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Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of populationbased screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on colonoscopic surveillance following adenoma removal includes 24 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of surveillance and other elements in the screening process, including multi-disciplinary diagnosis and management of the disease. [ABSTRACT FROM AUTHOR]

Background: A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening.Methods: We conducted a randomized controlled trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236,568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56,532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17,148) or the control group (no further contact; n = 17,144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance.Results: A total of 34,272 subjects (17,136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100,000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100,000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18% (rate ratio [RR] = 0.82, 95% confidence interval [CI] = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22% (RR = 0.78; 95% CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31% (RR = 0.69; 95% CI = 0.56 to 0.86) and mortality was reduced by 38% (RR = 0.62; 95% CI = 0.40 to 0.96) compared with the control group.Conclusion: A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality. [ABSTRACT FROM AUTHOR]

Background: A single sigmoidoscopy examination at around age 60 years has been proposed as a cost-effective strategy to prevent colorectal cancer. A multicenter randomized controlled trial, the SCORE trial, is in progress in Italy to estimate the impact of this strategy on colorectal cancer incidence and mortality and the duration of the protective effect. We present the baseline screening outcomes.Methods: A questionnaire was mailed to a random sample of 236 568 people aged 55-64 years to assess their eligibility for and interest in screening. Those reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. Eligible, interested respondents were assigned randomly to the control group (no further contact) or the intervention group (invitation to undergo sigmoidoscopy). Screenees with colorectal cancer, polyps larger than 5 mm, three or more adenomas, adenomas 5 mm or smaller with a villous component of more than 20%, or severe dysplasia were referred for colonoscopy.Results: Of the 56 532 respondents (23.9% of those invited), 34 292 were enrolled and 17 148 were assigned to the screening group. Of those, 9999 attended and 9911 were actually examined by sigmoidoscopy. Distal adenomas were detected in 1070 subjects (10.8%). Proximal adenomas were detected in 116 of 747 (15.5%) subjects without cancer at sigmoidoscopy who then underwent colonoscopy. A total of 54 subjects was found to have colorectal cancer, a rate of 5.4 per 1000 (54% of which were Dukes' A). The procedures were relatively safe, with two perforations (one in 9911 sigmoidoscopy exams and one in 775 colonoscopies) and one hemorrhage requiring hospitalization after polypectomy during colonoscopy. The pain associated with sigmoidoscopy was described as mild or less than expected by 83.3% of the screenees.Conclusion: Sigmoidoscopy screening is generally acceptable to recipients and safe. The high yield of advanced adenomas is consistent with the projected impact of sigmoidoscopy screening on colorectal cancer incidence. [ABSTRACT FROM AUTHOR]

The article presents a research that compares the efficacy between surgical and endoscopic cancer treatment of non-screen-detected and screen detected colorectal cancers of patients in Milan, Italy. Of the 228 colorectal cancer surgical operations done between January 2006 and August 2008, 106 of them were screen detected and 38 of the surgeries done were cancerous polyps. Meanwhile, of the 122 surgeries done on non-screen-detected cancers, 14 of them are cancerous polyps. Researchers found that tumuours found through screen detection showed favorable staging compared to lesions found through non-screen detection.

Objectives: A key element in ensuring appropriate balance of harms and benefits in cancer screening is to develop a priority set of performance and outcome indicators to be used in screening data evaluation systems. These indicators need to be equity-focused, aligned to new screening approaches and broad-based to cover possible opportunistic screening, but at the same time as limited as possible., Study Design: Indicators for breast, colorectal and cervical cancer screening programs were chosen through a consensus building Delphi methodology involving a panel of cancer screening experts., Methods: The list of indicators was developed using a multistage process. First, a systematic search was performed along with an extensive grey literature search to identify all potential existing indicators. Next, these indicators were refined by two expert groups, definitions and calculations were agreed upon, redundant indicators removed. A final list of 38 indicators was put forward into a Delphi study. 33 cancer screening experts were invited to take part. The Delphi study consisted of two rounds of an online survey and an online facilitated discussion between the cancer screening experts., Results: 23 indicators were chosen covering 10 predefined indicator categories with detection rate, examination coverage and interval cancer rate deemed most important. Outcome indicators such as crude incidence rate and time from screen to result notification, while ultimately reaching consensus were deemed of less importance., Conclusion: 23 priority indicators cover the entire screening pathway including harms, barriers and inequalities. These indicators have been piloted by the CanScreen-ECIS project., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

A guideline panel formulated a set of recommendations for breast cancer screening and diagnosis to implement clinical activities in Italy in alignment with the European Breast Cancer Guidelines on Screening and Diagnosis (European Commission Initiative on Breast Cancer-ECIBC). The panel issued national recommendations through adopting, adapting, and/or developing recommendations from the European guidelines (ADOLOPMENT approach). This process utilizes the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence to decision (EtD) framework. An additional PubMed search was conducted using search terms specific to Italy to tailor the EU guidelines to the national context. Nine articles were included as contextual evidence in the EtD. A total of 13 recommendations were finalized, either adapted or adopted to suit the national context. Organized breast cancer screening is strongly recommended for women aged 50-69 every 2 years, and it is conditionally recommended every 3 years for women aged 70-74, as well as every 1 or 2 years for women aged 45-49. Annual mammography received a strong recommendation against for women aged 50 and older. Developing shared national guidelines for the management of mammography screening will improve the standardization of processes across all settings, thereby promoting health equity., Competing Interests: Declarations. Conflict of interest: Silvia Deandrea is the President of the Italian Mammography Screening Group; Marco Rosselli Del Turco was a medical consultant for senology at FORA s.p.a. Paolo Giorgi Rossi is a member of the panel that developed the European guidelines on breast cancer screening and diagnosis, referred document for the ADOLOPMENT process; Livia Giordano is a member of the panel that developed the European guidelines on breast cancer screening and diagnosis, referred document for the ADOLOPMENT process; Elena Parmelli was a contract staff member at the Joint Research Centre (JRC) of the European Commission, Ispra, VA (Italy); Cannatà Vittorio has been Vice-President of the Italian Association of Medical Physics (AIFM); Isabella Castellano has been professional consultant for symposium “Choosing the best therapy in ER + /HER2- breast cancer” (Token of attendance at the National Congress of Anatomic Pathology, October 2019), Myriad Genetics, s.r.l.; Stefano Pacifici is the President of the Italian Association of Senology Radiographers (AITeRS); Trianni Annalisa is a member of the Italian Association of Medical Physics (AIFM); Paola Golinelli was reimbursed for participation in the European Federation of Organization for Medical Physics (EFOMP) Working Group on mammographic tomosynthesis equipment. Pierpaolo Pattacini received a software by I-CAD. The other authors have no relevant financial or non-financial interest to disclose. Competing interests: All panellists were required to disclose all financial, non-financial, personal, and institutional interests relevant to the scope of the guidelines by completing a standardized form, following SNLG guidance. The Scientific Committee (SC) assessed each individual interest, and ultimately, no panellist was excluded from the voting procedures. This policy was upheld throughout the entire process, including the selection of panel members, the generation and prioritization of research questions, and participation in the formulation of recommendations. The SC consistently monitored the declaration of conflicts of interest (COI). Ethical approval: Ethical approval was not necessary for this kind of scientific work. Informed consent: Not applicable., (© 2024. Italian Society of Medical Radiology.)

Background & Aims: A significant number of post fecal immunochemical test (FIT) colonoscopies in European-organized colorectal cancer (CRC) screening programs are performed beyond the recommended 31-day threshold due to overburdened colonoscopy services. We aimed to develop a simple predictive model to stratify CRC risk of FIT+ patients., Methods: In a cohort of screenees undergoing colonoscopy following a positive (≥20 μg hemoglobin/g feces) OC-sensor FIT result between 2004 and 2019, we derived and validated logistic regression-based models including variables independently associated with CRC and advanced neoplasms. Odds ratios (ORs) and 95% confidence intervals (CIs) were reported., Results: Overall, 40,276 patients (46% female; mean age, 66 ± 4 years) undergoing post FIT colonoscopy were included. Variables independently associated with CRC were age ≥70 years (OR, 1.20; 95% CI, 1.03-1.40), male sex (OR, 1.23; 95% CI, 1.11-1.37), fecal hemoglobin level (50-199 μg/g: OR, 2.84; 95% CI, 2.47-3.27; ≥200 μg/g: OR, 6.91; 95% CI, 5.99-7.98), and first round of FIT (OR, 1.53; 95% CI, 1.35-1.73). The discriminative ability of the model was good (area under the receiver operating characteristic, 0.75; 95% CI, 0.73-0.77) in the validation cohort. Applying the model would lead to over two-thirds decrease in delayed CRC diagnoses, considering various scenarios of timely colonoscopy scheduling after FIT+., Conclusions: We derived and validated a predictive model for risk stratification of patients with positive FIT in a large CRC screening cohort. Applying our model in screening practice would allow policy makers to effectively prioritize FIT+ individuals based on the risk of CRC, substantially reducing the rate of delayed CRC diagnosis., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Randomized Controlled Trials (RCT) demonstrated that guaiac-based fecal occult blood test (gFOBT), sigmoidoscopy, or colonoscopy are effective at reducing colorectal cancer (CRC) risk and mortality. Even if the impact of fecal immunochemical test (FIT) has not been evaluated within population-based RCT with mortality as the outcome, the results of comparative analyses with gFOBT provide strong indirect evidence of its effectiveness. Extensive information is also available on sensitivity and specificity of FIT, compared with gFOBT. FIT has almost universally replaced gFOBT in organized screening programs worldwide. Using FIT as a comparator is an efficient way to evaluate the effectiveness of new tests, with respect to test performance and relevant intermediate outcomes such as rates of interval cancer and late-stage cancer incidence. Direct comparison with FIT in the pre-screening evaluation of the accuracy of the new test will guide selection of the cut-off of the new test, and document the potential gain in sensitivity. Comparison in cross-sectional single-round screening evaluation can either use paired or parallel designs. Only parallel designs allow direct comparisons of participation rates. Relative accuracy can be derived in both designs with an assumption of similar colorectal cancer and precursor prevalence between groups in parallel designs. Finally, multiple-rounds prospective comparison will document potential effect on risk of CRC and precancerous lesions, and on absolute reductions in late-stage incidence as a proxy of mortality. This paper provides an overview of evidence and rationale for using FIT as a comparator for evaluating new non-invasive tests with repeated testing at short intervals., Competing Interests: Declarations Conflict of interest None declared., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The fecal immunochemical test for hemoglobin (FIT) is now a widely used non-invasive test in population-based organized screening programs for colorectal neoplasia. The positivity thresholds of tests currently in use are based on the fecal hemoglobin concentration (f-Hb), but the rationale for the adopted thresholds are not well documented. To understand current global usage of FIT in screening programs we conducted an international survey of the brands of FIT used, the f-Hb positivity threshold applied and the rationale for the choice., Methods: All members of the World Endoscopy Organization CRC Screening Committee were invited to complete an eight-element initial electronic survey exploring the key aims. Responses were obtained from 63 individuals, representing 38 specific locations in 28 countries. A follow-up survey on technical issues was offered to the 38 locations, with replies from 17 sites in 13 countries., Results: In-use quantitative FIT were provided by four main manufacturers; Minaris Medical (2 countries), Eiken Chemical Company/Polymedco (21), Alfresa Pharma (2) and Sentinel Diagnostics (4). Of the 38 screening sites, 15 used the threshold of 20 µg hemoglobin/g feces, while thresholds ranged between 8.5 and 120 ug/g in the remainder. Seven explanations were given for adopted FIT thresholds; maximizing the sensitivity for colorectal neoplasia (n = 23) was the most common followed by the availability of colonoscopy resources (n = 18). Predictive value, specificity, and cost effectiveness were less frequently reported as the rationale. Nine sites found it necessary to change the threshold that they had initially selected., Conclusions: This international survey has documented the wide range of FIT positivity thresholds that are in current use. Quantitative FITs enable programs to achieve the desired program outcomes within available resource constraints by adjusting the positivity threshold. This supports the need for enabling positivity threshold adjustment of emerging new screening tests based on novel predictive biomarkers, rather than providing inflexible test endpoints., Competing Interests: Declarations Conflict of interest Graeme P Young: Consultancy—Health First Systems, Institutional research support–Eiken Chemical Company. Han-Mo Chiu: Speaker honorarium—Olympus, Fujifilm, Boston Scientific, Research funding—Boston Scientific, Volition Rx, aether AI. Evelien Dekker: Institutional research support—FujiFilm. Consultancy—Olympus, Fujifilm, Ambu, InterVenn, Norgine, and Exact Sciences. Speaker’s fees—Olympus, GI Supply, Norgine, IPSEN/Mayoly, and FujiFilm. Harminder Singh: COI: Consultancy/advisory boards—Abbvie Canada, Amgen Canada, Roche Canada, Sandoz Canada, Organon Canada, Eli Lilly Canada, Takeda Canada, Pendopharm Inc, and Guardant Health, Inc. Institutional research support—Pfizer. Shares—VasCon. Erin L Symonds: Institutional research support—Eiken Chemical Company and Health First Systems. The authors declare no competing interests, and no financial arrangements related to the research or assistance with manuscript preparation., (© 2024. The Author(s).)