Examining anti-inflammatory therapies in the prevention of cardiovascular events: protocol for a systematic review and network meta-analysis of randomised controlled trials

Introduction
Inflammation is emerging as an important risk factor for atherosclerotic cardiovascular disease and has been a recent target for many novel therapeutic agents. However, comparative evidence regarding efficacy of these anti-inflammatory treatment options is currently lacking.

Methods and analysis
This systematic review will include randomised controlled trials evaluating the effect of anti-inflammatory agents on cardiovascular outcomes in patients with known cardiovascular disease. Studies will be retrieved from Medline, Embase, the Cochrane Central Register of Controlled Trials, as well as clinical trial registry websites, Europe PMC and conference abstract handsearching. No publication date or language restrictions will be imposed. Eligible interventions must have some component of anti-inflammatory agent. These include (but are not limited to): non-steroidal anti-inflammatory drugs (NSAIDs), colchicine, prednisone, methotrexate, canakinumab, pexelizumab, anakinra, succinobucol, losmapimod, inclacumab, atreleuton, LP-PLA2 (darapladib) and sPLA2 (varespladib). The primary outcomes will include major adverse cardiac events (MACE), and each individual component of MACE (myocardial infarction, stroke and cardiovascular death). Key secondary outcomes will include unstable angina, heart failure, all-cause mortality, cardiac arrest and revascularisation. Screening, inclusion, data extraction and quality assessment will be performed independently by two reviewers. Network meta-analysis based on the random effects model will be conducted to compare treatment effects both directly and indirectly. The quality of the evidence will be assessed with appropriate tools including the Grading of Recommendations, Assessment, Development and Evaluation profiler or Confidence in Network Meta-Analysis tool.

Ethics and dissemination
Ethics approval is not required for this systematic review. The findings will be disseminated through a peer-reviewed journal.

PROSPERO registration number
CRD42022303289.

Leggi
Giugno 2022

Role of cash transfers in mitigating food insecurity in India during the COVID-19 pandemic: a longitudinal study in the Bihar state

Objective
There are scant empirical data on the impacts of the COVID-19 pandemic on food security across the globe. India is no exception, with insights into the impacts of lockdown on food insecurity now emerging. We contribute to the empirical evidence on the prevalence of food insecurity in Bihar state before and after lockdown, and whether the government’s policy of cash transfer moderated negative effects of food insecurity or not.

Design
This was a longitudinal study.

Settings
The study was conducted in Gaya and Nalanda district of Bihar state in India from December 2019 to September 2020.

Participants
A total of 1797 households were surveyed in survey 1, and about 52% (n=939) were followed up in survey 2. Valid data for 859 households were considered for the analysis.

Main outcome measures
Using the Food Insecurity Experience Scale, we found that household conditions were compared before and after lockdown. The effect of cash transfers was examined in a quasi-experimental method using a longitudinal study design. Logistic regression and propensity score adjusted analyses were used to identify factors associated with food insecurity.

Results
Household food insecurity worsened considerably during lockdown, rising from 20% (95% CI 17.4 to 22.8) to 47% (95% CI 43.8 to 50.4) at the sample mean. Households experiencing negative income shocks were more likely to have been food insecure before the lockdown (adjusted OR 6.4, 95% CI 4.9 to 8.3). However, households that received cash transfers had lower odds of being food insecure once the lockdown was lifted (adjusted OR 0.75, 95% CI 0.56 to 0.99).

Conclusion
These findings provide evidence on how the swift economic response to the pandemic crises using targeted income transfers was relatively successful in mitigating potentially deep impacts of food insecurity.

Leggi
Giugno 2022

Point-of-care lung ultrasonography for early identification of mild COVID-19: a prospective cohort of outpatients in a Swiss screening center

Objectives
Early identification of SARS-CoV-2 infection is important to guide quarantine and reduce transmission. This study evaluates the diagnostic performance of lung ultrasound (LUS), an affordable, consumable-free point-of-care tool, for COVID-19 screening.

Design, setting and participants
This prospective observational cohort included adults presenting with cough and/or dyspnoea at a SARS-CoV-2 screening centre of Lausanne University Hospital between 31 March and 8 May 2020.

Interventions
Investigators recorded standardised LUS images and videos in 10 lung zones per patient. Two blinded independent experts reviewed LUS recording and classified abnormal findings according to prespecified criteria to investigate their predictive value to diagnose SARS-CoV-2 infection according to PCR on nasopharyngeal swabs (COVID-19 positive vs COVID-19 negative).

Primary and secondary outcome measures
We finally combined LUS and clinical findings to derive a multivariate logistic regression diagnostic score.

Results
Of 134 included patients, 23% (n=30/134) were COVID-19 positive and 77% (n=103/134) were COVID-19 negative; 85%, (n=114/134) cases were previously healthy healthcare workers presenting within 2–5 days of symptom onset (IQR). Abnormal LUS findings were significantly more frequent in COVID-19 positive compared with COVID-19 negative (45% vs 26%, p=0.045) and mostly consisted of focal pathologic B lines. Combining clinical findings in a multivariate logistic regression score had an area under the receiver operating curve of 80.3% to detect COVID-19, and slightly improved to 84.5% with the addition of LUS features.

Conclusions
COVID-19-positive patients are significantly more likely to have lung pathology by LUS. However, LUS has an insufficient sensitivity and is not an appropriate screening tool in outpatients. LUS only adds little value to clinical features alone.

Leggi
Giugno 2022

Acute kidney injury in patients with COVID-19 in the intensive care unit: evaluation of risk factors and mortality in a national cohort

Objectives
Acute kidney injury (AKI) is a frequent complication among critical ill patients with COVID-19, but the actual incidence is unknown as AKI-incidence varies from 25% to 89% in intensive care unit (ICU) populations. We aimed to describe the prevalence and risk factors of AKI in patients with COVID-19 admitted to ICU in Norway.

Design
Nation-wide observational study with data sampled from the Norwegian Intensive Care and Pandemic Registry (NIPaR) for the period between 10 March until 31 December 2020.

Setting
ICU patients with COVID-19 in Norway. NIPaR collects data on intensive care stays covering more than 90% of Norwegian ICU and 98% of ICU stays.

Participants
Adult patients with COVID-19 admitted to Norwegian ICU were included in the study. Patients with chronic kidney disease (CKD) were excluded in order to avoid bias from CKD on the incidence of AKI.

Primary and secondary outcome measures
Primary outcome was AKI at ICU admission as defined by renal Simplified Acute Physiology Score in NIPaR. Secondary outcome measures included survival at 30 and 90 days after admission to hospital.

Results
A total number of 361 patients with COVID-19 were included in the analysis. AKI was present in 32.0% of the patients at ICU admission. The risk for AKI at ICU admission was related to acute circulatory failure at admission to hospital. Survival for the study population at 30 and 90 days was 82.5% and 77.6%, respectively. Cancer was a predictor of 30-day mortality. Age, acute circulatory failure at hospital admission and AKI at ICU admission were predictors of both 30-day and 90-day mortality.

Conclusions
A high number of patients with COVID-19 had AKI at ICU admission. The study indicates that AKI at ICU admission was related to acute circulatory failure at hospital admission. Age, acute circulatory failure at hospital admission and AKI at ICU admission were associated with mortality.

Leggi
Giugno 2022

The effect of hindrance stressors on the emotional exhaustion among front-line healthcare workers in the recuperation period during the COVID-19 epidemic in China: a prospective cross-sectional study

Objectives
This study aimed to examine the influence and conditioning process of hindrance stressors on the emotional exhaustion of the front-line healthcare workers during recuperation, examine the potential mediating process of rumination, and explore the moderating role of organisational and family factors.

Setting
This cross-sectional study was conducted during 12–20 July 2020. Total 418 questionnaires were collected from front-line healthcare workers by random cluster sampling. Hierarchical regression was performed to analyse the mediating effect of affective rumination using SPSS25.0, while PROCESS was used to further investigate the moderating role of servant leadership and family support.

Participants
418 healthcare workers were investigated randomly from front-line medical teams. Inclusion criteria included worked as front-line health workers and participated in the fight against COVID-19 in Hubei; age ≥18 years; normal cognitive and comprehension abilities under physical and mental health; volunteer to participate in this study. Exclusion criteria included recently affected by major events other than COVID-19 or those with a history of neurasthenia and trauma.

Results
Using descriptive analysis of average value and SD measured by a five-item scale (MBI-GS), we found that front-line healthcare workers’ emotional exhaustion score (2.45±0.88) was at the medium level. Hindrance stressors, mediated by affective rumination, had a significant positive predictive effect on emotional exhaustion. Servant leadership negatively moderated the direct effect of hindrance stressors on emotional exhaustion (β=–0.106, p

Leggi
Giugno 2022

Exploring the psychological impact of working during COVID-19 on medical and nursing students: a qualitative study

Objectives
To identify the psychological impact of working during the COVID-19 pandemic on medical and nursing students’ psychological well-being. To inform recommendations for the provision of future student well-being support.

Design
An interpretative qualitative, semistructured interview study employing maximum variation sampling, snowball sampling and a thematic analysis.

Setting
A large West Midlands (UK) university with medical and nursing undergraduate and postgraduate programmes. Study undertaken between January and May 2020.

Participants
A purposive sample of eight medical (six women and two men) and seven nursing (all women) students who worked >2 weeks in a healthcare setting during the COVID-19 pandemic (from 1 March 2020 onwards).

Results
Four core themes with corresponding subthemes were identified: (1) COVID-19 sources of distress—working conditions, exposure to suffering, death and dying, relationships and teams, individual inexperience and student identity, (2) negative impact on mental health and well-being—psychological and emotional distress, delayed distress, exhaustion, mental ill health, (3) protective factors from distress—access to support, environment, preparation and induction, recognition and reward, time for breaks and rest and (4) positive experiences and meaningful outcomes.

Conclusions
Student pandemic deployment has had a significant negative impact on students’ psychological well-being, as a result of demanding working conditions, unprecedented exposure to death and suffering and lack of preparation for new job roles. Universities and healthcare organisations must formally acknowledge this impact and provide well-being support for distressed students working in such challenging contexts. They must also establish more supportive and inclusive healthcare environments for medical and nursing students in future pandemic and postpandemic circumstances, through the implementation of support systems and adequate preparation.

Leggi
Giugno 2022

Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study

Introduction
During the COVID-19 pandemic many non-acute elective surgeries were cancelled or postponed around the world. This has created an opportunity to study the effect of delayed surgery on health conditions prior to surgery and postsurgical outcomes in patients with postponed elective surgery. The control group of the Routine Postsurgical Anesthesia Visit to Improve Patient Outcome (TRACE I) study, conducted between 2016 and 2019, will serve as a control cohort.

Methods and analysis
TRACE II is an observational, multicentre, prospective cohort study among surgical patients with postponed surgery due to COVID-19 in academic and non-academic hospitals in the Netherlands. We aim to include 2500 adult patients. The primary outcome will be the 30-day incidence of major postoperative complications. Secondary outcome measures include the 30-day incidence of minor postoperative complications, 1 year mortality, length of stay (in hospital, medium care and intensive care), quality of recovery 30 days after surgery and postoperative quality of life up to 1 year following surgery. Multivariable logistic mixed-effects regression analysis with a random intercept for hospital will be used to test group differences on the primary outcome.

Ethics and dissemination
Ethical approval was obtained from the Institutional Review Board of Maastricht University Medical Centre+ and Amsterdam UMC. Findings will be presented at national and international conferences, as well as published in peer-reviewed scientific journals, with a preference for open access journals. Data will be made publicly available after publication of the main results.

Trial registration number
NL8841.

Leggi
Giugno 2022

Correlates of and changes in aerobic physical activity and strength training before and after the onset of COVID-19 pandemic in the UK: findings from the HEBECO study

Objectives
Understanding changes in moderate to vigorous aerobic physical activity (MVPA) and muscle-strengthening activity (MSA) at the start of the COVID-19 pandemic and their correlates (socio-demographics, health characteristics, living and exercise conditions and pre-pandemic MVPA/MSA) can inform interventions.

Design
A cross-sectional analysis of retrospective and concurrent data on MVPA/MSA.

Setting
An online survey in the UK.

Participants
2657 adults (weighted n=2442, 53.6% women) participating in the baseline survey (29 April 2020–14 June 2020) of the HEalth BEhaviours during the COVID-19 pandemic (HEBECO) study.

Primary and secondary outcome measures
Meeting WHO-recommended levels for MVPA/MSA/both (vs meeting neither) during the first lockdown and changes in MVPA/MSA from before to since the COVID-19 pandemic following stratification for pre-pandemic MVPA/MSA.

Results
A third of adults maintained (30.4%), decreased (36.2%) or increased (33.4%) MVPA. For MSA, the percentages were 61.6%, 18.2% and 20.2%, respectively. MVPA increased or decreased by an average of 150 min/week and 219 min/week, respectively, and MSA by 2 days/week. Meeting both MSA+MVPA recommendations since COVID-19 (vs meeting neither) was positively associated with meeting MVPA+MSA before COVID-19 (adjusted OR (aOR)=16.11, 95% CI 11.24 to 23.07) and education: post-16 years of age (aOR=1.57, 95% CI 1.14 to 2.17), and negatively associated with having obesity (aOR=0.49, 95% CI 0.33 to 0.73), older age (65+ years vs ≤34 years; aOR=0.53, 95% CI 0.32 to 0.87) and annual household income of

Leggi
Giugno 2022

Cross-sectional survey of changes in knowledge, attitudes and practice of mask use in Sydney and Melbourne during the 2020 COVID-19 pandemic

Objectives
Since mask uptake and the timing of mask use has the potential to influence the control of the COVID-19 pandemic, this study aimed to assess the changes in knowledge toward mask use in Sydney and Melbourne, Australia, during the 2020 COVID-19 pandemic.

Design
An observational study, using a cross-sectional survey, was distributed to adults in Sydney and Melbourne, Australia, during July–August 2020 (survey 1) and September 2020 (survey 2), during the COVID-19 pandemic in Australia.

Setting and participants
Participants aged 18 years or older and living in either Sydney or Melbourne.

Primary and secondary outcome measures
Demographics, risk measures, COVID-19 severity and perception, mask attitude and uptake were determined in this study.

Results
A total of 700 participants completed the survey. In both Sydney and Melbourne, a consistent decrease was reported in almost all risk-mitigation behaviours between March 2020 and July 2020 and again between March 2020 and September 2020. However, mask use and personal protective equipment use increased in both Sydney and Melbourne from March 2020 to September 2020. There was no significant difference in mask use during the pandemic between the two cities across both timepoints (1.24 (95% CI 0.99 to 1.22; p=0.072)). Perceived severity and perceived susceptibility of COVID-19 infection were significantly associated with mask uptake. Trust in information on COVID-19 from both national (1.77 (95% CI 1.29 to 2.44); p

Leggi
Giugno 2022

Investigation of the use of a sensor bracelet for the presymptomatic detection of changes in physiological parameters related to COVID-19: an interim analysis of a prospective cohort study (COVI-GAPP)

Objectives
We investigated machinelearningbased identification of presymptomatic COVID-19 and detection of infection-related changes in physiology using a wearable device.

Design
Interim analysis of a prospective cohort study.

Setting, participants and interventions
Participants from a national cohort study in Liechtenstein were included. Nightly they wore the Ava-bracelet that measured respiratory rate (RR), heart rate (HR), HR variability (HRV), wrist-skin temperature (WST) and skin perfusion. SARS-CoV-2 infection was diagnosed by molecular and/or serological assays.

Results
A total of 1.5 million hours of physiological data were recorded from 1163 participants (mean age 44±5.5 years). COVID-19 was confirmed in 127 participants of which, 66 (52%) had worn their device from baseline to symptom onset (SO) and were included in this analysis. Multi-level modelling revealed significant changes in five (RR, HR, HRV, HRV ratio and WST) device-measured physiological parameters during the incubation, presymptomatic, symptomatic and recovery periods of COVID-19 compared with baseline. The training set represented an 8-day long instance extracted from day 10 to day 2 before SO. The training set consisted of 40 days measurements from 66 participants. Based on a random split, the test set included 30% of participants and 70% were selected for the training set. The developed long short-term memory (LSTM) based recurrent neural network (RNN) algorithm had a recall (sensitivity) of 0.73 in the training set and 0.68 in the testing set when detecting COVID-19 up to 2 days prior to SO.

Conclusion
Wearable sensor technology can enable COVID-19 detection during the presymptomatic period. Our proposed RNN algorithm identified 68% of COVID-19 positive participants 2 days prior to SO and will be further trained and validated in a randomised, single-blinded, two-period, two-sequence crossover trial.
Trial registration number
ISRCTN51255782; Pre-results.

Leggi
Giugno 2022

Psychosocial determinants of adherence to public health and social measures (PHSMs) in 18 African Union Member States during the early phase of the COVID-19 pandemic: results of a cross-sectional survey

Objective
The objective of this study was to gain a better understanding of the psychosocial and sociodemographic factors that affected adherence to COVID-19 public health and social measures (PHSMs), and to identify the factors that most strongly related to whether citizens followed public health guidance.

Design
Cross-sectional study.

Setting and participants
Nationally representative telephone surveys were conducted from 4–17 August 2020 in 18 African Union Member States. A total of 21 600 adults (mean age=32.7 years, SD=11.4) were interviewed (1200 in each country).

Outcome measures
Information including sociodemographics, adherence to PHSMs and psychosocial variables was collected. Logistic regression models examined the association between PHSM adherence (eg, physical distancing, gathering restrictions) and sociodemographic and psychosocial characteristics (eg, risk perception, trust). Factors affecting adherence were ranked using the Shapley regression decomposition method.

Results
Adherence to PHSMs was high, with better adherence to personal than community PHSMs (65.5% vs 30.2%, p

Leggi
Giugno 2022

Indirect impacts of the COVID-19 pandemic at two tertiary neonatal units in Zimbabwe and Malawi: an interrupted time series analysis

Objectives
To examine indirect impacts of the COVID-19 pandemic on neonatal care in low-income and middle-income countries.

Design
Interrupted time series analysis.

Setting
Two tertiary neonatal units in Harare, Zimbabwe and Lilongwe, Malawi.

Participants
We included a total of 6800 neonates who were admitted to either neonatal unit from 1 June 2019 to 25 September 2020 (Zimbabwe: 3450; Malawi: 3350). We applied no specific exclusion criteria.

Interventions
The first cases of COVID-19 in each country (Zimbabwe: 20 March 2020; Malawi: 3 April 2020).

Primary outcome measures
Changes in the number of admissions, gestational age and birth weight, source of admission referrals, prevalence of neonatal encephalopathy, and overall mortality before and after the first cases of COVID-19.

Results
Admission numbers in Zimbabwe did not initially change after the first case of COVID-19 but fell by 48% during a nurses’ strike (relative risk (RR) 0.52, 95% CI 0.41 to 0.66, p

Leggi
Giugno 2022

Correction: Who is engaging with lateral flow testing for COVID-19 in The UK? The COVID-19 Rapid Survey of Adherence to Interventions and Responses (CORSAIR) study

Smith LE, Potts HW, Amlôt R, et al. Who is engaging with lateral flow testing for COVID-19 in the UK? The COVID-19 Rapid Survey of Adherence to Interventions and Responses (CORSAIR) study. BMJ Open 2022;12:e058060. doi: 10.1136/bmjopen-2021-058060 This article was previously published with an error. There is an issue with labelling for socio-economic grade. The item for this variable asks participants to state the profession of the highest earner in the household. We categorised participants into two groups: highest earner works in a manual occupation, and highest earner does not work in a manual occupation. The levels of these variables are referred to in some of our project’s manuscripts as ‘socio-economic grade C1DE’ and ‘socio-economic grade ABC1’, respectively. These would be better denoted as ‘highest earner in household works in a manual occupation’ and ‘highest earner in household does not work in a manual occupation’. This labelling error came…

Leggi
Giugno 2022

Global prevalence, treatment and outcome of tuberculosis and COVID-19 coinfection: a systematic review and meta-analysis (from November 2019 to March 2021)

Introduction
The COVID-19 outbreak poses a significant threat to the patients with tuberculosis (TB). TB and COVID-19 (TB–COVID) coinfection means the disease caused by both Mycobacterium tuberculosis and SARS-CoV-2 infection. Currently, the prevalence status, treatment and outcomes of the coinfection are poorly characterised. We aimed to systematically review the evidence on this topic and provide comprehensive information to guide the control and treatment of TB–COVID coinfection.

Methods
An extensive screening was conducted using six electronic databases to search eligible studies from 1 November 2019 to 19 March 2021. Prevalence rate, treatment and outcomes of TB–COVID coinfection were extracted. Random-effects models were used to calculate mean fatality rates of coinfection with 95% CIs. The risks of bias were assessed with the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Study Reporting Prevalence Data and JBI Critical Appraisal Checklist for Case Report. A meta-analysis was conducted for subgroups on in-hospital fatality rate.

Results
Forty-two studies were included into the analysis (35 case reports and 7 retrospective cohort studies). Nineteen countries reported coinfected patients, including high and low TB prevalence countries. The only study revealing prevalence rate came from West Cape Province, South Africa (people aged above 20 years, 0.04% until 1 June 2020 and 0.06% until 9 June 2020). The treatment regimens for coinfected patients were highly heterogeneous. The mean overall and in-hospital fatality rates of coinfection were 13.9% (95% CI: 1.6% to 26.2%) and 17.5% (95% CI: 8.9% to 26.0%). The mean in-hospital fatality rates for high-income countries (Italy and Argentina) and low/middle-income countries (LMICs) (India, Philippines, South Africa) were 6.5% (95% CI: –0.8% to ~13.9%) and 22.5% (95% CI: 19.0% to ~26.0%).

Conclusion
TB–COVID coinfection is common globally, and the coinfected patients suffer from higher fatality risk than patients with normal COVID-19. Outcomes shared significant differences between high-income countries and LMICs.

PROSPERO registration number
CRD42021253660.

Leggi
Giugno 2022