Optimizing Noninvasive Vagus Nerve Stimulation for Systemic Lupus Erythematosus: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Systemic lupus erythematosus is a chronic, multisystem, inflammatory disease of autoimmune etiology occurring predominantly in women. A major hurdle to the diagnosis, treatment, and therapeutic advancement of this disease is its heterogeneous nature, which presents as a wide range of symptoms such as fatigue, fever, musculoskeletal involvement, neuropsychiatric disorders, and cardiovascular involvement with varying severity. The current therapeutic approach to this disease includes the administration of immunomodulatory drugs that may produce unfavorable secondary effects. OBJECTIVE: This study explores the known relationship between the autonomic nervous system and inflammatory pathways to improve patient outcomes by treating autonomic nervous system dysregulation in patients via noninvasive vagus nerve stimulation. In this study, data including biomarkers, physiological signals, patient outcomes, and patient quality of life are being collected and analyzed. After completion of the clinical trial, a computer model will be developed to identify the biomarkers and physiological signals related to lupus activity in order to understand how they change with different noninvasive vagus nerve stimulation frequency parameters. Finally, we propose building a decision support system with integrated noninvasive wearable technologies for continuous cardiovascular and peripheral physiological sensing for adaptive, patient-specific optimization of the noninvasive vagus nerve stimulation frequency parameters in real time. METHODS: The protocol was designed to evaluate the efficacy and safety of transauricular vagus nerve stimulation in patients with systemic lupus erythematosus. This multicenter, national, randomized, double-blind, parallel-group, placebo-controlled study will recruit a minimum of 18 patients diagnosed with this disease. Evaluation and treatment of patients will be conducted in an outpatient clinic and will include 12 visits. Visit 1 consists of a screening session. Subsequent visits up to visit 6 involve mixing treatment and evaluation sessions. Finally, the remaining visits correspond with early and late posttreatment follow-ups. RESULTS: On November 2022, data collection was initiated. Of the 10 participants scheduled for their initial appointment, 8 met the inclusion criteria, and 6 successfully completed the entire protocol. Patient enrollment and data collection are currently underway and are expected to be completed in December 2023. CONCLUSIONS: The results of this study will advance patient-tailored vagus nerve stimulation therapies, providing an adjunctive treatment solution for systemic lupus erythematosus that will foster adoption of technology and, thus, expand the population with systemic lupus erythematosus who can benefit from improved autonomic dysregulation, translating into reduced costs and better quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05704153; https://clinicaltrials.gov/study/NCT05704153. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48387.

Síndrome da fragilidade e qualidade de vida em pessoas idosas hospitalizadas / Frailty syndrome and quality of life in hospitalized older adults

Resumo Objetivo analisar a relação entre a síndrome de fragilidade e qualidade de vida em pessoas idosas hospitalizadas. Métodos estudo de abordagem quantitativa e corte transversal, desenvolvido com uma amostra de 323 pessoas idosas assistidas em hospitais universitários da Paraíba, durante agosto de 2019 a julho de 2020. Os dados foram tabulados no SPSS, versão 26.0, mediante teste qui-quadrado de Pearson, teste de correlação de Spearman e regressão logística múltipla entre variáveis sociodemográficas, de fragilidade e qualidade de vida. Resultados dos participantes, 60,7% eram mulheres, 49,2% tinham idade entre 60 e 69 anos, 51% tinham cônjuge, 67,8%, sabiam ler e escrever, 89,2% moravam com pelo menos uma pessoa, 78,3% não exercia atividade laboral e 57,9% recebiam até um salário mínimo. A síndrome de fragilidade foi significativa com gênero, idade, letramento, atividade laboral, renda e qualidade de vida. Já a qualidade de vida foi estatisticamente significativa com gênero e atividade laboral, somente. Foi visto que não saber ler, não exercer atividade laboral e ter baixa qualidade de vida aumentava em 3,04 (IC95%; 1,70-5,44), 4,51 (IC95%; 2,39-8,49) e 3,81 (IC95%; 2,22-6,53), a probabilidade de ter síndrome da fragilidade, respectivamente; enquanto que não exercer atividade remunerada acrescia em 2,61 (IC95%; 1,45-4,73) a probabilidade de ter baixa qualidade de vida. Conclusões a síndrome da fragilidade está associada a uma redução na qualidade de vida de pessoas hospitalizadas, o que sinaliza propostas de melhorias para gestores hospitalares no que tange a assistência além das condições clínicas já estudadas no cotidiano laboral.

Abstract Objective to analyze the relationship between frailty syndrome and quality of life in hospitalized older adults. Methods a quantitative cross-sectional study of 323 older individuals was carried out at university hospitals of Paraíba from August 2019 to July 2020. Data were analyzed by SPSS, version 26.0, using Pearson´s chi-square, Spearman´s correlation and multiple logistic regression for sociodemographic, frailty and quality of life variables. Results regarding participant profile, 60.7% were women, 49.2% aged 60-69 years, 51% had a partner, 67.8% were literate, 89.2% lived with at least 1 other person, 78.3% were not working, and 57.9% received ≤ 1 minimum wage. Frailty syndrome was significantly associated with gender, age, literacy, work status, income, and quality of life. Quality of life was statistically significantly associated with only gender and work status. Results showed that illiteracy, not working and low quality of life increased the probability of frailty syndrome by 3.04 (95%CI; 1.70-5.4), 4.51 (95%CI; 2.39-8.49), and 3.81 (95%CI; 2.22-6.53), respectively; while not working increased the probability of low quality of life.by 2.61 (95%CI;1,45-4,73). Conclusions frailty syndrome was associated with low quality of life in the hospitalized older adults, indicating the need for measures by hospital managers to improve care beyond the clinical conditions addressed in routine practice.

A Prospective Cohort of SARS-CoV-2-Infected Health Care Workers: Clinical Characteristics, Outcomes, and Follow-up Strategy.

BACKGROUND: During the coronavirus disease 2019 (COVID-19) outbreaks, health care workers (HCWs) are at a high risk of infection. Strategies to reduce in-hospital transmission between HCWs and to safely manage infected HCWs are lacking. Our aim was to describe an active strategy for the management of COVID-19 in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected HCWs and investigate its outcomes. METHODS: A prospective cohort study of SARS-CoV-2-infected health care workers in a tertiary teaching hospital in Barcelona, Spain, was performed. An active strategy of weekly polymerase chain reaction screening of HCWs for SARS-CoV-2 was established by the Occupational Health department. Every positive HCW was admitted to the Hospital at Home Unit with daily assessment online and in-person discretionary visits. Clinical and epidemiological data were recorded. RESULTS: Of the 590 HCWs included in the cohort, 134 (22%) were asymptomatic at diagnosis, and 15% (89 patients) remained asymptomatic during follow-up. A third of positive cases were detected during routine screening. The most frequent symptoms were cough (68%), hyposmia/anosmia (49%), and fever (41%). Ten percent of the patients required specific treatment at home, while only 4% of the patients developed pneumonia. Seventeen patients required a visit to the outpatient clinic for further evaluation, and 6 of these (1%) required hospital admission. None of the HCWs included in this cohort required intensive care unit admission or died. CONCLUSIONS: Active screening for SARS-CoV-2 among HCWs for early diagnosis and stopping in-hospital transmission chains proved efficacious in our institution, particularly due to the high percentage of asymptomatic HCWs. Follow-up of HCWs in Hospital at Home units is safe and effective, with low rates of severe infection and readmission.

Hospital at home for the management of COVID-19: preliminary experience with 63 patients.

Alternatives to conventional hospitalization are needed to increase health systems resilience in the face of COVID-19 pandemic. Herein, we describe the characteristics and outcomes of 63 patients admitted to a single HaH during the peak of COVID-19 in Barcelona. Our results suggest that HaH seems to be a safe and efficacious alternative to conventional hospitalization for accurately selected patients with COVID-19.