High sensitivity of five colorectal screening programmes with faecal immunochemical test in the Veneto Region, Italy.

OBJECTIVE: Although guaiac-based faecal occult blood test screening has been shown to be effective in reducing colorectal cancer (CRC) mortality, it has been criticised mostly for its low sensitivity. Italian CRC screening programmes are based on immunochemical tests (iFOBT). We collected and analysed the interval cancers (ICs) found by five screening programmes to estimate their sensitivity. METHODS: ICs were identified in subjects who had a negative result in a screening examination from 2002 to 2007 (N=267,789); data were linked with 2002-2008 hospital discharge records. Analysis was based on the follow up of 468,306 person-years. The proportional incidence-based sensitivity was estimated overall and by sex, age class, time since last negative iFOBT result, anatomical site, and history of screening (first or subsequent test). RESULTS: Overall, 126 ICs were identified, compared to 572 expected cancers. The proportional incidences were 15.3% and 31.0% in the first and the second interval-years, respectively, with an overall episode sensitivity of 78.0% (95% CI: 73.8 to 81.6). Sensitivity was higher for males than females (80.1% vs 74.8%); no differences were observed by age, anatomical site or between programmes. The test sensitivity of iFOBT was 82.1% (95% CI 78.1% to 85.3%). CONCLUSIONS: iFOBT-based screening programmes showed a high performance in terms of sensitivity as estimated through the IC rates. The screening schedule utilised in our programmes (single iFOBT, positivity threshold of 100 ng Hb/ml of sample solution, inter-screening interval of 2 years) shows low rates of missed cancers that are diagnosed during the interval. HDR are a convenient and reliable source of data for IC studies.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy, 2007.

This survey, conducted by the Italian Breast Screening Network (GISMa), collects individual data yearly on about 50% of all screen-detected, operated lesions in Italy. The 2007 results show good overall quality of diagnosis and treatment and an improving trend over time. Critical issues were identified concerning waiting times, compliance with the recommendations on not performing frozen section examination on small lesions and on performing specimen X-rays. Preoperative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. For more than 80%of screen-detected invasive cancers the sentinel lymph node technique (SLN) was performed on the axilla, 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, also by means of a web data-warehouse, to regional and local screening programmes in order to allow multidisciplinary discussion and identification of the appropriate solutions to any problem documented by the data. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making audits effective in producing quality improvements with a shorter waiting times.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy for 2006 and preliminary results for 2007.

Within this survey, conducted by the Italian Breast Screening Network (Gruppo Italiano per lo Screening Mammografico, GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2006, results showed overall good diagnosis and treatment quality and an improving trend over time. Critical issues were identified in waiting times, compliance with recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. 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 in ductal carcinoma in situ deserves further investigation. The detailed results have been distributed to regional and local screening programmes, also by means of an online database, 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 and enough resources would provide the best setting for making audit effective in producing quality improvement with a shortening of waiting times.

Screening for colorectal cancer in Italy: 2006 survey.

We present the main results of the third survey of the Italian screening programmes for colorectal cancer carried out by the ONS (Osservatorio Nazionale Screening, National Centre for Screening Monitoring) on behalf of the Ministry of Health. During 2006, many new programmes were activated and by the end of the year, 44% of Italians aged 50-69 years were residing in areas covered by organised screening programmes (theoretical extension). Five regions had their entire population covered. In the South of Italy and Islands only one new programme was activated in 2006, with a 10% theoretical extension. The majority of programmes employ the faecal occult blood test (FOBT), while some have adopted the flexible sigmoidoscopy (PS) once in a lifetime, or a combination of both. Overall, about 2,107,000 subjects were invited to undergo FOBT, 70.3% of those to be invited within the year. The adjusted attendance rate was 44.6% and approximately 907,000 subjects were screened. Major differences in the attendance rate were observed among regions, with 10% of programmes reporting values lower than 26%. Positivity rate of FOBT programmes was 5.3% at first and 3.9% at repeat screening: it increased with age and was higher among males than females in all age groups. The average attendance rate to total colonoscopy (TC) was 81% (10th-9Oth percentiles: 64%, 93%). Completion rate of TC was 89%, with higher rates among males. At first screening, the detection rate (DR) per 1,000 screened subjects was 3.1 and 14.6 for invasive cancer and advanced adenomas (AA--adenomas with a diameter > or =1 cm, with villous/tubulo-villous type or with high-grade dysplasia), respectively; the corresponding figures at repeat screening were 1.3 per thousand for cancer and 7.7 per thousand for AA. The DR of cancer and adenomas increased with age and was higher among males; 25% of screen-detected cancers were in TNM stage III+. The positive predictive value (PPV) was 6.8% for cancer and 32.1% for AA at first screening, and 4.0% for cancer and 23.4% for AA at repeat screening. Given the high PPVof a positive FOBT, obtaining a high attendance at TC is therefore crucial. Seven programmes employed PS as the screening test: 51.4% of the target population (about 50,000 subjects) were invited and 7,589 subjects were screened, with an attendance rate of 29.2%. Overall, 88% of FS were classified as complete. TC referral rates ranged between 6.1 and 17.8%, due to different referral criteria. Among subjects referred to colonoscopy, the prevalence of proximal AA and cancer ranged from 6 to 18.2%. The overall DR (subjects with at least one advanced lesion) ranged from 4.9 to 7.5%. In conclusion, during 2006, organised colorectal cancer screening programmes in Italy grew considerably, covering almost half of the eligible population at a national level. Many programmes were activated in the second part of the year, thus their results should be evaluated with caution. However, reported experiences showed good results in terms of attendance and DR, although some critical aspects need to be carefully addressed when planning and implementing screening activity.

[Interval cancers as indicators of performance in screening programmes]. / I carcinomi di intervallo quali indicatori di performance di un programma di screening.

GISMa analyses the interval cancer (IS) topic providing guidelines and reference standards in addition to CE recommendations. IC identification is based on Cancer Registries (CR), if existing, or on hospital discharge records, in alternative. The optimal measure of IC frequency (inversely correlated with sensitivity) is the IC proportional incidence (observed IC/carcinomas expected in absence of screening). Other formulas (IC/IC + screen detected cancers; IC rate per 1000 negative screens) look less reliable. IC stage at diagnosis (if available through CR) must be compared with screen detected cancer and cancer detected in non-attenders. Review of mammograms preceding the IC (coded as screening error, minimal signs, or occult) should be done mainly with a blind procedure (IC mixed with negative controls), as this procedure is more representative of the original scenario and more respectful of radiologist's rights.

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.

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.

[Recommendations of a national Italian consensus conference on the opportunity of extending screening service by mammography to 40-49 and 70-74 years of age women]. / Raccomandazioni di una conferenza di consenso italiana sull'opportunità di estendere lo screening mammografico organizzato alle donne di 40-49 e 70-74 anni di età.

The Italian Mammography Screening Network (GISMa) held a national consensus conference in Bologna, May 25-26 2006. The large panel of participants included national experts in fields related to breast cancer and screening issues. The final aim was the production of a consensus statement which might become a standard reference for Italy. The consensus document (http://www.gisma.it) states that full national coverage by organized screening for breast (age 50-69), cervical and colorectal cancer is a priority, before any extension of organized mammography screening to younger or older age groups may be considered. If adequate resources are available, extension of organized screening for breast cancer until age 74 is recommended, at least for regular attenders until age 69. Extension of organized screening to women aged 40-49 may be considered at some conditions: (a) that resources are available, (b) that a 1-year interval is adopted, (c) that proper information of the limitations of screening is given to participants and (d) that priority is given to age 45-49.

Screening for colorectal cancer in Italy: 2005 survey.

We present the main results from the second survey of the Italian screening programmes for colorectal cancer carried out by the National Centre for Screening Monitoring on behalf of the Ministry of Health. During 2005, 52 programmes, adopting faecal occult blood testing (FOBT), sigmoidoscopy (FS), or a combination of both, were active in Italy. Overall, 827,473 subjects were invited to FOBT and 376,240 were screened; the adjusted attendance rate (47.1%) equals the best performances reported in the literature. Positivity rate of FOBT programmes was 5.8% at first and 4.1% at repeat screening: it increased with age and was higher among males than females in all age groups. The average attendance rate to colonoscopy (TC) was 82% (range: 56%-100%). Completion rate of TC was 91%, with higher rates among males. At first screening, the detection rate (DR) per 1000 screened subjects was 3.7 and 16.8 for invasive cancer and advanced adenomas (AA) (adenomas with a diameter > or =1 cm, with villous/tubulo-villous type or with high-grade dysplasia) respectively; the corresponding figures at repeat screening were 1.1 for cancer and 4.9 for AA. The DR of cancer and adenomas increased with age and it was higher among males, 55% of screen-detected cancers were at TNM stage I. The positive predictive value (PPV) was 7.4% for cancer and 32.9% for AA at first screening, and 4.5% for cancer and 20.5% for AA at repeat screening. Given this high PPV of positive FOBT, to obtain a high attendance at TC is crucial. The six FS programmes invited almost half of their target population (about 40,000 subjects) and 5,821 subjects were screened, with an attendance rate of 29.1%. Overall 89.0% of FS were classified as complete. TC referral rates ranged between 7.7 and 13.8%, due to different referral criteria. Among subjects referred to colonoscopy the prevalence of proximal AA and cancer ranged from 5.4 to 11.1%. The overall DR (subjects with at least one advanced lesion) ranged from 3.5 to 7.0%. In conclusion, during 2005 the organised programmes for colorectal cancer screening in Italy increased considerably, covering about one third of the eligible population at a national level. Many programmes were activated in the second part of the year, thus their results have to be evaluated with caution. However, the reported experiences showed good results in terms of attendance and DR, although some critical aspects need to be carefully addressed when planning and implementing screening activity.

Audit system on quality of breast cancer diagnosis and treatment (QT): results from the survey on screen-detected lesions in Italy, 2004.

Within this survey, conducted by the Italian Group for Mammography Screening (GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2004, overall results show a good diagnosis and treatment quality and an improving trend over time. Critical issues have been identified in waiting times, compliance to the recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis has reached an acceptable level, but room for improvement still exists. The sentinel lymph node technique (SLN) was performed on the axilla in almost 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 enable multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volumes would provide the best setting for effective audits leading to quality improvement.

Quality control of mammography screening in the Veneto Region. Evaluation of four programs at a local health unit level--analysis of the frequency and diagnostic pattern of interval cancers.

AIMS AND BACKGROUND: Service mammography screening has been reported to have suboptimal performance compared to controlled trials. The aim of this study was to evaluate the sensitivity of the mammography screening program in four Local Health Units (ASL) and the possible causes of diagnostic error in cases further surfacing as interval cancers. MATERIAL AND METHODS: Interval cancers were identified by cross checking of screened women databases with hospital discharge records reporting breast cancer. Proportional interval cancer incidence (observed interval cancers/expected invasive cancers) was determined by matching the database of women screened during 1999-2002 to the hospital discharge records databases during 1999-2003. The ratio of observed interval cancer rate to underlying incidence was compared to international standards and with literature data. Screening mammograms reported as negative and followed by interval cancers were randomly mixed with true-negative controls, and the resulting set underwent blind review by an external radiologist who applied the conventional criteria recommended for the classification of the type of diagnostic error (occult, minimal signs, screening error). RESULTS: Matching of screening archives with the hospital discharge records databases allowed for the identification of 154 invasive interval cancers compared to 480 expected. The proportional observed/expected interval cancer incidence in the first and second year of the interval was 21% and 46%, respectively (ASL 1 = 14% or 38%, ASL 2 = 19% or 48%, ASL 3 = 30% or 53%, ASL 4 = 25% or 49%). Radiological review included 38 further interval cancer cases, identified after the time limits defined for proportional interval cancer incidence assessment, and could not include 18 interval cancers, not retrieved from ASL 4 archives: overall, 174 interval cancers were reviewed, of which 135 were classified as occult (77.3%) (ASL 1 = 83.3%, ASL 2 = 71.1%, ASL 3 = 78.6%, ASL 4 = 75%), 12 (6.9%) as minimal signs (ASL 1 = 6.6%, ASL 2 = 11.5%, ASL 3 = 2.4%, ASL 4 = 5%), and 27 (15.5%) as screening error (ASL 1 = 8.3%, ASL 2 = 17.3%, ASL 3 = 19.0%, ASL 4 = 25%). CONCLUSIONS: Observed proportional interval cancer incidence was lower than commonly reported for service screening programs and currently recommended (< 30% in the first, < 50% in the second year of the interval). The analysis of interval cancer causes showed a screening error rate below the maximum acceptable standard (< 20% of interval cancers should be classified as screening error) in three of four programs and in average figures. Substantial differences observed among single programs (one did not comply to recommended standards) suggest that space is available for the improvement of overall performance by optimizing program organization and by further training of radiologists. Overall, the analysis showed a good sensitivity of the screening program in the Veneto Region, although the performance was inferior to that of excellence centers, and further action to improve it is possible. Assessment and review of interval cancers is an early indicator of screening efficacy which has not yet been fully adopted in Italian screening programs. Although using hospital discharge records to identify interval cancers may be affected by limited errors, such a procedure is particularly convenient, as data from hospital discharge records are available much in advance compared to cancer registries and are the most reliable source of information for areas uncovered by a cancer registry. Hospital discharge records-based procedures for interval cancers assessment should be employed routinely in screening programs.

Screening for colorectal cancer in Italy: 2004 survey.

We present the main results of the first national survey of organised screening programmes, conducted by the Italian Group for Colorectal Cancer Screening (GISCoR). During 2004, 18 programs, adopting faecal occult blood testing (FOBT), sigmoidoscopy (FS), or a combination of both, were active in Italy. Overall, 331,333 subjects were invited to undergo FOBT and 165,480 were screened; the attendance rate (51.3%) equals the best performances reported in the literature. Positivity rate was 5.4% at first and 3.9% at repeat screening: it increased with age and was higher among men than among women in all age groups. The average attendance rate at colonoscopy (TC) was 83% (range: 70%-100%; median: 85%). Completion rate of TC was 92%, with higher rates among males. At first screening, the detection rate (DR) per 1000 screened subjects was 2.8 and 11.6 for cancer (CRC) and "high-risk" adenomas (HRA) (> or =3 adenomas, 1 adenoma > or =1 cm, or with villous component >20%, or with high grade dysplasia) respectively; the corresponding figures at repeat screening were 1.2 for CRC and 4.9 for HRA. The DR of CRC and adenomas increased with age and it was higher among men than among women; 51% of screen-detected CRCs were at TNM stage 1. The positive predictive value (PPV) was 6.3% for CRC and 25.8% for HRA at first screening, and 3.6% for CRC and 15.1% for HRA at repeat screening. Given this high PPV of positive FOBT, to obtain a high attendance at TC is crucial. In the three FS programmes 15,688 subjects were invited and 4884 were screened (attendance rate: 31.9%). TC referral rates ranged between 7.6% and 14.0%, due to different referral criteria. Among subjects referred to colonoscopy the prevalence of HRA and CRC ranged from 7.9 to 9.9%. The overall DR (subjects with at least one advanced lesion) ranged from 5.5 to 7.0%. Comparing the DR at FS and FOBT in the same age range. FS showed a higher sensitivity both for HRA (DR was four times higher) and for CRC. In conclusion, colorectal cancer screening looks feasible. The reported experiences showed good results in terms of attendance and DR, although some critical aspects need to be carefully addressed when planning and implementing screening activity.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results from the survey on screen-detected lesions in Italy, 2003-2004.

Within the Italian Breast Screening Network, individual data are collected yearly on about 50% of all screen-detected operated lesions. In 2003 results showed a good overall quality of diagnosis and treatment, and an improving trend over time. Critical issues were identified in the number of cancers diagnosed pre-operatively, which is still below standards, and in the waiting times for surgery. Compliance with recommendations as to not performing frozen section on small lesions and unnecessary axillary dissection for ductal carcinoma in situ still have not reached the target. The sentinel lymph node technique was performed on the axilla in more than 60% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. Preliminary data for 2004 show further progress towards better quality, particularly in pre-operative diagnosis and in the avoidance of frozen section. The detailed results of this survey 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.

Stage-specific incidence of breast cancer before the beginning of organized screening programs in Italy.

OBJECTIVE: To measure stage-specific geographic and time variability of breast cancer in seven Italian areas before the onset of organized screening programs. METHODS: All invasive cancers (8689 cases) arising in women aged 40-79 years during the pre-screening period 1985-1997, were considered. Multiple Poisson regression analysis was performed. RESULTS: About 39% of the cases were classified as "early," 52% as "advanced," and 9% as "unspecified" stage. Age-adjusted incidence rates showed a significant geographic variation for early but not for advanced cancers (range: 58-103 cases/100,000 and 104-125 cases/100,000, respectively). The result was confirmed in the multiple regression analysis after adjustment for year of diagnosis and age. Early breast cancer risk adjusted for age and registry showed a significant increase over time (+3.9% per year for all ages, and +6.2% per year for age category 50-79). In contrast, a decreasing time trend was observed for advanced cancer of 3 cm or over in women aged less than 60. CONCLUSIONS: In our study, early breast cancer incidence varied both by geographic area and time before the commencement of screening. The differences in early-stage incidence may well be related to differences in availability of "spontaneous" mammography. Late-stage incidence decreased over time in younger women and for very advanced cases, but not in the older ones, nor for cancers less than 3 cm. Early detection outside organized screening was only partially efficient in reducing advanced breast cancer incidence. The trend of incidence of advanced disease, as previously proposed, is confirmed to be a valid early indicator of effectiveness of screening.