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This study aims to identify the trajectory of psychological well-being during the COVID-19 pandemic among community-dwelling older adults and to clarify the association between coping behavior in the early stage of the pandemic and the trajectory of psychological well-being. The study was based on a cohort study, known as "the Otassha Study.” We administered three follow-up surveys to 720 older adults who participated in the survey in October 2019 (T0): T1: June 2020, T2: October 2020, and T3: October 2021. Furthermore, we assessed coping behavior in T1 via a self-developed questionnaire comprising 10 items. Psychological well-being was assessed by the WHO-5 Well-Being Index (score range: 0 to 25) in all surveys. The trajectories of psychological well-being were identified by group-based trajectory modeling. The association between coping behaviors and trajectory patterns was assessed using multinomial logistic regression analysis. Furthermore, among the 508 participants who participated in the follow-up survey two times or more, three patterns of the trajectory of psychological well-being were identified: heavily decreased group (n = 39), decreased group (n = 352), and increased group (n = 39). "Walking” as a coping behavior had a significantly higher odds ratio (OR) to be in the increased group (OR = 2.32, 95 % confidence interval (CI) 1.06–5.05, p = 0.035) compared to the heavily decreased group. "Conversations with family living together” had a slightly higher OR to become an increased group (OR = 1.96, 95 % CI: 0.87–4.41, p = 0.106), and "actively gathering information on COVID-19” had a slightly lower OR to become the decreased group (OR = 0.53, 95 % CI: 0.26–1.06, p = 0.072) compared to the heavily decreased group. The results of this study suggest how maintaining health in the early stage of the pandemic had a great influence on the long-term health status. © 2022 The Authors
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Background and ObjectivesThere are concerns on the safety of SARS-CoV-2 vaccination in patients with a history of Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN). The aim of this study was to determine the risk of recurrence of GBS and exacerbations of CIDP or MMN after SARS-CoV-2 vaccination.MethodsWe conducted a prospective, multicenter cohort study from January 2021 to August 2021. Patients known in 1 of 3 Dutch University Medical Centers with research focus on immune-mediated neuropathy and members of the Dutch Patient Association for Neuromuscular Diseases were invited to participate if they were 18 years or older and diagnosed with GBS, CIDP, or MMN. Participants completed a series of questionnaires at 4 different time points: study baseline (1), within 48 hours before any SARS-CoV-2 vaccination (2 and 3, if applicable), and 6 weeks after their last vaccination (4). Participants unwilling to get vaccinated completed the last questionnaire (4) 4 months after study baseline. We assessed recurrences of GBS, any worsening of CIDP or MMN-related symptoms, treatment alterations, and hospitalization.ResultsOf 1,152 individuals to whom we sent the questionnaires, 674 (59%) signed informed consent. We excluded 153 individuals, most often because they had already received a SARS-CoV-2 vaccination or had had the infection (84%) before study baseline. Of 521 participants included in analyses, 403 (81%) completed the last questionnaire (time point 4). None of 162 participants with a history of GBS had a recurrence after vaccination. Of 188 participants with CIDP, 10 participants (5%) reported a worsening of symptoms within 6 weeks after vaccination. In 5 (3%) of these patients, maintenance treatment was modified. Two of 53 participants with MMN (4%) reported a worsening of symptoms, and treatment modification was reported by 1 participant.DiscussionWe found no increased risk of GBS recurrence and a low to negligible risk of worsening of CIDP or MMN-related symptoms after SARS-CoV-2 vaccination. Based on our data, SARS-CoV-2 vaccination in patients with these immune-mediated neuropathies seems to be safe. © American Academy of Neurology.
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Background: Olfactory dysfunction (OD) is a common symptom of Corona Virus Disease 2019 (COVID-19). It is defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and represents one of the early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey has shown that some post-COVID-19 patients had no improvement 1 month after discharge from the hospital. Objective: To explore the efficacy of acupuncture for OD in COVID-19 infected patients and to determine whether acupuncture could have benefits over sham acupuncture for OD in post-COVID-19 patients. Methods: This is a single-blind, randomized controlled, cross-over trial. We plan to recruit 40 post-COVID-19 patients with smell loss or smell distortions lasting for more than 1 month. Qualified patients will be randomly allocated to the intervention group (real acupuncture) or the control group (sham acupuncture) at a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 weeks (Cycle 1) and a 2-week follow-up. After the follow-up, the control group will be subjected to real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will undergo the 4-week sham acupuncture. The primary outcomes will be the score changes on the questionnaire of olfactory functioning and olfaction-related quality of life at week 6, 8, 12, and 14 from the baseline. The secondary outcomes will be the changes in the olfactory test score at week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC). Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 patients. This may provide a new treatment option for patients.
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Background: Allergen exposure chamber (AEC) is a clinical facility that allows exposure to allergenic airborne particles in controlled environment. Although AECs offer stable levels of airborne allergens, the validation of symptoms and other endpoints induced by allergen challenge is key for their recommendation as a plausible tool for the assessment of patients, especially in clinical research. This study aimed to demonstrate the reproducibility of defined clinical endpoints after AEC house dust mite (HDM) challenge under optimal conditions in patients with allergic rhinitis (AR). Method: HDM was distributed at different concentrations. The assessment was subjective by the patients: total nasal symptom score (TNSS), visual analog scale (VAS), and objective by the investigator: acoustic rhinometry, peak nasal inspiratory flow (PNIF), and nasal secretion weight. Safety was assessed clinically and by peak expiratory flow rate (PEFR) and forced expiratory volume in the first second (FEV1). Results: Constant environment: temperature, humidity, and carbon dioxide (CO2) concentration were maintained during all challenges. The concentration of HDM on average remained stable within the targeted values: 1000, 3000, 5000, 7000 particles (p)/m3. Most symptoms were observed at concentrations 3000 p/m3 or higher. The symptoms severity and other endpoints results were reproducible. 5000 p/m3, and challenge duration of 120 min were found optimal. The procedure was safe with no lung function abnormalities due to challenge. Conclusion: HDM challenge in ALL-MED AEC offers a safe and reliable method for inducing symptoms in AR patients for the use in controlled clinical studies including allergen immunotherapy. © 2022 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
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Objective: Self-restraint from activities due to the COVID-19 pandemic has limited the range of activities and interpersonal relationships for older persons. Moreover, prolonged restraint has been reported to increase the risk of frailty and sarcopenia. Therefore, we examined the effects of changes in exercise habits on physical function and psychological status of older patients with hypertension throughout their self-restraint lifestyle from 2020 to 2022 in the 1-year follow-up study. Design and Methods: Participants were patients with hypertension aged 65 years or older attending outpatient clinics at our institution who could obtain information on exercise habits, history of falls, comprehensive geriatric assessment, and muscle strength. We conducted the same survey in the first year and one year later. The subjects were classified into four groups by combining their exercise habits in the first year with or without one year later. That is Group A: with exercise habits at both times of the survey;Group B: with exercise habits in the first year and without exercise habits one year later;Group C: without exercise habits in the first year and with exercise habits one year later;and Group D: without exercise habits at both times of the survey. Written consent forms were obtained from all participants. Our institutional review board approved the study protocol. Results: The study participants were 183 patients (Group A: 119, Group B: 26, Group C: 17, Group D: 21). The age of the participants was 76.1 ± 5.5 years, 82 (44.8%) were male, and the duration of hypertension was 18.4 ± 11.5 years. Changes in exercise habits were not associated with physical function, history of falls, and comprehensive geriatric assessment at one year. However, when the results were examined separately for men and women, the geriatric depression scale was significantly higher in women in Group B (Dunnett test, p = 0.0094) than in Group A, suggesting that the tendency toward depression had progressed. Group B women also had more falls one year later (chi-square 12.04, p = 0.0072). Conclusions: In a 1-year follow-up study during the COVID-19 pandemic, a relatively high proportion of older patients with hypertension attending our hospital maintained their exercise habits, but 14% of cases lost their exercise habits. Only women showed the development of depression and increased risk of falls when exercise habits were lost. Women were more susceptible to the effects of environmental changes than men in older patients with hypertension.
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The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC. © 2023, Editorial department of Chinese Medical Ethics. All rights reserved.
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Purpose: To compare the efficacy of 0.1 % w/w Liposomal Amphotericin-B gel with 10 % w/w Povidone-Iodine and saline nasal douching in preventing revision surgery in patients with CAM. Study design: Multi-arm, parallel randomized control trial. Study setting: The trial was conducted in the Department of ENT, All India Institute of Medical Sciences (AIIMS) Bhubaneswar. Methods: Participants: Microbiologically and histologically proven cases of mucormycosis who underwent surgical debridement were included in the study. Interventions: Postoperatively, patients were randomized into three groups based on the type of topical intervention received, in the form of Lipid-based Amphotericin B gel, povidone‑iodine ointment or saline nasal douching. Outcome: Requirement of revision surgery in postoperative cases of CAM. Randomization: Participants were allotted to one of the three arms by block randomization. Blinding: Single-blinded trial. Results: Numbers randomized: 15 participants were randomized to each group. Recruitment: Completed recruiting. Numbers analyzed: 15 participants were analyzed in each group. Outcomes: Control arm's risk of revision surgery was 4.50 (95 % CI: 1.16–17.44) times than Lipid-based Amphotericin B gel arm and 1.50 (95 % CI: 0.71–3.16) times that of the Povidone- Iodine arm. The difference was statistically significant (p = 0.02) for Amphotericin but not for Povidone-Iodine. Conclusions: Topical Amphotericin-B gel application in the postoperative cavity can decrease the need for revision surgery and help in early recovery. Trial registration: CTRI/2021/10/037257. Clinical Trials Registry of India. © 2022 Elsevier Inc.
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Introduction: Cardiovascular events are the leading cause of mortality in patients with chronic kidney disease on hemodialysis (CKD-HD). Recent evidence suggests that coronavirus-19 disease (COVID-19) would induce vascular endothelial function alterations to increase cardiovascular risk. However, whether COVID-19 contributes to endothelial dysfunction in patients with CKD-HD is unclear. Objective: To assess whether COVID-19 worsens endothelial function in a cohort of patients with chronic kidney disease on hemodialysis. Materials and Methods: Patients with chronic kidney disease on hemodialysis were divided into those without COVID-19 (CKD;n = 68) and mild COVID-19 (CKD-C19;n = 11, WHO criteria and PCR+). Informed consent was obtained. Systolic (SBP), diastolic (DBP) and mean (MAP) blood pressures, heart rate (HR), and endothelial function (EF) were evaluated for reactive hyperemia. It was determined dry weight, height, fat mass index (FMI), muscle mass index (MMI), and body mass index (BMI). Results were compared with normal people without CKD (Control = C, n = 10). Results: CKD and CKD-C19 presented a high SBP compared to the controls and without differences between them (C: 119 ± 3, n = 10 vs. CKD: 145 ± 2, n = 68 vs. CKD-C19: 143 ± 3 mmHg, n = 11;p < 0.05 vs. C). Patients CKD-C 19 presented greater endothelial dysfunction compared to CKD and the control group (EF: CKD-C19:2 ± 1, n = 11 vs CKD:4.5 ± 1, n = 28 vs. C:12.1 ± 1, n = 10;p < 0.05). In CKD and C-C19 an increase in BMI was observed in conjunction with an increase in fat mass, without differences in the muscle mass index between both groups (X2:p: NS). No association was observed between EF and BMI or IMG. Conclusions: The present study indicates that COVID-19 would aggravate endothelial dysfunction in patients with chronic kidney disease on hemodialysis. This would not be related to increased BMI or elevated blood pressure. However, more studies are needed to determine the role of COVID-19 on vascular function in this population. (Table Presented).
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Background: The COVID-19 pandemic presents challenges in participant recruitment strategies for clinical research involving people with opioid use disorders recently engaged in treatment. We describe challenges to participant recruitment in a trial comparing virtual buprenorphine treatment platform to office-based buprenorphine treatment. Methods: The parent study was a cohort trial of telehealth delivered buprenorphine treatment compared to office-based buprenorphine treatment, however, due to the pandemic potential participant recruitment for both arms became virtual. Between 9/27/2021 and 7/11/2022, telephone, email, flyers, and word-of-mouth were used to recruit study participants from each treatment setting. Recruitment tracking documents recorded the primary outcomes: number of outreach attempts and most effective contact methods. Results: Treatment settings provided contact information for 1485 potential study participants. Information was incorrect or disconnected for 282 (19%) individuals, 695 (47%) did not respond to outreach, and 508 (34%) responded to outreach. Of these responders, 369 were interested in study participation, 259 completed the online informed consent and screening assessment, and 148 met eligibility criteria and enrolled in the study. A total of 3804 virtual outreach attempts across 1485 potential participants were made, resulting in an average of 2.7 attempts per contact and a mean of 25.7 attempts per enrolled participant (n = 148). Conclusion: Conducting research during the COVID-19 pandemic required shifting from in-person to virtual recruitment strategies to contact and engage potential study participants. Virtual recruitment for this population during a pandemic appears to be less efficient and hindered efforts to meet recruitment goals. © 2022
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Rationale: APECED is a life-threatening monogenic disorder characterized by multiorgan autoimmunity. Most patients harbor autoantibodies (auto-abs) to type-1 interferons (IFNs), which are important mediators of viral defense. Auto-abs to type-1 IFNs are associated with severe COVID-19 and may play a role in other viral infections including by varicella zoster virus (VZV). A recent study of 44 European APECED patients reported increased susceptibility to VZV, and a correlation between VZV recurrence and auto-abs to IFN-α. The clinical, immunophenotypic, and auto-ab characteristics of APECED patients in the USA with VZV are described. Methods: Data was obtained from 103 participants on a prospective, natural history study after informed consent. Auto-abs to IFN-α, IFN-β or IFN-ω were measured using a multiplex particle-based assay. Unpaired t tests or U Mann Whitney tests were used, with Holm correction for multiple comparisons, where appropriate. Results: Twenty-six patients reported childhood chickenpox (mean onset 5.6 years) and 2 (7.7%) required hospitalization for severe disease. Nineteen patients (18%) had at least one episode of shingles (median onset 13 years;range, 4-55 years) and 4 had >1 episode. Fifteen of the 19 patients with shingles (79%) were not receiving immunosuppressive medications during their first infection. VZV IgG levels;total and percent CD3, CD8, CD4, CD19, NK cells;and auto-abs to IFN-α, IFN-β and IFN-ω did not significantly differ between patients with or without recurrent shingles. Conclusions: A subset of APECED patients develop early-onset, recurrent VZV infections even in the absence of immunosuppression. The mechanisms underlying susceptibility to VZV in APECED require further study.
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Purpose: To report a case of a 51-year- old male who developed dermatomyositis following the second dose of coronavirus disease (COVID-19) vaccine. Method(s): Case report Result: Case: We report a case of 51-year- old male who developed erythematous maculopapular rash on the upper anterior chest and upper back along with symmetric proximal muscle weakness two months after receiving his second dose of CoronaVac vaccine. His symptoms were followed by edema in the periorbital area which later involved the upper and lower extremities. He had dysphagia and weight loss. He had no known family history of autoimmune diseases. Physical examination revealed macular erythema over the lower anterior neck and upper back. Heliotrope rash and hyperkeratotic pink scaly papules on bilateral lateral second digits (mechanic's hands) were seen. Symmetric proximal muscle weakness in the upper and lower extremities was objectified. Blood tests showed elevated muscle enzymes (total CK: 3899 U/L, CK MB mass: 15.4 ng/mL, LDH: 683, AST: 232 U/L, ALT: 66 IU/L) elevated ESR (36) and normal CRP. Anti Jo 1 and anti U1 RNP were negative. Work up for systemic infection, thyroid function and malignancy were unremarkable. Diagnosis: Diagnosis of dermatomyositis was made based on clinical history and physical exam findings of symmetric proximal weakness, presence of heliotrope rash, V sign and shawl sign. Laboratory tests revealed elevated total CK, CK MB mass, LDH, AST, ALT and ESR consistent with an inflammatory myositis. Intervention(s): Hydrocortisone 1 mg/kg/day was started. Azathioprine was commenced on the 3rd hospital day. Ethical consideration: Informed consent for both written and photographic content was secured and patient confidentiality was observed. Conclusion(s): This case highlights the possible association between COVID 19 vaccine and this rare autoimmune disease. We hypothesize that among patients with genetic predisposition, the possibility of vaccines triggering and unmasking an autoimmune event is possible. (Figure Presented).
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Purpose: To report a case of a 66-year- old Filipino male who developed spontaneous knee hemarthrosis following enoxaparin prophylaxis. Method(s): Case report Result: Case: We report a case of a 66-year- old Filipino male who developed spontaneous hemarthrosis of the left knee following enoxaparin use as venous thromboembolism prophylaxis. Pertinent in the medical history was the diagnosis of chronic kidney disease and chronic respiratory failure as sequelae of COVID 19 infection. During the course of admission, the patient developed acute pain and swelling of the left knee. He was bedridden and no prior traumatic events were noted. Coagulation parameters were within normal range. Arthrocentesis revealed viscous hemorrhagic synovial fluid (25 ml) with fluid analysis showing predominance of red blood cells (Red blood cells: 680,000/muL, White blood cells: 7200/muL) with no crystals seen on polarizing microscopy. Microbial culture was negative. Intravenous methylprednisolone was given and enoxaparin was continued. One day post arthrocentesis, there was improvement of pain and joint function. Joint swelling resolved. Patient had no recurrence of joint pain and swelling. Ethical consideration: Informed consent for both written and photographic content was secured and patient confidentiality was observed. Conclusion(s): Our patient is an elderly with chronic kidney disease who recently recovered from COVID 19 infection. He received prophylactic dose of enoxaparin at 40 mg every 24 hours subcutaneously. No other drugs that can affect hemostasis were given. The patient's bleeding parameters were within normal during admission and at the onset of hemarthrosis. We hypothesize that elderly patients with chronic kidney disease receiving low dose enoxaparin may present with spontaneous hemarthrosis even in the absence of trauma. Whether the association between history of recent COVID-19 infection and hemarthrosis is co incidental or causal remains to be elucidated. Prompt aspiration can provide early diagnosis and facilitate proper treatment. (Figure Presented).
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The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC. © 2023, Editorial department of Chinese Medical Ethics. All rights reserved.
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INTRODUCTION The Prostate Cancer Transatlantic Consortium (CaPTC) has the goal of better understanding the burden of prostate cancer among Black men of West African descent. While prostate cancer disproportionately affects Blacks around the world, little research is done to understand what mental health and social support play a role in prostate cancer risk factors. The purpose of this 10-year longitudinal study is to establish a cohort of U.S.-born Black men, West African-born Black men who reside in the U.S, and West African Black men in Africa who would be prospectively and longitudinally followed to better understand the cause of prostate cancer and how different factors might influence it. METHODS Study staff partnered with community-based organizations, events, and stakeholders to engage with the priority population. Snowball sampling was also used for recruitment. All participants were made aware of the longitudinal nature of the study and that they would be contacted every two years for follow-up. Informed consent was done in community settings electronically and on paper. Once consent was received, participants completed the survey with a unique identifier and filled out a Cohort Contact sheet. They were given the option to complete this on their own or with the help of the study staff. Study Staff would then measure participants' weight, height, and waistline, to be recorded on the survey form. After this, participant saliva was collected and tracked with the unique identifier. All collected data was stored on RedCap and a Chi-squared test was utilized to identify statistical significance. RESULTS 803 participants are included in this data with 77 in Cameroon, 663 in Nigeria, and 59 in the United States. When asked about emotional support, 13.6% (US) 11.8% (Nigeria), and 14.3% (Cameroon) indicated never or rarely having emotional support. 5.8% of those in the United States, 5.6% of those in Nigeria, and 7.8% of those in Cameroon felt dissatisfied or very dissatisfied with their lives. The p-value for both was found to be <0.001, therefore, suggesting statistical significance. On the other hand, participants described having an average of 6.53 (US), 9.4 (Nigeria), and 8.26% (Cameroon) days where their mental health was not good. However, this was statistically insignificant with a p-value of .95. CONCLUSION Mental health issues have been on the rise since the COVID-19 pandemic. While many people of color have stigmatized needing mental health help, it is important to find ways to overcome this barrier in assessing mental health and social support needs. Future research should continue to ask mental health and social support questions in order to assess their role in prostate cancer risk factors.