A retrospective analysis of the factors associated with surgical checklist compliance using data from a local health unit in Italy, 2018–2021

Rationale: Since its publication, the World Health Organization Surgical Safety Checklist (SSC) has been progressively adopted by healthcare providers around the world to monitor and safeguard the delivery of surgeries. In one Italian region's health system, the SSC and other two surgery‐specific checklists were supplemented by a document that records any non‐conformity (NC) arising from the safety checks. Aims and Objectives: In this study, we investigated the factors associated with NCs using data from a local health unit (LHU). The secondary aim of this study was to explore the potential impact of the coronavirus crisis on surgical checklist compliance. Methods: We used data on surgical activity from the Modena LHU between 2018and 2021 and the accompanying NC documents. The primary goal was to estimate the relative risk (RR) of NCs according to several factors, including checklist incompleteness and surgery class (elective, urgent or emergency), using Poisson regression. A similar analysis was performed separately for 2018–2019 and2020–2021 to assess the COVID‐19 potential impact. Results and Conclusions: Checklist compliance in the LHU was 95%, with the presence of NCs in about 7% of surgeries. The factors that increased the RR were incompleteness of the checklist (adjusted RR = 3.12; 95% confidence interval[CI] = 2.86–3.40), urgent surgeries (adjusted RR [aRR] = 1.59; 95% CI = 1.47–1.72),emergencies (aRR = 2.09; 95% CI = 1.15–3.79), and surgeries with more than four procedures (aRR = 1.64; 95% CI = 1.41–1.92). Most notably, the RR for incomplete checklists showed a negative association with NCs before the COVID‐19 outbreak but positive afterwards. Checklist compliance was overall satisfactory, though the observation of noncompliant checklists of about 1000 per year suggests there is stillroom for improvement. Moreover, attention to the checklist best practices and organization of outpatient workload may have been affected by the exceptional circumstances of the pandemic

Outbreak of colonizations by extended-spectrum β-lactamase-producing Escherichia coli sequence type 131 in a neonatal intensive care unit, Italy.

BACKGROUND: Extended spectrum β-lactamases (ESBLs) often associated with resistance to aminoglycosides and fluoroquinolones have recently emerged in community-associated Escherichia coli. The worldwide clonal dissemination of E. coli sequence type (ST)131 is playing a prominent role. We describe an outbreak of colonizations by ESBL-producing E. coli (ESBL-E. coli) in the neonatal intensive care unit (NICU) of the University Hospital, Palermo, Italy. METHODS: An epidemiological investigation was conducted with the support of molecular typing. All children admitted to the NICU and colonized by ESBL-E. coli between January and June 2012, were included in the study. Cases were defined as infants colonized by E. coli resistant to third generation cephalosporins and fluoroquinolones. A case–control study was also performed to identify possible risk factors. RESULTS: During the outbreak period, 15 infants were found to be colonized by ESBL-E. coli. The epidemic strain demonstrated continuous transmission throughout the outbreak period. Case–control study identified a lower birth weight as the only risk factor for colonization. The strain belonged to the sequence-type 131 community-associated clone. Transmission control interventions, including contact precautions and cohorting, restriction of the new admissions, sanitization of surfaces and equipment and targeted training sessions of the NICU staff, were successful in interrupting the outbreak. CONCLUSIONS: Although invasive infections did not develop in any of the 15 colonized neonates, our report highlights the need to strictly monitor the spill in the NICU setting of multidrug resistant community-associated organisms. Our findings confirm also the role of active surveillance in detecting the silent spread of ESBL-producing Gram negatives in a critical healthcare setting and trigging the implementation of infection control measures. As β-lactam and fluoroquinolone resistant E. coli strains are increasingly spreading in the community, this event could become a more serious challenge

Epidemic spread of ST1-MRSA-IVa in a neonatal intensive care unit, Italy.

BACKGROUND: Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has recently emerged as an important pathogen in neonatal intensive care units (NICUs). The purposes of this study were to characterize methicillin-resistant isolates from an outbreak in a NICU, to examine the genetic traits and clonality of CA-MRSA, and to review the characteristics and outcomes of the neonatal cases and investigate the routes of entry and transmission of the MRSA outbreak strain in the NICU under study. METHODS: The study NICU practiced an active surveillance program for multidrug-resistant organisms, including weekly cultures for detection of MRSA from nasal swabs among all the admitted neonates. All first isolates from surveillance cultures and all clinical isolates were submitted for susceptibility testing and genotyping. Data from each infant’s medical records were prospectively included in a database, and the clinical features and outcomes of the colonized/infected infants were assessed. RESULTS: A total of 14 infants were colonized or infected by a strain of ST1-MRSA-IVa between April and August 2011. The CA-MRSA strain appeared to have been introduced to the NICU by an infected infant transferred from another hospital. The outbreak was successfully contained by multifaceted infection control interventions. CONCLUSIONS: The results of this study confirm that NICU is a healthcare setting with a critical permeability to CA-MRSA. Active surveillance including molecular typing can help to detect and monitor the spread of antimicrobial drug-resistant organisms, and thus trigger timely control interventions

Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) for uterine fibroids: our experience on patients’ eligibility

Learning objectives The aim of our work is to discuss the clinical and technical eligibility for MRgFUS of women with symptomatic uterine fibroids emphasizing the lack of knowledge of this technique among both patients and physicians. Background MRgFUS represents a feasible, effective, and completely noninvasive thermal ablation procedure that may be alternatively used as a fertility-preserving technique in selected cases. To date, no absolute inclusion criteria have been defined to establish treatment indications and most cases are referred for MRgFUS treatment after many clinical and imaging examinations. Findings and procedure details From June 2012 to August 2013, 29 outpatients women (mean age 43.14±5.96 years) with uterine fibroids were considered clinically eligible for MRgFUS by a general practitioner or a gynecologist and underwent pretreatment pelvic imaging to determine candidacy for the procedure. 13 patients were technical eligible: 11 were treated and 1 of the treated patients underwent myomectomy anyway. Most frequent reasons for ineligibility were: thickness of subcutaneous fat layer, not avoidable bowel interposition, extensive cutaneous scars, fibroid size/structure/location, severe adenomyosis, uterine size, poor compliance and patients’ decision of alternative treatments. In 11 of the 29 patients the pelvic MR could be avoided since the reason of ineligibility could be detected through an accurate clinical examination and/or by ultrasound imaging. Conclusion In our experience MRgFUS treatment is technically possible in less than a half (44,8%) of outpatients women with symptomatic fibroids. However, we can speculate that this result is partially due to the lack of knowledge about of MRgFUS technique among both patients and physicians

EVALUATION OF PELVIC FLOOR DYSFUNCTIONS WITH DEFECO-MR: AN ACCURATE MR PROTOCOL AND A RADIOLOGICAL TEMPLATE

To review MRI technique and protocol in the assessment of pelvic floor dysfunction (PDF). - To identify signs that are useful for the surgeon - To provide the key points for aradiological template - To provide the key points for a radiological template

Patients perception of ionising radiation risks in CT ionising exposure. Does dose bill works?

Communicating to patients the magnitude of risk related to ionizing radiation exposure is problematic because of the uncertainty in estimates derived principally from epidemiological studies of large populations [1-6]. Euratom directive 59/2013 requires that dose bill will be part of the radiological report in European Countries [7]. However, how a risk is framed has a profound effect on risk perception. To date, no previous studies evaluated which could be the best way to make patient friendly dose bill. Our aim was to evaluate patients' perception of radiation exposure related to routine CT and their understanding after dose bill

PATIENTS' KNOWLEDGE AND AWARENESS OF RADIATION DOSE AND RISKS FROM CT: DO PATIENTS NEED A PERSONALIZED COMMUNICATION OF DOSE BILL?

In the last decades exposure to ionizing radiations in computed tomography (CT) has constantly increased. Only a few years ago it was quite difficult to assess how much radiation had been delivered to a patient during a CT examination. Nowadays, the technical challenges of dose data reporting between CT scanners from different vendors have been met, making dose tracking a reality since these dose data are automatically stored in the picture achieving system of the radiology department. Most authors affirm communication of CT risk to patients should be personalized, but no studies investigate if a tailored communication is needed. Aim of our study is to understand how patients' characteristics may condition the comprehension of this information

Enzyme replacement therapy with velmanase alfa (human recombinant alpha-mannosidase) : novel global treatment response model and outcomes in patients with alpha-mannosidosis

Alpha-mannosidosis is an ultra-rare monogenic disorder resulting from a deficiency in the lysosomal enzyme alpha-mannosidase, with a prevalence estimated to be as low as 1:1,000,000 live births. The resulting accumulation of mannose-rich oligosaccharides in all tissues leads to a very heterogeneous disorder with a continuum of clinical manifestations with no distinctive phenotypes. Long-term enzyme replacement therapy (ERT) with velmanase alfa is approved in Europe for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis. The clinical heterogeneity and rarity of the disease limit the sensitivity of single parameters to detect clinically relevant treatment effects. Thus, we propose a novel multiple variable responder analysis to evaluate the efficacy of ERT for alpha-mannosidosis and present efficacy analyses for velmanase alfa using this method. Global treatment response to velmanase alfa (defined by response to ≥2 domains comprising pharmacodynamic, functional, and quality of life outcomes) was applied post hoc to data from the pivotal placebo-controlled rhLAMAN-05 study and to the longer-term integrated data from all patients in the clinical development program (rhLAMAN-10). After 12 months of treatment, a global treatment response was achieved by 87% of patients receiving velmanase alfa (n=15) compared with 30% of patients receiving placebo (n=10). Longer-term data from all patients in the clinical program (n=33) showed 88% of patients were global responders, including all (100%) pediatric patients (n=19) and the majority (71%) of adult patients (n=14). The responder analysis model demonstrates a clinically meaningful treatment effect with velmanase alfa and supports the early initiation and continued benefit of longer-term treatment of all patients with alpha-mannosidosis with this ERT.Phase I/II studies rhLAMAN-02, -03, and -04 and phase III study rhLAMAN-05 were conducted under and co-funded by the EU FP7 project ALPHA-MAN [FP7-HEALTH-2010-261331]. Long-term continuation studies rhLAMAN-07 and -09 were initially sponsored by Zymenex A/S and are currently sponsored by Chiesi Farmaceutici S.p.A. Zymenex sponsored rhLAMAN-10. Chiesi Farmaceutici S.p.A. funded third-party writing assistance for the current manuscript, provided by PAREXEL.https://www.elsevier.com/locate/ymgmeam2019Paediatrics and Child Healt

Risk of SARS-CoV-2 infection in migrants and ethnic minorities compared with the general population in the European WHO region during the first year of the pandemic. A systematic review

Background: Migrants and ethnic minorities have suffered a disproportionate impact of the COVID-19 pandemic compared to the general population from different perspectives. Our aim was to assess specifically their risk of infection in the 53 countries belonging to the World Health Organization European Region, during the first year of the pandemic. Methods: We conducted a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO CRD42021247326). We searched multiple databases for peer-reviewed literature, published on Medline, Embase, Scisearch, Biosis and Esbiobase in 2020 and preprints from PubMed up to 29/03/2021. We included cross-sectional, case-control, cohort, intervention, case-series, prevalence or ecological studies, reporting the risk of SARS-CoV-2 infection among migrants, refugees, and ethnic minorities. Results: Among the 1905 records screened, 25 met our inclusion criteria and were included in the final analysis. We found that migrants and ethnic minorities during the first wave of the pandemic were at increased exposure and risk of infection and were disproportionately represented among COVID-19 cases. However, the impact of COVID-19 on minorities does not seem homogeneous, since some ethnic groups seem to be more at risk than others. Risk factors include high-risk occupations, overcrowded accommodations, geographic distribution, social deprivation, barriers to access to information concerning preventive measures (due to the language barrier or to their marginality), together with biological and genetic susceptibilities. Conclusions: Although mixed methods studies will be required to fully understand the complex interplay between the various biological, social, and cultural factors underlying these findings, the impact of structural determinants of health is evident. Our findings corroborate the need to collect migration and ethnicity-disaggregated data and contribute to advocacy for inclusive policies and programmatic actions tailored to reach migrants and ethnic minorities