Identifying the Influencing Factors of Depressive Symptoms among Nurses in China by Machine Learning: A Multicentre Cross-Sectional Study

Background. Nurses' high workload can result in depressive symptoms. However, the research has underexplored the internal and external variables, such as organisational support, career identity, and burnout, which may predict depressive symptoms among Chinese nurses via machine learning (ML). Aim. To predict nurses' depressive symptoms and identify the relevant factors by machine learning (ML) algorithms. Methods. A self-administered smartphone questionnaire was delivered to nurses to evaluate their depressive symptoms;1,431 questionnaires and 28 internal and external features were collected. In the training set, the use of maximum relevance minimum redundancy ranked the features' importance. Five ML algorithms were used to establish models to identify nurses' depressive symptoms using different feature subsets, and the area under the curve (AUC) determined the optimal feature subset. Demographic characteristics were added to the optimal feature subset to establish the combined models. Each model's performance was evaluated using the test set. Results. The prevalence rate of depressive symptoms among Chinese nurses was 31.86%. The optimal feature subset comprised of sleep disturbance, chronic fatigue, physical fatigue, exhaustion, and perceived organisation support. The five models based on the optimal feature subset had good prediction performance on the test set (AUC: 0.871–0.895 and accuracy: 0.798–0.815). After adding the significant demographic characteristics, the performance of the five combined models slightly improved;the AUC and accuracy increased to 0.904 and 0.826 on the test set, respectively. The logistic regression analysis results showed the best and most stable performance while the univariate analysis results showed that external and internal personal features (AUC: 0.739–0.841) were more effective than demographic characteristics (AUC: 0.572–0.588) for predicting nurses' depressive symptoms. Conclusions. ML could effectively predict nurses' depressive symptoms. Interventions to manage physical fatigue, sleep disorders, burnout, and organisational support may prevent depressive symptoms.

Admission avoidance in acute epistaxis: A prospective national audit during the initial peak of the COVID-19 pandemic.

OBJECTIVES: To report changes in practice brought about by COVID-19 and the implementation of new guidelines, and to explore factors relating to unscheduled re-presentations for patients discharged from the emergency department (ED). DESIGN: Prospective multicentre national audit over 12 weeks from 6th April 2020. SETTING: UK secondary care ENT departments. PARTICIPANTS: Adult patients with acute epistaxis. MAIN OUTCOME MEASURES: Re-presentation within 10 days for patients discharged from the ED. RESULTS: Eighty three centres from all four UK nations submitted 2631 valid cases. The majority of cases were ED referrals (89.7%, n = 2358/2631). 54.6% were discharged from the ED following ENT review (n = 1267/2322), of whom 19.5% re-presented within 10 days (n = 245/1259) and 6.8% were ultimately admitted (n = 86/1259). 46.7% of patients had a non-dissolvable pack inserted by ED prior to referral to ENT (n = 1099/2355). The discharge rates for ED patients and their subsequent re-presentation rates were as follows: non-dissolvable packs, 29.5% discharged (n = 332/1125), 18.2% re-presented (n = 60/330); dissolvable products, 71.1% discharged (n = 488/686), 21.8% re-presented (n = 106/486); cautery only, 89.2% discharged (n = 247/277), 20.0% re-presented (n = 49/245); and no intranasal intervention, 85.5% discharged (n = 200/234), 15.2% re-presented (n = 30/198). Univariable logistic regression showed that not being packed by ED, antiplatelet medications, failed cautery and recent epistaxis treatment were significant predictors of re-presentation within 10 days. CONCLUSIONS: Management of acute epistaxis was notably affected during the initial peak of the pandemic, with a shift towards reduced admissions. This national audit highlights that many patients who may previously have been admitted to hospital may be safely discharged from the ED following acute epistaxis.

Iliopsoas haematoma during extracorporeal membrane oxygenation: A registry report from the COVID-19 critical care consortium across 30 countries.

INTRODUCTION: Iliopsoas haematoma (IPH) during extracorporeal membrane oxygenation (ECMO) is a rare bleeding complication that can be fatal due to its progression to abdominal compartment syndrome, but its incidence and risk factors are not well known. We have previously reported an IPH incidence rate of 16% in Japan. Among possible reasons for this high incidence, ethnicity has been hypothesised to play a role. Therefore, we used an international multi-centre cohort registry to test this hypothesis by determining the incidence rate of IPH. METHODS: This study was performed using the COVID-19 Critical Care Consortium database, conducted in 30 countries across five continents between 3 January 2020, and 20 June 2022. RESULTS: Overall, 1102 patients received ECMO for COVID-19-related acute respiratory distress syndrome. Of them, only seven were reported to have IPH, indicating an incidence rate of 0.64%, with comparable rates between the countries. The IPH group tended to have a higher mortality rate (71.4%) than the non-IPH group (51%). CONCLUSIONS: Overall incidence of IPH in the studied COVID-19 ECMO cohort was 0.64%. Most cases were reported from Japan, Belgium, and Italy. In our study, this rare complication did not appear to be confined to Asian patients. Due to the high fatality rate, awareness about the occurrence of IPH should be recognised.

Specialized palliative care for hospitalized patients with SARS-CoV-2 infection: an analysis of the LEOSS registry.

PURPOSE: Symptom control for patients who were severely ill or dying from COVID-19 was paramount while resources were strained and infection control measures were in place. We aimed to describe the characteristics of SARS-CoV-2 infected patients who received specialized palliative care (SPC) and the type of SPC provided in a larger cohort. METHODS: From the multi-centre cohort study Lean European Open Survey on SARS-CoV-2 infected patients (LEOSS), data of patients hospitalized with SARS-CoV-2 infection documented between July 2020 and October 2021 were analysed. RESULTS: 273/7292 patients (3.7%) received SPC. Those receiving SPC were older and suffered more often from comorbidities, but 59% presented with an estimated life expectancy > 1 year. Main symptoms were dyspnoea, delirium, and excessive tiredness. 224/273 patients (82%) died during the hospital stay compared to 789/7019 (11%) without SPC. Symptom control was provided most common (223/273; 95%), followed by family and psychological support (50% resp. 43%). Personal contact with friends or relatives before or during the dying phase was more often documented in patients receiving SPC compared to patients without SPC (52% vs. 30%). CONCLUSION: In 3.7% of SARS-CoV-2 infected hospitalized patients, the burden of the acute infection triggered palliative care involvement. Besides complex symptom management, SPC professionals also focused on psychosocial and family issues and aimed to enable personal contacts of dying patients with their family. The data underpin the need for further involvement of SPC in SARS-CoV-2 infected patients but also in other severe chronic infectious diseases.

Clinical characteristics and molecular epidemiology of human metapneumovirus in children with acute lower respiratory tract infections in China, 2017 to 2019: A multicentre prospective observational study.

Human metapneumovirus (HMPV) infection is one of the leading causes of hospitalization in young children with acute respiratory illness. In this study, we prospectively collected respiratory tract samples from children who were hospitalized with acute lower respiratory tract infection in six hospitals in China from 2017 to 2019. HMPV was detected in 145 out of 2733 samples (5.3%) from the hospitalized children. The majority of HMPV-positive children were under the age of two (67.6%), with a median age of one year. HMPV can independently cause acute lower respiratory tract infection in young children, while all patients showed mild clinical symptoms. Of all the co-infected patients, HMPV was most commonly detected with enterovirus (EV) or rhinovirus (RhV) (38.0%, followed by respiratory syncytial virus (RSV) (32.0%). The highest detection rate occurred from March to May in both northern and southern China. Out of 145 HMPV positive samples, 48 were successfully typed, of which 36 strains were subgrouped into subtypes A2c (75%), eight strains were included in subtype B1 (16.7%), and four strains were included in subtype B2 (8.3%). Moreover, 16 A2c strains contained 111-nucleotide duplications in the G gene. Twenty-seven complete HMPV genomes were successfully obtained, and 25 (92.6%) strains belonged to subtype A2c, whereas one strain was included in subgroup B1 and another was included in subgroup B2. A total of 277 mutations were observed in the complete genomes of 25 A2c strains. All results presented here improve our understanding of clinical characteristics and molecular epidemiology of HMPV infection in children.

Influenza vaccine effectiveness against influenza A subtypes in Europe: Results from the 2021-2022 I-MOVE primary care multicentre study.

BACKGROUND: In 2021-2022, influenza A viruses dominated in Europe. The I-MOVE primary care network conducted a multicentre test-negative study to measure influenza vaccine effectiveness (VE). METHODS: Primary care practitioners collected information on patients presenting with acute respiratory infection. Cases were influenza A(H3N2) or A(H1N1)pdm09 RT-PCR positive, and controls were influenza virus negative. We calculated VE using logistic regression, adjusting for study site, age, sex, onset date, and presence of chronic conditions. RESULTS: Between week 40 2021 and week 20 2022, we included over 11 000 patients of whom 253 and 1595 were positive for influenza A(H1N1)pdm09 and A(H3N2), respectively. Overall VE against influenza A(H1N1)pdm09 was 75% (95% CI: 43-89) and 81% (95% CI: 45-93) among those aged 15-64 years. Overall VE against influenza A(H3N2) was 29% (95% CI: 12-42) and 25% (95% CI: -41 to 61), 33% (95% CI: 14-49), and 26% (95% CI: -22 to 55) among those aged 0-14, 15-64, and over 65 years, respectively. The A(H3N2) VE among the influenza vaccination target group was 20% (95% CI: -6 to 39). All 53 sequenced A(H1N1)pdm09 viruses belonged to clade 6B.1A.5a.1. Among 410 sequenced influenza A(H3N2) viruses, all but eight belonged to clade 3C.2a1b.2a.2. DISCUSSION: Despite antigenic mismatch between vaccine and circulating strains for influenza A(H3N2) and A(H1N1)pdm09, 2021-2022 VE estimates against circulating influenza A(H1N1)pdm09 were the highest within the I-MOVE network since the 2009 influenza pandemic. VE against A(H3N2) was lower than A(H1N1)pdm09, but at least one in five individuals vaccinated against influenza were protected against presentation to primary care with laboratory-confirmed influenza.

Effectiveness of complete primary vaccination against COVID-19 at primary care and community level during predominant Delta circulation in Europe: multicentre analysis, I-MOVE-COVID-19 and ECDC networks, July to August 2021.

IntroductionIn July and August 2021, the SARS-CoV-2 Delta variant dominated in Europe.AimUsing a multicentre test-negative study, we measured COVID-19 vaccine effectiveness (VE) against symptomatic infection.MethodsIndividuals with COVID-19 or acute respiratory symptoms at primary care/community level in 10 European countries were tested for SARS-CoV-2. We measured complete primary course overall VE by vaccine brand and by time since vaccination.ResultsOverall VE was 74% (95% CI: 69-79), 76% (95% CI: 71-80), 63% (95% CI: 48-75) and 63% (95% CI: 16-83) among those aged 30-44, 45-59, 60-74 and ≥ 75 years, respectively. VE among those aged 30-59 years was 78% (95% CI: 75-81), 66% (95% CI: 58-73), 91% (95% CI: 87-94) and 52% (95% CI: 40-61), for Comirnaty, Vaxzevria, Spikevax and COVID-19 Vaccine Janssen, respectively. VE among people 60 years and older was 67% (95% CI: 52-77), 65% (95% CI: 48-76) and 83% (95% CI: 64-92) for Comirnaty, Vaxzevria and Spikevax, respectively. Comirnaty VE among those aged 30-59 years was 87% (95% CI: 83-89) at 14-29 days and 65% (95% CI: 56-71%) at ≥ 90 days between vaccination and onset of symptoms.ConclusionsVE against symptomatic infection with the SARS-CoV-2 Delta variant varied among brands, ranging from 52% to 91%. While some waning of the vaccine effect may be present (sample size limited this analysis to only Comirnaty), protection was 65% at 90 days or more between vaccination and onset.

Symptom-based remote assessment in post-treatment head and neck cancer surveillance: A prospective national study.

OBJECTIVES: To report the incidence of locoregional recurrence in head and neck cancer (HNC) patients under surveillance following treatment undergoing symptom-based remote assessment. DESIGN: A 16-week multicentre prospective cohort study. SETTING: UK ENT departments. PARTICIPANTS: HNC patients under surveillance following treatment undergoing symptom-based telephone assessment. MAIN OUTCOME MEASURES: Incidence of locoregional recurrent HNC after minimum 6-month follow-up. RESULTS: Data for 1078 cases were submitted by 16 centres, with follow-up data completed in 98.9% (n = 1066). Following telephone consultation, 83.7% of referrals had their face-to-face appointments deferred (n = 897/1072). New symptoms were reported by 11.6% (n = 124/1072) at telephone assessment; 72.6% (n = 90/124) of this group were called for urgent assessments, of whom 48.9% (n = 44/90) came directly for imaging without preceding clinical review. The sensitivity and specificity for new symptoms as an indicator of cancer recurrence were 35.3% and 89.4%, respectively, with a negative predictive value of 99.7% (p = .002). Locoregional cancer identification rates after a minimum of 6 months of further monitoring, when correlated with time since treatment, were 6.0% (n = 14/233) <1 year; 2.1% (n = 16/747) between 1 and 5 years; and 4.3% (n = 4/92) for those >5 years since treatment. CONCLUSIONS: Telephone assessment, using patient-reported symptoms, to identify recurrent locoregional HNC was widely adopted during the initial peak of the COVID-19 pandemic in the United Kingdom. The majority of patients had no face-to-face reviews or investigations. New symptoms were significantly associated with the identification of locoregional recurrent cancers with a high specificity, but a low sensitivity may limit symptom assessment being used as the sole surveillance method.

Comparative study shows that 1 in 7 Spanish children with COVID-19 symptoms were still experiencing issues after 12 weeks.

AIM: We investigated prolonged symptoms in children after COVID-19, including the clinical characteristics and risk factors. METHODS: This multicentre retrospective study focused on 451 children under 18 years old who were diagnosed with symptomatic COVID-19 between 14 March and 31 December 2020. Persistent symptoms were analysed with a telephone questionnaire by the attending physicians from 1 August to 30 September 2021. A control group of 98 with no history of COVID-19, who were treated for other reasons, was also included. RESULTS: Most (82.0%) of the cases had mild infections that required outpatient care and 5.1% were admitted to the paediatric intensive care unit (PICU). We found that 18.4% had symptoms that lasted 4-12 weeks. There were also 14.6% who were symptomatic for longer than 12 weeks and the odds risks were higher for children aged 5 years or more (OR 3.0), hospitalised (OR 3.9), admitted to the PICU (OR 4.3) and with relatives who were symptomatic for 12 weeks or more (OR 2.8). The controls had similar percentages of prolonged symptoms, despite having no history of COVID-19, especially those who were older than 5 years. CONCLUSION: This study confirmed that a worrying percentage of children had prolonged symptoms after COVID-19.

Antimicrobial Use in Hospitalised Patients with COVID-19: An International Multicentre Point-Prevalence Study.

Studies suggest that the incidence of coinfections in patients with the coronavirus disease 2019 (COVID-19) is low, but a large number of patients receive antimicrobials during hospitalisation. This may fuel a rise in antimicrobial resistance (AMR). We conducted a multicentre point-prevalence survey in seven tertiary university hospitals (in medical wards and intensive care units) in Croatia, Italy, Serbia and Slovenia. Of 988 COVID-19 patients, 521 were receiving antibiotics and/or antifungals (52.7%; range across hospitals: 32.9-85.6%) on the day of the study. Differences between hospitals were statistically significant (χ2 (6, N = 988) = 192.57, p < 0.001). The majority of patients received antibiotics and/or antifungals within 48 h of admission (323/521, 62%; range across hospitals: 17.4-100%), their most common use was empirical (79.4% of prescriptions), and pneumonia was the main indication for starting the treatment (three-quarters of prescriptions). The majority of antibiotics prescribed (69.9%) belonged to the "Watch" group of the World Health Organization AWaRe classification. The pattern of antimicrobial use differed across hospitals. The data show that early empiric use of broad-spectrum antibiotics is common in COVID-19 patients, and that the pattern of antimicrobial use varies across hospitals. Judicious use of antimicrobials is warranted to prevent an increase in AMR.

Pathways to mental health care in Nepal: a 14-center nationwide study.

BACKGROUND: Pathways to care studies are feasible and tested means of finding the actual routes taken by patients before reaching proper care. In view of the predominance of nonprofessional service providers and the lack of previous large studies on pathways in Nepal, this multicenter study is needed. The aim of the study was to trace the various pathways and carers involved in mental health care; assess clinical variables such as the duration of untreated illness, clinical presentation and treatment; and compare geographically and culturally diverse landscapes. METHODS: This was a cross-sectional, convenience sampling study performed at 14 centers where new cases were being taken. The World Health Organization Study of the Pathways-to-Care Schedule was applied. The Nepali version of the encounter form was used. The data were collected between 17 September and 16 October 2020 and were analyzed using the Statistical Package for the Social Sciences (SPSS). Additionally, perspectives from local investigators were collected and discussed. RESULTS: Most of the first carers were native/religious faith healers (28.2%), followed by psychiatrists (26%). The median duration for the first psychiatric consultation was 3 weeks. The duration of untreated illness was 30.72 ± 80.34 (median: 4) weeks, and the time taken for this journey was 94.99 ± 274.58 (median: 30) min. The longest delay from the onset of illness to psychiatric care was for epilepsy {90.0 ± 199.0 (median: 25.5)} weeks, followed by neurotic illness {22.89 ± 73.45 (median: 2)} and psychotic illness {10.54 ± 18.28 (median: 2)} weeks. Overall, most patients with severe mental illnesses (SMIs) had their first contact with faithhealers (49%), then met with medical doctors (13%) or psychiatrists (28%). Marked differences in clinical presentation surfaced when hilly centers were compared with the Terai belt. CONCLUSIONS: Faith healers, general practitioners and hospital doctors are major carers, and the means of educating them for proper referral can be considered. The investigators see several hindrances and opportunities in the studied pathways. The employment of more mental health professionals and better mental health advocacy, public awareness programs and school education are suggested strategies to improve proper mental health care.

COVID-19 in lung transplant recipients: an overview of the Swedish national experience.

Although it is known that solid organ transplant recipients fare worse after COVID-19 infection, data on the impact of COVID-19 on clinical outcomes and allograft function in lung transplant (LTx) recipients are limited and based mainly on reports with short follow-up. In this nationwide study, all LTx recipients with COVID-19 diagnosed from 1 February 2020 to 30 April 2021 were included. The patients were followed until 1 August 2021 or death. We analysed demographics, clinical features, therapeutic management and outcomes, including lung function. Forty-seven patients were identified: median age was 59 (10-78) years, 53.1% were male, and median follow-up was 194 (23-509) days. COVID-19 was asymptomatic or mild at presentation in 48.9%. Nine patients (19.1%) were vaccinated pre-COVID infection. Two patients (4.3%) died within 28 days of testing positive, and the overall survival rate was 85.1%. The patients with asymptomatic or mild symptoms had a higher median % expected forced expiratory volume during the first second than the patients with worse symptoms (P = 0.004). LTx recipients develop the entire spectrum of COVID-19, and in addition to previously acknowledged risk factors, lower pre-COVID lung function was associated with more severe disease presentation.

Vaccine effectiveness against symptomatic SARS-CoV-2 infection in adults aged 65 years and older in primary care: I-MOVE-COVID-19 project, Europe, December 2020 to May 2021.

We measured COVID-19 vaccine effectiveness (VE) against symptomatic SARS-CoV-2 infection at primary care/outpatient level among adults ≥ 65 years old using a multicentre test-negative design in eight European countries. We included 592 SARS-CoV-2 cases and 4,372 test-negative controls in the main analysis. The VE was 62% (95% CI: 45-74) for one dose only and 89% (95% CI: 79-94) for complete vaccination. COVID-19 vaccines provide good protection against COVID-19 presentation at primary care/outpatient level, particularly among fully vaccinated individuals.

The Pediatric Emergency Research Network (PERN): A decade of global research cooperation in paediatric emergency care.

OBJECTIVES: The Pediatric Emergency Research Network (PERN) was launched in 2009 with the intent for existing national and regional research networks in paediatric emergency care to organise globally for the conduct of collaborative research across networks. METHODS: PERN has grown from five to eight member networks over the past decade. With an executive committee comprising representatives from all member networks, PERN plays a supportive and collaborative rather than governing role. The full impact of PERN's facilitation of international collaborative research, although somewhat difficult to quantify empirically, can be measured indirectly by the observed growth of the field, the nature of the increasingly challenging research questions now being addressed and the collective capacity to generate and implement new knowledge in treating acutely ill and injured children. RESULTS: Beginning as a pandemic response studying H1N1 influenza risk factors in children, PERN research has progressed to multiple observational studies and ongoing global randomised controlled trials (RCTs). As a recent example, PERN has developed sufficient network infrastructure to enable the rapid initiation of a prospective observational study in response to the current COVID-19 pandemic. CONCLUSIONS: Following its success with developing global research, the PERN goal now is to promote the implementation of scientific advances into everyday clinical practice by: (i) expanding the capacity for global RCTs; (ii) deepening the focus on implementation science; (iii) increasing attention to healthcare disparities; and (iv) expanding PERN's reach into resource-restricted regions. Through these actions, PERN aims to meet the needs of acutely ill and injured children throughout the world.

Global Prevalence and Drivers of Dental Students' COVID-19 Vaccine Hesitancy.

BACKGROUND: Acceleration of mass vaccination strategies is the only pathway to overcome the COVID-19 pandemic. Healthcare professionals and students have a key role in shaping public opinion about vaccines. This study aimed to evaluate the attitudes of dental students globally towards COVID-19 vaccines and explore the potential drivers for students' acceptance levels. METHODS: A global cross-sectional study was carried out in February 2021 using an online questionnaire. The study was liaised by the scientific committee of the International Association of Dental Students (IADS), and data were collected through the national and local coordinators of IADS member organizations. The dependent variable was the willingness to take the COVID-19 vaccine, and the independent variables included demographic characteristics, COVID-19-related experience, and the drivers of COVID-19 vaccine-related attitude suggested by the WHO SAGE. RESULTS: A total of 6639 students from 22 countries, representing all world regions, responded to the questionnaire properly. Their mean age was 22.1 ± 2.8 (17-40) years, and the majority were females (70.5%), in clinical years (66.8%), and from upper-middle-income economies (45.7%). In general, 22.5% of dental students worldwide were hesitant, and 13.9% rejected COVID-19 vaccines. The students in low- and lower-middle-income (LLMI) economies had significantly higher levels of vaccine hesitancy compared to their peers in upper-middle- and high-income (UMHI) economies (30.4% vs. 19.8%; p < 0.01). CONCLUSIONS: The global acceptance level of dental students for COVID-19 vaccines was suboptimal, and their worrisome level of vaccine hesitancy was influenced by the socioeconomic context where the dental students live and study. The media and social media, public figures, insufficient knowledge about vaccines, and mistrust of governments and the pharmaceutical industry were barriers to vaccination. The findings of this study call for further implementation of epidemiology (infectious diseases) education within undergraduate dental curricula.

COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. TRIAL DESIGN: Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. PARTICIPANTS: Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. INTERVENTION AND COMPARATOR: Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. MAIN OUTCOMES: The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). RANDOMISATION: Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + "standard of care": "standard of care"). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) BLINDING (MASKING): This is an open-label trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. TRIAL STATUS: The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. TRIAL REGISTRATION: Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601 , registered June 8, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Impact of COVID-19 pandemic on rheumatoid arthritis from a Multi-Centre patient-reported questionnaire survey: influence of gender, rural-urban gap and north-south gradient.

During the coronavirus disease-2019 (COVID-19) pandemic there were several barriers to treatment access and medication adherence in rheumatoid arthritis (RA) patients. There is no information regarding the RA patient health status in Egypt during the COVID-19. Thus,the aim of this work was to study the impact of the pandemic on RA patients through a patient-reported questionnaire and to determine the influence of gender, geographic regions. This multi-centre study initiated by the Egyptian College of Rheumatology (ECR) was conducted on 1037 RA patients attending rheumatology clinics from 10 governorates. The questionnaire provided covered socio-demographic data, health/disease status, information/knowledge about COVID-19 and medical/family history of the infection. Patients mean age was 44.2 ± 12.3 years;855 females and 182 males; 539(52%) from rural and 497(48%) from urban areas. 41.8% reported a striking difficulty to obtain hydroxychloroquine during the pandemic. The majority (70%) considered maintaining a regular visit to the rheumatologist in addition to remote contact mainly by phone (44.4%) or via WhatsApp (33.1%), in particular among male and urban patients. Urban patients were more likely to be infected by COVID-19 (12.9% vs 6.2%; p < 0.0001) than rural. Northern cities had more patients with suspected COVID-19 (13.9% vs 6.1%; p < 0.0001); was significantly associated with more disease flares (30.8% vs 5.8%) with subsequent change in the RA treatment (20.9% vs 6.4%; p < 0.0001). Patients with RA faced remarkable difficulty to obtain their medications with subsequent change in their disease status. The challenges of the pandemic have hastened changes in the way we deliver health care.

Absence of association between 2019-20 influenza vaccination and COVID-19: Results of the European I-MOVE-COVID-19 primary care project, March-August 2020.

BACKGROUND: Claims of influenza vaccination increasing COVID-19 risk are circulating. Within the I-MOVE-COVID-19 primary care multicentre study, we measured the association between 2019-20 influenza vaccination and COVID-19. METHODS: We conducted a multicentre test-negative case-control study at primary care level, in study sites in five European countries, from March to August 2020. Patients presenting with acute respiratory infection were swabbed, with demographic, 2019-20 influenza vaccination and clinical information documented. Using logistic regression, we measured the adjusted odds ratio (aOR), adjusting for study site and age, sex, calendar time, presence of chronic conditions. The main analysis included patients swabbed ≤7 days after onset from the three countries with <15% of missing influenza vaccination. In secondary analyses, we included five countries, using multiple imputation with chained equations to account for missing data. RESULTS: We included 257 COVID-19 cases and 1631 controls in the main analysis (three countries). The overall aOR between influenza vaccination and COVID-19 was 0.93 (95% CI: 0.66-1.32). The aOR was 0.92 (95% CI: 0.58-1.46) and 0.92 (95% CI: 0.51-1.67) among those aged 20-59 and ≥60 years, respectively. In secondary analyses, we included 6457 cases and 69 272 controls. The imputed aOR was 0.87 (95% CI: 0.79-0.95) among all ages and any delay between swab and symptom onset. CONCLUSIONS: There was no evidence that COVID-19 cases were more likely to be vaccinated against influenza than controls. Influenza vaccination should be encouraged among target groups for vaccination. I-MOVE-COVID-19 will continue documenting influenza vaccination status in 2020-21, in order to learn about effects of recent influenza vaccination.

Epidemiological and clinical characteristics of 70 cases of coronavirus disease and concomitant hepatitis B virus infection: A multicentre descriptive study.

The interaction between existing chronic liver diseases caused by hepatitis B virus (HBV) infection and COVID-19 has not been studied. We analysed 70 COVID-19 cases combined with HBV infection (CHI) to determine the epidemiological, clinical characteristics, treatment and outcome. We investigated clinical presentation, imaging and laboratory parameters of COVID-19 patients of seven hospitals from Jan 20 to March 20, 2020. Multivariate analysis was used to analyse risk factors for progression of patients with COVID-19 combined with HBV infection. Compared with COVID-19 without HBV infection (WHI) group, patients with dual infection had a higher proportion of severe/critically ill disease (32.86% vs. 15.27%, P = .000), higher levels of alanine aminotransferase (ALT), aspartate transaminase (AST) and activated partial thromboplastin (APTT) [50(28-69)vs 21(14-30), P = .000; 40(25-54) vs 23(18-30), P = .000; 34.0(27.2-38.7) vs 37.2(31.1-41.4), P = .031]. The utilization rates of Arbidol and immunoglobulin were significantly higher than those in the co-infected group [48.57% vs. 35.64%, P < .05; 21.43% vs. 8.18%, P < .001], while the utilization rate of chloroquine phosphate was lower (1.43% vs 14.00%, P < .05) in the co-infected patients group. Age and c-reactive protein (CRP) level were independent risk factors for recovery of patients with COVID-19 combined with HBV infection. The original characteristics of COVID-19 cases combined with HBV infection were higher rate of liver injury, coagulation disorders, severe/critical tendency and increased susceptibility. The elderly and patients with higher level of CRP were more likely to experience a severe outcome of COVID-19.

Admission avoidance in tonsillitis and peritonsillar abscess: A prospective national audit during the initial peak of the COVID-19 pandemic.

OBJECTIVES: To report changes in practice brought about by COVID-19 and the implementation of new guidelines for the management of tonsillitis and peritonsillar abscess (PTA), and to explore factors relating to unscheduled re-presentations for patients discharged from the emergency department (ED). DESIGN: Prospective multicentre national audit over 12 weeks from 6 April 2020. SETTING: UK secondary care ENT departments. PARTICIPANTS: Adult patients with acute tonsillitis or PTA. MAIN OUTCOME MEASURES: Re-presentation within 10 days for patients discharged from the ED. RESULTS: 83 centres submitted 765 tonsillitis and 416 PTA cases. 54.4% (n = 410) of tonsillitis and 45.3% (187/413) of PTAs were discharged from ED. 9.6% (39/408) of tonsillitis and 10.3% (19/184) of PTA discharges re-presented within 10 days, compared to 9.7% (33/341) and 10.6% (24/224) for those admitted from ED. The subsequent admission rate of those initially discharged from ED was 4.7% for tonsillitis and 3.3% for PTAs. IV steroids and antibiotics increased the percentage of patients able to swallow from 35.8% to 72.5% for tonsillitis (n = 270/754 and 441/608) and from 22.3% to 71.0% for PTA (n = 92/413 and 265/373). 77.2% of PTAs underwent drainage (n = 319/413), with no significant difference in re-presentations in those drained vs not-drained (10.6% vs 9.5%, n = 15/142 vs 4/42, P = .846). Univariable logistic regression showed no significant predictors of re-presentation within 10 days. CONCLUSIONS: Management of tonsillitis and PTA changed during the initial peak of the pandemic, shifting towards outpatient care. Some patients who may previously have been admitted to hospital may be safely discharged from the ED.