sociodemographic characteristics. Results: In San Francisco-Oakland, the 10-year adjusted risk ratio for breast cancer deaths among HMO patients compared with fee-for-service patients was 0.71 (95% confidence interval [CI] = 0.59-0.87) and was comparable for all deaths. In Seattle-Puget Sound, the risk ratio for breast cancer deaths was 1.01 (95% CI = 0.77-1.33) but somewhat lower for all deaths. Women enrolled in HMOs were more likely to receive breast-conserving surgery than women in fee-for-service (odds ratio = 1.55 in San Francisco-Oakland; 3.39 in Seattle). HMO enrollees undergoing breast-conserving surgery were also more likely to receive adjuvant radiotherapy (San Francisco-Oakland odds ratio = 2.49; Seattle odds ratio = 4.62). Conclusions: Long-term survival outcomes in the two prepaid group practice HMOs in this study were at least equal to, and possibly better than, outcomes in the fee-for-service system. In addition, the use of recommended therapy for early stage breast cancer was more frequent in the two HMOs. [J. Natl Cancer Inst 1997;89:1683-91]

Background: Previous studies have demonstrated that mammographic breast density increases following the initiation of estrogen replacement therapy (ERT). The effect, if any, that this increase in density has on the specificity (related to false-positive readings) and the sensitivity (related to false-negative readings) of screening mammography is unknown. Purpose: Using a retrospective cohort study design, we assessed the effects of ERT on the specificity and the sensitivity of screening mammography. Methods: Participants (n = 8779) were postmenopausal women, aged 50 years or older, who were enrolled in a health maintenance organization located in western Washington state and who entered a breast cancer screening program between January 1988 and June 1993. Two-view mammography was performed as part of a comprehensive breast cancer screening visit. Menopausal status, as well as demographic and risk-factor information, was recorded via self-administered questionnaires. Hormonal replacement therapy type and use were determined from questionnaire data and from an automated review of pharmacy records. Individuals diagnosed with breast cancer within 12 months of their first screening-program mammograms were identified through use of a regional cancer registry. Risk ratios (RRs) plus 95% confidence intervals (CIs) of false-positive as well as false-negative examinations among current and former ERT users (with never users as the reference group) were calculated. Reported P values are two-sided. Results: The specificity of mammographic screening was lower for current users of ERT than for never users or former users. Defining a positive mammographic reading as any non-normal reading (either suspicious for cancer or indeterminate), the adjusted RR (95% CI) of a false-positive reading for current users versus never users was 1.33 (1.15-1.54) (P

Purpose: This study was conducted to evaluate the effect of stage at diagnosis, age, and level of comorbidity (presence of other illness) on the costs of treating three types of cancer among members of a health maintenance organization. Methods: Among 388 000 members enrolled anytime during 1990 and 1991 in group Health Cooperative (GHC) of Puget Sound (Washington State), we estimated the total and net direct costs of medical care for colon, prostate, and breast cancers, including both incident (290, 554, and 645 patients, respectively) and prevalent (1046, 1295, and 2299 patients, respectively) cases. We summarized costs for initial, continuing, and terminal phases of care. Net costs were the difference between the costs of the care of each case subject and the average costs of the care for all enrollees without the cancer of interest who were of the same sex and in the same 5-year age group. Differences in estimated total and net costs by stage at diagnosis, age, and comorbidity were separately evaluated using multivariate regression modeling. All P values were two-sided. Comorbidity was based on a score calculated from 1988 pharmacy data. Results: Total costs of initial care increased with stage at diagnosis for colon (P = .0013) and breast (P

The increased uses of mammography and breast physical examination are part of the early detection objectives of the National Cancer Institute and have become a national priority. However, there are limitations in resources, mammographic equipment, and trained personnel. One approach has been to limit mammographic screening to women who belong to increased risk groups. Unfortunately, research has shown this technique to be ineffective, since it fails to include a large number of women who are likely to develop breast cancer. A more workable solution is to vary the recommended interval of mammographic screening, depending upon the risk category of the individual. This method has several advantages. More women are recommended to have mammographic screening, and yet the total number of screenings need not increase. In addition, the small but finite risks of mammographic screening are more concentrated among the women who are also the most likely to benefit. (The risks of the screening itself are, in fact, smaller than the risks involved with following up what would otherwise turn out to be false positives reports.) Such a program of risk determination has been instituted in a large northwest health maintenance organization (HMO) serving 400,000 members. After completing a questionnaire and noting such factors as age of first menstruation, nulliparity, first birth over 30, breast cancer in a first degree relative, and so forth, the woman is assigned to one of four risk categories. Women in the lowest category have mammography only when referred by their physician. In the next three categories, women are suggested to have mammographic exams at five-, three-, and one-year intervals. The net result is that within this HMO the number of mammographic exams has not increased, but the percentage of women over 40 who are eligible for mammography has risen from 57 to 83 percent. (Consumer Summary produced by Reliance Medical Information, Inc.)

Background: Choice of treatment for early-stage breast cancer depends on many factors, including the size and stage of the cancer, the woman's age, comorbid conditions, and perhaps the costs of treatment. We compared the costs of all medical care for women with early-stage breast cancer cases treated by breast-conserving therapy (BCT) or mastectomy. Methods: A total of 1675 women 35 years old or older with incident early-stage breast cancer were identified in a large regional nonprofit health maintenance organization in the period 1990 through 1997. The women were treated with mastectomy only (n = 183), mastectomy with adjuvant hormonal therapy or chemotherapy (n = 417), BCT with radiation therapy (n = 405), or BCT with radiation therapy and adjuvant hormonal therapy or chemotherapy (n = 670). The costs of all medical care for the period 1990 through 1998 were computed for each woman, and monthly costs were analyzed by treatment, adjusting for age and cancer stage. All statistical tests were two-sided. Results: At 6 months after diagnosis, the mean total medical care costs for the four groups differed statistically significantly (P [is less than] .001), with BCT being more expensive than mastectomy. The adjusted mean costs were $12 987, $14 309, $14 963, and $15 779 for mastectomy alone, mastectomy with adjuvant therapy, BCT plus radiation therapy, and BCT plus radiation therapy with adjuvant therapy, respectively. At 1 year, the difference in costs was still statistically significant (P [is less than] .001), but costs were influenced more by the use of adjuvant therapy than by type of surgery. The 1-year adjusted mean costs were $16 704, $18 856, $17 344, and $19 081, respectively, for the four groups. By 5 years, BCT was less expensive than mastectomy (P [is less than] .001), with 5-year adjusted mean costs of $41 930, $45 670, $35 787, and $39 926, respectively. Costs also varied by age, with women under 65 years having higher treatment costs than older women. Conclusions: BCT may have higher short-term costs but lower long-term costs than mastectomy. [J Natl Cancer Inst 2001;93:447-55]

Background: Screening mammography is the best method to reduce mortality from breast cancer, yet some breast cancers cannot be detected by mammography. Cancers diagnosed after a negative mammogram are known as interval cancers. This study investigated whether mammographic breast density is related to the risk of interval cancer. Methods: Subjects were selected from women participating in mammographic screening from 1988 through 1993 in a large health maintenance organization based in Seattle, WA. Women were eligible for the study if they had been diagnosed with a first primary invasive breast cancer within 24 months of a screening mammogram and before a subsequent one. Interval cancer case subjects (n = 149) were women whose breast cancer occurred after a negative or benign mammographic assessment. Screen-detected control subjects (n = 388) were diagnosed after a positive screening mammogram. One radiologist, who was blinded to cancer status, assessed breast density by use of the American College of Radiology Breast Imaging Reporting and Data System. Results: Mammographic sensitivity (i.e., the ability of mammography to detect a cancer) was 80% among women with predominantly fatty breasts but just 30% in women with extremely dense breasts. The odds ratio (OR) for interval cancer among women with extremely dense breasts was 6.14 (95% confidence interval [CI] = 1.95-19.4), compared with women with extremely fatty breasts, after adjustment for age at index mammogram, menopausal status, use of hormone replacement therapy, and body mass index. When only those interval cancer cases confirmed by retrospective review of index mammograms were considered, the OR increased to 9.47 (95% CI = 2.78-32.3). Conclusion: Mammographic breast density appears to be a major risk factor for interval cancer. [J Natl Cancer Inst 2000;92:1081-7]

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 postcard 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. [J Natl Cancer Inst 2000;92: 233-42]

Background: Despite the mortality benefits of breast cancer screening, not all women receive regular mammography. Such factors as age, socioeconomic status, and physician recommendation have been associated with greater use of screening. However, we do not know whether having an abnormal mammogram affects future screening. Objective: To examine the effect of a false-positive mammogram on adherence to the next recommended screening mammogram. Design: Prospective cohort study. Setting: The breast cancer screening program at Group Health Cooperative, a health maintenance organization in Washington state. Patients: 5059 women 40 years of age or older with no history of breast cancer or breast surgery who had false-positive (n = 813) or true-negative (n = 4246) index screening mammograms between 1 August 1990 and 31 July 1992. Measurements: Screening rates and odds ratios for recommended interval screening up to 42 months after the index mammogram. Results: After adjustment for differences in age; previous use of mammography; family history of breast cancer; exogenous hormone use; and age at menarche, first child-birth, and menopause, women with false-positive index mammograms were more likely than those with true-negative index mammograms to obtain their next recommended screening mammogram (odds ratio, 1.21 [95% CI, 1.01 to 1.45]). The relation between a false-positive mammogram and the likelihood of adherence to screening in the next recommended interval was strongest among women who had not previously undergone mammography (odds ratio, 1.66 [CI, 1.26 to 2.17]). Conclusions: Having a false-positive mammogram did not adversely affect screening behavior in the next recommended interval. Women with false-positive mammograms, especially those without previous mammography, were more likely to return for the next scheduled screening. Ann Intern Med. 1999;131:1-6., Women who have had a false-positive mammogram did not become alienated from regular screening, but in fact were more likely to return for the next scheduled screening than others. Of 5,059 women over 40 years of age with no history of breast cancer or breast surgery, 813 had false-positive results. Following up intermittently for up to 42 months, and after adjusting for differences in age, previous mammograms, family histories, and such, the women who had false-positives were more likely to return for the next screening by a ratio of 1.21 to 1.00. Those for whom this was the first mammogram returned at a rate of 1.66 to 1.00

IMPORTANCE: Approximately 24 million US individuals receive care at federally qualified health centers, which historically have low rates of colorectal cancer screening. The US Preventive Services Task Force recommends routine colorectal cancer screening for individuals aged 50 to 75 years. OBJECTIVE: To determine the effectiveness of an electronic health record (EHR)-embedded mailed fecal immunochemical test (FIT) outreach program implemented in health centers as part of standard care. DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon and California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer screening during the accrual interval (February 4, 2014 to February 3, 2015). INTERVENTIONS: Electronic health record-embedded tools to identify eligible adults and to facilitate implementation of a stepwise mailed intervention involving (1) an introductory letter, (2) a mailed FIT, and (3) a reminder letter; training, collaborative learning, and facilitation through a practice improvement process. MAIN OUTCOMES AND MEASURES: Effectiveness was measured as clinic-level proportions of adults who completed a FIT, and secondarily, any colorectal cancer screening within 12 months of accrual or by August 3, 2015. Implementation was measured as clinic-level proportions of adults who were mailed an introductory letter and ordered a FIT. RESULTS: Twenty-six clinics with 41 193 adults (mean [SD] age, 58.5 [6.3] years; 22 994 women) were randomized to receive the direct mail colorectal screening intervention (13 clinics; 21 134 patients) or usual care (13 clinics; 20 059 patients). Compared with usual care clinics, intervention clinics had significantly higher adjusted clinic-level proportion of participants who completed a FIT (13.9% vs 10.4%; difference, 3.4 percentage points; 95% CI, 0.1%-6.8%) and any colorectal cancer screening (18.3% vs 14.5%; difference, 3.8 percentage points; 95% CI, 0.6%-7.0%). We observed large variation across health centers in effectiveness (FIT completion differences range, −7.4 percentage points to 17.6 percentage points) and implementation (proportion who were mailed a FIT range, 6.5% to 68.2%). The number needed to mail to achieve a completed FIT was 4.8 overall, and 4.0 in clinics that mailed a FIT reminder. CONCLUSIONS AND RELEVANCE: An EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening. Higher rates of colorectal cancer screening occurred in clinics that successfully implemented the mailed outreach program. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01742065

The Group Health Cooperative of Puget Sound is the largest health maintenance organization in the US which is governed by consumers. Since 1985 the Cooperative has had a screening program for breast cancer. However, unlike programs which recommend screening simply on the basis of age, the Cooperative recommends screening based on the calculated risk of the individual woman. Such a method dramatically reduces the cost of the program. Among women over 50, those without any risk factors are encouraged to have mammography every three years. Those with a first degree relative, i.e. mother, sister, or daughter, with breast cancer or with two minor risk factors are urged to have mammography every two years. Women with two first degree relatives with breast cancer, or a personal history of breast cancer, or abnormal breast tissue, should have mammography on a yearly basis. The recommendations for women between 40 and 50 are similar; they are urged to have a yearly mammogram if they have major risk factors. A single first degree relative with breast cancer is an indication for biannual mammography, and minor factors are an indication for mammography every three years. Women under 40 without any major or minor risk factors should receive mammography only on referral by their physician. For the purposes of breast screening, minor risk factors have been defined as a more distant relative with breast cancer, menarche before 11 or menopause after 54, first child after 30 or no children, or a previous breast biopsy. Using this risk-based method has resulted in about 10 early case findings per 1,000 women, which is nearly double the rate of programs without patient pre-selection based on risk. Although this is indicative of risk concentration, much more time will be needed before a comparison of breast cancer incidence in all the risk groups can be analyzed for cancer staging (which reflects severity) at diagnosis and mortality rate. (Consumer Summary produced by Reliance Medical Information, Inc.)

Objective. To compare treatment patterns and the ten-year survival of prostate cancer patients in two large, nonprofit, group/staff HMOs to those of patients receiving care in the fee-for-service health setting. Data Sources/Study Design. A cohort of men age 65 and over diagnosed with prostate cancer between 1985 and the end of 1992 and followed through 1994. Subjects (n = 21,741) were ascertained by two population-based tumor registries covering the greater San Francisco-Oakland and Seattle-Puget Sound areas. Linkage of registry data with Medicare claims data and with HMO inpatient utilization data allowed the determination of health plan enrollment and the measurement of comorbid conditions. Multivariate regression models were used to examine HMO versus FFS treatment and survival differences adjusting for sociodemographic and clinical characteristics. Principal Findings. Among cases with non-metastatic prostate cancer, HMO patients were more likely than FFS patients to receive aggressive therapy (either prostatectomy or radiation) in San Francisco-Oakland (odds ratio [OR] = 1.69, 95% CI = 1.46-1.96) but not in Seattle (OR = 1.15, 0.93-1.43). Among men receiving aggressive therapy, HMO cases were three to five times more likely to receive radiation therapy than prostatectomy. Overall mortality was equivalent over ten years (HMO versus FFS mortality risk ratio [RR] = 1.01, 0.94-1.08), but prostate cancer mortality was higher for HMO cases than for FFS cases (RR = 1.25, 1.13-1.39). Conclusion. Despite marked treatment differences for clinically localized prostate cancer, overall ten-year survival for patients enrolled in two nonprofit group/staff HMOs was equivalent to survival among patients receiving care in the FFS setting, even after adjustment for sociodemographic and clinical characteristics. Similar overall but better prostate cancer-specific survival among FFS patients is most plausibly explained by differences between the HMO and FFS patients in both tumor characteristics and unmeasured patient selection factors. Key Words. Outcomes research, healthcare insurance plans, managed care, prostate cancer treatments, prostate cancer survival, Dramatic changes have occurred in the U.S. healthcare system in the past two decades, with enrollment in health maintenance organizations (HMOs) increasing from 4 percent to 20 percent of the [...]

Multiple clinical practice guidelines exist for breast and cervical cancer screening, and differ in aggressiveness with respect to the recommended frequency and target populations for screening.

The population served by Federally Qualified Health Centers (FQHCs) has lower levels of cancer screening compared with the general population and suffers a disproportionate cancer burden. To address these disparities, 3 federal agencies and a primary care association established and tested the feasibility of a Regional Cancer Collaborative (RCC) in 2005.

Medical expenditures adjusted for price differences are a barometer of total resources devoted to patient care and thus may reflect treatment differentials.

Abstract Objective: We evaluated the association of pre-term delivery (PTD), low birth weight (LBW), and fetal death with breast density by age at mammogram and years since birth. Methods: Subjects were women aged =55 years who had a screening mammogram between 1 June 1996 and 1 August 1997 in Seattle, Washington, and whose records were linked to their previous state birth (1 January 1968 to 1 August 1997) or fetal death (1/1/1984–8/1/1997) records. We used unconditional logistic regression, adjusting for age at mammogram, body mass index, age at first birth, and menopausal status, to calculate the odds of dense (extremely or heterogeneously dense by BI-RADS) (n=3593) versus fatty breasts (scattered fibroglandular tissue or almost entirely fat) (n=2378) for women with a prior PTD (<34, 34–36 versus =37 weeks gestation), LBW (<2500 versus =2500 g), or fetal death (stillborn 20 weeks gestation versus live birth). Results: The odds for denser breasts increased among women with PTD at <34 weeks gestation who were =45 years at time of mammogram (odds ratio (OR) and 95 confidence interval (CI)=2.8 (1.3–6.1)) and for whom <10 years had elapsed since pregnancy (OR=8.8 (1.7–45.8)). We observed similar increases in density among women with LBW (OR=3.3 (1.3–8.2)) when <10 years had elapsed. Conclusions: PTD and LBW may have a transitory effect on breast density.

It is not well understood whether breast density is a marker of cumulative exposure to estrogen or a marker of recent exposure to estrogen. The authors examined the relationship between bone mineral density (BMD; a marker of lifetime estrogen exposure) and breast density.The authors conducted a cross‐sectional analysis among 1800 postmenopausal women ≥ 54 years. BMD data were taken from two population‐based studies conducted in 1992–1993 (n = 1055) and in 1998–1999 (n = 753). The authors linked BMD data with breast density information collected as part of a mammography screening program. They used linear regression to evaluate the density relationship, adjusted for age, hormone therapy use, body mass index (BMI), and reproductive covariates.There was a small but significant negative association between BMD and breast density. The negative correlation between density measures was not explained by hormone therapy or age, and BMI was the only covariate that notably influenced the relationship. Stratification by BMI only revealed the negative correlation between bone and breast densities in women with normal BMI. There was no relationship in overweight or obese women. The same relationship was seen for all women who had never used hormone therapy, but it was not significant once stratified by BMI.BMD and breast density were not positively associated although both are independently associated with estrogen exposure. It is likely that unique organ responses obscure the relationship between the two as indicators of cumulative estrogen exposure. Cancer 2004. © 2004 American Cancer Society.

Breast-conserving surgery (BCS) with radiation (BCSR) requires a multidisciplinary care approach between surgeons and radiation oncologists. This retrospective cohort study examined the use of preoperative radiation oncology consultation and whether use of or distance to this care was associated with treatment choice among 1188 women age ≥ 65 years who were diagnosed with local or regional breast carcinoma in Washington State in 1994 and 1995. Study outcomes included rates of BCSR; BCS alone; and mastectomy; and radiation therapy among women who underwent BCS. Only 29% of patients in the current study consulted with a radiation oncologist preoperatively, and less than half of the patients (46.6%) consulted with either a medical oncologist or a radiation oncologist. Among women who underwent either BCSR or mastectomy, the odds of undergoing BCSR among women who had a preoperative radiation oncology consultation were 6.7 times the odds of women who did not have the consultation (P ≤ 0.001). Similarly, the odds of receiving radiation therapy among women who underwent BCS and had a preoperative radiation oncology consultation were 5 times the odds of women who did not have the consultation (P &lt; 0.001). The 3.4% of women who lived > 50 miles from the radiation therapy center had the lowest BCSR rate (15.8%) and had the lowest radiation therapy rate among women who underwent BCS (54.5%), although these findings were not statistically significant in adjusted analyses. A preoperative visit with a radiation oncologist was associated strongly with BCSR use. More should be done to evaluate the role of multidisciplinary consultation in the decision to use BCSR. Cancer 2004;100:701–9. © 2004 American Cancer Society.

The costs to an insurer of a 10-year maternal serum alpha-feto protein (MSAFP) screening program were subtracted from future medical care costs avoided by the insurer (benefits) to examine whether such a program would be cost-justified from the perspective of a managed health care system (i.e., result in net costs ≥ 0). The analysis considered MSAFF screening for neural tube defects (NTDs) alone and then was repeated to consider screening for both NTDs and Down's syndrome. Using a 5 discount rate for future dollars, the costs to the insurer of a screening program for NTDs alone over 10 years exceeded costs avoided by 10.00 per person screened. Adding screening for Down's syndrome using the same MSAFP test increased the net cost by 22.00 to a total of -32.00 per screenee. The estimate of the cost to the insurer was sensitive to assumptions regarding the costs of medical care avoided, the expense of MSAFP, the proportion of screened women requiring a genetic amniocentesis, and the cost of that procedure. The conclusion that screening would not result in a cost savings to the insurer was not changed by reasonable assumptions regarding 1) the appropriate discount rate; 2) the costs of MSAFP; 3) the costs of genetic amniocentesis; 4) the sensitivity of MSAFP; 5) the proportion of the population requiring genetic amniocentesis; and 6) the costs of 10 years of medical care for someone affected by Down's syndrome or an NTD. Other analyses suggested that screening for NTDs or Down's syndrome would be cost-justified when viewed from the perspective of society. The present work suggests this conclusion does not hold when the perspective of the insurer is taken because avoided costs of care realized by society exceed those realized by the insurer.

This chapter has outlined some principles of tumor growth, test characteristics, and the evaluation of screening technologies. We have emphasized that test specificity is the critical parameter in the evaluation of technologies because it is the healthy people who will suffer the most from the adverse effects of screening. We have also emphasized that the efficacy of a test is best evaluated by examining mortality reductions in comparable populations. The purpose has been to assist clinicians with their interpretation of the literature.

Multilevel interventions, implemented at the individual, physician, clinic, health-care organization, and/or community level, increasingly are proposed and used in the belief that they will lead to more substantial and sustained changes in behaviors related to cancer prevention, detection, and treatment than would single-level interventions. It is important to understand how intervention components are related to patient outcomes and identify barriers to implementation. Designs that permit such assessments are uncommon, however. Thus, an important way of expanding our knowledge about multilevel interventions would be to assess the impact of interventions at different levels on patients as well as the independent and synergistic effects of influences from different levels. It also would be useful to assess the impact of interventions on outcomes at different levels. Multilevel interventions are much more expensive and complicated to implement and evaluate than are single-level interventions. Given how little evidence there is about the value of multilevel interventions, however, it is incumbent upon those arguing for this approach to do multilevel research that explicates the contributions that interventions at different levels make to the desired outcomes. Only then will we know whether multilevel interventions are better than more focused interventions and gain greater insights into the kinds of interventions that can be implemented effectively and efficiently to improve health and health care for individuals with cancer. This chapter reviews designs for assessing multilevel interventions and analytic ways of controlling for potentially confounding variables that can account for the complex structure of multilevel data.

The complex environmental context must be considered as we move forward to improve cancer care and, ultimately, patient and population outcomes. The cancer care continuum represents several care types, each of which includes multiple technical and communication steps and interfaces among patients, providers, and organizations. We use two case scenarios to 1) illustrate the variability, diversity, and interaction of factors from multiple levels that affect care quality and 2) discuss research implications and provide hypothetical examples of multilevel interventions. Each scenario includes a targeted literature review to illustrate contextual influences upon care and sets the stage for theory-informed interventions. The screening case highlights access issues in older women, and the survivorship case illustrates the multiple transition challenges faced by patients, families, and organizations. Example interventions show the potential gains of implementing intervention strategies that work synergistically at multiple levels. While research examining multilevel intervention is a priority, it presents numerous study design, measurement, and analytic challenges.

This summary reflects on this monograph regarding multilevel intervention (MLI) research to 1) assess its added value; 2) discuss what has been learned to date about its challenges in cancer care delivery; and 3) identify specific ways to improve its scientific soundness, feasibility, policy relevance, and research agenda. The 12 submitted chapters, and discussion of them at the March 2011 multilevel meeting, were reviewed and discussed among the authors to elicit key findings and results addressing the questions raised at the outset of this effort. MLI research is underrepresented as an explicit focus in the cancer literature but may improve implementation of studies of cancer care delivery if they assess contextual, organizational, and environmental factors important to understanding behavioral and/or system-level interventions. The field lacks a single unifying theory, although several psychological or biological theories are useful, and an ecological model helps conceptualize and communicate interventions. MLI research designs are often complex, involving nonlinear and nonhierarchical relationships that may not be optimally studied in randomized designs. Simulation modeling and pilot studies may be necessary to evaluate MLI interventions. Measurement and evaluation of team and organizational interventions are especially needed in cancer care, as are attention to the context of health-care reform, eHealth technology, and genomics-based medicine. Future progress in MLI research requires greater attention to developing and supporting relevant metrics of level effects and interactions and evaluating MLI interventions. MLI research holds an unrealized promise for understanding how to improve cancer care delivery.

Health care in the United States is notoriously expensive while often failing to deliver the care recommended in published guidelines. There is, therefore, a need to consider our approach to health-care delivery. Cancer care is a good example for consideration because it spans the continuum of health-care issues from primary prevention through long-term survival and end-of-life care. In this monograph, we emphasize that health-care delivery occurs in a multilevel system that includes organizations, teams, and individuals. To achieve health-care delivery consistent with the Institute of Medicine's six quality aims (safety, effectiveness, timeliness, efficiency, patient-centeredness, and equity), we must influence multiple levels of that multilevel system. The notion that multiple levels of contextual influence affect behaviors through interdependent interactions is a well-established ecological view. This view has been used to analyze health-care delivery and health disparities. However, experience considering multilevel interventions in health care is much less robust. This monograph includes 13 chapters relevant to expanding the foundation of research for multilevel interventions in health-care delivery. Subjects include clinical cases of multilevel thinking in health-care delivery, the state of knowledge regarding multilevel interventions, study design and measurement considerations, methods for combining interventions, time as a consideration in the evaluation of effects, measurement of effects, simulations, application of multilevel thinking to health-care systems and disparities, and implementation of the Affordable Care Act of 2010. Our goal is to outline an agenda to proceed with multilevel intervention research, not because it guarantees improvement in our current approach to health care, but because ignoring the complexity of the multilevel environment in which care occurs has not achieved the desired improvements in care quality outlined by the Institute of Medicine at the turn of the millennium.

To achieve the benefit of cancer screening, appropriate follow-up of abnormal screening test results must occur. Such follow-up requires traversing the transition between screening detection and diagnosis, including several steps and interfaces in care. This article reviews factors and interventions associated with follow-up of abnormal tests for cervical, breast and colorectal cancers. We synthesized 12 reviews of descriptive and intervention studies published between 1980 and 2008. There was wide variability in definition of follow-up, setting, study population, and reported prevalence rates. Correlates of follow-up included patient characteristics (eg, knowledge and age), social support, provider characteristics, practice (eg, having reminders systems), community and professional norms (eg, quality measures), and policy (eg, federal programs). Effective interventions included patient education and support; delivery systems design changes, such as navigation; and information system changes, most notably patient tracking and physician reminders. Few studies focused explicitly on interfaces and steps of care, such as communication between primary care and specialists, or simultaneously targeted the multilevel factors that affect care. Future practice and research priorities should include development of clear operational definitions of the steps and interfaces related to patients, providers, and organizations; reflect evolving guidelines and new technologies; determine priorities for intervention testing; and improve measures and apply appropriate study designs.

Cancer screening is a process of care consisting of several steps and interfaces. This article reviews what is known about the association between organizational factors and cancer screening rates and examines how organizational strategies can address the steps and interfaces of cancer screening in the context of both intraorganizational and interorganizational processes. We reviewed 79 studies assessing the relationship between organizational factors and cancer screening. Screening rates are largely driven by strategies to 1) limit the number of interfaces across organizational boundaries; 2) recruit patients, promote referrals, and facilitate appointment scheduling; and 3) promote continuous patient care. Optimal screening rates can be achieved when health-care organizations tailor strategies to the steps and interfaces in the cancer screening process that are most critical for their organizations, the providers who work within them, and the patients they serve.

Critical questions about cancer prevention, care, and outcomes increasingly require research involving large patient populations and their care delivery organizations. The Cancer Research Network (CRN) includes 11 integrated health systems funded by the National Cancer Institute (NCI) to conduct collaborative cancer research. This article describes the challenges of constructing a productive consortium of large health systems, and explores the CRN's responses. The CRN was initially funded through an NCI cooperative agreement in 1999 and has since received a second 4-year grant. Leadership and policy development are provided through a steering committee, subcommittees, and an external advisory committee. The CRN includes integral and affiliated research projects supported by a Scientific and Data Resources Core. Three characteristics of the CRN intensified the general challenges of consortium research: 1) its members are large health systems with legitimate concerns about confidentiality of data about enrollees, providers, and the organization; 2) CRN research projects often generate highly sensitive data about quality of care; and therefore 3) each participating organization wants a strong voice in CRN direction. CRN experience to date confirms that a consortium of health systems with internal research capacity can address a range of important cancer research questions that would be difficult to study in other venues. The advantages and challenges of consortium research are explored, with suggestions for the development, execution, and management of multisystem population laboratories.

Background: Delay in diagnosis of breast cancer can occur at several points on the diagnostic pathway. We examined characteristics of women with breast cancer who before diagnosis actively refused recommended follow-up of tests or symptoms suggestive of breast cancer. Methods: We identified women aged 50 years or older diagnosed with late-stage (metastatic disease or tumors ≥ 3cm at diagnosis) and a matched sample of women with early-stage (tumors < 3 cm) breast cancer from 1995 to 1999. Using medical records, we investigated clinical characteristics, use of health care, and documentation of care refusal during the 3 years before diagnosis. We used logistic regression models to compare refusers to nonrefusers. Results: Of the 2694 women studied, 7.2% refused provider follow-up advice during the 3 years. These women were more likely to have late-stage breast cancer at diagnosis than were nonrefusers (odds ratio [OR] = 1.9, 95% confidence interval [CI] = 1.4 to 2.6). They were more likely to be aged 75 years or older (OR = 1.9, 95% CI = 1.4 to 2.7 compared with age 50–64) or to have six or more children (OR = 2.3, 95% CI = 1.3 to 4.2 compared to women with one to two children). Clinical factors associated with refusal included low use of mammography, high use of clinical breast exam, and missed appointments. A minority of women who refused had a reason documented in the medical record; the most frequent reasons were avoidance–denial–fatalism, fear of diagnostic tests, and fear of surgery or disfigurement. Conclusions: Our results suggest that certain demographic and clinical characteristics are associated with women's refusal of diagnostic testing for breast cancer. Further study is needed on refusers' characteristics and on how such refusals affect outcomes. Efforts aimed at identifying and counseling women with abnormal results who refuse follow-up are warranted.