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Introduction: Novel beta-lactam/beta-lactamase inhibitor (BIBLI) combinations are commercially available and have been used for treating carbapenem-resistant Klebsiella pneumoniae (CRKP) infections. Continuous surveillance of susceptibility profiles and resistance mechanism identification are necessary to monitor the evolution of resistance within these agents., Objective: The purpose of this study was to evaluate the susceptibility rates of ceftazidime/avibactam, imipenem/relebactam and meropenem/vaborbactam in CRKP isolated from patients with bloodstream infections who underwent screening for a randomized clinical trial in Brazil., Methods: Minimum inhibitory concentrations (MICs) were determined for meropenem, ceftazidime/avibactam, imipenem/relebactam and meropenem/vaborbactam using the gradient diffusion strip method. Carbapenemase genes were detected by multiplex real-time polymerase chain reaction. Klebsiella pneumoniae carbapenemase (KPC)-producing isolates showing resistance to any BLBLI and New Delhi Metallo-beta-lactamase (NDM)-producing isolates with susceptibility to any BLBLI isolates were further submitted for whole-genome sequencing., Results: From a total of 69 CRKP isolates, 39 were positive for bla KPC , 19 for bla NDM and 11 for bla KPC and bla NDM . KPC-producing isolates demonstrated susceptibility rates above 94 % for all BLBLIs. Two isolates with resistance to meropenem/vaborbactam demonstrated a Gly and Asp duplication at the porin OmpK36 as well as a truncated OmpK35. All NDM-producing isolates, including KPC and NDM coproducers, demonstrated susceptibility rates to ceftazidime/avibactam, imipenem/relebactam and meropenem/vaborbactam of 0 %, 9.1-21.1 % and 9.1-26.3 %, respectively. Five NDM-producing isolates that presented susceptibility to BLBLIs also had porin alterations CONCLUSIONS: This study showed that, although high susceptibility rates to BLBLIs were found, KPC-2 isolates were able to demonstrate resistance probably as a result of porin mutations. Additionally, NDM-1 isolates showed susceptibility to BLBLIs in vitro., Competing Interests: Competing interests A.P.Z. is a research fellow of the National Council for Scientific and Technological Development (CNPq/Brazil). The authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Mucoepidermoid carcinomas (MECs) are a form of salivary gland malignancy. They are classified according to histological grade and perineural invasion (PNI). In another cancer subtypes, positive-PNI suggests increased poor prognosis; however, the role of isolated positive-PNI salivary gland MEC can still be better investigated as a risk factor. This study investigated whether isolated PNI is independently associated with poor outcomes. Retrospective study, cohort case-series, single-center hospital from 2009 to 2019. Patient demographics, primary tumor, intervention, and survival data are included. Univariate, multivariate, and Kaplan-Meier survival curve analyses were used for comparison.The study group consisted of 32 patients (15 PNI-positive tumors, and 17 PNI-negative tumors), all admitted for surgery. Univariate analysis showed differences in grade ( p  = 0.038), positive margins ( p  = 0.034), soft tissue invasion ( p  < 0.001), pathological stage ( p  = 0.014), recurrence ( p  = 0.015), distant metastasis ( p  = 0.015) and MEC related death ( p  = 0.015). The risk in PNI-positive patients to develop soft tissue invasion and positive surgical margins was OR  = 8.57 and OR  = 4.88, respectively. Multivariate analysis found age differences ( p  = 0.038), with OR  = 1.08. The Disease Specific Survival (DSS) was worst in the PNI-positive group ( log-rank p-value  = 0.0011), where the probability of dying occurred in the 12-24 months period ( log-rank p-value  = 0.002). PNI-positive salivary gland MEC is an independent prognostic factor, with poor DSS, increased locoregional recurrence, close correlation with a more aggressive pattern of the disease, and should be reviewed as a high grade histological criteria. Our findings may imply changes in the clinical approach with a more aggressive attitude in the overall treatment., Competing Interests: Conflict of interestThe authors declare no Competing Interests in this article., (© Association of Otolaryngologists of India 2021.)

Objective: To describe the IMPACTO-MR, a Brazilian nationwide intensive care unit platform study focused on the impact of health care-associated infections due to multidrug-resistant bacteria., Methods: We described the IMPACTO-MR platform, its development, criteria for intensive care unit selection, characterization of core data collection, objectives, and future research projects to be held within the platform., Results: The core data were collected using the Epimed Monitor System® and consisted of demographic data, comorbidity data, functional status, clinical scores, admission diagnosis and secondary diagnoses, laboratory, clinical, and microbiological data, and organ support during intensive care unit stay, among others. From October 2019 to December 2020, 33,983 patients from 51 intensive care units were included in the core database., Conclusion: The IMPACTO-MR platform is a nationwide Brazilian intensive care unit clinical database focused on researching the impact of health care-associated infections due to multidrug-resistant bacteria. This platform provides data for individual intensive care unit development and research and multicenter observational and prospective trials.

Objectives: To investigate whether the effect of a flexible ICU visiting policy that includes flexible visitation plus visitor education on anxiety symptoms of family members is mediated by satisfaction and involvement in patient care., Design: We embedded a multivariable path mediation analysis within a cluster-randomized crossover trial as a secondary analysis of The ICU Visits Study (ClinicalTrials.gov number: NCT02932358)., Setting: Thirty-six medical-surgical ICUs in Brazil., Patients: Closest relatives of adult ICU patients., Interventions: Flexible visitation (12 hr/d) supported by family education or usual restricted visitation (median, 1.5 hr/d)., Measurements and Main Results: Overall, 863 family members were assessed (mean age, 44.7 yr; women, 70.1%). Compared with the restricted visitation (n = 436), flexible visitation (n = 427) resulted in better mean anxiety scores (6.1 vs 7.8; mean difference, -1.78 [95% CI, -2.31 to -1.22]), as well as higher standardized scores of satisfaction (67% [95% CI, 55-79]) and involvement in patient care (77% [95% CI, 64-89]). The mediated effect of flexible visitation on mean anxiety scores through each incremental sd of satisfaction and involvement in patient care were -0.47 (95% CI, -0.68 to -0.24) and 0.29 (95% CI, 0.04-0.54), respectively. Upon exploratory analyses, emotional support, helping the ICU staff to understand patient needs, helping the patient to interpret ICU staff instructions, and patient reorientation were the domains of involvement in patient care associated with increased anxiety., Conclusions: A flexible ICU visiting policy reduces anxiety symptoms among family members and appears to work by increasing satisfaction. However, increased participation in some activities of patient care as a result of flexible visitation was associated with higher severity of anxiety symptoms., Competing Interests: Drs. Rosa, Sganzerla, Schneider, Robinson, Kochhann, da Silva, Medeiros, and Falavigna report grants from Brazilian Ministry of Health during the conduct of study. Drs. Rosa’s, Sganzerla’s, and Medeiros’s institutions received funding from Brazilian Ministry of Health. Dr. da Silva received funding from Brazilian Ministry of Health. Dr. Amaral’s institution received funding from Hospital Moinhos de Vento. Drs. Amaral, Prestes, and Medeiros disclosed government work. Dr. Prestes’ institution received funding from Hospital Universitário da Universidade Federal do Piauí. Dr. Falavigna received funding from Roche, Novartis, Abbvie, Boehringer Ingelheim, Ultragenix, PTC Therapeutics, and Sanofi Genzime, and he received support for article research from the Canadian Institutes of Health Research. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2021 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Introduction: The long-term effects caused by COVID-19 are unknown. The present study aims to assess factors associated with health-related quality of life and long-term outcomes among survivors of hospitalization for COVID-19 in Brazil., Methods: This is a multicenter prospective cohort study nested in five randomized clinical trials designed to assess the effects of specific COVID-19 treatments in over 50 centers in Brazil. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed-up for a period of 1 year by means of structured telephone interviews. The primary outcome is the 1-year utility score of health-related quality of life assessed by the EuroQol-5D3L. Secondary outcomes include all-cause mortality, major cardiovascular events, rehospitalizations, return to work or study, physical functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living, dyspnea assessed by the modified Medical Research Council dyspnea scale, need for long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-Revised, and self-rated health assessed by the EuroQol-5D3L Visual Analog Scale. Generalized estimated equations will be performed to test the association between five sets of variables (1- demographic characteristics, 2- premorbid state of health, 3- characteristics of acute illness, 4- specific COVID-19 treatments received, and 5- time-updated postdischarge variables) and outcomes., Ethics and Dissemination: The study protocol was approved by the Research Ethics Committee of all participant institutions. The results will be disseminated through conferences and peer-reviewed journals.

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain., Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium., Design, Setting and Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018., Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation., Main Outcomes and Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory)., Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation., Conclusions and Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium., Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.

Klebsiella pneumoniae carbapenemase-producing K. pneumoniae (KPC-KP) bloodstream infections (BSIs) are related to high mortality rates, and combination therapy has been associated with lower mortality in patients treated mostly with colistin. There is a paucity of studies addressing polymyxin B (PMB) treatment for KPC-KP infections. This was a retrospective cohort study of patients with monomicrobial KPC-KP BSIs. The primary outcome was 30-day mortality. Antimicrobial therapy was defined as empirical (started within the first 48 h) or definitive (initiated after >48 h) and was evaluated as follows: monotherapy (only one in vitro active agent or combination therapy of one in vitro active agent plus one or more in vitro non-active agents); and combination therapy with two or more in vitro active agents. A total of 82 KPC-KP BSIs were included; 40 patients (48.8%) died in the first 30 days. Mortality of patients treated with the combination of two in vitro active antimicrobial agents, mostly PMB plus amikacin, was significantly lower (37.5%) compared with monotherapy (64.7%) (P= 0.01). Combination therapy [adjusted hazard ratio (aHR) = 0.40, 95% confidence interval (CI) 0.22-0.83; P = 0.01] was independently associated with lower 30-day survival when controlled for non-surgical admission (aHR = 2.33, 95% CI 1.14-4.80; P = 0.02) and use of vasoactive drugs (aHR = 7.37, 95% CI 3.01-18.02; P < 0.01). In conclusion, combination therapy with two in vitro active agents, mostly PMB plus amikacin, showed a survival benefit compared with other regimens., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Unlabelled: OBJECT.: A previous study published by the authors showed that a single intervention could not change the baseline attitudes toward neurotrauma prevention. The present study was designed to evaluate the effectiveness of multiple interventions in modifying knowledge and attitudes for the prevention of neurotrauma in Brazilian preteens and adolescents., Methods: In a randomized controlled trial, fifth-year primary school (PS) and second-year high school (HS) students were divided into a control and 2 intervention (single/multiple) groups. The study was conducted in the following 8 stages: T1, questionnaire to measure baseline characteristics; T2, lecture on trauma prevention; T3, reapplying the questionnaire used in T1; T4, Traffic Department intervention; T5, a play about trauma and its consequences; T6, Fire Department intervention; T7, Emergency Medical Service intervention; and T8, reapplying the questionnaire used in T1 and T3. Positive answers were considered those affirming the use of safety devices "always or sometimes" and negative as "never" using safety devices., Results: The sample consisted of 535 students. Regarding attitudes, students in all groups at any stage of measurement showed protective behavior more than 95% of the time about seat belt use. There were only differences between attitudes in PS and HS students on T8 assessment concerning the use of safety equipment on bikes in the multiple-intervention group and concerning the use of safety equipment on skateboards and rollerblades in single- and multiple-intervention groups. These differences were caused mainly by the reduction in positive answers by the HS group, rather than by the increase in positive or protective answers by the PS group. However, there was no difference when the control and intervention groups were compared, independent of the attitudes or the student groups studied. The most important reason for not using protective devices was the belief that they would not get hurt., Conclusions: Multiple and different types of educational interventions, such as lectures, scenes from plays about trauma and its consequences, traffic and fire department intervention, and medical emergency intervention directed to preteens and adolescents from public and private schools did not modify most students' attitudes toward injury prevention. Clinical trial registration no: U1111-1121-0192 (National System of Ethics and Research in Brazil).

Pseudomonas aeruginosa is one of the major pathogens responsible for a wide variety of severe nosocomial and community acquired infections. Numerous vaccine candidates and several monoclonal antibodies have been developed over the past 40 years but only a few have reached clinical trials and none of these vaccine candidates has obtained market authorization. The understanding of P. aeruginosa pathogenesis and its virulence factors is essential in the identification of immunogens that can be used for a P. aeruginosa vaccine. This review summarizes the present status of vaccine development for this important pathogen.

Object: Trauma is the leading cause of mortality and morbidity in children, young people, and working-age adults. Because of the high incidence of intentional and unintentional injuries in young people, it is necessary to implement injury-prevention programs and measure the efficacy of these initiatives. The authors evaluated the effectiveness of an injury-prevention program in high school students in a city in southern Brazil., Methods: In a randomized controlled study, 1049 high school students were divided into a control group and intervention group. The study was conducted in the following 3 stages: a questionnaire was applied 1 week before the educational intervention (P0), shortly after the intervention (P1), and 5 months later (P3). In the control group, a questionnaire based on the Pense Bem Project was applied at the 3 time stages, without any intervention between the stages., Results: The postintervention analysis evidenced a slight change in knowledge about unintentional spinal cord and brain injuries. Regarding attitudes, the only significant improvement after the intervention lecture was in the use of helmets, which remained high 5 months later. A substantial number of students only partially agreed with using safety behaviors. The only significant postintervention change was the major agreement to check swimming pool depth before entering the water (P0 89% and P1 97.8%, p < 0.001; P2 92.8%, p = 0.005)., Conclusions: An educational intervention based on a single lecture improved students' knowledge of traumatic brain and spinal cord injuries, but this type of intervention did not modify most attitudes toward injury prevention. Clinical trial registration no.: U1111-1121-0192.

The nature and frequency of cystic fibrosis mutations in Brazil is not uniform due to the highly varied ethnic composition of the population. The average frequency of the F508del mutation has been reported to be 48.6%. Other common mutations in Brazil are G542X, R1162X, and N1303K. The aim of this study was to analyze the frequency of 8 mutations (F508del, G542X, R1162X, N1303K, W1282X, G85E, 3120+1G>A, and 711+1G>T) in a sample of 111 newborn patients with cystic fibrosis diagnosed by the Cystic Fibrosis Neonatal Screening Program of Minas Gerais State. The mutations were tested by allele-specific oligonucleotide PCR with specially designed primers. An allele frequency of 48.2% was observed for the F508del mutation, and allele frequencies of 5.41, 4.50, 4.05, and 3.60% were found for the R1162X, G542X, 3120+1G>A, and G85E mutations, respectively. The genotypes obtained were in Hardy-Weinberg equilibrium. These data demonstrate that the 8-mutation panel studied here has extensive coverage (68%) for the cystic fibrosis mutations in Minas Gerais. These data improve our knowledge of cystic fibrosis in Brazil, particularly in this region. In addition, this investigation contributed to the establishment of a sensitive and population-specific mutation panel, which can be helpful for molecular diagnosis of cystic fibrosis.