How a faecal immunochemical test screening programme changes annual colorectal cancer incidence rates: an Italian intention-to-screen study.

BACKGROUND: This study aimed to evaluate the effectiveness of a biennial faecal immunochemical test (FIT) screening programme in reducing annual colorectal cancer (CRC) incidence in its dynamic target population. METHODS: The target population included over 1,000,000 persons aged 50-69 living in a region of northern Italy. The average annual response rate to invitation was 51.4%. Each observed annual age-standardised (Europe) rate per 100,000 persons between 2005, the year of introduction of the programme, and 2016 was compared with each expected annual rate as estimated with age-period-cohort (men) and age-period (women) models. RESULTS: For both sexes, the rates observed in 1997-2004 and those expected in 2005-2016 were stable. Observed rates increased in 2005, peaked in 2006 (the first full year of screening), dropped significantly below the expected level in 2009, and continued to decrease until 2013 (the eighth full year), after which no further significant changes occurred. In the pooled years 2013-2016, the observed incidence rate per 100,000 persons was 102.2 [95% CI: 97.4, 107.1] for men, 75.6 [95% CI: 71.6, 79.7] for women and 88.4 [95% CI: 85.3, 91.5] for both sexes combined, with an observed:expected incidence rate ratio of 0.68 [95% CI: 0.65, 0.71], 0.79 [95% CI: 0.76, 0.82] and 0.72 [95% CI: 0.66, 0.81], respectively. DISCUSSION: The study provided multiple consistent proofs of a causal relationship between the introduction of screening and a stable 28% decrease in annual CRC incidence after eight years.

Effects of Attendance to an Organized Fecal Immunochemical Test Screening Program on the Risk of Colorectal Cancer: An Observational Cohort Study.

BACKGROUND & AIMS: This cohort study compared colorectal cancer (CRC) incidence and mortality between people who participated in an Italian regional biennial fecal immunochemical test (FIT) screening program and people who did not. METHODS: The program started in 2005. The target population included over 1,000,000 people aged 50 to 69 years. The FIT was a one-sample OC-Sensor (Eiken Chemical Co, Tokyo, Japan) (cutoff, ≥20 µg hemoglobin/g feces). The average annual response rate to invitation was 51.4%. The records of people invited up to June 2016 were extracted from the screening data warehouse. Attenders were subjects who responded to the first 2 invitations or to the single invitation sent them before they became ineligible. Non-attenders were subjects who did not respond to any of these invitations. The records were linked with the regional CRC registry. People registered up to December 2016 were identified. Self-selection-adjusted incidence rate ratios (IRRs) and incidence-based CRC mortality rate ratios (MRRs) for attenders to non-attenders, with 95% confidence intervals (CIs), were calculated. RESULTS: The cohort generated 2,622,131 man-years and 2,887,845 woman-years at risk with 4490 and 3309 CRC cases, respectively. The cohort of attenders was associated with an IRR of 0.65 (95% CI, 0.61-0.69) for men, 0.75 (95% CI, 0.70-0.80) for women and 0.69 (95% CI, 0.66-0.72) for both sexes combined. The self-selection-adjusted IRR was 0.67 (95% CI, 0.62-0.72) for men and 0.79 (95% CI, 0.72-0.88) for women. The IRR for stage I, II, III, and IV CRC was 1.35 (95% CI, 1.20-1.50), 0.61 (95% CI, 0.53-0.69), 0.60 (95% CI, 0.53-0.68) and 0.28 (95% CI, 0.24-0.32) for men and 1.64 (95% CI, 1.43-1.89), 0.60 (95% CI, 0.52-0.69), 0.73 (95% CI, 0.63-0.85) and 0.35 (95% CI, 0.30-0.42) for women. The overall incidence-based CRC MRR was 0.32 (95% CI, 0.28-0.37) for men, 0.40 (95% CI, 0.34-0.47) for women and 0.35 (95% CI, 0.31-0.39) for both sexes combined. The adjusted MRR was 0.35 (95% CI, 0.29-0.41) for men and 0.46 (95% CI, 0.37-0.58) for women. CONCLUSIONS: Attendance to a FIT screening program is associated with a CRC incidence reduction of 33% among men and 21% among women, and a CRC mortality reduction of 65% and 54%, respectively.

Results of Compliant Participation in Five Rounds of Fecal Immunochemical Test Screening for Colorectal Cancer.

BACKGROUND & AIMS: We investigated the magnitude and temporal patterns of the decreasing trend in main performance measures of fecal immunochemical test (FIT) screening for colorectal cancer (CRC) observed in second and subsequent rounds. METHODS: We followed up 494,187 participants from the first round of a regional biennial FIT screening program in Italy (cut-off value for positivity, 20 µg hemoglobin/g feces) for 5 total rounds (2005-2016). At each round, only compliant participants were eligible. Performance measures from the first, third, fourth, and fifth rounds were compared with those from the second round (the first incidence round) using rate ratios from multivariate Poisson regression models and relative risk ratios from multinomial logistic regression models. RESULTS: Between the second and the third rounds, a significant 20% to 30% decrease was found in the proportion of men with a positive FIT result (from 5.2% to 4.3%) and in detection rates of advanced adenoma (from 13.4 to 10.2 per 1000), CRC (from 1.7 to 1.4 per 1000), and advanced neoplasia (from 15.1 to 11.6 per 1000). Positive predictive values (PPVs) decreased by 10% or less between the second and third rounds. Detection rates and PPVs for adenoma stabilized by the fourth and fifth rounds. The PPVs for advanced adenoma, CRC, and advanced neoplasia decreased slightly in men and women by the fourth and fifth rounds. The detection rate of proximal colon cancer stabilized after the second round, whereas the detection rate of distal colon cancer decreased until the fourth round in men (from 0.7 to 0.3 per 1000), and the fifth round in women. CONCLUSIONS: These findings support the notion that FIT screening prevents progression of a subset of advanced adenomas. Screening intensity could be modulated based on results from previous rounds, with a risk-based strategy.

[Oncological organized screening programmes in the COVID-19 era: an Italian survey on accrued delays, reboot velocity, and diagnostic delay estimates]. / Ritardi maturati dai programmi di screening oncologici ai tempi del COVID-19 in Italia, velocità della ripartenza e stima dei possibili ritardi diagnostici.

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.

Estimating the impact of an organised screening programme on cervical cancer incidence: A 26-year study from northern Italy.

The impact of the organised cervical cancer (CC) screening programmes implemented in Europe since the 1990s has been insufficiently evaluated. We investigated the changes in CC incidence following the introduction of a screening programme in the Emilia-Romagna Region (northern Italy). The study period was 1988-2013. The programme, targeting women aged 25-64 years (1,219,000 in 2018), started in 1998. The annual incidence rates that would be expected in 1998-2013 in the absence of screening were estimated, first, by analysing the annual rates in 1988-1997 with a log-linear model and, second, by analysing the annual rates in 1988-2013 with an age-period model in which the period effect was enforced to be linear. Cervical adenocarcinoma incidence trend over the entire period was used to validate both estimates. Observed annual rates were compared to the two series of expected ones with the incidence rate ratio (IRR). Incidence remained stable during 1988-1997, peaked in 1998 and then decreased until 2007, when it stabilised. The two series of expected rates were virtually coincident and their trends roughly paralleled the stable adenocarcinoma incidence trend. After 2007, the median IRR was 0.60 (95% confidence interval, 0.45-0.81) based on the log-linear model and 0.58 (95% confidence interval, 0.34-0.97) based on the age-period model. Thirty-six to seventy-five CC cases were prevented annually for an average annual frequency of 6.5 per 100,000 women in the target population. In summary, consistent circumstantial evidences were obtained that the organised screening programme brought about a 40% reduction in annual CC incidence after 10 years.

Annual mammography at age 45-49 years and biennial mammography at age 50-69 years: comparing performance measures in an organised screening setting.

OBJECTIVE: To compare the results of 5 years of annual mammography screening at age 45-49 with the results of 5 years of biennial screening at age 50-54 and 55-69. METHODS: In an Italian screening programme, data from 1,465,335 mammograms were analysed. Recall rates, invasive assessment rates, surgical biopsy (including excisional biopsy and definitive surgical treatment) rates, and cancer detection rates were calculated for the first screen (first) and, cumulatively, for the second and subsequent screens (second+). RESULTS: The rate ratios between younger women and the two groups of older ones were (in parentheses, original figures per 1000 mammograms if not otherwise specified): recall rate: first 1.11 (103.6 vs. 93.5) and 1.11 (vs. 93.2), second+ 2.10 (208.9 vs. 99.7) and 2.77 (vs. 75.5); invasive assessment rate: first 0.94 (23.0 vs. 24.5) and 0.94 (vs. 24.6), second+ 1.63 (35.8 vs. 22.0) and 1.56 (vs. 23.0); surgical biopsy rate: first 0.68 (5.9 vs. 8.6) and 0.45 (vs. 13.2), second+ 1.35 (11.5 vs. 8.5) and 0.88 (vs. 13.0); total detection rate: first 0.63 (4.3 vs. 6.7) and 0.37 (vs. 11.7), second+ 1.30 (8.9 vs. 6.8) and 0.74 (vs. 12.0); total positive predictive value of surgical biopsy: first 0.93 (72.8% vs. 78.0%) and 0.82 (vs. 88.9%), second+ 0.96 (77.2% vs. 80.5%) and 0.83 (vs. 92.7%). CONCLUSION: Younger women experienced two to threefold higher cumulative recall rates at second+ screens and limited differences in surgical biopsy rate. Albeit encouraging, these results must be completed with further investigation, especially on interval cancer incidence. KEY POINTS: • At repeated screens, cumulative recall rate was two- to threefold higher for younger women. • Differences in cumulative surgical referral and surgical biopsy rates were moderate. • Differences in positive predictive value of surgical biopsy were particularly small.

Extension of the target age range of mammography screening programme and governance of mammography practice in the Emilia-Romagna Region (Northern Italy). / Estensione dell'età-bersaglio del programma di screening mammografico e governo della pratica mammografica in Emilia-Romagna.

"OBJECTIVES: to evaluate the effectiveness of the regional law No.1035 enacted in 2009 by the local government of the Emilia- Romagna Region (Northern Italy) with the purpose of revising the rules of access to breast-care services. The law dictated the extension of the organised mammography screening programme to women aged 45-49 and 70-74 years in order to decrease their spontaneous screening rates and, thus, the waiting times for the access to diagnostic mammography by women of all ages. DESIGN: study of time trends (joinpoint regression analysis and before/ after analysis) in annual percent mammography rates and in waiting times for access to clinical radiology facilities (2006-2014) among resident women. The information was taken from the regional Department of Health. SETTING: public and accredited private radiology facilities. MAIN OUTCOME MEASURES: age-specific and waiting-time-specific (months) percent rates of organised screening mammography, spontaneous screening mammography, and diagnostic mammography. RESULTS: following the regional law No.1035, screening rates among women aged 45-49 and 70-74 years reached levels comparable to those attained by women aged 50-69 years. Spontaneous screening rates dropped and waiting times for spontaneous screening mammography (women aged 40-44 years) were cut. For diagnostic mammography, the rates remained stable, except for a decrease among women aged 35-39 and 45-49 years, and waiting times decreased in a constant manner over the study period. CONCLUSIONS: the above-mentioned law met most of its goals. Comprehensive programmes regulating mammography practice at the population level can be effective."

Appropriateness of endoscopic surveillance recommendations in organised colorectal cancer screening programmes based on the faecal immunochemical test.

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.

Colorectal cancer screening of immigrants to Italy. Figures from the 2013 National Survey.

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.

Screening for colorectal cancer in Italy: 2011-2012 survey.

We present the main results of the 2011-2012 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 2012, 112 programmes were active, of which 11 had been activated during 2012 and 4 during 2011. The national theoretical extension increased from 66% of Italians aged 50-69 years residing in areas covered by organized screening programmes in 2010 to 73.7% in 2012. The majority of programmes employ the fecal immunochemical test (FIT), while some have adopted flexible sigmoidoscopy (FS) once in a lifetime and FIT for non-responders to FS. Overall, about 7,744,000 subjects were invited to undergo FIT, 53.1% of those to be invited within the two years. The adjusted attendance rate was 47.1%and 3,531,937 subjects were screened. Large differences in the attendance rate were observed among regions. Positivity rate of FIT programmes was 5.2% at first screening (range: 1.0-12.4%) and 4.0% at repeat screening (range: 3.4-6.4%). The average attendance rate to total colonoscopy (TC) was 81.2% and in two regions (Molise and Campania) it was lower than 70%. Completion rate for total colonoscopy (TC) was 91%. Among the 1,316,327 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.0 for invasive cancer and 9.1 ‰ for advanced adenomas (AA, adenomas with a diameter ≥1 cm, with villous/tubulo-villous type or high-grade dysplasia). As expected, the corresponding figures in the 2,215,610 subjects at repeat screening were lower (1.0‰ and 6.8‰ for invasive cancer and AA, respectively). Many programmes reported some difficulties in guaranteeing TC in the appropriate time frame to FIT+ subjects: in 15% of cases the waiting time was longer than two months. Ten programmes in 2011 and eight in 2012 employed FS as the screening test: 24,549 subjects were screened in the two years, with an attendance rate of 24.5%. Overall, 85.9% of FSs were classified as complete. Overall, TC referral rate was 9.8% and the DR per 1,000 screened subjects was 3.0 and 48.2 for invasive cancer and AA, respectively.

Problems, solutions, and perspectives in the evaluation of interval cancers in Italian mammography screening programmes: a position paper from the Italian group for mammography screening (GISMa).

In this position paper, a self-convened team of experts from the Italian Group for Mammography Screening (Gruppo italiano screening mammografico, GISMa) pointed out the problems that increasingly hamper the feasibility and validity of the estimate of the proportional incidence of interval breast cancer (IBC) in Italy, suggested potential solutions and an agenda for research, and proposed that the question of the sensitivity of mammography be viewed in a larger perspective, with a greater attention to radiological review activities and breast radiology quality assurance programmes. The main problems are as follows: the coverage of cancer registration is incomplete; the robustness of using the pre-screening incidence rates as underlying rates decreases with time since the start of screening; the intermediate mammograms performed for early detection purposes may cause an overrepresentation of IBCs; the classification of many borderline screening histories is prone to subjectivity; and, finally, the composition of cohorts of women with negative screening results is uncertain, because several mammography reports are neither clearly negative nor clearly positive, and because of the limitations and instability of the electronic mammography records. Several possibilities can be considered to cope with these issues: standard methods for using the hospital discharge records in the identification of IBCs should be established; for the calculation of regional estimates of the underlying incidence, a suitable mathematical model should be identified; the definition of IBC according to the 2008 GISMa guidelines needs to be updated, especially with respect to in situ cancers and to invasive cancers with borderline screening histories; a closer adherence to standard screening protocols, with a simplified patient management, would make it easier to objectively identify IBCs; alternative methods for estimating the sensitivity of mammography should be taken into consideration; and, finally, analysis could be restricted to the absolute incidence rate of IBC, which would make comparison of the risk between neighbouring populations possible. Epidemiologists must extend their attention to the prevention of the risk of IBC and the implementation of breast radiology quality assurance practices. Epidemiologists and radiologists can share common objectives: it is necessary to promote the idea that the availability of a registry-based series of IBCs is not a prerequisite for their radiological review; radiological review of breast cancers greater than 20mm in size detected at second and subsequent screens, that are potential substitutes for IBCs, needs radiological and epidemiological validation studies; the advent of digital mammography brings about the possibility to create libraries of mammograms accessible online, which enables the conduct of large studies of the diagnostic variability of radiologists; and, finally, epidemiologists and radiologists have the responsibility to monitor the effects that a loss of cumulative professional experience in screening centres, due to the imminent retirement of a substantial proportion of healthcare workforce, could cause on their performance.

Rationale and development of an on-line quality assurance programme for colposcopy in a population-based cervical screening setting in Italy.

BACKGROUND: Colposcopy, the key step in the management of women with abnormal Pap smear results, is a visual technique prone to observer variation, which implies the need for prolonged apprenticeship, continuous training, and quality assurance (QA) measures. Colposcopy QA programmes vary in level of responsibility of organizing subjects, geographic coverage, scope, model, and type of actions. The programmes addressing the clinical standards of colposcopy (quality of examination and appropriateness of clinical decisions) are more limited in space and less sustainable over time than those focused on the provision of the service (resources, accessibility, etc.). This article reports on the protocol of a QA programme targeting the clinical quality of colposcopy in a population-based cervical screening service in an administrative region of northern Italy. METHODS/DESIGN: After a situation analysis of local colposcopy audit practices and previous QA initiatives, a permanent web-based QA programme was developed. The design places more emphasis on providing education and feedback to participants than on testing them. The technical core is a log-in web application accessible on the website of the regional Administration. The primary objectives are to provide (1) a practical opportunity for retraining of screening colposcopists, and (2) a platform for them to interact with colposcopists from other settings and regions through exchange and discussion of digital colposcopic images. The retraining function is based on repeated QA sessions in which the registered colposcopists log-in, classify a posted set of colpophotographs, and receive on line a set of personal feedback data. Each session ends with a plenary seminar featuring the presentation of overall results and an interactive review of the test set of colpophotographs. This is meant to be a forum for an open exchange of views that may lead to more knowledge and more diagnostic homogeneity. The protocol includes the criteria for selection of colpophotographs and the rationale for colposcopic gold standards. DISCUSSION: This programme is an ongoing initiative open to further developments, in particular in the area of basic training. It uses the infrastructure of the internet to give a novel solution to technical problems affecting colposcopy QA in population-based screening services.

The impact of the COVID-19 pandemic on Italian population-based cancer screening activities and test coverage: Results from national cross-sectional repeated surveys in 2020.

Background: In Italy, regions have the mandate to implement population-based screening programs for breast, cervical, and colorectal cancer. From March to May 2020, a severe lockdown was imposed due to the COVID-19 pandemic by the Italian Ministry of Health, with the suspension of screening programs. This paper describes the impact of the pandemic on Italian screening activities and test coverage in 2020 overall and by socioeconomic characteristics. Methods: The regional number of subjects invited and of screening tests performed in 2020 were compared with those in 2019. Invitation and examination coverage were also calculated. PASSI surveillance system, through telephone interviews, collects information about screening test uptake by test provider (public screening and private opportunistic). Test coverage and test uptake in the last year were computed by educational attainment, perceived economic difficulties, and citizenship. Results: A reduction of subjects invited and tests performed, with differences between periods and geographical macro areas, was observed in 2020 vs. 2019. The reduction in examination coverage was larger than that in invitation coverage for all screening programs. From the second half of 2020, the trend for test coverage showed a decrease in all the macro areas for all the screening programs. Compared with the pre-pandemic period, there was a greater difference according to the level of education in the odds of having had a test last year vs. never having been screened or not being up to date with screening tests. Conclusions: The lockdown and the ongoing COVID-19 emergency caused an important delay in screening activities. This increased the preexisting individual and geographical inequalities in access. The opportunistic screening did not mitigate the impact of the pandemic. Funding: This study was partially supported by Italian Ministry of Health - Ricerca Corrente Annual Program 2023 and by the Emilian Region DGR 839/22.

[Screening for colorectal cancer in Italy, 2010 survey]. / Lo screening colorettale in Italia, survey 2010.

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.

Clinical Epidemiology of Microinvasive Cervical Carcinoma in an Italian Population Targeted by a Screening Programme.

(1) Background: This population-based study aimed at identifying the factors associated with the likelihood of detection of stage IA cervical carcinoma-versus the detection of stage IB through IV cervical carcinoma-and the patterns of surgical treatment. (2) Methods: Between 1995-2016, 3750 patients living in the Emilia-Romagna Region (northern Italy) were registered with cervical carcinoma, including 2942 eligible patients (median age, 53). Multivariate analysis was performed using binary logistic regression models. (3) Results: The likelihood of stage IA cervical carcinoma (n = 876, 29.8%) did not change over time, decreased with increasing patient age, and was lower for patients with adenocarcinoma and grade 3-4 disease. Three hundred and fifty (40.0%) patients had a conservative treatment, 317 (36.2%) had hysterectomy, 197 (22.5%) had hysterectomy with lymph node dissection (LND), and 12 (1.4%) had a conservative treatment with LND. The proportion of hysterectomy decreased from 70.6% in 1995-1999 to 46.9% in 2011-2016. The likelihood of hysterectomy increased above the age of 40. Among screening-aged (25-64 years) patients, the likelihood of hysterectomy did not differ between screen-detected and non-screen-detected ones. Hysterectomy was increasingly combined with LND. High tumour grade was the strongest determinant of LND during hysterectomy. (4) Conclusions: This study provided a multifaceted overview of stage IA cervical carcinoma over the last decades.

Cancer screening programmes in Italy during the COVID-19 pandemic: an update of a nationwide survey on activity volumes and delayed diagnoses.

INTRODUCTION: In Italy, regional governments are in charge of implementing cervical, breast and colorectal cancer screening programmes. The 2020 Coronavirus pandemic led to a national lockdown and the temporary suspension of several non-urgent healthcare activities, including cancer screening. This paper aims to describe the results of a national survey carried out by the National Centre for Screening Monitoring (ONS) on cervical, breast and colorectal cancer screening activities in 2020. MATERIALS AND METHODS: A national survey was conducted by ONS in 2020 to assess: the number of screening invitations by Region; the volumes of screening tests and the attitude to attend the screening programme compared to 2019; the number of delayed diagnoses of malignant or pre-malignant lesions caused by the slowing down of screening programmes, based on the average Region-specific screening detection rate for cervical, breast and colorectal cancers. RESULTS: Screening tests for breast, colorectal and cervical cancer decreased by 37.6%, 45.5% and 43.4% in 2020 compared with 2019. In 2020 the estimated numbers of undiagnosed lesions are: 3,324 breast cancers, 1,299 colorectal cancers, 7,474 colorectal advanced adenomas and 2,782 CIN2 or more severe cervical lesions. Participation in cancer screening programmes decreased by 15%, 15% and 20%, for cervical, breast and CRC screening, respectively. DISCUSSION AND CONCLUSIONS: An urgent call to action is needed to prevent further delays and to limit the impact of the pandemic on cancer diagnosis and prevention.

Screening for colorectal cancer in Italy, 2009 survey.

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.

Screening for colorectal cancer in Italy: 2008 survey.

We present the main results from the fifth 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 2008, 87 programmes were active (14 had been activated during the year), and 52,9%of Italians aged 50- 69 years were residing in areas covered by organised screening programmes (theoretical extension). Ten Regions had their whole population covered. In the South of Italy and Islands, 12 new programmes were activated in 2008, including those of Abruzzo and Molise Regions, with an increase of theoretical extension from 7% to 21%. The majority of programmes employ the faecal occult blood test (FOBT), while some have adopted flexible sigmoidoscopy (FS) once in a lifetime, or a combination of both. Overall, about 2,593,000 subjects were invited to undergo FOBT, 71%of those to be invited within the year. The adjusted attendance rate was 47.5% and approximately 1,171,000 subjects were screened. Large differences in the attendance rate were observed among Regions, with 10% of programmes reporting values lower than 30%. Positivity rate of FOBT programmes was 5.9% at first screening (range 2.0-11%) and 4% at repeat screening (range 2.9-6.5%). The average attendance rate for total colonoscopy (TC) was 81.3% and in three Regions it was lower than 70%. Completion rate of TC was 92.2%. Among the 665,264 subjects attending screening for the first time, the detection rate (DR) per 1,000 screened subjects was 2.7 for invasive cancer and 13.1 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 552,391 subjects at repeat screening were lower (1.3‰ and 8.3‰ 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 16.0% of cases the waiting time was longer than two months. Seven programmes employed FS as the screening test: 58.8% of the target population (about 50,000 subjects) were invited and 8,135 subjects were screened, with an attendance rate of 27.2%. Overall, 83% of FS were classified as complete. Overall TC referral rate was 13.5% and the DR per 1,000 screened subjects was 4.7 and 47.5 for invasive cancer and AA, respectively.

Proportional incidence of interval colorectal cancer in a large population-based faecal immunochemical test screening programme.

BACKGROUND: The European guidelines for quality assurance in colorectal cancer (CRC) screening recommend that interval cancer rate be expressed as a proportion of background incidence rate. AIM: To determine the crude and adjusted proportional incidence of interval CRC in an Italian regional two-yearly faecal immunochemical test (FIT) screening programme. METHODS: The programme (year of implementation, 2005) is targeted at over 1,000,000 people aged 50-69 years. The test is a one-sample OC-Sensor (Eiken Chemical Co., Tokyo, Japan). The study covered one-third of the regional area. Excerpts of 434,295 eligible negative FIT records dated 2005-2012 from 193,193 subjects were retrieved from the regional CRC screening data warehouse. By 31 December 2013, the cohort accumulated 198,302 man-years and 235,370 woman-years. Interval CRCs were identified by record-linkage with the local population-based cancer registry. Their number was divided by the expected number, estimated with age-period-cohort models, to obtain the proportional incidence. RESULTS: The proportional incidence of interval CRC for men and women was, respectively, 0.06 (95% confidence interval (CI), 0.04-0.09) and 0.17 (95% CI, 0.13-0.23) in the first interval year, and 0.21 (95% CI, 0.16-0.26) and 0.28 (95% CI, 0.22-0.36) in the second year. CONCLUSIONS: The results were acceptable and in line with previous studies.