Support after COVID-19 study: a mixed-methods cross-sectional study to develop recommendations for practice

Objectives of study stage 1 were to: explore people’s experiences of illness due to COVID-19 while feeling socially isolated or socially isolating; identify perceptions of what would support recovery; and synthesise insights into recommendations for supporting people after COVID-19. Study stage 2 objectives were to engage stakeholders in evaluating these recommendations and analyse likely influences on access to the support identified.
Design
A two-stage, multimethod cross-sectional study was conducted from a postpositivist perspective. Stage 1 included an international online survey of people’s experiences of illness, particularly COVID-19, in isolation (n=675 full responses). Stage 2 involved a further online survey (n=43), two tweetchats treated as large online focus groups (n=60 and n=27 people tweeting), two smaller focus groups (both n=4) and one interview (both using MS teams).

Setting
Stage 1 had an international emphasis, although 87% of respondents were living in the UK. Stage 2 focused on the UK.

Participants
Anyone aged 18+ and able to complete a survey in English could participate. Stage 2 included health professionals, advocates and people with lived experience.

Main outcome measures
Descriptive data and response categories derived from open responses to the survey and the qualitative data.

Results
Of those responding fully to stage 1 (mean age 44 years); 130 (19%) had experienced COVID-19 in isolation; 45 had recovered, taking a mean of 5.3 (range 1–54) weeks. 85 did not feel they had recovered; fatigue and varied ‘other’ symptoms were most prevalent and also had most substantial negative impacts. Our draft recommendations were highly supported by respondents to stage 2 and refined to produce final recommendations.

Conclusions
Recommendations support access to progressive intensity and specialism of support, addressing access barriers that might inadvertently increase health inequalities. Multidisciplinary collaboration and learning are crucial, including the person with COVID-19 and/or Long Covid in the planning and decision making throughout.

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Agosto 2022

Randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among patients with COVID-19 in India: trial protocol

Introduction
Presently, there are few population-level strategies to address SARS-CoV-2 infection except preventive measures such as vaccination. Micronutrient deficiency, particularly vitamin D and zinc deficiency, has been associated with dysregulated host responses, and may play an important role in COVID-19.

Methods and analysis
We have designed a 2×2 factorial, randomised, double-blind, multi-centre placebo-controlled trial to evaluate the effect of vitamin D and zinc on COVID-19 outcomes in Maharashtra, India. COVID-19 positive individuals are recruited from hospitals in Mumbai and Pune. Participants are provided (1) vitamin D3 bolus (180 000 IU) maintained by daily dose of 2000 IU and/or (2) zinc gluconate (40 mg daily), versus placebo for 8 weeks. Participants undergo a detailed assessment at baseline and at 8 weeks, and are monitored daily in hospital or every 3 days after leaving the hospital to assess symptoms and other clinical measures. A final follow-up telephone call occurs 12 weeks post-enrolment to assess long-term outcomes. The primary outcome of the study is to time to recovery, defined as time to resolution of all of fever, cough and shortness of breath. Secondary outcomes include: duration of hospital stay, all-cause mortality, necessity of assisted ventilation, change in blood biomarker levels and individual symptoms duration. Participant recruitment commenced on April 2021.

Ethics and dissemination
Ethical approval was obtained from institutional ethical committees of all participating institutions. The study findings will be presented in peer-reviewed medical journals.

Trial registration numbers
NCT04641195, CTRI/2021/04/032593, HMSC (GOI)-2021-0060.

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Agosto 2022

Long-Term Evolocumab in Patients with Established Atherosclerotic Cardiovascular Disease

Circulation, Ahead of Print. Background: In FOURIER, the PCSK9 inhibitor evolocumab reduced LDL-C and risk of cardiovascular events and was safe and well-tolerated over 2.2 years median follow-up. However, large-scale, long-term data are lacking.Methods: The parent FOURIER trial randomized 27,564 patients with ASCVD and LDL-C ≥70mg/dl on statin to evolocumab versus placebo. Patients completing FOURIER at participating sites were eligible to receive evolocumab in two open-label extension studies (FOURIER-OLE) in the United States and Europe; primary analyses were pooled across studies. The primary endpoint was the incidence of adverse events. Lipid values and major adverse cardiovascular events were prospectively collected.Results: 6,635 patients were enrolled in FOURIER-OLE (3355 randomized to evolocumab and 3280 to placebo in parent study). Median follow-up in FOURIER-OLE was 5.0 years; maximum exposure to evolocumab in parent plus FOURIER-OLE was 8.4 years. At 12 weeks in FOURIER-OLE, median LDL-C was 30 mg/dl and 63.2% achieved LDL-C 8 years that did not exceed those observed in the original placebo arm during the parent study and led to further reductions in cardiovascular events compared with delayed treatment initiation.

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Agosto 2022

Anticoagulation and Antiplatelet Therapy for Prevention of Venous and Arterial Thrombotic Events in Critically Ill Patients with COVID-19: COVID-PACT

Circulation, Ahead of Print. Background:The efficacy and safety of prophylactic full-dose anticoagulation and antiplatelet therapy in critically-ill COVID-19 patients remains uncertain.Methods:COVID-PACT was a multicenter, 2×2 factorial, open-label, randomized-controlled trial with blinded endpoint adjudication in ICU-level patients with COVID-19. Patients were randomized to a strategy of full-dose anticoagulation or standard-dose prophylactic anticoagulation. Absent an indication for antiplatelet therapy, patients were additionally randomized to either clopidogrel or no antiplatelet therapy. The primary efficacy outcome was the hierarchical composite of death due to venous or arterial thrombosis, pulmonary embolism, clinically-evident deep venous thrombosis (DVT), type 1 myocardial infarction, ischemic stroke, systemic embolic event or acute limb ischemia, or clinically-silent DVT, through hospital discharge or 28 days. The primary efficacy analyses included an unmatched win-ratio and time-to-first event analysis while patients were on-treatment. The primary safety outcome was fatal or life-threatening bleeding. The secondary safety outcome was GUSTO moderate/severe bleeding. Recruitment was stopped early in 03/2022 (∼50% planned recruitment) due to waning ICU-level COVID-19 rates.Results:At 34 centers in the United States, 390 patients were randomized between anticoagulation strategies and 292 between antiplatelet strategies (382 and 290 in the on-treatment analyses). At randomization, 99% of patients required advanced respiratory therapy, including 15% requiring invasive mechanical ventilation; 40% required invasive ventilation during hospitalization. Comparing anticoagulation strategies, a greater proportion of wins occurred with full-dose anticoagulation (12.3%) versus standard-dose prophylactic anticoagulation (6.4%; win ratio 1.95, 95%CI 1.08-3.55, p=0.028). Results were consistent in time-to-event analysis for the primary efficacy endpoint (full-dose versus standard-dose incidence 19/191 [9.9%] vs 29/191 [15.2%]; HR 0.56, 95%CI 0.32-0.99, p=0.046). The primary safety endpoint occurred in 4 (2.1%) on full-dose and in 1 (0.5%) on standard-dose (p=0.19); the secondary safety endpoint occurred in 15 (7.9%) versus 1 (0.5%; p=0.002). There was no difference in all-cause mortality (HR 0.91, 95%CI 0.56-1.48; p=0.70). There were no differences in the primary efficacy or safety endpoints with clopidogrel versus no antiplatelet therapy.Conclusions: In critically-ill patients with COVID-19, full-dose anticoagulation, but not clopidogrel, reduced thrombotic complications with an increase in bleeding, driven primarily by transfusions in hemodynamically stable patients, and no apparent excess in mortality.

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Agosto 2022

Using community influencer groups to address COVID-19 misinformation and vaccine hesitancy in Uganda: a protocol for a prospective quasi-experimental study

Introduction
Coronovirus disease 2019 (COVID-19) misinformation has been reported globally and locally. This has the potential to influence public risk perception and reduce the acceptance of the COVID-19 vaccine. This study aims to determine the prevalence of COVID-19 misinformation and vaccine hesitancy in Buikwe district. The study will also pilot a social mobilisation intervention using community influencers and determine its effect on COVID-19 misinformation and vaccine hesitancy.

Methods and analysis
The study will be conducted using a quasi-experimental study design, in which two villages will be assigned to the intervention arm and two villages assigned controls. A mixed-methods technique employing both quantitative and qualitative methods will be employed. Data will be collected from healthy men and women aged 18 years and older who reside in the selected villages. The study will be implemented in three phases. First, a baseline study of 12 in-depth interviews with key informants and 6 focus group discussions and a household survey among 632 participants will be done. Second, an intervention employing dialogue-based social mobilisation approach using 10-man community groups per village will be developed and implemented. These will be trained and facilitated to educate and sensitise their communities about COVID-19. Third, an end-line household survey done after 6-months of intervention implementation in the four villages to assess the effect of the intervention on COVID-19 misinformation and vaccine hesitancy. Post-intervention qualitative evaluation will be done after the endline quantitative assessment. Preliminary analysis of the endline quantitative analysis will inform any revisions of the discussion guides. Qualitative data collected will be analysed using thematic content analysis while quantitative data will be analysed using 2 tests or logistic regression, by intention-to-treat analysis.

Ethics and dissemination
The study was reviewed for ethics and approved by the Makerere University School of Health Sciences Research Ethics Committee, reference number MakSHSREC-2020-45 and the Uganda National Council of Science and Technology, reference number HS1140ES. Study finding shall be presented to the district and national COVID-19 task force and at scientific gatherings and published in a peer-reviewed journal.

Trial registration number
PACTR202102846261362.

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Agosto 2022

Impact of COVID-19 pandemic on screening and diagnosis of patients with prostate cancer: a systematic review protocol

Introduction
With the exponential progress of patients with COVID-19, unexpected restrictions were directed to limit SARS-CoV-2 dissemination and imposed health-system an entire reformation to diminish transmission risk. These changes likely have caused the full range of cancer screenings and diagnosis gaps. Regardless of the recommendations, prostate cancer (PCa) screening/diagnosis programmes were momentarily postponed. Prostate-specific antigen (PSA) testing has been an inexpensive, low-invasive and relatively precise means of detection for PCa screening that would improve the uncovering of any type of PCa. Unfortunately, a decrease in PSA screening would significantly decrease PCa detection, with non-negligible growth in PCa-specific death. This review is designed to improve our understanding of the impact of the COVID-19 pandemic on the screening and diagnosis of patients with PCa.

Methods and analysis
This systematic review will be reported in accordant with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. A comprehensive search has been executed through five main electronic databases: PubMed/MEDLINE, Web of Science, Scopus, Embase and ProQuest until 1 March 2022. Besides, grey literature, preprint studies and references of included studies will be searched. The main keywords have been used to perform the search strategy: COVID-19, prostatic neoplasms. All the relevant studies that met the inclusion criteria will be screened, selected and then extracted data by two independent authors. The quality assessment of the included studies will be performed by the Newcastle-Ottawa Scale. In case of any disagreement between the two authors in selecting, extracting data and assessing the quality of included studies, it will be resolved via consensus and checked by the third author.

Ethics and dissemination
As this study will be a systematic review without human participants’ involvement, there will be no requirement for ethics approval. Findings will be presented at conferences and in a peer-reviewed journal.

PROSPERO registration number
CRD42021291656.

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Agosto 2022

Moral distress among clinicians working in US safety net practices during the COVID-19 pandemic: a mixed methods study

Objective
To explore the causes and levels of moral distress experienced by clinicians caring for the low-income patients of safety net practices in the USA during the COVID-19 pandemic.

Design
Cross-sectional survey in late 2020, employing quantitative and qualitative analyses.

Setting
Safety net practices in 20 US states.

Participants
2073 survey respondents (45.8% response rate) in primary care, dental and behavioural health disciplines working in safety net practices and participating in state and national education loan repayment programmes.

Measures
Ordinally scaled degree of moral distress experienced during the pandemic, and open-ended response descriptions of issues that caused most moral distress.

Results
Weighted to reflect all surveyed clinicians, 28.4% reported no moral distress related to work during the pandemic, 44.8% reported ‘mild’ or ‘uncomfortable’ levels and 26.8% characterised their moral distress as ‘distressing’, ‘intense’ or ‘worst possible’. The most frequently described types of morally distressing issues encountered were patients not being able to receive the best or needed care, and patients and staff risking infection in the office. Abuse of clinic staff, suffering of patients, suffering of staff and inequities for patients were also morally distressing, as were politics, inequities and injustices within the community. Clinicians who reported instances of inequities for patients and communities and the abuse of staff were more likely to report higher levels of moral distress.

Conclusions
During the pandemic’s first 9 months, moral distress was common among these clinicians working in US safety net practices. But for only one-quarter was this significantly distressing. As reported for hospital-based clinicians during the pandemic, this study’s clinicians in safety net practices were often morally distressed by being unable to provide optimal care to patients. New to the literature is clinicians’ moral distress from witnessing inequities and other injustices for their patients and communities.

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Agosto 2022

Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol

Introduction
Prophylactic human papillomavirus (HPV) vaccines have been shown to be highly effective in protecting women against cervical infections, high-grade abnormalities and cancer caused by the targeted HPV types. However, the evidence for their effectiveness in women living with HIV (WLWH) is less clear.

Methods
WLWH and HIV-negative women who likely did (birth cohorts 1996 and later) and WLWH and HIV(–) negative who likely did not (birth cohorts before 1996) receive HPV vaccination (n=3028; 757 participants for each of the four groups). Between groups, we will compare cervicovaginal, anal and oral prevalent and 6–12 month persistent HPV6/11/16/18 infections as measured using a modified AmpFire HPV genotyping assay that tests for 15 high-risk or intermediate-risk HPV genotypes, HPV6 and HPV11. We will also compare the HPV immune response in HPV-vaccinated WLWH to HPV-vaccinated HIV-negative women using an anti-HPV16 and anti-HPV18 ELISA. Vaccination status will be confirmed through national vaccination records.

Analysis
We will calculate point prevalence and prevalence of 6–12 month persisting infections by individual HPV-type specific infections and groups of infections for each anatomic site and for each group of women. Results will be stratified by age at vaccination, age at enrolment and the number of doses (3 vs 2) as well as other factors possibly associated with HPV prevalence. Differences in endpoints between groups, overall and between subgroups, will be tested for statistical significance (p

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Agosto 2022

Troponin and short-term mortality in hospitalised patients with COVID-19 infection: a retrospective study in an inner-city London hospital

Objective
To investigate the association between troponin positivity in patients hospitalised with COVID-19 and increased mortality in the short term.

Setting
Homerton University Hospital, an inner-city district general hospital in East London.

Design
A single-centre retrospective observational study.

Participants
All adults admitted with swab-proven RT-PCR COVID-19 to Homerton University Hospital from 4 February 2020 to 30 April 2020 (n=402).

Outcome measures
We analysed demographic and biochemical data collected from the patient record according to the primary outcome of death at 28 days during hospital admission.

Methods
Troponin positivity was defined above the upper limit of normal according to our local laboratory assay ( >15.5 ng/L for females, >34 ng/L for males). Univariate and multivariate logistical regression analyses were performed to evaluate the link between troponin positivity and death.

Results
Mean age was 65.3 years for men compared with 63.8 years for women. A 2 test showed survival of patients with COVID-19 was significantly higher in those with a negative troponin (p=3.23×10–10) compared with those with a positive troponin. In the multivariate logistical regression, lung disease, age, troponin positivity and continuous positive airway pressure were all significantly associated with death, with an area under the curve of 0.889, sensitivity of 0.886 and specificity of 0.629 for the model. Within this model, troponin positivity was independently associated with short-term mortality (OR 2.97, 95% CI 1.34 to 6.61, p=0.008).

Conclusions
We demonstrated an independent association between troponin positivity and increased short-term mortality in COVID-19 in a London district general hospital.

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Agosto 2022

COVID-19 postacute care major organ damage: a systematic review

Background
Major organ complications have been reported in patients hospitalised for COVID-19; most studies lacked controls.

Objective
Examine major organ damage postdischarge among adults hospitalised for COVID-19 versus non-COVID-19 controls.

Data sources
MEDLINE, Embase and Cochrane Library from 1 January 2020 to 19 May 2021.

Study eligibility criteria
English language studies of adults discharged from hospital for COVID-19; reporting major organ damage. Single review of abstracts; independent dual review of full text.

Study appraisal and synthesis methods
Study quality was assessed using the Joanna Briggs Institute Appraisal Checklist for Cohort Studies. Outcome data were not pooled due to heterogeneity in populations, study designs and outcome assessment methods; findings are narratively synthesised.

Results
Of 124 studies in a full evidence report, 9 included non-COVID controls and are described here. Four of the nine (three USA, one UK) used large administrative databases. Four of the remaining five studies enrolled

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Agosto 2022

Experienced stigma and applied coping strategies during the COVID-19 pandemic in Germany: a mixed-methods study

Objective
Health-related stigma is considered a social determinant of health equity and a hidden burden of disease. This study aimed to assess the level and dimensions of stigma and respective coping mechanisms in COVID-19 survivors.

Methods
A mixed-methods study with sequential explanatory design was conducted at the University Hospital of Ulm, Germany. Stigma was assessed using the Social Impact Scale (SIS) including adult COVID-19 survivors with mild-to-severe disease. Subsequently, 14 participants were sampled with regard to gender, age and severity of disease for in-depth interviews to understand how stigma was experienced and coping strategies were applied. The questionnaire was analysed using descriptive statistics, t-test and analysis of variance. Content analysis was used for qualitative data.

Results
From 61 participants, 58% were men and mean age was 51 years. The quantitative analysis of the SIS indicated an intermediate level of experienced stigma. Participants experienced stigma mainly as ‘social rejection’ (M=14.22, SD=4.91), followed by ‘social isolation’ (M=10.17, SD=4.16) and ‘internalised shame’ (M=8.39, SD=3.32). There was no significant difference in experienced stigma regarding gender, education, occupational status or residual symptoms. However, participants between 30 and 39 years of age experienced higher levels of stigma than other age groups (p=0.034). The qualitative analysis revealed how stigma seemed to arise from misconceptions creating irrational fear of infection, leading to stereotyping, vilification, discrimination and social exclusion of COVID-19 survivors, leaving them feeling vulnerable. Stigma cut through all social levels, from the individual level at the bottom to the institutional and societal level at the top. Social networks protected from experiencing stigma.

Conclusion
COVID-19-related stigma is a relevant burden in the ongoing pandemic. Providing accurate information and exposing misinformation on disease prevention and treatment seems key to end COVID-19-related stigma.

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Agosto 2022

Changes in life satisfaction, depression, general health and sleep quality of Spanish older women during COVID-19 lockdown and their relationship with lifestyle: an observational follow-up study

Objetives
To analyse the effects of COVID-19 lockdown on mental well-being variables of older women, and to determine the influence of lifestyle and age on such effects. The hypothesis of the study was that all parameters related to mental well-being would worsen in older women during the COVID-19 lockdown.

Design
Observational follow-up study. Pre lockdown measurements were taken before the lockdown. Post lockdown measurements were taken as soon as began the de-escalation.

Setting
Senior centres in the Region of Murcia (Spain).

Participants
The sample was composed of 40 older women volunteers, over 54 years of age (mean age=62.35±8.15 years).

Primary and secondary outcome measures
Pre lockdown and post lockdown evaluations were carried out face to face. The following questionnaires were completed: Satisfaction with Life Scale, The Center for Epidemiologic Studies Depression Scale, The Short Form 36 Health Survey, The Pittsburgh Sleep Quality Index, the Global Physical Activity Questionnaire and Prevention with Mediterranean Diet.

Results
Post lockdown, a worsening was found in the variables of life satisfaction (p=0.001); depression (p

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Agosto 2022

Cohort profile: the British Columbia COVID-19 Population Mixing Patterns Survey (BC-Mix)

Purpose
Several non-pharmaceutical interventions, such as physical distancing, handwashing, self-isolation, and school and business closures, were implemented in British Columbia (BC) following the first laboratory-confirmed case of COVID-19 on 26 January 2020, to minimise in-person contacts that could spread infections. The BC COVID-19 Population Mixing Patterns Survey (BC-Mix) was established as a surveillance system to measure behaviour and contact patterns in BC over time to inform the timing of the easing/re-imposition of control measures. In this paper, we describe the BC-Mix survey design and the demographic characteristics of respondents.

Participants
The ongoing repeated online survey was launched in September 2020. Participants are mainly recruited through social media platforms (including Instagram, Facebook, YouTube, WhatsApp). A follow-up survey is sent to participants 2–4 weeks after completing the baseline survey. Survey responses are weighted to BC’s population by age, sex, geography and ethnicity to obtain generalisable estimates. Additional indices such as the Material and Social Deprivation Index, residential instability, economic dependency, and others are generated using census and location data.

Findings to date
As of 26 July 2021, over 61 000 baseline survey responses were received of which 41 375 were eligible for analysis. Of the eligible participants, about 60% consented to follow-up and about 27% provided their personal health numbers for linkage with healthcare databases. Approximately 83.5% of respondents were female, 58.7% were 55 years or older, 87.5% identified as white and 45.9% had at least a university degree. After weighting, approximately 50% were female, 39% were 55 years or older, 65% identified as white and 50% had at least a university degree.

Future plans
Multiple papers describing contact patterns, physical distancing measures, regular handwashing and facemask wearing, modelling looking at impact of physical distancing measures and vaccine acceptance, hesitancy and uptake are either in progress or have been published.

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Agosto 2022

Folic acid and methotrexate use and their association with COVID-19 diagnosis and mortality: a case-control analysis from the UK Biobank

Objective
To determine if methotrexate or folic acid prescription was associated with differential risk for COVID-19 diagnosis or mortality.

Design
Case–control analysis.

Setting
The population-based UK Biobank (UKBB) cohort.

Participants
Data from 380 380 UKBB participants with general practice prescription data for 2019–2021. Updated medical information was retrieved on 13 December 2021.

Primary and secondary outcome measures
The outcomes of COVID-19 diagnosis and COVID-19-related mortality were analysed by multivariable logistic regression. Exposures evaluated were prescription of folic acid and/or methotrexate. Criteria for COVID-19 diagnosis were (1) a positive SARS-CoV-2 test or (2) ICD-10 code for confirmed COVID-19 (U07.1) or probable COVID-19 (U07.2) in hospital records, or death records. By these criteria, 26 003 individuals were identified with COVID-19 of whom 820 were known to have died from COVID-19. Logistic regression statistical models were adjusted for age sex, ethnicity, Townsend deprivation index, body mass index, smoking status, presence of rheumatoid arthritis, sickle cell disease, use of anticonvulsants, statins and iron supplements.

Results
Compared with people prescribed neither folic acid nor methotrexate, people prescribed folic acid supplementation had increased risk of diagnosis of COVID-19 (OR 1.51 (1.42–1.61)). The prescription of methotrexate with or without folic acid was not associated with COVID-19 diagnosis (p≥0.18). People prescribed folic acid supplementation had positive association with death after a diagnosis of COVID-19 (OR 2.64 (2.15–3.24)) in a fully adjusted model. The prescription of methotrexate in combination with folic acid was not associated with an increased risk for COVID-19-related death (1.07 (0.57–1.98)).

Conclusions
We report an association of increased risk for COVID-19 diagnosis and COVID-19-related death in people prescribed folic acid supplementation. Our results also suggest that methotrexate might attenuate these associations.

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Agosto 2022