Time trends (2006-2015) of quality indicators in EUSOMA-certified breast centres.

AIM OF THE STUDY: The European Society of Breast Cancer Specialists (EUSOMA) has fostered a voluntary certification process for breast centres to establish minimum standards and ensure specialist multidisciplinary care. Prospectively collected anonymous information on primary breast cancer cases diagnosed and treated in the units is transferred annually to a central EUSOMA data warehouse for continuous monitoring of quality indicators (QIs) to improve quality of care. Units have to comply with the EUSOMA Breast Centre guidelines and are audited by peers. The database was started in 2006 and includes over 110,000 cancers from breast centres located in Germany, Switzerland, Belgium, Austria, The Netherlands, Spain, Portugal and Italy. The aim of the present study is assessing time trends of QIs in EUSOMA-certified breast centres over the decade 2006-2015. MATERIALS AND METHODS: Previously defined QIs were calculated for 22 EUSOMA-certified breast centres (46122 patients) during 2006-2015. RESULTS: On the average of all units, the minimum standard of care was achieved in 8 of 13 main EUSOMA QIs in 2006 and in all in 2015. All QIs, except removal of at least 10 lymph nodes at axillary clearance and oestrogen receptor-negative tumours (T > 1 cm or N+) receiving adjuvant chemotherapy, improved significantly in this period. The desirable target was reached for two QIs in 2006 and for 7 of 13 QIs in 2015. CONCLUSION: The EUSOMA model of audit and monitoring QIs functions well in different European health systems and results in better performance of QIs over the last decade. QIs should be evaluated and adapted on a regular basis, as guidelines change over time.

The effect of EUSOMA certification on quality of breast cancer care.

AIM OF THE STUDY: The European Society of Breast Cancer Specialists (EUSOMA) has fostered a voluntary certification process for breast units to establish minimum standards and ensure specialist multidisciplinary care. In the present study we assess the impact of EUSOMA certification for all breast units for which sufficient information was available before and after certification. MATERIALS AND METHODS: For 22 EUSOMA certified breast units data of 30,444 patients could be extracted from the EUSOMA database on the evolution of QI's before and after certification. RESULTS: On the average of all units, the minimum standard of care was achieved for 12/13 QI's before and after EUSOMA certification (not met for DCIS receiving just one operation). There was a significant improvement of 5 QI's after certification. The proportion of patients with invasive cancer undergoing an axillary clearance containing >9 lymph nodes (91.5% vs 89.4%, p 0.003) and patients with invasive cancer having just 1 operation (83.1% vs 80.4%, p < 0.001) dropped, but remained above the minimum standard. The targeted standard of breast care was reached for the same 4/13 QI's before and after EUSOMA certification. CONCLUSION: Although the absolute effect of EUSOMA certification was modest it further increases standards of care and should be regarded as part of a process aiming for excellence. Dedicated units already provide a high level of care before certification, but continuous monitoring and audit remains of paramount importance as complete adherence to guidelines is difficult to achieve.

The requirements of a specialist Breast Centre.

INTRODUCTION: In recognition of the advances and evidence based changes in clinical practice that have occurred in recent years and taking into account the knowledge and experience accumulated through the voluntary breast unit certification programme, Eusoma has produced this up-dated and revised guidelines on the requirements of a Specialist Breast Centre (BC). METHODS: The content of these guidelines is based on evidence from the recent relevant peer reviewed literature and the consensus of a multidisciplinary team of European experts. The guidelines define the requirements for each breast service and for the specialists who work in specialist Breast Centres. RESULTS: The guidelines identify the minimum requirements needed to set up a BC, these being an integrated Breast Centre, dealing with a sufficient number of cases to allow effective working and continuing expertise, dedicated specialists working with a multidisciplinary approach, providing all services throughout the patients pathway and data collection and audit. It is essential that the BC also guarantees the continuity of care for patients with advanced (metastatic) disease offering treatments according to multidisciplinary competencies and a high quality palliative care service. The BC must ensure that comprehensive support and expertise may be needed, not only through the core BC team, but also ensure that all other medical and paramedical expertise that may be necessary depending on the individual case are freely available, referring the patient to the specific care provider depending on the problem. CONCLUSIONS: Applying minimum requirements and quality indicators is essential to improve organisation, performance and outcome in breast care. Efficacy and compliance have to be constantly monitored to evaluate the quality of patient care and to allow appropriate corrective actions leading to improvements in patient care.

Indications for breast magnetic resonance imaging. Consensus document "Attualità in senologia", Florence 2007.

The clinical use of breast magnetic resonance (MR) imaging is increasing, especially for applications requiring paramagnetic contrast-agent injection. This document presents a synthetic list of acceptable indications with potential advantages for women according to evidence from the literature and the expert opinion of the panel that developed this statement. We generally recommend that breast MR imaging be performed in centres with experience in conventional breast imaging [mammography and ultrasonography (US)] and needle-biopsy procedures (under stereotactic or US guidance) as well as in breast MR imaging and second-look US for findings not revealed by conventional imaging performed before MR imaging. In our opinion, there is no evidence in favour of breast MR imaging as a diagnostic tool to characterise equivocal findings at conventional imaging when needle-biopsy procedures can be performed, nor for the study of asymptomatic, non-high-risk women with negative conventional imaging. After a description of technical and methodological requirements, we define the indications and limitations of breast MR imaging for surveillance of high-risk women, local staging before surgery, evaluation of the effect of neoadjuvant chemotherapy, breast previously treated for carcinoma, carcinoma of unknown primary syndrome, nipple discharge and breast implants.

Physical characteristics of five clinical systems for digital mammography.

The purpose of this study was to evaluate and compare the physical characteristics of five clinical systems for digital mammography (GE Senographe 2000D, Lorad Selenia M-IV, Fischer Senoscan, Agfa DM 1000, and IMS Giotto) currently in clinical use. The basic performances of the mammography systems tested were assessed on the basis of response curve, modulation transfer function (MTF), noise power spectrum, noise equivalent quanta (NEQ), and detective quantum efficiency (DQE) in an experimental setting closely resembling the clinical one. As expected, all the full field digital mammography systems show a linear response curve over a dynamic range from 3.5 to 500 microGy (0.998

Guidelines on the standards for the training of specialised health professionals dealing with breast cancer.

According to EUSOMA position paper 'The requirements of a specialist breast unit', each breast unit should have a core team made up of health professionals who have undergone specialist training in breast cancer. In this paper, on behalf of EUSOMA, authors have identified the standards of training in breast cancer, to harmonise and foster breast care training in Europe. The aim of this paper is to contribute to the increase in the level of care in a breast unit, as the input of qualified health professionals increases the quality of breast cancer patient care.

Computer-aided detection (CAD) of cancers detected on double reading by one reader only.

We evaluated the role of computer-aided detection (CAD) in cancers undergoing double reading and detected by one reader only. A series of 33 cancers, originally missed by the first reader and detected by the second reader, and 75 negative controls were processed to assess CAD sensitivity, and was read by the six radiologists who originally missed the cancers with the help of CAD printouts. CAD case-based sensitivity, specificity and positive predictive value were 51.5%, 18.6% and 21.7%, respectively. Average sensitivity of all radiologists in all cancers in the series was 74.7%, being higher for CAD+ (86.2%) than for CAD- (62.5%) cancers (P<0.01). When reading cancer cases that they had originally missed, radiologists had a sensitivity of 75.8%, which was higher for CAD+ (100.0%) than for CAD- (58.3%) cancers. The average recall rate was 14.2%, the majority of recalls (45 out of 64) occurring for lesions marked by CAD. CAD may help in detecting at most half of cancers missed at a single reading but detected by a second reader.

The role of arbitration of discordant reports at double reading of screening mammograms.

OBJECTIVE: To asses the effectiveness of arbitration of discordant double readings in mammography screening. DESIGN: A retrospective study of 1217 consecutive arbitrations. SETTING: A subset of discordant double readings from the Florence screening programme underwent arbitration by a third reader. RESULTS: Positive arbitration of 1217 discordant double readings prompted assessment in 476 cases (39.2%), detecting 30 cancers (6.3%). Of 741 negative arbitrations (60.8%), 311 have been followed up thus far, and two cancers (0.64%) occurred in the site previously suspected at one of the two independent readings. Arbitration had a sensitivity of 86.3% and a negative predictive value of 99.3%. Arbitration reduced the overall referral rates from 3.82% to 2.59% (relative decrease 32.1%). Due to false-negative arbitration, cancers detected per 1000 women screened would decrease from 4.58 to 4.50 (relative decrease 1.7%). For every cancer missed due to false-negative arbitration, 151 unnecessary recalls and 21,248 euro would have been saved, whereas the saved cost per screened woman due to arbitration was 1.72 euro. DISCUSSION: Arbitration of discordant double reading would substantially reduce referral rates with a limited reduction in cancer detection rate, and may be recommended as a routine procedure. Greater benefit from arbitration might be expected in the presence of high referral rates at independent double reading, a common scenario in a newly implemented service screening.

Second reading of screening mammograms increases cancer detection and recall rates. Results in the Florence screening programme.

OBJECTIVE: To assess double reading effectiveness in mammography screening. DESIGN: Retrospective study of 177,631 consecutive mammograms double read during 1998-2003. SETTING: The Florence screening programme, involving 11 trained radiologists. Abnormalities reported by at least one reader prompted assessment. RESULTS: The referral rate was 2.89% for the first reader, 3.15% for the second reader, and 3.59% for either reader. Of 713 total cancers detected, 43 were suspected only by the second reader (6.4% relative, 0.024% increase in absolute detection rate) and had a lower stage compared to the first reader (pTis-pT1b = 65.7 versus 52.0%): 41 were reviewed and classified (error type) as "minimal sign" in six, and "screening error" in 35 cases, or as BI-RADS 3 in one, 4a in 20, 4b in 13, and 4c in three cases. The second reading cost was 2.70 per woman examined, or 11,168 per additional cancer detected (versus 11,585 at a single reading). DISCUSSION: Second reading is effective in detecting a limited number of additional cancer cases. Tumour stage (one-third over 1 cm in diameter) and review findings (high rate of "screening errors" and BI-RADS R4b-c categories) suggest that second reading detects small "difficult cases" as well as larger cancers missed due to fatigue or loss of attention. Second reading reduces screening specificity to a minor extent, and since cancer detection at second reading seems cost-effective the procedure is recommendable in routine practice.

Comparison of standard and double reading and computer-aided detection (CAD) of interval cancers at prior negative screening mammograms: blind review.

The study evaluates the role of computer-aided detection (CAD) in improving the detection of interval cancers as compared to conventional single (CONV) or double reading (DOUBLE). With this purpose, a set of 89 negative cases was seeded with 31 mammograms reported as negative and developing interval cancer in the following 2-year interval (false negative (FN)=11, minimal signs (MS)=20). A total of radiologists read the set with CONV and then with CAD. Overall, there were 589 cancer and 1691 noncancer readings with both CONV and CAD. Double reading was simulated by combining conventional readings in all 171 possible combinations of 19 radiologists, resulting in a total of 5301 cancer and 15 219 noncancer readings. Conventional single, DOUBLE and CAD readings were compared in terms of sensitivity and recall rate. Considering all 19 readings, cancer was identified in 190 or 248 of 589 readings (32.2 vs 42.1%, chi(2)=11.80, df=1, P<0.01) and recalls were 287 or 405 of 1691 readings (16.9 vs 23.9%, chi(2)=24.87, df=1, P<0.01) at CONV or CAD, respectively. When considering FN and MS cases separately, sensitivity at CONV or CAD was 50.2 or 62.6% (chi(2)=6.98, df=1, P=0.01) for FN and 22.3 or 30.7% (chi(2)=6.47, df=1, P=0.01) for MS cases, respectively. Computer-aided detection (average of 19 readings) was slightly and not significantly less sensitive (sensitivity: 42.1 vs 46.1%, chi(2)=3.24, df=1, P=0.07) but more specific (recall rate 23.9 vs 26.1%, chi(2)=3.8, df=1, P=0.04) as compared to DOUBLE (average of 171 readings). Average sensitivity for FN cases only was 62.6% for CAD and 64.8% for DOUBLE (chi(2)=0.32, df=1, P=0.58). Corresponding values for MS cases were 30.7% for CAD and 35.7% for DOUBLE (chi(2)=3.53, df=1, P=0.06). Compared to CONV, CAD allowed for improved sensitivity, though with reduced specificity, both effects being statistically significant. Computer-aided detection was almost as sensitive as DOUBLE but significantly more specific. Computer-aided detection might be used in the current practice to improve sensitivity of conventional single reading. Based on estimates of screening sensitivity and FN/MS interval cancer expected frequency, the absolute increase of screening sensitivity expected by introducing CAD-assisted reading may be estimated around 0.9%. The use of CAD as a possible surrogate to conventional DOUBLE needs to be confirmed by further studies, which should include a cost-effective analysis.

Assessment of the early impact of the population-based breast cancer screening programme in Florence (Italy) using mortality and surrogate measures.

The aim of this study was to evaluate the effects by the end of 1999 of the Florence breast screening programme that started in 1990. Approximately 60000 women (aged 50-69 years) were enrolled from 1990 to 1993. Breast cancer cases diagnosed from 1990 to 1996 were partitioned by the method of detection, classified by their tumour size and nodal status and followed-up for mortality at on the 31 December 1999. Incidence-based mortality in the 50-74-year-old women and advanced carcinomas rates were assessed. Due to low compliance (approximately 60%) and the long enrollment phase, only approximately 35% of the total age-specific population person-years were screened. The number of invasive cases diagnosed was 1122, 17% higher than the 958 expected. After the prevalence screening, a reduction of approximately a quarter in advanced carcinomas was observed in the invited women (Odds Ratio (OR): 0.74; 95% Confidence Interval (CI): 0.55-0.98). In the period 1990-1999, 547 breast cancer deaths were observed: 78 (14%) occurred in women invited and half of these in never responders, 385 (70%) occurred in cases diagnosed before screening started. Disproportionate numbers of deaths occurred in women with advanced tumours. The 19% mortality reduction for the invited women was of borderline statistical significance (observed/expected (O/E) deaths: 0.81; 95% CI: 0.64-1.01); by a one-sided test the result would be unequivocally significant. The mortality reduction attributable to screening in the whole population over the 10-year period was 3.2%. The incidence-based mortality analysis confirmed the current follow-up time is too short for screening to have had a major effect on the breast cancer mortality trends. Screening performance might be improved by a higher level of compliance and shorter interval times, but the estimate of the mortality reduction for the invited and the lower rate of advanced carcinomas confirmed that the effect of the programme is in the expected direction.

[Assessment of diagnostic accuracy of mammography carried out for secondary prevention. Results of a test with a sample caseload conducted by 75 Italian radiologists]. / Valutazione dell'accuratezza diagnostica nella mammografia eseguita con fini di prevenzione secondaria. Risultati di una prova su casistica campione sostenuta da 75 radiologi italiani.

PURPOSE: To report the results of a test performed by 75 volunteer radiologists involved in screening program in Italy. MATERIAL AND METHODS: The test includes 12 screening detected cancers and 6 cancers (4 screening detected and 2 interval lesions) with minimal signs at review of a previous negative mammogram. Data on previous experience in mammography (years of activity, years of screening activity, total number of mammograms read and number of mammograms read per year) were also collected. RESULTS: Standards for passing the test were at least 83.3% for sensitivity for screening detected cancers and at most 30% for recall rate among negative cases. Mean sensitivity was 83.9% (median 83.3%, range 50-100%) and mean recall rate was 16.3 (median 14.4%, range 3.8-42.4%). In all, 44 radiologists (58.7%) passed the test. On average 1.4 of 6 cancers with minimal signs were correctly identified. According to readers' experience (at least 5 years in mammographic activity, at least 3 years in screening mammography, at least 10,000 total mammograms read, at least 5,000 per year) radiologists were classified as expert (13) or not (62): no difference in test performance was observed between the two groups. The only significant association occurred for years of mammographic activity and sensitivity. DISCUSSION AND CONCLUSIONS: Test results suggest the need for proper training of radiologists prior to involvement in a screening program. Seeding proficiency tests with cancers with minimal signs was of no benefit as far as evaluation is concerned.

Proficiency test for screening mammography: results for 117 volunteer Italian radiologists.

OBJECTIVE: To analyse the performance of a large sample of Italian radiologists undergoing a proficiency test for screening mammography. DESIGN: Evaluation of performance indicators according to reference standards determined by a panel of experts (sensitivity (reference standard > or = 80%), recall rate (reference standard < or = 15%)). SETTING: 117 Italian radiologists of varying experience (years of practice 0.5-18, average 5.9; mammograms read 500-51,000, average 13,000), all currently reporting clinical mammography and planning to take part in screening in the near future. RESULTS: Eighty four of 117 (72%) radiologists reached the standard for sensitivity, 88 (75%) reached the standard for recall rate, and only 59 (50%) reached both standards and passed the proficiency test. The probability of passing the test was significantly correlated with mammographic practice (p = 0.015), mammograms read (p = 0.024), and mammograms read/year (p = 0.043). DISCUSSION: The performance of a large sample of Italian radiologists currently reporting clinical mammography was disappointing, indicating the need for proper training of at least 50% of the tested subjects. When implementing organised screening the health authority should set up a proper process for training and accrediting radiologists, and a proficiency test should be part of such a process.

Solid nonpalpable breast lesions. Success and failure of guided fine-needle aspiration cytology in a consecutive series of 2444 cases.

PURPOSE: To evaluate the contribution of guided fine-needle aspiration cytology in reducing unnecessary biopsies of benign solid nonpalpable breast lesions with low suspicion of malignancy at mammography. MATERIAL AND METHODS: An evaluation was made of a consecutive series of 2444 solid nonpalpable breast lesions detected by mammography and undergoing guided (sonography or stereotaxy) fine-needle aspiration cytology. Surgical biopsy was made in the presence of strong suspicion of malignancy at mammography and/or of abnormal cytology. RESULTS: The sensitivity was 96.7% and the specificity 77.7% (average follow-up 2.77 years). False-negative/inadequate cytology associated with low suspicion of malignancy at mammography resulted in a diagnostic delay in 27 cancer cases (invasive 20, intraductal 7). On the other hand, cytology led to surgical biopsy in 53 cancer cases which might not otherwise have been biopsied because of low radiological suspicion of cancer. Surgical biopsy of all cases, to avoid diagnostic delays, would have increased the benign biopsy rate by a factor of 4.5, with a rise in the benign: malignant biopsy ratio from 0.44:1 to 1.93:1. CONCLUSION: Stereotaxy- or ultrasound-guided fine-needle aspiration cytology of nonpalpable mammographic abnormalities can achieve a sharp reduction in unnecessary benign biopsies in cases of low suspicion of malignancy at mammography.

[Cost-benefit analysis of a mammography screening program extended to all the national territory]. / Analisi costo-efficacia di un programma di screening mammografico esteso a tutto il territorio nazionale.

A cost-effectiveness analysis has been conducted in order to evaluate effects and costs of a nationwide mammographic breast cancer screening programme compared with no screening in a 30 years period. The analysis includes seven different phases of breast cancer, from the screening programme itself to the treatment of terminal illness. The estimates use italian published data and field studies. The calculations were performed with the Miscan computer simulation package: a programme providing for the screening of women aged 50-69 at two years intervals might be expected to result in a 1,650 deaths prevented and 14,500 years of life gained each year. The overall net costs of the programme were assessed at between 2,893 and 3,212 thousand million lire, the cost per life saved between 59.8 and 66.4 million lire and the cost per life-year gained between 6.6 and 7.3 million lire (between 10.7 and 11.5 million lire with a 5% discount rate, an estimate lower than that of German programme). The analysis produces important information for the Italian policy debate over mammography and it also contributes to the development of economic evaluation in our country.

[Test for the assessment of the diagnostic accuracy of mammography. Results of 103 tests carried out by Italian radiologists]. / Test per la valutazione dell'accuratezza diagnostica nella mammografia. Risultati di 103 test sostenuti da radiologi italiani.

This study reports the results of some voluntary Italian radiologists performing 103 proficiency tests in clinical (100 patients, 32 cancers) and screening mammography (150 patients, 17 cancers). Relative to the average accuracy of a panel of expert radiologists, 12 of 49 readers (27%) and 32 of 54 readers (56%) passed the clinical and screening mammography test, respectively. The results were significantly correlated with the readers' previous experience (years of mammographic practice [< 2, 2-4, > 4] and number of mammograms read [< 5,000, 5-10,000, > 10,000]). The rate of passed test was: < 2 years = 0%, 2-4 years = 40%, > 4 years = 66.6% (P = 0.002); < 5,000 mammograms read = 15.3%, 5-10,000 = 28.5%, > 10,000 = 69.2% (P = 0.02). The best results were achieved by the readers with a previous reading experience of at least 10,000 mammograms, a figure which might be used as the reference for a future criterion of accreditation on a national basis. Proper training before reporting mammography is fundamental to ensure a good diagnostic performance. The low number of tests performed in most Italian mammographic practice facilities makes local training highly questionable and requires quite a long time. Reference centers, adequately equipped for training, should be identified for this purpose. Proficiency tests such as those described in the present study are useful to assess individual performance and should be a part of a training program.

Reproducibility of histological diagnosis of breast lesions: results of a panel in Italy.

Sixteen pathologists independently examined and classified a series of 81 breast lesions selected from the files of several Italian Pathology Departments in the context of a national task force on breast cancer (FONCAM). A four category classification system was used for analysis; according to the majority diagnosis (MD), simply defined as the most frequently reported in the panel, the series included 37 benign lesions without atypia (45.7%), nine atypical hyperplasias (11.1%), 18 in situ (22.2%) and 17 invasive carcinomas (21.0%). Concordance, estimated for all possible pair-wise comparisons between pathologists, was good (mean kappa value: 0.59). A comparison between the diagnoses of each pathologist and the panel majority diagnosis was also made. Overall, a global kappa value of 0.72 was found (range 0.57-0.85), with category-specific values being excellent for invasive carcinoma (0.89) and benign lesions without atypia (0.77), relatively good for in situ carcinoma (0.69) but poor for atypical hyperplasia (0.38). These results confirm that quality assurance procedures are particularly indicated for large screening programmes for breast cancer, and suggest that for atypical lesions strict diagnostic criteria should be adopted.

[The procedures and results of a quality control program in mammography carried out on a regional basis]. / Procedure e risultati di un programma di controllo di qualità in mammografia svolto su base regionale.

In 1990 the region of Tuscany instituted a quality control program for mammography, in order to check the working conditions of mammography centers in the region, to investigate the feasibility of applying some working standards in line with European recommendations, and to promote the training of personnel. The program involves the following: a test of newly acquired mammographic equipment to establish that it meets the required standards; an annual test of generators, X-ray beams, grid, AEC, screen-film system, film processing, dose and image quality; daily test (phantom radiography and film sensitometry) performed by the personnel of each mammographic Unit; and a sustained advisory service for the technical problems occurring between checks. Thirty-nine of 57 centers participated on a voluntary basis, and 135 checks were performed annually. The results of the program show a performance below the recommended standard in relation to AEC, film sensitometry and the adequacy of lights in dark rooms in 40%, 50% and 63%, respectively, of the centers. Entrance exposure was over 1500 mR, with a maximum value of 3450 mR, in 6 cases in the first round. 5 cases in second, and only 1 case in the third. In general, the results are slightly improving, but mammography optimization is still a long way off. It is necessary to carry out suitable programs for quality control in mammography on a regional basis and to establish precise guidelines for individual mammographic Units to follow in order to meet the European standards.