Roadmap to improve the organized cancer screening programs - The case of colorectal cancer screening in Montenegro.

BACKGROUND: Implementation of organized cancer screening programs comes with many challenges and barriers, which may inhibit the achievement of the screening activities' desired benefits. In this paper we outline a plan for improving the colorectal cancer (CRC) screening system in Montenegro. METHODS: We formulated a roadmap, which was generally defined as a country-specific strategic plan to improve cancer screening programs. The roadmap development was an iterative, step-by-step process. First, we described the current screening program, then identified and described key barriers, and finally proposed actions to overcome them. Multiple sources of information (e.g., documents, expert opinions) were collected and processed by local and international stakeholders. RESULTS: The CRC screening program was implemented between 2013-2019 by gradually increasing the invitation of the target population. Key barriers of the implementation were defined: 1) Lack of colonoscopy capacity in the northern part of the country; 2) Inadequate information technology systems; 3) Inadequate public promotion of screening. The defined actions were related to overcoming lack of available resources (e.g., financial, human and technological), to improve the policy environment and the knowledge, and to facilitate information sharing. CONCLUSION: The collaboration between local stakeholders of CRC screening and researchers experienced in planning and evaluating screening programs resulted in the first comprehensive description of CRC screening in Montenegro, detailed understanding of key barriers that emerged during implementation and a carefully designed list of actions. The implementation of these actions and the evaluation of whether barriers were solved will be captured in the upcoming period by maintaining this collaboration.

Testing behavioral economics messages to increase non-responders' participation in organized colorectal cancer-screening programs: A randomized controlled trial.

This study aimed to evaluate the impact of behavioral economic-inspired messages on participation in colorectal cancer (CRC) screening programs. We conducted a randomized-controlled trial involving 11,505 non-responders to the CRC screening programs in Florence, Rome, and Turin in 2020. Participants aged 54-70 years were randomly assigned to four conditions. Individuals in the control conditions received a standard invitation letter while the three intervention groups included an additional paragraph featuring either i. normative feedback [F] message (giving feedback that invited subjects did not participate); ii. Minority norm [MN] message (only a minority did not participate); iii. F+ MN message (combining both messages). The primary outcome was the screening participation rate 90 days after the invitation was completed. A multivariate analysis was conducted adjusting for gender, age and birthplace. Overall, screening participation rates were 5.3% in the control condition, 7.0% in the F, 8.2% in the MN, and 7.4% in the F + MN arms (p = 0.002). Invited subjects in the MN arm were more likely to participate (adjusted Odds Ratio[aOR] = 1.38; 95% Confidence Interval [95%CI,1.13-1.68]), particularly those aged 54-59 years (aOR = 1.52; 95%CI:1.16-1.98), and 60-64 (aOR = 1.57; 95%CI:1.62-; 95%CI: 1.06-2.48). Additionally, individuals aged 60-64 invited in F and F + MN arms demonstrated a higher likelihood of participation (aOR for F arm = 1.60; 95%CI: 1.06-2.41; aOR for F + MN arm = 1.99; 95%CI: 1.35-2.92). The inclusion of MN and/or F messages in the invitation letter increased participation among previous non-responders <65 years. Behavioral economics is a promising area of interest for enhancing CRC screening participation. TRIAL REGISTRATION: ISRCTN registration number: ISRCTN11841256.

Overcoming barriers: Modelling the effect of potential future changes of organized breast cancer screening in Italy.

OBJECTIVES: Organized breast cancer screening may not achieve its full potential due to organizational and cultural barriers. In Italy, two identified barriers were low attendance in Southern Italy and, in Italy as a whole, underscreening and overscreening in parts of the eligible population. The objective of this study was to identify potential changes to overcome these barriers and to quantify their costs and effects. METHODS: To assess the impact of potential measures to improve breast cancer screening in Italy, we performed an evaluation of costs and effects for increasing adherence for Southern Italy and harmonizing screening intervals (biennial screening) for the whole of Italy, using an online tool (EU-TOPIA evaluation tool) based on the MIcrosimulation SCreening ANalysis (MISCAN) model. RESULTS: Increasing adherence in Southern Italy through investing in mobile screening units has an acceptable cost-effectiveness ratio of €9531 per quality-adjusted life year gained. Harmonizing the screening interval by investing in measures to reduce opportunistic screening and simultaneously investing in mobile screening units to reduce underscreening is predicted to gain 1% fewer life-years, while saving 19% of total screening costs compared to the current situation. CONCLUSIONS: Increasing adherence in Southern Italy and harmonizing the screening interval could result in substantial improvements at acceptable costs, or in the same benefits at lower costs. This example illustrates a systematic approach that can be easily applied to other European countries, as the online tools can be used by stakeholders to quantify effects and costs of a broad range of specific barriers, and ways to overcome them.

Performance indicators in breast cancer screening in the European Union: A comparison across countries of screen positivity and detection rates.

Comparable performance indicators for breast cancer screening in the European Union (EU) have not been previously reported. We estimated adjusted breast cancer screening positivity rate (PR) and detection rates (DR) to investigate variation across EU countries. For the age 50-69 years, the adjusted EU-pooled PR for initial screening was 8.9% (cross-programme variation range 3.2-19.5%) while DR of invasive cancers was 5.3/1,000 (range 3.8-7.4/1,000) and DR of ductal carcinoma in situ (DCIS) was 1.3/1,000 (range 0.7-2.7/1,000). For subsequent screening, the adjusted EU-pooled PR was 3.6% (range 1.4-8.4%), the DR was 4.0/1,000 (range 2.2-5.8/1,000) and 0.8/1,000 (range 0.5-1.3/1,000) for invasive and DCIS, respectively. Adjusted performance indicators showed remarkable heterogeneity, likely due to different background breast cancer risk and awareness between target populations, and also different screening protocols and organisation. Periodic reporting of the screening indicators permits comparison and evaluation of the screening activities between and within countries aiming to improve the quality and the outcomes of screening programmes. Cancer Screening Registries would be a milestone in this direction and EU Screening Reports provide a fundamental contribution to building them.

Optimizing the Quality of Colorectal Cancer Screening Worldwide.

Screening, followed by colonoscopic polypectomy (or surgery for malignant lesions), prevents incident colorectal cancer and mortality. However, there are variations in effective application of nearly every aspect of the screening process. Screening is a multistep process, and failure in any single step could result in unnecessary morbidity and mortality. Awareness of variations in operator- and system-dependent performance has led to detailed, comprehensive recommendations in the United States and Europe on how colonoscopy screening should be performed and measured. Likewise, guidance has been provided on quality assurance for nonprimary colonoscopy-based screening programs, including strategies to maximize adherence. Quality improvement is now a validated science, and there is clear evidence that higher quality prevents incident cancer and cancer death. Quality must be addressed at the levels of the system, provider, and individuals, to maximize the benefits of screening for any population. We review the important aspects of measuring and improving the quality of colorectal cancer screening.

Cost-effectiveness of colorectal cancer screening programmes using sigmoidoscopy and immunochemical faecal occult blood test.

OBJECTIVE: Several European countries are implementing organized colorectal cancer (CRC) screening programmes using faecal immunochemical test (FIT) and/or flexible sigmoidoscopy (FS), but the cost-effectiveness of these programmes is not yet available. We aimed to assess cost-effectiveness, based on data from the established Piedmont screening programme. METHODS: Using the Piedmont programme data, a Markov model was constructed comparing three strategies in a simulated cohort of 100,000 subjects: single FS, biennial FIT, or sequential strategy (FS + FIT offered to FS non-responders). Estimates for CRC incidence and mortality prevention were derived from studies of organized screening. Cost analysis for FS and FIT was based on data from organized programmes. Incremental cost-effectiveness ratios (ICER) between the different strategies were calculated. Sensitivity and probabilistic analyses were performed. RESULTS: Direct costs for FS, and for FIT at first and subsequent rounds, were estimated as €160, €33, and €21, respectively. All the simulated strategies were effective (10-17% CRC incidence reduction) and cost-effective vs. no screening (ICER <€1000 per life-year saved). FS and FS + FIT were the only cost-saving strategies, with FS least expensive (€15 saving per person invited). FS + FIT and FS were the only non-dominated strategies. FS + FIT were more effective and cost-effective than FS (ICER €1217 per life-year saved). The residual marginal uncertainty was mainly related to parameters inherent to FIT effectiveness and adherence. CONCLUSIONS: Organized CRC screening programmes are highly cost-effective, irrespective of the test selected. A sequential approach with FS and FIT appears the most cost-effective option. A single FS is the least expensive, but convenient, approach.

A health systems approach to identifying barriers to breast cancer screening programmes. Methodology and application in six European countries.

The benefits of population-based screening for breast cancer are now accepted although, in practice, programmes often fail to achieve their full potential. In this paper, we propose a conceptual model that situates screening programmes within the broader health system to understand the factors that influence their outcomes. We view the overall screening system as having multiple sub-systems to identify the population at risk, generate knowledge of effectiveness, maximise uptake, operate the programme, and optimise follow-up and assurance of subsequent treatment. Based on this model we have developed the Barriers to Effective Screening Tool (BEST) for analysing government-led, population-based screening programmes from a health systems perspective. Conceived as a self-assessment tool, we piloted the tool with key informants in six European countries (Estonia, Finland, Hungary, Italy, The Netherlands and Slovenia) to identify barriers to the optimal operation of population-based breast cancer screening programmes. The pilot provided valuable feedback on the barriers affecting breast cancer screening programmes and stimulated a greater recognition among those operating them of the need to take a health systems perspective. In addition, the pilot led to further development of the tool and provided a foundation for further research into how to overcome the identified barriers.

Results of a health systems approach to identify barriers to population-based cervical and colorectal cancer screening programmes in six European countries.

The aim of this study was to identify barriers to effective cervical and colorectal cancers screening programmes in Europe. The Barriers to Effective Screening Tool (BEST), based on a health systems approach, was completed by teams of three to six experts on cancer screening in each of the six countries involved in leading the EU-TOPIA project (TOwards imProved screening for breast, cervical and colorectal cancer In All of Europe). While the basic components of screening systems and the challenges they face, such as low participation, are similar, there are also many differences, both in the structures underpinning particular functions, such as maintenance of populationregisters and monitoring outcomes, and the ways that they operate. Many of these lie outside the strict organisational boundaries of screening programmes. BEST offers a means to identify and prioritise issues for further detailed exploration. The holistic health systems approach to assessing barriers differs from previous approaches. Those focus on individual characteristics that determine participation. The approach described here provides additional opportunities to improve outcomes with measures that are largely within the control of those managing the health system.

A comparative effectiveness trial of two faecal immunochemical tests for haemoglobin (FIT). Assessment of test performance and adherence in a single round of a population-based screening programme for colorectal cancer.

AIM: To compare acceptability and diagnostic accuracy of a recently available faecal immunochemical test (FIT) system (HM-JACKarc) with the FIT routinely used in an established screening programme (OC-Sensor). DESIGN: Randomised controlled trial (ISRCTN20086618) within a population-based colorectal cancer (CRC) screening programme. Subjects eligible for invitation in the Umbria Region (Italy) programme were randomised (ratio 1:1) to be screened using one of the FIT systems. RESULTS: Screening uptake among the 48 888 invitees was the same for both systems among subjects invited in the first round and higher with OC-Sensor than with HM-JACKarc (relative risk (RR): 1.03; 95% CI 1.02 to 1.04) among those invited in subsequent rounds. Positivity rate (PR) was similar with OC-Sensor (6.5%) as with HM-JACKarc (6.2%) among subjects performing their first FIT screening and higher with OC-Sensor (5.6%, RR: 1.25, 95% CI 1.12 to 1.40) than with HM-JACKarc (4.4%) among those screened in previous rounds. Positive predictive value (PPV) (OC-Sensor: 25.9%, HM-JACKarc: 25.6%) and detection rate (DR) (OC-Sensor: 1.40%; HM-JACKarc: 1.42%) for advanced neoplasia (AN: CRC + advanced adenoma) were similar among subjects performing their first FIT screening. The differences in the AN PPV (OC-Sensor: 20.3%, HM-JACKarc: 22.6%) and DR (OC-Sensor: 0.96%, HM-JACKarc: 0.83%) among those screened in previous rounds were not statistically significant. The number needed to scope to detect one AN was 3.9 (95% CI 5.8 to 2.9) and 3.9 (95% CI 5.5 to 2.9) at first and 4.9 (95% CI 5.8 to 4.2) and 4.4 (95% CI 5.3 to 3.7) at subsequent screening, with OC-Sensor and HM-JACKarc, respectively. CONCLUSIONS: Our results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting. TRIAL REGISTRATION NUMBER: ISRCTN20086618; Results.

A comparison of different strategies used to invite subjects with a positive faecal occult blood test to a colonoscopy assessment. A randomised controlled trial in population-based screening programmes.

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.

Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial.

BACKGROUND: Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening. METHODS/DESIGN: An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected. DISCUSSION: This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01739608.

CT colonography: preliminary assessment of a double-read paradigm that uses computer-aided detection as the first reader.

PURPOSE: To compare diagnostic performance and time efficiency of double-reading first-reader computer-aided detection (CAD) (DR FR CAD) followed by radiologist interpretation with that of an unassisted read using segmentally unblinded colonoscopy as reference standard. MATERIALS AND METHODS: The local ethical committee approved this study. Written consent to use examinations was obtained from patients. Three experienced radiologists searched for polyps 6 mm or larger in 155 computed tomographic (CT) colonographic studies (57 containing 10 masses and 79 polyps ≥ 6 mm). Reading was randomized to either unassisted read or DR FR CAD. Data sets were reread 6 weeks later by using the opposite paradigm. DR FR CAD consists of evaluation of CAD prompts, followed by fast two-dimensional review for mass detection. CAD sensitivity was calculated. Readers' diagnoses and reviewing times with and without CAD were compared by using McNemar and Student t tests, respectively. Association between missed polyps and lesion characteristics was explored with multiple regression analysis. RESULTS: With mean rate of 19 (standard deviation, 14; median, 15; range, 4-127) false-positive results per patient, CAD sensitivity was 90% for lesions 6 mm or larger. Readers' sensitivity and specificity for lesions 6 mm or larger were 74% (95% confidence interval [CI]: 65%, 84%) and 93% (95% CI: 89%, 97%), respectively, for the unassisted read and 77% (95% CI: 67%, 85%) and 90% (95% CI: 85%, 95%), respectively, for DR FR CAD (P = .343 and P = .189, respectively). Overall unassisted and DR FR CAD reviewing times were similar (243 vs 239 seconds; P = .623); DR FR CAD was faster when the number of CAD marks per patient was 20 or fewer (187 vs 220 seconds, P <01). Odds ratio of missing a polyp with CAD decreased as polyp size increased (0.6) and for polyps visible on both prone and supine scans (0.12); it increased for flat lesions (9.1). CONCLUSION: DR FR CAD paradigm had similar performance compared with unassisted interpretation but better time efficiency when 20 or fewer CAD prompts per patient were generated.

[Methods to increase participation in cancer screening programmes]. / Metodi per aumentare la partecipazione ai programmi di screening oncologici.

OBJECTIVE: to synthesize scientific evidences about methods to increase cervical, breast and colorectal cancer screening participation. METHODS: a multidisciplinary working group has been set up to define the scope of the report and to conduct the evaluation. The scope and the final evaluation have been submitted to a stakeholder committee, including the Ministry of Health, the National Screening Observatory, regional screening program coordinators, scientific societies, and Lega Italiana Lotta ai Tumori, for comments and integrations. A systematic review of the principal biomedical and social literature databases was conducted to identify experimental and observational studies, updating the existing review by Jepson and coll. (Health Technol Assess. 2000;4(14):i-vii, 1-133). RESULTS: 5900 have been identified, 900 relevant for the topic.Among those, 148 reported quantitative information on intervention efficacy, other 90 came from the previous review. Organised screening programmes, based on invitation letter or on GP involvement,were consistently effective in increasing participation compared to spontaneous screening. Interventions are classified according to their target: individual, community, test simplification, health operators, health service organization. The report presents meta-analyses on efficacy, analyses of cost-effectiveness, impact on organisation and social inequality, and ethical and legal issues, of all the intervention reported in the literature. CONCLUSIONS: there are several interventions consistently effective in any context, some of them have minimal impact on costs and health service resources.

Standardization of whole slide image morphologic assessment with definition of a new application: Digital slide dynamic morphometry.

BACKGROUND: In histopathology, the quantitative assessment of various morphologic features is based on methods originally conceived on specific areas observed through the microscope used. Failure to reproduce the same reference field of view using a different microscope will change the score assessed. Visualization of a digital slide on a screen through a dedicated viewer allows selection of the magnification. However, the field of view is rectangular, unlike the circular field of optical microscopy. In addition, the size of the selected area is not evident, and must be calculated. MATERIALS AND METHODS: A digital slide morphometric system was conceived to reproduce the various methods published for assessing tumor budding in colorectal cancer. Eighteen international experts in colorectal cancer were invited to participate in a web-based study by assessing tumor budding with five different methods in 100 digital slides. RESULTS: The specific areas to be tested by each method were marked by colored circles. The areas were grouped in a target-like pattern and then saved as an .xml file. When a digital slide was opened, the .xml file was imported in order to perform the measurements. Since the morphometric tool is composed of layers that can be freely moved on top of the digital slide, the technique was named digital slide dynamic morphometry. Twelve investigators completed the task, the majority of them performing the multiple evaluations of each of the cases in less than 12 minutes. CONCLUSIONS: Digital slide dynamic morphometry has various potential applications and might be a useful tool for the assessment of histologic parameters originally conceived for optical microscopy that need to be quantified.

How to enhance physician and public acceptance and utilisation of colon cancer screening recommendations.

Colorectal Cancer (CRC) screening delivery is a multidisciplinary undertaking, aiming at reducing mortality from and incidence of CRC without adversely affecting the health status of participants. The adoption of a public health perspective involves commitment to ensure equity of access and sustainability of the program over time. We reviewed available evidence concerning predictors of CRC screening uptake and the impact of interventions to improve adoption of screening using conceptual frameworks defining the role of determinants of preventive behaviours and the reach and target of interventions. The results of this review indicate that policy measures aimed at supporting screening delivery, as well as organisational changes, influencing the operational features of preventive services, need to be implemented, in order to allow individual's motivation to be eventually realised. To ensure coverage and equity of access and to maximise the impact of the intervention, policies aimed at implementing organised programs should be adopted, ensuring that participation in screening and any follow-up assessment should not be limited by financial barriers. Participants and providers beliefs may determine the response to different screening modalities. To achieve the desired health impact, an active follow-up of people with screening abnormalities should be implemented, supported by the introduction of infrastructural changes and multidisciplinary team work, which can ensure sustainability over time of effective interventions. Continuous monitoring as well as the adoption of plans to evaluate for program effectiveness represent crucial steps in the implementation of a successful program.

[Effective laws for tobacco control: EU directives and Italian legislation]. / Interventi legislativi efficaci per il controllo del tabagismo: direttive dell'Unione Europea e applicazioni in Italia.

Effective tobacco control policies include law issuing: bans/restrictions on smoking in public areas and workplaces, increasing of taxes on tobacco products, bans on advertising of tobacco products, warning labels on cigarette boxes. For some of these policies the European Union (EU) has introduced specific directives that EU member states have to put into law. This paper briefly presents literature data, EU directives and the laws consequently issued in Italy. The importance of standardizing European legislation, especially for those policies that are not enforced by EU directives is also discussed. In Italy and in some other European countries smoking is forbidden in public and work-places, despite no EU directive. The positive impact of this ban in these countries suggests that it should be considered a priority in the European policies against tobacco in order to reduce the gap between literature recommendations and actions.

Predicting proximal advanced neoplasms at screening sigmoidoscopy.

PURPOSE: This study was designed to assess the predictive value for advanced proximal neoplasms (cancer, adenoma > or = 10 mm, or villous component > 20 percent, or severe dysplasia) of the characteristics of distal polyps. METHODS: The study was conducted among patients, aged 55 to 64 years, referred for colonoscopy in the Italian trial of sigmoidoscopy screening for colorectal cancer. Patients reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. We compared the prevalence of advanced proximal neoplasia in patients with "low-risk" (1-2 tubular adenomas, < 10 mm, with low-grade dysplasia, or hyperplastic polyp) and in those with "high-risk" (size, > or = 10 mm, or > or = 3 adenomas, or villous component > 20 percent, or severe dysplasia) polyps in the distal colon. RESULTS: Of 426 patients with polyps > 5 mm, 29 (6.9 percent) were detected with an advanced proximal neoplasm (including 4 colorectal cancers). The prevalence of proximal advanced neoplasia was 9.4 percent among patients with high-risk distal polyps and 2.5 percent among those with low-risk lesions (adjusted odds ratio, 3.19; 95 percent confidence interval, 1.06-9.59). Approximately 40 people with low-risk distal polyps 6 to 9 mm should undergo colonoscopy to detect one proximal advanced neoplasm; the corresponding number for patients with high-risk distal polyps is 10. CONCLUSIONS: The 2.5 percent prevalence of proximal advanced neoplasms among people with low-risk 6-mm to 9-mm distal polyps is similar to the prevalence observed among people without distal polyps. Restricting colonoscopy referral to patients with high-risk distal polyps might represent a cost-effective strategy in a screening context.

Baseline findings of the Italian multicenter randomized controlled trial of "once-only sigmoidoscopy"--SCORE.

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.