Timing and sequence of vaccination against COVID-19 and influenza (TACTIC):a single-blind, placebo-controlled randomized clinical trial

Background: Novel mRNA-based vaccines have been used to protect against SARS-CoV-2, especially in vulnerable populations who also receive an annual influenza vaccination. The TACTIC study investigated potential immune interference between the mRNA COVID-19 booster vaccine and the quadrivalent influenza vaccine, and determined if concurrent administration would have effects on safety or immunogenicity. Methods: TACTIC was a single-blind, placebo-controlled randomized clinical trial conducted at the Radboud University Medical Centre, the Netherlands. Individuals ≥60 years, fully vaccinated against COVID-19 were eligible for participation and randomized into one of four study groups: 1) 0.5 ml influenza vaccination Vaxigrip Tetra followed by 0.3 ml BNT162b2 COVID-19 booster vaccination 21 days later, (2) COVID-19 booster vaccination followed by influenza vaccination, (3) influenza vaccination concurrent with the COVID-19 booster vaccination, and (4) COVID-19 booster vaccination only (reference group). Primary outcome was the geometric mean concentration (GMC) of IgG against the spike (S)-protein of the SARS-CoV-2 virus, 21 days after booster vaccination. We performed a non-inferiority analysis of concurrent administration compared to booster vaccines alone with a predefined non-inferiority margin of −0.3 on the log10-scale. Findings: 154 individuals participated from October, 4, 2021, until November, 5, 2021. Anti-S IgG GMCs for the co-administration and reference group were 1684 BAU/ml and 2435 BAU/ml, respectively. Concurrent vaccination did not meet the criteria for non-inferiority (estimate −0.1791, 95% CI −0.3680 to −0.009831) and antibodies showed significantly lower neutralization capacity compared to the reference group. Reported side-effects were mild and did not differ between study groups. Interpretation: Concurrent administration of both vaccines is safe, but the quantitative and functional antibody responses were marginally lower compared to booster vaccination alone. Lower protection against COVID-19 with concurrent administration of COVID-19 and influenza vaccination cannot be excluded, although additional larger studies would be required to confirm this. Trial registration number: EudraCT: 2021-002186-17 Funding: The study was supported by the ZonMw COVID-19 Programme.</p

The CHIP-Family study to improve the psychosocial wellbeing of young children with congenital heart disease and their families: design of a randomized controlled trial

Background: Children with congenital heart disease (CHD) are at increased risk for behavioral, emotional, and cognitive problems. They often have reduced exercise capacity and participate less in sports, which is associated with a lower quality of life. Starting school may present more challenges for children with CHD and their families than for families with healthy children. Moreover, parents of children with CHD are at risk for psychosocial problems. Therefore, a family-centered psychosocial intervention for children with CHD when starting school is needed. Until now, the 'Congenital Heart Disease Intervention Program (CHIP) - School' is the only evidence-based intervention in this field. However, CHIP-School targeted parents only and resulted in non-significant, though positive, effects as to child psychosocial wellbeing. Hence, we expanded CHIP by adding a specific child module and including siblings, creating the CHIP-Family intervention. The CHIP-Family study aims to (1) test the effects of CHIP-Family on parental mental health and psychosocial wellbeing of CHD-children and to (2) identify baseline psychosocial and medical predictors for the e

The Influence of Exercise Training on Quality of Life and Psychosocial Functioning in Children with Congenital Heart Disease:A Review of Intervention Studies

Children and adolescents operated upon for congenital heart disease may show reduced exercise capacity and physical activity, associated with lowered quality of life. This review presents intervention studies on the influence of an exercise program on quality of life and psychosocial functioning in children with severe congenital heart disease. Participation in an exercise program among young people with complex congenital heart disease seemed to have positive effects on quality of life and passive leisure time spent. However, more effects of the exercise programs may have been expected. For future research it is important to critically evaluate the content of the exercise programs

Associations between exercise capacity, physical activity, and psychosocial functioning in children with congenital heart disease: a systematic review

Children and adolescents operated upon for congenital heart disease (ConHD) may show reduced exercise capacity and physical activity, possibly associated with lowered self-esteem and quality of life (QoL). The studies into associations between these parameters have not been reviewed before. Review of studies into associations between exercise capacity, physical activity, respectively exercise training, and psychosocial functioning of ConHD youngsters. PubMed, Embase and reference lists of related articles. Articles published between January 2000 and December 2012 into exercise capacity and/or physical activity, and a measure of psychosocial functioning in children with ConHD. Two investigators independently reviewed the identified articles for eligibility, and one author extracted the data. Although exercise capacity was strongly related to physical domains of parent-reported and self-reported QoL, it was almost never associated with psychosocial domains of QoL. Physical activity was rarely associated with physical or psychosocial domains of QoL. Remarkably, self-reported depressive symptoms were associated with both physical and psychosocial QoL. The few studies into exercise-training programmes showed promising results in QoL and emotional and behavioral problems, but they contained methodological flaws. No clear relationships were found between exercise capacity, physical activity, and QoL in children and adolescents with ConHD. Therefore we recommend assessing QoL separately, preferably both self-reported and parent-reported. Since depressive symptoms were associated with reduced physical and psychosocial QoL, screening on these symptoms is also recommende

Psychosocial needs of children undergoing an invasive procedure for a CHD and their parents

The aim of this study was to investigate the psychosocial needs of both parents of children with CHD (aged 0-18 years) and patients themselves (aged 8-18 years) in the week before cardiac surgery or a catheter intervention. Patients Eligible participants included all consecutive patients (0-18 years) scheduled to undergo cardiac surgery or a catheter intervention in our hospital between March, 2012 and July, 2013. Psychosocial needs were assessed using a disease-specific questionnaire designed for this study, consisting of a 83-item parent version and a 59-item child version (for children ⩾8 years), each covering five domains: physical/medical, emotional, social, educational/occupational, and health behaviour; two items assessed from whom and in what format psychosocial care was preferred. Quality of life was also assessed. Interventions If parents/patients reported a need for psychosocial care, referral to adequate mental health-care professionals was arranged. More than 40% of participating parents and >50% of participating children reported a need for psychosocial care on each of the five domains. Needs for psychosocial care for parents themselves were highest for those with children aged 0-12 years. Parents and patients report clear preferences when asked from whom and in what format they would like to receive psychosocial care. Quality of life was relatively high for both parents and patients. Psychosocial care interventions in our hospital increased significantly after the implementation of this study. Results show that psychosocial care is rated as (very) important by both parents and children during an extremely stressful period of their lif

Neurocognitive functioning and health-related quality of life of children after pediatric intensive care admission: a systematic review

Objective : This study systematically reviewed recent findings on neurocognitive functioning and health-related quality of life (HRQoL) of children after pediatric intensive care unit admission (PICU). Data sources : Electronic databases searched included Embase, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar. The search was limited to studies published in the last five years (2015–2019). Study selection : Original studies assessing neurocognitive functioning or HRQoL in children who were previously admitted to the PICU were included in this systematic review. Data extraction : Of the 3649 identified studies, 299 met the inclusion criteria based on title abstract screening. After full-text screening, 75 articles were included in the qualitative data reviewing: 38 on neurocognitive functioning, 33 on HRQoL, and 4 on both outcomes. Data synthesis : Studies examining neurocognitive functioning found overall worse scores for general intellectual functioning, attention, processing speed, memory, and executive functioning. Studies investigating HRQoL found overall worse scores for both physical and psychosocial HRQoL. On the short term (≤ 12 months), most studies reported HRQoL impairments, whereas in some long-term studies HRQoL normalized. The effectiveness of the few intervention studies during and after PICU admission on long-term outcomes varied. Conclusions : PICU survivors have lower scores for neurocognitive functioning and HRQoL than children from the general population. A structured follow-up program after a PICU admission is needed to identify those children and parents who are at risk. However, more research is needed into testing interventions in randomized controlled trials aiming on preventing or improving impairments in critically ill children during and after PICU admission

Effect of exercise training on sports enjoyment and leisure-time spending in adolescents with complex congenital heart disease: the moderating effect of health behavior and disease knowledge

The aim of this study was to evaluate the effects of a standardized exercise program on sports enjoyment and leisure-time spending in adolescents with congenital heart disease and to know what the moderating impact of their baseline health behavior and disease knowledge is. Included were 93 patients, aged 10 to 25, with surgical repair for tetralogy of Fallot or with a Fontan circulation for single-ventricle physiology, of 5 participating centers of pediatric cardiology in The Netherlands. They were randomly allocated, stratified for age, gender, and type of congenital heart disease to a 12-week period with either: (1) three times per week standardized exercise training or (2) care as usual (randomization ratio 2:1). At baseline and after 12 weeks, participants completed Web-based questionnaires and were interviewed by phone. Primary analyses tested changes from baseline to follow-up in sports enjoyment and leisure-time spending in the exercise group vs. control group. Secondary analyses concerned the moderating influence of baseline health behavior and disease knowledge on changes from baseline to follow-up, and comparison with normative data. At follow-up, the exercise group reported a decrease in passive leisure-time spending (watching television and computer usage) compared with controls. Exercise training had no effect on sports enjoyment and active leisure-time spending. Disease knowledge had a moderating effect on improvement in sports enjoyment, whereas health behavior did not. Compared with normative data, patients obtained similar leisure time scores and lower frequencies as to drinking alcohol and smoking. Exercise training decreased passive, but not active, leisure-time spending. It did not influence sports enjoymen

The association between subjective health status and 14-year mortality in post-PCI patients

Poor subjective health status significantly predicted short-term mortality in patients with coronary artery disease (CAD). However, the relation between subjective health status and long-term mortality remains limited in patients treated with PCI. The aim of this study is to investigate the association between subjective health status and 14-year mortality in patients treated with percutaneous coronary intervention (PCI). A consecutive cohort with 1111 patients treated for CAD who completed the SF-36 questionnaire was included between 2001 and 2002 as part of the RESEARCH registry. After adjustment, physical functioning (HR: 1.96; 95% CI: 1.59-2.43), social functioning (HR: 1.53; 95% CI: 1.24-1.88), role limitations due to physical functioning (HR: 1.75; 95% CI: 1.41-2.16), role limitations due to emotional functioning (HR: 1.34; 95%CI: 1.08-1.67), mental health (HR: 1.52; 95% CI: 1.24-1.88), vitality (HR: 1.66; 95% CI: 1.35-2.03), bodily pain (HR: 1.63; 95% CI: 1.32-2.02) and general health (HR: 1.82; 95% CI: 1.49-2.23) were all associated with an increased risk of 14-year mortality. Physical and mental subjective health status as measured with the SF-36 appeared to be a strong predictor for 14-year mortality in post-PCI patient

Depression and anxiety symptoms as predictors of mortality in PCI patients at 10 years of follow-up

Depression has been shown to be an independent risk factor for short-term mortality in patients with coronary artery disease (CAD). There are studies suggesting that depression might also be associated with long-term mortality. Anxiety has also been associated with mortality. This study aimed to further investigate the predictive value of depression and anxiety symptoms on all-cause mortality, 10 years after percutaneous coronary intervention (PCI). The study population comprised a consecutive series of CAD patients (n = 1411) treated with PCI between September 2001 and October 2002 at the Erasmus Medical Centre, Rotterdam. The Hospital Anxiety and Depression Scale (HADS) was completed by 1112 patients at baseline to assess levels of depression and anxiety. The endpoint was defined as all-cause mortality. The prevalence of depression and anxiety was 24.8% and 27.7%, respectively. The cumulative all-cause mortality rate in depressed patients was 37% versus 20% in non-depressed patients (log-rank p  < 0.001). After adjustment, depression remained a predictor of all-cause mortality (hazard ratio (HR) 1.77; 95% confidence interval (CI) 1.36-2.29). Cumulative survival rates did not differ for anxious versus non-anxious patients (log-rank p = .79). However, after adjustment, anxiety was associated with an increased risk for all-cause mortality (HR 1.50; 95% CI 1.14-1.98). A sub-analysis showed that cumulative survival rates did not differ for depressed and anxious patients versus depressed but non-anxious patients (log-rank p = 0.46). Depression is associated with an increased risk of 77% for all-cause mortality, 10 years post-PCI, independently of anxiety. Although anxiety was associated with all-cause mortality, it has no additional value in the case of co-occurring depressio