Efficacy,immunogenicity, and safety of available vaccines in children on biologics: A systematic review and meta-analysis

Vaccinations are essential for preventing infectious diseases in children with chronic diseases as they have increased risk of infection from frequent use of biologics. Response to immunizations in this group is not well known.ObjectiveA systematic review was performed to evaluate three primary outcomes: efficacy; immunogenicity; and safety of vaccines in children with chronic conditions treated with biologics.MethodsThe protocol for our systematic review and meta-analysis was registered and published with PROSPERO. We searched electronic bibliographic databases for studies published from 2009 to 2019, focusing on vaccinations in children with chronic conditions treated with biologics.ResultsWe retrieved 532 records. Thirty-one full-text articles were selected, and 14 were included in the meta-analysis. No significant publication bias was found. Efficacy: limited data are available regarding the efficacy of vaccination, as most studies have focused on immunogenicity as surrogate outcome for efficacy. Immunogenicity: patients receiving anti-TNF-alpha therapy had a statistically significant risk of poor seroconversion (p = 0.028) and seroprotection by the serotype B influenza vaccine [inflammatory bowel disease (IBD) p = 0.013; juvenile idiopathic arthritis (JIA) p = 0.004]. We found adequate responses with H1N1 and H3N2 serotypes. Few studies existed for pneumococcal, hepatitis A virus, hepatitis B virus, varicella-zoster virus, Measles Mumps Rubella virus, and multiple vaccine administration. Safety: vaccine administration was not associated with serious side effects, but JIA patients on anti-TNF alpha therapy had a statistically significant risk of presenting with myalgia or arthralgia postinfluenza vaccine (p = 0.014).ConclusionsMore evidence concerning efficacy, immunogenicity, and safety of vaccinations is needed to guide physicians in the vaccine decision process for this pediatric population.     

Sofosbuvir-velpatasvir en pacientes mexicanos con hepatitis C: una revisión retrospectiva

IntroductionThe sofosbuvir-velpatasvir (SOF/VEL) combination is a direct-acting antiviral therapy that is authorized and available in Mexico, making the performance of a real-world multicenter study that evaluates the sustained virologic response at 12 weeks post-treatment a relevant undertaking.MethodsA retrospective review of the case records of 241 patients seen at 20 hospitals in Mexico was conducted to assess hepatitis C treatment with the SOF/VEL combination (n = 231) and the sofosbuvir/velpatasvir/ribavirin (SOF/VEL/RBV) combination (n = 10). The primary efficacy endpoint was the percentage of patients that achieved SVR at 12 weeks after the end of treatment.ResultsOverall SVR was 98.8% (95% CI 97.35-100%). Only three patients did not achieve SVR, two of whom had cirrhosis and a history of previous treatment with peg-IFN. Of the subgroups analyzed, all the patients with HIV coinfection, three patients with genotype 3, and the patients treated with the SOF/VEL/RBV combination achieved SVR. The subgroups with the lower success rates were patients that were treatment-experienced (96.8%) and patients with F1 fibrosis (95.5%). The most frequent adverse events were fatigue, headache, and insomnia. No serious adverse events were reported.ConclusionTreatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.     

Accuracy of intentionally tilted implant placement in the maxilla using dynamic navigation: a retrospective clinical analysis

The aim of this retrospective study was to investigate the accuracy of dynamic navigation for the placement of intentionally tilted implants in the posterior maxilla. The study included 12 patients with edentulism or continuous multiple tooth loss, who had 48 implants inserted under dynamic navigation guidance in the posterior maxilla. Twenty-four implants near maxillary sinuses were intentionally tilted. The average platform deviation was 1.3 ± 0.4 mm (range 0.8–2.3 mm), apex deviation was 1.1 ± 0.5 mm (range 0.2–2.3 mm), and axis deviation was 3.1 ± 1.0° (range 1.8–6.7°). The other 24 implants were axially positioned. The average platform deviation was 1.5 ± 0.5 mm (range 0.7–3.1 mm), apex deviation was 1.3 ± 0.7 mm (range 0.5–3.1 mm), and axis deviation was 3.2 ± 1.5° (range 1.5–7.7°). There was no significant difference in platform deviation, apex deviation, or axis deviation between the tilted implants and implants in the axial position (P > 0.05). This analysis indicates that a dynamic navigation system can be used as a method of guidance to place intentionally tilted implants as accurately as axially positioned implants in the posterior maxilla, thereby preventing damage to the maxillary sinuses and the need to graft bone.     

Adherence to a Mediterranean Lifestyle and Changes in Frequency,Severity, and Localization of Pain in Older Adults

ObjectiveTo assess the association between adherence to a Mediterranean lifestyle and changes in pain, and its characteristics over time in older adults.Patients and MethodsWe analyzed data from 864 and 862 community-dwelling individuals aged 65+ years from the Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain (Seniors-ENRICA) Seniors-ENRICA-1 (2008–2010 to 2012) and Seniors-ENRICA-2 (2015–2017 to 2019) cohorts, with a median follow-up of 2.8 and 2.4 years, respectively. Adherence to a Mediterranean lifestyle was assessed at baseline with the 27-item Mediterranean lifestyle (MEDLIFE) index. Pain changes over time were calculated with a pain scale that assessed the frequency, severity, and the number of pain locations both at baseline and follow-up. Multivariable-adjusted relative risk ratios (RRRs) were obtained using multinomial logistic regression.ResultsIn the pooled cohorts, after a median follow-up of 2.6 years, pain worsened for 697 participants, improved for 734, and did not change for 295. Compared with the lowest category of MEDLIFE adherence, those in the highest category showed an RRR of improvement vs worsening of overall pain of 1.85 (95% CI, 1.28 to 2.67; P-trend<.001). MEDLIFE adherence was also linked to improvement in pain frequency (RRR, 1.98; 95% CI, 1.31 to 3.01; P-trend=.001), pain severity (RRR, 2.00; 95% CI, 1.33 to 3.00; P-trend=.001), and a reduction in the number of pain locations (RRR, 1.68; 95% CI, 1.13 to 2.50; P-trend=.004). Limitations of this study are the use of self-reported lifestyle data.ConclusionA Mediterranean lifestyle was associated with improvement of pain characteristics in older adults. Experimental studies should assess the efficacy of an integral lifestyle approach for the management of pain in older adults.     

社区动脉粥样硬化风险研究的进展和展望

社区动脉粥样硬化风险（ARIC）研究是1987年由美国心、肺和血液研究所资助的关注非洲裔美国人心血管健康的最大研究。旨在调查心脏病的危险因素以及心血管疾病与认知之间的联系。ARIC研究的许多发现加深了对动脉粥样硬化性心血管病病因的了解,在心血管病预防领域做出了重大贡献,证明了以人群为基础的研究对改善健康和预防疾病的重要性。主要概述ARIC研究的起源、目的、研究设计、对心血管医学的贡献以及未来的发展方向。     

Subtypes of insomnia and the risk of chronic spinal pain: the HUNT study

ObjectiveTo examine the association between subtypes of insomnia and the risk of chronic spinal pain.MethodsThe study comprised 16,401 participants without chronic spinal pain at baseline who were followed for ∼11 years. People were categorized into ‘no insomnia symptoms’, ‘subthreshold insomnia’, and ‘insomnia’. Insomnia was defined according to the diagnostic classification system requiring both daytime and nighttime symptoms, and further categorized into subtypes based on nighttime symptoms (ie, sleep onset latency [SOL-insomnia], wake after sleep onset [WASO-insomnia], early morning awakening [EMA-insomnia], or combinations of these). Subthreshold insomnia comprised those with only daytime impairment or one or more nighttime symptoms. Chronic spinal pain was defined as pain in either ‘neck’, ‘low back’, or ‘upper back’, or a combination of these.ResultsIn multivariable regression analysis using people without insomnia as reference, people with subthreshold insomnia or insomnia had relative risks (RRs) of chronic spinal pain of 1.29 (95% confidence interval [CI] 1.21–1.38) and 1.50 (95% CI 1.34–1.68), respectively. The RRs for people with one nighttime symptom were 1.30 (95% CI 0.83–2.05) for WASO-insomnia, 1.32 (95% CI 1.06–1.65) for EMA-insomnia, and 1.70 (95% CI 1.32–2.18) for SOL-insomnia, respectively. Combinations of nighttime insomnia symptoms gave RRs from 1.45 (95% CI 1.08–1.94) for WASO + EMA-insomnia to 1.72 (95% CI 1.36–2.19) for all nighttime symptoms (SOL + WASO + EMA-insomnia).ConclusionsThese findings suggest that the risk of chronic spinal pain is highest among persons with insomnia subtypes characterized by sleep onset latency or among those having insomnia symptoms in all parts of the sleep period.     

Sleep duration and mortality – Influence of age and occupational group in retired individuals

The importance of sleep duration for health or mortality attracts much public attention. Prior work indicates that both long and short sleep duration predicts mortality, with optimal sleep duration (lowest risk) at 7 h. However, we believe this may differ between subgroups. This may be the case with, for example, age groups (due to aging), or blue-collar and white-collar worker (due to work exposure). It is also likely that retirement, which permits extension of the time in bed, may confound analyses. The purpose of the present study was to investigate how occupational group (blue-collar/white-collar worker) and age influence the pattern of association between sleep duration and mortality in retired individuals. Retired individuals were selected since it was hypothesized that effects of occupation may accumulate over years and since the transition into retirement may be a confounder. We used a sample of 14 000 individuals from the Swedish Twin Registry, which had provided data on sleep duration and a number of covariates. Cox proportional hazards analysis was applied to data. The results show that occupational group did not influence the association, but showed significant hazard ratios (HR) for long (≥9.5 h) and short (<6.5 h) sleep in both groups (HR > 1.35), with optimal sleep duration (lowest HR) with a wide span (6.5–9.5 h). Age groups in tertiles also showed significant U-shapes, with a wide span (6.5–9.5 h) for the younger 2/3 (54–74 years), but a weaker pattern for the oldest third (≥75 years), for which optimal sleep fell in the 6.5–7.5 h interval. It was concluded that occupational group does not influence the association between sleep duration and mortality in retired individuals, but that age does.     

Long-term health-related quality of life of breast cancer survivors remains impaired compared to the age-matched general population especially in young women. Results from the prospective controlled BREX exercise study

ObjectiveTo investigate long-term health-related quality of life (HRQoL) changes over time in younger compared to older disease-free breast cancer survivors who participated in a prospective randomized exercise trial.MethodsSurvivors (aged 35–68 years) were randomized to a 12-month exercise trial after adjuvant treatment and followed up for ten years. HRQoL was assessed with the generic 15D instrument during follow-up and the younger (baseline age ≤ 50) and older (age >50) survivors’ HRQoL was compared to that of the age-matched general female population (n = 892). The analysis included 342 survivors.ResultsThe decline of HRQoL compared to the population was steeper and recovery slower in the younger survivors (p for interaction < 0.001). The impairment was also larger among the younger survivors (p = 0.027) whose mean HRQoL deteriorated for three years after treatment and started to slowly improve thereafter but still remained below the population level after ten years (difference −0.017, 95% CI: −0.031 to −0.004). The older survivors’ mean HRQoL gradually approached the population level during the first five years but also remained below it at ten years (difference −0.019, 95% CI: −0.031 to −0.007). The largest differences were on the dimensions of sleeping and sexual activity, on which both age groups remained below the population level throughout the follow-up.ConclusionsHRQoL developed differently in younger and older survivors both regarding the most affected dimensions of HRQoL and the timing of the changes during follow-up. HRQoL of both age groups remained below the population level even ten years after treatment.     

Changes in Health Literacy during the first year following a kidney transplantation: Using the Health Literacy Questionnaire

ObjectivesThe study aimed to identify changes in health literacy (HL) and associated variables during the first year following a kidney transplantation.MethodsA total of 196 transplant recipients were included in a prospective follow-up study. The patients answered the Health Literacy Questionnaire (HLQ) at 5 days, 8 weeks, 6 and 12 months following the kidney transplantation. Mixed linear models were used to analyze changes in HL and backward elimination was used to identify variables associated with HL.ResultsTwo main patterns of change were identified: a) HL increased during the first 8 weeks of close follow-up and b) in several domains, the positive increase from 5 days to 8 weeks flattened out from 5 days to 6 and 12 months. Self-efficacy, transplant-related knowledge, and general health were core variables associated with HL.ConclusionsOverall, HL increased during the 8 weeks of close follow-up following the kidney transplantation, while 6 months seem to be a more vulnerable phase. Furthermore, low self-efficacy, less knowledge, and low self-perceived health may represent vulnerable characteristics in patients.Practical implicationsFuture kidney transplant care should take into account patients’ access to and appraisal of health information and social support, and draw attention to potentially vulnerable groups.     

Child and family predictors of insomnia from early childhood to adolescence

BackgroundInsomnia is prevalent among children and adolescents and is associated with a wide range of negative outcomes. Knowledge about its determinants is therefore important, but due to the lack of longitudinal studies, such knowledge is limited. The aim of the present inquiry is to identify child and family predictors of future pediatric insomnia within a psycho-bio-behavioral framework.MethodsA representative community sample (n = 1,037) was followed biennially from 4 to 14 years of age (2007–2017). Insomnia was defined based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and was diagnosed by a semistructured clinical interview of children (from age eight years of age) and parents (all ages). Predictors included parent ratings of child emotional reactivity, family functioning, and marital conflict; self-reports of personality; and teacher-rated emotion regulation skills.ResultsRandom intercept cross-lagged analyses revealed that within-person increases (ie, relative to the child's typical levels across childhood) in emotional reactivity and decreases in emotion regulation skills predicted insomnia diagnosis two years later from ages 4 to 14 after adjusting for previous insomnia and all unmeasured time-invariant factors. Previous insomnia was the strongest predictor of later insomnia, whereas family functioning and marital conflict did not predict insomnia.ConclusionsIncreases in emotional reactivity and decreases in emotion regulation skills predicted insomnia above and beyond all unmeasured time-invariant factors and could be targets for interventions. Previous insomnia predicted later insomnia, thereby underscoring the importance of detecting, preventing, and treating insomnia at an early age.