Abstract

BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.

Abstract

INTRODUCTION We investigated the effectiveness of a multidomain intervention to preserve cognitive function in older adults at risk for dementia in Germany in a cluster-randomized trial. METHODS Individuals with a Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) risk score ≥ 9 aged 60 to 77 years were recruited. After randomization of their general practitioner (GP), patients received a multidomain intervention (including optimization of nutrition and medication, and physical, social, and cognitive activity) or general health advice and GP treatment as usual over 24 months. Primary outcome was global cognitive performance (composite z score, based on domain-specific neuropsychological tests). RESULTS Of 1030 participants at baseline, n = 819 completed the 24-month follow-up assessment. No differences regarding global cognitive performance (average marginal effect = 0.010, 95% confidence interval: -0.113, 0.133) were found between groups at follow-up. Perceived restrictions in intervention conduct by the COVID-19 pandemic did not impact intervention effectiveness. DISCUSSION The intervention did not improve global cognitive performance. HIGHLIGHTS Overall, no intervention effects on global cognitive performance were detected. The multidomain intervention improved health-related quality of life in the total sample. In women, the multidomain intervention reduced depressive symptoms. The intervention was completed during the COVID-19 pandemic.

Abstract

BACKGROUND About one in 11 adults worldwide suffers from diabetic disease with constantly increasing prevalence; from the 529 million patients registered in 2021, the number of people with diabetes was predicted to rise to approximately 1.31 billion in 2050. In Italy, 5.9% of the population is diabetic, with a higher prevalence with increasing age and in the South of the country. Yoga and Mindfulness could represent a valid support for the care of diabetic subjects especially in a stressful caring context such as the Covid-19 pandemic. STUDY DESIGN A scoping review was conducted to achieve the goals of the study. Yoga or Mindfulness interventions on diabetic subjects were specifically analyzed and qualitative-quantitative data collected in the selected randomized controlled trials were extensive for possible meta-analysis. METHODS The review was conducted by two independent practitioners and a third one was consulted in case of conflict. The PRISMA method was used for both the selection and reporting of the studies to be included. Specific PICOS and search strategies have been developed on PubMed, Embase and PsycINFO databases. Included in the review were: randomised controlled trials, full dissertation articles and papers in English with a time limit on May 31, 2022. RESULTS The Review included 22 studies; 12 on Mindfulness, 9 on Yoga and one about both disciplines; among these, one studied patients with Type 1 Diabetes, 14 with Type 2 Diabetes, 6 with both and one with Gestational Diabetes. Only one paper studied adolescent subjects while the other 21 focused on a range of adult subjects. The studies showed that Yoga and Mindfulness have strong potential not only on stress management, but also on clinical-metabolic parameters. CONCLUSIONS The recent Covid-19 pandemic has certainly redesigned a new way of treating and managing chronic diseases, such as diabetes. An increasingly fragile population, and with the growing need to reduce overall stress levels, could find alternative practices in Yoga and Mindfulness to support conventional therapies.

Abstract

BACKGROUND Most adolescent girls fail to meet current physical activity guidelines. Physical activity behaviours track from childhood into adulthood and providing adolescent girls with opportunities to be physically active may have health benefits beyond childhood. The effects of walking interventions on adult cardiometabolic health are known, however less is understood about the potential of walking to promote physical activity in adolescents. Following the Walking In ScHools (WISH) feasibility study, this definitive trial aimed to evaluate the effectiveness of a novel, low-cost, school-based walking intervention at increasing physical activity levels of adolescent girls (aged 12-14 years). METHODS Female pupils were recruited from eighteen schools across the border region of Ireland and in Northern Ireland. In intervention schools (n = 9), girls aged 15-18 years, were trained as walk leaders, and led the younger pupils in 10-15 min walks before school, at break and lunch recess. All walks took place in school grounds and pupils were encouraged to participate in as many walks as possible each week. The primary outcome measure was accelerometer determined total physical activity (counts per minutes, cpm). RESULTS In total, 589 pupils were recruited to the study. At baseline, pupils engaged in a median (interquartile range (IQR)) 35.7 (21.2) mins moderate-vigorous physical activity (MVPA) per day and only 12% (n = 66) of participants met physical activity guidelines (60 min MVPA per day). The intervention was delivered for a mean (standard deviation (SD)) 19.9 ± 0.97 weeks. The mean post-intervention total physical activity for the intervention group was 676 cpm and 710 cpm in the control group. Post-intervention total physical activity did not statistically differ between groups when adjusted for age, body mass index z-scores and baseline physical activity (mean difference, -33.5, 95% CI = -21.2 to 88.1; p = 0.213). CONCLUSIONS 'Scaling-up' physical activity interventions is challenging and despite a promising feasibility study, the results of this fully powered trial suggest that in this context, the WISH intervention did not increase device measured physical activity. Since the COVID-19 pandemic, school environments have changed and although pupils enjoyed the programme, attendance at walks was low, indicating that there is a need to better understand how to implement interventions within schools. TRIAL REGISTRATION ISRCTN; ISRCTN12847782; Registered 2nd July 2019.

Abstract

Effect sizes from previously reported trials are often used to determine the meaningful change in weight in childhood obesity prevention interventions because information on clinically meaningful differences is lacking. Estimates from previous trials may be influenced by statistical significance; therefore, it is important that they have a low risk of type 1 error. A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness according to risk of type 1 error. Eighty-four randomized controlled trials were identified. A large range of assumptions were applied in the sample size calculations. The most common primary outcome was BMI, with detectable effect size differences used in sample size calculations ranging from 0.25 kg/m2 (followed up at 2 years) to 1.1 kg/m2 (at 9 months) and BMI z-score ranging from 0.1 (at 4 years) to 0.67 (at 3 years). There was no consistent relationship between low risk of type 1 error and reports of higher or lower effectiveness. Further clarity of the size of a meaningful difference in weight in childhood obesity prevention trials is required to support evaluation design and decision-making for intervention and policy. Type 1 error risk does not appear to impact effect sizes in a consistent direction.

Abstract

OBJECTIVES To conduct a systematic review and meta-analysis to evaluate the prevalence of thyroid disorders in COVID-19 patients. DATA SOURCES Scopus, PubMed, ISI Web of Science, and Google Scholar databases were used in this review. We also consider the results of grey literature. STUDY SELECTIONS Cohort, cross-sectional, and case-control studies were included. DATA EXTRACTION AND SYNTHESIS The required data were extracted by the first author of the article and reviewed by the second author. The Pooled prevalence of outcomes of interest was applied using the meta-prop method with a pooled estimate after Freeman-Tukey Double Arcsine Transformation to stabilize the variances. OUTCOMES AND MEASURED The different thyroid disorders were the main outcomes of this study. The diseases include non-thyroidal illness syndrome, thyrotoxicosis, hypothyroidism, isolated elevated free T4, and isolated low free T4. RESULTS Eight articles were included in our meta-analysis(Total participants: 1654). The pooled prevalence of events hypothyroidism, isolated elevated FT4, isolated low FT4, NTIS, and thyrotoxicosis were estimated (Pooled P = 3%, 95% CI:2-5%, I2: 78%), (Pooled P = 2%, 95% CI: 0-4%, I2: 66%), (Pooled P = 1%, 95% CI: 0-1%, I2: 0%), (Pooled P = 26%, 95% CI: 10-42%, I2: 98%), and (Pooled P = 10%, 95% CI: 4-16%, I2: 89%), respectively. CONCLUSION Thyroid dysfunction is common in COVID-19 patients, with a high prevalence of non-thyroidal illness syndrome (NTIS) and thyrotoxicosis. Our meta-analysis found a 26% prevalence of NTIS and a 10% prevalence of thyrotoxicosis. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42022312601.

Abstract

INTRODUCTION Even after the peak of the COVID-19 pandemic, the number of mild cases remains high, requiring continuous control. Curcumin, owing to its anti-inflammatory properties, can suppress vital proliferation and cytokine secretion in animal models. We developed a highly absorbable curcumin, curcuRouge® (cR), which is approximately 100 times more orally bioavailable than conventional curcumin. We evaluated the effect of cR on the inhibition of disease progression in asymptomatic or mildly symptomatic COVID-19 patients. METHODS This study evaluated the effect of 7-day oral intake of cR (360 mg twice daily). Patients within 5 days of COVID-19 diagnosis were randomly assigned to a placebo or cR group in a double-blind manner. RESULTS Primary endpoint events [body temperature (BT) ≥ 37.5 °C and saturation of percutaneous oxygen (SpO2) < 96%] were fewer than expected, and the rate of these events was 2.8% in the cR group (2/71) and 6.0% in the placebo group (4/67); hazard ratio (HR) = 0.532, 95% confidence interval (CI) 0.097-2.902. Patients receiving cR tended to take fewer antipyretic medications than those receiving placebo (HR = 0.716, 95% CI 0.374-1.372). Among patients with a normal range of BT at baseline, the BT change rate was significantly (p = 0.014) lower in the cR group (- 0.34%) versus placebo (- 0.01%). CONCLUSION The relative suppression of event rates and antipyretic medications taken, and significant decrease of subclinical BT support the anti-inflammatory effects of cR in asymptomatic or mildly symptomatic patients with COVID-19. TRIAL REGISTRATION Japan Registry of Clinical Trials (CRB5200002).

Abstract

BACKGROUND In recent years, the outbreak of COVID-19 caused by SARS-CoV-2 has been witnessed globally. However, the impact of SARS-CoV-2 infection on thyroid dysfunction and subclinical thyroid dysfunction remains unclear. Therefore, this meta-analysis aimed to assess the effects of SARS-CoV-2 infection on thyroid dysfunction and its relationship with the severity of COVID-19. METHODS We systematically searched databases including PubMed, Willey Library, Embase, Web of Science, CNKI, Wanfang, and VIP. We focused on randomized controlled trials, case-control studies, and cohort studies published between December 2019 and August 2023, examining the association between SARS-CoV-2 infection and hypothyroidism, with a specific emphasis on the severity of the infection. The quality of the research was assessed using the Newcastle-Ottawa Scale (NOS), while statistical analysis was conducted using the meta and metafor packages in R 4.2.1 software. RESULTS For the meta-analysis, a total of eight articles were identified based on strict inclusion and exclusion criteria. For the association between SARS-CoV-2 infection and hypothyroidism, three studies (266 samples) comparing TSH levels of COVID-19 and control groups showed no difference in TSH levels [SMD=-0.04,95%CI(-1.22,1.15),P=0.95]. Additionally, two studies examining TT3 (a sample of 176 cases) and two studies examining TT4 (a sample of 176 cases) also showed no difference in TT3 and TT4 between the COVID-19 group and the control group, respectively. However, when evaluating the severity of COVID-19, six studies (565 samples) showed that TSH in the severe group was significantly lower than in the mild group [SMD = -0.55, 95% CI (-0.96, -0.14)], while FT3 was also lower in the severe group [SMD = -0.96, 95% CI (-1.24, -0.67)]. No noticeable differences were observed between the severe and mild groups in their TT3, FT4, and TT4 levels. CONCLUSION SARS-CoV-2 infection may have detrimental effects on thyroid function in individuals with severe symptoms. More research is needed to confirm and explore this relationship. SYSTEMATIC REVIEW REGISTRATION https://www.crd.york.ac.uk/PROSPERO, identifier CRD42023486042.

Abstract

OBJECTIVES To assess mortality and different clinical factors derived from the development of atraumatic pneumothorax (PNX) and/or pneumomediastinum (PNMD) in critically ill patients as a consequence of COVID-19-associated lung weakness (CALW). DESIGN Systematic review with meta-analysis. SETTING Intensive Care Unit (ICU). PARTICIPANTS Original research evaluating patients, with or without the need for protective invasive mechanical ventilation (IMV), with a diagnosis of COVID-19, who developed atraumatic PNX or PNMD on admission or during hospital stay. INTERVENTIONS Data of interest were obtained from each article and analyzed and assessed by the Newcastle-Ottawa Scale. The risk of the variables of interest was assessed with data derived from studies including patients who developed atraumatic PNX or PNMD. MAIN VARIABLES OF INTEREST Mortality, mean ICU stay and mean PaO2/FiO2 at diagnosis. RESULTS Information was collected from 12 longitudinal studies. Data from a total of 4901 patients were included in the meta-analysis. A total of 1629 patients had an episode of atraumatic PNX and 253 patients had an episode of atraumatic PNMD. Despite the finding of significantly strong associations, the great heterogeneity between studies implies that the interpretation of results should be made with caution. CONCLUSIONS Mortality among COVID-19 patients was higher in those who developed atraumatic PNX and/or PNMD compared to those who did not. The mean PaO2/FiO2 index was lower in patients who developed atraumatic PNX and/or PNMD. We propose grouping these cases under the term COVID-19-associated lung weakness (CALW). OBJETIVO Evaluar la mortalidad y diversos factores clínicos derivados del desarrollo de neumotórax (NTX) y/o neumomediastino (NMD) atraumáticos en pacientes críticos como consecuencia de la debilidad pulmonar asociada a COVID-19 (DPAC). DISEÑO: Revisión sistemática con metaanálisis. ÁMBITO Unidad de Cuidados Intensivos (UCI). PARTICIPANTES Investigaciones originales en las que se evaluase a pacientes, con o sin necesidad de ventilación mecánica invasiva (VMI), con diagnóstico de COVID-19 que hubiesen desarrollado NTX o NMD atraumáticos al ingreso o durante su estancia hospitalaria. INTERVENCIONES Se obtuvieron los datos de interés de cada artículo que fueron analizados y evaluados por la Escala Newcastle-Ottawa. El riesgo de las variables de interés principales se evaluó por los datos derivados de los estudios que incluyeron a pacientes que desarrollaron NTX o NMD atraumáticos. VARIABLES DE INTERÉS PRINCIPALS Mortalidad, estancia media en la UCI y PaO2/FiO2 media en el momento diagnóstico. RESULTADOS Se recogieron datos de 12 estudios longitudinales. En el metaanálisis se incluyeron datos de un total de 4.901 pacientes, entre los cuales 1.629 presentaron un episodio de NTX y 253 de NMD atraumáticos. A pesar de encontrar asociaciones significativamente fuertes, la alta heterogeneidad entre los estudios hace que la interpretación de los resultados deba hacerse con cautela. CONCLUSIONES La mortalidad de los pacientes COVID-19 fue mayor en los que desarrollaron NTX y/o NMD atraumáticos con respecto a los que no lo hicieron. La media del índice PaO2/FiO2 fue menor en los pacientes que desarrollaron NTX y/o NMD atraumáticos. Proponemos agrupar bajo el término deDPAC estos casos.

Abstract

PURPOSE Serum electrolyte imbalances are highly prevalent in COVID-19 patients. However, their associations with COVID-19 outcomes are inconsistent, and of unknown prognostic value. We aim to systematically clarify the associations and prognostic accuracy of electrolyte imbalances (sodium, calcium, potassium, magnesium, chloride and phosphate) in predicting poor COVID-19 clinical outcome. METHODS PubMed, Embase and Cochrane Library were searched. Odds of poor clinical outcome (a composite of mortality, intensive-care unit (ICU) admission, need for respiratory support and acute respiratory distress syndrome) were pooled using mixed-effects models. The associated prognostic sensitivity, positive and negative likelihood ratios (LR + , LR-) and predictive values (PPV, NPV; assuming 25% pre-test probability), and area under the curve (AUC) were computed. RESULTS We included 28 observational studies from 953 records with low to moderate risk-of-bias. Hyponatremia (OR = 2.08, 95% CI = 1.48-2.94, I2 = 93%, N = 8), hypernatremia (OR = 4.32, 95% CI = 3.17-5.88, I2 = 45%, N = 7) and hypocalcemia (OR = 3.31, 95% CI = 2.24-4.88, I2 = 25%, N = 6) were associated with poor COVID-19 outcome. These associations remained significant on adjustment for covariates such as demographics and comorbidities. Hypernatremia was 97% specific in predicting poor outcome (LR + 4.0, PPV = 55%, AUC = 0.80) despite no differences in CRP and IL-6 levels between hypernatremic and normonatremic patients. Hypocalcemia was 76% sensitive in predicting poor outcome (LR- 0.44, NPV = 87%, AUC = 0.71). Overall quality of evidence ranged from very low to moderate. CONCLUSION Hyponatremia, hypernatremia and hypocalcemia are associated with poor COVID-19 clinical outcome. Hypernatremia is 97% specific for a poor outcome, and the association is independent of inflammatory marker levels. Further studies should evaluate if correcting these imbalances help improve clinical outcome.