Computer-aided detection of breast cancer: has promise outstripped performance?
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Biomedical subjects
Publications and source records attributed to Joann G Elmore.
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BACKGROUND: Variations in mammography interpretations may have important clinical and economic implications. To evaluate international variability in mammography interpretation, we analyzed published reports from community-based screening programs from around the world. METHODS: A total of 32 publications were identified in MEDLINE that fit the study inclusion criteria. Data abstracted from the publications included features of the population screened, examination technique, and clinical outcomes, including the percentage of mammograms judged to be abnormal, positive predictive value of an abnormal mammogram (PPV(A)), positive predictive value of a biopsy performed (PPV(B)), and percentages of breast cancer patients with ductal carcinoma in situ (DCIS) and minimal disease (DCIS and/or tumor size < or =10 mm). North American screening programs were compared with those from other countries using meta-regression analysis. All statistical tests were two-sided. RESULTS: Wide ranges were noted for the percentage of mammograms judged to be abnormal (1.2%-15.0%), for PPV(A) (3.4%-48.7%), for PPV(B) (5.0%-85.2%), for percentage diagnosed with DCIS (4.3%-68.1%), and for percentage diagnosed with minimal disease (14.0%-80.6%). The percentage of mammograms judged to be abnormal were 2-4 percentage points higher in North American screening programs than they were in programs from other countries, after adjusting for covariates such as percentage of women who were less than 50 years of age and calendar year in which the mammogram was performed. The percentage of mammograms judged to be abnormal had a negative association with PPV(A) and PPV(B) (both P<.001) and a positive association with the frequency of DCIS cases diagnosed (P =.008) and the number of DCIS cases diagnosed per 1000 screens (P =.024); no consistent relationship was observed with the proportion of breast cancer diagnoses reported as having minimal disease or the number of minimal disease cases diagnosed per 1000 screens. CONCLUSION: North American screening programs appear to interpret a higher percentage of mammograms as abnormal than programs from other countries without evident benefit in the yield of cancers detected per 1000 screens, although an increase in DCIS detection was noted.
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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.
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OBJECTIVE: To implement a computerized system to gather and transmit medical record information from six sites to a centralized database for two cancer prevention studies. METHODS: Microsoft Access 97 was selected as the application for the system. Sites purchased Access and hardware meeting technical specifications required for the system. A developer worked with the lead investigator and medical record abstractors to develop a 'back-end' database to hold the desired data while maintaining a user-friendly 'front-end' interface. Abstractors trained on a paper version of the abstraction form were then trained to use the system. Meeting minutes and technical notes were used in summarizing the approach and process. Observations were collected through discussions. RESULTS: We overcame multiple obstacles to develop computerized systems supporting medical record data collection at multiple sites. Although system development slowed implementation of the study, the system produced data for cleaning and analysis immediately. Overall the approach decreased the time from study implementation to manuscript submission. Development time for a second system was substantially reduced. CONCLUSIONS: Computerized systems for medical record abstraction at multiple sites convey substantial benefit. We present a schematic approach to facilitate development of similar systems in the future.
BACKGROUND: Previous studies have shown that the agreement among radiologists interpreting a test set of mammograms is relatively low. However, data available from real-world settings are sparse. We studied mammographic examination interpretations by radiologists practicing in a community setting and evaluated whether the variability in false-positive rates could be explained by patient, radiologist, and/or testing characteristics. METHODS: We used medical records on randomly selected women aged 40-69 years who had had at least one screening mammographic examination in a community setting between January 1, 1985, and June 30, 1993. Twenty-four radiologists interpreted 8734 screening mammograms from 2169 women. Hierarchical logistic regression models were used to examine the impact of patient, radiologist, and testing characteristics. All statistical tests were two-sided. RESULTS: Radiologists varied widely in mammographic examination interpretations, with a mass noted in 0%-7.9%, calcification in 0%-21.3%, and fibrocystic changes in 1.6%-27.8% of mammograms read. False-positive rates ranged from 2.6% to 15.9%. Younger and more recently trained radiologists had higher false-positive rates. Adjustment for patient, radiologist, and testing characteristics narrowed the range of false-positive rates to 3.5%-7.9%. If a woman went to two randomly selected radiologists, her odds, after adjustment, of having a false-positive reading would be 1.5 times greater for the radiologist at higher risk of a false-positive reading, compared with the radiologist at lowest risk (95% highest posterior density interval [similar to a confidence interval] = 1.17 to 2.08). CONCLUSION: Community radiologists varied widely in their false-positive rates in screening mammograms; this variability range was reduced by half, but not eliminated, after statistical adjustment for patient, radiologist, and testing characteristics. These characteristics need to be considered when evaluating false-positive rates in community mammographic examination screening.
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BACKGROUND: Although the effectiveness of breast self-examination (BSE) has not been established, it is widely practiced and taught. However, it is not clear which patients and providers are involved in BSE teaching, nor how often it occurs. We undertook this study at a large New England Health Maintenance Organization (HMO) to answer these questions. METHODS: The study was a retrospective cohort of 2242 randomly selected women aged 40-69 with no history of breast cancer and at least one screening clinical breast examination, followed over a ten-year period, including their medical providers (n = 356). Data were collected via computerized medical records. RESULTS: Sixty-eight percent of women had documented BSE teaching at least once in the ten years, increasing from 13% taught in 1983 to 36% in 1993 (p = 0.001). Teaching was related to younger age, increasing numbers of clinical breast examinations, screening mammograms, and prior BSE teachings. Patient race, income, family history of breast cancer, and estrogen replacement use were not related to teaching. Sixty-one percent of all providers taught BSE at least once during the ten years. Internists (OR 6.37, 95% CI 2.23-17.3) and non-physician providers (OR 12.8, 95% CI 3.0-54.4) were more likely to teach at least half of their patients than were obstetrician-gynecologists. Recent medical school graduates taught BSE more often. Provider gender was not associated with teaching. CONCLUSIONS: Over two-thirds of women patients in this HMO setting were taught BSE and the majority of providers taught BSE at least once during the ten years. Rates of teaching tripled over the decade. It is important to establish the effectiveness of BSE and its appropriate role in breast cancer screening.
BACKGROUND: Few studies have examined the impact of women's personal costs on obtaining a screening mammogram in the United States. METHODS: All women obtaining screening mammograms at nine Connecticut mammography facilities during a 2-week study period were asked to complete a questionnaire. Facilities included urban and rural fixed sites and mobile sites. The survey included questions about insurance coverage, mammogram payment, and personal costs in terms of transportation, family care, parking, and lost work time from the women's perspective. RESULTS: The response rate was 62% (731 of 1189). Thirty-two percent of respondents incurred some type of personal cost, including lost work time, family care, and parking. Women incurring personal costs were more likely than those without personal costs to attend an urban facility (46% vs. 23%, p < 0.01) and be under the age of 50 (40% vs. 26%, p < 0.01). Overall, 61% of women listed convenience and 17% listed cost as a reason for choosing a mammography facility; 23% reported that cost might prevent them from obtaining a future mammogram. CONCLUSIONS: One third of women obtaining mammograms may be incurring personal costs. These personal costs should be considered in future cost-effectiveness analyses.