Search

Background: Faecal immunochemical test (FIT)-based screening is effective in reducing colorectal cancer (CRC) incidence, but its sensitivity for proximal lesions remains low., Objectives: We compared age-adjusted CRC surgical resection rates across anatomic sites (proximal colon, distal colon, rectum), age groups and sex over 20 years in a large Italian population. We particularly focused on changes in trends following FIT-screening implementation in the target population (50-69 years)., Design: This retrospective study analysed data from the Veneto Region's administrative Hospital Discharge Dataset, involving over 54 000 patients aged 40-89 (43.4% female) who underwent CRC surgery between 2002 and 2021., Results: Overall, surgery rates increased until 2007 (annual percentage changes: 2.5% in males, 2.9% in females) and then declined (-4.2% in males, -3.4% in females). This decline was steeper for distal and rectal cancers compared with proximal cancer, suggesting a shift towards more right-sided CRC surgery.In males, the prescreening increase in proximal surgery was reversed after screening implementation (slope change: -6%) while the prescreening decline accelerated for distal (-4%) and rectal (-3%) surgeries. In females, stable prescreening trends shifted downward for all sites (-5% for proximal, -8% for distal and -7% for rectal surgery). However, the change in trends between prescreening and postscreening periods was not different across anatomic sites for either sex (all slope change differences in pairwise comparisons were not statistically significant)., Conclusion: The shift towards proximal surgery may not be entirely due to the FIT's low sensitivity but may reflect an underlying upward trend in proximal cancers independent of screening., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The implementation of FIT programs reduces incidence and mortality from CRC in the screened subjects. The ultimate efficacy for CRC morbidity and mortality prevention in a FIT program depends on the colonoscopy in FIT+ subjects that has the task of detecting and removing these advanced lesions. Recently, there has been growing evidence on factors that influence the quality of colonoscopy specifically withing organized FIT programs, prompting to dedicated interventions in order to maximize the benefit/harm ratio of post-FIT colonoscopy. This document focuses on the diagnostic phase of colonoscopy, providing indications on how to standardise colonoscopy in FIT+ subjects, regarding timing of examination, management of antithrombotic therapy, bowel preparation, competence and sedation., Competing Interests: Conflict of Interest None., (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

The optimal mammography screening strategy for women aged 45-49 years is a matter of debate. We present the RIBBS study protocol, a quasi-experimental, prospective, population-based study comparing a risk- and breast density-stratified screening model (interventional cohort) with annual digital mammography (DM) screening (observational control cohort) in a real-world setting. The interventional cohort consists of 10,269 women aged 45 years enrolled between 2020 and 2021 from two provinces of the Veneto Region (northen Italy). At baseline, participants underwent two-view digital breast tomosynthesis (DBT) and completed the Tyrer-Cuzick risk prediction model. Volumetric breast density (VBD) was calculated from DBT and the lifetime risk (LTR) was estimated by including VBD among the risk factors. Based on VBD and LTR, women were classified into five subgroups with specific screening protocols for subsequent screening rounds: (1) LTR ≤ 17% and nondense breast: biennial DBT; (2) LTR ≤ 17% and dense breast: biennial DBT and ultrasound; (3) LTR 17-30% or LTR > 30% without family history of BC, and nondense breast: annual DBT; (4) LTR 17-30% or > 30% without family history of BC, and dense breast: annual DBT and ultrasound; and (5) LTR > 30% and family history of BC: annual DBT and breast MRI. The interventional cohort is still ongoing. An observational, nonequivalent control cohort of 43,000 women aged 45 years participating in an annual DM screening programme was recruited in three provinces of the neighbouring Emilia-Romagna Region. Cumulative incidence rates of advanced BC at three, five, and ten years between the two cohorts will be compared, adjusting for the incidence difference at baseline.Trial registration This study is registered on Clinicaltrials.gov (NCT05675085)., (© 2024. The Author(s).)

Fecal immunochemical tests (FIT) are among the most commonly used tests for colorectal cancer (CRC) screening programs worldwide. However, no randomised controlled trials have been carried out evaluating the impact of FIT-based screening programs (FIT-progr) on CRC incidence and mortality rates. Italian FIT-progr represent one of the most widespread and established experience worldwide. This paper reviews the evidence on the impact of FIT-progr on CRC incidence, tumor stage at diagnosis, mortality and surgery rates, deriving from Italian routine programs, i.e., outside the research setting. Unfortunately, the application of FIT-progr in Italy can be considered as an unplanned experimental model, due to the differences between Regions, both in health system management and adherence of the target population to the screening programs. The analysis of the manuscripts considered in the review, confirms that FIT-progr are effective in reducing CRC incidence and mortality rates and in improving the rate of endoscopic treatment of early invasive lesions. The review also highlights that FIT-progr are less performing for proximal colon than for distal colon and rectum., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2022. Published by Elsevier Ltd.)

Background: The impact of a faecal immunochemical test-based colorectal cancer (CRC) screening program in terms of patient prognosis could be affected by lead-time bias, which artificially increases the survival of screen-detected patients due to the early diagnosis., Aims: To provide a description of the impact of the CRC screening program in the Trentino Region (Italy), including the Cure Fraction (CF), a prognostic indicator not affected by lead-time bias., Methods: The program started in 2008, inviting the resident population aged 50-69 years. In this retrospective cohort study, 1,697 CRC diagnosed between 2003 and 2014 in patients aged 50-69 years were classified as pre-screening (PS), screen-detected (SD), interval cancers (IC) and not-screen-detected (NSD). We compared groups by stage at diagnosis and CF. Trends in CRC mortality were reported., Results: The proportion of stage I among SD cases was 51%, higher than PS (19%; OR 4.66, 95%CI 3.50-6.20), NSD (20.6%; OR 3.96, 95%CI 2.95-5.32) and IC (33.3%; OR 2.11, 95%CI 1.10-4.04). The CF of PS, NSD and SD cases was respectively 57% (95%CI 54-60%), 60% (95%CI 58-63%) and 93% (95%CI 89-96%). CRC mortality dropped from 40.7 to 25.6\100,000., Conclusion: The program significantly improved the prognosis of patients, decreasing CRC mortality and incidence of advanced CRCs., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Objective: To assess faecal immunochemical test sensitivity for cancer in a very large population-based cohort followed up for six rounds with biennial faecal immunochemical test repetition., Methods: This study is based on interval colorectal cancers diagnosed in a cohort of subjects aged 50-69 undergoing repeated faecal immunochemical test screening (six rounds) from 2002 to 2015. Test sensitivity was calculated using both the Proportional Interval Cancer Rate and the Interval Cancer Proportion method., Results: Among 441,647 faecal immunochemical tests (123,347 individuals), 150 interval colorectal cancers were detected after a negative faecal immunochemical test. Interval colorectal cancer incidence rate was 1.87 per 10,000 person-years (95%CI: 1.60-2.20), and it was higher during the second interval year (rate ratio: 1.78; 95%CI: 1.28-2.47), for proximal locations (rate ratio: 3.00; 95%CI: 1.92-4.68), and among 60-71 year old subjects (rate ratio: 2.37; 95%CI: 1.61-3.50). The Proportional Interval Cancer Rate was 13.1%, with an overall faecal immunochemical test sensitivity of 86.9% (95%CI: 84.7-89.0). Sensitivity was lowest at the first round (81.5%; 95%CI: 75.6-86.2), and increased to 91.9% (95%CI: 83.9-96.5) for subsequent rounds. Applying the Interval Cancer Proportion method, sensitivity was 83.9% (95%CI: 81.3-86.2), and it was highest at the first round (89.0%; 95%CI: 85.7-91.6), ranging between 73% and 83.1% at subsequent rounds., Conclusions: A faecal immunochemical test sensitivity for cancer higher than 80% resulted in a low incidence of interval colorectal cancers, representing an accurate estimate of one of the major limits of screening programmes. Due to intrinsic biases, the Proportional Interval Cancer Rate and the Interval Cancer Proportion methods generated different trends in faecal immunochemical test sensitivity by screening round.

Background: Post-colonoscopy adverse events are a key quality indicator in population-based colorectal cancer screening programs, and affect safety and costs. This study aimed to assess colonoscopy-related adverse events and mortality in a screening setting., Methods: We retrieved data from patients undergoing colonoscopy within a screening program (fecal immunochemical test every 2 years, 50-69-year-olds, or post-polypectomy surveillance) in Italy between 2002 and 2014, to assess the rate of post-colonoscopy adverse events and mortality. Any admission within 30 days of screening colonoscopy was reviewed to capture possible events. Mortality registries were also matched with endoscopy databases to investigate 30-day post-colonoscopy mortality. Association of each outcome with patient-/procedure-related variables was assessed using multivariable analysis., Results: Overall, 117 881 screening colonoscopies (66 584, 56.5 %, with polypectomy) were included. Overall, 497 (0.42 %) post-colonoscopy adverse events occurred: 281 (0.24 %) bleedings (3.69‰/0.68‰, operative/diagnostic procedures) and 65 (0.06 %) perforations (0.75‰/0.29‰, respectively). At multivariable analysis, bleeding was associated with polyp size (≥ 20 mm: odds ratio [OR] 16.29, 95 % confidence interval [CI] 9.38-28.29), proximal location (OR 1.46, 95 %CI 1.14-1.87), and histology severity (high risk adenoma: OR 5.6, 95 %CI 2.43-12.91), while perforation was associated with endoscopic resection (OR 2.91, 95 %CI 1.62-5.22), polyp size (OR 4.34, 95 %CI 1.46-12.92), and proximal location (OR 1.94, 95 %CI 1.12-3.37). Post-colonoscopy mortality occurred in 15 /117 881 cases (1.27/10 000 colonoscopies)., Conclusions: In an organized screening program, post-colonoscopy adverse events were rare but not negligible. The most frequent event was post-polypectomy bleeding, especially after resection of large (≥ 20 mm) and proximal lesions., Competing Interests: The authors declare that they have no conflicts of interest., (Thieme. All rights reserved.)

BACKGROUND : Colorectal cancer (CRC) screening programs based on fecal immunochemical testing (FIT) generate substantial pressure on colonoscopy capacity in Europe. Thus, a relevant proportion of FIT-positive patients undergo colonoscopy after the recommended 30-day interval, which may be associated with an excess CRC risk. METHODS : In a cohort of 50-69-year-old patients undergoing biennial rounds of FIT (OC-Hemodia latex agglutination test; cutoff 20 µg hemoglobin/g feces) between 2004 and 2017, we assessed the outcome at colonoscopy (low/high risk adenoma/CRC/advanced stage CRC) among FIT-positive patients, according to different time intervals. The association of each outcome with waiting time, and demographic and clinical factors, was analyzed through multivariable analysis. RESULTS : 123 138/154 213 FIT-positive patients (79.8 %) underwent post-FIT colonoscopy. Time to colonoscopy was ≤ 30 days, 31-180 days, and ≥ 181 days in 50 406 (40.9 %), 71 724 (58.3 %), and 1008 (0.8 %) patients, respectively. At colonoscopy, CRC, high risk adenoma, and low risk adenoma were diagnosed in 4813 (3.9 %), 30 500 (24.8 %), and 22 986 (18.7 %) patients, respectively. An increased CRC prevalence at colonoscopy was observed for a time to colonoscopy of ≥ 270 days (odds ratio [OR] 1.75, 95 % confidence interval [CI] 1.15-2.67), whereas it was stable for waiting times of < 180 days. The proportion of advanced CRC also increased after 270 days (OR 2.79, 95 %CI 1.03-7.57). No increase for low or high risk adenomas according to time to colonoscopy was observed. CONCLUSION : In a European FIT-based screening program, post-FIT colonoscopy after 9 months was associated with an increased risk of CRC and CRC progression., Competing Interests: The authors declare that they have no conflicts of interest., (Thieme. All rights reserved.)

Objective: To assess the potential impact of a melanoma screening programme, compared with usual care, on direct costs and life expectancy in the era of targeted drugs and cancer immunotherapy., Methods: Using a Whole Disease Model approach, a Markov simulation model with a time horizon of 25 years was devised to analyse the cost-effectiveness of a one-time, general practitioner-based melanoma screening strategy in the population aged over 20, compared with no screening. The study considered the most up-to-date drug therapy and was conducted from the perspective of the Veneto regional healthcare system within the Italian National Health Service. Only direct costs were considered. Sensitivity analyses, both one-way and probabilistic, were performed to identify the parameters with the greatest impact on cost-effectiveness, and to assess the robustness of our model., Results: Over a 25-year time horizon, the screening intervention dominated usual care. The probabilistic sensitivity analyses confirmed the robustness of these findings. The key drivers of the model were the proportion of melanomas detected by the screening procedure and the adherence of the target population to the screening programme., Conclusions: The screening programme proved to be a dominant option compared with usual care. These findings should prompt serious consideration of the design and implementation of a regional or national melanoma screening strategy within a National Health Service.

Objectives: to describe the course of Italian organized cancer screening programmes during the COVID-19 emergency; to provide estimates of the diagnosis of malignant or pre-malignant lesions that will face a diagnostic delay due to the slowing down of screening activities., Design: quantitative survey of aggregated data for each Region and overall for Italy relating to screening tests carried out in the period January-May 2020 compared to those of the same period of 2019; estimate of diagnostic delays starting from the calculation of the average detection rate of the last 3 years available (specific by Region)., Setting and Participants: Italian mass screening programmes. Data on the tests carried out in the target population of the breast (women 50-69 years old), cervix (women 25-64 years old), and colorectal (women and men 50-69 years old) cancer screening., Main Outcome Measures: the cumulative delay (in absolute numbers and as a percentage) in the period January-May 2020 compared to the same period of 2019, by Region; the difference of screening tests (in absolute number and in percentage) performed in May 2020 compared to May 2019; the estimate of the fewer lesions diagnosed in 2020 compared with 2019 with relative 95% confidence intervals (95%CI); the 'standard months' of delay (proportion of fewer tests carried out from January to May 2020 for the corresponding number of months)., Results: 20 Regions out of 21 participated. In the period January-May 2020, the fewer screening tests performed in comparison with the same period of 2019 were: 472,389 (equal to 53.8%) with an average delay of standard months of 2.7 for mammography screening; 585,287 (equal to 54.9%) with an average delay of standard months of 2.7 for colorectal screening; 371,273 (equal to 55.3%) with an average delay of 2.8 standard months for cervical screening. The estimated number of undiagnosed lesions is 2,201 (95%CI 2,173-2,220) breast cancers; 645 (95%CI 632-661) colorectal carcinomas; 3,890 (95%CI 3,855-3,924) advanced colorectal adenomas and 1,497 (95%CI 1,413-1,586) CIN2 or more serious lesions., Conclusions: mass screenings need to be restarted as quickly as possible. In order to make up for the delay that is accumulating, it is necessary to provide for wider delivery times, greater resources, and new organizational approaches. It will also be essential to develop communication strategies suitable for promoting participation during this emergency.

Objective: To assess the 5-year risk of high-grade lesions in women with a transient high-risk HPV infection., Design: Population-based cohort study., Setting: HPV primary testing within population-based organised cervical cancer screening programmes., Population: Italian women enrolled in seven pilot projects and attending the second round., Methods: On the basis of the cytology triage performed on HPV-positive women, immediate colposcopy or HPV repeat at 12 months was recommended. Data were collected at the subsequent round 3-4 years after HPV infection clearance., Main Outcome Measures: Rates of HPV infection, CIN2+ and CIN3+ detection at subsequent round after HPV clearance, and relative risks (RR) in comparison with HPV-negative women (with 95% confidence interval)., Results: Data on 1230 women (1027 aged 25-64 years and 203 aged 35-64 years) have been analysed. Overall compliance with repeat HPV testing was 84%. In comparison with HPV-negative women, those with a transient HPV infection had higher proportions of HPV positivity (15% versus 3.7%) and of CIN2+ lesions (0.87% versus 0.23%) in round two; most of these (7/10) were CIN2; no cancers were detected, and CIN3 occurred in 3/1230 (0.24%)., Conclusions: HPV-based protocols for cervical cancer screening allow long intervals for HPV-negative women; it is important to monitor the clinical outcome in the women with transient high-risk HPV infection. CIN3 detection is similar to that observed in routine European cytology-based screening programmes (CIN3+: 2.7‰); 5-year intervals may provide reasonable protection but longer intervals are not recommended., Tweetable Abstract: A screening interval of 5 years (but no longer) appears safe in women with transient HPV detection., (© 2019 Royal College of Obstetricians and Gynaecologists.)

Background: The long-term performance of colorectal cancer (CRC) screening programmes based on a 2-year faecal immunochemical test (FIT) is still unclear., Methods: In a sample of 50 to 69-year-olds repeatedly screened with the FIT (OC-Hemodia latex agglutination test; cut-off: 20 µg haemoglobin/g faeces), we examined: (1) the FIT positivity rate, the CRC and advanced adenoma detection rate and the FIT's positive predictive value (PPV) for advanced neoplasia, at each round of screening and (2) the cumulative CRC and advanced adenoma detection rate after five rounds of FIT., Results: Over 12 years (2002-2014), 123 347 individuals were administered the FIT up to six times, and 781 CRCs and 4713 advanced adenomas were diagnosed. The CRC and advanced adenoma detection rates declined substantially from the first to the third (rate ratio (RR) 0.25, 95% CI 0.20 to 0.32) and second (RR 0.51, 95% CI 0.47 to 0.56) rounds, respectively, and then remained stable. The PPV for advanced neoplasia dropped by 18% in the second round (RR 0.82, 95% CI 0.77 to 0.89), with no further reduction thereafter due to a concomitant decline in the FIT positivity rate (RR first to sixth rounds: 0.56, 95% CI 0.53 to 0.60).The cumulative CRC and advanced adenoma detection rates over five consecutive rounds were 8.5‰ (95% CI 7.8 to 9.2), and 58.9‰ (95% CI 56.9 to 61.0), respectively., Conclusions: Repeated FIT significantly reduces the burden of colorectal disease while facilitating an efficient use of colonoscopy resources. The cumulative detection rate after five rounds of FIT is similar to primary screening with colonoscopy, supporting the need to account for the cumulative sensitivity of repeated FITs when evaluating the test's efficacy., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Short-term studies have reported that the fecal immunochemical test (FIT) is less accurate in detecting proximal than distal colorectal neoplasia., Objective: To assess the long-term detection rates for advanced adenoma and colorectal cancer (CRC), according to anatomical location., Design: Retrospective study., Setting: Population-based, organized screening program in the Veneto region of Italy., Participants: Persons aged 50 to 69 years who completed 6 rounds of FIT screening., Measurements: At each screening round, the detection rates for advanced adenoma and cancer, as well as the proportional interval cancer rate (PICR), were calculated by anatomical location (proximal colon, distal colon, or rectum)., Results: Between 2002 and 2014, a total of 123 347 participants had 441 647 FITs. The numbers of advanced adenomas and cancer cases detected, respectively, were 1704 and 200 in the proximal colon, 3703 and 324 in the distal colon, and 1220 and 209 in the rectum. Although the detection rate for proximal colon cancer declined only from the first to the second screening round (0.63 to 0.36 per 1000 screenees), the rate for both distal colon and rectal cancer steadily decreased across 6 rounds (distal colon, 1.65 in the first round to 0.17 in the sixth; rectum, 0.82 in the first round to 0.17 in the sixth). Similar trends were found for advanced adenoma (proximal colon, 5.32 in the first round to 4.22 in the sixth; distal colon, 15.2 in the first round to 5.02 in the sixth). Overall, 150 cases of interval cancer were diagnosed. The PICR was higher in the proximal colon (25.2% [95% CI, 19.9% to 31.5%]) than the distal colon (6.0% [CI, 3.9% to 8.9%]) or rectum (9.9% [CI, 6.9% to 13.7%])., Limitations: Participants with irregular attendance were censored. Those who had a false-positive result on a previous FIT but negative colonoscopy results were included in subsequent rounds., Conclusion: This FIT-based, multiple-round, long-term screening program had a negligible reduction in detection rates for neoplastic lesions in the proximal versus the distal colon after the first round. This was related to a higher PICR in the proximal colon and suboptimal efficacy in preventing the age-related proximal shifting of CRC., Primary Funding Source: None.

Objective: The impact of organized screening programs on breast cancer (BC) mortality is unclear in an era of high spontaneous referral of women to mammography. The aim of this study was to analyze if the introduction of mammographic screening programs reduced BC mortality in the Veneto region, Italy, despite already widespread spontaneous access to mammography., Methods: In Veneto, screening was introduced in different years between 1999 and 2009 across 21 local health units (LHUs), inviting asymptomatic women aged 50-69 years to undergo mammography biennially. We compared BC mortality for the 1995-2014 period of women aged 40-49 and 50-74 years who were resident in LHUs where screening programs started in 2003 (early LHUs) with women resident in LHUs where screening was introduced later (late LHUs). Poisson regression models were applied to incidence-based mortality (IBM), including only deaths from BC arising within the screening period., Results: In the prescreening period and until 2010, BC mortality rates in early and late LHUs were similar in both age groups. In the last study period (2010-2014), we observed a 10% decrease in overall BC mortality in early compared to late LHU, limited to women aged 50-74 years. IBM was reduced by 8% (95% CI 1%-16%) in the overall study period and by 16% (6%-25%) in 2010-2014., Conclusions: In the Veneto region, screening programs were associated with a significant impact on BC-specific mortality; such effect appeared at least 8 years after screening implementation.

Background: The Verona population-based breast cancer (BC) screening program provides biennial mammography to women aged 50-69 years. Based on emerging evidence of enhanced detection, the program transitioned to digital breast tomosynthesis (DBT) screening., Methods: This is a prospective pilot evaluation of DBT with synthesised 2D mammography screening implemented during April 2015-March 2017; the rate and characteristics of cancers detected at DBT screening were compared with those detected at the preceding digital mammography (DM) screening round (April 2013-March 2015) in the same screening program. Distribution of imaging and tumour characteristics were compared., Results: Amongst 34,071 women screened in the Verona DBT pilot, 315 BCs were detected; 153 BCs were detected amongst 29,360 women in the DM screening round. Estimated CDRs were 9.2/1000 (95% CI 8.3-10.3) DBT screens versus 5.2/1000 (95% CI 4.4-6.1) DM screens, P < 0.001. Statistically significant differences were found in the distribution of whether recall by one/both screen readers (more BCs recalled by both readers at DBT than DM); whether detected on one/two views (higher proportion detected on only one view at DBT than DM); type of radiological lesions; tumour stage, pT and histological categories (lower proportion of DCIS/pTis, higher proportions of pT1a and pT1b, and higher proportion of invasive cancers of special types, at DBT than DM); and tumour grade (higher proportion of grade I at DBT than DM). There were no differences in distributions of nodal and hormone receptor (ER/PR) status., Conclusions: Our findings provide early insights into the extent that transitioning to DBT screening may modify the characteristics of screen-detected breast cancer to inform discussion regarding pros and cons of DBT screening; although our data provide some reassurance that DBT does not increase the proportion of screen-detected DCIS, they highlight mixed findings on comparative tumour characteristics, suggesting a potential for enhancing screening benefit and possibly also over-diagnosis from DBT screening.

Background & Methods: The prospective 'screening with tomosynthesis or standard mammography' (STORM) trial recruited women participating in biennial breast screening in Italy (2011-2012), and compared sequential screen-readings based on 2D-mammography alone or based on tomosynthesis (integrated 2D/3D-mammography). The STORM trial showed that tomosynthesis screen-reading significantly increased breast cancer detection compared to 2D-mammography alone. The present study completes reporting of the trial by examining interval breast cancers ascertained at two year follow-up., Results: 9 interval breast cancers were identified; the estimated interval cancer rate was 1.23/1000 screens [9/7292] (95%CI 0.56 to 2.34) or 1.24/1000 negative screens [9/7235] (95%CI 0.57 to 2.36). In concurrently screened women who attended the same screening services and received 2D-mammography, interval cancer rate was 1.60/1000 screens [40/25,058] (95% CI 1.14 to 2.17) or 1.61/1000 negative screens [40/24,922] (95% CI 1.15 to 2.18). Estimated screening sensitivity for the STORM trial was 85.5% [59/69] (95%CI 75.0%-92.8%), and that for 2D-mammography screening was 77.3% [136/176] (95%CI 70.4%-83.2%)., Conclusion: Interval breast cancer rate amongst screening participants in the STORM trial was marginally lower (and screening sensitivity higher) than estimates amongst 2D-screened women; these findings should be interpreted with caution given the small number of interval cases and the sample size of the trial. Much larger screening studies, or pooled analyses, are required to examine interval cancer rates arising after breast tomosynthesis screening versus digital mammography screening., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Objective In Italy, colorectal screening programmes using the faecal immunochemical test from ages 50 to 69 every two years have been in place since 2005. We aimed to measure the incidence of interval cancers in the two years after a negative faecal immunochemical test, and compare this with the pre-screening incidence of colorectal cancer. Methods Using data on colorectal cancers diagnosed in Italy from 2000 to 2008 collected by cancer registries in areas with active screening programmes, we identified cases that occurred within 24 months of negative screening tests. We used the number of tests with a negative result as a denominator, grouped by age and sex. Proportional incidence was calculated for the first and second year after screening. Results Among 579,176 and 226,738 persons with negative test results followed up at 12 and 24 months, respectively, we identified 100 interval cancers in the first year and 70 in the second year. The proportional incidence was 13% (95% confidence interval 10-15) and 23% (95% confidence interval 18-25), respectively. The estimate for the two-year incidence is 18%, which was slightly higher in females (22%; 95% confidence interval 17-26), and for proximal colon (22%; 95% confidence interval 16-28). Conclusion The incidence of interval cancers in the two years after a negative faecal immunochemical test in routine population-based colorectal cancer screening was less than one-fifth of the expected incidence. This is direct evidence that the faecal immunochemical test-based screening programme protocol has high sensitivity for cancers that will become symptomatic.

Objective: To compare the results from an initial negative human papillomavirus (HPV) test with re-screening after 3 years in women attending two HPV-based screening programmes., Design: Population-based cohort study., Setting: Two cervical service screening programmes in Italy., Population: Women aged 25-64 years invited to screening from April 2009 to October 2015., Methods: Eligible women were invited to undergo an HPV test. Those with a negative HPV test went on to the next screening round 3 years later. Cytology triage was performed for HPV+ (HPV by Hybrid Capture 2) samples, with immediate colposcopy (if abnormal) and HPV re-testing 1 year later (if negative)., Main Outcome Measures: Participation rate, positivity at HPV and at triage, referral rate to colposcopy, positive predictive value for cervical intraepithelial neoplasia grade 2+ (CIN2+) at colposcopy, and detection rate for CIN2+., Results: We present the results from 48 751 women at the first screening and 22 000 women at re-screening 3 years later. The response rate was slightly higher at the second screening (74.5 versus 72.1% at the first screening; referral rate, RR 1.11; 95% confidence interval, 95% CI, 1.07-1.14). Compared with the first screening, we observed a significant reduction at the second screening in terms of HPV positivity (RR 0.55, 95% CI 0.51-0.60), referral rate to colposcopy (RR 0.47, 95% CI 0.41-0.53), CIN2+ detection rate (RR 0.24, 95% CI 0.13-0.39), and positive predictive value (PPV) for CIN2+ at colposcopy (RR 0.51, 95% CI 0.29-0.87)., Conclusions: The very low frequency of disease and inadequate PPV at colposcopy indicate that a 3-year interval after a negative HPV test is too short., Tweetable Abstract: Three years after a negative HPV the frequency of cervical disease is so low that re-screening is inefficient., (© 2017 Royal College of Obstetricians and Gynaecologists.)

Background: Women positive to human papillomavirus (HPV+) testing at cervical screening need triage, typically cytology and immediate colposcopy in case of atypical squamous cells of undetermined significance (ASCUS) or worse (ASCUS+) or, in cytology-normal HPV+ women, HPV test repeat after 1 year and colposcopy referral if still HPV+. Our hypothesis was that substantial variations in triage positivity and sensitivity may produce little variation in overall referral to colposcopy and on sensitivity of the entire screening process., Methods: Centre- and age-aggregated data from 72,869 women aged 35-64 years were derived from 10 organised screening programmes which have piloted HPV screening in Italy since 2012. Overall colposcopy referral was evaluated as a function of immediate colposcopy referral and overall CIN2+ detection as a function of the proportion of all CIN2+ detected by immediate referral (a proxy of cytology's sensitivity). We fitted additive regression models, adjusted for centre, age, compliance to HPV retesting and to colposcopy, by generalised estimation equations., Results: The proportion of HPV+ women directly referred to colposcopy varied across programmes (20-57%; average 37%) and so did CIN2+ detection (49-94%; average 77%). Overall, 63% (range 41-75%) of HPV+ were referred to colposcopy either immediately or at HPV repeat. An absolute 10% increase in immediate colposcopy referral resulted in 4.2% (95% CI: 3.3-5.1%) increase in overall referral. An absolute 10% increase in cytology's sensitivity resulted in a 1.1% (95% CI: 0.1-2.0%) increase in overall CIN2+ detection., Conclusions: Repeat HPV testing limits the effect of subjectivity of cytology interpretation on overall referral and sensitivity. These will change only slightly when replacing cytology with another test if the interval to HPV repeat remains unchanged., (Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: To assess the appropriateness of recommendations for endoscopic surveillance in organised colorectal cancer (CRC) screening programmes based on the faecal immunochemical test (FIT)., Design: 74 Italian CRC screening programmes provided aggregated data on the recommendations given after FIT-positive colonoscopies in 2011 and 2013. Index colonoscopies were divided into negative/no adenoma and low- risk, intermediate-risk and high-risk adenomas. Postcolonoscopy recommendations included a return to screening (FIT after 2 years or 5 years), an endoscopic surveillance after 6 months or after 1 year, 3 years or 5 years, surgery or other. We assessed the deviation from the postcolonoscopy recommendations of the European Guidelines in 2011 and 2013 and the correlation between overuse of endoscopic surveillance in 2011 and the process indicators associated with the endoscopic workload in 2013., Results: 49 704 postcolonoscopy recommendations were analysed. High-risk, intermediate-risk and low-risk adenomas, and no adenomas were reported in 5.9%, 19.3%, 15.3% and 51.5% of the cases, respectively. Endoscopic surveillance was inappropriately recommended in 67.4% and 7%, respectively, of cases with low-risk and no adenoma. Overall, 37% of all endoscopic surveillance recommendations were inappropriate (6696/17 860). Overuse of endoscopic surveillance was positively correlated with the extension of invitations (correlation coefficient (cc) 0.29; p value 0.03) and with compliance with post-FIT+ colonoscopy (cc 0.25; p value 0.05), while it was negatively correlated with total colonoscopy waiting times longer than 60 days (cc -0.26; p value 0.05)., Conclusions: In organised screening programmes, a high rate of inappropriate recommendations for patients with low risk or no adenomas occurs, affecting the demand for endoscopic surveillance by a third., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Cervical cancer screening programmes in Italy actively invite all 25-64-year-old resident women for the Pap test every 3 years irrespective of their citizenship. Immigrant women come from countries where screening is absent or poorly implemented and the prevalence of human papillomavirus is often high. These women therefore have significant risk factors for cervical cancer. The Italian Group for Cervical Cancer Screening promoted a survey of all the screening programmes on the participation and the positivity and detection rates in Italian and foreign women in 2009-2011. Aggregated data for participation, cytology results, compliance with colposcopy and histology results were collected, distinguishing between women born in Italy and abroad. All comparisons were age adjusted. Forty-eight programmes out of 120 participated in the immigrant survey, with 3 147 428 invited and 1 427 412 screened Italian women and 516 291 invited and 205 948 screened foreign women. Foreign women had a slightly lower participation rate compared with Italians (39.9 vs. 45.4%), whereas compliance with colposcopy was similar (90%). Foreigners showed a higher risk of pathological findings than Italians: cytology positivity [relative risk (RR)=1.25, 95% confidence interval (CI) 1.24-1.27] and detection rate for cervical intraepithelial neoplasia grade 2 (CIN2) (RR=1.39, 95% CI 1.31-1.47), CIN3 (RR=2.07, 95% CI 1.96-2.18) and cancer (RR=2.68, 95% CI 2.24-3.22). The ratio between cancer and CIN was higher in immigrants (0.06 vs. 0.04, P<0.01). Foreign women had a higher risk of cervical precancer and cancer. Because of their high risk and because opportunistic screening does not cover this often disadvantaged group, achieving high participation in screening programmes for foreigners is critical to further reducing the cervical cancer burden in Italy.

Background: Colorectal cancer screening programmes in Italy invite 50-69-year-old residents for a faecal immunochemical test every two years, regardless of their citizenship., Methods: The 2013 National Survey on Italian colorectal cancer screening programmes compared immigrants born in low- or middle-income countries with subjects who were born in Italy, by collecting aggregated data on compliance, faecal immunochemical test results, compliance with colonoscopy, detected lesions and stage at diagnosis separately for Italians and immigrants., Results: Overall, 85 screening programmes invited 3,292,451 subjects, of whom 192,629 had been born abroad (5.9%). Compliance with invitation was lower in immigrants (34.3% vs. 51.3% in Italians), with p<0.001. Compliance was higher in females, regardless of the country of birth, in the youngest age group of immigrants but in the oldest of Italians. Immigrants showed a borderline excess of standardised faecal immunochemical test positivity rate at first screening (5.4% vs. 5.1% in Italians, p=0.05) and a significant excess at repeat screenings (4.8% vs. 4.4%, p=0.002). The detection rates for carcinoma and advanced adenomas were lower in immigrants than in Italians at first screening (respectively 1.34‰ vs. 1.62‰ and 8.41‰ vs. 9.25‰) - although the differences were not statistically significant - but not at repeat screening (respectively 1.06‰ vs. 0.98‰ and 6.90‰ vs. 6.79‰)., Conclusions: Migrants showed a lower compliance with screening than Italians. The prevalence of neoplasia was lower at first screening and similar to the Italians' at repeat screenings., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: To assess variation in the main colonoscopy quality indicators in organised colorectal cancer (CRC) screening programmes based on faecal immunochemical test (FIT)., Design: Data from a case-series of colonoscopies of FIT-positive subjects were provided by 44 Italian CRC screening programmes. Data on screening history, endoscopic procedure and histology results, and additional information on the endoscopy centre and the endoscopists were collected. The adenoma detection rate (ADR) and caecal intubation rate (CIR) were assessed for the whole population and the individual endoscopists. To explore variation in the quality indicators, multilevel analyses were performed according to patient/centre/endoscopist characteristics., Results: We analysed 75 569 (mean age: 61.3 years; men: 57%) colonoscopies for positive FIT performed by 479 endoscopists in 79 centres. ADR ranged from 13.5% to 75% among endoscopists (mean: 44.8%). ADR was associated with gastroenterology specialty (OR: 0.87 for others, 95% CI 0.76 to 0.96) and, at the endoscopy centre level, with the routine use of sedation (OR: 0.80 if occasional (<33%); 95% CI 0.64 to 1.00) and availability of screening-dedicated sessions (OR: 1.35; 95% CI 1.11 to 1.66). CIR ranged between 58.8% and 100% (mean: 93.1%). Independent predictors of CIR at the endoscopist level were the yearly number of screening colonoscopies performed (OR: 1.51 for endoscopists with >600 colonoscopies; 95% CI 1.11 to 2.04) and, at the endoscopy centre level, screening-dedicated sessions (OR: 2.18; 95% CI 1.24 to 3.83) and higher rates of sedation (OR: 0.47 if occasional; 95% CI 0.24 to 0.92)., Conclusions: The quality of colonoscopy was affected by patient-related, endoscopist-related and centre-related characteristics. Policies addressing organisational issues should improve the quality of colonoscopy in our programme and similar programmes., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: Colorectal cancer (CRC) screening programmes based on the guaiac faecal occult blood test (gFOBT) reduce CRC-specific mortality. Several studies have shown higher sensitivity with the faecal immunochemical test (FIT) compared with gFOBT. We carried out an ecological study to evaluate the impact of FIT-based screening programmes on CRC mortality., Design: In the Veneto Region (Italy), biennial FIT-based screening programmes that invited 50-69-year-old residents were introduced in different areas between 2002 and 2009. We compared CRC mortality rates from 1995 to 2011 between the areas where screening started in 2002-2004 (early screening areas (ESA)) and areas that introduced the screening in 2008-2009 (late screening areas (LSA)) using Poisson regression models. We also compared available data on CRC incidence rates (1995-2007) and surgical resection rates (2001-2012)., Results: Before the introduction of screening, CRC mortality and incidence rates in the two areas were similar. Compared with 1995-2000, 2006-2011 mortality rates were 22% lower in the ESA than in the LSA (rate ratio (RR)=0.78; 95% CI 0.68 to 0.89). The reduction was larger in women (RR=0.64; CI 0.51 to 0.80) than in men (RR=0.87; CI 0.73 to 1.04). In the ESA, incidence and surgery rates peaked during the introduction of the screening programme and then returned to the baseline (2006-2007 incidence) or dropped below initial values (surgery after 2007)., Conclusions: FIT-based screening programmes were associated with a significant reduction in CRC mortality. This effect took place much earlier than reported by gFOBT-based trials and observational studies., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Aim: To estimate the impact of an advance notification letter on participation in sigmoidoscopy (FS) and fecal immunochemical test (FIT) screening., Methods: Eligible subjects, invited in 3 Italian population based programmes using FS and in 5 using FIT, were randomised (1:1:1), within GP, to: A) standard invitation letter; B) advance notification followed after 1month by the standard invitation; and C) B+indication to contact the general practitioner (GP) to get advice about the decision to be screened. We calculated the 9-month attendance and the incremental cost of each strategy. We conducted a phone survey to assess GP's utilization and predictors of participation., Results: The advance notification was associated with a 20% increase in the attendance among 15,655 people invited for FS (B vs A - RR: 1.17, 95% CI: 1.10-1.25; C vs A - RR: 1.19, 95% CI: 1.12-1.27); the incremental cost ranged between 10 and 9 Euros. Participation in FIT screening (N=23,543) was increased only with simple pre-notification (B vs A - RR: 1.06, 95% CI: 1.02-1.10); the incremental cost was 22.5 Euros. GP consultation rate was not increased in group C., Conclusions: An advance notification represents a cost-effective strategy to increase participation in FS screening; its impact on the response to FIT screening was limited., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: The purpose of this parallel randomised controlled trial was to compare compliance with different modalities used to invite patients with a positive immunochemical faecal occult blood test (FIT+) for a total colonoscopy (TC)., Method: FIT+ patients from nine Italian colorectal cancer screening programmes were randomised to be invited for a TC initially by mail or by phone and, for non-compliers, to be recalled by mail, for counselling with a general practitioner, or to meet with a specialist screening practitioner (nurse or healthcare assistant)., Results: In all, 3777 patients were randomised to different invitation strategies. Compliance with an initial invitation by mail and by phone was similar (86.0% vs. 84.0%, relative risk - RR: 1.02; 95%CI 0.97-1.08). Among non-responders to the initial invitation, compliance with a recall by appointment with a specialist practitioner was 50.4%, significantly higher than with a mail recall (38.1%; RR:1.33; 95%CI 1.01-1.76) or with a face-to-face counselling with the GP (30.8%; RR:1.45;95%CI 1.14-1.87)., Conclusion: Compliance with an initial invitation for a TC by mail and by phone was similar. A personal meeting with a specialist screening practitioner was associated with the highest compliance among non-compliers with initial invitations, while the involvement of GPs in this particular activity seemed less effective., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To present the results of the first 2 years of a human papillomavirus (HPV) test-based screening programme outside the research context., Design: Population-based cohort study., Setting: A cervical service screening programme in Italy., Population: Women aged 25-64 years invited to screening from April 2009 to April 2011., Methods: Eligible women were invited to undergo an HPV test: those with a negative HPV test went on to the next screening episode; those with a positive HPV went on to triage with a Pap smear. Women with positive cytology (i.e. positive for atypical squamous cells of undetermined significance or worse, ASC-US+) were referred to colposcopy, whereas those with negative cytology were referred to repeat HPV testing 1 year later., Main Outcome Measures: Participation rate, positivity at HPV and at triage, referral rate to colposcopy, positive predictive value for cervical intraepithelial neoplasia grade 2+ (CIN2+) at colposcopy, and detection rate for CIN2+., Results: Participation increased compared with the previous Pap programme (60.6 versus 43.9%). The HPV positivity rate was 7.0; 39.6% of Pap smears were scored as positive, and therefore 2.8% of the women screened were referred for immediate colposcopy. The compliance of women who scored positive for HPV and negative for Pap for repeat HPV testing at 12 months was 78.6%, and the HPV positivity rate was 56.6%. The overall referral rate to colposcopy was 4.6%. The overall detection rate for CIN2+ was 4.5 versus 1.5% of the Pap programme (25-34 years, 8.2%; 35+ years, 3.6%)., Conclusions: Compared with the traditional Pap test, the HPV programme recorded a higher response to invitation and an increased DR for CIN2+. The most critical aspects were the reading of cytology in women that were positive for HPV and the increased workload at colposcopy., (© 2013 RCOG.)

Italian national guidelines recommend to regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998 we collected aggregated tables of data from Italian organised cervical screening programmes in order to centrally compute process indicators. Data on women invited during 2010 and screened up to April 2011 were considered. In 2010, the target population of Italian organised screening programmes included 13,538,080 women, corresponding to 80.1% of Italian women aged 25-64 years. Compliance to invitation was 39.8%, with a strong North-South decreasing trend. However, it should be considered that many women are screened outside organised programmes. Among screened women, 4.7% were referred for repeat cytology and 62.7% of them complied; 2.5% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.9% among women referred because of ASC-US or more severe cytology and 88.7% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASC-US or more severe cytology for CIN2 or more severe histology was 16.0%. The unadjusted detection rate of CIN2 or more severe histology was 3.2 per 1,000 screened women (3.5 standardised on the Italian population, truncated 25-64).

We present the main results of the 2010 survey of the Italian screening programmes for colorectal cancer carried out by the National centre for screening monitoring (Osservatorio nazionale screening, ONS) on behalf of the Ministry of health. By the end of 2010, 105 programmes were active, 9 of which had been activated during the year, and 65% of Italians aged 50-69 years were residing in areas covered by organised screening programmes (theoretical extension). Twelve regions had their whole population covered. In the South of Italy and Islands, 5 new programmes were activated in 2010, with a theoretical extension of 29%. The majority of programmes employed the faecal occult blood test (FIT), while some adopted flexible sigmoidoscopy (FS) once in a lifetime and FIT for non-responders to FS. Overall, about 3,404,000 subjects were invited to undergo FIT, 47.2% of those to be invited within the year. The adjusted attendance rate was 48% and approximately 1,568,796 subjects were screened. Large differences in the attendance rate were observed among regions: 10% of programmes reported values lower than 24%. Positivity rate of FIT programmes was 5.5% at first screening (range: 1.6-11.3%) and 4.3% at repeat screening (range: 3.2-6.7%). The average attendance rate to total colonoscopy (TC) was 81.4% and in one region it was lower than 70%. Completion rate for total colonoscopy (TC) was 88.7%. Among the 740,281 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.4 for invasive cancer and 10.3 for advanced adenomas (AA - adenomas with a diameter ≥1 cm, with villous/tubulo-villous type or with high-grade dysplasia). As expected, the corresponding figures in the 843,204 subjects at repeat screening were lower (1.2‰ and 7.6‰ for invasive cancer and AA, respectively). The DR of cancer and adenomas increased with age and was higher among males. Many programmes reported some difficulties in guaranteeing TC in the appropriate time frame to FIT+ subjects: in 16% of cases the waiting time was longer than two months. Nine programmes employed FS as the screening test: 98% of the target population (about 60,000 subjects) were invited, and 13,629 subjects were screened, with an attendance rate of 24%. Overall, 87% of FS were classified as complete. TC referral rate was 9.5% and the DR per 1,000 screened subjects was 2.8 and 40.6 for invasive cancer and AA, respectively.

Italian national guidelines recommend to regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998, we collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. Data on women invited during 2009 and screened up to April 2010 were considered. In 2009, the target population of Italian organised screening programmes included 13,120,269 women, corresponding to 78.0%of Italian women aged 25-64 years. Compliance to invitation was 39.3%, with a strong North-South decreasing trend. However, it should be considered that many women are screened outside the organised programmes. Of the women screened, 4.7%were referred for repeat cytology and 60.8% of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.1% among women referred because of ASC-US or more severe cytology and 89.3% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASC-US or more severe cytology for CIN2 or more severe histology was 16.2%. The unadjusted detection rate of CIN2 or more severe histology was 3.2 per 1,000 screened women (3.2 standardised on the Italian population, truncated 25-64).

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 2008-2009 results show good overall quality of diagnosis and treatment and an improving trend over time. Critical issues were identified, including waiting times and compliance with the recommendations on not performing frozen section examination on small lesions. Pre-operative diagnosis reached the acceptable target, but there is a large variation between regions and programmes. For almost 90% 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-based 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 shorter waiting times.

We present the main results of the sixth survey of the Italian screening programmes for colorectal cancer carried out by the National centre for screening monitoring (Osservatorio nazionale screening, ONS) on behalf of the Ministry of health. By the end of 2009, 98 programmes were active, of which 13 had been activated during the year, and 59% of Italians aged 50-69 years were residing in areas covered by organised screening programmes (theoretical extension). Eleven regions had their whole population covered. In the South of Italy and Islands, 4 new programmes were activated in 2009, with a theoretical extension of 22%. The majority of programmes employ the faecal occult blood test (FOBT), while some have adopted flexible sigmoidoscopy (FS) once in a lifetime and FOBT for non-responders to FS. Overall, about 2,935,000 subjects were invited to undergo FOBT, 40% of those to be invited within the year. The adjusted attendance rate was 50% and approximately 1,426,000 subjects were screened. Large differences in the attendance rate were observed among regions, with 10% of programmes reporting values lower than 29%. Positivity rate of FOBT programmes was 5.6% at first screening (range: 2.5-12.4%) and 4.2% at repeat screening (range: 2.5-7.3%). The average attendance rate to total colonoscopy (TC) was 82.5%and in one region it was lower than 70%. Completion rate for total colonoscopy (TC) was 91.2%. Among the 631,460 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.4 for invasive cancer and 11.6 for advanced adenomas (AA - adenomas with a diameter ≥ 1 cm, with villous/tubulo-villous type or with high-grade dysplasia). As expected, the corresponding figures in the 824,562 subjects at repeat screening were lower (1.3‰ and 7.6‰ for invasive cancer and AA, respectively). The DR of cancer and adenomas increased with age and was higher among males. Many programmes reported some difficulties in guaranteeing TC in the appropriate time frame to FOBT+ subjects: in 16% of cases the waiting time was longer than two months. Nine programmes employed FS as the screening test: 65% of the target population (about 60,000 subjects) were invited and 9 511 subjects were screened, with an attendance rate of 24.3%. Overall, 81% of FS were classified as complete. Overall TC referral rate was 11% and the DR per 1,000 screened subjects was 2.6 and 43.7 for invasive cancer and AA, respectively.

In 2009, screening programmes in Italy continued to have positive results, as well as retaining some of the issues encountered in previous years. Overall, in 2009 over 9,000,000 people were invited to undergo a screening examination (3,547,000, 2,522,000 and 2,994,000, for cervical, breast, and colorectal cancer, respectively). More than 4 million people actually took up the invitation (1,393,000, 1,363,000, and 1,423,000 for cervical, breast, and colorectal cancer, respectively). The screening activities led to the finding of 5,973 breast cancers (36% of annual occurring breast cancers in Italy in the 50-69 year age group), 4 454 CIN2 or more severe cervical lesions, 2,556 colorectal cancers (16% of annual occurring CRC cancer in Italy in the 50-69 year age group), and 13,554 advanced adenomas.

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.

Background: The estimation of breast cancer screening sensitivity is a major aim in the quality assessment of screening programmes. The proportional incidence method for the estimation of the sensitivity of breast cancer screening programmes is rarely used to estimate the underlying incidence rates., Methods: We present a method to estimate episode and programme sensitivity of screening programmes, based solely on cancers detected within screening cycles (excluding breast cancer cases at prevalent screening round) and on the number of incident cases in the total target population (steady state). The assumptions, strengths and limitations of the method are discussed. An example of calculation of episode and programme sensitivities is given, on the basis of the data from the IMPACT study, a large observational study of breast cancer screening programmes in Italy., Results: The programme sensitivity from the fifth year of screening onwards ranged between 41% and 48% of the total number of cases in the target population. At steady state episode sensitivity was 0.70, with a trend across age groups, with lowest values in women aged 50-54 years (0.52) and highest in those 65-69 (0.77)., Conclusions: The method is a very serviceable tool for estimating sensitivity in service screening programmes, and the results are comparable with those of other methods of estimation.

Objective: To assess the 5-year risk of high-grade lesions in women with a transient high-risk HPV infection.Design: Population-based cohort study.Setting: HPV primary testing within population-based organised cervical cancer screening programmes.Population: Italian women enrolled in seven pilot projects and attending the second round.Methods: On the basis of the cytology triage performed on HPV-positive women, immediate colposcopy or HPV repeat at 12 months was recommended. Data were collected at the subsequent round 3-4 years after HPV infection clearance.Main Outcome Measures: Rates of HPV infection, CIN2+ and CIN3+ detection at subsequent round after HPV clearance, and relative risks (RR) in comparison with HPV-negative women (with 95% confidence interval).Results: Data on 1230 women (1027 aged 25-64 years and 203 aged 35-64 years) have been analysed. Overall compliance with repeat HPV testing was 84%. In comparison with HPV-negative women, those with a transient HPV infection had higher proportions of HPV positivity (15% versus 3.7%) and of CIN2+ lesions (0.87% versus 0.23%) in round two; most of these (7/10) were CIN2; no cancers were detected, and CIN3 occurred in 3/1230 (0.24%).Conclusions: HPV-based protocols for cervical cancer screening allow long intervals for HPV-negative women; it is important to monitor the clinical outcome in the women with transient high-risk HPV infection. CIN3 detection is similar to that observed in routine European cytology-based screening programmes (CIN3+: 2.7‰); 5-year intervals may provide reasonable protection but longer intervals are not recommended.Tweetable Abstract: A screening interval of 5 years (but no longer) appears safe in women with transient HPV detection. [ABSTRACT FROM AUTHOR]

Objective: To compare the results from an initial negative human papillomavirus (HPV) test with re-screening after 3 years in women attending two HPV-based screening programmes.Design: Population-based cohort study.Setting: Two cervical service screening programmes in Italy.Population: Women aged 25-64 years invited to screening from April 2009 to October 2015.Methods: Eligible women were invited to undergo an HPV test. Those with a negative HPV test went on to the next screening round 3 years later. Cytology triage was performed for HPV+ (HPV by Hybrid Capture 2) samples, with immediate colposcopy (if abnormal) and HPV re-testing 1 year later (if negative).Main Outcome Measures: Participation rate, positivity at HPV and at triage, referral rate to colposcopy, positive predictive value for cervical intraepithelial neoplasia grade 2+ (CIN2+) at colposcopy, and detection rate for CIN2+.Results: We present the results from 48 751 women at the first screening and 22 000 women at re-screening 3 years later. The response rate was slightly higher at the second screening (74.5 versus 72.1% at the first screening; referral rate, RR 1.11; 95% confidence interval, 95% CI, 1.07-1.14). Compared with the first screening, we observed a significant reduction at the second screening in terms of HPV positivity (RR 0.55, 95% CI 0.51-0.60), referral rate to colposcopy (RR 0.47, 95% CI 0.41-0.53), CIN2+ detection rate (RR 0.24, 95% CI 0.13-0.39), and positive predictive value (PPV) for CIN2+ at colposcopy (RR 0.51, 95% CI 0.29-0.87).Conclusions: The very low frequency of disease and inadequate PPV at colposcopy indicate that a 3-year interval after a negative HPV test is too short.Tweetable Abstract: Three years after a negative HPV the frequency of cervical disease is so low that re-screening is inefficient. [ABSTRACT FROM AUTHOR]