M. Rosselli Del Turco

Quality indicators in breast cancer care

To define a set of quality indicators that should be routinely measured and evaluated to confirm that the clinical outcome reaches the requested standards, Eusoma has organised a workshop during which twenty four experts from different disciplines have reviewed the international literature and selected the main process and outcome indicators available for quality assurance of breast cancer care. A review of the literature for evidence-based recommendations have been performed by the steering committee. The experts have identified the quality indicators also taking into account the usability and feasibility. For each of them it has been reported: definition, minimum and target standard, motivation for selection and level of evidence (graded according to AHRO). In overall 17 main quality indicators have been identified, respectively, 7 on diagnosis, 4 on surgery and loco-regional treatment, 2 on systemic treatment and 4 on staging, counselling, follow-up and rehabilitation. Breast Units in Europe are invited to comply with these indicators and monitor them during their periodic audit meetings.

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.

Time interval since last test in a breast cancer screening programme: a case-control study in Italy.

STUDY OBJECTIVE: To evaluate a population based screening programme for breast cancer. DESIGN: This was a case-control study of women dying of breast cancer between 1977 and 1987 who had been invited to take part in a screening programme. SETTING: Community based study of women aged between 40 and 70 years (total population about 35,000 at 1981 census), living in 23 small towns near Florence, Italy. PARTICIPANTS: 103 cases were identified from death certification, and 515 living controls (five per case) selected for year of birth and town of residence. MEASUREMENTS AND MAIN RESULTS: Screening history was obtained from computer archive. Sociodemographic information was obtained from town registry offices and directly from relatives of the deceased and from the controls by postal questionnaire, and if necessary telephone or personal interview. Analysis was carried out on two age groups--40-49 years and 50+ years at diagnosis--and considered the number of screening tests and the time interval since the last test, separately and together. In the older age group, women with at least one screening test in the previous 2 1/2 years showed a 50% reduction in risk (odds ratio 0.49, 95% confidence interval [CI] 0.25-0.95). If they had also had another previous negative screen the risk was reduced to one third (odds ratio 0.35, 95% CI 0.14-0.85). There was a significant trend of decreasing risk with increasing number of screens in older women. No clear evidence of a similar protective effect was shown for women in the 40-49 year age group. CONCLUSIONS: A significant protective effect of the screening programme is evident in older women but not in younger ones. The data do not allow an assessment of optimal screening interval because of the small number of previously screened cases.

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.RiassuntoLa RM mammaria è in fase di crescente utilizzo clinico, soprattutto per le applicazioni che richiedono la somministrazione di mezzo di contrasto (MdC) paramagnetico. Il presente documento propone una codificazione sintetica delle indicazioni accettabili con potenziale vantaggio per le donne, secondo la valutazione delle evidenze presenti in letteratura e l’opinione del gruppo di esperti estensori del documento. In generale si raccomanda che l’indagine sia eseguita presso centri che siano in grado di combinare l’esperienza senologica relativa all’imaging convenzionale e ai prelievi agobioptici con quella specifica in RM mammaria e che garantiscano l’esecuzione del second look ecografico per i reperti non rilevati all’imaging convenzionale pre-RM. Non si ritiene che vi siano evidenze in favore dell’utilizzo della RM quale approccio diagnostico nella caratterizzazione di reperti equivoci all’imaging convenzionale in tutte le situazioni nelle quali sia praticabile il prelievo agobioptico sotto guida ecografica o stereotassica né in favore dello studio di donne non ad alto rischio asintomatiche e con imaging convenzionale negativo. Sono qui definiti i requisiti tecnici e metodologici di esecuzione dell’indagine e indicazioni e limiti relativi a: sorveglianza delle donne ad alto rischio di tumore mammario; stadiazione locale pretrattamento chirurgico; valutazione dell’effetto della chemioterapia neoadiuvante; mammella trattata per carcinoma; carcinoma unknown primary syndrome; mammella secernente; protesi mammarie.

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.

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.

A Model-based Prediction of the Impact on Reduction in Mortality by a Breast Cancer Screening Programme in the City of Florence, Italy

The efficacy of breast cancer screening for women older than 50 years has been shown in several studies. Service screening is now ongoing or planned in several countries in Europe. MISCAN, a computer simulation programme, has been used to analyse data from the Florence District Programme (FDP) breast cancer experience. First, the model was fitted to the screening results for the period 1975-1986. A good correspondence between the model outcomes and the FDP results was achieved. It was then used to predict the impact on mortality of the new starting programme of the city of Florence (63,000 women, 50-69 years old). Assuming a 70% attendance rate, then for the city of Florence, 2563 screen-detected breast cancers are predicted for the period 1991-2020 out of the total number of 9095 breast cancers for all ages (28%). A total of 3720 deaths for breast cancer are expected without screening. An absolute reduction of 472 deaths (13%) is predicted for the whole population. The estimated number of years of life gained by screening until 2020 is 4354. Simulation by MISCAN has previously been a useful support tool for decision-making about screening. The present paper is the first based on a southern European experience. The possibility of applying MISCAN to predict the impact of a national programme in Italy is discussed.

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 QIs before and after certification. RESULTS On the average of all units, the minimum standard of care was achieved for 12/13 QIs before and after EUSOMA certification (not met for DCIS receiving just one operation). There was a significant improvement of 5 QIs 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 QIs 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.

Breast cancer early diagnosis experience in Florence: can a self referral policy achieve the results of service screening?

STUDY OBJECTIVE--To assess the impact of a breast clinic on a specific target population and evaluate early diagnosis performance indicators for breast cancer in the presence of a self referral policy. DESIGN--Women living in Florence between 1980 and 1989 who had undergone mammography at a self referral breast clinic were studied. Main outcome measures were the use of mammography in relation to age, symptoms, and the interval between two subsequent tests, and early diagnosis performance indicators were the detection rate (DR), the prevalence/incidence ratio, and the proportion of early detected cancers. Performance indicators were compared with those from formal screening programmes. SETTING--Florence, Italy. PATIENTS--All mammograms performed at the clinic from 1980-89 in 40-69 year old women living in Florence were examined (n = 42,226). Records included the date of birth and of the examination, the reason for testing (asymptomatic/presence of pain/presence of symptoms other than pain), and the TNM classification for breast cancer cases. MAIN RESULTS--The total number of mammograms performed per annum increased by 70% over the decade, but much of this was routine repeat mammography (54.1% in 1989). Rates of first examinations in asymptomatic women increased in the second half of the decade from 17 per 1000 in 1985 to 31 per 1000 in 1989. Mammographic coverage decreased with increasing age from 12.6% in 40-49 year olds to 6.0% in 60-69 years old. Performance indicators of the activity in asymptomatic women were comparable with those expected in service screening. The proportion of not advanced cancers detected in asymptomatic women was 62.3% with a DR of 5.3 per 1000, and the average prevalence/incidence ratio was 2.9. CONCLUSIONS--High quality mammography performed in a breast clinic in self referred asymptomatic women can achieve as good results as a formal invitation screening service. Only a few of these women will benefit, but those who do are likely to be younger (40-49 year old women).

Analysis of the results of a proficiency test in screening mammography at the CSPO of Florence: review of 705 tests

Purpose.The aim of this study was to evaluate the performance of a sample of Italian radiologists undergoing a proficiency test of screening mammography.Materials and methods.We retrospectively analysed the results of 705 tests (537 first tests, 168 repeat tests) taken during 1997–2005 by 537 Italian radiologists. The test, consisting of 17 screendetected cancer cases and 133 negative controls, was validated by a panel of expert readers defining a minimum standard as to sensitivity for cancer and recall rate of negative controls. Success rates were assessed as a function of previous experience in mammography (years of experience, total mammograms read, mammograms read in the last year).Results.A total of 176 radiologists successfully passed the test at their first attempt (32.7%). Success correlated with experience, measured in terms of years of experience (5-year cutoff: χ2 for trend=4.17, p=0.04), total mammograms read (χ2 for trend =11.8, p=0.002) or mammograms read in the last year (χ2 for trend=6.27, p=0.04). Training improves performance at repeat testing: after a first negative attempt, a second attempt was successful in 50.6% of cases (74/146) and a third in 68.1% (15/22).Conclusions.A substantial proportion of Italian radiologists taking the test showed limited proficiency in screening mammography. This finding is consistent with several reports of poor performance of service screening compared with reference standards. As expected, test performance is associated with experience, suggesting that the current policy of employing nondedicated, untrained, general radiologists in screening should be reconsidered. Test performance improves with training (courses, consultation of teaching atlases). Several screening programmes in Italy have been implemented without prior adequate radiologist training. Radiologist training needs to be considered a priority, at least in those screening programmes that are still to be implemented in one third of the country.