Binaural hearing in monaural conductive or mixed hearing loss fitted with unilateral Bonebridge.

Objective: To determine the benefits of binaural hearing rehabilitation in patients with monaural conductive or mixed hearing loss treated with a unilateral bone conduction implant (BCI). Methods: This monocentric study includes 7 patients with monaural conductive or mixed hearing loss who underwent surgical implantation of a unilateral BCI (Bonebridge, Med-El). An ITA Matrix test was performed by each patient included in the study - without and with the BCI and in three different settings - to determine the summation effect, squelch effect and head shadow effect. Subjective hearing benefits were assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Results: The difference in signal to noise ratio of patients without and with BCI was 0.79 dB in the summation setting (p < 0.05), 4.62 dB in the head shadow setting (p < 0.05) and 1.53 dB (p = 0.063) in the squelch setting. The APHAB questionnaire revealed a subjective discomfort in the presence of unexpected sounds in patients using a unilateral BCI (aversiveness score) compared to the same environmental situations without BCI, with a mean discomfort score of 69.00% (SD ± 21.24%) with monaural BCI versus 25.67% (SD ± 16.70%) without BCI (difference: -43.33%, p < 0.05). In terms of global score, patients wearing a unilateral Bonebridge implant did not show any significant differences compared to those without hearing aid (difference: -4.00%, p = 0.310). Conclusions: Our study shows that the use of a unilateral BCI in patients affected by monaural conductive or mixed hearing loss can improve speech perception under noise conditions due to the summation effect and to the decrease of the head shadow effect. However, since monaural BCIs might lead to discomfort under noise conditions in some subjects, a pre-operative assessment of the possible individual benefit of a monaural BCI should be carried out in patients affected by unilateral conductive or mixed hearing loss in order to investigate the possible additional effect of the fitting of hearing aids.

Hip prosthesis and colon surgery, a decade of surveillance on surgical site infections in Italy, a prospective cohort study: rates, trends, and disease burden in DALYs.

BACKGROUND: Surveillance programs are a key element of interventions aiming to reduce rates of surgical site infections (SSIs). The aim of this study was to evaluate rates and trends of SSIs following hip arthroplasty and colon surgery procedures in Piedmont, a region in North-western Italy, from 2010 to 2019. Further, we aimed to assess the burden of SSIs in terms of Disability-Adjusted Life-Years (DALYs). METHODS: A prospective cohort study was conducted among 42 hospitals participating in the surveillance system. Procedure-specific SSI rates were calculated and the 2010 - 2019 trend was evaluated using Spearman's Rho test. Patients were stratified according to age, sex and infection risk index according to life expectancy in order to calculate DALYs, using a modified version of the ECDC's BCoDE toolkit: disease models for both procedure types were adapted to incorporate long-term disability associated with SSIs. RESULTS: Overall, 20,356 hip arthroplasty and 11,011 colon surgery procedures were monitored over 10 years and were included in our analyses. Hip arthroplasty and colon surgery cumulative SSIs rates were 1.5% and 8% respectively. Using the Spearman's Rho test, we evaluated a significant downward trend from 2010 to 2019 for colon surgery interventions (Rs - 0.7, p < 0.05), while there was no difference for hip arthroplasty. (Rs - 0.04, p > 0.05). Regarding disease burden, a total of 955.3 (95%CI 837.7-1102.98) and 208.65 (95%CI 180.87-240.90) DALYs were calculated for SSIs following hip arthroplasty, whilst 76.58 (95%CI 67.15-90.71) and 38.62 (95% CI 33.09-45.36) DALYs for SSIs in colon surgery, in 2010 and 2019, respectively. CONCLUSIONS: The significant decrease both in terms of incidence and DALYs found in this study for colon surgery and the stability for hip arthroplasty support the role of surveillance networks in improving quality of care. Despite the smaller SSI rate, the burden associated with SSIs following hip arthroplasty was higher, which is important to consider in light of the aging population in Italy.

Comparison of Active Bone Conduction Hearing Implant Systems in Unilateral and Bilateral Conductive or Mixed Hearing Loss.

BACKGROUND: To assess and compare binaural benefits and subjective satisfaction of active bone conduction implant (BCI) in patients with bilateral conductive or mixed hearing loss fitted with bilateral BCI and patients with monaural conductive hearing loss fitted with monaural BCI. METHODS: ITA Matrix test was performed both on patients affected by bilateral conductive or mixed hearing loss fitted with monaural bone conduction hearing implant (Bonebridge, Med-El) before and after implantation of contralateral bone conduction hearing implant and on patients with monaural conductive or mixed hearing loss before and after implantation of monaural BCI. The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire was administered to both groups of subjects and the results were compared with each other. RESULTS: Patients of group 1 reported a difference of 4.66 dB in the summation setting compared to 0.79 dB of group 2 (p < 0.05). In the squelch setting, group 1 showed a difference of 2.42 dB compared to 1.53 dB of group 2 (p = 0.85). In the head shadow setting, patients of group 1 reported a difference of 7.5 dB, compared to 4.61 dB of group 2 (p = 0.34). As for the APHAB questionnaire, group 1 reported a mean global score difference of 11.10% while group 2 showed a difference of -4.00%. CONCLUSIONS: Bilateral BCI in patients affected by bilateral conductive or mixed hearing loss might show more advantages in terms of sound localisation, speech perception in noise and subjective satisfaction if compared to unilateral BCI fitting in patients affected by unilateral conductive hearing impairment. This may be explained by the different individual transcranial attenuation of each subject, which might lead to different outcomes in terms of binaural hearing achievement. On the other hand, patients with unilateral conductive or mixed hearing loss fitted with monaural BCI achieved good results in terms of binaural hearing and for this reason, there is no absolute contraindication to implantation in those patients.

Antibody responses to BNT162b2 SARS-CoV-2 mRNA vaccine among healthcare workers and residents of long-term care facilities: A cohort study in Northern Italy.

Background and Aims: Long-term care facilities (LTCFs) have been severely impacted by COVID-19, with a disproportionate amount of SARS-CoV-2 infections and related deaths occurring among residents. Methods: This study is part of an ongoing multicenter, prospective cohort study conducted among healthcare workers (HCWs) and residents of 13 LTCFs in Northern Italy designed to evaluate SARS-CoV-2 specific immunoglobulin class G (IgG) titers before and following vaccination with Pfizer/BNT162b2 SARS-CoV-2 mRNA vaccine (two doses of vaccine, 21 days apart). Serum samples were obtained from participants (t0) before vaccination, and (t1) 2 weeks after and analyzed to determine anti-S1 IgG antibodies. Results: Five hundred and thirty-four participants were enrolled (404 subjects participated in both blood draws). Seropositivity was 50.19% at t0 and 99% at t1, with a significant difference in IgG titers. A higher proportion of residents were seropositive at t0 compared with HCWs, with significantly higher IgG titers among residents at both t0 and t1. Pre-existing immunity also had a significant effect on postvaccination IgG titers. However, a significant difference in titers at t1 between HCWs and residents considering only participants seropositive at t0 was found, with higher median titers among previously seropositive residents. Conclusion: Findings of this study provide scientific evidence endorsing the policy of universal vaccination in LTCFs.

Hand hygiene monitoring: Comparison between app and paper forms for direct observation.

Healthcare-associated infections (HAIs) are a global public health threat. Italy is one of the countries with the highest prevalence of HAI. Hand hygiene (HH) is a pillar of infection prevention and control. Monitoring HH is necessary to improve HH compliance, and direct observation is considered the gold standard. Transcription and analysis of data collected during direct observation of HH compliance with the WHO paper form are time-consuming. We collected, during a 9-day observation period, HH opportunities and compliance both with a smartphone application (SpeedyAudit) and with the WHO paper form. Then, we investigated the difference in the required time for data transcription and analysis between the WHO paper form and the use of the app. The difference in the required time for data transcription and analysis was significant with a mean time of 2 s using the app and about 14-54 min/day using paper form (p = .004) while no significant difference was found in measured compliance rates between the two data collecting methods. HH monitoring with an app is time-saving, and the app we used was easy to use.

Serological Responses up to 9 Months following COVID-19 mRNA Vaccination in Residents and Health-Care Workers of Long-Term Care Facilities: A Multicenter Prospective Cohort Study in Northern Italy.

Long-term care facilities (LTCFs) were severely affected by COVID-19, in particular in Northern Italy. We aimed to assess antibody responses among residents and healthcare workers (HCWs) of 13 LTCFs through serum samples collected at three time points: prior to, two weeks, and 9 months after receiving Pfizer/BNT162b2 SARS-CoV-2 mRNA vaccine (respectively t0, t1, and t2). IgG antibodies targeted towards the S1 domain of the spike protein were measured, and results were expressed in binding antibody units (BAU/mL). Friedman's average rank test was performed to compare antibody titres between the three time points. Two logistic regression models were built to identify independent predictors of (1) developing and (2) maintaining a significant antibody response to vaccination, using a previously identified threshold. In total, 534 subjects were enrolled (371 HCWs and 163 residents). The antibody titres at t1 were the highest; at t2, the IgG titres significantly decreased, remaining however 10 times higher compared to titres at t0. Previous infection was the only significant predictor of developing and maintaining a response over threshold in both models. Results of this study provided further insights on the humoral response elicited by vaccination, and on host factors determining variations in its magnitude and kinetics.

Hand Hygiene Practices during the COVID-19 Pandemic in Northern Italy: Assessment of Compliance Rates Measured by Direct Observation and Alcohol-Based Handrub Usage.

Hand hygiene (HH) is among the most effective measures for reducing the transmission of healthcare-associated infections and SARS-CoV-2. We aimed to assess HH practices among healthcare workers (HCWs) of three hub hospitals in Northern Italy during the COVID-19 pandemic, by assessing HH compliance measured by direct observation and alcohol-based handrub usage. An observational study was conducted over a period of three months, between February and April 2021. HH compliance audits were conducted using the WHO My 5 Moments for HH approach. Multivariable logistic regression was used to evaluate independent predictors of HH compliance: ward type, HCW category and HH indication. Spearman correlation was used to investigate the relationship between HH compliance and alcohol-based handrub consumption. In total, 2880 HH opportunities were observed, with an overall compliance of 68%. Significant differences were found in compliance rates across ward types, HCW categories and HH indications. The mean alcohol-based handrub usage among included wards was 41.63 mL/PD. No correlation was identified between compliance rates and alcohol-based handrub consumption (ρ 0.023, p 0.943). This study provided a snapshot of HH practices in a pandemic context, which could be useful as a reference for future studies.

Seroprevalence of infection-induced SARS-CoV-2 antibodies among health care users of Northern Italy: results from two serosurveys (October-November 2019 and September-October 2021).

OBJECTIVES: The objective was to estimate the seroprevalence of SARS-CoV-2 in autumn 2019 (before case zero was identified in Italy) and 2021 among residual sera samples from health care users in the Piedmont region of northwestern Italy. METHODS: Two serosurveys were conducted. Using a semiquantitative method, samples were tested for the presence of immunoglobulin G (IgG) antibodies against the S1 domain of the spike protein. Samples with positive test results from the 2019 survey were independently retested using a multiplex panel to detect IgG antibodies against the receptor binding domain, S1 and S2 domains, and nucleocapsid. Samples with positive test results from the 2021 survey underwent repeat testing with enzyme-linked immunosorbent assay to detect anti-nucleocapsid IgG antibodies. Prevalence rates according to gender and age groups, together with their respective 95% confidence intervals (CIs), were calculated. RESULTS: Overall, the proportion of samples with positive test results was 2/353 in 2019 and 22/363 in 2021, with an estimated seroprevalence of 0.27% (95% CI 0-1.86) and 6.21% (95% CI 3.9-9.31) in 2019 and 2021 respectively. CONCLUSION: Results of this study support the hypothesis that the virus was circulating in Italy as early as autumn 2019. The role of these early cases in broader transmission dynamics remains to be determined.

Speech in Noise With Bilateral Active Bone Conduction Implant for Conductive and Mixed Hearing Loss.

OBJECTIVE: To evaluate speech in noise results and subjective benefit in bilateral active bone conduction implant (ABCI) for bilateral mixed hearing loss. STUDY DESIGN: Prospective, comparative. SETTING: Ear, Nose and Throat Unit, Department of Surgical Sciences, University of Turin. PATIENTS: Seven patients with conductive/mixed hearing loss. INTERVENTIONS: Patients underwent simultaneous or sequential bilateral surgery for ABCI. MAIN OUTCOME MEASURES: The speech intelligibility in noise was assessed with the Ita Matrix test in summation, squelch and head shadow settings. First, the tests were performed with one device activated in the ear with lower speech recognition score, then with both devices. Patients filled in an Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire to investigate the hearing aid benefit. RESULTS: When bilateral devices were activated, an improvement of signal-to-noise ratio was observed in all settings. The difference between bilateral and unilateral stimulation is 4.66 dB ( p = 0.016) in the summation, 2.24 dB ( p = 0.047) in the squelch, 7.50 dB ( p = 0.016) in the head shadow setting.Looking at the APHAB global score (GS), patients report lower mean scores, hence less difficulties, when using two devices (GS, 21.9%; standard deviation (SD), 8.28) rather than one (GS, 33.0%; SD, 10.24) ( p = 0.018). CONCLUSION: In symmetric mixed bilateral hearing loss, rehabilitation with an ABCI fitted bilaterally shows audiologic advantages in speech perception in noise, not only thanks to the summation effect and by reducing head shadow but also by improving the binaural unmasking based on the squelch effect. Audiometric outcomes are confirmed by the GSs obtained in the APHAB questionnaire.

Cancers: What Are the Costs in Relation to Disability-Adjusted Life Years? A Systematic Review and Meta-Analysis.

Cancers currently represent a leading cause of morbidity and mortality, and precisely estimating their burden is crucial for evidence-based decision-making. This study aimed at understanding the average costs of cancer-related disability-adjusted life years (DALYs) and highlighting possible differences in economic estimates obtained with diverse approaches. We searched four scientific databases to identify all the primary literature simultaneously investigating cancer-related costs and DALYs. In view of the different methodologies, studies were divided into two groups: those estimating costs starting from DALYs, and those independently performing cost and DALY analyses. The latter were pooled to compute costs per disease-related DALY: meta-analytic syntheses were performed for total costs and indirect costs, and in relation to the corresponding gross domestic product (GDP) per capita. The quality of included studies was assessed through the Quality of Health Economic Studies instrument. Seven studies were selected. Total and indirect pooled costs per DALY were, respectively, USD 9150 (95% CI: 5560-15,050) and USD 3890 (95% CI: 2570-5880). Moreover, the cost per cancer-related DALY has been found to be, on average, 32% (95% CI: 24-42%) of the corresponding countries' GDP per capita. Costs calculated a priori from DALYs may lead to results widely different from those obtained after data retrieval and model building. Further research is needed to better estimate the economic burden of cancer in terms of costs and DALYs.

A cross-sectional study of SARS-CoV-2 seropositivity among healthcare workers and residents of long-term facilities in Italy, January 2021.

Long-term care facilities (LTCFs) are high-risk settings for SARS-CoV-2 infection. This study aimed to describe SARS-CoV-2 seropositivity among residents of LTCFs and health-care workers (HCWs). Subjects were recruited in January 2021 among unvaccinated HCWs of LTCFs and hospitals and residents of LTCFs in Northern Italy. Information concerning previous SARS-CoV-2 infections and a sample of peripheral blood were collected. Anti-S SARS-CoV-2 IgG antibodies were measured using the EUROIMMUN Anti-SARS-CoV-2 QuantiVac ELISA kit (EUROIMMUN Medizinische Labordiagnostika AG). For subjects with previous COVID-19 infection, gender, age, type of subject (HCW or resident), and time between last positive swab and blood draw were considered as possible determinants of two outcomes: the probability to obtain a positive serological result and antibody titer. Six hundred and fifty-eight subjects were enrolled. 56.1% of all subjects and 65% of residents presented positive results (overall median antibody titer: 31.0 RU/ml). Multivariable models identified a statistically significant 4% decrease in the estimated antibody level for each 30-day increase from the last positive swab. HCWs were associated with significant odds for seroreversion over time (OR: 0.926 for every 30 days, 95% CI: 0.860-0.998), contrary to residents (OR: 1.059, 95% CI: 0.919-1.22). Age and gender were not factors predicting seropositivity over time. Residents could have a higher probability of maintaining a seropositive status over time compared to HCWs.

Surgical site infection prevention through bundled interventions in hip replacement surgery: A systematic review.

BACKGROUND: Bundles have shown to improve patient outcomes in several settings. Surgical site infections (SSIs) following joint replacement surgery are associated with severe outcomes. We aimed to determine the effectiveness of non-pathogen specific bundled interventions in reducing SSIs after hip arthroplasty procedures. MATERIALS AND METHODS: A systematic review and meta-analysis were conducted according to the PRISMA statement guidelines (PROSPERO registration number CRD42020203031). PubMed, Embase and Cochrane databases were searched for studies evaluating SSI prevention bundles in hip replacement surgery, excluding studies evaluating pathogen-specific bundles. Records were independently screened by two authors. The primary outcome was the SSI rate in intervention and control groups or before and after bundle implementation. Secondary outcomes of interest were bundle compliance and the number and type of bundle components. A meta-analysis was conducted using raw data, by calculating pooled relative risk (RR) SSI estimates to assess the impact of bundled interventions on SSI reduction. RESULTS: Eleven studies were included in the qualitative review and four studies comprising over 20 000 patients were included in the quantitative synthesis. All included studies found bundles were associated with reduced SSI rates. The pooled RR estimated from the fixed-effects model was 0.76 (95% confidence interval 0.61-0.96, p 0.022) with 49.8% heterogeneity. CONCLUSIONS: Results support the effectiveness of non-pathogen specific bundled interventions in preventing SSIs following hip arthroplasty. A "core" group of evidence-based elements for bundle development were identified.

Pertussis immunisation during pregnancy: Antibody levels and the impact of booster vaccine.

Pertussis (whooping cough) is a highly infectious disease caused by Bordetella pertussis. Mothers lacking adequate immunity and contracting the disease represent the biggest risk of transmission to new-borns, for which the disease is often a threat. The aim of the study was to estimate the frequency of pertussis susceptibility among pregnant women, in order to point out the need for a vaccine recall during pregnancy, and to evaluate the antibody response in already vaccinated women. A cross-sectional observational study was conducted in the blood test centre of "St. Anna" Obstetrics and Gynaecology Hospital in Turin (Piedmont, Italy). Eligibility criteria included pregnant women coming to the centre for any blood test, aged 18 or above and with gestational age between 33 and 37 weeks at the moment of the blood draw. The data collection was carried out from May 2019 to January 2020 and the concentration of anti-Pertussis Toxin (anti-PT) IgG was measured through the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Two-hundred women (median age 35) were enrolled: 132 (66%) had received at least one dose of pertussis vaccine, 82 of which during pregnancy. Recently vaccinated women had significantly higher antibody titres (even 12-15 times as high) compared to those vaccinated more than 5 years before or never vaccinated at all (p < 0.0001). Moreover, 95.1% of recently vaccinated women had anti-PT IgG levels above 10 IU/ml, and 85.4% above 20 IU/ml, while the same proportions were as low as 37% and 21% (respectively) in the group of women not vaccinated in pregnancy. This study confirmed that the vaccination is greatly effective in ensuring high antibody titres in the first months after the booster vaccine, with considerable differences in anti-PT IgG compared to women vaccinated earlier or never vaccinated at all, and therefore vaccinating pregnant women against pertussis still represents a valuable strategy.

Cost-Effectiveness Analysis of the Prophylactic Use of Ertapenem for the Prevention of Surgical Site Infections after Elective Colorectal Surgery.

Standard surgical antimicrobial prophylaxis (SAP) regimens are less effective in preventing surgical site infections (SSIs) due to rising antimicrobial resistance (AMR) rates, particularly for patients undergoing colorectal surgery. This study aimed to evaluate whether ertapenem should be a preferred strategy for the prevention of SSIs following elective colorectal surgery compared to three standard SAP regimens: amoxicillin-clavulanate, cefoxitin, and cefazolin plus metronidazole. A cost-effectiveness analysis was conducted using decision tree models. Probabilities of SSIs and AMR-SSIs, costs, and effects (in terms of quality-adjusted life-years) were considered in the assessment of the alternative strategies. Input parameters integrated real data from the Italian surveillance system for SSIs with data from the published literature. A sensitivity analysis was conducted to assess the potential impact of the decreasing efficacy of standard SAP regimens in preventing SSIs. According to our models, ertapenem was the most cost-effective strategy only when compared to amoxicillin-clavulanate, but it did not prove to be superior to cefoxitin and cefazolin plus metronidazole. The sensitivity analysis found ertapenem would be the most cost-effective strategy compared to these agents if their failure rate was more than doubled. The findings of this study suggest ertapenem should not be a preferred strategy for SAP in elective colorectal surgery.

Preeclampsia and intrauterine growth restriction: Role of human umbilical cord mesenchymal stem cells-trophoblast cross-talk.

BACKGROUND: Oxidative stress is involved in the pathogenesis and maintenance of pregnancy-related disorders, such as intrauterine growth restriction (IUGR) and preeclampsia (PE). Human umbilical cord mesenchymal stem cells (hUMSCs) have been suggested as a possible therapeutic tool for the treatment of pregnancy-related disorders in view of their paracrine actions on trophoblast cells. OBJECTIVES: To quantify the plasma markers of peroxidation in patients affected by PE and IUGR and to examine the role of oxidative stress in the pathophysiology of PE and IUGR in vitro by using hUMSCs from physiological and pathological pregnancies and a trophoblast cell line (HTR-8/SVneo). STUDY DESIGN: In pathological and physiological pregnancies the plasma markers of oxidative stress, arterial blood pressure, serum uric acid, 24h proteinuria, weight gain and body mass index (BMI) were examined. Furthermore, the pulsatility index (PI) of uterine and umbilical arteries, and of fetal middle cerebral artery was measured. In vitro, the different responses of hUMSCs, taken from physiological and pathological pregnancies, and of HTR-8/SVneo to pregnancy-related hormones in terms of viability and nitric oxide (NO) release were investigated. In some experiments, the above measurements were performed on co-cultures between HTR-8/SVneo and hUMSCs. RESULTS: The results obtained have shown that in pathological pregnancies, body mass index, serum acid uric, pulsatility index in uterine and umbilical arteries and markers of oxidative stress were higher than those found in physiological ones. Moreover, in PE and IUGR, a relation was observed between laboratory and clinical findings and the increased levels of oxidative stress. HTR-8/SVneo and hUMSCs showed reduced viability and increased NO production when stressed with H2O2. Finally, HTR-8/SVneo cultured in cross-talk with hUMSCs from pathological pregnancies showed a deterioration of cell viability and NO release when treated with pregnancy-related hormones. CONCLUSION: Our findings support that hUMSCs taken from patients affected by PE and IUGR have significant features in comparison with those from physiologic pregnancies. Moreover, the cross-talk between hUMSCs and trophoblast cells might be involved in the etiopathology of IUGR and PE secondary to oxidative stress.