AUDIT SYSTEM ON QUALITY OF BREAST CANCER DIAGNOSIS AND TREATMENT (QT)

Transcription

1 AUDIT SYSTEM ON QUALITY OF BREAST CANCER DIAGNOSIS AND TREATMENT (QT) Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy in 2005 and preliminary results for 2006 Maria Piera Mano, 1 Vito Distante, 2 Mariano Tomatis, 1 Diego Baiocchi, 3 Alessandra Barca, 3 Rita Bordon, 1 Giovanni Donati, 4 Luigi Filippini, 5 Alfonso Frigerio, 1 Paola Mantellini, 6 Carlo Naldoni, 7 Giovanni Pagano, 8 Deborah Ramera, 5 Alessandra Ravaioli, 9 Anna Sapino, 10 Mario Taffurelli, 11 Marcello Vettorazzi, 12 Federica Zangirolami, 13 Manuel Zorzi, 12 Luigi Cataliotti, 2 Marco Rosselli del Turco, 6 Nereo Segnan, 1 Antonio Ponti 1 1 CPO Piemonte, Torino; 2 Clicnica chirurgica I, AOU Careggi, Firenze; 3 ASP Lazio: 4 Servizio di chirurgia toracica, Aosta; 5 Senologia, Spedali civili, Brescia; 6 CSPO Istituto Scientifico Prevenzione Oncologica, Firenze; 7 Assessorato alle politiche per la salute, Regione Emilia-Romagna; 8 AUSL Roma H, Albano Laziale (Roma); 9 Registro Tumori della Romagna, IRST, Forlì; 10 Istituto Anatomia patologica, Università di Torino; 11 Dip Scienze chirurgiche e anestesiologiche, Chirurugia d urgenza, Università di Bologna; 12 Registro Tumori Veneto, Istituto Oncologico Veneto IRCCS, Padova, 13 CPO Ravenna Abstract Within this survey, conducted by the Italian Group of Mammography Screening (GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2005, results showed overall good diagnosis and treatment quality, and an improving trend over time. Critical issues were identified in waiting times, compliance with the recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis has reached the acceptable target, but room for improvement still exists. The sentinel lymph node technique (SLN) was performed on the axilla in more than 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN deserves further investigation. The detailed results have been distributed to local and regional screening programmes in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume would provide the best setting for making audit effective in producing quality improvement. (Epidemiol Prev 2008; 32 (2) Suppl 1: 77-84) Keywords: breast cancer screening qualità treatment survey, Italy Mammography screening acts on a delicate balance of human benefits and costs which is highly sensitive to the quality not only of screening itself but of the entire process of care for screen-detected lesions. Therefore, screening programmes should perform audits of further assessment, histopathological diagnosis, and treatment, as well as of the screening test itself. 1,2 The mammography screening movement in Europe has been forefront in introducing quality assurance and monitoring in all stages of breast cancer management and care. The European breast cancer screening network has produced an individual record database and audit system, named QT (Audit system on Quality of breast cancer Treatment), which can be freely downloaded from or from the EUSO- MA (European Society of Breast Cancer Specialists) website ( It is available in six languages (English, French, German, Italian, Spanish, Hungarian) and has users in several European countries. 77

2 THE NATIONAL CENTRE FOR SCREENING MONITORING SIXTH REPORT The Italian Group for Mammography Screening (GISMa) has implemented a quality assurance programme on care of screen-detected breast cancer since 1997 and results of this activity are published yearly in the reports of the ONS (Osservatorio Nazionale Screening, National Centre for Screening Monitoring). 3 The aim of this report is to show the results of the monitoring of diagnosis and treatment indicators in screen-detected lesions operated using open surgery in Italy in A number of preliminary results are also shown for Time trends for the years have been published in a previous report. 4 Methods Individual data on diagnosis and treatment of screen-detected cancers are recorded on QT either by the clinical staff in charge of the patients or by local screening organisation and evaluation Units. Regional programmes report data, yearly, to the national co-ordination office, which performs data quality control and analysis of outcome measures. The definitions of performance indicators which are being monitored are taken from Italian 5,6 and European 2,7,8 guidelines. Cases from a Region were excluded from the analyses if, for a given indicator, missing values exceeded 30%. Ranges for screening programmes or, when the numbers are small, for Regions, are also given. Although most programmes in Italy have designated surgical Units where the majority of the cases are referred, to avoid selection bias the study protocol required that participating programmes record all screen-detected cases, no matter where treatment had taken place. The index year for this report is Piemonte, Valle d Aosta, and Toscana use as index date the date of the screening test that originated surgical referral, while the remaining Regions use date of surgery. This document reports results that, in their preliminary version, were presented at the ONS meetings in December 2006 (Naples) and December 2007 (Rome). Data for the index year 2005 have been checked locally, updated, and discussed at specific meetings in most of the Regions involved. Results In 2005, 48 of 115 screening programmes belonging to GISMa participated in the QT project and individual data on 3,426 cases (age 50-69) were recorded (table 1). After exclusion of self-referred cases, interval cases, and double lesions, the remaining 3,010 cases (2,609 malignant, 401 benign) represented 53.8% of cancers and 36.5% of benign lesions reported in the ONS aggregated data survey, the results of which can be found in another chapter of this volume (Giorgi et al.). Except for Lombardia (represented by the city of Brescia) and Puglia (represented by the city of Lecce), the remaining Regions co-ordinated the QT survey at the regional level including all or nearly all (Lazio) their screening programmes. In the time period , about 18,000 screendetected lesions were documented in QT in 10 Italian Regions (table 1). Distribution of cases by histopathological diagnosis and age at diagnosis is reported in table 2. Of all invasive and micro-invasive cancers, 28.1% were node positive (missing values: 4.1%). Grade (missing values: 4.7%) was intermediate for 54.6% of invasive and micro-invasive cases, the remainders being distributed almost equally between grade 1 (21.9%) and grade 3 (23.5%). Nuclear grade of ductal carcinoma in situ (DCIS) was distributed as follows: 28.4% grade 1, 38.4% grade 2, 33.2% grade 3 (missing values: 14%). Results of outcome measures are shown in tables 3 and 4. The number of eligible cases for each outcome measure and the number of missing values are also shown. The proportion of cancers with pre-operative cytological or micro-histological diagnosis (table 3) was slightly above the acceptable target of 70% (regional range: 63-85%; programme range: 22-97%). Cases for which pre- 78

3 AUDIT SYSTEM ON QUALITY OF BREAST CANCER DIAGNOSIS AND TREATMENT (QT) Number of programmes (preliminary) Piemonte and Valle d Aosta Lombardia Veneto Emilia-Romagna Toscana Umbria Lazio Campania Puglia Sicilia Total Number of cases (preliminary) Piemonte and Valle d Aosta ,170 1,175 1,107 Lombardia Veneto Emilia-Romagna Toscana Umbria Lazio Puglia Campania Sicilia Total 1,635 1,890 2,093 2,460 3,008 3,426 3,548 Table 1: Italian survey on diagnosis and treatment of screen-detected breast lesions, Number of screening programmes and cases, by Region. Histopathological diagnosis All cases Age Age N % N % N % Benign Lobular carcinoma in situ (LIN) Ductal carcinoma in situ Micro-invasive Invasive 2, , Unknown Total 3, , , Table 2: Italian survey on diagnosis and treatment of screen-detected breast lesions, Distribution by final histopathological diagnosis and age. Outcome measure Eligible cases Missing % Result % (CI 95%) Target % Pre-operative diagnosis in cancers (C4-5,B4-5) 2, ( ) - Pre-operative diagnosis in cancers (C5,B5) 2, ( ) 70 Non-inadequate cytology if final diagnosis 1, ( ) 90 is cancer Absolute sensitivity C5 1, ( ) 60 Grade available 2, ( ) 95 Estrogen receptors available 2, ( ) 95 The following Regions have been excluded from calculation for certain quality objectives due to missing values >30%: Lazio (pre-operative diagnosis and number of diagnostic sessions), Veneto (cytology and number of diagnostic sessions). Table 3: Summary of diagnostic indicators, Results are calculated on eligible cases excluding cases with missing information. 79

4 THE NATIONAL CENTRE FOR SCREENING MONITORING SIXTH REPORT operative diagnosis was not available are distributed by reason in table 5. Failure to perform cytology or micro-histology was responsible for 16% of these cases. The fact that the diagnosis was suspicion of malignancy (C4 or B4), rather than a higher degree of certainty, was responsible for 51% of the cases. Only 63% of cancers received surgery within one month from referral (programme range: 55-78%), and 52% within two months from the date of screening (table 4). About 20% of cases with surgical referral had not yet received surgery three months after screening (programme range: 0-52%). Guidelines recommend to avoid intra-operative examination or frozen section (even on margins) in lesions under 10 mm because of limited accuracy and the risk of deteriorating the specimen and impairing subsequent examination. 1,5-8 The result of this indicator (table 4) was below the target, as in 2005 frozen section was performed on about one out of four cases (regional range: 63-85%). Italian guidelines recommend the performance of two-view specimen X-rays on all non-palpable lesions and set the numerical target at 95%. 5 Given the high proportion of missing values for number of views and palpability, a simplified indicator was calculated (table 4) which gives a result of 66%, short of the target. It is improving over time, however, as the corresponding result for 2003 was 44% and for 2004 was 56%. Breast conservation, both for invasive cancer and DCIS, is at very high levels (table 4), which have been maintained over the years (table 6). On the other hand, when mastectomy was performed in 2005, only about half of the cases in which it was indicated received immediate breast reconstruction (table 4). In 2005, about 7% of cases of DCIS (regional Outcome measure Eligible cases Missing % Result % (CI 95%) Target % Waiting time for surgery from referral 30 days 2, ( ) 80 Waiting time for surgery from screening test 2, ( ) - 60 days Waiting time for surgery from screening test 2, ( ) - 90 days Correct excision at first surgical biopsy 1, ( ) 95 Frozen section not performed in cancers 10 mm ( ) 95 Specimen X-ray (invasive cancers 10 mm ( ) 95 treated by conservation surgery) Only one operation after pre-operative diagnosis 1, ( ) 90 Conservative surgery in invasive cancers 1, ( ) mm Conservative surgery in in situ cancers 20 mm ( ) 85 Margins >1 mm after last surgery 2, ( ) ( 95) Number lymphnodes >9 in axillary dissection ( ) 95 Axillary staging by SLN only in pn0 1, ( ) 95 No axillary dissection in DCIS ( ) 95 No axillary dissection or SLN in benign lesions, ( ) 95 LIN, and DCIS low or intermediate grade Immediate reconstruction after mastectomy ( ) - Immediate reconstruction after mastectomy ( ) 80 (DCIS and invasive ca 30 mm, pn0) The following Regions have been excluded from calculation for certain quality objectives due to missing values >30%: Brescia (waiting time from surgical referral, breast conservation surgery in invasive carcinoma), Emilia-Romagna (correct excision and specimen X-ray, breast reconstruction), Lazio (waiting times from mammography and from surgical referral), Veneto (waiting time from mammography, correct excision and specimen X-ray). Table 4: Summary of surgical indicators, Results are calculated on eligible cases excluding cases with missing information. Results short of numerical target are shown in bold. 80

5 AUDIT SYSTEM ON QUALITY OF BREAST CANCER DIAGNOSIS AND TREATMENT (QT) N % Pre-operative diagnosis not performed Unsatisfactory False Negative (C2 or B2) Dubious (C3 o B3) Suspicious (C4 o B4) TOTAL Table 5: Distribution of malignant cases without pre-operative diagnosis (C5 or B5) by reason, range: 3-14%) received clearance of the axilla (table 4), a procedure known for its complications and which is unnecessary in these cases. In 2003, DCIS cases treated with axillary clearance were more than 10%, but in 2004 the result of this indicator reached the target, as they were less than 5%. This survey also makes it possible to study the gradual introduction of the sentinel lymph node (SLN) technique, a less harmful operation compared to axillary clearance. An increasing proportion of invasive cancers (almost 80% in 2006) and, similarly but less appropriately, of DCIS (55%), were treated with SLN over time (figure 1). The proportion of node negative invasive cases staged by SLN only (table 4) was 72.1% in 2005 (regional range: 50-89%). Given the high frequency of operations on the axilla for DCIS (about half of the cases, independent of size or grade, data not shown), a specific analysis was performed on pre-operative diagnosis for DCIS during In this time period, 846 cases of DCIS were diagnosed and 568 operations were performed in cases with a pre-operative diagnosis of DCIS. Of these 568 cases, 371 were confirmed as DCIS (positive predictive value: 65.3%), while the remaining were invasive (n=99) or microinvasive (n=51) at final histopathological diagnosis. Therefore, 44% of DCIS cases (371 of 846) were known as such before surgery. This figure was higher compared to the time period , when it was 33%. However, the proportion of DCIS cases receiving axillary dissection remained identical (7.2%) in the two time periods. Furthermore, it should be noted that SLN was 100 N % Normal tissue Fibroadenoma Cysts Atypical ductal hyperplasia Atypical lobular hyperplasia Atypical apocrine metaplasia Fibrocystic breast disease Benign phylloid tumour Sclerosing adenosis Radial scar Papilloma/papillomatosis Other Unknown TOTAL Table 6: Distribution by histological type of benign lesions operated using open surgery (synchronous lesions excluded), performed, in 2005, in about 10% of lesions which were benign at post-operative diagnosis and in 30% of lobular carcinoma in situ, a result similar to 2003 and Merging together benign lesions, LIN, and DCIS of low and intermediate grade, SLN was performed on 29.2% of these cases (regional range: 15-54%) (table 4). Overtreatment may also result from unnecessary surgical breast operations on benign lesions. This issue is illustrated by table 6, where benign lesions operated using open surgery are distributed by histopathological type. An indicator measures the invasive carcinoma DCIS Figure 1. Italian survey on diagnosis and treatment of screen-detected breast cancers, trend in the use of SLN technique, (%). 81

6 THE NATIONAL CENTRE FOR SCREENING MONITORING SIXTH REPORT benign lesions at no increased risk for malignancy (all except papilloma, sclerosing adenosis, radial scar, atypical hyperplasia, phylloid tumours) as the proportion of all operated benign lesions (excluding double lesions and lesions with missing histological type). The result of this indicator (table 4) is 43.1% for the whole of Italy with a regional range of 38 to 51%. Table 7 shows time trends from 1997 to 2006 for selected performance parameters, with the analysis limited to the three screening programmes that contributed cases during the whole period. The frequency of pre-operative diagnosis and the avoidance of frozen section in small lesions showed evident improvement over time, while waiting times grew longer. Discussion In 2005, most outcome measures were close to or met the target set by GISMa. 6 The main exceptions were waiting times for surgery, and compliance with the recommendation to avoid frozen section on small lesions and perform specimen X-ray and immediate reconstruction after mastectomy. At regional and local level, reasons for the considerable delay between screening and treatment should be examined, and possible measures should be considered to solve the issue. Although included in the table on surgical indicators, waiting time from screening to surgery concerns the entire screening process. It is encouraging that finally, after several years, the acceptable target for pre-operative diagnosis has been met. The proportion of cancers with preoperative cytological or micro-histological diagnosis (table 3) has clearly increased over time (table 7 and reference 4), probably also as a reflection of an increasing use of micro-histology techniques. However, there is still a wide margin for improvement before the European desirable target of 90% is reached. 8 This is also supported by the finding of a considerable variation between programmes: about 50% of programmes do not reach the acceptable target, while 15% meet the desirable target. The analysis of the use of axillary operation and pre-operative diagnosis in DCIS stresses the importance of pre-operative pathological and radiological diagnosis of DCIS and of multi-disciplinary pre-operative discussion of cases. In multidiscipli- Indicators (%) Target Pre-operative diagnosis in cancers (C4-5,B4-5) Correct excision at first surgical biopsy Frozen section not performed in cancers 10 mm Conservative surgery ininvasive cancers 20 mm Conservative surgery in in situ cancers 20 mm Number lymph nodes >9 in axillary dissection No axillary dissection in DCIS Waiting time for surgery from referral 21days Only programmes having contributed data for the whole period (Firenze, Modena, Torino) are included. Table 7: Italian survey on diagnosis and treatment of screen-detected breast lesions. Time trends for selected indicators,

7 AUDIT SYSTEM ON QUALITY OF BREAST CANCER DIAGNOSIS AND TREATMENT (QT) nary discussion, procedures should be defined that would minimise the risk of unnecessary axillary clearance or SLN as well as minimize multiple operative sessions. Even more so for the findings on SLN in lesions labelled as benign at post-operative diagnosis, only a minority of them attributable to the complete excision of a malignant lesion during pre-operative vacuum assisted biopsies. Results of outcome measures emerging from this survey should be verified and discussed in detail at the level of each local screening programme or clinical Breast Unit, with regional co-ordination: this should allow the most useful information and indications for action to emerge. Conclusions The establishment of specialist multidisciplinary Breast Units is essential to improve waiting times as well as the quality of care. 9 Running a monitoring system for quality of screening and care requires dedicated resources, particularly data managers with some clinical expertise, and an appropriate organisation for collecting data and making the best use of them. 9 An individual, be it a physician, a breast nurse, or a data manager, should be made responsible for co-ordinating data collection and reporting to the screening programme evaluation Unit as well as to each Breast Unit collaborating with the programme. For auditing to produce change, feedback and careful analysis of emerging problems is necessary, and the best setting for these activities is multidisciplinary meetings. Although many of the indicators relate to individual skill or knowledge of recommendations, most involve the team as well. Discussion of data analysis reports during multidisciplinary meetings often prompts improvement of quality of data, such as reduction of missing values and accurate item definition, classification, and coding. The detailed results of this survey have been distributed to local and regional screening programmes in order to allow the identification of appropriate solutions to any problems documented by the data. Quality improvement and experience gained during audits are likely to promote update and corrections in guidelines and in the monitoring system itself, thus closing the quality cycle. Experience gained within population screening programmes in the monitoring of diagnosis and treatment of screen-detected cases can be extended to clinical cases. QT has been designed for and is being used by clinical Breast Units to monitor diagnosis and treatment of breast lesions in symptomatic as well as asymptomatic women. Acknowledgments This survey was conducted by the multidisciplinary Group on therapy of the Italian Breast Screening Network (clinical consultants: Vito Distante and Maria Piera Mano), with co-ordination by CPO Piemonte. The project and the development of QT were sponsored by the programmes Europe Against Cancer and EUNICE (European Network for Information on Cancer) of the European commission, ONS, AIRC, LILT, Regione Piemonte and Fondazione San Paolo, Torino. We are grateful to the many clinical specialists and people involved in screening evaluation and organisation who contributed to data collection and to multidisciplinary discussion of results and to the regional screening co-ordination centres in Emilia-Romagna, Lazio, Piemonte, Toscana, Valle d Aosta, and Veneto. References 1. National Co-ordination Group for Surgeons working in Breast Cancer Screening. Quality Assurance Guidelines for Surgeons in Breast Cancer Screening. NHSBSP, Publication n. 20, Perry N et al. Quality assurance in the diagnosis of breast disease. Eur J Cancer 2001; 37:

8 THE NATIONAL CENTRE FOR SCREENING MONITORING SIXTH REPORT 3. Distante V, Mano MP, Ponti A. Monitoring surgical treatment of screen-detected breast lesions in Italy. Eur J Cancer 2004; 40: Ponti A et al. Audit system on Quality of breast cancer diagnosis and Treatment (QT): results from the survey on screen detected lesions in Italy, In: Rosselli del Turco M, Zappa M. The National Centre for Screening Monitoring. Fourth report. Epidemiol Prev 2006; 1 (Suppl. 3): Forza Operativa Nazionale sul Carcinoma Mammario. I Tumori della mammella. Linee guida sulla diagnosi, il trattamento e la riabilitazione. Firenze, Updated in: Attualità in Senologia 2005; 46: Mano MP et al. e il Gruppo GISMa sul trattamento. Monitoraggio e promozione della qualità del trattamento del carcinoma mammario nelle Unità di senologia e nei programmi di screening in Italia. Attualità in Senologia 2001; 10 (Suppl. 1). 7. Rutgers EJT et al. Quality control in locoregional treatment for breast cancer. Eur J Cancer 2001; 37: Perry N et al. eds. European guidelines for quality assurance in breast cancer screening and diagnosis. 4th edition. European commission, Europe against Cancer Programme, Luxembourg Blamey R et al. Breast units: future standards and minimum requirements. Eur J Cancer 2000; 36: