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PubMed1993

Requirements for accrediting bodies of mammography facilities--FDA. Interim rule with request for comments.

The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA), which requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This rule establishes procedures for application to FDA for approval as an accrediting body and requirements and responsibilities of such bodies. This action is being taken to assure adequate and consistent evaluation of mammography facilities on a nationwide level and to help assure their compliance with quality standards. The agency requests comments on the contents of this document.

Accreditation↗
PubMed1994

Quality standards and certification requirements for mammography facilities--FDA. Interim rule; opportunity for public comment.

The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA). The MQSA requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This regulation, which amends two previously published interim rules, modifies and adds to the definitions previously set forth. In addition, the interim rule provides a mechanism to request permission to meet alternative requirements, other than those previously set forth, if the proposed alternative requirement is at least as effective as the existing quality standards in achieving quality mammography services for women.

Ambulatory Care Facilities↗
PubMed1999

The clinical epidemiological investigation of diagnostic modalities in breast cancer detection--a comparison of ultrasonography and mammography.

We reviewed the medical records and images of 39 women with palpable breast masses, including 18 cases with breast cancer and 21 cases with benign breast mass, to compare diagnostic accuracy and clinical agreement between ultrasonography and mammography in breast cancer detection. We showed that the operating characteristics of ultrasonography, including sensitivity, specificity and positive likelihood ratio, were superior to that of mammography. We also confirmed that the established malignant criteria for malignancy, including lobulated shape, irregular contour and non-uniform internal echo in ultrasonography, and stellate mass in mammography, were statistically significant in distinguishing breast cancer from benign breast lesion. Moreover, the interobserver agreement kappa of ultrasonography and mammography were 0.64 and 0.59, respectively. Ultrasonography was also superior to mammography in attaining clinical agreement between the different observers in breast cancer detection.

Breast Neoplasms↗
PubMed1989

Utilization of screening mammography by primary care physicians.

Although mammography is the primary modality for the detection of early breast cancer, routine screening of asymptomatic women in the U.S. has not occurred. A survey of the referral practices for breast cancer screening of 513 Virginia primary care physicians was conducted. An average percentage of 39% of women age 35 to 40, 55% of women age 40 to 50, and 57% of women over age 50 were referred for screening mammography. Gynecologists referred the greatest number of women for screening. An increase of mammography referrals was repeated by 81% of physicians; 21% of physicians stated that they referred all women over 50 for screening. Half of the physicians believed that women in their community were unaware of the benefits of mammography screening. Major deterrents were the cost of mammography and the lack of third-party coverage.

Adult↗
PubMed1999

Patterns and characteristics of repeat mammography among women 50 years and older.

Whereas efforts encouraging women to obtain initial mammograms are laudable, the importance of returning for subsequent routine mammograms cannot be minimized. The purpose of this study was to measure the timing, patterns, and characteristics of repeat screening mammography over time in a defined population of health maintenance organization members for whom mammography was a fully covered benefit. We identified all women ages 50-74 years who were enrolled in a southeastern Michigan health maintenance organization, assigned to a large medical group, and received at least one screening mammogram with a normal result between January 1, 1989 and December 31, 1996. Using administrative and radiology data, we calculated the proportion of women who received a subsequent mammogram within 2 years and the time to subsequent screening, both overall and stratified by demographic characteristics. We also examined screening patterns over a 5-year period. Of the 8749 women included in this study, 66.0% [95% confidence interval (CI), 65.0-67.0%] were subsequently screened within 2 years. We found slightly higher rates among Caucasians and married women. The proportion of women who received repeat mammography increased with estimated household income [9.5% difference between the highest and lowest categories (95% CI, 6.5-12.5%)]. The median time to subsequent screening was 17.7 months, and the probability of repeat screening was higher for women whose initial mammogram was between January 1992 and December 1994 compared to those receiving an initial mammogram between January 1989 and December 1991 (9.6% difference; 95% CI, 7.5-11.7%). Repeat mammography has improved over time; however, socioeconomic status could contribute to longer-than-intended intervals between screening when translated into real-world clinical practice. In a setting where most physicians recommended annual screening, we found that the median time to subsequent screening was delayed by 6 months. If annual mammography is the goal, recommendations should be made with the understanding of how the timing of repeat screening occurs in clinical practice.

Aged↗
PubMedDate not supplied

Screening mammography rates by specialty of the usual care physician.

CONTEXT: Although Medicare began paying for screening mammography in 1991, utilization among enrollees has been low. PRACTICE PATTERN EXAMINED: The relation between the specialty of the usual care physician and the proportion of women 65 years of age and older receiving mammography. DATA SOURCE: 100% Medicare Part B claims for 186,526 female enrollees residing in Maine, New Hampshire, and Vermont during 1993 and 1994. RESULTS: Among women of the target screening age (65 to 69 years), 55.4%, received mammography during the 2-year period. The highest rates of mammography were observed in women whose usual care physician was a gynecologist (77.9%; 95% CI, 75.8 to 79.9), followed by those treated by an internist (67.1%; CI, 66.5 to 67.7), family practitioner (58.1%; CI, 57.4 to 58.9), general practitioner (47.4%; CI, 45.4 to 49.5), and other specialists (41.3%; CI, 40.1 to 42.5). The lowest rates were observed in women who had no physician visits during the 2-year period (9.5%; CI, 8.7 to 10.4). Although screening rates were lower in women aged 70 years and older, a similar pattern was observed. CONCLUSIONS: The probability of a Medicare enrollee's receiving screening mammography is strongly influenced by the specialty of her usual care physician. Covering a preventive service does not guarantee its use.

Aged↗
PubMed1999

Ultrasonography as adjunct to mammography in the evaluation of breast tumors.

PURPOSE: The aims of the study was to analyze the features of cancers missed as tumor on ultrasonography (US), to determine the predictive power of US tumor descriptors in the differentiation of benign and malignant breast tumors, to evaluate US as adjunct to mammography, and to assess the validity and reliability of mammographic, US, and combined interpretation of breast tumors. MATERIAL AND METHODS: Prospectively recorded mammographic and US findings of 355 malignant breast tumors among 2,985 consecutive patients who underwent breast US were compared with clinical findings and pathologic subtypes of the tumors. In addition, a 10-year material of 95 invasive lobular carcinomas (ILCs) were investigated. Three retrospective studies assessed the validity and reliability of mammographic, US, and combined interpretation of 200 palpable mammographically noncalcified breast masses by four radiologists. RESULTS: A total of 97.5% of the palpable and 67.9% of the nonpalpable malignant neoplasms were detected as tumor on US. Most carcinomas missed as tumor on US were ductal carcinomas in situ (DCISs) and microinvasive ductal cancers dominated by DCIS manifesting with suspicious calcifications on mammography. Irregular shape, irregular contour, extensively hypoechogenicity, hyperechoic rim (halo), and distortion of the surrounding tissue were the US features with the highest odds of predicting carcinomas. A pseudocapsule is the strongest predictor of a benign tumor, the odds of cancer being 0.03 in nonpalpable and 0.08 in palpable breast tumors. A negative predictive value of 100% in palpable and 96% in nonpalpable tumors was achieved using strict US criteria. In patients with ILC, US measurements predicted tumor size more accurately than mammography. US as adjunct to mammography correctly diagnosed ("upgraded") 9.5% of tumors with benign or indeterminate mammographic diagnoses. Excluding mammographically conclusive malignant tumors and carcinomas presenting with microcalcifications. US correctly upgraded 42% of the palpable and 44% of the nonpalpable cancers. Combined mammographic-US interpretation offers the highest diagnostic performance in noncalcified breast tumors. The lowest interobserver agreement was found in US interpretation. CONCLUSION: The impact of US in mixed cancer populations is limited. US is, however, a valuable adjunct to mammography in patients with nonconclusive mammographic findings. Negative predictive values on US approaching 100% may be achieved using strict criteria for a benign diagnosis. A considerable interobserver variation in the US interpretation is a limiting factor for the potential of breast US in the differentiation of benign and malignant breast tumors.

Adolescent↗
PubMed2000

Digital detectors in mammography. A technological overview.

At a first glance the future of digital mammography seems very bright considering the wealth of offerings for new detectors, made by companies on the market or in journals. However technically spoken, digital mammography is one of the most demanding applications in the spectrum of radiology along with a high degree of cost consciousness in the mammography screening programs. The functional requirements are so high for digital mammography that only the best and most expensive components are good enough to compete with the current screen-film systems. Next difficulties are the lack of quality standards for digital detectors, not at all existing in the past and still under discussion, and the non-existence or changing of approval procedures. This is discouraging the industries to enter the field and is slowing down the phase-in time. After these obstacles are removed, there will come the discussions on acceptance of digital mammography within the professional community, due to the 'look' of the images and also the need to gain confidence with these images.

Costs and Cost Analysis↗
PubMedDate not supplied

Usefulness of technetium-99m tetrofosmin mammoscintigraphy as compared to mammography for detecting and differentiating palpable breast masses of young Taiwanese women.

Sixty young Taiwanese women with palpable breast masses detected by mammography and/or physical examinations underwent technetium-99m tetrofosmin (Tc-TETRO) mammoscintigraphy to assess its value for detecting and differentiating breast masses. The results showed that 42 of the 45 cases of breast carcinoma were detected by Tc-TETRO mammoscintigraphy. Fourteen of the 15 o benign breast lesions were differentiated by Tc-TETRO mammoscintigraphy. The diagnostic sensitivity, specificity, positive predictive value negative predictive value and accuracy of Tc-TETRO mammoscintigraphy were 93% 93% 98% 82% and 93% respectively. Thirty-eight of the 45 cases of breast carcinoma were detected by mammography. Twelve of the 15 of benign breast lesions were differentiated by mammography. The diagnostic sensitivity, specificity, positive predictive value, negative predictive value and accuracy of mammography were 84% 80% 93% 63% and 83% respectively. We concluded that Tc-TETRO mammoscintigraphy when compared to mammography significantly improves the accuracy of detection and differentiation of breast cancer in Taiwanese women.

Adult↗
PubMed2000

Factors associated with repeat mammography screening.

BACKGROUND: Even organizations with differing mammography recommendations agree that regular repeat screening is required for mortality reduction. However, most studies have focused on one-time screening rather than repeat adherence. We compare trends in beliefs and health-related behaviors among women screened and adherent to the National Cancer Institute's screening mammography recommendations (on schedule), those screened at least once and nonadherent (off schedule), and those never screened. METHODS: Our data are from a baseline telephone interview conducted among 1,287 female members of Blue Cross Blue Shield of North Carolina who were aged either 40 to 44 years or 50 to 54 years. RESULTS: The 3 groups differed significantly on beliefs and health-related behaviors, with the off-schedule group almost consistently falling between the on-schedule and never screened groups. Off-schedule women were more likely than on-schedule women, but less likely than those never screened, to not have a clinical breast examination within 12 months, to be ambivalent about screening mammography, to be confused about screening guidelines, and to not be advised by a physician to get a mammogram in the past 2 years. Off-schedule women perceived their breast cancer risk as lower and were less likely to be up to date with other cancer screening tests. CONCLUSIONS: Our findings suggest that women who are off schedule are in need of mammography-promoting interventions, including recommendations from and discussion with their health care providers. Because they are more positive and knowledgeable about mammography than women who have never been screened, they may benefit from brief interventions from health care providers that highlight the importance of repeat screening.

Adult↗
PubMed2001

Predictors of mammography use among Canadian women aged 50-69: findings from the 1996/97 National Population Health Survey.

BACKGROUND: Screening mammography, although recommended every 2 years for women aged 50-69, is thought to be underused among select groups of Canadian women. METHODS: We used data from the 1996/97 National Population Health Survey to describe current patterns in mammography use (including reasons for not having a mammogram within the 2 years before the survey and future screening intentions) in Canada and to determine factors associated with nonparticipation and time-inappropriate use (mammogram 2 or more years before the survey) among women aged 50-69. RESULTS: Among respondents aged 50-69, 79.1% (95% confidence interval [CI] 76.9%-81.2%) reported ever having had a mammogram, and 53.6% (95% CI 51.4%-55.9%) had had a recent (time-appropriate) mammogram (within the 2 years before the survey). Only 0.6% (95% CI 0.3%-0.9%) of recently screened women reported problems of access, and few reported personal or health system barriers as reasons for not obtaining a recent mammogram. Over 50% of the women who had not had a recent mammogram reported that they did not think it was necessary, and only 28.2% (95% CI 23.8%-32.7%) of those who had never had a mammogram planned to have one within the 2 years following the survey. The rate of time-appropriate mammography varied significantly by province, from 41.1% (95% CI 29.3%-52.9%) in Newfoundland to 69.4% (95% CI 61.3%-77.6%) in British Columbia. Significant predictors of never having had a mammogram included higher age, residence in a rural area, Asia as place of birth, no involvement in volunteer groups, no regular physician or recent medical consultations (including recent blood pressure check), current smoking, infrequent physical activity and no hormone replacement therapy. INTERPRETATION: Despite increases in mammography screening rates since the 1994/95 National Population Health Survey, current estimates indicate that almost 50% of women aged 50-69 have not had a time-appropriate mammogram. Our findings confirm continued low mammography participation rates among older women and those in rural areas, select ethnic groups and women with negative health care and lifestyle characteristics.

Age Factors↗
PubMedDate not supplied

Recent mammography use among African-American women.

OBJECTIVE: The incidence of breast cancer in Black women is lower, but their mortality rate is higher, compared to White women. Lower rates of mammography use among Black women in the past may have resulted in later diagnosis of breast cancer, leading to shorter survival periods and higher mortality rates. We assessed recent mammography use in a large national study, the Black Women's Health Study. DESIGN: In 1995, 27,632 US Black women aged 40-69 years completed mailed questionnaires, which included questions on mammography use. RESULTS: Seventy-three percent of women aged 40-49, and 82% of those aged 50-69, reported having had a mammogram within the previous three years. Use was greater among women with higher levels of education, and among those who had cystic breast disease or a mother or sister with breast cancer. CONCLUSIONS: The high rate of recent mammography use among participants in the Black Women's Health Study agrees with national data. If breast cancer mortality rates in Black women continue to exceed those in White women, despite the lower incidence among Black women, reasons other than differential mammography use must be sought.

Adult↗
PubMed2001

[When will mammography screening reduce breast cancer mortality?].

BACKGROUND: Norwegian authorities have decided to start a mass mammography screening programme. One third of the population has been included in a pilot study from 1996. The Cancer Registry of Norway maintains that there will be at least a 30% reduction in mortality, but that an effect may not be detected until the ten-year follow-up. METHODS: We assume that the effect of mammography screening is constantly increasing over a ten-year period before maximum effect is reached. We also assume that the effect of screening in the age group 50-74 years is 80% of maximum effect. We simulate Norwegian breast cancer mortality rates under the assumption that mammography screening reduces breast cancer mortality in the age group 50-69 years with 15% and 30% effects, respectively. We also simulate 30% and 50% effect in the pilot study. RESULTS: If the effect in the Norwegian population is 30%, one may expect to see a significant decline after five years; however, if the effect is only 15%, one has to wait for a longer time. If the effect is 50%, as the Cancer Registry of Norway has argued, one should see a significant effect in the pilot study after six years. CONCLUSIONS: We think it a contradiction to argue that mammography screening reduces breast cancer mortality by 30%, but that one has to wait ten years to observe an effect on national mortality rates. We suggest that the breast cancer mortality rate in the pilot study is estimated. We also argue that observed reductions of less than 10% in Sweden, Finland and England are strong evidence that the effect of mammography today is far less than 30%.

Aged↗
PubMed2001

Quality assurance for screening mammography data collection systems in 22 countries.

OBJECTIVES: To document the mammography data that are gathered by the organized screening programs participating in the International Breast Cancer Screening Network (IBSN), the nature of their procedures for data quality assurance, and the measures used to assess program performance and impact. METHODS: A detailed questionnaire covering multiple aspects of quality assurance in screening mammography was mailed to IBSN representatives in 23 countries. RESULTS: Countries collect a wealth of screening mammography data, much of it computerized. Most countries have designated staff for data quality assurance. All provide staff training, and most have documentation requirements for data collection. Nearly all have one or more procedures to maintain data confidentiality. Countries are heterogeneous in collecting and assessing data to monitor screening program performance and impact. CONCLUSIONS: Demonstrating that population-based screening mammography reduces breast cancer mortality requires collection of high-quality data on key aspects of the multi-step screening process. Assuring the quality of data collection systems for screening mammography programs is an important and evolving area for IBSN countries.

Breast Neoplasms↗
PubMedDate not supplied

[Pain and anxiety related to mammography in breast cancer patients. Psychological evaluation in an experimental study].

PURPOSE: Previous research focusing on one-time screening rather than repeat adherence, have largely pointed out that anxiety levels and pain expectation are the most common factors which may act as a barrier to mammography. These studies also show that anxiety pain and depression are very often associated with the experience of mammography. The aim of this study was to evaluate whether a supportive psychological intervention can be effective in reducing these feelings in patients undergoing follow-up mammography MATERIAL AND METHODS: The study was performed on 60 women who had already received a diagnosis of breast cancer. In order to detect the variables of depression, anxiety and pain before and after mammography the following questionnaires were administered to the patients: State-Trait Anxiety Inventory (STAI), Self-rating Depression Scale (SDS), Visual Analog Scale (VAS). RESULTS AND CONCLUSION: The results of this study show that our psychological intervention significantly lowered the levels of state anxiety and pain but it had no effect on depression. A psychological approach giving patients both emotional and informational support about the examination, may significantly reduce state anxiety levels and the pain felt during mammography.

Adult↗
PubMed2001

Family physicians' initiative to increase compliance with screening mammography--an innovative community project.

BACKGROUND: Breast cancer is the most common malignancy among women in Israel and throughout the world. Israeli women aged 50-75 years are advised to undergo a mammographic screening examination every 2 years. However, the lack of a structured referral system is reflected in the low utilization rate of mammography. OBJECTIVES: To describe an innovative program in which family physicians in an urban clinic developed a model framework for referrals, coordinated with radiologists and surgeons, aimed at increasing compliance among women referred for mammography. METHODS: A community-based study was conducted, outside of the regular reception hours, in a neighborhood practice with a population of 527 women aged 50-75. A referral system under the supervision of family physicians was designed, and the women received appointments for mammography at specified days and hours. The results of the examination were sent to the physician who used dedicated time to continue the diagnostic and/or therapeutic process, as appropriate. At the physician's instructions a research assistant contacted the women who did not keep their appointments, and scheduled a second appointment. RESULTS: In 1993, the year prior to the study, when women referred themselves for mammography, the utilization rate was 9%. During the study year the utilization rate was 77%. Women born in Europe or America had higher compliance rates than women born in Asia or Africa (81% vs. 72%, respectively). Married women were more compliant than unmarried women (81% vs. 70%, respectively). No correlation was found between compliance and age, family history of cancer in general, or breast cancer in particular. Six new cases of breast cancer were detected. CONCLUSIONS: The initiative of family physicians increased the utilization of mammography among women under their care. Family physicians allocated time outside of their regular reception hours for the program. A relatively large number of new malignancies were found, but this impression should be confirmed or negated by a large-scale study using the same methods.

Aged↗
PubMed2002

Assessing screening mammography utilization in an urban area.

This study was conducted to determine the predictors of screening mammography among women 40 years old and older residing in South Central Los Angeles, California. The population is predominately African American and Hispanic. Using Computer Assisted Telephone Interview (CATI) software and the Random Digit Dialing (RDD) method, a 54-item, 20-min questionnaire was administered to 505 women. All interviews were conducted in English or Spanish. The Health Belief Model provided the conceptual framework for the design of the questionnaire. A majority (81.8%) of the participants reported having at least one mammogram in their lifetime, with African Americans reporting the lowest rate (74.7%). Multiple logistic regression analyses found that 4 of the 23 independent variables assessed were predictive of ever users of mammography (p < 0.05), while 6 independent variables were predictive of never users of mammography (p < 0.05). A significant finding of this study is the lower rate of screening mammography utilization in this sample compared to estimates for the general population. The results of this study also suggest that substantial improvements in the rate of screening mammography could be achieved if women in their 40s, who are without health insurance, were referred by their physicians to have affordable mammograms every year or two.

Adult↗
PubMed2002

State certification of mammography facilities. Final rule.

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments implement the "States as Certifiers" (SAC) provisions of the Mammography Quality Standards Act of 1992 (MQSA). These amendments permit FDA to authorize individual States to certify mammography facilities, conduct facility inspections, enforce the MQSA quality standards, and administer other related functions. The amendments establish the standards to be met by States receiving this authority. They also establish procedures for application, approval, evaluation, and withdrawal of approval of States as certification agencies. FDA retains oversight responsibility for the activities of the States to which this authority is given. Mammography facilities certified by those States must continue to meet the quality standards established by FDA for mammography facilities nationwide.

Ambulatory Care Facilities↗