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Factors affecting phantom scores at annual mammography facility inspections by the U.S. Food and Drug Administration.

RATIONALE AND OBJECTIVES: The authors performed this study to evaluate the factors affecting phantom image score at the annual inspection of mammography facilities. MATERIALS AND METHODS: In 1997, three U.S. Food and Drug Administration (FDA)-trained inspectors performed inspections of all mammography facilities in North Carolina. All federal and state inspection data were collected and evaluated by using linear regression analysis. Factors affecting the American College of Radiology phantom scores were assessed. RESULTS: Phantom score was affected by inspector identity, view box luminance, and optical density. All of these factors had a statistically significant effect on mass score (P < .05). Inspector identity yielded a statistically significant effect on speck group score, fibril score, and total score. Luminance yielded a statistically significant effect on both speck group score and total score. CONCLUSION: Phantom scoring should be automated to allow for more consistent interobserver scoring. In addition, radiology facilities can improve the likelihood of receiving a passing phantom score by reducing the ambient light and increasing the view box luminance in the location where the images are evaluated and the phantom is scored routinely. Radiologists should also consider increasing phantom and clinical image optical density to allow for improved phantom testing outcomes.

Breast Diseases↗

Impact of health technology assessment on preventive screening in Belgium: case studies of mammography in breast cancer, PSA screening in prostate cancer, and ultrasound in normal pregnancy.

OBJECTIVE: To describe how scientific evidence has influenced healthcare policy making in Belgium in the field of sickness prevention for mammography, PSA testing in prostate cancer screening, and use of ultrasound in pregnancy. METHODS: Review of published and gray literature and interviews with stakeholders and experts. RESULTS: At the end of 1999, a systematic national/regional screening program had not yet been implemented for any of the three screening strategies. A systematic breast cancer screening program is being prepared for implementation only in Flanders. This limited impact can be attributed to the fragmentation in healthcare policy, the different options among the different regions, fragmentation in healthcare practice, the strong impact of healthcare stakeholders (provider groups and sickness funds) on decision making, and limited attention to scientific evidence in health policy and technology assessment. CONCLUSIONS: Health technology assessment has had very little impact on policy and practice in use of mammography, PSA testing, and ultrasound in pregnancy in Belgium.

Adolescent↗

Mammography, routine ultrasonography in pregnancy, and PSA screenings in Italy.

OBJECTIVE: To present current scientific statements and practice on mammography, ultrasonography in pregnancy, and PSA within the Italian National Health Service (NHS). METHODS: Information on the three screenings was found in several position papers prepared by working groups at national and regional levels. RESULTS: For mammography the adjusted mortality rate for breast cancer increased in the last four decades and decreased in the last few years. Only 4.9% of women aged 50-70 years are covered by screening. In 1996 a consensus paper stated that biennial examination for women aged 50-69 years should be offered to reduce breast cancer mortality. A national program for breast cancer screening was launched under the responsibility of regional governments, but data about its implementation are not yet available. Regarding PSA screening, the results show that prostate cancer is the fourth most frequent neoplasm in males. A formal evaluation of prostate cancer screening was done in 1995 by the National Research Council and the Italian Association for Cancer Research; they did not recommend the NHS implement this service. In the National Health Plan 1998-2000, prostate cancer screening is not mentioned. So far, an organized and standardized screening program, based on routine PSA testing, does not exist in Italy. Nevertheless, a lot of PSA tests are performed at the clinical level to detect early prostate cancers. The results with regard to routine ultrasonography in pregnancy show that in 1996 the birth rate was 9.30 per 1,000 inhabitants, with 536,740 live births. In the period from 1992-94, the percentage of babies with a birth weight less than 2,500 gm and less than 1,500 gm were 5.85% and 0.91%, respectively. A formal screening program for detecting fetal growth retardation, based on the routine ultrasonography in the third trimester of the normal pregnancy, doesn't exist in Italy, but this test is widely performed. It is paid for under NHS coverage. CONCLUSION: In 1998 the National Health Plan 1998-2000 stated that the NHS should offer only evidence-based preventive and diagnostic interventions and stressed the importance of appropriate use of health technology.

Adult↗

Health technology assessment and screening in The Netherlands: case studies of mammography in breast cancer, PSA screening in prostate cancer, and ultrasound in normal pregnancy.

OBJECTIVE: To review the assessment and implementation of three screening methods: mammography for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy. METHODS: To review policy documents and published papers dealing with prevention and screening in the Netherlands, focusing on the three screening methods specified. RESULTS: The results indicate that the Netherlands has an active establishment devoted to health technology assessment (HTA). The Netherlands government has also made prevention a high priority in the health services system. Within prevention policy, HTA is given an important place. The general policy is that prevention programs should meet high standards of effectiveness and efficiency, as well as ethical, legal, and social acceptability. In addition, the Netherlands may be unique in the world in having a specific law requiring that proposals for population screening must be carefully assessed before they are implemented. CONCLUSIONS: The three cases examined in this paper have all been assessed, and the conclusions are similar to those presented in the synthesis published in this issue (33). In the case of mammography, the assessment was followed by a rational implementation of a national screening program for breast cancer. In the other two cases, however, despite negative conclusions from assessment, the tests are frequently carried out, especially in what has been termed opportunistic screening. Prostate cancer screening seems to be spreading rapidly. Use of ultrasound in pregnancy is frequent, not necessarily for medical reasons but because parents wish to have a picture of their fetus. The conclusion is that HTA is well established in the Netherlands, as illustrated in these three cases, and policy is based on the assessments done. However, practice is not in accord with the assessment in the cases of prostate cancer and routine ultrasound. Policies to deal effectively with opportunistic screening are difficult to imagine.

Adult↗

The effects of mailed reminders and tailored messages on mammography screening.

A mail campaign to promote mammography screening was tested with 3,887 Medicare recipients in North Dakota who had not had a mammogram in 2 1/2 years. Three types of mailings were compared: (1) a simple reminder message, (2) a reminder accompanied by a persuasive communication emphasizing personal risk, and (3) a reminder accompanied by a message tailored to the participants' chief barrier to having a mammogram. Overall, subsequent mammography rates for women in these conditions did not differ from the rate observed among women who did not receive any mailing. However, post-hoc analyses suggested that women who reported a barrier to having a mammogram were more likely to have a mammogram. Population-wide mail campaigns of the kinds tested here may be generally ineffective for Medicare recipients who are obtaining screenings infrequently. Tailoring messages may be one potentially effective intervention, if investigators can develop ways to increase responses to inquiries about barriers.

Aged↗

Validation of scales measuring attitudes and norms related to mammography screening in women veterans.

Validation of psychosocial measures for use in mammography screening research has been given inadequate attention in the literature. The authors report on the validation of 5 measures examining 4 attitudinal constructs (i.e., pros, cons, outcome expectations, and cancer worries) and 1 social influence construct (i.e., subjective norms) in a 22-item inventory. The study participants consisted of a national, randomly sampled population of women veterans (n = 2,910). After minor revision of scales, the authors found independent measures for 4 constructs: pros, cons, cancer worries, and subjective norms. The authors concluded that these scales have acceptable psychometric properties; support construct validity; and provide brief, reliable, and valid measures of attitudes toward and norms regarding mammography screening. These scales may be useful for intervention research.

Attitude to Health↗

The predictive value of positive test results in screening for breast cancer by mammography in the Nijmegen programme.

After 10 years of screening for breast cancer by mammography in Nijmegen, the predictive value of positive screening results (PV+) was evaluated. The percentage of women with breast cancer in the group of referred women (PV+) for women under age 50 was 16-26%, regardless of the number of screening examinations they had. The percentage of women with breast cancer in the group of women who were biopsied was 25-40%, regardless of the number of examinations. For women aged 50 and over the predictive value was 34-57% and 58-90% respectively. It was further evaluated whether characteristics such as age, Quetelet index, parity, and Wolfe-classification could be used to increase the PV+ in women who were identified as positive by mammography. A logistic regression model analysis showed that true-positive and false-positive cases differ significantly only in terms of age and breast complaints. Although the model had a good fit, it could not be used to distinguish false-positive from true-positive test results.

Age Factors↗

Breast cancer incidence after the start of mammography screening in Denmark.

Mammography screening may lead to overdiagnosis of asymptomatic breast cancers, that would otherwise not have given rise to clinical symptoms. This aspect was studied in three regional screening programmes in Denmark, which started in Copenhagen municipality, Fyn county, and Frederiksberg municipality in 1991, 1993, and 1994, respectively. In these regions, we compared time trends in incidence of invasive breast cancer with the rest of Denmark. Since the number of clinical mammograms was relatively low, it was reasonable to assume that the breast cancer incidence outside the three screening regions represented the incidence of a population with low-intensity opportunistic screening. In Copenhagen and Fyn, a prevalence peak in incidence was seen during the first invitation round. During the subsequent invitation rounds, the incidence dropped to a level in line with the incidence expected without screening. The pattern was different in the small municipality of Frederiksberg, where the sensitivity was low during the first invitation round. Inclusion of screen-detected ductal carcinoma in situ cases did not change these results. The experiences from Copenhagen and Fyn show that organised mammography screening can operate without overdiagnosis of breast cancer.

Aged↗

Current applications and future direction of MR mammography.

Compared with triple assessment for symptomatic and occult breast disease, magnetic resonance mammography (MRM) offers higher sensitivity for the detection of multifocal cancer, which is important in selecting patients appropriately for breast-conserving surgery. It is an ideal tool for the screening of patients with a high risk of breast cancer or where there is axillary disease or nipple discharge and conventional imaging has not revealed the primary focus. Techniques are now available to biopsy lesions only apparent on MRM. MRM can differentiate scar tissue from tumour; therefore, it is useful in patients in which there is possible recurrent disease. Clinical and X-ray mammographic assessment of response to neoadjuvant chemotherapy may be unreliable because of replacement of the tumour with scar tissue. MRM can identify responders and nonresponders with more accuracy. It is the modality of choice for the assessment of breast implants for rupture with accuracy higher than X-ray mammography and ultrasound. Advances in both spatial and temporal resolutions, the imaging sequences employed, pharmacokinetic modelling of contrast uptake, the use of dedicated and now phased-array breast coils, and gadolinium-based contrast agents have all played their part in the advancement of this imaging technique. Despite the limitations of patient compliance, scan-time and cost, this review describes how MRM has become a valuable tool in breast disease, especially in cases of diagnostic uncertainty. However, MRM must make the transition from research institutions into routine clinical practice.

Breast Diseases↗

Beyond mammography screening: quality assurance in breast cancer diagnosis (The QuaMaDi Project).

As many breast cancer cases are detected outside mammographic screening, a multidisciplinary quality management (QuaMaDi) project involving gynaecologists, double reading by radiologists. and centralised assessment, documentation, evaluation and feedback was implemented into routine breast cancer diagnosis in part of Schleswig-Holstein (Germany) with a population of 365,000 women. A cohort of 59,514 patients eligible for diagnostic mammography was examined from May 2001 to December 2005 and quality indicators, breast cancer incidence and tumour stage distribution were analysed. A total of 102,744 diagnostic processes were initiated, for 23.8% of which (24,470) a third expert reading at the reference centre was performed. Further assessment was recommended for 6.3% (6442) of all patients. In total, 1056 breast cancer cases were diagnosed (10.3 per 1000 examinations). Patients of the QuaMaDi project had a higher proportion of 'in situ' and T1 tumours (62.6% vs Schleswig-Holstein: 48.6%), showing that the implementation of high standards in routine diagnostic mammography can improve the quality of breast cancer diagnosis and care.

Adolescent↗

Breast compression in mammography: how much is enough?

The amount of breast compression that is applied during mammography potentially influences image quality and the discomfort experienced. The aim of this study was to determine the relationship between applied compression force, breast thickness, reported discomfort and image quality. Participants were women attending routine breast screening by mammography at BreastScreen New South Wales Central and Eastern Sydney. During the mammographic procedure, an 'extra' craniocaudal (CC) film was taken at a reduced level of compression ranging from 10 to 30 Newtons. Breast thickness measurements were recorded for both the normal and the extra CC film. Details of discomfort experienced, cup size, menstrual status, existing breast pain and breast problems were also recorded. Radiologists were asked to compare the image quality of the normal and manipulated film. The results indicated that 24% of women did not experience a difference in thickness when the compression was reduced. This is an important new finding because the aim of breast compression is to reduce breast thickness. If breast thickness is not reduced when compression force is applied then discomfort is increased with no benefit in image quality. This has implications for mammographic practice when determining how much breast compression is sufficient. Radiologists found a decrease in contrast resolution within the fatty area of the breast between the normal and the extra CC film, confirming a decrease in image quality due to insufficient applied compression force.

Adult↗

Breast cancers invisible on mammography.

BACKGROUND: A proportion of the cancers 'missed' at mammography are invisible even with the benefit of hindsight. The aim of the present study was to identify a group of women with proven breast cancer whose mammograms did not show a suspicious lesion even in retrospect (i.e. the truly mammographically occult cancers), and to compare them with mammogram-positive cancers. METHODS: A total of 1757 breast cancers was diagnosed at the Wesley Breast Clinic's Screening or Diagnostic Services between July 1987 and August 1997. One hundred and twenty cases were identified where, after independent review by two of the authors, no mammographic abnormality could be found in the region where the cancer was subsequently found. These 120 cases were compared with 1548 cancers considered to have a lesion visible on mammography, whether benign, indeterminate, suspicious or malignant in appearance. RESULTS: In 90% of the mammogram-negative cancers, a clinical abnormality led to further investigation, while the remainder were found incidentally on ultrasound. There were a higher proportion of dense breasts, and of women aged 40-49, in the mammogram-negative cancers than in the mammogram-positive cancers. The mammogram-negative cancers were of smaller size overall, but three of them were surprisingly large (7-11 cm). In both the mammogram-positive and -negative cancers approximately 60% were ductal invasive cancers. CONCLUSIONS: Where factors are present that make mammographically occult malignancy more likely (e.g. age 40-49 and dense breasts), women may be targeted for further investigation by other modalities. This is essential in the presence of a clinical abnormality.

Adult↗

Increasing mammography practice by African American women.

PURPOSE: This study examines the effectiveness of the Witness Project, a culturally competent cancer education program that trains cancer survivors to promote early detection and increased breast self-examination and mammography in a population of rural, underserved, African American women. DESCRIPTION OF STUDY: The primary setting for the Witness Project-an intensive, community-based, culturally sensitive educational program that incorporates spirituality and faith-was the African American church. Baseline and 6-month follow-up surveys were obtained from 206 African American women in two intervention counties and from 204 African American women in two control counties in the rural Mississippi River Delta region of Arkansas. RESULTS: Witness Project participants significantly increased (P <.0001) their practice of breast self-examination and mammography (P <.005) compared with the women in the control counties. CLINICAL IMPLICATIONS: These results demonstrate that intensive, community-based, culturally sensitive educational programming incorporating the spiritual environment of the faith community, such as the Witness Project, can positively influence breast cancer screening behaviors among rural, underserved African American women. Through the use of community churches and cancer survivors, breast cancer screening activities can be improved in this population.

Adult↗

Evaluation of tumor angiogenesis with contrast-enhanced dynamic magnetic resonance mammography.

The goal of this research was to correlate dynamic magnetic resonance (MR) mammographic contrast enhancement and microvessel densities in breast masses. Forty-six female patients with breast masses detected by mammography and/or ultrasonography were included in the study. MR contrast enhancements of the lesions were investigated dynamically using axial three-dimensional fast low-angle shot sequences. After excisional biopsy or mastectomy, immunohistochemical staining with factor VIII-RA was performed, followed by microvessel density measurements. Contrast enhancement patterns in dynamic MR mammography were compared with microvessel density measurements using Student's t-test, Pearson's moment correlation coefficients, and one-way analysis of variance (ANOVA). Malignant lesions exhibited three different enhancement patterns: 1) a peak enhancement within 120 seconds (early phase), followed by a decrease in the delayed phase (25 cases); 2) an increase in the early phase, followed by a plateau in the delayed phase (9 cases); and 3) an increase throughout the examination without any peak (5 cases). In benign lesions, signal intensity did not exhibited a peak in five cases, whereas in two cases enhancement was increased in the early phase and made a plateau in the delayed phase. A significant correlation was found between microvessel density and the percentage of maximal signal increase following paramagnetic contrast administration (r=0.322, p<0.05). Dynamic enhancement patterns and rates of maximal signal increase predict microvessel density in breast malignancies and may possibly be used as prognostic indicators.

Adult↗

Screening mammography behavior after a false positive mammogram.

This pilot study describes women's interpretations of the experience of a false positive mammogram followed by a negative biopsy and the impact of this experience on subsequent participation in screening mammography. A 25-min, open-ended telephone interview was administered in 1992 to 30 women over age 39 who had negative biopsies in 1987 preceded by abnormal mammograms. Almost twice as many women reported getting regular mammograms after the biopsy (60%) as did before 1987 (33%). Most received their next mammogram after the biopsy within the recommended interval (73%), and those getting regular mammograms prior to the biopsy experience were more likely than those who did not have a prior habit of undergoing mammography to continue to get them afterwards. These preliminary findings suggest that a negative breast biopsy after a positive mammogram does not reduce a patient's likelihood of undergoing screening in the future. In fact, it may serve as an impetus for increased compliance with screening recommendations.

Adult↗

An investigation into why two-view mammography is better than one-view in breast cancer screening.

AIM: To determine why two-view mammography in screening for breast cancer is more effective than using a single medio-lateral oblique view. MATERIALS AND METHODS: In the United Kingdom Coordinating Committee on Cancer Research randomized trial of one- vs two-view mammography in breast cancer screening the oblique view was assessed by one radiologist and two views (oblique and cranio-caudal) assessed by another. For the present study the mammographic films were retrieved from the screening centres and assessed by three consultant radiologists. Mammographic films were available from 110 women; 87 had their breast cancer detected by both one and two views and in 23 it was missed by one view but detected using two views. Outcome measures were breast size, location and size of the cancer, mammographic features, presence of microcalcification and overall radiological assessment. RESULTS: Although 23 cancers were missed in the original trial when one view was used, only two were not visible on the oblique view. Cancers missed using a single oblique view (and only detected if the cranio-caudal view was available with the oblique) tended to be smaller by about 4 mm (P = 0.05), centrally located in the breast (P = 0.16), not spiculated or round, (P </= 0. 001) and lacked microcalcification (P = 0.15). Breast size and breast radiographic density were not significantly associated with breast cancer detection. CONCLUSIONS: The results provide the basis for the observation that two-view mammographic screening is more effective than one-view mammographic screening.Hackshaw, A. (2000). Clinical Radiology55, 454-458.

Breast Neoplasms↗

Optimizing surveillance mammography following breast conservation surgery.

AIMS: Prompt detection and treatment of local recurrence (LR) following breast conservation surgery (BCT) may improve subsequent survival. Following early reports demonstrating increased LR in the first years after surgery, a practice of surveillance mammography starting 1 year from diagnosis has become established. Increasing use of adjuvant chemotherapy with adriamycin-containing regimens has resulted in radiotherapy being postponed, so that the first mammogram coincides with the acute radiotherapy reaction, resulting in patient discomfort and poor quality films. We wished to determine if the 1-year mammogram could safely be omitted. METHODS: We reviewed 1151 consecutive patients treated with BCT for in situ, stage I or II disease over a 10-year period. All patients had clear resection margins and, where indicated, underwent axillary surgery and adjuvant treatment. This consisted of radiotherapy (40 Gy with a 5 Gy boost), chemotherapy and/or tamoxifen. RESULTS: Overall, the 5-year actuarial rate of local recurrence was 4.8%. The cumulative risk of LR at 12 months was 0.3% (three patients) and 1.9% (20 patients) at 24 months. This included all cases of high-grade DCIS (>30 mm in size) and all but one tumour with a Nottingham Prognostic index (NPI) of >6.0 which recurred locally. CONCLUSION: Even including those patients generally accepted to be at high risk of LR, the cumulative risk of LR was only 0.3% at 12 months from surgery. We now therefore schedule routine biennial mammography from time of surgery except for those with high risk of early local recurrence such as extensive, high-grade in situ disease.

Breast Neoplasms↗

[Indications and limitations of mammography in the diagnosis of breast tumour (author's transl)].

Malignancy of a palpable, circumscribed, solid breast tumour can be clarified only by diagnostic extripation and subsequent histological examination. None of the known physical methods approaches the histological examination in diagnostic accuracy. Since, however, diagnostic accuracy is as important here as with every form of malignant tumour, mammography is superfluous in case of palable tumour. If results of mammography and palpation are equivocal, it must be decided whether histological examination or expectant waiting for a specified period with serial controls is necessary. The fact that "small" carcinomas can be removed surgically may put the patient at risk if this procedure is practised too widely for cosmetic reasons or in the belief that this is sufficient. Yet radical removal is the cardinal requirement in operations for carcinoma of the breast. Radical operation with complete removal of the axillary lymph nodes is thus not a retrogressive step.

Axilla↗