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1.
Sci Rep ; 13(1): 8813, 2023 05 31.
Article in English | MEDLINE | ID: covidwho-20240029

ABSTRACT

Mother-to-child transmission of SARS-CoV-2 has been reported since the onset of the COVID-19 pandemic. We conducted a study to summarize evidence on the risk of mother-to-child transmission in the first 30 days after birth in high-income countries and to evaluate the association between preventive measures and the risk of infection for the neonate. A systematic review and meta-analysis were undertaken following PRISMA guidelines. The National Library of Medicine, Web of Science, and Excerpta Medica databases were screened on February 26, 2022. All prospective observational studies addressing the frequency of infection in infants born to mothers SARS-CoV-2 positive were included. Twenty-six studies were included, reporting data of 2653 mothers with SARS-CoV-2 and 2677 neonates. The proportion meta-analysis pointed out an overall estimate of SARS-CoV-2 infection among infants of 2.3% (95% CI: 1.4-3.2%). Data from studies with (1.4%, 95% CI: 0.8-2) and without (1.3%, 95% CI: 0.0-2.7%) rooming-in provided similar risk of infection. Adopting at least two prevention measures during rooming-in resulted in a rate of mother-to-child infection of 1.0% (95%CI: 0.3-1.7%). The results of this study show a low rate of perinatal infection, support the rooming-in and confirm the effectiveness of preventive measures in reducing the risk of mother-to-child viral transmission.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Pregnancy , Infant , Infant, Newborn , Humans , Female , COVID-19/epidemiology , SARS-CoV-2 , Infectious Disease Transmission, Vertical/prevention & control , Pandemics , Developed Countries , Pregnancy Complications, Infectious/epidemiology , Observational Studies as Topic
2.
JMIR Public Health Surveill ; 9: e40650, 2023 05 30.
Article in English | MEDLINE | ID: covidwho-20244857

ABSTRACT

BACKGROUND: The COVID-19 pandemic has the potential to accelerate another pandemic: physical inactivity. Daily steps, a proxy of physical activity, are closely related to health. Recent studies indicate that over 7000 steps per day is the critical physical activity standard for minimizing the risk of all-cause mortality. Moreover, the risk of cardiovascular events has been found to increase by 8% for every 2000 steps per day decrement. OBJECTIVE: To quantify the impact of the COVID-19 pandemic on daily steps in the general adult population. METHODS: This study follows the guidelines of the MOOSE (Meta-analysis Of Observational Studies in Epidemiology) checklist. PubMed, EMBASE, and Web of Science were searched from inception to February 11, 2023. Eligible studies were observational studies reporting monitor-assessed daily steps before and during the confinement period of the COVID-19 pandemic in the general adult population. Two reviewers performed study selection and data extraction independently. The modified Newcastle-Ottawa Scale was used to assess the study quality. A random effects meta-analysis was conducted. The primary outcome of interest was the number of daily steps before (ie, January 2019 to February 2020) and during (ie, after January 2020) the confinement period of COVID-19. Publication bias was assessed with a funnel plot and further evaluated with the Egger test. Sensitivity analyses were performed by excluding studies with low methodological quality or small sample sizes to test the robustness of the findings. Other outcomes included subgroup analyses by geographic location and gender. RESULTS: A total of 20 studies (19,253 participants) were included. The proportion of studies with subjects with optimal daily steps (ie, ≥7000 steps/day) declined from 70% before the pandemic to 25% during the confinement period. The change in daily steps between the 2 periods ranged from -5771 to -683 across studies, and the pooled mean difference was -2012 (95% CI -2805 to -1218). The asymmetry in the funnel plot and Egger test results did not indicate any significant publication bias. Results remained stable in sensitivity analyses, suggesting that the observed differences were robust. Subgroup analyses revealed that the decline in daily steps clearly varied by region worldwide but that there was no apparent difference between men and women. CONCLUSIONS: Our findings indicate that daily steps declined substantially during the confinement period of the COVID-19 pandemic. The pandemic further exacerbated the ever-increasing prevalence of low levels of physical activity, emphasizing the necessity of adopting appropriate measures to reverse this trend. Further research is required to monitor the consequence of long-term physical inactivity. TRIAL REGISTRATION: PROSPERO CRD42021291684; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=291684.


Subject(s)
COVID-19 , Humans , Female , COVID-19/epidemiology , Pandemics , Exercise , Prevalence , Observational Studies as Topic
3.
Medicina (Kaunas) ; 59(5)2023 May 12.
Article in English | MEDLINE | ID: covidwho-20242764

ABSTRACT

Background: Colchicine has been proposed as a cytokine storm-blocking agent for COVID-19 due to its efficacy as an anti-inflammatory drug. The findings of the studies were contentious on the role of colchicine in preventing deterioration in COVID-19 patients. We aimed to evaluate the efficacy of colchicine in COVID-19-hospitalized patients. Design: A retrospective observational cohort study was carried out at three major isolation hospitals in Alexandria (Egypt), covering multiple centers. In addition, a systematic review was conducted by searching six different databases for published studies on the utilization of colchicine in patients with COVID-19 until March 2023. The primary outcome measure was to determine whether colchicine could decrease the number of days that the patient needed supplemental oxygen. The secondary outcomes were to evaluate whether colchicine could reduce the number of hospitalization days and mortality rate in these patients. Results: Out of 515 hospitalized COVID-19 patients, 411 were included in the survival analysis. After adjusting for the patients' characteristics, patients not receiving colchicine had a shorter length of stay (median: 7.0 vs. 6.0 days) and fewer days of supplemental oxygen treatment (median: 6.0 vs. 5.0 days), p < 0.05, but there was no significant difference in mortality rate. In a subgroup analysis based on oxygen equipment at admission, patients admitted on nasal cannula/face masks who did not receive colchicine had a shorter duration on oxygen supply than those who did [Hazard Ratio (HR) = 0.76 (CI 0.59-0.97)]. Using cox-regression analysis, clarithromycin compared to azithromycin in colchicine-treated patients was associated with a higher risk of longer duration on oxygen supply [HR = 1.77 (CI 1.04-2.99)]. Furthermore, we summarized 36 published colchicine studies, including 114,878 COVID-19 patients. Conclusions: COVID-19-hospitalized patients who were given colchicine had poorer outcomes in terms of the duration of supplemental oxygen use and the length of their hospital stay. Therefore, based on these findings, the use of colchicine is not recommended for COVID-19-hospitalized adults.


Subject(s)
COVID-19 , Adult , Humans , Colchicine/therapeutic use , Retrospective Studies , SARS-CoV-2 , Oxygen Saturation , Oxygen/therapeutic use , Observational Studies as Topic
4.
BMC Public Health ; 23(1): 1018, 2023 05 30.
Article in English | MEDLINE | ID: covidwho-20240623

ABSTRACT

BACKGROUND: Coronavirus disease (COVID-19) is a contagious disease caused by the severe acute new coronavirus called SARS-CoV-2. Devastating social, economic, and health service utilisation-related activities. Increased burden and lifestyle changes due to confinement. OBJECTIVE: This study aimed to investigate and determine the determinants of obesity during the coronavirus disease (COVID-19) pandemic from 2019 to 2023. METHODS: Observational studies published between December 2019 and January 2023 were thoroughly searched using a PRISMA flow chart. PubMed, Google Scholar, Web of Science, HINARI, Scopus, and Embase databases were used. Two reviewers independently identified and critically evaluated the relevant literature. Studies that reported weight gain or involved BMI measurements of 25 kg/m2 or BMI z-scores for children during the COVID-19 lockdown were selected for inclusion. The Newcastle-Ottawa Scale (NOS) was used as a quality assessment instrument in nonrandomised studies to evaluate study quality. All the contributing determinants of weight increase were identified, gathered, and synthesised. RESULTS: This systematic review identified 40 studies with a total population of 5,681,813 from 22 countries, of which 74.6% were male. The sample size from included articles ranged from 37 to 5,315,435. Of the 40 selected articles, 24 focused on adults, five on adolescents, three on children, and eight on children and adolescents. Physical inactivity, sedentary behaviour, bad eating habits, behavioural lifestyle, excessive stress, depression, anxiety, behavioural risk factors, sex, and ethnic minorities were associated with obesity during the COVID-19 pandemic lockdown. CONCLUSION: During the COVID-19 pandemic, physical inactivity, sedentary lifestyle, and poor eating patterns were the most common risk factors for obesity. Additionally, unhealthy eating habits, excessive behavioural stress, depression, anxiety, low mood, age, gender, and ethnic minorities have been identified as risk factors for obesity during the COVID-19 pandemic.


Subject(s)
COVID-19 , Pandemics , Adult , Adolescent , Child , Male , Humans , Female , COVID-19/epidemiology , SARS-CoV-2 , Communicable Disease Control , Obesity/epidemiology , Weight Gain , Observational Studies as Topic
5.
Diabetologia ; 66(8): 1395-1412, 2023 08.
Article in English | MEDLINE | ID: covidwho-2326108

ABSTRACT

AIMS/HYPOTHESIS: To provide a systematic overview of the current body of evidence on high-risk phenotypes of diabetes associated with COVID-19 severity and death. METHODS: This is the first update of our recently published living systematic review and meta-analysis. Observational studies investigating phenotypes in individuals with diabetes and confirmed SARS-CoV-2 infection with regard to COVID-19-related death and severity were included. The literature search was conducted from inception up to 14 February 2022 in PubMed, Epistemonikos, Web of Science and the COVID-19 Research Database and updated using PubMed alert to 1 December 2022. A random-effects meta-analysis was used to calculate summary relative risks (SRRs) with 95% CIs. The risk of bias was evaluated using the Quality in Prognosis Studies (QUIPS) tool and the certainty of evidence using the GRADE approach. RESULTS: A total of 169 articles (147 new studies) based on approximately 900,000 individuals were included. We conducted 177 meta-analyses (83 on COVID-19-related death and 94 on COVID-19 severity). Certainty of evidence was strengthened for associations between male sex, older age, blood glucose level at admission, chronic insulin use, chronic metformin use (inversely) and pre-existing comorbidities (CVD, chronic kidney disease, chronic obstructive pulmonary disease) and COVID-19-related death. New evidence with moderate to high certainty emerged for the association between obesity (SRR [95% CI] 1.18 [1.04, 1.34], n=21 studies), HbA1c (53-75 mmol/mol [7-9%]: 1.18 [1.06, 1.32], n=8), chronic glucagon-like peptide-1 receptor agonist use (0.83 [0.71, 0.97], n=9), pre-existing heart failure (1.33 [1.21, 1.47], n=14), pre-existing liver disease (1.40 [1.17, 1.67], n=6), the Charlson index (per 1 unit increase: 1.33 [1.13, 1.57], n=2), high levels of C-reactive protein (per 5 mg/l increase: 1.07 [1.02, 1.12], n=10), aspartate aminotransferase level (per 5 U/l increase: 1.28 [1.06, 1.54], n=5), eGFR (per 10 ml/min per 1.73 m2 increase: 0.80 [0.71, 0.90], n=6), lactate dehydrogenase level (per 10 U/l increase: 1.03 [1.01, 1.04], n=7) and lymphocyte count (per 1×109/l increase: 0.59 [0.40, 0.86], n=6) and COVID-19-related death. Similar associations were observed between risk phenotypes of diabetes and severity of COVID-19, with some new evidence on existing COVID-19  vaccination status (0.32 [0.26, 0.38], n=3), pre-existing hypertension (1.23 [1.14, 1.33], n=49), neuropathy and cancer, and high IL-6 levels. A limitation of this study is that the included studies are observational in nature and residual or unmeasured confounding cannot be ruled out. CONCLUSIONS/INTERPRETATION: Individuals with a more severe course of diabetes and pre-existing comorbidities had a poorer prognosis of COVID-19 than individuals with a milder course of the disease. REGISTRATION: PROSPERO registration no. CRD42020193692. PREVIOUS VERSION: This is a living systematic review and meta-analysis. The previous version can be found at https://link.springer.com/article/10.1007/s00125-021-05458-8 FUNDING: The German Diabetes Center (DDZ) is funded by the German Federal Ministry of Health and the Ministry of Culture and Science of the State North Rhine-Westphalia. This study was supported in part by a grant from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD).


Subject(s)
COVID-19 , Diabetes Mellitus , Male , Humans , SARS-CoV-2 , Prognosis , Phenotype , Observational Studies as Topic
6.
BMC Psychiatry ; 23(1): 328, 2023 05 10.
Article in English | MEDLINE | ID: covidwho-2323011

ABSTRACT

BACKGROUND: Social prescribing is a mechanism of connecting patients with non-medical forms of support within the community and has been shown to improve mental health and wellbeing in adult populations. In the last few years, it has been used in child and youth settings with promising results. Currently, pathways are being developed for social prescribing in Child and Adolescent Mental Health Services (CAMHS) to support children and young people on treatment waiting lists. The Wellbeing While Waiting study will evaluate whether social prescribing benefits the mental health and wellbeing of children and young people. METHODS: This study utilises an observational, hybrid type II implementation-effectiveness design. Up to ten CAMHS who are developing social prescribing pathways as part of a programme run across England with support from the Social Prescribing Youth Network will participate. Outcomes for children and young people receiving social prescribing whilst on CAMHS waiting lists will be compared to a control group recruited prior to the pathway roll-out. Questionnaire data will be collected at baseline, 3 months and 6 months. Primary outcomes for children and young people are mental health symptoms (including anxiety, depression, stress, emotional and behavioural difficulties). Secondary outcomes include: loneliness, resilience, happiness, whether life is worthwhile, life satisfaction, and service use. An implementation strand using questionnaires and interviews will explore the acceptability, feasibility, and suitability of the pathway, potential mechanisms of action and their moderating effects on the outcomes of interest, as well as the perceived impact of social prescribing. Questionnaire data will be analysed mainly using difference-in-differences or controlled interrupted time series analysis. Interview data will be analysed using reflexive thematic analysis. DISCUSSION: The Wellbeing While Waiting study will provide the first rigorous evidence of the impact of social prescribing for children and young people on waiting lists for mental health treatment. Findings will help inform the prioritisation, commissioning, and running of social prescribing in other CAMHS. To maximise impact, findings will be available on the study website ( https://sbbresearch.org ) and disseminated via national and international networks. TRIAL REGISTRATION: N/A.


Subject(s)
Mental Health Services , Mental Health , Adult , Child , Adolescent , Humans , England , Psychotherapy , Anxiety , Observational Studies as Topic
7.
Thorax ; 77(6): 606-615, 2022 06.
Article in English | MEDLINE | ID: covidwho-2316148

ABSTRACT

PURPOSE: To prospectively validate two risk scores to predict mortality (4C Mortality) and in-hospital deterioration (4C Deterioration) among adults hospitalised with COVID-19. METHODS: Prospective observational cohort study of adults (age ≥18 years) with confirmed or highly suspected COVID-19 recruited into the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) WHO Clinical Characterisation Protocol UK (CCP-UK) study in 306 hospitals across England, Scotland and Wales. Patients were recruited between 27 August 2020 and 17 February 2021, with at least 4 weeks follow-up before final data extraction. The main outcome measures were discrimination and calibration of models for in-hospital deterioration (defined as any requirement of ventilatory support or critical care, or death) and mortality, incorporating predefined subgroups. RESULTS: 76 588 participants were included, of whom 27 352 (37.4%) deteriorated and 12 581 (17.4%) died. Both the 4C Mortality (0.78 (0.77 to 0.78)) and 4C Deterioration scores (pooled C-statistic 0.76 (95% CI 0.75 to 0.77)) demonstrated consistent discrimination across all nine National Health Service regions, with similar performance metrics to the original validation cohorts. Calibration remained stable (4C Mortality: pooled slope 1.09, pooled calibration-in-the-large 0.12; 4C Deterioration: 1.00, -0.04), with no need for temporal recalibration during the second UK pandemic wave of hospital admissions. CONCLUSION: Both 4C risk stratification models demonstrate consistent performance to predict clinical deterioration and mortality in a large prospective second wave validation cohort of UK patients. Despite recent advances in the treatment and management of adults hospitalised with COVID-19, both scores can continue to inform clinical decision making. TRIAL REGISTRATION NUMBER: ISRCTN66726260.


Subject(s)
COVID-19 , Adolescent , Adult , COVID-19/therapy , Hospital Mortality , Humans , Observational Studies as Topic , Prognosis , SARS-CoV-2 , State Medicine , World Health Organization
8.
Trials ; 24(1): 328, 2023 May 13.
Article in English | MEDLINE | ID: covidwho-2318414

ABSTRACT

BACKGROUND: The clinical manifestation of COVID-19 is associated with infection and inflammation of the lungs, but there is evidence to suggest that COVID-19 may also affect the structure and function of the cardiovascular system. At present, it is not fully understood to what extent COVID-19 impacts cardiovascular function in the short- and long-term following infection. The aim of the present study is twofold: (i) to define the effect of COVID-19 on cardiovascular function (i.e. arterial stiffness, cardiac systolic and diastolic function) in otherwise healthy individuals and (ii) to evaluate the effect of a home-based physical activity intervention on cardiovascular function in people with a history of COVID-19. METHODS: This prospective, single-centre, observational study will recruit 120 COVID-19-vaccinated adult participants aged between 50 and 85 years, i.e. 80 with a history of COVID-19 and 40 healthy controls without a history of COVID-19. All participants will undergo baseline assessments including 12-lead electrocardiography, heart rate variability, arterial stiffness, rest and stress echocardiography with speckle tracking imaging, spirometry, maximal cardiopulmonary exercise testing, 7-day physical activity and sleep measures and quality of life questionnaires. Blood samples will be collected to assess the microRNA expression profiles, cardiac and inflammatory biomarkers, i.e. cardiac troponin T; N-terminal pro B-type natriuretic peptide; tumour necrosis factor alpha; interleukins 1, 6 and 10; C-reactive protein; D-dimer; and vascular endothelial growth factors. Following baseline assessments, COVID-19 participants will be randomised 1:1 into a 12-week home-based physical activity intervention aiming to increase their daily number of steps by 2000 from baseline. The primary outcome is change in left ventricular global longitudinal strain. Secondary outcomes are arterial stiffness, systolic and diastolic function of the heart, functional capacity, lung function, sleep measures, quality of life and well-being (depression, anxiety, stress and sleep efficiency). DISCUSSION: The study will provide insights into the cardiovascular implications of COVID-19 and their malleability with a home-based physical activity intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05492552. Registered on 7 April 2022.


Subject(s)
COVID-19 , Cardiovascular System , Middle Aged , Humans , Aged , Aged, 80 and over , SARS-CoV-2 , Quality of Life , Prospective Studies , Exercise , Lung , Treatment Outcome , Randomized Controlled Trials as Topic , Observational Studies as Topic
9.
Sci Rep ; 13(1): 7804, 2023 05 13.
Article in English | MEDLINE | ID: covidwho-2316406

ABSTRACT

The novel pandemic caused by SARS-CoV-2 has been associated with increased burden on healthcare system. Recognizing the variables that independently predict death in COVID-19 is of great importance. The study was carried out prospectively in a single ICU in northern Greece. It was based on the collection of data during clinical practice in 375 adult patients who were tested positive for SARS-CoV-2 between April 2020 and February 2022. All patients were intubated due to acute respiratory insufficiency and received Invasive Mechanical Ventilation. The primary outcome was ICU mortality. Secondary outcomes were 28-day mortality and independent predictors of mortality at 28 days and during ICU hospitalization. For continuous variables with normal distribution, t-test was used for means comparison between two groups and one-way ANOVA for multiple comparisons. When the distribution was not normal, comparisons were performed using the Mann-Whitney test. Comparisons between discrete variables were made using the x2 test, whereas the binary logistic regression was employed for the definition of factors affecting survival inside the ICU and after 28 days. Of the total number of patients intubated due to COVID-19 during the study period, 239 (63.7%) were male. Overall, the ICU survival was 49.6%, whereas the 28-day survival reached 46.9%. The survival rates inside the ICU for the four main viral variants were 54.9%, 50.3%, 39.7% and 50% for the Alpha, Beta, Delta and Omicron variants, respectively. Logistic regressions for outcome revealed that the following parameters were independently associated with ICU survival: wave, SOFA @day1, Remdesivir use, AKI, Sepsis, Enteral Insufficiency, Duration of ICU stay and WBC. Similarly, the parameters affecting the 28-days survival were: duration of stay in ICU, SOFA @day1, WBC, Wave, AKI and Enteral Insufficiency. In this observational cohort study of critically ill COVID-19 patients we report an association between mortality and the wave sequence, SOFA score on admission, the use of Remdesivir, presence of AKI, presence of gastrointestinal failure, sepsis and WBC levels. Strengths of this study are the large number of critically ill COVID-19 patients included, and the comparison of the adjusted mortality rates between pandemic waves within a two year-study period.


Subject(s)
Acute Kidney Injury , COVID-19 , Sepsis , Adult , Humans , Male , Female , SARS-CoV-2 , Critical Illness , Intensive Care Units , Retrospective Studies , Observational Studies as Topic
10.
Lipids Health Dis ; 22(1): 61, 2023 May 08.
Article in English | MEDLINE | ID: covidwho-2316013

ABSTRACT

BACKGROUND: Many commonly used drugs were evaluated as repurposed treatment options since the emergence of the COVID-19 pandemic. The benefit of lipid-lowering agents has been controversial in this regard. In this systematic review, we assessed the effect of these medications as adjunctive therapy in COVID-19 by the inclusion of randomized controlled trials (RCTs). METHODS: We searched four international databases including PubMed, the Web of Science, Scopus, and Embase for RCTs in April 2023. The primary outcome was mortality, while other efficacy indices were considered secondary outcomes. In order to estimate the pooled effect size of the outcomes, considering the odds ratio (OR) or standardized mean difference (SMD) and 95% confidence interval (CI), random-effect meta-analyses was conducted. RESULTS: Ten studies involving 2,167 COVID-19 patients using statins, omega-3 fatty acids, fenofibrate, PCSK9 inhibitors, and nicotinamide as intervention compared to control or placebo, were included. No significant difference was found in terms of mortality (OR 0.96, 95% CI 0.58 to 1.59, p-value = 0.86, I2 = 20.4%) or length of hospital stay (SMD -0.10, 95% CI -0.78 to 0.59, p-value = 0.78, I2 = 92.4%) by adding a statin to the standard of care. The trend was similar for fenofibrate and nicotinamide. PCSK9 inhibition, however, led to decreased mortality and an overall better prognosis. Omega-3 supplementation showed contradicting results in two trials, suggesting the need for further evaluation. CONCLUSION: Although some observational studies found improved outcomes in patients using lipid-lowering agents, our study found no benefit in adding statins, fenofibrate, or nicotinamide to COVID-19 treatment. On the other hand, PCSK9 inhibitors can be a good candidate for further assessment. Finally, there are major limitations in the use of omega-3 supplements in treating COVID-19 and more trials are warranted to evaluate this efficacy.


Subject(s)
COVID-19 , Fatty Acids, Omega-3 , Fenofibrate , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , PCSK9 Inhibitors , Randomized Controlled Trials as Topic , Hypolipidemic Agents/therapeutic use , Fatty Acids, Omega-3/therapeutic use , Proprotein Convertase 9 , Observational Studies as Topic
11.
JAMA ; 328(24): 2446-2447, 2022 12 27.
Article in English | MEDLINE | ID: covidwho-2315319

ABSTRACT

This Guide to Statistics and Methods describes the use of target trial emulation to design an observational study so it preserves the advantages of a randomized clinical trial, points out the limitations of the method, and provides an example of its use.


Subject(s)
Causality , Observational Studies as Topic , Research Design , Comparative Effectiveness Research
12.
BMJ Open ; 13(5): e072493, 2023 05 10.
Article in English | MEDLINE | ID: covidwho-2313206

ABSTRACT

INTRODUCTION: Comprehensive studies mapping domain-specific trajectories of recovery after stroke and biomarkers reflecting these processes are scarce. We, therefore, initiated an exploratory prospective observational study of stroke cases with repeated evaluation, the FIND Stroke Recovery Study. We aim to capture trajectories of recovery from different impairments, including cognition, in combination with broad profiling of blood and imaging biomarkers of the recovery. METHODS AND ANALYSIS: We recruit individuals with first-ever stroke at the stroke unit at the Sahlgrenska University Hospital, Sweden, to FIND. The inclusion started early 2018 and we aim to enrol minimum 500 patients. Neurological and cognitive impairments across multiple domains are assessed using validated clinical assessment methods, advanced neuroimaging is performed and blood samples for biomarker measuring (protein, RNA and DNA) at inclusion and follow-up visits at 3 months, 6 months, 1 year, 2 years and 5 years poststroke. At baseline and at each follow-up visit, we also register clinical variables known to influence outcomes such as prestroke functioning, stroke severity, acute interventions, rehabilitation, other treatments, socioeconomic status, infections (including COVID-19) and other comorbidities. Recurrent stroke and other major vascular events are identified continuously in national registers. ETHICS AND DISSEMINATION: FIND composes a unique stroke cohort with detailed phenotyping, repetitive assessments of outcomes across multiple neurological and cognitive domains and patient-reported outcomes as well as blood and imaging biomarker profiling. Ethical approval for the FIND study has been obtained from the Regional Ethics Review Board in Gothenburg and the Swedish Ethics Review Board. The results of this exploratory study will provide novel data on the time course of recovery and biomarkers after stroke. The description of this protocol will inform the stroke research community of our ongoing study and facilitate comparisons with other data sets. TRIAL REGISTRATION NUMBER: The protocol is registered at http://www. CLINICALTRIALS: gov, Study ID: NCT05708807.


Subject(s)
COVID-19 , Stroke , Humans , Biomarkers , Cohort Studies , Longitudinal Studies , Observational Studies as Topic , Stroke/therapy
13.
Adv Ther ; 40(6): 2693-2709, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2314274

ABSTRACT

Since their approval by the Food and Drug Administration (FDA) in 1989, proton pump inhibitors (PPIs) have become one of the most highly utilized drugs in the United States, assuming a position as one of the top 10 most prescribed medications in the country. The purpose of PPIs is to limit the amount of gastric acid secreted by the parietal cells via irreversible inhibition of the H+/K+-ATPase pump, therefore maintaining an elevated gastric acid pH of greater than 4 for 15-21 h. Even though PPIs have many clinical uses, they are not without their adverse effects, mimicking achlorhydria. Besides electrolyte abnormalities and vitamin deficiencies, long-term use of PPIs has been linked to acute interstitial nephritis, bone fractures, poor COVID-19 infection outcomes, pneumonia, and possibly an increase in all-cause mortality. The causality between PPI use and increased mortality and disease risk can be questioned since most studies are observational. Confounding variables can greatly affect an observational study and explain the wide-ranging associations with the use of PPIs. Patients on PPIs are generally older, obese, sicker with a higher number of baseline morbidities, and on more medications than the compared PPI non-users. These findings suggest that PPI users are at a higher risk of mortality and complications based on pre-existing conditions. This narrative review aims to update readers on the concerning effects that proton pump inhibitor use can have on patients and give providers a resource to create informed decisions on appropriate PPI use.


Subject(s)
COVID-19 , Fractures, Bone , Humans , Proton Pump Inhibitors/adverse effects , Fractures, Bone/drug therapy , Kidney , Observational Studies as Topic
14.
JMIR Public Health Surveill ; 8(12): e41606, 2022 12 14.
Article in English | MEDLINE | ID: covidwho-2311654

ABSTRACT

BACKGROUND: Previous studies have reported a potential negative correlation between physical activity (PA) and mobile phone addiction (MPA) among adolescents and young adults. To date, the strength of this correlation has not been well characterized. OBJECTIVE: This review and meta-analysis aimed to synthesize available empirical studies to examine the correlations between PA and MPA among adolescents and young adults. We also explored several potential moderators, including time of data collection, country or region, and type of population, associated with the relationship between PA and MPA. METHODS: Four electronic databases (PubMed, Scopus, PsycINFO, and Web of Science) were searched from database inception to March 2022 to identify relevant studies. The pooled Pearson correlation coefficients and their corresponding 95% CIs for the relationship between PA and MPA were calculated using the inverse variance method. The methodological quality of the included cross-sectional studies was determined based on the Joanna Briggs Institute appraisal checklist. The study conformed to the PRISMA (Preferred Reporting Items for Systematic Review and Meta-analyses) guidelines. RESULTS: In total, 892 relevant articles were identified, of which 22 were selected based on the inclusion and exclusion criteria. The final meta-analysis included 17 of the 22 studies. Results of random effects modeling revealed a moderate correlation between PA and MPA among adolescents and young adults (summary r=-0.243, P<.001). Sensitivity and publication bias analyses further demonstrated the robustness of our results. All the included studies were scored as high quality with a low risk of bias. Subgroup analysis further indicated that none of the hypothesized moderators (time of data collection, country or region, and type of population) significantly affected the relationship between PA and MPA, as confirmed by the mixed effects analysis. In addition, in the data collection subgroups, medium effect sizes were obtained for data collected before COVID-19 (r=-0.333, P<.001) and data collected during COVID-19 (r=-0.207, P<.001). In subgroup analyses for country or region, the correlation coefficient for China and other developing regions showed a similarly moderate effect size (r=-0.201, P<.001 and r= -0.217, P<.001, respectively). However, the effect sizes for developed regions were not significant (r=-0.446, P=.39). In a subgroup analysis based on the type of population, we found that the effect size for young adults was moderate (r=-0.250, P<.001). However, that of adolescents was not significant (r=-0.129, P=.24). CONCLUSIONS: Our results demonstrate a moderately negative relationship between PA and MPA among young adults. The strength of this relationship was not influenced by the time of data collection, country or region, or type of population.


Subject(s)
COVID-19 , Adolescent , Humans , Young Adult , Cross-Sectional Studies , Exercise , Health Status , Technology Addiction , Observational Studies as Topic
15.
BMJ Open ; 13(4): e070670, 2023 04 24.
Article in English | MEDLINE | ID: covidwho-2297328

ABSTRACT

INTRODUCTION: Adopting a social determinants of health perspective, this project aims to study how disproportionate COVID-19 mortality among immigrants in Sweden is associated with social factors operating through differential exposure to the virus (eg, by being more likely to work in high-exposure occupations) and differential effects of infection arising from socially patterned, pre-existing health conditions, differential healthcare seeking and inequitable healthcare provision. METHODS AND ANALYSIS: This observational study will use health (eg, hospitalisations, deaths) and sociodemographic information (eg, occupation, income, social benefits) from Swedish national registers linked using unique identity numbers. The study population includes all adults registered in Sweden in the year before the start of the pandemic (2019), as well as individuals who immigrated to Sweden or turned 18 years of age after the start of the pandemic (2020). Our analyses will primarily cover the period from 31 January 2020 to 31 December 2022, with updates depending on the progression of the pandemic. We will evaluate COVID-19 mortality differences between foreign-born and Swedish-born individuals by examining each mechanism (differential exposure and effects) separately, while considering potential effect modification by country of birth and socioeconomic factors. Planned statistical modelling techniques include mediation analyses, multilevel models, Poisson regression and event history analyses. ETHICS AND DISSEMINATION: This project has been granted all necessary ethical permissions from the Swedish Ethical Review Authority (Dnr 2022-0048-01) for accessing and analysing deidentified data. The final outputs will primarily be disseminated as scientific articles published in open-access peer-reviewed international journals, as well as press releases and policy briefs.


Subject(s)
COVID-19 , Emigrants and Immigrants , Adult , Female , Humans , Sweden/epidemiology , Social Factors , Social Determinants of Health , Observational Studies as Topic
16.
BMC Pulm Med ; 23(1): 97, 2023 Mar 22.
Article in English | MEDLINE | ID: covidwho-2294217

ABSTRACT

BACKGROUND: Despite a high paediatric tuberculosis (TB) burden globally, sensitive and specific diagnostic tools are lacking. In addition, no data exist on the impact of pulmonary TB on long-term child lung health in low- and middle-income countries. The prospective observational UMOYA study aims (1) to build a state-of-the-art clinical, radiological, and biological repository of well-characterised children with presumptive pulmonary TB as a platform for future studies to explore new emerging diagnostic tools and biomarkers for early diagnosis and treatment response; and (2) to investigate the short and long-term impact of pulmonary TB on lung health and quality of life in children. METHODS: We will recruit up to 600 children (0-13 years) with presumptive pulmonary TB and 100 healthy controls. Recruitment started in November 2017 and is expected to continue until May 2023. Sputum and non-sputum-based samples are collected at enrolment and during follow-up in TB cases and symptomatic controls. TB treatment is started by routine care services. Intensive follow-up for 6 months will allow for TB cases to retrospectively be classified according to international consensus clinical case definitions for TB. Long-term follow-up, including imaging, comprehensive assessment of lung function and quality of life questionnaires, are done yearly up to 4 years after recruitment. DISCUSSION: The UMOYA study will provide a unique platform to evaluate new emerging diagnostic tools and biomarkers for early diagnosis and treatment response and to investigate long-term outcomes of pulmonary TB and other respiratory events on lung health in children.


Subject(s)
Mycobacterium tuberculosis , Tuberculosis, Pulmonary , Tuberculosis , Child , Humans , Prospective Studies , Longitudinal Studies , South Africa , Quality of Life , Retrospective Studies , Tuberculosis, Pulmonary/diagnosis , Tuberculosis, Pulmonary/drug therapy , Lung/diagnostic imaging , Observational Studies as Topic
17.
BMJ Open ; 13(4): e065221, 2023 04 17.
Article in English | MEDLINE | ID: covidwho-2304253

ABSTRACT

INTRODUCTION: The SARS-CoV-2 pandemic remains a threat to public health. Soon after its outbreak, it became apparent that children are less severely affected. Indeed, opposing clinical manifestations between children and adults are observed for other infections. The SARS-CoV-2 outbreak provides the unique opportunity to study the underlying mechanisms. This protocol describes the methods of an observational study that aims to characterise age dependent differences in immune responses to primary respiratory infections using SARS-CoV-2 as a model virus and to assess age differences in clinical outcomes including lung function. METHODS AND ANALYSIS: The study aims to recruit at least 120 children and 60 adults that are infected with SARS-CoV-2 and collect specimen for a multiomics analysis, including single cell RNA sequencing of nasal epithelial cells and peripheral blood mononuclear cells, mass cytometry of whole blood samples and nasal cells, mass spectrometry-based serum and plasma proteomics, nasal epithelial cultures with functional in vitro analyses, SARS-CoV-2 antibody testing, sequencing of the viral genome and lung function testing. Data obtained from this multiomics approach are correlated with medical history and clinical data. Recruitment started in October 2020 and is ongoing. ETHICS AND DISSEMINATION: The study was reviewed and approved by the Ethics Committee of Charité - Universitätsmedizin Berlin (EA2/066/20). All collected specimens are stored in the central biobank of Charité - Universitätsmedizin Berlin and are made available to all participating researchers and on request. TRIAL REGISTRATION NUMBER: DRKS00025715, pre-results publication.


Subject(s)
COVID-19 , Adult , Child , Humans , SARS-CoV-2 , Leukocytes, Mononuclear , Specimen Handling , Nose , Observational Studies as Topic
18.
Curr Opin Allergy Clin Immunol ; 21(6): 545-552, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-2272215

ABSTRACT

PURPOSE OF REVIEW: Antisevere acute respiratory syndrome-corona virus 2 (SARS-CoV-2) vaccines may provide prompt, effective, and safe solution for the COVID-19 pandemic. Several vaccine candidates have been evaluated in randomized clinical trials (RCTs). Furthermore, data from observational studies mimicking real-life practice and studies on specific groups, such as pregnant women or immunocompromised patients who were excluded from RCTs, are currently available. The main aim of the review is to summarize and provide an immunologist's view on mechanism of action, efficacy and safety, and future challenges in vaccination against SARS-CoV-2. RECENT FINDINGS: mRNA and recombinant viral vector-based vaccines have been approved for conditional use in Europe and the USA. They show robust humoral and cellular responses, high with efficacy in prevention of COVID-19 infection (66.9 95%) and favorable safety profile in RCTs. High efficacy of 80-92% was observed in real-life practice. A pilot study also confirmed good safety profile of the mRNA vaccines in pregnant women. Unlike in those with secondary immunodeficiencies where postvaccination responses did not occur, encouraging results were obtained in patients with inborn errors of immunity. SUMMARY: Although both RCTs and observational studies suggest good efficacy and safety profiles of the vaccines, their long-term efficacy and safety are still being discussed. Despite the promising results, clinical evidence for specific groups such as children, pregnant and breastfeeding women, and immunocompromised patients, and for novel virus variants are lacking. VIDEO ABSTRACT: http://links.lww.com/COAI/A21.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Pandemics/prevention & control , Primary Immunodeficiency Diseases/immunology , SARS-CoV-2/immunology , COVID-19/epidemiology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/adverse effects , Humans , Immunocompromised Host , Observational Studies as Topic , Pilot Projects , Primary Immunodeficiency Diseases/complications , Primary Immunodeficiency Diseases/genetics , Treatment Outcome , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects
19.
J Clin Neurosci ; 111: 57-70, 2023 May.
Article in English | MEDLINE | ID: covidwho-2273466

ABSTRACT

BACKGROUND: Although global vaccination against COVID-19 infection has its excellence, potential side effects are yet of concern. Several lines of evidence have proposed ADEM occurrence after SARS-CoV-2 infection. Moreover, a large number of case reports and case series have also suggested the casual association between ADEM and COVID-19 vaccination. To better understand the development of ADEM following COVID-19 vaccination and its potential association, we aimed to systematically review ADEM cases reported after COVID-19 vaccination. METHODS: We conducted a comprehensive systematic search using three databases including PubMed, Scopus, and Web of Science. Studies that reported ADEM after COVID-19 vaccination were eligible to include in our study. Observational studies, case reports, and case series which reported cases of ADEM with sufficient detail to confirm clinical diagnosis following COVID-19 vaccination were eligible to enter our study. RESULTS: Twenty studies were included in our systematic review after the abstract and full-text screening with a total of 54 cases. Among included patients, 45 (85.1 %) developed ADEM after the first dose of the COVID-19 vaccine, and seven (12.9 %) cases experienced ADEM after the second dose. The median time interval between vaccination and neurological symptoms was 14 days which ranged from 12 h to 63 days. Twelve (22.2 %) patients experienced symptoms of muscle weakness, ten (18.5 %) presented unconsciousness, nine (16.6 %) patients had urinary complaints, nine (16.6 %) had visual impairments, and five (9.2 %) experienced a seizure. After treatments, four (13.8 %) patients died. Forty-six patients had clinical improvement (85.1 %), also improvement in brain MRI was observed among 44 (81.4 %) patients. CONCLUSION: In conclusion, it is not clear that ADEM could be a potential complication of COVID-19 vaccination based on the current evidence and further studies are needed. However, this rare condition should not trigger stopping the mass vaccination programs since the only way to eradicate the current pandemic of COVID-19 is to extend the number of immunized people.


Subject(s)
COVID-19 Vaccines , COVID-19 , Encephalomyelitis, Acute Disseminated , Humans , COVID-19/prevention & control , COVID-19/complications , COVID-19 Vaccines/adverse effects , Encephalomyelitis, Acute Disseminated/etiology , Encephalomyelitis, Acute Disseminated/diagnosis , Observational Studies as Topic , SARS-CoV-2 , Vaccination/adverse effects
20.
Medicina (Kaunas) ; 59(2)2023 Jan 29.
Article in English | MEDLINE | ID: covidwho-2279394

ABSTRACT

Background: Since the start of the global pandemic of coronavirus disease 2019 (COVID-19), not only adults but also many children have suffered from it. However, the clinical characteristics of long COVID in children remain unclear. Methods: In this retrospective observational study conducted in a single facility, we reviewed the medical records of all long COVID patients who visited Okayama University Hospital from February 2021 to October 2022, and we compared the clinical characteristics of long COVID in teenagers (11 to 18 years of age) with those in adults. Results: Data for 452 long COVID patients including 54 teenagers (11.9%) were analyzed. Fatigue was the most frequent symptom in teenagers (55.6% of the patients) and also in adults. On the other hand, the percentage of teenagers who complained of headache, which was the second most frequent complaint, was significantly higher than the percentage of adults (35.2% vs. 21.9%, p < 0.05). A comparison of the frequencies of symptoms depending on the viral variant showed that fatigue and headache were predominant symptoms in the Omicron variant phase. Of the 50 teenagers who were enrolled in schools, 28 (56.0%) could not attend school due to long COVID symptoms. The most common symptoms as reasons for absence from school were fatigue (85.7% of the patients), headache (42.9%), and insomnia (32.1%). Conclusions: Attention should be paid to the symptoms of fatigue and headache in teenagers with long COVID.


Subject(s)
COVID-19 , Post-Acute COVID-19 Syndrome , Adult , Child , Adolescent , Humans , East Asian People , SARS-CoV-2 , Fatigue , Headache , Observational Studies as Topic
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