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1.
Brazilian Journal of Physical Therapy ; : 100469, 2022.
Article in English | ScienceDirect | ID: covidwho-2165115

ABSTRACT

Background A stratified approach to exercise therapy may yield superior clinical and economic outcomes, given the large heterogeneity of individuals with knee osteoarthritis (OA). Objective To evaluate the cost-effectiveness during a 12-month follow-up of a model of stratified exercise therapy compared to usual exercise therapy in patients with knee OA, from a societal and healthcare perspective. Methods An economic evaluation was conducted alongside a cluster-randomized controlled trial in patients with knee OA (n = 335), comparing subgroup-specific exercise therapy for a ‘high muscle strength subgroup', ‘low muscle strength subgroup', and ‘obesity subgroup' supplemented by a dietary intervention for the ‘obesity subgroup' (experimental group), with usual (‘non-stratified') exercise therapy (control group). Clinical outcomes included quality-adjusted life years – QALYs (EuroQol-5D-5 L), knee pain (Numerical Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score in daily living). Costs were measured by self-reported questionnaires at 3, 6, 9 and 12-month follow-up. Missing data were imputed using multiple imputation. Data were analyzed through linear regression. Bootstrapping techniques were applied to estimate statistical uncertainty. Results During 12-month follow-up, there were no significant between-group differences in clinical outcomes. The total societal costs of the experimental group were on average lower compared to the control group (mean [95% confidence interval]: € 405 [-1728, 918]), albeit with a high level of uncertainty. We found a negligible difference in QALYs between groups (mean [95% confidence interval]: 0.006 [-0.011, 0.023]). The probability of stratified exercise therapy being cost-effective compared to usual exercise therapy from the societal perspective was around 73%, regardless of the willingness-to-pay threshold. However, this probability decreased substantially to 50% (willingness-to-pay threshold of €20.000/QALY) when using the healthcare perspective. Similar results were found for knee pain and physical functioning. Conclusions We found no clear evidence that stratified exercise therapy is likely to be cost-effective compared to usual exercise therapy in patients with knee OA. However, results should be interpreted with caution as the study power was lower than intended, due to the Coronavirus disease (COVID-19) pandemic.

2.
Journal of Multidisciplinary Healthcare ; 15:2725-2733, 2022.
Article in English | EMBASE | ID: covidwho-2154475

ABSTRACT

Background and Objective: Anxiety influences job burnout and health. This study aimed to establish a nomogram to predict the anxiety status of medical staff during the coronavirus disease (COVID-19) pandemic. Method(s): A total of 600 medical members were randomized 7:3 and divided into training and validation sets. The data was collected using a questionnaire. Logistic regression analysis and Akaike information criterion (AIC) were applied to investigate the risk factors for anxiety. Odds ratio (OR) and 95% confidence interval (95% CI) were calculated to establish a nomogram. Result(s): Participation time (OR=44.28, 95% CI=13.13~149.32), rest time (OR=38.50, 95% CI=10.43~142.19), epidemic prevention area (OR=10.16, 95% CI=3.51~29.40), epidemic prevention equipment (OR=15.24, 95% CI=5.73~40.55), family support (OR=9.63, 95% CI=3.55~26.11), colleague infection (OR=6.25, 95% CI=2.18~19.11), and gender (OR=3.30, 95% CI=1.15~9.47) were the independent risk factors (P<0.05) for anxiety in medical staff. The areas under the receiver operating characteristic (ROC) curves of the training and validation sets were 0.987 and 0.946, respectively. The decision curve's net benefit shows the nomogram's clinical utility. Conclusion(s): The nomogram established in this study exhibited an excellent ability to predict anxiety status with sufficient discriminatory power and calibration. Our findings provide a protocol for predicting and identifying anxiety status in medical staff during the COVID-19 pandemic. Copyright © 2022 Liu et al.

3.
European Psychiatry ; 65(Supplement 1):S487, 2022.
Article in English | EMBASE | ID: covidwho-2153964

ABSTRACT

Introduction: COVID 19 has led to dramatic changes in the lives of people leading to an increase in stress and anxiety. Music intervention is a non-medicated method for relieving anxiety. This current study aims to understand whether music can be effectively used to alleviate anxiety in admitted COVID-19 patients. Objective(s): To study the effect of music on anxiety in patients admitted for COVID-19 in a tertiary care hospital in New Delhi Methods: 34 patients (17 females &17 males) were randomly divided into two groups, a control (N=17) and a music group (N=17). Vitals of all the patients were noted. Patients of the music group were asked to listen to relaxing instrumental for 30 minutes, while patients of the control group were asked to relax for 30 minutes. Vitals of all the patients were noted again. Patients were asked to fill State Trait Anxiety Inventory (STAI) before and after intervention. Result(s): The post-intervention mean scores of STAI after the music session were lower in the music group than the control group [95.06 (SD 8.5)) versus 102.37 (SD 10.3)]. The differences in mean values of pre- to post-intervention changes between both groups after music session were statistically significant. Conclusion(s): Our findings suggest that listening to music lowers anxiety. As music is non- invasive and free of side-effects we recommend that music intervention service should be used to improve health care quality.

4.
European Psychiatry ; 65(Supplement 1):S245, 2022.
Article in English | EMBASE | ID: covidwho-2153860

ABSTRACT

Introduction: The evidence for the positive effects of mindfulnessbased interventions on psychological well-being and physical health has been convincing in recent years. As a specific form of such an intervention, the Mindful Self-Compassion (MSC) training program was developed to promote self-compassion and mindfulness. An initial study on an adapted version of the MSC training program considered it to be beneficial in psychiatric inpatient rehabilitation. Objective(s): The present study aims to further evaluate the link between MSC and psychological symptoms as well as quality of life. Method(s): A randomized controlled trial was conducted from September 2020 to August 2021. A total of 228 patients (64% female, 36% male) participated in a six-week psychiatric rehabilitation program to assess the impact of an adapted MSC training program compared to the control intervention of Progressive Muscle Relaxation training (PMR) on psychological well-being. Both training programs took place once a week for 75 minutes as part of a standardized inpatient rehabilitation program. The participants completed the Self-Compassion Scale (SCS), the Brief Symptom Inventory (BSI-18), and the Short-Form-Health-Survey-12 (SF-12) pre and post intervention. Result(s): At the moment, statistical analyses are being carried out. Detailed results will be presented on the poster. Conclusion(s): The results of this study will contribute to rehabilitation research as they provide further insight into the role of MSC in the treatment of mental disorders. In addition, the clinical implications, and possible effects of changes in the rehabilitation program during the COVID-19 pandemic on the protocol and the results of this study will be discussed.

5.
J Med Internet Res ; 24(11): e40719, 2022 Nov 21.
Article in English | MEDLINE | ID: covidwho-2141432

ABSTRACT

BACKGROUND: Depression has a high prevalence among young adults, especially during the COVID-19 pandemic. However, mental health services remain scarce and underutilized worldwide. Mental health chatbots are a novel digital technology to provide fully automated interventions for depressive symptoms. OBJECTIVE: The purpose of this study was to test the clinical effectiveness and nonclinical performance of a cognitive behavioral therapy (CBT)-based mental health chatbot (XiaoE) for young adults with depressive symptoms during the COVID-19 pandemic. METHODS: In a single-blind, 3-arm randomized controlled trial, participants manifesting depressive symptoms recruited from a Chinese university were randomly assigned to a mental health chatbot (XiaoE; n=49), an e-book (n=49), or a general chatbot (Xiaoai; n=50) group in a ratio of 1:1:1. Participants received a 1-week intervention. The primary outcome was the reduction of depressive symptoms according to the 9-item Patient Health Questionnaire (PHQ-9) at 1 week later (T1) and 1 month later (T2). Both intention-to-treat and per-protocol analyses were conducted under analysis of covariance models adjusting for baseline data. Controlled multiple imputation and δ-based sensitivity analysis were performed for missing data. The secondary outcomes were the level of working alliance measured using the Working Alliance Questionnaire (WAQ), usability measured using the Usability Metric for User Experience-LITE (UMUX-LITE), and acceptability measured using the Acceptability Scale (AS). RESULTS: Participants were on average 18.78 years old, and 37.2% (55/148) were female. The mean baseline PHQ-9 score was 10.02 (SD 3.18; range 2-19). Intention-to-treat analysis revealed lower PHQ-9 scores among participants in the XiaoE group compared with participants in the e-book group and Xiaoai group at both T1 (F2,136=17.011; P<.001; d=0.51) and T2 (F2,136=5.477; P=.005; d=0.31). Better working alliance (WAQ; F2,145=3.407; P=.04) and acceptability (AS; F2,145=4.322; P=.02) were discovered with XiaoE, while no significant difference among arms was found for usability (UMUX-LITE; F2,145=0.968; P=.38). CONCLUSIONS: A CBT-based chatbot is a feasible and engaging digital therapeutic approach that allows easy accessibility and self-guided mental health assistance for young adults with depressive symptoms. A systematic evaluation of nonclinical metrics for a mental health chatbot has been established in this study. In the future, focus on both clinical outcomes and nonclinical metrics is necessary to explore the mechanism by which mental health chatbots work on patients. Further evidence is required to confirm the long-term effectiveness of the mental health chatbot via trails replicated with a longer dose, as well as exploration of its stronger efficacy in comparison with other active controls. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100052532; http://www.chictr.org.cn/showproj.aspx?proj=135744.


Subject(s)
COVID-19 , Mental Health , Humans , Young Adult , Female , Adolescent , Male , Depression/therapy , Single-Blind Method , Pandemics
6.
J Telemed Telecare ; 28(10): 764-770, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2138416

ABSTRACT

Long-term weight loss can reduce the risk of type 2 diabetes for people living with obesity and reduce complications for patients diagnosed with type 2 diabetes. We investigated whether a telehealth lifestyle-coaching program (Liva) leads to long-term (24 months) weight loss compared to usual care. In a randomized controlled trial, n = 340 participants living with obesity with or without type 2 diabetes were enrolled and randomized via an automated computer algorithm to an intervention group (n = 200) or to a control group (n = 140). The telehealth lifestyle-coaching program comprised of an initial one-hour face-to-face motivational interview followed by asynchronous telehealth coaching. The behavioural change techniques used were enabled by individual live monitoring. The primary outcome was a change in body weight from baseline to 24 months. Data were assessed for n = 136 participants (40%), n = 81 from the intervention group and n = 55 from the control group, who completed the 24-month follow-up. After 24 months mean body weight and body mass index were reduced significantly for completers in both groups, but almost twice as much was registered for those in the intervention group which was not significant between groups -4.4 (CI -6.1; -2.8) kg versus -2.5 (CI -3.9; -1.1) kg, P = 0.101. Haemoglobin A1c was significantly reduced in the intervention group -3.1 (CI -5.0; -1.2) mmol/mol, but not in the control group -0.2 (CI -2.4; -2.0) mmol/mol without a significant between group difference (P = 0.223). Low completion was partly due to coronavirus disease 2019. Telehealth lifestyle coaching improve long-term weight loss (> 24 months) for obese people with and without type 2 diabetes compared to usual care.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 2 , Mentoring , Telemedicine , Humans , Diabetes Mellitus, Type 2/prevention & control , Weight Loss , Telemedicine/methods , Life Style , Obesity/therapy , Primary Health Care
7.
Geriatr Gerontol Int ; 2022 Nov 25.
Article in English | MEDLINE | ID: covidwho-2136839

ABSTRACT

AIM: Radio-Taiso, a traditional exercise program in Japan, may serve as a coping strategy for older adults with frailty during the COVID-19 pandemic. This phase II trial tested program adherence and safety and explored the potential effectiveness of a home-based Radio-Taiso. METHODS: This assessor-blind parallel randomized controlled trial included community-dwelling Jolder Japanese adults with frailty and pre-frailty. Fifty-eight eligible participants were randomly allocated to intervention and control groups. Intervention participants performed 3-5-min sessions of Radio-Taiso one to four times per day for 12 weeks. Feasibility criteria were set at practice and retention rates of ≥75%. Safety was monitored by assessing all adverse events reported by participants during the intervention period, irrespective of causality. Potential effectiveness was exploratorily assessed using items that allow clinical interpretation of changes: mobility and health-related quality of life (HR-QoL), assessed using the modified short physical performance battery (SPPB) and the SF-36, respectively. RESULTS: Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. In the intention-to-treat analysis, there was no clinically significant difference in the change in SPPB score between groups (-0.4 points, 95% confidence interval [CI], -1.2, 0.3); however, the intervention group scored higher in the mental component of HR-QoL than did the control group (3.4 points, 95% CI: -1.1, 7.8). CONCLUSIONS: The preliminary data indicate that a phase III trial is feasible, focusing on the mental aspect of HR-QoL as the primary outcome. Geriatr Gerontol Int 2022; ••: ••-••.

8.
Archives of Clinical Infectious Diseases ; 17(5) (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2144849

ABSTRACT

Background: Coronavirus disease 2019 (COVID-19) has turned into a global public health crisis since the end of 2019. It may thus take years to develop new drugs, so evaluating the existing ones can play a key role in suppressing or even mitigating the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Objective(s): This study reflected on the effects of ivermectin (IVM) and metronidazole (MTR) vs. standard treatment protocols on symptoms, humoral immune responses, and outcomes of COVID-19 in hospitalized patients. Method(s): This triple-blinded randomized controlled trial (RCT) of IVM and MTR vs. standard treatment protocols was conducted from February 2021 to May 2021. A total number of 107 participants were accordingly selected from all patients infected with SARS-CoV-2 and positive results for SARS-CoV-2 based on the reverse transcription-polymerase chain reaction (RT-PCR) or the computerized tomography (CT) scan results at three teaching hospitals affiliated to Shiraz University of Medical Sciences, Shiraz, Iran. In this RCT, several indicators, including some vital signs, biomedical parameter, length of hospital stay (LOS), and death, were considered the outcomes. Result(s): A total number of 107 patients were recruited in this study. The results revealed that 10 patients (10.4%) expired during hospitalization. The mortality rate in IVM group (4.5%) was lower compared with MTZ (15.8%) and standard treatment (11.8%) (P = 169). After five days, the mean differences of lymphocyte and neutrophil counts differed significantly between groups (P = 0.020 and P = 0.029, respectively). But, other outcomes did not differ (P > 0.05). Conclusion(s): Based on this RCT, neither IVM nor MTZ could significantly affect COVID-19 patients' recovery patterns compared with the standard treatment protocols. Hence, more studies are needed to test diverse combinations of immunological response trigger-ing and anti-inflammatory drugs. Moreover, including and relying on IVM in clinical guidelines for COVID-19 should be cautioned and based on more evidence. Copyright © 2022 Author(s).

9.
Journal of Medical Imaging and Radiation Oncology ; 66(Supplement 1):32-33, 2022.
Article in English | EMBASE | ID: covidwho-2136558

ABSTRACT

Purpose: Chest radiographs (CXRs) are an important tool for COVID-19 disease management and progression.1 A number of international thoracic/radiology societies have developed structured reporting templates to reduce interpretation variability and measure concordance.2 Recent research into COVID-19 templates have used small data sets, small numbers of radiologists and focused on predictive disease progression. The aim of this study is to evaluate the utility of three (Australian, British, Dutch) CXR qualitative reporting templates in a large Sydney teaching hospital. Methods and Materials: Twelve staff specialist radiologists were recruited to participate in the study. Retrospective CXRs between 2020-21 were collected and organized into test sets, containing the CXRs of 50 PCR-positive COVID-19 patients and classified as 'classic/ characteristic' for radiology signs of COVID-19 disease (30 cases) or 'indeterminate' for radiological signs (20 cases) by two expert radiologists. A further 10 CXRs of patients who were imaged for an 'alternative' diagnosis and 10 CXRs that had been reported 'normal' were included. Radiologists were assigned to one of three image sets, with the 70 images randomized and instructed to report the cases using three templates: the Royal Australian and New Zealand College of Radiology (RANZCR), British Society of Thoracic Imaging (BSTI) and modified Co-RADS (Dutch)3. Fleiss' Kappa Coefficient was used for agreement between radiologists on each template (inter-reader), and for radiologist's agreement within themselves using the three templates (intra-reader). Result(s): Inter-reader agreement between radiologists was highest for the BSTI template at 0.46 (moderate agreement), followed by RANZCR (0.36) and modified CO-RADS (0.31) (fair agreement). For all templates, agreement was highest for 'normal CXRs" and lowest for 'indeterminate', with moderate or fair agreement for the 'classic' COVID-19 cases (BSTI 0.44;RANZCR 0.31;mod-CO-RADS 0.31). The intra-reader agreement across the 3 templates for 'classic/characteristic' COVID cases was 0.61, for 'normal' cases 0.76 and 'alternative' 0.68 (all at substantial agreement), indicating that radiologists largely were consistent with classification of cases. Conclusion(s): The BSTI template yielded the highest agreement among radiologists for reporting COVID-19 CXRs as well as for 'normal' and 'alternative'. There was a large range of intra-reader agreement for all 4 types of patient presentations, however the level of agreement equal to or higher than 'moderate'. Structured reporting templates have yielded promising results for concordance between radiologists and reliability within radiologist's reporting of CXRs. Further investigation of radiology lexicon within templates is required to seek reasons for variation in concordance, as well as the demographics of readers.

10.
J Integr Complement Med ; 2022.
Article in English | PubMed | ID: covidwho-2134719

ABSTRACT

Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm);disease severity by SCORing Atopic Dermatitis (SCORAD);and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3;SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0;SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Trial registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.

11.
Research and Practice in Thrombosis and Haemostasis Conference ; 6(Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2128168

ABSTRACT

Background: Convalescent plasma (CP) obtained from patients following recovery from COVID-19 is an option for treatment, since antibodies may have antiviral and anticoagulation effect. Aim(s): The goal of this review is to present the latest evidence in the use of CP for COVID-19, raise questions regarding donor selection, collection, testing of CP, timing and volume of CP, and offer recommendations for future research. Method(s): -Systematic review of all published available literature assessing the use of CP for COVID-19. -Simple scoring was structured (0 min-10max). Minimal score (O) gives maximal possibility of successfully treatment with CP in COVID-19 patients and the opposite. This scoring system was applied into chosen 54 published studies. Result(s): We analyzed data in 18 published Case reports, 31 Case series, 11 Observational studies, and 5 RTc. According to our score min.score 0 was not obtained in any type of study, either score 1 or 2. Only one observational study has score 3. In this group score vary from 3 to 9.5, but most studies had a high score (6 -9). In the group of case reports score was from 4 to 8 (the largest number had a score of 7). In case report studies the score vary from 4 (just one case) to 8. Higher scores were registered in the largest number of case reports also. In the case series that were the most numerous (31) available reports concerning research in CP treatment of COVID 9 patients, the minimum score was 5 (only one series), the max score was 10, and most series had a score of 6 to 9. The number of randomized studies was the lowest, only 5. In this group, the score ranged from 6.5 -9. Conclusion(s): Despite a number of performed studies there is not god enough pretreatment estimation for success of CP treatment in COVID.

12.
Journal of the American Society of Nephrology ; 33:252-253, 2022.
Article in English | EMBASE | ID: covidwho-2124615

ABSTRACT

Background: Televisits have become a more widely used since the COVID pandemic in 2020. However, pts in underserved populations may not be as knowledgable about electronic health resources and may not be able to access this type of health care visit, worsening health care disparities. We examined the relationship between electronic health literacy and acceptance of televisits in an underserved inner-City population of pts with CKD. Method(s): 38 randomly selected CKD pts were surveyed in a face to face fashion including a demographics section, the eHEALS electronic health literacy assessment (scored from 8 to 40), and additional sections on televisit history. eHEALS is a validated 8 question survey that characterizes the subjective ability to find and use electronic health resources. Result(s): Mean age of the pts. was 67+/-15 yrs. 66% were female, 74% did not attend any college, 60% make less than $25,000 per year. 21% did not have any Internet access, 5.3% did not own a cell phone, and 5.3% of cell phone owners did not own a smart phone. 61% need help using the internet. The mean eHEALS of those who need help using the internet is 21.1+/-6.0 vs 27.5+/-8.6 (p=<0.05) for those who do not need help.76% of pts. had a televisit before the survey, of which 76% were telephone only and 24% had visits by both telephone and video. No participant had only used video. Those who had televisits did not differ based on age, education, gender and income from those who did not. Of the 24% of participants who did not have televisits, 100% need help using the internet vs 48% who had televisits (p=0.006). Mean eHEALS score of those who had a televisit was 25.1+/-7.9 vs 18.9+/-4.9 for those who did not (p=0.01). Conclusion(s): In our population of older inner-city CKD patients, 1. Almost one quarter had no home internet access, and over half needed help using it 2. Pts who needed help had lower eHealth literacy and were less likely to have televisits. 3. Televisit use related to eHealth literacy rather than age, education or income. 4. Administering eHEALS may identify people who would benefit most from in person visits, directed educational materials to help with televisits or for whom support should be provided 5. The rise in use of telehealth may further health resource inequities if eHealth literacy is not recognized as a potential negative social determinant in vulnerable populations.

13.
Cardiovasc Drugs Ther ; 2022 Nov 29.
Article in English | MEDLINE | ID: covidwho-2128802

ABSTRACT

PURPOSE: Patients hospitalized with COVID-19 may develop a hyperinflammatory, dysregulated cytokine "storm" that rapidly progresses to acute respiratory distress syndrome, multiple organ dysfunction, and even death. Remote ischaemic conditioning (RIC) has elicited anti-inflammatory and cytoprotective benefits by reducing cytokines following sepsis in animal studies. Therefore, we investigated whether RIC would mitigate the inflammatory cytokine cascade induced by COVID-19. METHODS: We conducted a prospective, multicentre, randomized, sham-controlled, single-blind trial in Brazil and South Africa. Non-critically ill adult patients with COVID-19 pneumonia were randomly allocated (1:1) to receive either RIC (intermittent ischaemia/reperfusion applied through four 5-min cycles of inflation (20 mmHg above systolic blood pressure) and deflation of an automated blood-pressure cuff) or sham for approximately 15 days. Serum was collected following RIC/sham administration and analyzed for inflammatory cytokines using flow cytometry. The endpoint was the change in serum cytokine concentrations. Participants were followed for 30 days. RESULTS: Eighty randomized participants (40 RIC and 40 sham) completed the trial. Baseline characteristics according to trial intervention were overall balanced. Despite downward trajectories of all cytokines across hospitalization, we observed no substantial changes in cytokine concentrations after successive days of RIC. Time to clinical improvement was similar in both groups (HR 1.66; 95% CI, 0.938-2.948, p 0.08). Overall RIC did not demonstrate a significant impact on the composite outcome of all-cause death or clinical deterioration (HR 1.19; 95% CI, 0.616-2.295, p = 0.61). CONCLUSION: RIC did not reduce the hypercytokinaemia induced by COVID-19 or prevent clinical deterioration to critical care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04699227.

14.
Phytother Res ; 2022 Nov 24.
Article in English | MEDLINE | ID: covidwho-2128041

ABSTRACT

Until now, no specific and effective treatment exists for coronavirus disease 2019 (COVID-19). Since honey and Nigella sativa (HNS) have established antiviral, antibacterial, antiinflammatory, antioxidant, and immunomodulatory properties, we tested their efficacy for this disease in a multicenter, placebo-controlled, and randomized clinical trial at four medical care facilities in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the trial. Patients were randomly assigned in a 1:1 ratio to receive either honey (1 g kg-1 day-1 ) and Nigella sativa seeds (80 mg kg-1 day-1 ) or a placebo for up to 13 days along with standard care. The outcomes included symptoms' alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. Three hundred and thirteen patients, 210 with moderate and 103 with severe disease, underwent randomization from April 30 to July 29, 2020. Among the moderate cases, 107 were assigned to HNS, whereas 103 were assigned to the placebo group. Among the severe cases, 50 were given HNS, and 53 were given the placebo. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (moderate cases: 4 vs. 7 days, Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, p < 0.0001 and for severe cases: 6 vs. 13 days, HR: 4.04; 95% CI: 2.46-6.64; p < 0.0001). HNS also cleared the virus earlier than placebo in both moderate cases (6 vs. 10 days, HR: 5.53; 95% CI: 3.76-8.14, p < 0.0001) and severe cases (8.5 vs. 12 days, HR: 4.32; 95% CI: 2.62-7.13, p < 0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% vs. 10.9% among moderate cases (OR: 0.07; 95% CI: 0.03-0.13, p < 0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR: 0.03; 95% CI: 0.01-0.09, p < 0.0001). In severe cases, the mortality rate was less than 1/4th in the HNS group than in placebo (4% vs. 18.87%, OR: 0.18; 95% CI: 0.02-0.92, p = 0.029). No HNS-related adverse effects were observed. HNS, compared with placebo, significantly improved symptoms, expedited viral load clearance, and reduced mortality in COVID-19 patients. This trial was registered on April 15, 2020 with ClinicalTrials.gov Identifier: NCT04347382.

15.
Global Mental Health ; 9:508-520, 2022.
Article in English | Web of Science | ID: covidwho-2121465

ABSTRACT

Background. Yazidis in the Kurdistan Region of Iraq have been exposed to recurrent traumatic experiences associated with genocide and gender-based violence (GBV). In 2014, ISIS perpetrated another genocide against the Yazidi community of Sinjar. Women and girls were held captive, raped and beaten. Many have been forced into displacement. Rates of post-traumatic stress disorder (PTSD) and suicide are high. Limited research has evaluated interventions delivered to this population. Methods. This review explores how the global evidence on psychosocial interventions for female survivors of conflict-related sexual violence applies to the context of the female Yazidi population. We used a realist review to explore mechanisms underpinning complex psychosocial interventions delivered to internally displaced, conflict-affected females. Findings were cross-referenced with eight realist, semi-structured interviews with stakeholders who deliver interventions to female Yazidis in the Kurdistan Region of Iraq. Interviews also allowed us to explore the impact of COVID-19 on effectiveness of interventions. Results. Seven mechanisms underpinned positive mental health outcomes (reduced PTSD, depression, anxiety, suicidal ideation): safe spaces, a strong therapeutic relationship, social connection, mental health literacy, cultural-competency, gender-matching and empowerment. Interviews confirmed relevance and applicability of mechanisms to the displaced female Yazidi population. Interviews also reported increased PTSD, depression, suicide and flashbacks since the start of the COVID-19 pandemic, with significant disruptions to interventions. Conclusion. COVID-19 is just one of many challenges in the implementation and delivery of interventions. Responding to the mental health needs of female Yazidis exposed to chronic collective violence requires recognition of their sociocultural context and everyday experiences.

16.
Jundishapur Journal of Microbiology ; 15(8) (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2115383

ABSTRACT

Background: Limited medications are available for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) infection. Whether bromhexine can prevent or mitigate symptomatic infection after virus exposure is undetermined. Objective(s): We aimed to evaluate bromhexine's effect on preventing COVID-19 after close contact exposure. Method(s): A multi-center randomized, double-blind, placebo-controlled clinical trial was conducted on 372 adults (>= 18 years) who had close contact within four days with a household member with confirmed COVID-19. They were randomly assigned to receive bromhexine 8 mg (n = 187) or placebo (n = 185) three times a day for two weeks. The primary outcome was the incidence of symptomatic COVID-19. Secondary outcomes included hospitalization or death, confirmed COVID-19 by Polymerase Chain Reaction (PCR) in symptomatic patients, and adverse drug reactions. Result(s): The incidence of symptomatic COVID-19 was significantly lower in individuals who received bromhexine than in those who received the placebo (16 [8.6%] vs. 34 [18.4%], relative risk = 0.47, P = 0.005). PCR confirmation was reported in 13 (7.0%) and 26 (14.1%) individuals in the bromhexine and placebo groups, respectively (P = 0.025), with a relative risk reduction of 50%. The hospitalization rate, death, and medication side effects did not vary significantly between the bromhexine and placebo arms. Conclusion(s): Bromhexine is an effective, non-invasive, affordable agent with a low side-effect profile to prevent symptomatic COVID-19. Early use of bromhexine potentially provides another layer of protection;hence, it can play a role in controlling the pan-demic. Copyright © 2022, Author(s).

17.
Phytother Res ; 2022 Nov 16.
Article in English | MEDLINE | ID: covidwho-2119295

ABSTRACT

Coronavirus disease 2019 (COVID-19) has become a global epidemic, and there is no specific treatment for anti-COVID-19 drugs. However, treatment of COVID-19 using Chinese herbal medicine (CHM) has been widely practiced in China. PubMed, Embase, Cochrane Library, CNKI, Wanfang and VIP databases were searched to evaluate the efficacy and safety of CHM in the treatment of COVID-19. Twenty-six studies were included in this meta-analysis. The included cases were all patients diagnosed with COVID-19 according to the "New Coronary Virus Pneumonia Diagnosis and Treatment Program," with a total of 2,407 cases. Patients were treated with CHM, including 36 prescriptions, and 105 flavors of CHM were included. The results of the meta-analysis showed that the CHM group improved in lung CT, clinical cure rate, clinical symptom score and time to negative for viral nucleic acid. However, this study still has many limitations due to the limited number of included studies. Therefore, high-quality RCT studies are needed to provide more reliable evidence for CHM treatment of COVID-19. In conclusion, CHM may significantly improve the clinical manifestations and laboratory indicators of patients with COVID-19. In addition, no serious adverse reactions were found after CHM treatment. Therefore, CHM may be used as a potential candidate for COVID-19. HIGHLIGHTS: COVID-19 has become a global epidemic, and there is no specific treatment for anti-COVID-19 drugs. CHM has made a new breakthrough in the treatment of COVID-19. CHM may relieve lung CT images of COVID-19 patients. CHM may improve clinical symptoms of COVID-19 patients. CHM may inhibit the expression of inflammatory factors in patients with COVID-19.

18.
J Clin Epidemiol ; 152: 116-124, 2022 Oct 06.
Article in English | MEDLINE | ID: covidwho-2117227

ABSTRACT

OBJECTIVE: To explore qualitatively the relationship between selected trial design choices and proxies for a scientific and clinical uptake in a cohort of published randomized controlled trials (RCTs) of corticosteroids for COVID-19, to identify design characteristics that may result in trials with potential to eliminate equipoise, achieve uptake, and help reduce research waste. STUDY DESIGN AND SETTING: A systematic literature search and qualitative, narrative review of published RCTs (up to April 13, 2021) evaluating the effectiveness of systemic corticosteroids in treatment of COVID-19. We extracted information on sample size, number of centers, single-country or multi-country conduct, dates of initiation and of publication, risk of bias and pragmatism scores, and also on an impact measured by citation in scientific literature and in clinical guidelines. We qualitatively compared design features of the highest impact vs. other trials. RESULTS: Randomised Evaluation of COVID-19 Therapy (RECOVERY) was by the most impactful of the seven eligible RCTs as it was 10 times more frequently cited in peer-reviewed literature and influenced all the selected COVID-19 treatment guidelines. All trials started recruiting from similar dates. RECOVERY was a single-country, multicentre platform trial at low risk of bias, features which also fail to distinguish it from the other trials. RECOVERY was distinguished by more strongly pragmatic design features, more centers, and more rapid recruitment resulting in a larger sample size and early publication. CONCLUSION: Higher pragmatism scores may contribute to recruiting more centers and more rapid recruitment of patients at each center, leading to larger size, earlier publication, and greater scientific and guideline uptake. By eliminating equipoise, RECOVERY rendered other simultaneous trials redundant. Further work is needed to confirm these findings in a larger quantitative study and to identify the individual contribution of each characteristic of pragmatism to conduct and impact of trials and their interaction in different national contexts. Until then, research waste might be reduced by designing trials with as many of the characteristics of RECOVERY as is feasible.

19.
Contemp Clin Trials ; 122: 106955, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2116905

ABSTRACT

BACKGROUND: Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs), which can act as a barrier for regaining pre-illness functional levels. Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19. METHODS: This study protocol describes an open-label randomized controlled trial comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent (> 2 months) cognitive sequela in post-COVID-19 condition. The study aims to recruit 240 participants aged 18 to 65 years with a history of SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life. Participants will be block randomized (computer-algorithm) to either group-based GMT (n = 120) or WL (n = 120). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered once a week. The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version, a self-report measure assessing everyday EF difficulties, specifically metacognition, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures, and tertiary outcomes include rating scales of cognition, emotional health, quality of life, and fatigue. CONCLUSION: Study findings could contribute to providing an evidence-based treatment option for symptoms that are frequent and debilitating following a prevalent condition. TRIAL REGISTRATION NUMBER: NCT05494424.


Subject(s)
COVID-19 , Cognitive Behavioral Therapy , Adult , Humans , Quality of Life , Cognitive Behavioral Therapy/methods , Surveys and Questionnaires , Treatment Outcome , SARS-CoV-2 , Cognition , Randomized Controlled Trials as Topic
20.
Pilot Feasibility Stud ; 8(1): 239, 2022 Nov 12.
Article in English | MEDLINE | ID: covidwho-2115804

ABSTRACT

BACKGROUND: Gait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors. METHODS: A parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety. RESULTS: Between November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study. CONCLUSION: We believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown. TRIAL REGISTRATION: ISRCTN, ISRCTN10874601 , Registered on 05/03/2018.

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