Trends in hospital acquired New Delhi metallo-beta-lactamase-producing Enterobacterales in Tuscany (Italy) from 2019 to 2021: impact of the COVID-19 pandemic.

OBJECTIVES: In Tuscany, Italy, New Delhi metallo-beta-lactamase-producing carbapenem-resistant Enterobacterales (NDM-CRE) in hospitalized patients has increasingly been observed since 2018, leading in 2019 to the implementation of enhanced control measures successfully reducing transmission. We describe the NDM-CRE epidemiology during the COVID-19 pandemic in Tuscany. METHODS: Data on NDM-CRE patients hospitalized in five Tuscan hospitals were collected from January 2019 to December 2021. Weekly rates of NDM-CRE cases on hospital days in medical and critical-care wards were calculated. In March-December 2020, NDM-CRE rates were stratified by COVID-19 diagnosis. Multi-variate regression analysis was performed to assess outcomes' differences among two periods analysed and between COVID-19 populations. RESULTS: Since March 2020, an increase in NDM-CRE cases was observed, associated with COVID-19 admissions. COVID-19 patients differed significantly from non-COVID-19 ones by several variables, including patient features (age, Charlson index) and clinical history and outcomes (NDM-CRE infection/colonization, intensive care unit stay, length of stay, mortality). During the pandemic, we observed a higher rate of NDM-CRE cases per hospital day in both non-COVID-19 patients (273/100,000) and COVID-19 patients (370/100,00) when compared with pre-pandemic period cases (187/100,00). CONCLUSIONS: Our data suggest a resurgence in NDM-CRE spread among hospitalized patients in Tuscany during the COVID-19 pandemic, as well as a change in patients' case-mix. The observed increase in hospital transmission of NDM-CRE could be related to changes in infection prevention and control procedures, aimed mainly at COVID-19 management, leading to new challenges in hospital preparedness and crisis management planning.

[Digitization and Virtual Healthcare in a teaching hospital (Pisa, Italy) during COVID-19 emergency]. / Digitalizzazione e Virtual Healthcare nell'Azienda Ospedaliero Universitaria Pisana (AOUP) ai tempi dell'emergenza COVID-19.

The initial phases of COVID-19 emergency in Italy highlighted the technical delay that the national health system has accumulated in health services digitalization. Italian hospitals rapidly applied a demand systems for virtual health services based on tele-triage, tele-consultation and tele-visits procedures. This led, in the following months, the integration of virtual healthcare services applicable to the Azienda Ospedaliero Universitaria Pisa (AOUP). In particular, BCure system represents an important technological investment for the remote management of care protocols and the analysis of the complete use of health services. This is a unique system for sharing information between specialists, general practitioners and patients.

First trimester pregnancy outcomes in a large IVF center from the Lombardy County (Italy) during the peak COVID-19 pandemic.

At the beginning of 2020, the Italian Lombardy region was hit by an "epidemic tsunami" which was, at that point in time, one of the worst pandemics ever. At that moment the effects of SARS-COV 2 were still unknown. To evaluate whether the pandemic has influenced ART (Assisted Reproduction Techniques) outcomes in an asymptomatic infertile population treated at one of the major COVID-19 epicentres during the weeks immediately preceding lockdown. All ART procedures performed during two time periods were compared: November 1st, 2018 to February 28th, 2019 (non-COVID-19 risk) and November 1st, 2019 to February 29th, 2020 (COVID-19 risk). In total 1749 fresh cycles (883 non-COVID-19 risk and 866 COVID-19 risk) and1166 embryos and 63 oocytes warming cycles (538 and 37 during non-COVID and 628 and 26 during COVID-19 risk, respectively) were analysed. Clinical pregnancies per cycle were not different: 370 (25.38%) in non-COVID versus 415 (27.30%) (p = 0.237) during COVID-19 risk. There were no differences in biochemical pregnancy rates 52 (3.57%) versus 38 (2.50%) (p = 0.089) nor in ectopic pregnancies 4 (1.08%) versus 3 (0.72%) (p = 0.594), spontaneous miscarriages 84 (22.70%) versus 103 (24.82%) p = 0.487, nor in intrauterine ongoing pregnancies 282 (76.22%) versus 309 (74.46%) p = 0.569. A multivariate analysis investigating differences in spontaneous miscarriage rate showed no differences between the two timeframes. Our results support no differences in asymptomatic infertile couples' ART outcomes between the pre COVID and COVID-19 periods in one of the earliest and most severe pandemic areas.

One step further: randomised single-centre trial comparing the direct and afterload techniques of embryo transfer.

STUDY QUESTION: What are the differences in ease of use between two different embryo transfer (ET) techniques: the preload direct approach and the afterload approach. SUMMARY ANSWER: The afterload technique seems to reduce the rate of difficult ETs. WHAT IS KNOWN ALREADY: Numerous published trials now document that the ET procedure has an impact on pregnancy and delivery rates after IVF. Difficult transfers should be avoided, as they reduce implantation and pregnancy rates. Preload direct ETs with soft catheters under ultrasound guidance is currently considered the best procedure. However, when using soft catheters, it is not known which technique is preferable or which one should be implemented to reduce the operator factor. STUDY DESIGN, SIZE, DURATION: This prospective randomised unblinded controlled clinical trial, included 352 ultrasound-guided ETs assigned to either direct ET or afterload ET, between September 2017 and March 2019. The sample size was calculated based on the historical rate of difficult ETs encountered between 2014 and 2015 with a direct ET procedure. PARTICIPANTS/MATERIALS, SETTING, METHODS: The inclusion criteria were women 18-38 years old, with BMI between 18 and 28, receiving a single-thawed blastocyst transfer. The exclusion criteria were use of testicular sperm and preimplantation genetic testing (PGT) cycles. The primary outcome was the rate of difficult or suboptimal transfers defined as: advancement of the outer sheath (specific for the direct transfer), multiple attempts, use of force, required manipulation, use of a stylet or tenaculum, dilatation, or use of a different catheter. The secondary outcome was clinical pregnancy rate. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 352 frozen ETs were randomised, with 176 patients in each group. The two arms were homogeneous for female and male age, female BMI, duration of infertility, secondary infertility, previous deliveries or miscarriages, myomas, previous surgery to the uterine cavity, cycle day at ovulation trigger, freeze all cycles, first transfers, indication for treatment, endometrial preparation protocol and duration, endometrial thickness, and blastocyst grade at vitrification. Across the entire population, 85 (24.1%) ETs were defined as difficult. The rate of difficult transfers was significantly higher in the direct ET group than in the afterload group: 68 (38.6%) versus 17 (9.7%), respectively (OR 0.17, 95% CI 0.09-0.30, P < 0.001). The mean percentage in the rate of difficult transfers per operator was 22.5% (SD ± 14.5%), of which 36.1% (SD ± 23.4%) were in the direct group compared with 8.6% (± 8.2%) in the afterload group (P < 0.001). The difficult transfer rate among operators varied from 0 to 43.8% (0-77.8% in the direct group and 0 to 25.0% in the afterload group). The clinical pregnancy rates (42.0% vs 48.3%, P = 0.239 in the direct and afterload groups, respectively) were not significantly different between the groups. LIMITATIONS, REASONS FOR CAUTION: There were 18 experienced operators who participated in the trial. Conclusions about the pregnancy rate should not be generalised, since the sample analysis was not performed on this outcome and, although clinically relevant, the difference was not significantly different. WIDER IMPLICATIONS OF THE FINDINGS: The rate of difficult transfers was significantly higher in the direct ET group compared with the afterload ET group, although a wide variation was observed among operators. Further studies regarding the association between transfer technique and ART outcomes are required. STUDY FUNDING/COMPETING INTEREST(S): No specific funding was sought and there are no competing interests. TRIAL REGISTRATION NUMBER: NCT03161119. TRIAL REGISTRATION DATE: 5 April 2017. DATE OF FIRST PATIENT'S ENROLMENT: 26 September 2017.

[Skills tracing and activation of multi-professional teams in response to COVID-19 pandemic]. / Mappatura delle competenze ed attivazione di equipe multi professionali in risposta ad emergenza pandemica COVID-19.

The rapid spread of Covid-19 epidemic led to a change in the organizational strategies of all Italian healthcare facilities. From January 31, 2020 (starting date of the state of national health emergency) Asst Valle Olona has prepared a reorganization of the supply units passing from a traditional division system to a structure that foresees the presence of traditional wards and a set of areas dedicated exclusively to the of Covid 19 treatments.The study aims to represent the method used for the redistribution of human capital in the new areas for identified, mapped, evaluated and reordered skills. The method may guarantee assistance to Covid-19 patients with the greatest number of human resources available and adequately trained.

The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome?

STUDY QUESTION: Is Ongoing Pregnancy Rate (OPR) operator-dependent, and can experience improve embryo transfer efficiency? SUMMARY ANSWER: OPR is influenced by the operators who perform the embryo transfer (ET), and experience does not assure proficiency for everyone. WHAT IS KNOWN ALREADY: ET remains the critical step in assisted reproduction. Although many other factors such as embryo quality and uterine receptivity impact embryo implantation, the proper ET technique is clearly an operator-dependent variable and as such it should be objectively standardized. STUDY DESIGN, SIZE, DURATION: Retrospective comparative analysis including all fresh ETs performed between January 1996 and December 2016 at the Humanitas Fertility Center after IVF-ICSI cycles. PARTICIPANTS/MATERIALS, SETTING, METHODS: IVF/ICSI fresh ETs performed by 32 operators, 19 824 cycles in all, were analyzed. All transfers consisting of freehand insertion of a preloaded soft catheter into the uterine cavity under transabdominal ultrasound guidance were considered. Two different statistical analyses were performed. First, a logistic regression model with a random intercept for the operator was used to estimate the heterogeneity of the rate of success among operators, accounting for woman age, FSH, number of oocytes retrieved, fertilization rate, year of the procedure, number and stage of transferred embryos and operator's experience. Second, the relationship between experience and pregnancy rate was estimated separately for each operator by logistic regression, and operator-specific results were combined and compared in a random-effects meta-analysis. In both analyses, the operator's experience at time t was measured in terms of number of embryo transfers performed before t. MAIN RESULTS AND THE ROLE OF CHANCE: The heterogeneity among operators was highly significant (P value <0.001) and explained 44.5% of the total variability. The odds ratio of success of the worst operator in respect to the mean was equal to 0.84. For the best operator, the odds ratio of success was equal to 1.13 in respect to the mean. Based on the meta-analysis of the relationship between operator's experience and success rate, it resulted that, on average, the operators' performance did not improve with additional transfers. LIMITATIONS, REASONS FOR CAUTION: At our center, operators become independent for ET's after performing between 30 and 50 transfers under supervision. It is also possible that other relevant factors, such as embryologists on duty for the ET, have not been included in the present analysis and this may represent a potential bias. Among these, it should be mentioned that the embryologists on duty for the ET were not taken into consideration. WIDER IMPLICATIONS OF THE FINDINGS: Continued performance analysis and the use of a digital simulator could help operators to test their expertise over time and either correct poor performance or avoid doing transfers. STUDY FUNDING/COMPETING INTEREST(S): None. TRIAL REGISTRATION NUMBER: NCT03561129.

Knowledge, experiences, and attitudes toward Mantoux test among medical and health professional students in Italy: a cross-sectional study.

BACKGROUND: The World Health Organization's Action Framework for tuberculosis elimination in low-tuberculosis incidence countries includes the screening for active and latent tuberculosis in selected high-risk groups, including health care workers. In this context, medical and health profession students, exposed to nosocomial tuberculosis transmission during training and clinical rotations, are target populations for tuberculosis screening. No updated data are available on tuberculosis screening practice and knowledge of medical and health profession students in Italy. METHODS: Within the activities Italian Study Group on Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine and Public Health, we carried out a multicentre cross-sectional study to assess knowledge, attitude and practices on tuberculosis prevention and control among Medical, Dentistry, Nursing and other health professions' students. Students were enrolled in the study on a voluntary basis and were administered a previously piloted structured questionnaire. Logistic regression models were applied to explore knowledge on tuberculosis prevention by selected socio-demographic variables and University-based tuberculosis prevention practice. RESULTS: Students of seventeen Universities across Italy participated in the study, and 58.2% of them received compulsory tuberculin skin test either at enrollment or while attending clinical practice. A total of 5,209 students filled the questionnaire. 37.7% were medicine and dentistry students (Group 1), 44.9% were nursing students (Group 2) and 17.4% were other health professions' students (Group 3). Age and gender had different distributions by groups, as well as knowledge and practice on tuberculin skin test. 84.4% of the study population (95% CI = 83.3-85.3) was aware of the existence of the tuberculin skin test, 74.4% (95% CI = 73.2-75.6) knew what is the first-level screening test for latent tuberculosis and only 22.5% (95% CI = 21.4-23.6) knew how to proceed after a positive tuberculin skin test result. Overall, knowledge on tuberculosis prevention was higher in Group 2 and lower Group 3, as compared to Group 1. CONCLUSION: In Italy, the knowledge on tuberculosis screening among University students is generally good. To reduce some of the criticalities found among the different study courses, it would be appropriate to harmonize both the regulations on tuberculosis screening practices for admission to University courses, and the educational activities on the topic of tuberculosis, to be extended to all workers involved in health care setting.

Survey on Energy Drinks consumption and related lifestyle among students of two Italian high schools.

BACKGROUND: The European Food Safety Authority (EFSA) has identified some risk factors for the occurrence of side effects linked to energy drinks (EDs) consumption by young people. EDs consumption has been evaluated in a sample of students in Italy together with some aspects of their lifestyle. METHODS: The survey was performed in two high schools from September 2016 to June 2017. 583 students between 14 to 18 years were recruited and a standard questionnaire (EFSA checklist) was used to collect information on responders characteristics, beverages consumption, EDs with alcohol, and EDs and sports. RESULTS: Despite 350 out of 583 responders (60%) consumed EDs, only 146 out of 583 (25%) were EDs-alcohol consumers. Moreover, 208 out of 379 (55%) of all physically active adolescents reported frequent EDs consumption before sport trainings. CONCLUSIONS: Study results highlight the need for primary prevention measures in communication campaigns and training delivered by school to limit potential health threats related to excess of EDs consumption.

Detection of viable but non-culturable legionella in hospital water network following monochloramine disinfection.

BACKGROUND: Prevention of legionellosis remains a critical issue in healthcare settings where monochloramine (MC) disinfection was recently introduced as an alternative to chlorine dioxide in controlling Legionella spp. contamination of the hospital water network. Continuous treatments with low MC doses in some instances have induced a viable but non-culturable state (VBNC) of Legionella spp. AIM: To investigate the occurrence of such dormant cells during a long period of continuous MC treatment. METHODS: Between November 2010 and April 2015, 162 water and biofilm samples were collected and Legionella spp. isolated in accordance with standard procedures. In sampling sites where MC was <1.5mg/L, VBNC cells were investigated by ethidium monoazide bromide (EMA)-real-time polymerase chain reaction (qPCR) and 'resuscitation' test into Acanthamoeba polyphaga CCAP 1501/18. According to the Health Protection Agency protocol, free-living protozoa were researched in 60 five-litre water samples. FINDINGS: In all, 136 out of 156 (87.2%) of the samples taken from sites previously positive for L. pneumophila ST269 were negative by culture, but only 47 (34.5%) negative by qPCR. Although no positive results were obtained by EMA-qPCR, four out of 22 samples associated with MC concentration of 1.3 ± 0.5mg/L showed VBNC legionella resuscitation. The presence of the amoeba A. polyphaga in the hospital water network was demonstrated. CONCLUSION: Our study is the first report evidencing the emergence of VNBC legionella during a long period of continuous MC treatment of a hospital water network, highlighting the importance of keeping an appropriate and uninterrupted MC dosage to ensure the control of legionella colonization in hospital water supplies.

Rate of Legionella pneumophila colonization in hospital hot water network after time flow taps installation.

In hospital water systems legionellae may be resistant to disinfectants in pipework, which is a problem particularly in areas where there is low flow or stagnation of water. We evaluated legionella colonization of a water network of an Italian hospital after time flow taps (TFTs) installation in proximity to dead legs. The water volume flushed was 64 L/day from May 2016, and 192 L/day from December 2016. Before TFTs installation, Legionella pneumophila sg2-14 was detected in all points (4 × 104 ± 3.1 × 104 cfu/L). All sites remained positive (2.9 × 104 ± 1.9 × 104 cfu/L) through November 2016. From December 2016 legionella persisted in one point only (2 × 102 to 6.8 × 103 cfu/L). TFTs with chemical disinfection may reduce legionella colonization associated with dead legs.

Evaluation and control of microbial and chemical contamination in dialysis water plants of Italian nephrology wards.

BACKGROUND: Patients receiving haemodialysis are exposed to a large volume of dialysis fluid. The Italian Society of Nephrology (ISN) has published guidelines and microbial quality standards on dialysis water (DW) and solutions to ensure patient safety. AIM: To identify microbial and chemical hazards, and evaluate the quality of disinfection treatment in DW plants. METHODS: In 2015 and 2016, water networks and DW plants (closed loop and online monitors) of nine dialysis wards of Italian hospitals, hosting 162 dialysis beds overall, were sampled on a monthly basis to determine the parameters provided by ISN guidelines. Chlorinated drinking water was desalinated by reverse osmosis and distributed to the closed loop which feeds all online monitors. Disinfection with peracetic acid was performed in all DW plants on a monthly basis. FINDINGS: Over the 24-month study period, seven out of nine DW plants (78%) recorded negative results for all investigated parameters. Closed loop contamination with Burkholderia cepacia was detected in a DW plant from January 2015 to March 2015. Pseudomonas aeruginosa was isolated from March 2016 to May 2016 in the closed loop of another DW plant. These microbial contaminations were eradicated by shock disinfection with sodium hypochlorite and peracetic acid, followed by water flushing. CONCLUSION: These results highlight the importance of chemical and physical methods of DW disinfection. The maintenance of control measures in water plants hosted in dialysis wards ensures a microbial risk reduction for all dialysis patients.

Experimental comparison of point-of-use filters for drinking water ultrafiltration.

BACKGROUND: Waterborne pathogens such as Pseudomonas spp. and Legionella spp. may persist in hospital water networks despite chemical disinfection. Point-of-use filtration represents a physical control measure that can be applied in high-risk areas to contain the exposure to such pathogens. New technologies have enabled an extension of filters' lifetimes and have made available faucet hollow-fibre filters for water ultrafiltration. AIM: To compare point-of-use filters applied to cold water within their period of validity. METHODS: Faucet hollow-fibre filters (filter A), shower hollow-fibre filters (filter B) and faucet membrane filters (filter C) were contaminated in two different sets of tests with standard bacterial strains (Pseudomonas aeruginosa DSM 939 and Brevundimonas diminuta ATCC 19146) and installed at points-of-use. Every day, from each faucet, 100 L of water was flushed. Before and after flushing, 250 mL of water was collected and analysed for microbiology. FINDINGS: There was a high capacity of microbial retention from filter C; filter B released only low Brevundimonas spp. counts; filter A showed poor retention of both micro-organisms. CONCLUSION: Hollow-fibre filters did not show good micro-organism retention. All point-of-use filters require an appropriate maintenance of structural parameters to ensure their efficiency.

Evaluation of a modified cleaning procedure in the prevention of carbapenem-resistant Acinetobacter baumannii clonal spread in a burn intensive care unit using a high-sensitivity luminometer.

BACKGROUND: Enhanced environmental cleaning practices are among the most accepted measures for controlling the spread of carbapenem-resistant Acinetobacter baumannii (CR-Ab). AIM: To evaluate the impact of heightened cleaning on an ongoing CR-Ab outbreak in a burn intensive care unit (BICU) of an Italian teaching hospital, where chlorhexidine-60% isopropyl alcohol was applied as a complementary disinfectant on high-touch surfaces. METHODS: Compliance with the microbial limit proposed for the BICU by AFNOR-NF-S90-351 (20 colony-forming units/100cm2) was assessed by plate count, and compared with the results obtained with intracellular adenosine triphosphate (ATP) detection. Genotyping was performed using pulsed-field gel electrophoresis. FINDINGS: During the standard cleaning regimen, three out of 23 samples (13%) gave results over the AFNOR limit and five (21.7%) showed unacceptable ATP levels with 100 relative light units/100cm2 as the benchmark limit (sensibility 86.4%, specificity 92.2%). Following improvement of the cleaning procedure, only two samples out of 50 (4%) did not satisfy the microbiological criteria and seven (14%) exceeded the ATP limit. In a successive phase, eight of 30 samples collected showed unacceptable results (27%). CONCLUSIONS: Adding chlorhexidine-60% isopropyl alcohol as complementary disinfectant proved to be effective for reducing environmental microbial contamination, ATP levels and CR-Ab infection/colonization in patients admitted to the BICU. Real-time monitoring by ATP assay was useful for managing the cleaning schedule and reducing hospital infections, although the calculated values must be interpreted as cleanliness indicators rather than risk indicators.

Colonization by Legionella spp. of water networks in residential buildings of the Province of Pisa, Italy.

BACKGROUND: Despite the increase of community acquired cases of legionellosis in Italy over the last years, the Italian guidelines do not give indications for prevention and control of Legionella in the hot water networks (or centralized conditioning systems) of residential buildings. We performed a survey on eight medium sized apartment buildings in the Pisa district to assess the prevalence of Legionella spp. in the water network and the respondance to drinking water requisites at the point of use, according to the Italian norms. METHODS: For each building two hot water and three cold water samples (located at water entrance from the aqueduct network into the building pipework, at the exit from pressure autoclave, and at a remote tap) were collected. RESULTS: Legionella was detected in 20% of residential buildings, mostly in those with a central hot water production system. CONCLUSIONS: The study highlights a condition of potential risk for susceptible population subgroups and supports the need for measures of risk assessment and control.

Risk factors influencing BRONJ staging in patients receiving intravenous bisphosphonates: a multivariate analysis.

The objective of this study was to determine, retrospectively, the influence of various risk factors on the staging of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in a population attending a department of dentistry and oral surgery in Italy. Data were collected from the electronic and paper medical records of 90 patients receiving intravenous bisphosphonates. Two experienced and calibrated examiners used the American Association of Oral and Maxillofacial Surgeons updated 2009 classification to record the stage of BRONJ lesions. Multivariate ordinal logistic regression was performed to determine individual risk factors negatively affecting BRONJ staging. The factors associated with a worse BRONJ staging were high bisphosphonate cumulative dose (odds ratio (OR) 1.70, 95% confidence interval (CI) 1.02-2.82; P=0.04), smoking (OR 1.80, 95% CI 1.03-2.80; P=0.04), steroid intake (OR 1.70, 95% CI 1.00-2.87; P=0.05), and a maxillary location of the lesion (OR 3.50, 95% CI 1.81-6.77; P<0.01). Tooth extraction was the event that most negatively influenced BRONJ staging (OR 1.60, 95% CI 1.00-2.81; P=0.05), in comparison to other events such as prosthetic trauma, implant treatment, oro-dental infection, and periodontal disease. Certain clinical and medical risk factors may determine a more severe staging of BRONJ lesions. Future studies are necessary to confirm these findings.

Solvent detergent vs. fresh frozen plasma in cirrhotic patients undergoing liver transplant surgery: a prospective randomized control study.

BACKGROUND: Although orthotopic liver transplantation (OLT) is nowadays considered standard practice at experienced centres, it can still be affected by a significant risk of massive bleeding and its related complications. Solvent/detergent plasma (S/D Plasma) has been proposed as an alternative to fresh frozen plasma (FFP) to curtail such complications. This study aimed at evaluating the efficacy of S/D Plasma in OLT patients by comparing it to FFP. MATERIALS AND METHODS: Sixty-three OLT patients were randomized into two groups depending on whether they were transfused with FFP or S/D plasma. A thromboelastography-based protocol aimed at achieving and maintaining predetermined coagulation goals was used to guide plasma transfusions. At the beginning and the end of surgery, standard laboratory coagulation tests were performed together with the assessment of the VII, VIII, V, XII factors and S protein blood levels. RESULTS: The two study groups equally achieved the thromboelastography goals but with a reduced amount of transfusions in the S/D plasma group (P < 0.0001). At the end of surgery, factors V and XII and S protein blood levels were lower in the S/D plasma patients who also showed lower INR, aPTT and antithrombin III levels. CONCLUSION: In cirrhotic patients undergoing OLT, the use of S\D plasma associated with thromboelastography allows the same clinical results but with a significant reduction in the amount of plasma transfusions.

Five years (2004-2009) of a restrictive law-regulating ART in Italy significantly reduced delivery rate: analysis of 10,706 cycles.

STUDY QUESTION: Was the delivery rate of ART cycles negatively affected by the enactment of the Law 40/2004 by the Italian Parliament which imposed a long list of restrictions for ART procedures? SUMMARY ANSWER: This large and extensive comparative analysis of ART outcomes prior to and after the introduction of the Law 40 revealed a significant reduction in pregnancy and delivery rates per cycle, independent of age or other clinical variables, once the law went into effect. WHAT IS KNOWN ALREADY: Several studies have been published on the effect of Law 40/2004 on ART outcomes, some authors demonstrating a negative impact of the Law in relation to specific etiologies of infertility, other authors showing opposite conclusions. STUDY DESIGN, SIZE, DURATION: Retrospective clinical study of 3808 patients treated prior to the enactment of the Law, September 1996-March 2004 (Group I) and 6898 treated during the Law, March 2004-May 2009 (Group II). PARTICIPANTS/MATERIALS, SETTING, METHODS: A total of 10 706 ART cycles were analysed, 3808 performed before and 6898 after the application of the Law. An intention-to-treat statistical analysis was performed to detect pregnancy and delivery rates (pregnancies ≥ 24 weeks) per started cycle. A P value of <0.05 was considered statistically significant. We analysed different outcomes: differences in fertilization, pregnancy and delivery rate, multiple pregnancies and miscarriage rates between the two time periods. MAIN RESULTS AND THE ROLE OF CHANCE: The delivery rate for started cycle was 20% before and 16.0% after the introduction of the Law representing a 25% reduction (P < 0.001). The multivariate analysis, corrected by female age of >38 years, duration of infertility, basal FSH level and number of retrieved oocytes, showed a 16% lower delivery rate (odds ratio: 0.84; confidence interval: 0.75-0.94). This statistical approach removed the risk that the observed effects were due to chance and confirmed unequivocally that the Law was an independent factor responsible for the reduced likelihood of a successful outcome. LIMITATIONS, REASONS FOR CAUTION: This is a retrospective study. A prospective randomized study, with patients treated in the same time period and randomized to restrictions or not, would have minimized potential limitations due to differences in years of treatments. WIDER IMPLICATIONS OF THE FINDINGS: Our findings based on the analysis of such a large number of cycles proved clearly and unequivocally that imposing restrictions on the practice of ART penalized patients. These data represent a relevant clinical contribution for countries still debating the enactment of restrictive limitations of ART.

Minimally invasive video assisted thyroidectomy versus endoscopic thyroidectomy via the areola approach: a retrospective analysis of safety, postoperative recovery, and patient satisfaction.

AIM: Minimally invasive video-assisted thyroidectomy (MIVAT) and endoscopic thyroidectomy through areola (ETA) access are among the endoscopic approaches for thyroidectomy that have been perfected, but reports comparing the two are lacking. This study evaluated the safety, postoperative recovery, and patient satisfaction of MIVAT compared with ETA. METHODS: This study included 119 patients undergoing MIVAT and 42 patients undergoing ETA from January 2006 to October 2009. Operative time, complications, postoperative recovery, cosmetic result, and patient satisfaction were analyzed. RESULTS: The ETA group had a higher percentage of women (100% vs. 78.2%, P<0.05) and was younger (33.5 vs. 39 years, P<0.05). Thyroid volume (24.5 vs. 14.5 mL, P<0.001) and nodular diameter (26 vs. 22 mm, P<0.05) were larger in ETA group. The MIVAT group had a shorter operative time (28.2 vs. 112.8 minutes) and a lower rate of intraoperative (7.2 vs. 21.2 mL) and postoperative (0 vs. 80 mL, P<0.0001) blood loss. Rates of conversion and complications were similar. Postoperative pain at 12 hours was 1.9 in MIVAT vs. 3.1 in ETA (P<0.0001). Hospitalization was 1 day in the MIVAT group vs. 3.5 days in ETA (P<0.0001). Patient satisfaction was similar. CONCLUSION: MIVAT and ETA showed similar results for safety, although ETA might be considered more invasive than MIVAT. Patients of both groups were equally satisfied with the cosmetic result. Differently from ETA, MIVAT allows total thyroidectomy to be performed also for malignant diseases. Although different, the two approaches were safe and reliable and both are valid options. Choice might depend on the surgeon's preference, thyroid size, type of disease, and the patient's expectation about cosmesis.