SIED-GISCOR recommendations for colonoscopy in screening programs: Part I - Diagnostic.

The implementation of FIT programs reduces incidence and mortality from CRC in the screened subjects. The ultimate efficacy for CRC morbidity and mortality prevention in a FIT program depends on the colonoscopy in FIT+ subjects that has the task of detecting and removing these advanced lesions. Recently, there has been growing evidence on factors that influence the quality of colonoscopy specifically withing organized FIT programs, prompting to dedicated interventions in order to maximize the benefit/harm ratio of post-FIT colonoscopy. This document focuses on the diagnostic phase of colonoscopy, providing indications on how to standardise colonoscopy in FIT+ subjects, regarding timing of examination, management of antithrombotic therapy, bowel preparation, competence and sedation.

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.

Indicators based on registers and administrative data for breast cancer: routine evaluation of oncologic care pathway can be implemented.

RATIONALE, AIMS AND OBJECTIVES: Assuring the best standards of care - in a sustainable way - in chronic diseases as breast cancer is nowadays an important challenge for any health system. The aim of this study was to present the methodology used to define a set of quality indicators, computable from administrative data for the pathway of care of breast cancer, and its application at a population level. METHOD: The cohort of 2007-2009 incident cases of breast cancer was identified through a network of six cancer registers in Northern Italy. Cases of sarcoma and lymphoma, patients with multiple primary cancers and those metastatic at diagnosis were excluded; 9614 women were retained for the analysis. For each indicator, the sub-cohort of women eligible for the diagnostic/therapeutic procedures was identified and calculations were performed through record linkage between the cohort and sources of health information. Data on potential available confounders or prognostic factors were also collected. RESULTS: For a few indicators, such as cyto-histological assessment before surgery (62%) and intensive follow-up (79%), deviation from recommendations was evident. Younger patients (≤50 years) more frequently needed a short term re-intervention, while older patients less frequently underwent reconstructive surgery and received palliative care. Several indicators had a great variability across hospitals. In some cases, this heterogeneity appeared to be related to the hospital size, with high-volume hospitals being more compliant to guidelines. CONCLUSION: It is possible to evaluate the quality of cancer care delivered in clinical practice in recent years, in order to implement interventions aimed to improve adherence to international standards of care.

Cervical cancer screening in immigrant women in Italy: a survey on participation, cytology and histology results.

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

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.

The impact of organized screening programmes on colorectal cancer (CRC) can be observed at a population level only several years after the implementation of screening. We compared CRC characteristics by diagnostic modality (screen-detected, non-screen-detected) as an early outcome to monitor screening programme effectiveness. Data on CRCs diagnosed in Italy from 2000 to 2008 were collected by several cancer registries. Linkage with screening datasets made it possible to divide the cases by geographic area, implementation of screening, and modality of diagnosis (screen-detected, non-screen-detected).We compared the main characteristics of the different subgroups of CRCs through multivariate logistic regression models. The study included 23,668 CRCs diagnosed in subjects aged 50-69 years, of which 11.9% were screen-detected (N=2,806), all from the North-Centre of Italy. Among screen-detected CRCs, we observed a higher proportion of males, of cases in the distal colon, and a higher mean age of the patients. Compared with pre-screening cases, screen-detected CRCs showed a better distribution by stage at diagnosis (OR for stage III or IV: 0.40, 95%CI: 0.36-0.44) and grading (OR for poorly differentiated CRCs was 0.86, 95%CI: 0.75-1.00). Screen-detected CRCs have more favourable prognostic characteristics than non-screen-detected cases. A renewed effort to implement screening programmes throughout the entire country is recommended.

[A set of indicators to monitor the adherence to the guidelines for the diagnosis and treatment of breast cancer]. / Indicatori per il monitoraggio dei percorsi diagnostico-terapeutici del tumore della mammella.

OBJECTIVES: to present a set of indicators developed from six Local Health Authorities of the Lombardy Region to monitor the diagnostic and therapeutic pathway of breast cancer patients, applied to 2007-2009 incident cases. DESIGN: retrospective cohort study. SETTING AND PARTICIPANTS: all subjects with primary breast cancer, incident in the period 2007-2009, and collected by cancer registries of Milano 1, Bergamo, Cremona, Milano, Milano 2 and Monza-Brianza (5,320,272 inhabitants) were included. MAIN OUTCOME MEASURES: through the use of combined current health databases (health registry, hospitalizations, outpatient, pharmaceutical prescription and specific database for anticancer drugs), for each incident case 34 different indicators have been developed to measure the appropriateness of the procedures provided for diagnosis, treatment (surgical and medical) and follow-up. For each indicator, we analyzed the relationship with age, stage, deprivation index, type of treatment, volume of the specific procedure of the hospital where primary surgery was performed. Estimates were adjusted using multilevel regression models. RESULTS: 12,988 incident cases, without metastatic diseases and other cancers, were included in the cohort: 62% were localized to the breast, 33% to the axillary lymph-nodes, 3% metastatic ab initio, and 2% with unknown stage. Deviations from the expected value of different magnitude depending on the type of indicator were observed: the most important differences were detected for the follow-up indicators. There was, in fact, an excess of several procedures in the first year of follow-up: 75% of the cases performed a dosage of a tumor marker, 67% an ecography or a CT scan or an MR, and 37% a bone scan. On the other hand, the access to neoadjuvant and adjuvant treatments in older women was far below the expected values. CONCLUSIONS: the study presents data derived from a large cohort of population cases; the set of indicators was validated by a board of oncologists. The use of indicators calculated by linking the cancer registries (that provide staging) and administrative databases allows the assessment of compliance to the guidelines for diagnosis and treatment of tumours. This experience shows that it is possible to develop a methodology, shared with clinicians, to define indicators that measure the distance between guidelines and current clinical practice in order to decrease variability, to limit inappropriateness, and to reduce unnecessary diagnostic tests for patients (and, consequently, hospitals organizational overload). In order to be sustainable and equitable, a health care system must be able to ensure implementation of protocols/procedures based exclusively on the best available scientific evidences.

The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial.

BACKGROUND: The organized Cervical Cancer Screening Programme (CCSP) in Italy might represent an occasion to deliver smoking cessation (SC) counselling to women attending the Pap test examination. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to SC counselling is not strong.Objective of the SPRINT trial was to evaluate the effectiveness of a standard SC counselling intervention delivered by trained midwives in the CCSP, and whether the adjunct of a PA counselling to the SC counselling might increase quit rates. METHODS/DESIGN: We undertook a randomized controlled trial of 1,100 women undergoing the Pap examination in the three study centres Florence, Turin, and Mantua: 363 were randomly assigned to the SC counselling arm, 366 to the SC + PA counselling arm, and 371 to the control group. The intervention was a standard brief SC counselling combined with a brief counselling on increasing PA, and was tailored according to the Di Clemente-Prochaska motivational stages of change for SC and/or PA. Primary outcomes were quit rates, improvement in the motivational stages of change for SC, and reduced daily cigarette consumption. Analysis was by intention to treat. RESULTS: Participants randomized in both intervention arms and in the preparation stage of change for SC doubled their likelihood of quitting at 6-month follow-up in comparison to controls (odds ratio [OR]=2.1, 95% confidence interval [95% CI]:1.0-4.6). Moreover, participants in the intervention arms and in the contemplation stage were more likely to reduce their daily cigarette consumption after the intervention (OR=1.8, 95% CI:1.1-3.0). Our study did not show any effect of PA counselling on various outcomes. CONCLUSIONS: Smoking cessation counselling delivered by midwives to smokers in preparation and contemplation stages of change during the Pap-smear screening was effective and should be recommended, given the high number of women attending the cervical cancer screening programme in Italy. Moreover, the daily number of women invited for the Pap-smear examination should be slightly lowered, in order to let midwives deliver SC counselling to smokers. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52660565.

[Extension of organised cervical cancer screening programmes in Italy and their process indicators, 2010 activity]. / Estensione dei programmi organizzati di screening del cancro cervicale in Italia e loro indicatori di processo, attività 2010.

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

The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial.

BACKGROUND: Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population. METHODS/DESIGN: Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants. DISCUSSION: Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN52660565.

Extension of organised cervical cancer screening programmes in Italy and their process indicators, 2009 activity.

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

Extension of organised cervical cancer screening programmes in Italy and their process indicators: 2008 activity.

Italian national guidelines recommend to Regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998, we collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. Data on women invited during 2008 and screened up to April 2009 were considered. In 2008, the target population of Italian organised screening programmes included 13,094,025 women, corresponding to 78.4% of Italian women aged 25-64 years. Compliance to invitation was 39.7%, with a strong North-South decreasing trend. However, it should be considered that many women are screened outside the organised programmes. Of the women screened, 5.2%were referred for repeat cytology and 63.0% of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 85.1%among women referred because of ASCUS or more severe cytology and 89.3%among those referred because of HSIL or more severe cytology.The positive predictive value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 16.0%. The unadjusted detection rate of CIN2 or more severe histology was 3.1 per 1,000 screened women (3.0 standardised on the Italian population, truncated 25-64).

Extension of organised cervical cancer screening programmes in Italy and their process indicators: 2007 activity.

Italian national guidelines recommend to Regions the implementation of organised screening programmes for cervical cancer. As in previous years since 1998, we collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. Data on women invited during 2007 and screened up to April 2008 were considered. In 2007, the target population of Italian organised screening programmes included 11,872,810 women, corresponding to 71.8% of Italian women aged 25-64 years. Uptake of invitation was 39.8%, with a clear North-South decreasing trend. It should, however, be considered that many women are screened outside the organised programmes. Of the women screened, 5.0% were referred for repeat cytology and 60.4 % of them complied; 2.4% of screened women were referred to colposcopy. Compliance with colposcopy referral was 82.3% among women referred because of ASCUS or more severe cytology and 89.5% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 16.0%. The unadjusted detection rate of CIN2 or more severe histology was 2.9 per 1,000 screened women (3.1 standardised on the Italian population, truncated 25-64).

Extension of organised cervical cancer screening programmes in Italy and their process indicators.

Since 1996, Italian national guidelines recommend that Regions implement organised screening programmes for cervical cancer. As in previous years since 1998, we have collected from Italian organised cervical screening programmes aggregated tables of data in order to centrally compute process indicators. In 2006, the target population of Italian organised screening programmes included 11,362,580 women, corresponding to 69% of Italian women aged 25-64 years. However, taking into account the proportion of women invited, the actual extension was 52.9%. Compliance to invitation was 38.5%, with a clear North-South decreasing trend. It should, however, be considered that many women are screened outside the organised programmes. The remaining process indicators deal with women invited during 2005 and screened up to April 2006 Of these, 6.1% were recommended to repeat cytology and 57% of them complied; 2.3% of screened women were referred to colposcopy. Compliance to colposcopy was 84.7% among women referred because of ASCUS or more severe cytology and 90% among those referred because of HSIL or more severe cytology. The positive predictive value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 16.8%. There was a relevant variability of both referral rate and PPV that were inversely related. The unadjusted detection rate of histologically confirmed CIN2 or more severe was 2.7 per 1,000 screened women (2.6 standardised on the Italian population, truncated 25-64).

Extension of organised cervical cancer screening programmes in Italy and their process indicators.

Since 1996, Italian national guidelines have recommended to regions the implementation of organised screening programmes for cervical cancer. As in the previous years, starting from 1998, we collected aggregated tables of data from Italian organised cervical screening programmes in order to centrally compute process indicators. In 2005, the target population of Italian organised screening programmes included 10,969,571 women, corresponding to 66.7% of Italian women aged 25-64 years. However, these programmes invited only 24.8% of their target population in 2005, vs. 33.3% expected in order to invite the entire target population in the 3-year recommended interval. Compliance to invitation was 36.7%, with a clear North-South decreasing trend. It must however be considered that many women are screened outside the organised programmes. The remaining process indicators deal with women invited during 2004 and screened up to April 2005. Unsatisfactory smears were 3.1%. It was recommended to 6.1% of women to repeat cytology, and 61% of them complied. Some (2.5%) of screened women were referred to colposcopy. Compliance to colposcopy was 84.7% among women referred because of ASCUS or more severe cytology and 88.2% among those referred because of HSIL or more severe cytology. The Positive Predictive Value (PPV) of referral because of ASCUS or more severe cytology for CIN2 or more severe histology was 15.5%. There was a relevant variability of both referral rate and PPV, that were inversely related, and 10 % ofprogrammes referred > 5% of women, suggesting too broad criteria of interpretation of cytology. The unadjusted detection rate ofhistologically confirmed CIN2 or more severe was 2.7 per 1000 screened women (3.0 per 1000, standardised on the Italian population, truncated 25-64).

Activity level and process indicators of organised programmes for cervical cancer screening in Italy.

The target population of Italian organised cervical screening programmes that were active (that invited at least 1000 women) in 2004 was 10,206,741 women, corresponding to 64% of the Italian female population in the 25-64 year age range. This proportion was 66%, 83% and 49% in Northern, Central, and Southern Italy respectively. Some 27% of this target population was invited during 2004. Among women invited in 2004, 37.7% had cytology within organised programmes up to April 2005 (46.2%, 36.0% and 26.2% in Northern, Central, and Southern Italy respectively). It must be kept in mind that many women have spontaneous tests that are not registered in organised programmes. Further data on women invited in 2003 were collected as aggregated tables, provided by the local screening registration systems. We obtained data from 99 programmes with an overall target population of 8,698,480 women. At least 70% of programmes could provide data for most indicators. Overall, 3.2% of smears were classified as unsatisfactory. At a national level 6.6% of women was advised to repeat cytology and 62.2% of them actually did. However 13/71 programmes recommended repeat cytology to > 10% of screened women. Nationwide, 2.6% of screened women were referred to colposcopy. The Positive Predictive Value (PPV) of detecting a biopsy-proven Cervical Intraepithelial Neoplasia grade 2 (CIN2) or more severe among women referred because of cytology "Atypical Squamous Cells of Undetermined Significance" or more severe was 15.0%. There was however a relevant variability: 9/90 programmes had a referral rate >5%. There was an inverse correlation between referral rate and PPV. Compliance with recommended colposcopy was 86% (91% among women with high-grade cytology). The raw detection rate of biopsy-proven CIN2+ was 2.7 per 1000 screened women (2.8 per 1000 when standardised on the Italian population). In conclusion, during 2004 there was a further increase of active organised programmes, especially in Southern Italy. This is important, as spontaneous activity is known to be low there. Despite this rise, quality indicators were stable. However, in a few programmes, the use of excessively broad criteria in the interpretation of cytology decides an excessively high rate of referrals to colposcopy.