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Comparison of full-field digital mammography and film-screen mammography: image quality and lesion detection.

The objective of this study is to compare image quality and lesion detection for full field digital mammography (FFDM) and film-screen mammography (FSM). In 200 women we performed digital mammography of one breast and film-screen mammography of the other breast. Imaging parameters were set automatically. Image quality, visualization of calcifications and masses were rated by three readers independently. Mean glandular dose was calculated for both systems. We found no significant difference in mean glandular dose. Image quality was rated by reader A/B/C as excellent for FFDM in 153/155/167 cases and for FSM in 139/116/114 cases (p<0.03/0.001/0.001). Microcalcifications were detected by FFDM in 103/89/98 and by FSM in 76/76/76 cases (p<0.01/0.06/0.01). Detection of masses did not differ significantly. FFDM provided significantly better visibility of skin and nipple-areola region (p<0.01). FFDM demonstrated improved image quality compared with film-screen mammography. Microcalcification detection was also significantly better with the digital mammography system for two of the three readers.

Adult↗

Has the mammography quality standards act affected the mammography quality in North Carolina?

OBJECTIVE: The United States Food and Drug Administration implemented federal regulations governing mammography under the Mammography Quality Standards Act (MQSA) of 1992. During 1995, its first year in implementation, we examined the impact of the MQSA on the quality of mammography in North Carolina. MATERIALS AND METHODS: All mammography facilities were inspected during 1993-1994, and again in 1995. Both inspections evaluated mean glandular radiation dose, phantom image evaluation, darkroom fog, and developer temperature. Two mammography health specialists employed by the North Carolina Division of Radiation Protection performed all inspections and collected and codified data. RESULTS: The percentage of facilities that met quality standards increased from the first inspection to the second inspection. Phantom scores passing rate was 31.6% versus 78.2%; darkroom fog passing rate was 74.3% versus 88.5%; and temperature difference passing rate was 62.4% versus 86.9%. CONCLUSION: In 1995, the first year that the MQSA was in effect, there was a significant improvement in the quality of mammography in North Carolina. This improvement probably resulted from facilities' compliance with federal regulations.

Mammography↗

The New Mexico Mammography Project. Screening mammography performance in Albuquerque, New Mexico, 1991 to 1993.

BACKGROUND: This project was designed to collect and link population-based mammography and breast carcinoma data to assess the performance of community mammography screening. METHODS: Computerized data were collected from all radiology practices in Albuquerque, New Mexico. The data were linked by computer match to breast carcinomas in a statewide cancer registry. Analysis is based on 126,466 screening mammogram studies performed on 87,443 female residents of New Mexico between the ages of 35 and 84 by 5 radiology groups. Sensitivity, specificity, positive predictive value, and call back rates were calculated as indicators of the discriminative performance of mammography. Carcinoma size and stage distribution were analyzed as outcome measurements. RESULTS: The computer match linked 634 breast carcinomas to the 126,466 screening mammogram series. The community-wide sensitivity was 79.9%, and specificity was 90.5%. The predictive value of an abnormal screen was 4.3%, and that of a biopsy recommendation result was 16.9%. The call back rate was 11.4%. The median invasive breast carcinoma size was 15 mm, 20.3% of carcinomas were in situ, 18.3% were lymph node positive, and 68.1% were Stage 0 or Stage 1. CONCLUSIONS: Mass screening mammography as practiced in Albuquerque, New Mexico, is able to detect breast carcinomas at early, treatable stages. The stage distribution of carcinomas is similar to that seen in successful clinical trials. However, measures of mammography performance show lower sensitivity, more additional studies, and more biopsy recommendations in this community setting than have been reported by expert mammographers.

Adult↗

Mammography screening matters for young women with breast carcinoma: evidence of downstaging among 42-49-year-old women with a history of previous mammography screening.

BACKGROUND: Breast carcinoma is the leading cause of death for women between the ages of 40 and 49 years, yet questions linger regarding the effectiveness of screening mammography in reducing mortality rates among women of this age. In the current study, the authors report on the association between cancer stage at diagnosis and a history of mammography screening in a clinical setting that has emphasized informed choice regarding mammography screening for women in this age group. METHODS: Previous mammographic screening for 247 breast cancer patients 42-49 years of age who were diagnosed at Kaiser Permanente Colorado during 1994-2000 was evaluated relative to cancer stage. Cancer stage was dichotomized into early (American Joint Committee on Cancer [AJCC] Stages 0 and I) and late (AJCC Stages II-IV) and previous screening was defined as at least one normal screening mammogram within 24 months before the breast carcinoma diagnosis. RESULTS: Women who were screened were less likely to be diagnosed at a late stage than were women who were not screened (40% vs. 52% late stage, respectively). Adjusted for age, year of diagnosis, and family history, screened women were 0.56 (95% confidence interval = 0.32-0.97) times as likely as unscreened women to be diagnosed at a late stage. CONCLUSIONS: Women 42-49 of years with breast carcinoma who undergo regular screening mammography have a more favorable cancer stage than do women with breast carcinoma who do not undergo regular screening. This downstaging of breast carcinoma is likely to translate into improved breast carcinoma survival resulting from screening mammography for women 40-49 years of age.

Adult↗

Comparison of full-field digital mammography to screen-film mammography with respect to diagnostic accuracy of lesion characterization in breast tissue biopsy specimens.

RATIONALE AND OBJECTIVES: This study was performed to investigate whether full-field digital mammography (FFDM) is at least as accurate as screen-film mammography with respect to breast lesion characterization. MATERIALS AND METHODS: Seventy-nine breast surgical specimens were obtained by means of preoperative needle localization with surgical excision from 79 patients. The specimens were imaged with both screen-film mammography and FFDM. Six radiologists specialized in breast imaging analyzed both sets of images and characterized the visualized lesions on a five-point scale: 1, definitely not malignant; 2, probably not malignant; 3, possibly malignant; 4, probably malignant; and 5, definitely malignant. Receiver operating characteristic curve analysis of the data was then performed to assess for differences between modalities in the radiologists' ability to predict breast malignancy. RESULTS: The areas under the receiver operating characteristic curves for the prediction of breast malignancy in surgical biopsy specimens were not statistically significantly different for FFDM and screen-film mammography. CONCLUSION: The results demonstrate that with breast surgical specimens, FFDM is similar in diagnostic accuracy to screen-film mammography.

Adult↗

Current practice of screening mammography in the United States: data from the National Survey of Mammography Facilities.

PURPOSE: To describe the extent to which screening mammography (SCM) has been organized according to the public health concept of low-cost, high-quality, and population-based screening, selected indicators of U.S. mammography facilities were evaluated. MATERIALS AND METHODS: Data from the National Cancer Institute's phase I of the National Survey of Mammography Facilities were analyzed. This data base consists of questionnaire information obtained in 1992 from a 10% random sample of U.S. mammography facilities. RESULTS: Of 1,057 facilities, 634 (60%) distinguished SCM from diagnostic mammography (DXM). In facilities providing SCM (n = 535), 477 (89%) used the mediolateral oblique (MLO) view and/or the craniocaudal (CC) view. While 898 (85%) of all facilities requested clinical follow-up of abnormal mammograms, only 285 (27%) facilities actually received this information. Only 137 (13%) facilities operated at high volume (> or = 15 mammograms per day per machine), and 211 (20%) used batch interpretation. Average cost of a screening mammogram was $89 (range, $10-$225). CONCLUSIONS: While more facilities are distinguishing SCM from DXM and obtain MLO and CC views, SCM does not appear to be organized for high volume and low cost.

Costs and Cost Analysis↗

U.S. screening mammography services with mobile units: results from the National Survey of Mammography Facilities.

PURPOSE: To investigate elements of mobile facilities for mammography in the United States. MATERIALS AND METHODS: The prevalence and performance of mobile facilities for mammography in the United States were studied with regard to cost, price, quality assurance, and access. Data were acquired from the National Cancer Institute's National Survey of Mammography Facilities, conducted in 1992. RESULTS: Of the 1,057 facilities surveyed, 2.4% were identified as mobile and accounted for 3% of mammography examinations performed. All mobile facilities reported accreditation by the American College of Radiology, and 92% were in Statistically Metropolitan Areas. Most were affiliated with community hospitals or private radiology practice and were more likely to be associated with lower fees, convenient operating hours, batch interpretation, and computerized reporting than were their stationary counterparts. CONCLUSION: Mobile mammography facilities compare favorably with stationary facilities. The use of these mobile units in the United States, however, has been limited.

Accreditation↗

The price of mammography in the United States: data from the National Survey of Mammography Facilities.

Data from the National Survey of Mammography Facilities are used to explore the efficiency of service delivery by mammography facilities. Screening mammography generally costs $100 or more. This study outlines principles recommended to lower unit costs of screening mammography and examines the extent to which facilities surveyed employed them. It reports charges, volume, and other facility characteristics, comparing them with the assumptions regarding these features in a study by the Physician Pricing Review Commission. That study, sponsored by the federal government, concluded that screening mammography can be delivered for around $60; however, only 14 percent of the facilities achieved the requisite volume of 15 or more mammograms per day. Facilities must become more efficient in order to charge the lower rates. This case study may have relevance for other potentially expensive preventive measures and medical procedures.

Data Collection↗

[When are recommended breast biopsies carried out, and what information does the physician responsible for mammography receive? Experiences with 317 breast biopsy in a regional quality assurance project for screening mammography].

In a regional quality assurance project for screening mammography (German Mammography Study), 27,335 women were screened in 40 participating, office-based mammography units from 1990-1992. Screening led to 317 biopsies with a positive predictive value of 0.33. All biopsy documentation available to the mammography physicians was analysed with a view towards biopsy interval and completeness of information fed back to the Mx physicians. Biopsy recommendations were acted upon in 29% of cases within 2 weeks. With the exception of the dignity Mx physicians were incompletely informed about biopsy results. The surgical procedure was known in the doctors' offices in 62% of the cases. Specimen radiographies were not done regularly. A pathology report was available overall in 42 of 106 malignant cases, respectively. With the exception of the histological diagnosis itself, no variable mentioned in the reports was documented completely. Only one third of the physicians received such reports routinely. Fail-safe information are requested by Mx physicians and can help them to better target biopsy recommendations. A (regional) quality assurance center should be made responsible to analyse the flow of information in mammography screening, to fill in gaps and to speed up professional cooperation.

Biopsy↗

The impact of the Mammography Quality Standards Act on the availability of mammography facilities.

BACKGROUND: The Mammography Quality Standards Act (MQSA) became effective October 1, 1994, and requires all mammography facilities to meet quality standards as promulgated by the Food and Drug Administration (FDA). The FDA undertook an assessment of the MQSA federal certification requirements on the availability of mammography facilities. METHODS: A survey of states on mammography facility closures between October 1, 1993, and October 1, 1994, was conducted. MapInfo software was used to link zip codes to demographic databases. The characteristics of closed facilities were compared to certified facilities as of December 15, 1994. RESULTS: A total of 369 facilities (3.5%) had closed. This closure rate was comparable to previous years' rates (2.5-10%). As of December 15, 1994, 10,142 certified facilities were operating. Relative to their distribution in the United States, closures in rural areas were proportional, but there were more facility closures in the minority areas and in poverty areas. However, the relative distributions of facilities to these areas' populations were unchanged. CONCLUSIONS: Impact on facility availability has been minimal.

Female↗

[Value and significance of digital full-field mammography within the scope of mammography screening].

To evaluate the digital technique for screening mammography various experimental studies and clinical examinations were performed by using direct full-field digital mammography (FFDM). The findings concerning the detectability and characterization of microcalcifications and soft tissue masses as well as the radiation exposure were compared to the state-of-the-art conventional screen-film mammography (SFM). The results of these studies revealed a high performance of the digital images, which are at least equivalent to the conventional images, whereas digital spot views were significantly superior to conventional ones particularly in the detection of microcalcifications. This was especially true, when the potential of post-processing was used. In addition, the sensitivity of FFDM should be increased, if computer-aided-diagnosis (CAD) is available. Furthermore, the patient radiation dose can be significantly reduced. Additional advantages are quick and easy handling, efficient data transfer and digital archiving. Thus, FFDM will become an important tool in screening mammography.

Breast Neoplasms↗

Contrast-detail detectability analysis: comparison of a digital spot mammography system and an analog screen-film mammography system.

RATIONALE AND OBJECTIVES: The authors compared the contrast-detail detectability properties of an optically coupled charge-coupled device (CCD) digital mammography system with those of a conventional analog screen-film mammography system. METHODS: A proprietary contrast-detail phantom was imaged with both systems. Twelve observers viewed analog and digital images obtained at seven different mean glandular doses. Contrast-detail-dose curves were generated on the basis of the readers' visual perceptions. Interobserver errors were also calculated. In addition, the authors applied a theoretical model for lesion detectability to calculate and compare the digital and analog mammography systems. RESULTS: The readers' contrast-detail detectability was significantly superior with the digital system in the detail and contrast ranges evaluated (P < .001). CONCLUSION: The performance of the readers paralleled the performance predicted by the theoretical model for the two imaging systems. The following features account for the superior performance of the digital mammography system: (a) higher quantum efficiency of the phosphor, (b) wider dynamic range, (c) better contrast transfer characteristics, and, most important, (d) greater photon flux at the phosphor entrance.

Contrast Sensitivity↗

[Radiation exposure in full-field digital mammography with a flat-panel x-ray detector based on amorphous silicon in comparison with conventional screen-film mammography].

PURPOSE: Comparison of radiation exposure between a digital amorphous silicon and a screen-film based mammography system. Evaluation of a possible potential of full-field digital mammography in order to decrease the radiation dose. METHODS: The average glandular dose for phantom thicknesses from 30 to 60 mm was calculated from experimentally determined entrance surface air kerma for a digital and a conventional mammography system. The effect of reducing the detector dose and of changing the radiation quality on radiation exposure and on image quality were investigated. RESULTS: By using the delivered settings of the automatic exposure control (AEC) devices, both mammographic systems needed nearly the same doses. Regulations and guidelines on radiation doses were complied. With the digital system, a reduction of radiation exposure of up to 40% by using a higher radiation quality and decreasing slightly the detector dose without loss of diagnostic image quality, might be possible. CONCLUSION: The potential of full-field digital mammography for radiation dose reduction, as shown in the present phantom study, needs however, a careful examination under clinical conditions.

Female↗

[Experimental studies on image quality in conventional film screen system, digital phosphor storage plate mammography in mangnification technique and digital mammography in CCD-technique].

UNLABELLED: Comparison of image quality between conventional film screen system, digital phosphor storage plate mammography in magnification technique and digital mammography in CCD-technique. MATERIALS AND METHODS: Radiograms of a RMI-mammography phantom were acquired using a conventional film screen system, two digital storage plate systems and two digital systems in CCD-technique. Additionally, the radiograms of one digital phosphor storage plate system were postprocessed emphasizing contrast and included in the comparison. RESULTS: The detectability of details was the best with the digital mammography in CCD-technique in comparison with the conventional film screen technique resp. digital phosphor storage plate in magnification technique. CONCLUSIONS: Based on these results there is the possibility to replace the conventional film screen system by further studies--this has to be confirmed.

Breast Neoplasms↗

Screening mammography in Finland--1.5 million examinations with 97 percent specificity. Mammography Working Group, Radiological Society of Finland.

A nationwide mammography screening program including women aged 50 59 years at the time of the first invitation and involving more than 100 radiologists was started in Finland in January, 1987. From 1987 through 1997, a total of 1690496 invitations to biennial two-view mammography screening was sent out. The compliance for screening was 88.5% with 1 495744 screening examinations performed during this 11-year period. There were 49020 recalls (3.28% of those attending) for further work-up studies and 9689 women (0.65% of those attending) were referred for surgery. The total number of screening-detected breast cancers was 5595, giving a detection rate of 3.7 cancers per 1000 screening studies. More than half (57.7%) of all surgical biopsies revealed breast cancer and 67.8% of the invasive cancers were at Stage I. The positive predictive value of referral to surgical biopsy increased from 33.2% in 1987 to 65.5% in 1997. and the ratio of malignant to benign biopsies more than tripled from the first to the fifth year of screening. The observed/expected ratio of invasive cancer detection was 2.44. Only 0.27% (1 out of every 372) of all screening mammograms were followed by a benign biopsy, and 2.90% (1 out of every 34) of all screening mammograms were followed by the women being recalled for further studies and not found to have breast cancer. This gave a specificity of recall after screening mammography greater than 97.0% and a specificity of referral to surgical biopsy greater than 99.7%. Measures of specificity improved considerably during the first three years of the screening program. The high specificity of screening mammography can be attributed to the nature of the screening process as well as to the opportunity for individual radiologists to attain a greater level of experience and competence. The decision to recall appears to have been crucial in determining the specificity.

Biopsy↗

Average glandular dose in routine mammography screening using a Sectra MicroDose Mammography unit.

The Sectra MicroDose Mammography system is based on direct photon counting (with a solid-state detector), and a substantially lower dose to the breast than when using conventional systems can be expected. In this work absorbed dose measurements have been performed for the first unit used in routine mammography screening (at the Hospital of Helsingborg, Sweden). Two European protocols on dosimetry in mammography have been followed. Measurement of half value layer (HVL) cannot be performed as prescribed, but this study has demonstrated that non-invasive measurements of HVL can be performed accurately with a sensitive and well collimated solid-state detector with simultaneous correction for the energy dependence. The average glandular dose for a 50 mm standard breast with 50% glandularity, simulated by 45 mm polymethylmethacrylate, was found to be 0.21 and 0.28 mGy in March and December 2004, respectively. These values are much lower than for any other mammography system on the market today. It has to be stressed that the measurements were made using the current clinical settings and that no systematic optimisation of the relationship between absorbed dose and diagnostic image quality has been performed within the present study. In order to further increase the accuracy of absorbed dose measurements for this unit, the existing dose protocols should be revised to account also for the tungsten/aluminium anode/filter combination, the multi-slit pre-collimator device and the occurrence of a dose profile in the scanning direction.

Air↗

The negative impact of MQSA (Mammography Quality Standards Act) on rural mammography programs.

Since Roentgen's discovery in 1895, physicians and scientists have found ways to use x-ray to evaluate and diagnose disease. In 1960, Dr. Richard Egan modified an x-ray machine to image the breast, for example. In 1982, one study found that deaths from breast cancer could be reduced 40 percent by using screening mammography. In 1991, Congress appropriated $90 million for breast cancer research, a figure that rose to $406 million several years later. The Mammography Quality Standards Act (MQSA), passed in 1992, requires all mammography facilities to meet minimum quality standards for equipment, radiologists, physicists and technologists. Regulations require extensive records of medical audit and outcome analysis, personnel qualification and medical reporting. Inspection and certification are now the responsibility of the Food and Drug Administration (FDA). Although they ensure compliance with the law, these inspections cost each facility $1,549 annually and the average cost to reach compliance with MQSA is $18,000. These fees are easily absorbed by high-volume centers but are burdensome for smaller, lower volume centers. Screening exams, to be useful, must be simple, accessible and cost-effective. MQSA's regulations have added significant costs and in most cases, the smaller centers will be forced to raise prices or discontinue offering mammography for a segment of the population with little or no other recourse for screening. The FDA should look for ways to perform more cost-effective inspections that still enforce regulations and monitor quality. Inspections should be unannounced and fines raised for violations. Implementation costs must be more realistic and the amount of paperwork reduced.

Ambulatory Care Facilities↗

[ROC analysis comparing screen film mammography and digital mammography].

PURPOSE: To compare the diagnosis performances of radiologists on screen film versus digital mammography. MATERIAL: and methods: Two sets of 123 mammograms, screen film mammography and storage phosphor digital mammography, are studied comparatively with ROC analysis. RESULTS: Phantom study show that conventional method give better scores for usual tension but the detectability of smaller microcalcification is equivalent. To obtain with digital technic the same conventional score you have to increase the radiation dose. Roc Curves, simulated "detection" mode showed that radiologists performed with higher accuracy with conventional system but this difference is weekly statistically significant. ROC Curves, simulated "diagnostic" mode showed the same results wit no statistically significant difference but when the decision to go to the biopsy is the gold standard, ROC Curves were essentially equivalent for both film screen and digital mammography system. The readers consistently considered the digital mammograms to be less suspicious for cancer findings. The agreement study as proposed by the FDA indicate that probability of a positive digital mammograms given a positive screen film is 75% (threshold value 90%) and the probability of a negative digital mammograms given a negative analog film is 85% (threshold value 85%). CONCLUSION: Analysis of specific discrepancies indicate that spatial resolution is an essential limiting factor for digital method but high resolution phosphor plate are interesting in imaging treated breast, radioluscent lesion, fatty benign tumor, hamartoma, intramammary lymph node, breast with prosthesis.

Biopsy↗