Risultati per: Long COVID: principali risultati, meccanismi e raccomandazioni

Objectives
There are no established mortality risk equations specifically for unplanned emergency medical admissions which include patients with SARS-19 (COVID-19). We aim to develop and validate a computer-aided risk score (CARMc19) for predicting mortality risk by combining COVID-19 status, the first electronically recorded blood test results and the National Early Warning Score (NEWS2).

Design
Logistic regression model development and validation study.

Setting
Two acute hospitals (York Hospital—model development data; Scarborough Hospital—external validation data).

Participants
Adult (aged ≥16 years) medical admissions discharged over a 24-month period with electronic NEWS and blood test results recorded on admission. We used logistic regression modelling to predict the risk of in-hospital mortality using two models: (1) CARMc19_N: age+sex+NEWS2 including subcomponents+COVID19; (2) CARMc19_NB: CARMc19_N in conjunction with seven blood test results and acute kidney injury score. Model performance was evaluated according to discrimination (c-statistic), calibration (graphically) and clinical usefulness at NEWS2 thresholds of 4+, 5+, 6+.

Results
The risk of in-hospital mortality following emergency medical admission was similar in development and validation datasets (8.4% vs 8.2%). The c-statistics for predicting mortality for CARMc19_NB is better than CARMc19_N in the validation dataset (CARMc19_NB=0.88 (95% CI 0.86 to 0.90) vs CARMc19_N=0.86 (95% CI 0.83 to 0.88)). Both models had good calibration (CARMc19_NB=1.01 (95% CI 0.88 to 1.14) and CARMc19_N:0.95 (95% CI 0.83 to 1.06)). At all NEWS2 thresholds (4+, 5+, 6+) model, CARMc19_NB had better sensitivity and similar specificity.

Conclusions
We have developed a validated CARMc19 scores with good performance characteristics for predicting the risk of in-hospital mortality. Since the CARMc19 scores place no additional data collection burden on clinicians, it may now be carefully introduced and evaluated in hospitals with sufficient informatics infrastructure.

Annals of Internal Medicine, Volume 175, Issue 10, Page 1401-1410, October 2022.

Il 1 settembre l’Agenzia Ue del farmaco darà il via libera ai nuovi vaccini bivalenti efficaci anche contro Omicron. Attesa anche la circolare della Salute che introduce l’isolamento “light”.

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.

Objectives
The aim of this study was to examine the well-being experiences of consultants working in paediatric critical care (PCC) settings in the UK during the COVID-19 pandemic.

Design
Qualitative design using individual interviews and thematic analysis.

Setting
PCC.

Participants
Eleven medical consultants working in PCC in a range of PCC settings/transport teams in the UK from nine units participated. Participants ranged in years of experience as a consultant from four to 23 years.

Methods
A set of open semistructured questions were used to elicit information about participants’ experiences of workplace well-being. Interviews were audiorecorded and transcribed.

Findings
Thematic analysis identified six themes and data saturation was reached. These were as follows: (1) positive and negative impact of working during COVID-19, (2) job satisfaction and public scrutiny in the unique environment of PCC, (3) supporting the workforce through modified shift work, (4) perceptions of support and recognition offered from the hospital management, (5) successful coping strategies are personal and adaptive, and (6) importance of civility and good teamwork

Conclusion
Findings show that consultants’ well-being is challenged in a number of ways and that the solutions to the problem of burn-out are multifaceted. Action is required from individual consultants, clinical teams, hospital management and national regulatory bodies. Our work corroborates the recent General Medical Council report highlighting doctors’ core needs for well-being: autonomy, belonging, competence. Burn-out is a long-term problem, requiring sustainable solutions. Future research needs to develop and evaluate the effectiveness of evidence-based interventions to improve consultants’ well-being. Trials of effectiveness need to present evidence that will persuade hospital management to invest in their consultants’ well-being within the economic context of reduced budgets and limited PCC workforce.

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.

Objectives
The COVID-19 outbreak beginning in late 2019 has resulted in negative emotions among the public. However, many healthcare workers risked their lives by voluntarily travelling to the worst-hit area, Hubei Province, to support antipandemic work. This study explored the mental health changes in these healthcare workers and tried to discover the influencing factors.

Design
A longitudinal online survey was begun on 8 February 2020, using the snowball sampling method, and this first phase ended on 22 February 2020 (T1). The follow-up survey was conducted from 8 February to 22 February 2021 (T2).

Setting
Healthcare workers from outside of the Hubei area who went to the province to provide medical assistance.

Participants
963 healthcare workers who completed both surveys.

Measures
Self-Rating Scale of Sleep (SRSS), Generalised Anxiety Scale (GAD-7) and 9-item Patient Health Questionnaire (PHQ-9).

Results
There were no significant differences in the SRSS scores or in the GAD-7 scores between T1 and T2 (t=0.994, 0.288; p >0.05). However, the PHQ-9 score at T2 was significantly higher than the score at T1 (t=–10.812, p

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.

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.

About 5% of people who lost smell or taste had persistent dysfunction at 6 months.

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.

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.

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

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.

Sickle cell trait was associated with acute kidney injury and higher COVID-19 mortality.

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.