Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial.

BACKGROUND: Colorectal cancer screening is recommended for people aged 50-75 years, but the optimal screening test and strategy are not established. We aimed to compare single CT colonography versus three faecal immunochemical test (FIT) rounds for population-based screening of colorectal cancer. METHODS: This randomised controlled trial was done in Florence, Italy. Adults aged 54-65 years, never screened for colorectal cancer, were randomly assigned (1:2) by simple randomisation and invited by post to either a single CT colonography (CT colonography group) or three FIT rounds (FIT group; each round was done 2 years apart). Exclusion criteria included previous colorectal cancer, advanced adenoma, or inflammatory bowel disease, colonoscopy within the last 5 years or FIT within the last 2 years, and severe medical conditions. Participants who had a colonic mass or at least one polyp of 6 mm or more in diameter in the CT colonography group and those who had at least 20 µg haemoglobin per g faeces in the FIT group were referred for work-up optical colonoscopy. The primary outcome was detection rate for advanced neoplasia. Outcomes were assessed in the modified intention-to-screen and per-protocol populations. The trial is registered with ClinicalTrials.gov, NCT01651624. FINDINGS: From Dec 12, 2012, to March 5, 2018, 14 981 adults were randomised and invited to screening interventions. 5242 (35·0%) individuals (2809 [53·6%] women and 2433 [46·4%] men) were assigned to the CT colonography group and 9739 (65·0%) individuals (5208 [53·5%] women and 4531 [46·5%] men) were assigned to the FIT group. Participation in the screening intervention was lower in the CT colonography group (1286 [26·7%] of the 4825 eligible invitees) than it was for the FIT group (6027 [64·9%] of the 9288 eligible invitees took part in at least one screening round, 4573 [49·2%] in at least two rounds, and 3105 [33·4%] in all three rounds). The detection rate for advanced neoplasia of CT colonography was significantly lower than the detection rate after three FIT rounds (1·4% [95% CI 1·1-1·8] vs 2·0% [1·7-2·3]; p=0·0094) in the modified intention-to-screen analysis, but the detection rate was significantly higher in the CT colonography group than in the FIT group (5·2% [95% CI 4·1-6·6] vs 3·1% [2·7-3·6]; p=0·0002]) in the per-protocol analysis. Referral rate to work-up optical colonoscopy (the secondary outcome of the trial) was significantly lower for the CT colonography group than for the FIT group after three FIT rounds (2·7% [95% CI 2·2-3·1] vs 7·5% [7·0-8·1]; p<0·0001) in the modified intention-to-screen analysis, whereas no significant difference was observed in the per-protocol analysis (10·0% [8·4-11·8] vs 11·6% [10·8-12·4]). No major complications were observed in the CT colonography group after screening and work-up optical colonoscopy, whereas three cases of bleeding were reported in the FIT group after work-up optical colonoscopy (two after the first FIT and one after the second FIT). INTERPRETATION: Greater participation makes FIT more efficient than single CT colonography for detection of advanced neoplasia in population screening for colorectal cancer. Nonetheless, higher detection rate in participants and fewer work-up colonoscopies are possible advantages of CT colonography as a screening tool, which might deserve consideration in future trials. FUNDING: Government of Tuscany and Cassa di Risparmio di Firenze Foundation. TRANSLATION: For the Italian translation of the abstract see Supplementary Materials section.

Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the "ItaVision" randomized controlled trial.

BACKGROUND: The Endocuff Vision device (Arc Medical Design Ltd., Leeds, UK) has been shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicenter study assessed possible benefits and harms of using Endocuff Vision in a fecal immunochemical test (FIT)-based screening program. METHODS: Patients undergoing colonoscopy after a FIT-positive test were randomized 1:1 to undergo Endocuff-assisted colonoscopy or standard colonoscopy, stratified by sex, age, and screening history. Primary outcome was ADR. Secondary outcomes were ADR stratified by endoscopists' ADR, advanced ADR (AADR), adenomas per colonoscopy (APC), withdrawal time, and adverse events. RESULTS: 1866 patients were enrolled across 13 centers. After exclusions, 1813 (mean age 60.1 years; male 53.8 %) were randomized (908 Endocuff Vision, 905 standard colonoscopy). ADR was significantly higher in the Endocuff Vision arm (47.8 % vs. 40.8 %; relative risk [RR] 1.17, 95 % confidence interval [CI] 1.06-1.30), with no differences between arms regarding size or morphology. When stratifying for endoscopists' ADR, only low detectors (ADR < 33.3 %) showed a statistically significant ADR increase (Endocuff Vision 41.1 % [95 %CI 35.7-46.7] vs. standard colonoscopy 26.0 % [95 %CI 21.3-31.4]). AADR (24.8 % vs. 20.5 %, RR 1.21, 95 %CI 1.02-1.43) and APC (0.94 vs. 0.77; P  = 0.001) were higher in the Endocuff Vision arm. Withdrawal time and adverse events were similar between arms. CONCLUSION: Endocuff Vision increased ADR in a FIT-based screening program by improving examination of the whole colonic mucosa. Utility was highest among endoscopists with a low ADR.

Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy.

OBJECTIVE: To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer-CRC-or advanced adenoma). DESIGN: Prospective cohort of subjects aged 50-69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy. METHODS: All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method. RESULTS: The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels. CONCLUSION: The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.

Patients' experience of screening CT colonography with reduced and full bowel preparation in a randomised trial.

OBJECTIVES: To assess patients' experience of bowel preparation and procedure for screening CT colonography with reduced (r-CTC) and full cathartic preparation (f-CTC) that showed similar detection rate for advanced neoplasia in a randomised trial. METHODS: Six hundred seventy-four subjects undergoing r-CTC and 612 undergoing f-CTC in the SAVE trial were asked to complete two pre-examination questionnaires-(1) Life Orientation Test - Revised (LOT-R) assessing optimism and (2) bowel preparation questionnaire-and a post-examination questionnaire evaluating overall experience of CTC screening test. Items were analysed with chi-square and t test separately and pooled. RESULTS: LOT-R was completed by 529 (78%) of r-CTC and by 462 (75%) of f-CTC participants and bowel preparation questionnaire by 531 (79%) subjects in the r-CTC group and by 465 (76%) in the f-CTC group. Post-examination questionnaire was completed by 525 (78%) subjects in the r-CTC group and by 453 (74%) in the f-CTC group. LOT-R average score was not different between r-CTC (14.27 ± 3.66) and f-CTC (14.54 ± 3.35) (p = 0.22). In bowel preparation questionnaire, 88% of r-CTC subjects reported no preparation-related symptoms as compared to 70% of f-CTC subjects (p < 0.001). No interference of bowel preparation with daily activities was reported in 80% of subjects in the r-CTC group as compared to 53% of subjects in the f-CTC group (p < 0.001). In post-examination questionnaire, average scores for discomfort of the procedure were not significantly different between r-CTC (3.53 ± 0.04) and f-CTC (3.59 ± 0.04) groups (p = 0.84). CONCLUSIONS: Reduced bowel preparation is better tolerated than full preparation for screening CT colonography. KEY POINTS: • Reduced bowel preparation is better tolerated than full preparation for screening CT colonography. • Procedure-related discomfort of screening CT colonography is not influenced by bowel preparation. • Males tolerate bowel preparation and CT colonography screening procedure better than females.

Faecal immunochemical test in subjects not attending screening computed tomography colonography and colonoscopy in a randomized trial.

The aim of this study was to evaluate the participation and yield of the faecal immunochemical test (FIT) in nonattendees for computed tomography colonography (CTC) or optical colonoscopy (OC) screening, in the setting of a randomized trial. In the SAVE trial, 16087 individuals were randomly assigned and invited to one of four interventions for colorectal cancer screening: (i) biennial FIT for three rounds; (ii) reduced-preparation CTC; (iii) full-preparation CTC; and (iv) OC. Nonattendees of reduced-preparation CTC, full-preparation CTC and OC groups were invited to FIT. Here, we analysed the participation rate and the detection rate for cancer or advanced adenoma (advanced neoplasia) of FIT among nonattendees for reduced-preparation CTC, full-preparation CTC and OC. Nonattendees were 1721 of 2395 (71.9%) eligible invitees in the reduced-preparation CTC group, 1818 of 2430 (74.8%) in the full-preparation CTC group and 883 of 1036 (85.2%) in the OC group. Participation rates for FIT were 20.2% (347/1721) in nonattendees for reduced-preparation CTC, 21.4% (389/1818) in nonattendees for full-preparation CTC and 25.8% (228/883) in nonattendees for OC. Differences between both CTC groups and the OC group were statistically significant (P≤0.01), whereas the difference between reduced-preparation and full-preparation CTC groups was not statistically significant (P=0.38). The detection rate of FIT was not statistically significantly different among nonattendees for reduced-preparation CTC (0.9%; 3/347), nonattendees for full-preparation CTC (1.8%; 7/389) and nonattendees for OC (1.3%; 3/228) (P>0.05). Offering FIT to nonattendees for CTC or OC increases the overall participation in colorectal cancer screening and enables the detection of additional advanced neoplasia.

Cost analysis of colorectal cancer screening with CT colonography in Italy.

OBJECTIVE: Unit costs of screening CT colonography (CTC) can be useful for cost-effectiveness analyses and for health care decision-making. We evaluated the unit costs of CTC as a primary screening test for colorectal cancer in the setting of a randomized trial in Italy. METHODS: Data were collected within the randomized SAVE trial. Subjects were invited to screening CTC by mail and requested to have a pre-examination consultation. CTCs were performed with 64- and 128-slice CT scanners after reduced or full bowel preparation. Activity-based costing was used to determine unit costs per-process, per-participant to screening CTC, and per-subject with advanced neoplasia. RESULTS: Among 5242 subjects invited to undergo screening CTC, 1312 had pre-examination consultation and 1286 ultimately underwent CTC. Among 129 subjects with a positive CTC, 126 underwent assessment colonoscopy and 67 were ultimately diagnosed with advanced neoplasia (i.e., cancer or advanced adenoma). Cost per-participant of the entire screening CTC pathway was €196.80. Average cost per-participant for the screening invitation process was €17.04 and €9.45 for the pre-examination consultation process. Average cost per-participant of the CTC execution and reading process was €146.08 and of the diagnostic assessment colonoscopy process was €24.23. Average cost per-subject with advanced neoplasia was €3777.30. CONCLUSIONS: Cost of screening CTC was €196.80 per-participant. Our data suggest that the more relevant cost of screening CTC, amenable of intervention, is related to CTC execution and reading process.

CT colonography: role in FOBT-based screening programs for colorectal cancer.

Computed tomographic colonography (CTC) is a minimally invasive imaging examination for the colon, and is safe, well tolerated and accurate for the detection of colorectal cancer (CRC) and advanced adenoma. While the role of CTC as a primary test for population screening of CRC is under investigation, the fecal occult blood test (FOBT) has been recommended for population screening of CRC in Europe. Subjects with positive FOBT are invited to undergo total colonoscopy, which has some critical issues, such as suboptimal compliance, contraindications and the possibility of an incomplete exploration of the colon. Based on available data, the integration of CTC in FOBT-based population screening programs for CRC may fall into three scenarios. First, CTC is recommended in FOBT-positive subjects when colonoscopy is refused, incomplete or contraindicated. For these indications CTC should replace double-contrast barium enema. Second, conversely, CTC is not currently recommended as a second-level examination prior to colonoscopy in all FOBT-positive subjects, as this strategy is most probably not cost-effective. Finally, CTC may be considered instead of colonoscopy for surveillance after adenoma removal, but specific studies are needed.

Impact of a new sampling buffer on faecal haemoglobin stability in a colorectal cancer screening programme by the faecal immunochemical test.

Haemoglobin (Hb) stability in faecal samples is an important issue in colorectal cancer screening by the faecal immunochemical test (FIT) for Hb. This study evaluated the performance of the FIT-Hb (OC-Sensor Eiken) used in the Florence screening programme by comparing two different formulations of the buffer, both in an analytical and in a clinical setting. In the laboratory simulation, six faecal pools (three in each buffer type) were stored at different temperatures and analysed eight times in 10 replicates over 21 days. In the clinical setting, 7695 screenees returned two samples, using both the old and the new specimen collection device (SCD). In the laboratory simulation, 5 days from sample preparation with the buffer of the old SCD, the Hb concentration decreased by 40% at room temperature (25°C, range 22-28°C) and up to 60% at outside temperature (29°C, range 16-39°C), whereas with the new one, Hb concentration decreased by 10%. In the clinical setting, a higher mean Hb concentration with the new SCD compared with the old one was found (6.3 vs. 5.0 µg Hb/g faeces, respectively, P<0.001); no statistically significant difference was found in the probability of having a positive result in the two SCDs. Better Hb stability was observed with the new buffer under laboratory conditions, but no difference was found in the clinical performance. In our study, only marginal advantages arise from the new buffer. Improvements in sample stability represent a significant target in the screening setting.

Reduced and Full-Preparation CT Colonography, Fecal Immunochemical Test, and Colonoscopy for Population Screening of Colorectal Cancer: A Randomized Trial.

BACKGROUND: Population screening for colorectal cancer (CRC) is widely adopted, but the preferred strategy is still under debate. We aimed to compare reduced (r-CTC) and full cathartic preparation CT colonography (f-CTC), fecal immunochemical test (FIT), and optical colonoscopy (OC) as primary screening tests for CRC. METHODS: Citizens of a district of Florence, Italy, age 54 to 65 years, were allocated (8:2.5:2.5:1) with simple randomization to be invited by mail to one of four screening interventions: 1) biennial FIT for three rounds, 2) r-CTC, 3) f-CTC, 4) OC. Patients tested positive to FIT or CTC (at least one polyp ≥6mm) were referred to OC work-up. The primary outcomes were participation rate and detection rate (DR) for cancer or advanced adenoma (advanced neoplasia). All statistical tests were two-sided. RESULTS: Sixteen thousand eighty-seven randomly assigned subjects were invited to the assigned screening test. Participation rates were 50.4% (4677/9288) for first-round FIT, 28.1% (674/2395) for r-CTC, 25.2% (612/2430) for f-CTC, and 14.8% (153/1036) for OC. All differences between groups were statistically significant (P = .047 for r-CTC vs f-CTC; P < .001 for all others). DRs for advanced neoplasia were 1.7% (79/4677) for first-round FIT, 5.5% (37/674) for r-CTC, 4.9% (30/612) for f-CTC, and 7.2% (11/153) for OC. Differences in DR between CTC groups and FIT were statistically significant (P < .001), but not between r-CTC and f-CTC (P = .65). CONCLUSIONS: Reduced preparation increases participation in CTC. Lower attendance and higher DR of CTC as compared with FIT are key factors for the optimization of its role in population screening of CRC.

Colorectal cancer screening: tests, strategies, and perspectives.

Screening has a central role in colorectal cancer (CRC) control. Different screening tests are effective in reducing CRC-specific mortality. Influence on cancer incidence depends on test sensitivity for pre-malignant lesions, ranging from almost no influence for guaiac-based fecal occult blood testing (gFOBT) to an estimated reduction of 66-90% for colonoscopy. Screening tests detect lesions indirectly in the stool [gFOBT, fecal immunochemical testing (FIT), and fecal DNA] or directly by colonic inspection [flexible sigmoidoscopy, colonoscopy, CT colonography (CTC), and capsule endoscopy]. CRC screening is cost-effective compared to no screening but no screening strategy is clearly better than the others. Stool tests are the most widely used in worldwide screening interventions. FIT will soon replace gFOBT. The use of colonoscopy as a screening test is increasing and this strategy has superseded all alternatives in the US and Germany. Despite its undisputed importance, CRC screening is under-used and participation rarely reaches 70% of target population. Strategies to increase participation include ensuring recommendation by physicians, introducing organized screening and developing new, more acceptable tests. Available evidence for DNA fecal testing, CTC, and capsule endoscopy is reviewed.

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.

The impact of immunochemical faecal occult blood testing on colorectal cancer incidence.

BACKGROUND: The efficacy of colorectal cancer screening based on faecal immunochemical test, in terms of reduction of colorectal cancer incidence, is under debate. In the district of Florence, an organized screening programme based on faecal immunochemical test has been running since the early 1990s. The aim of this study was to compare the risk of developing colorectal cancer for subjects undergoing faecal immunochemical test with those who did not undergo the test in the same period. METHODS: Two cohorts were analyzed: subjects who underwent an initial faecal immunochemical test between 1993 and 1999 ("attenders"), and unscreened residents in the same municipalities invited to perform the faecal immunochemical test in the same period ("non-attenders"). Kaplan-Meier and Cox regression analysis were performed to evaluate the risk of developing colorectal cancer. RESULTS: The attenders' and non-attenders' cohorts included 6961 and 26,285 subjects, respectively. Cox analysis showed a reduction in colorectal cancer incidence of 22% in the attenders' compared to the non-attenders' cohort (hazard ratio = 0.78, 95% Confidence Interval: 0.65-0.93). CONCLUSION: Our results support the hypothesis that screening based on a single faecal immunochemical test every 2 years produces a significant decrease in colorectal cancer incidence after an average follow-up observation period of 11 years.

Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study).

BACKGROUND: Colorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening. METHODS/DESIGN: A total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥ 6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC. DISCUSSION: This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01651624.

Computed tomographic colonography in subjects with positive faecal occult blood test refusing optical colonoscopy.

BACKGROUND: Refusal of colonoscopy is a drawback of colorectal cancer screening programmes based on faecal occult blood test. Computed-tomographic-colonography is generally more accepted than colonoscopy. AIM: To compare adherence to computed-tomographic-colonography and second-invitation colonoscopy in subjects with positive faecal test refusing colonoscopy. METHODS: We performed a prospective study in 198 subjects with positive faecal test who refused first referral to colonoscopy in one endoscopy service of the Florence screening programme. Subjects were randomly invited to computed-tomographic-colonography (n = 100) or re-invited to colonoscopy (n = 98). Mail invitation was followed by a questionnaire administered by phone. Computed-tomographic-colonography findings were verified with colonoscopy. RESULTS: 32 subjects could not be reached, 71 (35.9%) had undergone colonoscopy on their own; 4 were excluded for contraindications; 30/48 (62.5%) in the computed-tomographic-colonography arm and 11/43 (25.6%) in the colonoscopy arm accepted the proposed examinations (p < 0.001). Four advanced adenomas and 1 cancer were found in the 28 subjects who ultimately underwent computed-tomographic-colonography and 2 advanced adenomas and 2 cancers in the 9 subjects who ultimately underwent second-invitation colonoscopy. CONCLUSION: Subjects with positive faecal occult blood test refusing colonoscopy show a higher adherence to computed-tomographic-colonography than to second invitation colonoscopy.

Cervical cancer screening visit as an occasion for counseling female smokers to quit.

AIMS AND BACKGROUND: In the last decades in Italy, a smaller decrease in smoking among women than in men has been observed and a younger age at start in young women. Nevertheless, gender-specific strategies for smoking cessation have rarely been developed, except those for pregnant women. A study was conducted to evaluate the feasibility of carrying out an intervention of primary prevention by counseling for smoking cessation the female smokers attending cervical cancer screening programs in Florence, Italy. METHODS: All female smokers attending the services for cervical cancer prevention at the Cancer Prevention and Research Institute in Florence, Italy, between March 2004 and January 2005, who volunteered to participate in the study, received a brief motivational stage-matched counseling for smoking cessation and a face to face interview at enrollment and after 6 and 12 months. The counseling was evaluated by comparing quit rates, changes in smoking intensity, and motivation to quit at the first and second follow-up periods to the same data collected at enrollment. Multivariate logistic regression analysis was performed to estimate the influence on smoking cessation of demographic characteristics, smoking habit and attitude to quit. RESULTS: 177 women participated in the study. After 1 year, a quit rate of 12.4% (95% CI, 7.5-17.3) was observed. Among those who never quit, there was a 39.3% reduction in the average daily cigarette consumption and a 51.9% reduction in smoking the first cigarette of the day immediately on awaking or just after breakfast. CONCLUSIONS: The results and the opportunity to contact a large number of female smokers on the occasion of cervical cancer screening suggest the importance to evaluate the efficacy of the intervention of primary prevention in this health setting.

[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.

[The diffusion of screening programmes in Italy, year 2010]. / La diffusione dei programmi di screening in Italia, anno 2010.

The national meeting of the National Centre for Screening Monitoring (ONS) was given the title "The screening during the crisis" as we realize that the severe economical crisis of our country influences all the health policies and, as a consequence, screening programs. Within this global scenario, the results of 2010 concerning screening programs can be considered as still positive even if the gap between the North and the Central Regions as compared to the South remains. In short, in 2010 almost 9.5 millions people were invited to undergo a screening examination (3,450,000; 2,496,000 and 3,464,000 for cervical, mammographic and colorectal cancer respectively). As compared to the previous year, a large increase was observed for colorectal screening.Whereas a slight decrease was observed both for cervical and for mammographic screening. The latter trend was partially due to the overload consequent to the extension of the programme to women younger than fifty in a couple of regions (Emilia-Romagna and Piemonte). More than 4.3 millions of subjects actually complied to the invitation (1,375,000; 1,382,000 and 1,582,000 for cervical, mammographic and colorectal cancer, respectively). As a consequence of these activities were identified 6,015 breast cancers (31% of annual occurring breast cancers in Italy in the age group 50-69 years according to the most update estimates of breast cancer occurrence), 4,597 CIN2 or more severe cervical lesions, 2,916 colorectal cancers (15% of annual occurring CRC cancer in Italy in the age group 50-69 years) and 15,049 advanced adenomas.

[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.

Familial risk of colorectal cancer in subjects attending an organised screening programme.

BACKGROUND: First degree relatives of colorectal cancer patients are at increased risk for the same disease. AIMS: To evaluate the prevalence of familial risk and its association with the occurrence of pathological significant lesions in subjects with positive faecal occult blood testing leading to colonoscopy. METHODS: Faecal occult blood testing is offered biennially to subjects aged 50-70. Subjects with a positive faecal test are invited to undergo colonoscopy. Familial history for colorectal cancer in subjects undergoing colonoscopy was routinely recorded. RESULTS: From 1995 to 2009, 4833 screenees with positive faecal occult blood test undergoing colonoscopy were enrolled. Twelve percent reported a positive first degree family history. Multivariate analysis evidenced that the probability of detecting pathological significant lesions was statistically associated with age, gender, type of test, repeated or first screening, and having at least 1 first degree relative with colorectal cancer. CONCLUSIONS: Subjects attending colonoscopy reporting a positive first degree family history are at increased risk for pathologically significant lesions.

What is the best screening strategy to detect advanced colorectal adenomas? Simulation from ongoing Italian screening experiences.

AIMS AND BACKGROUND: The best screening strategy for colorectal cancer is still debated. We simulated two screening strategies, namely flexible sigmoidoscopy (single episode) and immunological fecal occult blood test (FOBT) (five biennial rounds) and comparing their results as regards advanced adenomas and colorectal cancer detection. METHODS: A Markov model was developed to estimate the number of advanced adenomas and colorectal cancer detected with the two compared screening strategies. Two different scenarios, namely a) where the same compliance (50%) at both flexible sigmoidoscopy and immunological FOBT invitation is applied, and b) where the actual compliance observed at a national level (immunological FOBT, 45%; flexible sigmoidoscopy, 30%) is applied. RESULTS: In scenario a), immunological FOBT would detect a total of 20,573 adenomas and 3,952 colorectal cancers, performing 74,507 total colonoscopies compared to 20,939 and 2,511, respectively, detected by flexible sigmoidoscopy, with 17,985 total colonoscopies. In scenario b), immunological FOBT would detect 17,845 advanced adenomas with 65,215 colonoscopies performed compared to 12,672 detected by flexible sigmoidoscopy with 10,796 colonoscopies. The probability of having a colonoscopy for a subject attending all the five immunological FOBT rounds was 15.9%. CONCLUSIONS: The simulation suggests that also immunological FOBT screening may achieve a substantial detection of advanced adenomas and therefore may have an impact on colorectal cancer incidence.