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1.
Trials ; 21(1): 843, 2020 Oct 09.
Article in English | MEDLINE | ID: covidwho-2315489

ABSTRACT

BACKGROUND: Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. METHODS: A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. DISCUSSION: It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. TRIAL REGISTRATION: ClinicalTrials.gov NCT04228146 . Retrospectively registered on 14 January 2020.


Subject(s)
Cognitive Behavioral Therapy , Sleep Initiation and Maintenance Disorders , Depression/diagnosis , Depression/therapy , Hong Kong , Humans , Randomized Controlled Trials as Topic , Sleep Initiation and Maintenance Disorders/diagnosis , Sleep Initiation and Maintenance Disorders/therapy , Smartphone , Treatment Outcome
2.
Psychol Med ; 53(5): 1799-1813, 2023 04.
Article in English | MEDLINE | ID: covidwho-2293110

ABSTRACT

BACKGROUND: Despite its efficacy in treating comorbid insomnia and depression, cognitive behavioral therapy for insomnia (CBT-I) is limited in its accessibility and, in many countries, cultural compatibility. Smartphone-based treatment is a low-cost, convenient alternative modality. This study evaluated a self-help smartphone-based CBT-I in alleviating major depression and insomnia. METHODS: A parallel-group randomized, waitlist-controlled trial was conducted with 320 adults with major depression and insomnia. Participants were randomized to receive either a 6-week CBT-I via a smartphone application, proACT-S, or waitlist condition. The primary outcomes included depression severity, insomnia severity, and sleep quality. The secondary outcomes included anxiety severity, subjective health, and acceptability of treatment. Assessments were administered at baseline, post-intervention (week 6) follow-up, and week 12 follow-up. The waitlist group received treatment after the week 6 follow-up. RESULTS: Intention to treat analysis was conducted with multilevel modeling. In all but one model, the interaction between treatment condition and time at week 6 follow-up was significant. Compared with the waitlist group, the treatment group had lower levels of depression [Center for Epidemiologic Studies Depression Scale (CES-D): Cohen's d = 0.86, 95% CI (-10.11 to -5.37)], insomnia [Insomnia Severity Index (ISI): Cohen's d = 1.00, 95% CI (-5.93 to -3.53)], and anxiety [Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A): Cohen's d = 0.83, 95% CI (-3.75 to -1.96)]. They also had better sleep quality [Pittsburgh Sleep Quality Index (PSQI): Cohen's d = 0.91, 95% CI (-3.34 to -1.83)]. No differences across any measures were found at week 12, after the waitlist control group received the treatment. CONCLUSION: proACT-S is an efficacious sleep-focused self-help treatment for major depression and insomnia. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04228146. Retrospectively registered on 14 January 2020. http://www.w3.org/1999/xlink">https://clinicaltrials.gov/ct2/show/NCT04228146.


Subject(s)
Cognitive Behavioral Therapy , Depressive Disorder, Major , Sleep Initiation and Maintenance Disorders , Adult , Humans , Smartphone , Depression/therapy , Sleep Initiation and Maintenance Disorders/therapy , Depressive Disorder, Major/therapy
3.
J Pers ; 2022 Aug 04.
Article in English | MEDLINE | ID: covidwho-2283395

ABSTRACT

OBJECTIVES: Young people's experience of boredom and its psychological health sequelae have been exacerbated by the COVID-19 pandemic. The present study examined the moderating role of boredom beliefs-the extent to which one affectively dislikes boredom (boredom dislike) and cognitively accepts it (boredom normalcy)-on the association between boredom experience and mental well-being. We also validated a new measure of boredom beliefs in two different samples of young people. METHOD: We report data from a correlational study with British young people aged 12-25 (Study 1; N = 2495) and a 16-week eight-wave within-subject study with Israeli adolescents aged 12-18 (Study 2; N = 314). RESULTS: Across both studies, disliking boredom was associated with higher frequency and intensity of boredom. Boredom dislike moderated the negative association between boredom and mental well-being, such that the association was more salient among those who strongly disliked boredom. Normalizing boredom was positively associated with mental well-being. The measure of boredom beliefs demonstrated fair validity and reliability. CONCLUSION: Results provide novel insights into the potential buffering effect of boredom beliefs against the mental health impact of boredom, particularly at a time of reduced activity. These findings generalize across two different countries.

5.
J Appl Soc Psychol ; 2022 Sep 06.
Article in English | MEDLINE | ID: covidwho-2255768

ABSTRACT

Wearing face masks to prevent the spread of COVID-19 has proved controversial in many countries; conducting new research on the use of masks would be colored by this controversy. In 2012 (pre-COVID), we conducted an experiment on the effects of masks on social interaction. College students (N = 250) were assigned to find a previously unknown student in a lecture hall, converse, and evaluate the interaction. Half were assigned to wear a surgical mask, sunglasses, and a hat (all provided); half wore no extra gear. Mask wearing had no effect on the ease, authenticity, friendliness of the conversation, mood, discomfort, or interestingness of the interaction. There were no discernable consequences of political ideology on the partner selection process or the evaluation of the interaction. Mask-wearing did not disable successful social interaction in this setting.

6.
biorxiv; 2023.
Preprint in English | bioRxiv | ID: ppzbmed-10.1101.2023.04.20.537738

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has led to over 760 million cases and >6.8 million deaths worldwide. We developed a panel of human neutralizing monoclonal antibodies (mAbs) targeting the SARS-CoV-2 Spike protein using Harbour H2L2 transgenic mice immunized with Spike receptor binding domain (RBD) (1). Representative antibodies from genetically-distinct families were evaluated for inhibition of replication-competent VSV expressing SARS-CoV-2 Spike (rcVSV-S) in place of VSV-G. One mAb (denoted FG-10A3) inhibited infection of all rcVSV-S variants; its therapeutically-modified version, STI-9167, inhibited infection of all tested SARS-CoV-2 variants, including Omicron BA.1 and BA.2, and limited virus proliferation in vivo (1). To characterize the binding specificity and epitope of FG-10A3, we generated mAb-resistant rcVSV-S virions and performed structural analysis of the antibody/antigen complex using cryo-EM. FG-10A3/STI-9167 is a Class 1 antibody that prevents Spike-ACE2 binding by engaging a region within the Spike receptor binding motif (RBM). Sequencing of mAb-resistant rcVSV-S virions identified F486 as a critical residue for mAb neutralization, with structural analysis revealing that both the variable heavy and light chains of STI-9167 bound the disulfide-stabilized 470-490 loop at the Spike RBD tip. Interestingly, substitutions at position 486 were later observed in emerging variants of concern BA.2.75.2 and XBB. This work provides a predictive modeling strategy to define the neutralizing capacity and limitations of mAb therapeutics against emerging SARS-CoV-2 variants.


Subject(s)
Coronavirus Infections , Severe Acute Respiratory Syndrome , COVID-19 , Uterine Retroversion
7.
Front Med (Lausanne) ; 9: 1033181, 2022.
Article in English | MEDLINE | ID: covidwho-2231422

ABSTRACT

Background: Complementary and Integrative Medicine (CIM), including self-care healthy life-style promotion strategies, is widely used in Germany. Aim of this study was to assess the use of self-care and lifestyle interventions as well as mental/emotional state experienced during the COVID-19 pandemic. Methods: An exploratory cross-sectional online study was conducted with adults in Germany through an online survey. Custom-developed questions in respiratory disease-status (including COVID-19), CIM-based self-care/lifestyle interventions and dietary patterns, and mental/emotional state as well as parameters for wellbeing (World Health Organization Well-Being Index, WHO-5) and self-efficacy (General Self-Efficacy Short Scale, GSE-3) were assessed. Data was analyzed using frequency and parametric measures. Results: The online survey was performed from January to March 2021 and included 1,138 participants (81.5% female; mean age: 49.2 ± 13.7 years; 54.9% holding a university degree) living in Germany, of which 62 had had a positive SARS-CoV-2 test, 4 an influenza infection and 375 participants other respiratory infections. The following individual health promotion strategies were reported: spending time in nature (90%; n = 1,024), physical activity (69.3%; n = 789), naturopathic remedies (63.1%; n = 718), plant-based diet (56.3%; n = 640), and Mind-Body interventions (54.7%; n = 623). No differences in strategies between individuals with respiratory diseases or the sample overall were found. Well-being had a mean value of 15.2 ± 5 (WHO-5) and self-efficacy 4.1 ± 0.6 (GSE-3). Nearly 8% reported a low mental/emotional state regarding the COVID-19 pandemic. Conclusion: Self-care and lifestyle interventions during the COVID-19 pandemic were reported by participants who were predominantly female, middle-aged, and well-educated. Most participants showed an overall balanced mental/emotional state. Further studies should include a representative control group from the general population. Clinical trial registration: clinicaltrials.gov, identifier NCT04653727.

8.
J Clin Monit Comput ; 2022 Aug 02.
Article in English | MEDLINE | ID: covidwho-2226963

ABSTRACT

Novel technologies allow continuous wireless monitoring systems (CWMS) to measure vital signs and these systems might be favorable compared to intermittent monitoring regarding improving outcomes. However, device safety needs to be validated because uncertain evidence challenges the clinical implementation of CWMS. This review investigates the frequency of device-related adverse events in patients monitored with CWMS in general hospital wards. Systematic literature searches were conducted in PubMed and Embase. We included trials of adult patients in general hospital wards monitored with CWMS. Our primary outcome was the frequency of unanticipated serious adverse device effects (USADEs). Secondary outcomes were adverse device effects (ADEs) and serious adverse device effects (SADE). Data were extracted from eligible studies and descriptive statistics were applied to analyze the data. Seven studies were eligible for inclusion with a total of 1485 patients monitored by CWMS. Of these patients, 54 patients experienced ADEs (3.6%, 95% CI 2.8-4.7%) and no USADEs or SADEs were reported (0%, 95% CI 0-0.31%). The studies of the SensiumVitals® patch, the iThermonitor, and the ViSi Mobile® device reported 28 (9%), 25 (5%), and 1 (3%) ADEs, respectively. No ADEs were reported using the HealthPatch, WARD 24/7 system, or Coviden Alarm Management. Current evidence suggests that CWMS are safe to use but systematic reporting of all adverse device effects is warranted.

9.
Front Psychiatry ; 11: 574676, 2020.
Article in English | MEDLINE | ID: covidwho-2199306

ABSTRACT

Background: Increases in the incidence of psychological distress and alcohol use during the COVID-19 pandemic have been predicted. Behavioral theories of depression and alcohol self-medication theories suggest that greater social/environmental constraints and increased psychological distress during COVID-19 could result in increases in depression and drinking to cope with negative affect. The current study had two goals: (1) to examine self-reported changes in alcohol use and related outcomes after the introduction of COVID-19 social distancing requirements, and; (2) to test hypothesized mediation models to explain individual differences in self-reported changes in depression and alcohol use during the early weeks of the COVID-19 pandemic. Methods: Participants (n = 833) were U.S. residents recruited for participation in a single online survey. The cross-sectional survey included questions assessing environmental reward, depression, COVID-19-related distress, drinking motives, and alcohol use outcomes. Outcomes were assessed via retrospective self-report for two timeframes in the single survey: the 30 days prior to state-mandated social distancing ("pre-social-distancing"), and the 30 days after the start of state-mandated social distancing ("post-social-distancing"). Results: Depression severity, coping motives, and some indices of alcohol consumption (e.g., frequency of binge drinking, and frequency of solitary drinking) were significantly greater post-social-distancing relative to pre-social-distancing. Conversely, environmental reward and other drinking motives (social, enhancement, and conformity) were significantly lower post-social distancing compared to pre-social-distancing. Behavioral economic indices (alcohol demand) were variable with regard to change. Mediation analyses suggested a significant indirect effect of reduced environmental reward with drinking quantity/frequency via increased depressive symptoms and coping motives, and a significant indirect effect of COVID-related distress with alcohol quantity/frequency via coping motives for drinking. Discussion: Results provide early cross-sectional evidence regarding the relation of environmental reward, depression, and COVID-19-related psychological distress with alcohol consumption and coping motives during the early weeks of the COVID-19 pandemic. Results are largely consistent with predictions from behavioral theories of depression and alcohol self-medication frameworks. Future research is needed to study prospective associations among these outcomes.

10.
J Adolesc Health ; 72(5): 788-795, 2023 05.
Article in English | MEDLINE | ID: covidwho-2179973

ABSTRACT

PURPOSE: Hong Kong youth and young adults experienced unprecedented stress amid social unrest and the COVID-19 pandemic. Few studies have examined how these stressors were related to psychological distress among youth and young adults. This study assessed how psychological distress is associated with stress from social unrest, financial circumstances, and the COVID-19 pandemic, and whether poor sleep quality may explain these associations. METHODS: Participants of a representative phone survey included 1,501 Hong Kong youth and young adults (Mage = 26.1 (4.0); 48.2% female). We examined the associations between psychological distress and three types of stress (social unrest, financial, and COVID-19 stress), and the indirect effect of poor sleep. RESULTS: Eleven point nine percent, 4.1%, and 9.7% of respondents reported feeling very seriously distressed by social unrest, financial circumstances, and the COVID-19 pandemic, respectively. All three forms of stress were associated with poor sleep. The indirect effects of poor sleep on the association between all three forms of stress and psychological distress were identified. Moderated indirect effect analysis indicated that being female intensified the effect of COVID-19-related stress on psychological distress and that younger female youth and older male youth were more vulnerable to financial stress and social unrest stress (vs. older female youth and younger male youth). DISCUSSION: Sleep may be one mechanism that accounts for the association between psychological distress and protracted stressors among Hong Kong youth and young adults. These results suggest the importance of prioritizing sleep improvement in mental health interventions during times of societal change.


Subject(s)
COVID-19 , Psychological Distress , Sleep Initiation and Maintenance Disorders , Young Adult , Adolescent , Humans , Male , Female , Hong Kong/epidemiology , Pandemics , Sleep
11.
JB JS Open Access ; 7(2)2022.
Article in English | MEDLINE | ID: covidwho-2197636

ABSTRACT

Away rotations have become a critical factor for a successful orthopaedic surgery residency match. Away rotations significantly improve an applicant's chance of matching into an orthopaedic residency. Away rotations were limited during the 2020 to 2021 academic year because of the COVID-19 pandemic. During the 2021 to 2022 academic year, the American Association of Medical Colleges coalition recommended students only complete 1 rotation outside their home institution, whereas the American Orthopaedic Association Council of Residency Directors argued that multiple rotations should be allowed. We sought to quantify the impact of these restrictions on orthopaedic surgery applicants during the 2020 to 2021 residency application cycle. Methods: An online survey was sent to all applicants applying to the authors' home orthopaedic surgery program. The survey asked respondents to indicate how many away rotations they completed and how many they planned to complete but were unable to complete in the 2020 to 2021 application cycle. Historical match data were obtained from the National Resident Matching Program's publicly accessible Main Residency Match Data and Reports. Results: Survey responses were collected from 650 of 812 applicants (80%) to our program. Over a third of respondents (38.1%) reported completing 3 subinternship rotations during the 2020 to 2021 application cycle. Nearly a quarter of respondents (24.0%) reported completing 4 rotations. Most applicants (50.9%) were unable to complete 5 previously planned rotations because of pandemic-related restrictions, and 25.2% reported an inability to complete 4 rotations. Fewer applicants reported canceling 3 rotations (9.2%), 2 rotations (6.8%), or 1 (7.8%) rotation. Conclusions: Away rotations have been a traditional component of the orthopaedic surgery application process. Restrictions on away rotations in the 2020 to 2021 residency application cycle had affected the number of rotations that applicants were able to complete. However, despite those restrictions, over a third of applicants were able to complete at least 3 rotations. This suggests that the away rotation experience is variable for students and may be multifactorial; however, our study did not investigate the reasons for this. Accordingly, limiting away rotations may support an inequitable environment for medical students applying to orthopaedic surgery, and creating a consensus definition among medical schools, program directors, and orthopaedic chairs of away rotations, their duration, and the maximum number allowed would enhance fairness and reduce inconsistencies.

12.
J Ment Health ; : 1-7, 2022 Nov 16.
Article in English | MEDLINE | ID: covidwho-2119278

ABSTRACT

BACKGROUND: During the pandemic of COVID-19 Hong Kong lead one of the world's longest and most stringent quarantine measures. AIMS: To examine cross-sectionally (i) the relationship between the duration of mandatory hotel quarantine and mental health outcomes; (ii) whether indirect contact with nature and lifestyle factors (i.e. diet, sleep, exercises, social support, and sense of meaning), mitigated this relationship. METHODS: A group of 248 participants under 14 or 21-d mandatory hotel quarantine in Hong Kong completed an online questionnaire that included quarantine and lifestyle-related questions, as well as mental health outcome measures. RESULTS: For those under a 21-d quarantine, there was a significant effect of the week of quarantine on the level of depressive symptoms (Patient Health Questionnaire-4), which peaked in Week 2. Worse quality of sleep, a lower sense of meaning, and a longer set (but not completed) duration of quarantine were predictors of worse mental health outcomes. The positive relationship between the day of quarantine and the level of perceived stress was moderated by the indirect contact with nature. CONCLUSION: The results shed light on the potential negative impact of prolonged periods of quarantine on mental health outcomes and the possible protective factors.

13.
Frontiers in physiology ; 13, 2022.
Article in English | EuropePMC | ID: covidwho-2046229

ABSTRACT

Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection may negatively affect glucose metabolism. This study aims to assess glucose levels, prevalence of gestational diabetes mellitus (GDM) and perinatal outcome in women with history of COVID-19. To this purpose, a group of 65 patients with history of COVID-19 and 94 control patients were retrospectively recruited among pregnant women who attended the pregnancy outpatient department between 01/2020 and 02/2022. Glucose data from an oral glucose tolerance test (OGTT), GDM status and obstetric complications were assessed. We observed no differences in average (p = 0.37), fasting (p = 0.62) or post-load glucose concentrations (60 min: p = 0.19;120 min: p = 0.95) during OGTT. A total of 15 (23.1%) women in the COVID-19 group and 18 (19.1%) women in the control group developed GDM (p = 0.55). Moreover, caesarean section rate, weight percentiles and pregnancy outcomes were comparable between the groups (p = 0.49). In conclusion, in this study we did not identify a possible impact of COVID-19 on glucose metabolism in pregnancy, especially with regard to glucose concentrations during the OGTT and prevalence of GDM.

14.
BMC Pregnancy Childbirth ; 21(1): 574, 2021 Aug 21.
Article in English | MEDLINE | ID: covidwho-1910280

ABSTRACT

SARS-Cov-2 (Severe Acute Respiratory Coronavirus 2) infection confers a non-negligible risk for younger pregnant women with diabetes, which is still less well investigated. This topic was recently addressed by a systematic scoping review in BMC Pregnancy and Childbirth, aiming to summarize the complex interaction between SARS-Cov-2 infection, pregnancy and diabetes. This commentary will summarize and discuss the main findings of this article and its implications for future research.


Subject(s)
COVID-19/epidemiology , Infectious Disease Transmission, Vertical/prevention & control , Maternal Health/statistics & numerical data , Pregnancy Complications, Infectious/epidemiology , Pregnancy in Diabetics/epidemiology , Prenatal Care/methods , Female , Humans , Infant, Newborn , Pregnancy , Primary Prevention/methods
15.
Dan Med J ; 69(6)2022 May 16.
Article in English | MEDLINE | ID: covidwho-1877237

ABSTRACT

INTRODUCTION: During the first wave of the COVID-19 pandemic, visits to hospitals were prohibited. Therefore, new ways of communicating with relatives about and with patients were needed. This study aimed to explore experiences made with video calls in an adult ICU. METHODS: This study employed semi-structured group interviews conducted with six registered nurses from the ICU in a large hospital in Denmark who used video calls during the lockdown. Interviews were transcribed verbatim and analysed using systematic text condensation. RESULTS: The analyses indicated that video calls were a useful alternative to physical meetings. The advantages of video calls were that relatives had risk-free access to the ICU and the patient's treatment, whereas patients gained a window into their home, and nurses used less planning time than physical visit. Finally, patients were less distracted by video calls than by visits. The challenges identified with video calls were difficulties for nurses to care for relatives, ethical aspects and technical issues. CONCLUSIONS: Video calls were an effective tool for communication during the COVID-19 lockdown, presenting a number of advantages and challenges compared with in-person visits or telephone calls. By identifying and overcoming these challenges, video calls may become a beneficial supplement to in-person visits or telephone calls. FUNDING: none. TRIAL REGISTRATION: Approved by the Danish Data Protection Agency (P-2020-931).


Subject(s)
COVID-19 , Adult , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Humans , Intensive Care Units , Pandemics/prevention & control , Qualitative Research
16.
Dan Med J ; 69(6)2022 May 19.
Article in English | MEDLINE | ID: covidwho-1876980

ABSTRACT

INTRODUCTION: The coronavirus outbreak causes postponement of elective surgery. We evaluated how pain, function and general health were impacted by postponing elective knee and hip arthroplasty in patients with knee and hip osteoarthritis with no known surgery rescheduling date due to the coronavirus outbreak. METHODS: This study included 194 patients from a Danish public hospital with postponed elective primary knee or hip arthroplasty due to the lockdown. Patients responded to questionnaires when their surgery was cancelled and before surgery. Changes in pain and function were evaluated with the Oxford Knee and Hip Scores (OKS, OHS) and their general health with the EuroQol 5-dimension scale (EQ5D). Additionally, we asked about the patients' concerns and whether they felt improved, unchanged or deteriorated during the waiting period. RESULTS: Complete data were obtained for 110 (57%) patients, 59 and 51 awaiting knee or hip arthroplasty (median age 71 years, 62% were female), respectively. Arthroplasty was postponed for a median (range) 98 (63-161) days. A total of 34% were concerned that the postponement would lead to a poorer outcome. Mean OKS and OHS differences were 0 (95% confidence interval (CI): -1-1) and -1 (95% CI: -2-0) from surgery cancellation to re-scheduled surgery. The mean EQ5D index difference was 0.0 (95% CI: 0.0-0.1) for both groups. A total of 75 (68%) patients felt an important deterioration of their condition. CONCLUSIONS: Pre-operatively, patients worried about experiencing an altered treatment outcome due to postponed surgery and felt that their condition had deteriorated during the waiting period although this was not reflected in patient-reported outcome measures. FUNDING: Department of Orthopaedic Surgery. TRIAL REGISTRATION: not relevant.


Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Osteoarthritis, Hip , Aged , Female , Humans , Male , Osteoarthritis, Hip/surgery , Pain , Patient Reported Outcome Measures
17.
N Engl J Med ; 386(21): 1986-1997, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1864788

ABSTRACT

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).


Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Antifibrinolytic Agents/adverse effects , Antifibrinolytic Agents/therapeutic use , Canada , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Surgical Procedures, Operative , Thrombosis/chemically induced , Thrombosis/drug therapy , Tranexamic Acid/adverse effects , Tranexamic Acid/therapeutic use
18.
Medicine (Baltimore) ; 101(20): e29209, 2022 May 20.
Article in English | MEDLINE | ID: covidwho-1860981

ABSTRACT

ABSTRACT: Coronavirus-2019 (COVID-19) emerged in December 2019, causing significant changes in people's social lives and other human activities. The outbreak halted educational activities throughout the world. The Nigerian experience was unique in that most people were skeptical about the pandemic's existence. This practice contributed to the Nigerian people's fear of the COVID-19 outbreak. However, in Nigeria, there has never been a validated or established Covid-19 phobia scale, necessitating this study.This study was a pure validation study on COVID-19 phobia scale (C19PS). The study area was south-east states and a sample of 386 preschool practitioners in urban and rural communities of South East States, Nigeria participated in the study. The eligibility criteria include being a preschool teacher and demonstrating signs of COVID-19 phobia. The validation of the C19PS was done by subjecting the data gathered to principal axis factoring analysis with varimax rotation. The model fit for the data was tested using root mean square error of approximation and comparative fit index.It was found that the Kaiser-Meyer-Olkin value of .845 for the measure of the adequacy of the sample size. There was also a significant Bartlett's test of sphericity (P < .05). This implies that the correlation matrix for the C19PS is not an identity matrix. It was revealed that C19PS had good overall reliability (α = .896) and model fit (Root mean square error of approximation = .042, comparative fit index = .943) in a sample of Nigerian preschool practitioners.As a result, C19PS was recommended as a trustworthy tool for identifying persons who suffer from COVID-19 phobia.


Subject(s)
COVID-19 , Phobic Disorders , COVID-19/diagnosis , COVID-19/epidemiology , Child, Preschool , Humans , Nigeria/epidemiology , Psychometrics , Reproducibility of Results , Rural Population , School Teachers , Surveys and Questionnaires
19.
Exp Physiol ; 107(7): 665-673, 2022 07.
Article in English | MEDLINE | ID: covidwho-1807292

ABSTRACT

NEW FINDINGS: What is the topic of this review? Lactate is considered an important substrate for mitochondria in the muscles, heart and brain during exercise and is the main gluconeogenetic precursor in the liver and kidneys. In this light, we review the (patho)physiology of lactate metabolism in sepsis and coronavirus disease 2019 (COVID-19). What advances does it highlight? Elevated blood lactate is strongly associated with mortality in septic patients. Lactate seems unrelated to tissue hypoxia but is likely to reflect mitochondrial dysfunction and high adrenergic stimulation. Patients with severe COVID-19 exhibit near-normal blood lactate, indicating preserved mitochondrial function, despite a systemic hyperinflammatory state similar to sepsis. ABSTRACT: In critically ill patients, elevated plasma lactate is often interpreted as a sign of organ hypoperfusion and/or tissue hypoxia. This view on lactate is likely to have been influenced by the pioneering exercise physiologists around 1920. August Krogh identified an oxygen deficit at the onset of exercise that was later related to an oxygen 'debt' and lactate accumulation by A. V. Hill. Lactate is considered to be the main gluconeogenetic precursor in the liver and kidneys during submaximal exercise, but hepatic elimination is attenuated by splanchnic vasoconstriction during high-intensity exercise, causing an exponential increase in blood lactate. With the development of stable isotope tracers, lactate has become established as an important energy source for muscle, brain and heart tissue, where it is used for mitochondrial respiration. Plasma lactate > 4 mM is strongly associated with mortality in septic shock, with no direct link between lactate release and tissue hypoxia. Herein, we provide evidence for mitochondrial dysfunction and adrenergic stimulation as explanations for the sepsis-induced hyperlactataemia. Despite profound hypoxaemia and intense work of breathing, patients with severe coronavirus disease 2019 (COVID-19) rarely exhibit hyperlactataemia (> 2.5 mM), while presenting a systemic hyperinflammatory state much like sepsis. However, lactate dehydrogenase, which controls the formation of lactate, is markedly elevated in plasma and strongly associated with mortality in severe COVID-19. We briefly review the potential mechanisms of the lactate dehydrogenase elevation in COVID-19 and its relationship to lactate metabolism based on mechanisms established in contracting skeletal muscle and the acute respiratory distress syndrome.


Subject(s)
COVID-19 , Sepsis , Adrenergic Agents/metabolism , Humans , Hypoxia , Lactate Dehydrogenases/metabolism , Lactic Acid/metabolism , Muscle, Skeletal/metabolism , Oxygen/metabolism , Sepsis/complications , Sepsis/diagnosis
20.
Pharm Res ; 39(3): 541-551, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1777764

ABSTRACT

PURPOSE: Intranasally administered unfractionated heparin (UFH) and other sulfated polysaccharides are potential prophylactics for COVID-19. The purpose of this research was to measure the safety and pharmacokinetics of clearance of intranasally administered UFH solution from the nasal cavity. METHODS: Double-blinded daily intranasal dosing in C57Bl6 mice with four doses (60 ng to 60 µg) of UFH was carried out for fourteen consecutive days, with both blood coagulation measurements and subject adverse event monitoring. The pharmacokinetics of fluorescent-labeled UFH clearance from the nasal cavity were measured in mice by in vivo imaging. Intranasal UFH at 2000 U/day solution with nasal spray device was tested for safety in a small number of healthy human subjects. RESULTS: UFH showed no evidence of toxicity in mice at any dose measured. No significant changes were observed in activated partial thromboplastin time (aPTT), platelet count, or frequency of minor irritant events over vehicle-only control. Human subjects showed no significant changes in aPTT time, international normalized ratio (INR), or platelet count over baseline measurements. No serious adverse events were observed. In vivo imaging in a mouse model showed a single phase clearance of UFH from the nasal cavity. After 12 h, 3.2% of the administered UFH remained in the nasal cavity, decaying to background levels by 48 h. CONCLUSIONS: UFH showed no toxic effects for extended daily intranasal dosing in mice as well as humans. The clearance kinetics of intranasal heparin solution from the nasal cavity indicates potentially protective levels for up to 12 h after dosing.


Subject(s)
COVID-19 , Heparin , Animals , Anticoagulants/adverse effects , Humans , Mice , Mice, Inbred C57BL , Partial Thromboplastin Time
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