Epidemiological Study in Antiviral Innate Immunity.

This chapter summarizes the epidemiological study design of natural immune epidemiology studies based on recent COVID-19-related research. The epidemiological studies on antiviral innate immunity have mainly included randomized controlled trials (RCTs) and observational studies. Importantly, this chapter will discuss how to use these methodologies to answer an epidemiological question of natural immunity in the viral infection process based on previous studies. An observational case- or cohort-based study of antiviral innate immunity may support this theoretical hypothesis but is not appropriate for clinical practice or treatment. RCTs are the gold standard for epidemiological studies and occupy a greater role in the hierarchy of evidence.

Interoception, emotion regulation strategies and skin-picking behaviors - Results of an intensive longitudinal study.

Compulsive skin-picking is associated with emotion regulation difficulties, whose origins remain unclear. Interoception, plays an important role in effective emotion regulation. This study examined the relationship between interoception, emotion regulation strategies, and skin-picking in 136 individuals (85% women, aged 18-41), including 71 engaging in skin-picking and 65 psychologically healthy controls. We were interested in between-group differences in maladaptive and adaptive emotion regulation and aspects of interoception as well as associations of the latter with skin-picking symptoms and use of emotion regulation strategies. At baseline, we assessed habitual emotion regulation strategies (rumination, suppression, distraction, engagement, arousal control, reappraisal) and Interoceptive Sensibility (e.g., emotional awareness, body listening, self-regulation, noticing) through self-report questionnaires. Moreover, Interoceptive Accuracy (IAc) was measured via a Heartbeat Counting Task. Additionally, Ecological Momentary Assessment (EMA) over seven days was used to register use of emotion regulation strategies and the occurrence and severity of skin-picking episodes during that period. At baseline, the skin-picking group exhibited lower IAc, emotional awareness, and higher habitual use of rumination than control group. Lower IAc was associated with higher odds of reporting skin-picking episodes assessed during EMA. Body listening correlated with a reduced sense of control over skin-picking during EMA. In total sample, self-regulation was related to lower odds of using rumination during EMA and noticing with less use of cognitive reappraisal. The study highlights the complex relationship between interoception, emotion regulation, and skin-picking, offering new insights into the mechanisms underlying skin picking disorder.

Drug-induced pancreatitis: study of 38 patients. / Pancreatitis inducidas por fármacos: estudio de 38 pacientes.

INTRODUCTION: Acute pancreatitis (AP) is an inflammatory disease with multiple etiologies, and the emergence of complications. Between 0.1-5% of cases are attributed to drugs. The absence of specific characteristics complicates the diagnosis and treatment of drug-induced AP. Reviewing patients admitted with the diagnosis of drug-induced AP can provide information and improve its management. PATIENTS AND METHODS: This is a descriptive, observational, and retrospective study. All patients admitted to the Hospital Universitari de Bellvitge between June 2007 and March 2023 with suspected drug-induced AP were included. The data were obtained from the hospital pharmacovigilance program database. RESULTS: Thirty-eight patients with suspected drug-induced AP were identified, representing 0.62% of all adverse drug reactions (n=6.085). Of these, 65.8% (n=25) had a single suspected drug. The median latency period for the onset of adverse drug reactions was 160.5 days (IQR: 18-582 days), and the median hospital stay was 5 days (IQR: 3-7 days). Fifty-nine suspected drugs were identified, involving 26 active principles. Azathioprine and atorvastatin were the most frequent, with 9 cases each (15.2%), followed by enalapril with 8 cases (13.6%). Drug etiology was assessed in 23 cases (60.5%), and the suspected drug was discontinued in all cases. There was one fatal case documented (2.63%). CONCLUSION: This study can contribute to better understanding of drug-induced pancreatitis episodes. We propose a diagnostic algorithm that includes the assessment of the drug as a possible cause.

Prevalence and factors associated with the use of traditional medicine in individuals with hypercholesterolemia, hyperglycaemia, and arterial hypertension in Ecuador: results from a population-based study in two health districts.

BACKGROUND: While traditional medicine (TM) is employed by a significant portion of the global population for managing health issues, clinical guidelines and state recommendations often overlook this practice. The aim of this study was to describe the frequency of use of TM to control 3 metabolic risk factors (MRF): hypertension, hypercholesterolemia, and hyperglycaemia; and the sociodemographic, economic, and clinical characteristics associated with the use of TM. METHODS: Cross-sectional descriptive study that analyses data obtained from a representative population survey in 2 health districts, one urban in the south of Quito and another in a forested rural area with diverse ethnic groups in Esmeraldas, Ecuador. We include 602 individuals with at least one MRF. We calculated the proportion of people reporting the regular use of TM (herbal or traditional remedy) to control their MRF and we assessed potential associations with sociodemographic, economic, and clinical characteristics with a multivariable logistic regression model. RESULTS: In two very different sociocultural contexts in Ecuador we found that use of TM to control MRF was frequent (39.4% in Esmeraldas, 31.1% in Quito), frequently in combination with CM. There is a notable percentage of people, 33.9% in Esmeraldas and 39.0% in Quito, who did not take any treatment for their MRF, and the remainder used CM alone. In both settings, an individual's education lever was significantly associated with TM use. Whereas in Quito individuals with higher education more frequently treated their MRF with TM (aOR 2.04, 95% CI 1.03-3.90), in the rural, hard-to-reach context of Esmeraldas, it was more frequent among people with no formal schooling (aOR: 3.76; 95%CI 1.59-8.88), as well as those of younger age (aOR by year: 0.97; 95% CI 0.95-0.99) and afro ethnicity (aOR: 2.13; 95%CI 1.02-4.45). CONCLUSION: Traditional medicine is used by a significant proportion of the population in Ecuador, highlighting the need for a more accessible and intercultural healthcare approach. The health system should ensure access to the necessary information and resources for the management of their metabolic risk factors.

Within-person fluctuations of fatigue in patients with a clinical diagnosis of systemic sclerosis and its relationship with mood, pain, sleep and physical activity.

Objectives: To explore the within-person fluctuations of fatigue in systemic sclerosis and its association with negative affect, positive affect, pain, perceived exertion of physical activity and quality of sleep. Methods: We performed an ecological momentary assessment study in adult patients with a clinical diagnosis of systemic sclerosis. During 14 days, patients completed daily assessments of fatigue severity, negative affect, positive affect, pain, quality of sleep and perceived exertion of physical activity at four fixed time points. The day-to-day fluctuations in fatigue were quantified by the intra-individual variance and probability of acute change, capturing the magnitude and frequency of clinical relevant within-person day-to-day fluctuations, respectively. Using multilevel models, the within-person association between fatigue and the daily assessments were analysed. Results: Fifty-seven patients with systemic sclerosis participated. The mean (standard deviation) intra-individual variance was 1.08 (0.42) and the probability of acute change was mean (standard deviation) 0.40 (0.14), ranging from 0.08 to 0.77. For fatigue, a within-person variation of 51% was observed. Multilevel analyses showed that higher average levels and daily increases in negative affect, pain and perceived exertion of physical activity were associated with more fatigue, while the opposite was observed for positive affect and quality of sleep. Positive affect demonstrated the strongest association with fatigue fluctuations. Conclusion: This is the first quantitative study showing that fatigue in systemic sclerosis is characterized by a dynamic course and that approximately half of the day-to-day fluctuations within persons are clinically meaningful. Furthermore, our results indicate that integrating activities with positive impact on mood into fatigue treatment strategies might reduce the frequency of fatigue fluctuations.

Sensitivity analysis for unmeasured confounding in estimating the difference in restricted mean survival time.

The difference in restricted mean survival time has been increasingly used as an alternative measure to the hazard ratio in survival analysis. Although some statistical methods have been developed for estimating the difference in restricted mean survival time adjusted for measured confounders in observational studies, the impact of unmeasured confounding on the estimate has rarely been assessed. We develop a novel sensitivity analysis for the estimate of the difference in restricted mean survival time with respect to unmeasured confounding. After formulating the sensitivity analysis problem as an optimization problem, we explain how to obtain the sensitivity range of the difference in restricted mean survival time efficiently and assess its uncertainty using the percentile bootstrap confidence interval. Analytic results are provided for some important survival settings. Simulation studies show that the proposed methods perform well in various settings. We illustrate the proposed sensitivity analysis method by analyzing data from the German Breast Cancer Study Group study.

Association between lipid-lowering agents with intervertebral disc degeneration, sciatica and low back pain: a drug-targeted mendelian randomized study and cross-sectional observation.

BACKGROUND: Abnormal lipid metabolism is linked to intervertebral disc degeneration (IVDD), sciatica, and low back pain (LBP), but it remains unclear whether targeted interventions can prevent these issues. This study investigated the causal effects of lipid-lowering drug use on IVDD, sciatica, and LBP development. METHODS: Single-nucleotide polymorphisms (SNPs) linked to total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), and non-high-density-lipoprotein cholesterol (non-HDL-C) were obtained from the Global Lipids Genetics Consortium's genome-wide association study (GWAS). Genes near HMGCR, PCSK9, and NPC1L1 were selected to represent therapeutic inhibition targets. Using Mendelian randomization (MR) focusing on these drug targets, we identified causal effects of PCSK9, HMGCR, and NPC1L1 on the risk of developing IVDD, sciatica, and LBP, with coronary heart disease risk serving as a positive control. Using summary data from Mendelian randomization (SMR) analysis, we evaluated potential therapeutic targets for IVDD, sciatica, and LBP through protein quantitative trait loci (pQTL). The genetic associations with IVDD, sciatica, LBP, and coronary heart disease were derived from FinnGen (discovery) and UK Biobank (replication). Additionally, a cross-sectional observational study was performed using data from the National Health and Nutrition Examination Survey (NHANES) to further investigate the connection between LBP and statin use, with a sample size of 4343 participants. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were calculated to assess the outcomes. RESULTS: The NHANES-based cross-sectional study indicated that non-statin use was associated with an increased risk of developing LBP (OR = 1.29, 95% CI [1.04, 1.59], P = 0.019). Moreover, Inverse-variance weighting (IVW) analysis revealed that NPC1L1-mediated reductions in TC, LDL-C, and non-HDL-C concentrations were associated with a decreased risk of developing IVDD (P = 9.956E-03; P = 3.516E-02; P = 1.253E-04). Similarly, PCSK9-mediated reductions in LDL-C and TC concentrations were linked to a lower risk of developing sciatica (P = 3.825E-02; P = 2.709E-02). Sensitivity analysis confirmed the stability and reliability of the MR results. MST1 (macrophage stimulating 1) levels was inversely associated with IVDD, sciatica, and LBP risks. CONCLUSION: The results of cross-sectional study suggested that non-use of statins was positively correlated with LBP. The results of Mendelian randomization study suggest that NPC1L1 could lower the risk of developing IVDD by reducing TC, LDL-C, and non-HDL-C levels. Additionally, PCSK9 may reduce the risk of developing sciatica by lowering LDL-C and TC levels. In contrast, HMGCR appears to have no significant effect on IVDD, sciatica, or LBP development. Nonetheless, further research is needed to verify these preliminary results. MST1 warrants further exploration as a potential therapeutic target. It is necessary to do further research to validate these findings.

Discussion of Heated Tobacco Products on Twitter Following IQOS's Modified-Risk Tobacco Product Authorization and US Import Ban: Content Analysis.

BACKGROUND: Understanding public opinions about emerging tobacco products is important to inform future interventions and regulatory decisions. Heated tobacco products (HTPs) are an emerging tobacco product category promoted by the tobacco industry as a "better alternative" to combustible cigarettes. Philip Morris International's IQOS is leading the global HTP market and recently has been subject to important policy events, including the US Food and Drug Administration's (FDA) modified-risk tobacco product (MRTP) authorization (July 2020) and the US import ban (November 2021). Although limited in their legal implications outside the United States, these policy events have been quoted in global news outlets and Philip Morris International's promotional communications, showing how they may potentially impact global tobacco regulation. Given the impending return of IQOS to the US market, understanding how the policy events were received through social media discourse will provide valuable insights to inform global tobacco control policy. OBJECTIVE: This study aims to examine HTP-related social media discourse around important policy events. METHODS: We analyzed HTP-related posts on Twitter during the time period that included IQOS's MRTP authorization in the United States and the US import ban, examining personal testimonial, news/information, and direct marketing/retail tweets separately. We also examined how the tweets discussed health and policy. A total of 10,454 public English tweets (posted from June 2020 to December 2021) were collected using HTP-related keywords. We randomly sampled 2796 (26.7%) tweets and conducted a content analysis. We used pairwise co-occurrence analyses to evaluate connections across themes. RESULTS: Tweet volumes peaked around IQOS-related policy events. Among all tweets, personal testimonials were the most common (1613/2796, 57.7%), followed by news/information (862/2796, 30.8%) and direct marketing/retail (321/2796, 11%). Among personal testimonials, more tweets were positive (495/1613, 30.7%) than negative (372/1613, 23.1%), often comparing the health risks of HTPs with cigarettes (402/1613, 24.9%) or vaping products (252/1613, 15.6%). Approximately 10% (31/321) of the direct marketing/retail tweets promoted international delivery, suggesting cross-border promotion. More than a quarter of tweets (809/2796, 28.9%) discussed US and global policy, including misinterpretation about IQOS being a "safer" tobacco product after the US FDA's MRTP authorization. Neutral testimonials mentioning the IQOS brand (634/1613, 39.3%) and discussing policy (378/1613, 23.4%) showed the largest pairwise co-occurrence. CONCLUSIONS: Results suggest the need for careful communication about the meaning of MRTP authorizations and relative risks of tobacco products. Many tweets expressed HTP-favorable opinions referring to reduced health risks, even though the US FDA has denied marketing of the HTP with reduced risk claims. The popularity of social media as an information source with global reach poses unique challenges in health communication and health policies. While many countries restrict tobacco marketing via the web, our results suggest that retailers may circumvent such regulations by operating overseas.

Relationship between socioeconomic status and stroke: an observational and network Mendelian randomization study.

BACKGROUND: The relationship between socioeconomic status (SES) and stroke remains controversial, and the underlying mediator is unclear. This study aimed to assess the causal relationship of SES with stroke and its subtypes and to identify potential modifiable risk factors responsible for this relationship. METHODS: The study included 372,437 participants from the UK Biobank. Over an average period of 12.13 years, 6,457 individuals (2.7%) were recorded as having experienced a stroke. Cox proportional hazards model was used to determine the relationship between SES (average annual household income before tax and age at the end of full-time education) and stroke, ischemic stroke, and hemorrhagic stroke. Two-sample Mendelian randomization (MR) was employed to assess the causal relationship between SES and stroke and its subtypes. Furthermore, network MR was utilized to evaluate the potential mediating role of modifiable risk factors for stroke in this causal relationship. RESULTS: After adjusting for factors such as sociodemographic characteristics, health behaviors, health status, and past medical history, participants in the second highest income group showed the lowest risk of stroke, with a hazard ratio (HR) of 0.780 (95% confidence interval [CI]: 0.702-0.866), and for ischemic stroke, the HR was 0.701 (95% CI: 0.618-0.795). Those who completed full-time education at the latest age group(>18 years) had the lowest risk of stroke (HR: 0.906, 95% CI: 0.830-0.988) and ischemic stroke (HR: 0.897, 95% CI: 0.811-0.992). MR analysis showed that higher income and education were both associated with a lower risk of stroke (income: inverse-variance-weighted odds ratio [ORIVW] =0.796, 95% CI: 0.675-0.940, education: ORIVW = 0.631, 95% CI: 0.557-0.716) and ischemic stroke (income: ORIVW = 0.813, 95% CI: 0.684-0.966, education: ORIVW = 0.641, 95% CI: 0.559-0.735). Additionally, hypertension had the highest mediating effect on this relationship. It accounted for 57.12% of the effect of income on stroke, 51.24% on ischemic stroke, and 27% and 24% for education. CONCLUSION: Higher SES was associated with a lower risk of stroke and ischemic stroke, and hypertension had the highest mediating effect on this causal relationship. The results have significant public health implications, emphasizing the importance of early intervention to reduce the risk of stroke in low SES populations.

Real-world Study of Avelumab First-line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma in France: Overall Results from the Noninterventional AVENANCE Study and Analysis of Outcomes by Second-line Treatment.

BACKGROUND: Avelumab first-line maintenance treatment was approved for patients with advanced urothelial carcinoma (aUC) without progression following platinum-based chemotherapy (PBC), based on the results from the JAVELIN Bladder 100 phase 3 trial. OBJECTIVE: To report the results from AVENANCE, a real-world study of avelumab first-line maintenance treatment. DESIGN, SETTING, AND PARTICIPANTS: This is a retrospective and prospective, noninterventional study (NCT04822350). Eligible patients with aUC without progression on first-line PBC were enrolled at 82 centers in France between July 2021 and May 2022. The effectiveness population included 595 patients. The median follow-up was 26.3 mo. INTERVENTION: Previous, ongoing, or planned avelumab first-line maintenance treatment. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Overall survival (OS) from avelumab initiation (primary endpoint) and safety were evaluated. RESULTS AND LIMITATIONS: The median age was 73.0 yr, and performance status was 0/1 in 91% of patients and ≥2 in 9.3%. The most common prior first-line chemotherapy regimen was carboplatin plus gemcitabine (61%). At data cutoff (December 7, 2023), the median duration of avelumab treatment was 5.6 mo, 125 patients remained on avelumab, and 55% had received second-line treatment. The median OS from avelumab initiation was 21.3 mo (95% confidence interval [CI], 17.6-24.6), and the median progression-free survival was 5.7 mo (95% CI, 5.2-6.5). In exploratory analyses of this population without disease progression on PBC, the median OS from the start of first-line PBC was 26.5 mo overall, and in subgroups that received second-line enfortumab vedotin (n = 55) or PBC (n = 79), it was 41.5 and 24.5 mo, respectively. CONCLUSIONS: Real-world data from AVENANCE confirm the effectiveness and safety of avelumab first-line maintenance treatment in a heterogeneous population, supporting its recommendation for cisplatin-eligible and cisplatin-ineligible patients with aUC who are progression free after first-line PBC. In an exploratory analysis, a small subgroup that received a treatment sequence of first-line PBC without disease progression followed by avelumab first-line maintenance and second-line enfortumab vedotin had a median OS of >3 yr. PATIENT SUMMARY: A French real-world study, called AVENANCE, looked at avelumab maintenance treatment in people with advanced urothelial cancer whose tumor disappeared, shrank, or stopped growing with chemotherapy. Overall, results were consistent with those seen in a previous clinical trial, and on average, people treated with avelumab maintenance lived for 26.5 mo from the start of chemotherapy. Analyses of different groups of people found that survival varied, with people living for an average of 18-42 mo depending on what treatment they received after they finished avelumab treatment.

Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT).

BACKGROUND: Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. OBJECTIVE: With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. METHODS: LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. RESULTS: The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. CONCLUSIONS: LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. TRIAL REGISTRATION: ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/57183.

Association of platelet-to-HDL cholesterol ratio with frailty and all-cause mortality.

BACKGROUND: Frailty often requires intensive care, and the admission outcomes of frail patients are often poor. However, owing to the lack of reliable diagnostic indicators, quickly identifying frailty is challenging. The present study aimed to explore the associations of the platelet/high-density lipoprotein cholesterol ratio (PHR; a novel inflammatory indicator) with frailty and all-cause mortality. METHODS: The present study analyzed data from the National Health and Nutrition Examination Survey (NHANES) from 2005 to 2018. Frailty was assessed on the basis of the 49-item Frailty Index. The associations of the PHR with frailty and long-term survival prognosis were explored through weighted logistic regression, weighted restricted cubic spline (RCS), and weighted Cox regression, with adjustments for demographic factors, lifestyle, blood lipids, medication history, and complications. In addition, subgroup and interaction analyses were conducted. Finally, several sensitivity analyses were performed. RESULTS: A total of 15,615 adult participants were included, with 7,928 women (53.63%) and an average age of 60.76 years. After fully adjusting for confounding variables, the prevalence of frailty in the highest PHR quartile group of was significantly greater than that in the lowest quartile group (OR: 1.23, 95% CI: 1.04-1.47; P = 0.02). The RCS showed that the inflection point was 166.7. Before and after the inflection point, the PHR was negatively associated (OR: 0.88, 95% CI: 0.80-0.97, P = 0.01) and positively associated (OR: 1.10, 95% CI: 1.02-1.19, P = 0.01) with frailty, respectively. Subgroup analysis suggested that the association between PHR and frailty was stronger in women than in men. A total of 5,544 frail participants were included in the survival analysis. The RCS revealed that the PHR was associated with the all-cause mortality risk of frail participants in a U-shaped manner, with an inflection point of 240.4. Before and after the inflection point, the PHR decreased (HR: 0.89, 95% CI: 0.81-0.97, P = 0.01) and the all-cause mortality risk increased (HR: 1.08, 95% CI: 1.02-1.14, P = 0.01), respectively. CONCLUSION: The present study suggests that there is a J-shaped association between PHR and frailty in the adult population of the United States and that the association between the PHR and frailty is stronger in women. In addition, the PHR has a U-shaped relationship with the all-cause mortality risk of frail patients.

Associations between the geriatric nutritional risk index and the risk of and mortality associated with chronic kidney disease in older individuals.

BACKGROUND: Malnutrition is a complication of chronic kidney disease (CKD). Whether malnutrition, assessed via the geriatric nutritional risk index (GNRI), is associated with the incidence and risk of CKD in older individuals remains unclear. METHODS: Data from the National Health and Nutrition Examination Survey and the UK Biobank database were used. Older participants over 60 years old with available data for GNRI assessment and CKD diagnosis were enrolled. Logistic regression models and Cox regression models were used to assess associations between the geriatric nutritional risk index and the risk of and mortality associated with CKD. RESULTS: This study enrolled 13,162 participants from the NHANES and 66,326 participants from the UK Biobank. We identified 6,135 and 16,662 CKD patients in the NHANES and UK Biobank, respectively, with the majority being male (74% in the NHANES and 52% in the UK Biobank). The average age of CKD patients was 72.3 (SD 7.2) years in the NHANES and 64.9 (SD 2.9) years in the UK Biobank. The median follow-up times of older CKD patients were 81 months and 162 months in the NHANES and UK Biobank, respectively. According to the cross-sectional analysis, individuals with a lower GNRI had an increased likelihood of having CKD, with odds ratios of 1.38 (95% CI: 1.05-1.80, P = 0.020) in the NHANES and 2.35 (95% CI: 1.89-2.92, P < 0.001) in the UK Biobank. According to our analysis of the risk of incident CKD in the UK Biobank, a lower GNRI was associated with a greater incidence of CKD (HR: 1.11, 95% CI: 1.04-1.18; P = 0.002). According to the analysis of the risk of mortality, a lower GNRI was associated with an increased risk of death among older CKD patients (NHANES: HR: 1.69, 95% CI: 1.13-2.53, P = 0.011; UK Biobank: HR: 2.28, 95% CI: 1.94-2.69, P < 0.001). CONCLUSION: Malnutrition assessed by the GNRI was significantly and independently associated with the incidence of CKD. Moreover, CKD patients with malnutrition also have a high risk of mortality.

Relationship between Pharmacists' Emotional Intelligence and Job Performance: A Cross-Sectional Study in Saudi Arabia.

Pharmacists' job performance is crucial for improving pharmacy services. The purpose of this study was to evaluate the association of emotional intelligence with the job performance of pharmacists in Saudi Arabia. Using social media platforms, we disseminated an online questionnaire to pharmacists licensed to practice in Saudi Arabia between June and July 2022. The questionnaire was filled out by 352 pharmacists. The majority of the participants were women (60.5%) and working as community pharmacists (55.7%). On self-reported emotional intelligence and job performance scales, the respondents scored an average of 5.5 ± 0.9 (out of 7) and 4.0 ± 0.6 (out of 5), respectively. Multiple linear regression analyses revealed that emotional intelligence had a significant relationship with job performance (ß = 0.43, p < 0.001). In conclusion, the findings indicated that emotional intelligence may influence the job performance of pharmacists in Saudi Arabia. As the primary objective of every organization is to accomplish the best possible performance, prioritizing emotional intelligence is important. Further research is needed to identify the impact of emotional intelligence on work performance, which could potentially enhance clinical outcomes for patients.

Associations of exposure to PM2.5 and its compounds with carotid intima-media thickness among middle-aged adults.

BACKGROUND: Exposure to fine particulate matter (PM2.5) has been linked to an increased risk of atherosclerosis. However, it remains unclear whether specific compounds within PM2.5, rather than the overall mass, serve as a better indicator of adverse cardiovascular health outcomes associated with air pollution. METHODS: In this cross-sectional study, we included 3257 participants (aged 37-51 years) from the Coronary Artery Risk Development in Young Adults (CARDIA) study. Exposure to PM2.5 and its constituent compounds, black carbon (BC), ammonium, nitrate, organic matter, sulfate, mineral dust, and sea salt were included in the analyses. Carotid intima media thickness (cIMT; the average of common, bulb, and internal carotid) was measured by carotid ultrasonography. We assessed the cross-sectional associations of one-year exposure to PM2.5 and its compounds with mean cIMT using linear regression models adjusting for participants' demographics, individual- and neighborhood-level socioeconomic status, behavioral components, and health conditions. We also adopted Bayesian kernel machine regression (BKMR) models to investigate the association between the PM2.5 compound mixture and cIMT as well as the contribution of each compound to the association. RESULTS: Greater exposure to BC was associated with higher cIMT (mm) (ß =0.034, 95 % CI = 0.019-0.049, per IQR increase [0.56 µg/m3] of BC) among participants with a mean age of 45.0, consisting of 45.9 % Black and 54.1 % White males and females. The association was generally consistent across participants' demographic characteristics. In our BKMR analysis, BC exhibited a dose-response association with cIMT with a high contribution to the association of cIMT with PM2.5 compound as a mixture (posterior inclusion probability [PIP]: 1.00). CONCLUSIONS: Our findings suggest that certain compounds of PM2.5, such as BC, may offer more reliable indications of the impact of air pollution on cardiovascular health.

The effect of subjective postural vertical on forward flexed posture in Parkinson's disease.

BACKGROUND: We developed a novel method to measure the angle of subjective postural vertical (SPV) and showed that the SPV may be related to the exacerbation of the forward flexed posture. OBJECTIVES: The present study prospectively tested the effects of the subjective postural vertical on the exacerbation of the forward flexion of trunk (FFT) through long-term observation of Parkinson's disease patients. METHODS: Evaluation of the posture included measuring FFT, the angle of lateral flexion of trunk, and the angle at the position that the patient subjectively perceived as the vertical position at a stationary upright position immediately after standing up at the time of initial observation, 6 months later, and 1 year later. RESULTS: The SPV angles worsened significantly at 6 months and 1 year compared to the first measurements (9.3 ± 6.7° vs. 10.8 ± 8.2° and 10.6 ± 7.8°, P < 0.05), and the FFT angles worsened significantly at one year compared to the first measurements (11.1 ± 8.1° vs. 12.2 ± 8.8°, P = 0.004). Furthermore, using a hierarchical multiple regression model, the difference in SPV from the first visit to the first half year was considered a factor contributing to annual FFT change (P = 0.002). CONCLUSIONS: This longitudinal study of a large number of cases suggested that changes in SPV may precede changes in FFT.

The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals.

PURPOSE: The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers. METHODS: A multidisciplinary executive committee (EC) was established to guide the Oncology QCARD Initiative. The EC conducted a landscape review of published literature, guidances, and guidelines to evaluate relevant dimensions of data quality measurement. Guided by the review and informed by expert feedback, the Oncology QCARD Initial Protocol Characterization (IPC) provides a summary of minimum elements needed to adequately describe an initial clinical study concept that involves RWD and is intended to support decision-making. RESULTS: Fit-for-use data and fit-for-purpose design emerged as themes from the landscape analysis. Data that are fit-for-use are both relevant (sufficiently capturing exposure, outcomes, and covariates) and reliable (understanding data accrual and quality control and whether the data represent the underlying concepts they are intended to represent) to answer a specific research question. A fit-for-purpose design takes appropriate steps to ensure internal and external validity and allows for transparency in reporting. The QCARD-IPC focuses on high-level characteristics of RWD sources and study design domains including data temporality, population, medical product exposure, comparators, and covariates, endpoints, statistical analysis, and data quality assurance plans. CONCLUSIONS: Evaluation of studies including RWD requires understanding the data source, study design, and potential biases to preliminarily evaluate whether selected RWD are fit-for-use for the research question. The Oncology QCARD-IPC provides a structured, transparent approach to facilitate early review and enhanced communication between study sponsors and scientific reviewers of initial study proposals including RWD.

Combination therapy of dexamethasone, rituximab, and cyclosporine for adults with primary immune thrombocytopenia: a prospective observational study.

BACKGROUND: To assess the effectiveness of the combination of dexamethasone, rituximab, and cyclosporine in treating adults with primary immune thrombocytopenia (ITP). RESEARCH DESIGN AND METHODS: This prospective study enrolled consecutive adult patients diagnosed with ITP at the 967th Hospital of the Chinese People's Liberation Army Joint Service Support Force Hospital between November 2019 and February 2023. RESULTS: Twenty-eight patients (13 males, median age 43.5 years) were included. All patients previously experienced ineffective or relapsed ITP, with a median disease duration of 26.5 (range, 7-72) months. At baseline, the median platelet (PLT) count was 13.5 × 109/L (8.25-20 × 109/L). Following treatment, the PLT counts were significantly increased at weeks 1, 3, and 4. The early response rates at weeks 1 and 4 were 82.1% (23/28 patients) and 71.4% (20/28 patients), respectively. The 1-, 3-, and 6-month response rates were 71.4% (20/28), 67.9% (19/28), and 75% (21/28). The treatment-free survival rates at 12 and 24 months were 82.35% (14/17) and 71.43% (10/14), respectively. Six patients experienced transient adverse reactions. CONCLUSIONS: The combination of dexamethasone, rituximab, and cyclosporine may present a promising therapeutic option for patients with refractory ITP, with good tolerability and mild adverse reactions.

Biologic and targeted synthetic disease-modifying anti-rheumatic drugs improve body composition in rheumatoid arthritis patients more than conventional synthetic disease-modifying anti-rheumatic drugs: Results from the PRESENT study.

INTRODUCTION: The effects of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) and conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) on body composition and muscle function in rheumatoid arthritis (RA) patients requiring treatment enhancement were compared. METHODS: This multicenter, prospective, observational study (PRESENT Study) divided RA patients non-randomly into a csDMARD group (n = 100) and a b/tsDMARD group (n = 100). Changes in body composition and muscle function were examined in 80 patients in each group followed for 52 weeks. The percentages of new-onset and improved sarcopenia over 1 year were investigated. Patients in the b/tsDMARD group were divided into three groups by drug type: TNF inhibitors (n = 30), non-TNF inhibitors (n = 23), and JAK inhibitors (n = 27). RESULTS: Baseline median age and disease duration were 70.0 and 4.0 years, respectively. Changes in weight (24 and 52 weeks) and muscle mass (52 weeks) were significantly higher in the b/tsDMARD group (p = .035, p < .001, and p = .002, respectively). On multivariate logistic regression analysis, b/tsDMARD treatment (OR 3.21, p = .002), DAS28-ESR (OR 0.65 p = .011), and muscle mass (OR 0.90, p = .023) were independently associated with increased muscle mass at 52 weeks. The percentages of new-onset and improved sarcopenia were almost equal. There were no significant differences in the time-dependent changes (52 weeks) of clinical status, body composition, muscle function, and status of sarcopenia among TNF inhibitors, non-TNF inhibitors, and JAK inhibitors. CONCLUSIONS: Weight and muscle mass increased significantly more with b/tsDMARD than with csDMARD treatment. There were no differences in body composition changes by mode of action with b/tsDMARDs.