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High-Dose vs. Standard-Dose Influenza Vaccine in Heart Failure: A Prespecified Analysis of the DANFLU-2 Trial
Background: Influenza contributes substantially to disease burden in individuals with heart failure (HF) and is an established trigger of cardiovascular (CV) and HF events. Standard-dose inactivated influenza vaccine (SD-IIV) is recommended for HF, though immune responses may be attenuated. High-dose IIV (HD-IIV) was developed to enhance immunogenicity, but its effectiveness compared with SD-IIV against hospitalization for influenza and CV disease by HF status remains uncertain. Methods: This was a prespecified analysis of a pragmatic, prospective, individually randomized, open-label trial with registry-based endpoint-evaluation conducted in Denmark across the 2022/2023 to 2024/2025 influenza seasons. Citizens ≥65 years were randomized 1:1 to HD-IIV or SD-IIV. Outcomes included hospitalization for influenza-related illness, laboratory-confirmed influenza (LCI), any CV disease, cardio-respiratory disease, and HF, assessed by HF status. Effect of HD-IIV vs. SD-IIV in reducing risk of outcomes assessed was expressed as risk ratios (RR). Results: The trial randomized 332,438 participants (48.6% female, mean age 73.7±5.8 years), including 10,410 with HF at baseline (27.4% female, mean age 76.0±6.3 years). Overall, HD-IIV was associated with a statistically significant lower incidence of hospitalization for influenza-related illness, LCI, cardio-respiratory disease, CV disease, and HF compared with SD-IIV. In participants with HF, effect estimates were similar: RR for influenza-related hospitalization was 0.48 (95%CI, 0.20-1.06; p interaction =0.64), for LCI hospitalization 0.55 (95%CI, 0.29-1.02; p interaction =0.59), for cardio-respiratory hospitalization 0.89 (95%CI, 0.77-1.02; p interaction =0.34), for CV hospitalization 0.86 (95%CI, 0.72-1.02; p interaction =0.34), and for HF hospitalization 0.82 (95%CI, 0.61-1.11; p interaction =0.83). Findings were consistent across HF subgroups by disease duration, recency of hospitalization, most recent N-terminal pro-B-type natriuretic peptide, and presence of device therapy. Conclusions: In this prespecified exploratory analysis of the largest individually randomized influenza vaccine trial ever conducted, HD-IIV was associated with lower rates of influenza and CV hospitalizations compared with SD-IIV, with effect estimates similar across HF status at baseline and HF subgroups.
Caffeine Consumption, Psychological Distress, and Insomnia in a Cohort of Individuals with Depression.
IntroductionCaffeine is a widely consumed psychoactive compound that can cause anxiety and sleep difficulties, in part due to genetic variation. We investigated the association between caffeine consumption, psychological distress, and sleep difficulties in a genetically informative cohort of individuals with a history of depression.MethodsSurvey data and genetic information were sourced from the Australian Genetics of Depression Study (AGDS [n = 20,689, %female = 75%, mean age = 43 ± 15 years]). Associations between caffeine consumption and symptoms of distress and sleep disturbance, as well as 9 genetic variants associated with caffeine consumption behaviour, were assessed using linear regression.ResultsThe highest consumers of caffeine reported higher psychological distress measured by the Kessler 10 scale (β = 1.21, SE = 0.25, p = 1.4 × 10-6) compared to the lowest consumers. Consumption was associated with 2 genetic variants with effect sizes ∼0.35 additional caffeinated drinks/day between opposite homozygotes (p < 0.005). A deletion near MMS22L/POU3F2 was associated with 10% increased odds of reporting caffeine susceptibility (OR = 1.1 per deletion [95% CI: 1.04-1.17], p = 0.002).ConclusionsHigher rates of caffeine consumption were associated with higher levels of psychological distress, but not insomnia, in individuals with a history of depression. While the direction of causality is unclear, caffeine consumption may be a modifiable factor to reduce distress in individuals susceptible to mental health problems. Some of the previous findings of common variant associations with caffeine consumption and susceptibility were replicated.
Sex-stratified genome-wide association meta-analysis of major depressive disorder.
There are striking sex differences in the prevalence and symptomology of Major Depressive Disorder. Here, we conduct the largest sex-stratified genome wide association and genotype-by-sex interaction meta-analyses of Major Depressive Disorder to date (Females: 130,471 cases, 159,521 controls. Males: 64,805 cases, 132,185 controls). We identify 16 and eight independent genome-wide significant variants in females and males, respectively, including one novel variant on the X chromosome. Major Depressive Disorder in females and males shows substantial genetic overlap with a large proportion of variants displaying similar effect sizes across sexes. However, we also provide evidence for a higher burden of genetic risk in females which could be due to female-specific variants. Additionally, sex-specific pleiotropic effects may contribute to the higher prevalence of metabolic symptoms in females with Major Depressive Disorder. These findings underscore the importance of considering sex-specific genetic architectures in the study of health conditions, including Major Depressive Disorder, paving the way for more targeted treatment strategies.
Trends and variation in the incidence of hip fracture in England before, during, and after the COVID-19 pandemic (2014-2024): a population-based observational study.
Hip fractures are a common serious injury in older adults. The COVID-19 pandemic had a substantial impact on hip fracture prevention services, but contemporary data on incidence are scarce. We investigated recent trends and variation in the incidence of hip fracture in England. A population-based study was conducted of hip fracture hospital presentations in adults aged ≥50 years using English national secondary care data (January 2014-October 2024). Trends in incidence were compared across pre-pandemic (January 2014-February 2020), pandemic (March-2020-July-2021), and post-pandemic periods (August 2021-October 2024). Variation by age, sex, and area-level deprivation were explored. From 2014 to 2024, there were 704,762 hip fractures in 669,101 patients. Age-standardised incidence rates steadily declined from 2014 to 2019 from a mean monthly rate of 28.0-26.4 per 100,000 population. Incidence rates were below expected levels during the pandemic (IRR 0.96, 95% CI 0.94-0.97) but above expected levels in the post-pandemic period (IRR 1.03, 95% CI 1.01-1.04), resulting in 5595 more hip fractures than expected from August 2021 to October 2024. Hip fractures were more common in women, but temporal trends were consistent by sex. Incidence rates were higher in the most compared with the least deprived quintile; these inequalities remained largely unchanged by 2024 (IRR, 95% CI 1.67 [1.45-1.93] in men; 1.30 [1.19-1.42] in women). This study highlights an excess of hip fracture presentations to hospital since the COVID-19 pandemic, and continued disparities in incidence by deprivation, despite an overall decreasing long-term trend. More equitable prevention strategies are needed, such as through more widespread screening for fracture risk and better coverage of fracture liaison services. Authors are supported by the NIHR Oxford BRC.
Palliative care for Muslims and issues before death.
National and European directives have now enshrined within European law the requirement that healthcare professionals provide their patients with culturally appropriate and sensitive care. Although well intentioned, many health professionals find it difficult to translate these directives into practice. Barriers to providing culturally competent care include racism, institutional discrimination and gaps in our understanding of the interface between culture and health--this latter factor reflecting the lack of training in transcultural health care. In this paper, we concentrate on issues relating to the provision of palliative care near death to Muslims of South Asian origin in the UK, although much of what is said will equally be applicable to Muslims from other parts of the world. This is the first of two articles giving insights into the palliative care of Muslims. The second article 'Palliative care of Muslims and issues after death' will appear in a later issue.
Safer medicines management in primary care.
Errors in the medicines management process represent an important source of iatrogenic harm in primary care. Most errors result from underlying systems-based problems that are amenable to intervention and potentially preventable. In this paper, we seek to identify the frequency of medication-related morbidity in primary care, understand the underlying systemic reasons that increase risk of medication-related errors and iatrogenic harm, and suggest strategies for improving the safety of medicines management.
Randomised controlled trials in primary care: scope and application.
There is now widespread acknowledgement of the absence of a sound evidence base underpinning many of the decisions made in primary care. Randomised controlled trials represent the methodology of choicefor determining efficacy and effectiveness of interventions, yet researchers working in primary care have been reluctant to use intervention studies, favouring observational study designs. Unfamiliarity with the different trial designs now available, and the relative advantages and disadvantages conferred by each, may be one factor contributing to this paradox. In this paper, we consider the principal trial designs available to primary care researchers, discussing the contexts in which a particular design may prove most useful. This information will, we hope, also prove useful to primary care clinicians attempting to interpret trial findings.
House dust mite barrier bedding for childhood asthma: randomised placebo controlled trial in primary care [ISRCTN63308372].
BackgroundThe house dust mite is the most important environmental allergen implicated in the aetiology of childhood asthma in the UK. Dust mite barrier bedding is relatively inexpensive, convenient to use, and of proven effectiveness in reducing mattress house dust mite load, but no studies have evaluated its clinical effectiveness in the control of childhood asthma when dispensed in primary care. We therefore aimed to evaluate the effectiveness of house dust mite barrier bedding in children with asthma treated in primary care.MethodsPragmatic, randomised, double-blind, placebo controlled trial conducted in eight family practices in England. Forty-seven children aged 5 to 14 years with confirmed house dust mite sensitive asthma were randomised to receive six months treatment with either house dust mite barrier or placebo bedding. Peak expiratory flow was the main outcome measure of interest; secondary outcome measures included asthma symptom scores and asthma medication usage.ResultsNo difference was noted in mean monthly peak expiratory flow, asthma symptom score, medication usage or asthma consultations, between children who received active bedding and those who received placebo bedding.ConclusionsTreating house dust mite sensitive asthmatic children in primary care with house dust mite barrier bedding for six months failed to improve peak expiratory flow. Results strongly suggest that the intervention made no impact upon other clinical features of asthma.