Comparing accuracy of tomosynthesis plus digital mammography or synthetic 2D mammography in breast cancer screening: baseline results of the MAITA RCT consortium.

AIM: The analyses here reported aim to compare the screening performance of digital tomosynthesis (DBT) versus mammography (DM). METHODS: MAITA is a consortium of four Italian trials, REtomo, Proteus, Impeto, and MAITA trial. The trials adopted a two-arm randomised design comparing DBT plus DM (REtomo and Proteus) or synthetic-2D (Impeto and MAITA trial) versus DM; multiple vendors were included. Women aged 45 to 69 years were individually randomised to one round of DBT or DM. FINDINGS: From March 2014 to February 2022, 50,856 and 63,295 women were randomised to the DBT and DM arm, respectively. In the DBT arm, 6656 women were screened with DBT plus synthetic-2D. Recall was higher in the DBT arm (5·84% versus 4·96%), with differences between centres. With DBT, 0·8/1000 (95% CI 0·3 to 1·3) more women received surgical treatment for a benign lesion. The detection rate was 51% higher with DBT, ie. 2·6/1000 (95% CI 1·7 to 3·6) more cancers detected, with a similar relative increase for invasive cancers and ductal carcinoma in situ. The results were similar below and over the age of 50, at first and subsequent rounds, and with DBT plus DM and DBT plus synthetic-2D. No learning curve was appreciable. Detection of cancers >= 20 mm, with 2 or more positive lymph nodes, grade III, HER2-positive, or triple-negative was similar in the two arms. INTERPRETATION: Results from MAITA confirm that DBT is superior to DM for the detection of cancers, with a possible increase in recall rate. DBT performance in screening should be assessed locally while waiting for long-term follow-up results on the impact of advanced cancer incidence.

Prompt Resumption of Screening Programme Reduced the Impact of COVID-19 on New Breast Cancer Diagnoses in Northern Italy.

The aim of this study is to evaluate the real impact of COVID-19 during the entire 2020 period, compared with 2019. The data comes from a Cancer Registry in Northern Italy and we compared clinical and treatment characteristics of breast cancer by age, stage, treatment, and status screening. In 2020 there was no decrease in invasive tumours nor in in situ (513 vs. 493 and 76 vs. 73, respectively), while there was a significant decrease in surgery and increase in neoadjuvant chemotherapy (p = 0.016). In the screening range (aged 45-74), no change in stage and grading was observed. In the four periods examined there was an increase in new diagnoses during pre-lockdown, a decrease in tumours especially at age 75+ [IRR 0.45; 95%CI 0.25-0.79] during lockdown, a recovery of new diagnoses in women 45+ in the low incidence period while in the last period there was a significant increase only for ages 45-74 [IRR 1.48; 95% CI 1.11-1.98]. Screening activities were suspended from March to May, but over the summer and autumn the backlog was addressed. This suggests that a prompt resumption of programmed screening may have limited the impact of the pandemic on the delay of breast cancer diagnoses.

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.

BACKGROUND: Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA). METHODS: A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA. RESULTS: Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%). CONCLUSION: DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT03097653.

[The accuracy of the causes of death and the estimated trend: the case of cervix uteri]. / L'accuratezza delle cause di morte e la stima dei trend: il caso della cervice uterina.

BACKGROUND: reduction in cervical cancer mortality is the ultimate goal of the screening. Quality of death certificate reports has been improved over time, but they are still inaccurate, making it difficult to assess time trends in mortality. OBJECTIVES: to evaluate the accuracy of the topographic coding of causes of death and to estimate the mortality time trend for cervical cancer through the method of incidence-based mortality (IBM) using cancer registry (CR) data. DESIGN: from the mortality registry (MR), we extracted data on deaths for cervix uteri cancer, corpus uteri cancer, and uterus cancer not otherwise specified (NOS) referred to residents in Reggio Emilia (Emilia-Romagna Region, Northern Italy) from 1997 to 2013. Deaths were checked with the CR to verify the topographical site of the primary tumour. Furthermore, by using CR data, we constructed a cohort of incident cervical cancer cases diagnosed between 1997 and 2009 with a 5-year follow-up. We calculated cause-specific IBM (excluding ovary) and IBM for all cause, crude and standardized, and annual percentage change (APC). RESULTS: out of 369 deaths for uterine cancer, 269 were reported in the RT: 32 for cervix uteri cancer, 76 for corpus uteri cancer, 161 for uterus cancer NOS. 28 of the 32 persons who died for cervical cancer were incidents for cervix uteri cancer. 63 of the 76 who died for corpus uteri cancer were incidents for corpus uteri cancer. Of the 161 who died of uterus cancer NOS, 80 were incidents for corpus uteri cancer, 45 for cervix uteri cancer, 28 for uterus cancer NOS, 5 for vagina cancer, and 3 for cancer of other non-specified organs. Applying these proportions of misclassification, we can estimate that the real number of cervical cancer deaths is 2.4 folds the number of cases reported in the MR as cervical cancer. IBM for all causes decreased significantly over the years (APC: -9.5; 95%CI -17.1;-1.1); cause-specific IBM decreases, but not significantly (APC: -5.1; 95%IC -16.1;+7.3). There is no improvement in survival (r2=0.02; p=0.6), while the incidence shows a decrease (APC: -6.6;95%CI -10.0;-3.0). CONCLUSIONS: mortality for cervical cancer is still underestimated by deaths certificates: for each reported case, there are other 1.4 cases that are reported with other less specific causes.

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy.

OBJECTIVES: Colorectal cancer (CRC) screening using the fecal occult blood test (FOBT) has been shown to be effective in reducing cause-specific mortality. However, although it detects pre-cancerous adenomas, it is uncertain whether FOBT reduces the incidence of invasive cancer. The objective is to evaluate the impact of screening with immunochemical FOBT (FIT) on CRC incidence and mortality. METHODS: An organized screening program was implemented in 2005 in the province of Reggio Emilia (Northern Italy). The program invites the resident population aged 50-69 for FIT every 2 years. Subjects who test positive are referred for colonoscopy. Incidence was studied through cancer registry. Person-times of people aged 50-74 from 1997 to 2012 were classified for exposure to screening according to age and period. Furthermore, two open cohorts-one never screened (aged 50-69 in 1997) and one invited for screening (aged 50-69 in 2005)-were followed up for 8 years. RESULTS: A total of 171,785 people have been invited, and approximately 70% have undergone FIT at least once (272,197 tests). The rate of colonoscopy participation has been about 90%, and 2896 cancers have been recorded (1237 in the screening period). The age-adjusted and sex-adjusted incidence rate ratios as compared with pre-screening were 1.60 (95% confidence interval (CI), 1.43-1.79), 0.86 (95% CI, 0.78-0.94), and 0.59 (95% CI, 0.50-0.69) for the first round, subsequent rounds, and post screening, respectively. Cumulative incidence and incidence-based mortality decreased by 10% (95% CI, 3-17%) and 27% (95% CI, 15-37%), respectively. CONCLUSIONS: FIT screening leads to a decrease in the incidence of CRC and in its mortality.

Differences in diabetes prevalence and inequalities in disease management and glycaemic control by immigrant status: a population-based study (Italy).

BACKGROUND: The diabetes prevalence increases at an alarming rate around the world and understanding disparities in occurrence, care management, and health outcomes may be a starting point towards achieving more effective strategies to prevent and manage it. The aims of this study are to compare immigrants and Italians in terms of the differences in diabetes prevalence and to evaluate inequalities in disease management and glycaemic control by using information included in Reggio Emilia diabetes register. METHODS: We retrieved from the diabetes register subjects aged 20-74 on December 31(st), 2009. Using citizenship, we created three main groups: Italy, High Developed Countries (HDC), and High Migration Pressure Countries (HMPC). These were split into sub-regions of origin. We calculated age-adjusted prevalence by gender and sub-region. Using logistic regression model, we analyzed the association between area of origin and following indicators: 1) not being in care of diabetes clinics; 2) not having glycated haemoglobin (HbA1c) test in 2010; 3) among those tested, having a HbA1c value > = 9% (75 mmol/mol). RESULTS: We found 15,889 Italian and 1,295 HMPC citizens with diabetes. HMPC citizens had higher age-adjusted prevalence of diabetes than Italians (females 5.0% vs 3.6%; males 6.5% vs 5.5%). The excess was mostly due to a strong excess in immigrants from Southern Asia (females 9.7%, males 10.2%) and Northern Africa (females 9.3%, males 5.9%). HMPC citizens were cared for by diabetes clinics in a similar proportion than Italians (OR: 1.08; 95% CI: 0.93-1.25), but had a greater odds of not being tested for HbA1c (OR: 1.51; 95% CI: 1.34-1.71), as well as of having HbA1c values equal to or over 9% (OR: 2.06; 95% CI: 1.80-3.14). The outcomes were poorer in HMPC females for the first two outcomes, while there was no difference for the HbA1c values (Wald test for heterogeneity p = 0.0850; p = 0.0156; p = 0.6635, respectively). CONCLUSIONS: Our findings highlight the need for gender-oriented actions for prevention and early diagnosis of the diabetes to contrast the higher risk in Northern Africans and Southern Asians. Further studies are required to determine whether the protocols in use are adequate for different immigrant groups.

Sex differences in cardiovascular mortality in diabetics and nondiabetic subjects: a population-based study (Italy).

The objective of this study is to assess the impact of diabetes on cardiovascular mortality, focusing on sex differences. The inhabitants of Reggio Emilia province on December 31, 2009, aged 20-84 were followed up for three years for mortality. The exposure was determined using Reggio Emilia diabetes register. The age-adjusted death rates were estimated as well as the incidence rate ratios using Poisson regression model. Interaction terms for diabetes and sex were tested by the Wald test. People with diabetes had an excess of mortality, compared with nondiabetic subjects (all cause: IRR = 1.68; 95%CI 1.60-1.78; CVD: IRR = 1.61; 95%CI 1.47-1.76; AMI: IRR = 1.59; 95%CI 1.27-1.99; renal causes: IRR = 1.71; 95%CI 1.22-2.38). The impact of diabetes is greater in females than males for all causes (P = 0.0321) and for CVD, IMA, and renal causes. Further studies are needed to investigate whether the difference in cardiovascular risk profile or in the quality of care delivered justifies the higher excess of mortality in females with diabetes compared to males.

Cervical cancer epidemiology in foreign women in Northern Italy: role of human papillomavirus prevalence in country of origin.

This study compares the incidence and treatments of cervical neoplasia in foreigners from high migration countries and Italians in the Reggio Emilia province (Northern Italy) in 2002-2009. Standardized incidence ratios (SIRs) and 95% confidence intervals (95% CI) for cervical intraepithelial neoplasia grade 3 (CIN3) and cancer were calculated for foreigners versus Italian women; foreigners were also classified according to the prevalence of human papillomavirus (HPV) in their country of origin. The proportion of hysterectomies is presented as an indicator of inappropriate surgery in CIN3 and microinvasive cancers. A higher risk was observed in women from high human papillomavirus prevalence countries (HHPVC) both for cancer and for CIN3 (SIR=4.1, 95% CI=2.2-6.9; SIR=2.0, 95% CI 1.7-2.5, respectively), whereas in those from low human papillomavirus prevalence countries (LHPVC), no difference for cancer and a lower risk for CIN3 were observed (SIR=1.0, 95% CI 0.2-2.2; SIR=0.6, 95% CI 0.4-0.8, respectively). A lower CIN3/cancer ratio was found in women from HHPVC (2.6) and in women from LHPVC (3.6) than in Italians (7.4). The percentage of hysterectomies for CIN3 or microinvasive cancers was 3.4 in foreigners and 4.7 in Italians. A higher risk of cervical cancer was found in women from HHPVC compared with Italians and women from LHPVC, suggesting a role of HPV prevalence in the country of origin in the excess risk. The CIN3/cancer ratio was lower for both women from HHPVC and women from LHPVC, also suggesting a role of low screening uptake for cervical cancer incidence in immigrants.

Screening history of cervical cancers in Emilia-Romagna, Italy: defining priorities to improve cervical cancer screening.

Most invasive cervical cancers in industrialized countries are due to the lack of Pap test coverage, very few are due to screening failures. This study aimed at quantifying the proportion of invasive cancers occurring in nonscreened or underscreened women and that in women with a previous negative screening, that is, screening failure, during the first two screening rounds (1996-2002) and in the following rounds (2003-2008) in the Emilia-Romagna region. All cases of invasive cancers registered in the regional cancer registry between 1996 and 2008 were classified according to screening history through a record linkage with the screening programme registry. The incidence significantly decreased from 11.6/100 000 to 8.7/100 000; this decrease is due to a reduction in squamous cell cancers (annual percentage change -6.2; confidence interval: -7.8, -4.6) and advanced cancers (annual percentage change -6.6; confidence interval: -8.8, -4.3), whereas adenocarcinomas and microinvasive cancers were essentially stable. The proportion of cancers among women not yet invited and among nonresponders decreased over the two periods, from 45.5 to 33.3%. In contrast, the proportion of women with a previous negative Pap test less than 5 years and 5 years or more before cancer incidence increased from 5.7 to 13.3% and from 0.3 to 5.5%, respectively. Although nonattendance of the screening programme remains the main barrier to cervical cancer control, the introduction of a more sensitive test, such as the human papillomavirus DNA test, could significantly reduce the burden of disease.

Building a population-based diabetes register: an Italian experience.

AIMS: To describe the methodology used to set up the Reggio Emilia (northern Italy) Diabetes Register. The prevalence estimates on December 31st, 2009 are also provided. METHODS: The Diabetes Register covers all residents in the Reggio Emilia province. The register was created by deterministic linkage of six routinely collected data sources through a definite algorithm able to ascertain cases and to distinguish type of diabetes and model of care: Hospital Discharge, Drug Dispensation, Biochemistry Laboratory, Disease-specific Exemption, Diabetes Outpatient Clinics, and Mortality databases. Using these data, we estimated crude prevalence on December 31st, 2009 by sex, age groups, and type of diabetes. RESULTS: There were 25,425 ascertained prevalent cases on December 31st, 2009. Drug Dispensation and Exemption databases made the greatest contribution to prevalence. Analyzing overlapping sources, more than 80% of cases were reported by at least two sources. Crude prevalence was 4.8% and 5.9% for the whole population and for people aged 18 years and over, respectively. Males accounted for 53.6%. Type 1 diabetes accounted for 3.8% of cases, while people with Type 2 diabetes were the overriding majority (91.2%), and Diabetes Outpatient Clinics treated 75.4% of people with Type 2 diabetes. CONCLUSION: The Register is able to quantify the burden of disease, the first step in planning, implementing, and monitoring appropriate interventions. All data sources contributed to completeness and/or accuracy of the Register. Although all cases are identified by deterministic record linkage, manual revision and General Practitioner involvement are still necessary when information is insufficient or conflicting.