Information For Clinical Management Research Articles

Descriptive Analysis of Types and Diagnoses Associated with Lower Extremity Amputation: Analysis of the US Veterans Health Administration Database 2019-2023.

Veterans in the US have higher rates of lower extremity amputation (LEA) compared to the general population and these rates have increased between 2008 and 2018. There is limited data which directly evaluate the potential underlying comorbidities associated with LEA in the veterans' population especially with the most recent data. Such information is critical to help inform clinical management strategies to reduce the risk of amputations among our veterans. This was a retrospective observational study of adults in the Veterans Health Administration database who underwent LEA from January 1, 2019 to December 31, 2023. The date of the first LEA procedure was defined as the index date. Index LEA type, patient demographic at baseline, and clinical characteristics (including diagnoses for conditions associated with LEA and other comorbidities) 1year before and 30days after the index LEA procedure (except for bacterial infections which the identification period was 30days before and 30days after the index LEA procedure) were described. Of the 27,134 Veterans with LEA, 67.3% were ≥ 65years of age, 97.0% were male, and 65.3% were non-Hispanic white. The most common type of LEA was transmetatarsal (52.9%), followed by toe (21.9%), above-knee (15.4%), and below-knee (9.8%). The most prevalent diagnoses associated with LEA were diabetes (81.6%), bacterial infections (79.1%), and peripheral artery disease (PAD; 63.3%). Only 15 Veterans (< 0.1%) had a diagnosis for combat-related injuries to lower extremities. Diabetes and PAD are highly prevalent and among the main conditions associated with LEA among US Veterans. Earlier and more effective preventative and clinical management of these conditions offer an opportunity to significantly reduce the rates of LEA in this population.

Clinicopathological Characteristics and Kidney Outcomes in Biopsy-Confirmed Acute Interstitial Nephritis

IntroductionAcute interstitial nephritis (AIN) is a significant cause of acute kidney injury, with varying etiologies and outcomes. This study aimed to examine the causes, clinical characteristics, management, and kidney outcomes in patients with biopsy-confirmed AIN. MethodsA retrospective review was conducted on 166 patients diagnosed with AIN via kidney biopsy at Mayo Clinic between 2012 and 2023. Demographic, clinical, laboratory, and pathological data were collected. The primary outcome was kidney function recovery within the first six months. Statistical analyses included univariable and multivariable logistic regression, Kaplan-Meier survival analysis, and Cox proportional hazards modeling. ResultsMedications were the primary cause of AIN (67%), followed by autoimmune diseases (20%) and infections (6%). Within six months, 76% of patients achieved kidney recovery. Multivariable analysis indicated that moderate to severe interstitial fibrosis and tubular atrophy (IFTA) and dialysis requirement were associated with non-recovery, whereas a prebiopsy diagnosis of AIN was positively associated with kidney recovery. Drug-related AIN had higher recovery rates compared to all other causes (81% versus 66%, P = 0.04), and moderate to severe IFTA and dialysis need remained significant predictors for decreased recovery. Steroid therapy, used in 81% of patients, did not significantly influence kidney recovery in the overall cohort or in drug-induced AIN. ConclusionThis study provides insights into the characteristics and outcomes of biopsy-confirmed AIN. IFTA and dialysis requirement were significant factors associated with worse kidney outcomes. These findings may help inform clinical management and prognostication in AIN patients.

Age- and sex-specific biomechanics and extracellular matrix remodeling of the ascending aorta in a mouse model of severe Marfan syndrome.

Thoracic aortic aneurysm (TAA) is associated with Marfan syndrome (MFS), a connective tissue disorder caused by mutations in fibrillin-1. Sexual dimorphism has been recorded for TAA outcomes in MFS, but detailed studies on the differences in TAA progression in males and females and their relationships to outcomes have not been performed. The aims of this study were to determine sex differences in the diameter dilatation, mechanical properties, and extracellular matrix (ECM) remodeling over time in a severe mouse model (Fbn1mgR/mgR = MU) of MFS-associated TAA that has a shortened life span. Male and female MU and wildtype (WT) mice were used at 1-4 mo of age. Blood pressure and in vivo diameters of the ascending thoracic aorta were recorded using a tail-cuff system and ultrasound imaging, respectively. Ex vivo mechanics and ECM remodeling of the aorta were characterized using a biaxial test system and multiphoton imaging, respectively. We showed that mechanical properties, such as structural and material stiffness, and ECM remodeling, such as elastic and collagen fiber content, correlated with diameter dilatation during TAA progression. Male MU mice had accelerated rates of diameter dilatation, stiffening, and ECM remodeling compared with female MU mice which may have contributed to their decreased life span. The correlation of mechanical properties and ECM remodeling with diameter dilatation suggests that they may be useful biomarkers for TAA progression. The differences in diameter dilatation and life spans in male and female MU mice indicate that sex is an important consideration for managing thoracic aortic aneurysm in MFS. NEW & NOTEWORTHY Using a mouse model (Fbn1mgR/mgR = MU) of severe thoracic aortic aneurysm in Marfan syndrome (MFS), we found that male MU aorta had an accelerated time line and increased amounts of dilatation, stiffening, and extracellular matrix (ECM) remodeling compared with female MU aorta that may have contributed to an increased risk of fatigue failure with cyclic loading over time and a reduced life span. We suggest that aortic stiffness may provide useful information for clinical management of aneurysms in MFS.

Isolated non-immune-mediated second-degree atrioventricular block in the fetus: natural history and predictive factors for spontaneous recovery.

To determine the clinical course of fetal isolated non-immune-mediated second-degree atrioventricular block (AVB) and the factors associated with spontaneous recovery in these cases. Fetuses with isolated non-immune-mediated second-degree AVB were recruited prospectively between 2014 and 2022. These fetuses were divided into two groups: those which recovered spontaneously and those which did not. Maternal and fetal characteristics and intrauterine and postnatal outcomes were compared between the two groups. The study cohort included 20 fetuses with isolated non-immune-mediated second-degree AVB, diagnosed at a median gestational age of 22.0 (range, 17.0-35.0) weeks. In 12 fetuses, 1:1 atrioventricular conduction was restored spontaneously in utero and there was no recurrence during the postnatal follow-up period. In the remaining eight fetuses, second-degree AVB was maintained and, in six of these, the pregnancy was terminated on parental request. Of the two liveborn children who had persistent second-degree AVB prenatally, one had progressed to complete AVB at the latest follow-up, at the age of 34 months, but was asymptomatic, without heart enlargement or dysfunction. The other child progressed to complete AVB after delivery and was diagnosed with type-2 long QT syndrome. This infant died aged 2 months. Fetuses in the group that recovered spontaneously had earlier gestational age at diagnosis (median, 20.0 (range, 17.0-26.0) vs 24.5 (range, 18.0-35.0) weeks; P = 0.004) and higher atrial rate at diagnosis (median, 147 (range, 130-160) vs 138 (range, 125-149) bpm; P = 0.006) in comparison with the group that did not recover spontaneously. The best cut-off values for prediction of failure to recover spontaneously were 22.5 weeks' gestational age at diagnosis and 144 bpm atrial rate at diagnosis, with sensitivities of 87.5% and 75.0%, respectively, and specificities of 92.0% and 87.5%, respectively. The outcome of 60% of fetuses with isolated non-immune-mediated second-degree AVB was favorable. Earlier gestational age and higher atrial rate at diagnosis were associated with spontaneous reversion to normal sinus rhythm. Prenatal genetic testing should be performed in cases with persistent AVB, to exclude heritable disorders including long QT syndrome. These findings provide important information for clinical management and prenatal counseling in these cases. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

Cognitive, Social, and Emotional-Behavioral Outcomes in Children and Adolescents With Beckwith-Wiedemann Syndrome.

Although Beckwith-Wiedemann syndrome spectrum (BWSp) is not usually associated with intellectual disability, recent evidences calls for further investigation of cognitive development and academic skills in children with BWSp. Moreover, research has documented social difficulties and emotional-behavioral problems associated with BWSp. Nevertheless, a full characterization of socio-emotional development in BWSp is still lacking. In the current study, cognitive and socio-emotional development was assessed in 29 children with BWSp aged 5-18 years, using a test of nonverbal intelligence, a neuropsychological battery covering multiple domains, academic skills tests, and questionnaires evaluating autistic traits and emotional-behavioral problems. As expected, most participants showed adequate performance in cognitive tests. However, the findings also highlighted greater difficulties in language than visuospatial processing, strengths in social perception, as well as slowness in reading and mental calculation. The assessment of emotional-behavioral difficulties indicated a prevalent phenotype characterized by increased anxiety, low self-esteem, social withdrawal and a tendency to control externalizing reactions, but no associations with autistic traits, cognitive outcomes, and the clinical score proposed by the recent Consensus statement. Increased social perception and internalization problems likely result from coping strategies with social and care-related stress. Overall, the findings of this study inform clinical management and genetic counseling for children and adolescents with BWSp.

Eleven-Year Report of High Number of Diphtheria Cases in Children in East Java Province, Indonesia.

A high incidence of diphtheria cases in children in East Java province, Indonesia, has been observed since the beginning of this century. Despite many efforts, the outbreaks continue. This study aims to explain the high incidence of diphtheria in children in East Java province since 2013. This cross-sectional surveillance report-based study used data from 38 districts in East Java since 1 January 2013. Collected data included demographics, clinical information, additional examinations, immunization history, and close contact management. Over eleven years, there were 4009 diphtheria patients, of whom 2921 (72.86%) were under 18 years of age. Boys (59.77%) outnumbered girls, and the most common age category was >60-144 months (51.66%). Most cases had incomplete or zero immunization (76.16%). Tonsillopharyngeal diphtheria was the most common type (69.60%). The five top districts with the most cases were Surabaya, Sidoarjo, Kabupaten Blitar, Kota Malang, and Kabupaten Malang. The eleven-year case fatality rate (CFR) was 2.36% (69/2921). This study shows that diphtheria cases in children and adolescents in East Java have consistently been high, and low immunization coverage might still be the leading cause. There has also been a shift in the district distribution. Diphtheria outbreaks require complete and sustainable efforts, not just outbreak response immunizations.

The Medicine Revolution Through Artificial Intelligence: Ethical Challenges of Machine Learning Algorithms in Decision-Making.

The integration of artificial intelligence (AI) and its autonomous learning processes (or machine learning) in medicine has revolutionized the global health landscape, providing faster and more accurate diagnoses, personalization of medical treatment, and efficient management of clinical information. However, this transformation is not without ethical challenges, which require a comprehensive and responsible approach. There are many fields where AI and medicine intersect, such as health education, patient-doctor interface, data management, diagnosis, intervention, and decision-making processes. For some of these fields, there are some guidelines to regulate them. AI has numerous applications in medicine, including medical imaging analysis, diagnosis, predictive analytics for patient outcomes, drug discovery and development, virtual health assistants, and remote patient monitoring. It is also used in robotic surgery, clinical decision support systems, AI-powered chatbots for triage, administrative workflow automation, and treatment recommendations. Despite numerous applications, there are several problems related to the use of AI identified in the literature in general and in medicine in particular. These problems are data privacy and security, bias and discrimination, lack of transparency (Black Box Problem), integration with existing systems, cost and accessibility disparities, risk of overconfidence in AI, technical limitations, accountability for AI errors, algorithmic interpretability, data standardization issues, unemployment, and challenges in clinical validation. Of the various problems already identified, the most worrying are data bias, the black box phenomenon, questions about data privacy, responsibility for decision-making, security issues for the human species, and technological unemployment. There are still several ethical problems associated with the use of AI autonomous learning algorithms, namely epistemic, normative, and comprehensive ethical problems (overarching). Addressing all these issues is crucial to ensure that the use of AI in healthcare is implemented ethically and responsibly, providing benefits to populations without compromising fundamental values. Ongoing dialogue between healthcare providers and the industry, the establishment of ethical guidelines and regulations, and considering not only current ethical dilemmas but also future perspectives are fundamental points for the application of AI to medical practice. The purpose of this review is to discuss the ethical issues of AI algorithms used mainly in data management, diagnosis, intervention, and decision-making processes.

Aneurysm growth evaluation and detection: a computer-assisted follow-up MRA analysis

Growing intracranial aneurysms pose a high risk of rupture, making the detection and quantification of the growth crucial for timely treatment strategy adoption. In this paper we propose a computer-assisted approach based on the extraction of IA shapes from associated baseline and follow-up angiographic scans and non-rigid morphing of the two shapes. From the obtained shape deformations we computed four novel features, including differential volume (dV), surface area (dSA), aneurysm-size normalized median deformation path length (dMPL), and integral of cumulative deformation distances (dICDD). An experienced neuroradiologist manually extracted the IA shape models from the baseline and follow-up MRAs and, by utilizing size change and visual assessments, classified each aneurysm into stable with morphology changes, stable or growing. We investigated the classification performance and found that three of the novel and one cross-sectional feature exhibited significantly different mean values (p-value <0.05\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$< 0.05$$\\end{document}; Tukey’s HSD test) between the stable and growing IA groups, while the mean dICDD was significantly different between all the three groups. The cross-sectional features has sensitivity to growing IAs in range 0.05–0.86, while novel features had generally higher sensitivity in range 0.81–0.90, making them promising candidates as surrogate follow-up imaging-based biomarkers for IA growth detection. These findings may offer valuable information for clinical management of patients with IAs based on follow-up imaging.

Development and Evaluation of a Data Quality Management System for the Korea Biobank Network.

As the reliance on clinical epidemiological information from human specimens grows, so does the need for effective clinical information management systems, particularly for biobanks. Our study focuses on enhancing the Korea Biobank Network's (KBN) system with data quality verification features. By comparing the quality of data collected before and after these enhancements, we observed a notable improvement in data accuracy, with the error rate decreasing from 0.1198% to 0.0492%. This advancement underscores the importance of robust data quality management in supporting high-quality clinical research and sets a precedent for the development of clinical information management systems.

An opportunity missed: Strengthening health system data on multisystem inflammatory syndrome in children from low- and middle-income countries in Asia

BackgroundMultisystem inflammatory syndrome in children (MIS-C) is a severe complication associated with SARS-CoV-2 infection. The clinical epidemiology of MIS-C is not completely understood in low- and middle-income countries (LMICs) due to limited reporting, including in Asia where there was a substantial burden of COVID-19. We aimed to discuss the challenges of diagnosing MIS-C and factors which may cause children from Asian LMICs to have an increased risk of MIS-C. MethodsNot applicable. ResultsThe burden of MIS-C in Asian LMICs may be disproportionately high due to underlying risk factors, resource-limited health systems, and the increased infectivity and transmissibility of recent SARS-CoV-2 variants. Complex clinical features of MIS-C contributed to missed or delayed diagnosis and treatment, while underlying risk factors including ethnicity, chronic health conditions, and socioeconomic factors may have predisposed children in Asian LMICs to MIS-C. ConclusionsThere was a lack of data on the clinical epidemiology of MIS-C in Asian LMICs during the COVID-19 pandemic, despite reports of higher paediatric mortality rates compared to high-income countries. This highlights the need for LMICs to have strong surveillance systems to collect high-quality and timely data on newly emerging complications associated with a pandemic, such as MIS-C. This will lead to rapid understanding of these emerging complications, and inform clinical management, disease prevention and health system planning.

A Survey of Nurse Informatics Competencies of Professional Nurses in Clinical Practice Public Hospitals in South Africa.

This study used a cross-sectional descriptive survey to examine self-rated competence in nursing informatics among 205 nurses in clinical practice across two hospitals in the Western Cape. The TANIC© scale was used to rate the skills of participants in computer literacy, clinical information management, and information literacy. The highest rating was received for computer literacy, approaching a 'comfortable' competency level. Lower scores were received for clinical information management and information literacy, indicating 'novice' to 'advanced beginner' levels. The study showed that practicing nurses have a limited level of nursing informatics competence, especially in the domains of clinical information management and information literacy. These findings support the need for educational programmes to extend beyond basic computer skills and prioritize continuous professional development in nursing informatics.

Protocol Variation in Functional Coronary Angiography Among Patients With Suspected Angina With Non-Obstructive Coronary Arteries: A Nationwide Snapshot of Current Practice Within Australia and New Zealand

Functional coronary angiography (FCA) for endotype characterisation (vasospastic angina [VSA], coronary microvascular disease [CMD], or mixed) is recommended among patients with angina with non-obstructive coronary arteries. Whilst clear diagnostic criteria for VSA and CMD exist, there is no standardised FCA protocol. Variations in testing protocol may limit the widespread uptake of testing, generalisability of results, and expansion of collaborative research. At present, there are no data describing protocol variation across an entire geographic region. Therefore, we aimed to capture current practice variations in the approach to FCA to improve access and standardisation for diagnosis of coronary vasomotor disorders in Australia and New Zealand. Between July 2022 and July 2023, we conducted a national survey across all centres in Australia and New Zealand with an active FCA program. The survey captured attitudes towards FCA and protocols used for diagnosis of coronary vasomotor disorders at 33 hospitals across Australia and New Zealand. Survey responses were received from 39 clinicians from 33 centres, with representation from centres within all Australian states and territories and both North and South Islands of New Zealand. A total of 21 centres were identified as having an active FCA program. In general, respondents agreed that comprehensive physiology testing helped inform clinical management. Barriers to program expansion included cost, additional catheter laboratory time, and the absence of an agreed-upon national protocol. Across the clinical sites, there were significant variations in testing protocol, including the technique used (Doppler vs thermodilution), order of testing (hyperaemia resistance indices first vs vasomotor function testing first), rate and dose of acetylcholine administration, routine use of temporary pacing wire, and routine single vs multivessel testing. Overall, testing was performed relatively infrequently, with very little follow-on FCA performed, despite nearly all respondents believing this would be clinically useful. This survey demonstrates, for the first time, variations in FCA protocol among testing centres across two entire countries. Furthermore, whilst FCA was deemed clinically important, testing was performed relatively infrequently with little or no follow-on testing. Development and adoption of a standardised national FCA protocol may help improve patient access to testing and facilitate further collaborative research within Australia and New Zealand.

Climate Change and Psychiatry: The Correlation between the Mean Monthly Temperature and Admissions to an Acute Inpatient Unit.

Psychiatric disorders are large contributors to the global disease burden, but research on the impact of climate change on them is limited. Our aim is to investigate the correlation between temperature and exacerbations of psychiatric disorders to help inform clinical management and future public health policies. Temperature records for the summer months from 2013 to 2022 were obtained from the meteorological station of the Department of Physics of Turin University. Data on patients admitted to the acute psychiatric unit were extracted from registries of San Luigi Gonzaga University Hospital (Turin, Italy). Regression analyses were used to investigate the correlation between temperature and number of admissions and to test for confounding variables. A total of 1600 admissions were recorded. The monthly temperature and number of admissions were directly correlated (p = 0.0020). The correlation was significant for the subgroup of admissions due to Bipolar Disorders (p = 0.0011), but not for schizophrenia or major depressive disorder. After multiple regression analyses, the effect of temperature remained significant (p = 0.0406). These results confirm the impact of meteorological factors on mental disorders, particularly on BD. This can contribute to personalised follow-up and efficient resource allocation and poses grounds for studies into etiopathological mechanisms and therapeutic implications.

Type Disparity in Sodium-Glucose Cotransporter-2 Inhibitors in Incidences of Renal Cell Carcinoma: A Propensity-Score-Matched Cohort Study.

(1) Background: Recently, sodium-glucose cotransporter-2 inhibitors (SGLT2Is) have been reported to significantly reduce renal cell carcinoma (RCC) risk. However, the effect between individual SGLT2Is on RCC incidence in patients with type 2 diabetes (T2D) or heart failure is unclear. We conducted an observational analysis to explore type disparity in the prescription of SGLT2Is on RCC risk. (2) Methods: A nationwide retrospective cohort study using the Health and Welfare Data Science Center database (2016-2021) was conducted. Patients aged ≥40 years who took SGLT2Is were designated as the SGLT2I group, whereas propensity score 1:1-matched randomly selected patients without SGLT2Is were assigned to the non-SGLT2I group. The primary outcome was the risk of incident RCC between individual SGLT2Is. Multiple Cox regression modeling was conducted to analyze the association between individual SGLT2I use and RCC risk. (3) Results: After a 5.5-year follow-up, SGLT2I use was associated with a significantly lower risk of incident RCC (hazard: 0.62; 95% confidence interval [CI]: 0.44-0.89). Compared with non-users and after adjusting for the index year, sex, age, comorbidities, concurrent medication, and the risk of developing RCC, the hazard ratios of dapagliflozin, canagliflozin, and empagliflozin were 0.66 (95% CI: 0.53-0.83), 0.84 (95% CI: 0.46-1.30), and 0.71 (95% CI: 0.56-0.90), respectively. (4) Conclusions: Our data show a type-based effect of SGLT2Is on RCC risk. The type-based effect of SGLT2Is should be further studied for better clinical management information and for reducing RCC incidence in patients with T2D.

Evaluating the Impact of Chronic Care Model on Smoking Cessation: An Interventional Study.

This study aims to assess the effectiveness of the chronic care model (CCM) in helping primary healthcare workers quit smoking. The intervention involves implementing the CCM, which includes six key elements: the healthcare system, clinical care planning, clinical management information, self-management guidance, community resources, and decision-making. The study is based on a population of 60 primary healthcare workers who smoke. The main outcome measure is smoking cessation, determined by cotinine levels in urine at the baseline, and at 6 and 12 months after the intervention. Other potential results include alterations in smoking-related behaviors and attitudes. Data analysis involves using descriptive statistics and inferential tests to determine the intervention's effectiveness in smoking cessation among primary healthcare workers. The CCM is expected to have contributed to a substantial decrease in the smoking rate among primary healthcare workers. It is also seen that there is a great reduction in urine cotinine levels during the 12-month intervention period. Moreover, a positive shift in the smoking-related behaviors and attitudes of the participants is expected. This study provides key data about the effectiveness of the CCM in helping primary healthcare workers stop smoking. This statement emphasizes the importance of considering socioeconomic factors in the design and implementation of smoking cessation interventions. This ensures that people of different incomes and social statuses have equal access to quitting smoking and achieve similar results.

Conventional Cytogenetic Analysis and Array CGH + SNP Identify Essential Thrombocythemia and Prefibrotic Primary Myelofibrosis Patients Who Are at Risk for Disease Progression.

The Philadelphia chromosome-negative myeloproliferative neoplasms (Ph-MPNs) are a heterogeneous group of clonal hematopoietic malignancies that include polycythemia vera (PV), essential thrombocythemia (ET), and the prefibrotic form of primary myelofibrosis (prePMF). In this study, we retrospectively reviewed the karyotypes from conventional cytogenetics (CC) and array Comparative Genomic Hybridization + Single Nucleotide Polymorphism (aCGH + SNP) in patients with ET or prePMF to determine whether the combined analysis of both methodologies can identify patients who may be at a higher risk of disease progression. We performed a comprehensive genomic review on 169 patients with a clinical diagnosis of ET (154 patients) or prePMF (15 patients). Genomic alterations detected by CC or array-CGH + SNP were detected in 36% of patients. In patients who progressed, 68% had an abnormal genomic finding by either technology. There was a shorter progression-free survival (PFS) among patients who were cytogenetically abnormal or who were cytogenetically normal but had an abnormal aCGH + SNP result. Leveraging the ability to detect submicroscopic copy number alterations and regions of copy neutral-loss of heterozygosity, we identified a higher number of patients harboring genomic abnormalities than previously reported. These results underscore the importance of genomic analysis in prognostication and provide valuable information for clinical management and treatment decisions.

Increased CX3CL1 in cerebrospinal fluid and ictal serum t-tau elevations in migraine: results from a cross-sectional exploratory case-control study

BackgroundTo date, migraine is diagnosed exclusively based on clinical criteria, but fluid biomarkers are desirable to gain insight into pathophysiological processes and inform clinical management. We investigated the state-dependent profile of fluid biomarkers for neuroaxonal damage and microglial activation as two potentially relevant aspects in human migraine pathophysiology.MethodsThis exploratory study included serum and cerebrospinal fluid (CSF) samples of patients with migraine during the headache phase (ictally) (n = 23), between attacks (interictally) (n = 16), and age/sex-matched controls (n = 19). Total Tau (t-Tau) protein, glial fibrillary acidic protein (GFAP), ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), and neurofilament light chain (NfL) were measured with the Neurology 4-plex kit on a Single Molecule Array SR-X Analyzer (Simoa® SR-X, Quanterix Corp., Lexington, MA). Markers of microglial activation, C-X3-C motif chemokine ligand 1 (CX3CL1) and soluble triggering receptor expressed on myeloid cells 2 (sTREM2), were assessed using an immunoassay.ResultsConcentrations of CX3CL1 but not sTREM2 were significantly increased both ictally and interictally in CSF but not in serum in comparison to the control cohort (p = 0.039). ROC curve analysis provided an AUC of 0.699 (95% CI 0.563 to 0.813, p = 0.007). T-Tau in serum but not in CSF was significantly increased in samples from patients taken during the headache phase, but not interictally (effect size: η2 = 0.121, p = 0.038). ROC analysis of t-Tau protein in serum between ictal and interictal collected samples provided an AUC of 0.729 (95% CI 0.558 to 0.861, p = 0.006). The other determined biomarkers for axonal damage were not significantly different between the cohorts in either serum or CSF.DiscussionCX3CL1 in CSF is a novel potential fluid biomarker of migraine that is unrelated to the headache status. Serum t-Tau is linked to the headache phase but not interictal migraine. These data need to be confirmed in a larger hypothesis-driven prospective study.

Psychiatric adverse events associated with the COVID-19 vaccines approved in the Republic of Korea: a systematic review.

This systematic review evaluated psychiatric adverse events (AEs) following vaccination against coronavirus disease 2019 (COVID-19). We included studies that reported or investigated psychiatric AEs in individuals who had received an approved COVID-19 vaccine in the Republic of Korea. Systematic electronic searches of Ovid-Medline, Embase, CENTRAL, and KoreaMed databases were conducted on March 22, 2023. Risk of bias was assessed using the Risk of Bias Assessment Tool for Non-randomized Studies 2.0. The study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023449422). Of the 301 articles initially selected, 7 were included in the final analysis. All studies reported on sleep disturbances, and 2 highlighted anxiety-related AEs. Sleep disorders like insomnia and narcolepsy were the most prevalent AEs, while depression was not reported. Our review suggests that these AEs may have been influenced by biological mechanisms as well as the broader psychosocial context of the COVID-19 pandemic. Although this study had limitations, such as a primary focus on the BNT162b2 vaccine and an observational study design, it offered a systematic, multi-vaccine analysis that fills a critical gap in the existing literature. This review underscores the need for continued surveillance of psychiatric AEs and guides future research to investigate underlying mechanisms, identify risk factors, and inform clinical management.

Burden from Study Questionnaire on Patient Fatigue in Qualitative Congestive Heart Failure Research.

Mixed methods research forms the backbone of translational research methodologies. Qualitative research and subjective data lead to hypothesis generation and ideas that are then proven via quantitative methodologies and gathering objective data. In this vein, clinical trials that generate subjective data may have limitations, when they are not followed through with quantitative data, in terms of their ability to be considered gold standard evidence and inform guidelines and clinical management. However, since many research methods utilise qualitative tools, an initial factor is that such tools can create a burden on patients and researchers. In addition, the quantity of data and its storage contributes to noise and quality issues for its primary and post hoc use. This paper discusses the issue of the burden of subjective data collected and fatigue in the context of congestive heart failure (CHF) research. The CHF population has a high baseline morbidity, so no doubt the focus should be on the content; however, the lengths of the instruments are a product of their vigorous validation processes. Nonetheless, as an important source of hypothesis generation, if a choice of follow-up qualitative assessment is required for a clinical trial, shorter versions of the questionnaire should be used, without compromising the data collection requirements; otherwise, we need to invest in this area and find suitable solutions.

Abstract 822: A retrospective study on the disparities of hepatocellular carcinoma

Abstract Background: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer in adults and the third leading cause of cancer-related deaths worldwide. Studies report that the incidence of, and mortality from HCC vary significantly by age, sex, and race/ethnicity; however, disparities in the expression level of tumor biomarkers, liver functions, lipid profiles, and comorbidities have not been thoroughly investigated among subpopulations of patient with HCC. Methods: A retrospective study was conducted to review 247 serial HCC cases enrolled in the University of Mississippi Medical Center during June 2000 to May 2023. The entire HCC population was stratified into subpopulations by race, gender, age and BMI. Then comparisons were performed between two corresponding subpopulations in the expression level of HCC-related biomarkers including Alpha-FP, liver functions including albumin, ALT, AST, and ALP, plasma lipid profiles including cholesterol, and comorbidity conditions including cirrhosis in benign liver tissues, smoking, alcohol using, and illness with viral hepatitis. Two-tailed Student’s T-test was used to calculate the difference in mean values, and Chi-Square Test was used to compare the difference in rates or percentages. The significant p value was set at p&amp;lt;0.05. Results: In total 247 HCC cases, males were 178 (72.1%) and females were 69 (27.9%) with a male to female ratio of 2.6:1; black patients were 108 (43.7%), white patients were 127 (51.4%), and others were 4.9%. The mean age was 59.6 years and mean BMI was 27.04. AFP was the only one of detected tumor biomarkers showing disparities: it was significantly higher in patients of male (p=0.026), younger age (p&amp;lt;0.0001), lower BMI (p=0.039), smokers (p=0.0325) and illness with viral hepatitis (p=0.0007). Disparities in liver functions included: 1) AST was significantly higher in Black HCC patients (p=0.027); 2) no statistical difference of liver functions in gender; 3) younger HCC patients had significantly lower level of Albumin (p=0.006), and higher levels of ALT (p=0.014) and AST (p=0.0032); 4) HCC patients with lower BMI also had lower level of Albumin (p=0.015), and higher levels of AST (p=0.0480 and ALP (p=0.0057). There was no statistical difference of plasma lipid profiles between subpopulations, Black HCC patients except that Black HCC patients had significantly higher levels of cholesterol (p=0.0006) and HDL (p=0.048). In comorbidity, Black HCC patients had higher rates of alcohol using and existence of cirrhosis; and male HCC patients had higher rates of smoking, alcohol usage and viral hepatitis. Conclusions: HCC patients are greatly disparate in the expression level of tumor biomarkers, liver functions, plasma lipid profiles and comorbidity conditions between subpopulations stratified by race, gender, age and BMI. These results could provide useful information for clinical management and prognosis of patients with HCC. Citation Format: Xinchun Zhou, Barrett Aldridge, Nazar Rahmanov, Zhirong Liu, Jinghe Mao, Neha Varshney. A retrospective study on the disparities of hepatocellular carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 822.