Screening of women with aesthetic prostheses in dedicated sessions of a population-based breast cancer screening programme.

BACKGROUND: Women with aesthetic prostheses must be included in the target population of mammography screening programmes. Breast implants are radiopaque and partially obscure the breast tissue. This can be avoided with the use of the Eklund technique, which causes an increased radiation exposure. In this study, augmented women undergoing a dedicated protocol within a population-based screening programme were compared according to selected indicators with the standard screening population. Essential dosimetric parameters and their time trend were also assessed. MATERIALS AND METHODS: The study was conducted in a screening centre in Milan in the years 2009-2016. The screening protocol for women with breast implants included a double-read mammography with the Eklund views, ultrasound and clinical breast examination. RESULTS: A total of 28,794 women were enrolled, including 588 (2%) women with breast implants and 28,206 (98%) undergoing the standard screening protocol. The invasive assessment rate was 9.0‰ for women with breast implants vs. 15‰ in the standard cohort. The surgical referral rate was 2.2% vs. 0.9%. The detection rate was similar in the two groups (4.0 and 4.5‰, respectively). There were significant differences in the average glandular dose according to the mammography equipment. The use of the Eklund views increased over time. CONCLUSIONS: Screening of augmented women according to a specific protocol in the contexts of population-based programmes is feasible. Observed differences in screening indicators relative to the standard screening population require further research. The increasing use of Eklund views probably results from quality assurance measures associated with screening programmes.

[Women's perception, preconceptions, and information preferences for the limitations of breast cancer screening and overdiagnosis: a think-aloud study on the new information materials of the Agency for Health Protection of the Metropolitan Area of Milan]. / Percezione, pregiudizi e preferenze informative delle donne milanesi sui limiti dello screening mammografico e sulla sovradiagnosi: indagine think-aloud sul nuovo materiale comunicativo dell'Agenzia di tutela della salute della Città Metropolitana di Milano.

BACKGROUND: communicating breast cancer screening (BCS) limits and overdiagnosis implies providing complete and balanced information to allow informed decision-making. OBJECTIVES: to describe women's perceptions, preconceptions, and information preferences regarding the breast cancer screening (BCS) programme paper and web information materials of the Agency for Health Protection of the Metropolitan Area of Milan (Lombardy Region, Northern Italy). DESIGN: qualitative, descriptive study. SETTING AND PARTICIPANTS: participants' voluntary recruitment took place in the registration departments of three hospitals. Participants were purposively recruited based on sociodemographic characteristics of the target population of the programme (44 women aged 40-74 years, living in the Metropolitan Area of Milan). In each material type subgroup, different health literacy levels and age classes were included, until thematic saturation was reached. MAIN OUTCOME MEASURES: thematic analysis of qualitative data collected during think-aloud interviews. RESULTS: the thematic analysis identified 5 main themes: 1. validation of the information reported in the materials, according to the interviewees' personal experiences;2. information preferences of particular subgroups of women, which led to a tailored approach for the web materials;3. negative emotions elicited while receiving information regarding BCS limits, which guided the rewriting of certain definitions; 4. disproportioned risk perception, with greater weight attributed to the risk of false negative results than the risk of overdiagnosis; 5. organizational preferences regarding the type and frequency of the provided tests and the age limits of the programme. CONCLUSIONS: in the present sample of women living in the Metropolitan Area of Milan, knowledge and comprehension of overdiagnosis are scarce. The main reasons for distrust in the BCS programme rely on the preexisting beliefs regarding the most appropriate tests and age limits. These beliefs were established from previously received information, inconsistent with that officially provided by the programme.

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.

Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy, 2011-2012.

This annual survey, conducted by the Italian group for mammography screening (GISMa), collects individual data on diagnosis and treatment of about 50% of screen-detected, operated lesions in Italy. The 2011-2012 results show good overall quality and an improving trend over time. A number of critical issues have been identified, including waiting times (which have had a worsening trend over the years) and compliance with the recommendation of not performing frozen section examination on small lesions. Pre-operative diagnosis improved constantly over time, but there is still a large variation between Regions and programmes. For almost 90% of screen-detected invasive cancers a sentinel lymph node (SLN) biopsy was performed on the axilla, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN dissection for ductal carcinoma in situ, although apparently starting to decline, deserves further investigation. The detailed results have been distributed, among other ways by means of a web-based data-warehouse, to regional and local screening programmes, in order to allow multidisciplinary discussion and identification of the appropriate solutions to any issues documented by the data. The problem of waiting times should be assigned priority. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making monitoring effective in producing quality improvements with shorter waiting times.

Implementation of Failure Mode and Effects Analysis to the specimens flow in a population-based colorectal cancer screening programme using immunochemical faecal occult blood tests: a quality improvement project in the Milan colorectal cancer screening programme.

BACKGROUND: A multidisciplinary working group applied the Healthcare Failure Mode and Effects Analysis (HFMEA) approach to the flow of kits and specimens for the first-level test of a colorectal cancer screening programme using immunochemical faecal occult blood tests. METHODS: HFMEA comprised four steps: (1) identification and mapping of the process steps (subprocesses); (2) analysis of failure modes and calculation of the risk priority numbers (RPNs); (3) identification of corrective actions; and (4) follow-up and evaluation of corrective actions. RESULTS: The team identified 9 main failure modes, 12 effects and 34 associated causes. RPN scores ranged from 2 to 96. Failure modes within the first five positions in the ranking list ordered by RPN concerned: 'degraded haemoglobin in the specimen', 'mixed-up kits' and 'anonymous specimen'. All of these could lead to false-negative results and/or subjects with positive tests not being recalled for assessment. The team planned corrective actions for those failure modes. As a result, the follow-up of corrective actions showed a significant decrease in the proportion of anonymous kits from 11.6 to 4.8 per 1000 (relative reduction of 59%). The HFMEA exercise led to a reduction in: missed positive tests; missed cancer and high-risk adenomas; complaints about the communication of test results to a person who never did the test; and false-negative results due either to haemoglobin degradation or an expired sampling tube. CONCLUSIONS: HFMEA is a useful tool for reducing errors in colorectal cancer screening programmes using faecal occult blood tests and is characterised by a straightforward interpretation of results and ease of communication to healthcare managers and decision makers.

Production of proinflammatory cytokines and myocardial dysfunction after arterial switch operation in neonates with transposition of the great arteries.

OBJECTIVE: Neonates undergoing cardiac surgery have a systemic inflammatory reaction with release of proinflammatory cytokines, which could be responsible for myocardial dysfunction as a result of myocardial cell damage. The purpose of this study was to test the hypothesis that the production of proinflammatory cytokines during cardiac surgery would be associated with myocardial dysfunction after the arterial switch operation in neonates. METHODS: A total of 63 neonates with transposition of the great arteries were operated on with combined deep hypothermic circulatory arrest and low-flow cardiopulmonary bypass at a median age of 7 days. Perioperative plasma concentrations of interleukins 6 and 8 were correlated with myocardial dysfunction, as assessed clinically and by echocardiography within 24 hours after the operation, and with perioperative cardiac troponin T blood levels as a marker of myocardial cell damage. RESULTS: Myocardial dysfunction was observed in 11 patients (17.5%), and 2 of them died. Durations of cardiopulmonary bypass and aortic crossclamping, but not of circulatory arrest, were correlated with myocardial dysfunction. Patients with myocardial dysfunction had significantly higher cardiac troponin T blood levels at the end of cardiopulmonary bypass and 4 and 24 hours after the operation than did patients without myocardial dysfunction. Patients with myocardial dysfunction also had higher interleukin 6 plasma concentrations after cardiopulmonary bypass and 4 hours after the operation, as well as higher interleukin 8 plasma concentrations 4 and 24 hours after the operation, than did those without myocardial dysfunction. Postoperative interleukin 6 and 8 plasma concentrations were significantly correlated with postoperative cardiac troponin T blood levels. Multivariable analysis of independent risk factors for myocardial dysfunction comprising cytokine and troponin levels and bypass duration revealed interleukin 6 levels 4 hours after the operation as significant (P =.047). CONCLUSIONS: Cardiac operations in neonates stimulate the production of proinflammatory cytokines, which may contribute to myocardial cell damage and myocardial dysfunction.

The Chikungunya epidemic in Italy and its repercussion on the blood system.

BACKGROUND: The Chikungunya virus (CHIKV) is transmitted by Aedes mosquitoes and recently caused a massive epidemic on La Réunion Island, in the Indian Ocean. Between July and September 2007 it caused the first autochthonous epidemic outbreak in Europe, in the Region of Emilia-Romagna in the north-east of Italy. MATERIALS AND METHODS: After the first reports of an unusually high number of patients with a febrile illness of unknown origin in two contiguous villages, an outbreak investigation was carried out to identify the primary source of infection, the modes of transmission and the dynamics of the epidemic. An active surveillance system was also implemented. Laboratory diagnosis was performed through serology and polymerase chain reaction (PCR) analysis. Blood donation was discontinued in the areas involved from September to October 2007 and specific precautionary blood safety and self-sufficiency measures were adopted by the regional health and blood authorities and the National Blood Centre. An estimate method to early assess the risk of viraemic blood donations by asymptomatic donors was developed, as a tool for "pragmatic" risk assessment and management, aiming at providing a reliable order of magnitude of the mean risk of CHIKV transmission through blood transfusion. RESULTS: Two hundred and seventeen cases of CHIKV infection were identified between 4th July and 28th September. The disease was fairly mild in most of the cases. The precautionary measures adopted in the blood system caused a considerable reduction of the collection of blood components and of the delivery of plasma to the pharmaceutical industry for contract manufacturing. The estimated risk of CHIKV transmission through blood transfusion peaked in the third week of August. CONCLUSION: ACHIKV epidemic poses considerable problems for public health authorities, who not only need good routine programmes of vector control and epidemiological surveillance but also local and national emergency plans to sustain the blood supply, so as to promptly deal with the potentially severe effects of an epidemic outbreak, especially when affected areas locally require a significant blood inventory and at the same time represent a critical resource for other areas depending on external supplies of blood components.