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10.1101/2024.11.08.24316949

Reliability of large language model knowledge across brand and generic cancer drug names

Gallifant, J.; Chen, S.; Jain, S. K.; Moreira, P.; Topaloglu, U.; Aerts, H. J.; Warner, J. L.; La Cava, W. G.; Bitterman, D. S.

Danielle S Bitterman

Artificial Intelligence in Medicine (AIM) Program, Mass General Brigham, Harvard Medical School, Boston, MA, USA

2024-11-08

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oncology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24316949.source.xml

Purpose To evaluate the performance and consistency of large language models (LLMs) across brand and generic oncology drug names in various clinical tasks, addressing concerns about potential fluctuations in LLM performance due to subtle phrasing differences that could impact patient care. Methods This study evaluated three LLMs (GPT-3.5-turbo-0125, GPT-4-turbo, and GPT-4o) using drug names from the HemOnc ontology. The assessment included 367 generic-to-brand and 2,516 brand-to-generic pairs, 1,000 drug-drug interaction synthetic patient cases, and 2,438 immune-related adverse event (irAE) cases. LLMs were tested on drug name recognition, word association, drug-drug interaction (DDI) detection, and irAE diagnosis using both brand and generic drug names. Results LLMs demonstrated high accuracy in matching brand and generic names (GPT-4o: 97.38% for brand, 94.71% for generic, p < 0.0001). However, they showed significant inconsistencies in word association tasks. GPT-3.5-turbo-0125 exhibited biases favoring brand names for effectiveness (OR 1.43, p < 0.05) and being side-effect-free (OR 1.76, p < 0.05). DDI detection accuracy was poor across all models (<26%), with no significant differences between brand and generic names. Sentiment analysis revealed significant differences, particularly in GPT-3.5-turbo-0125 (brand mean 0.6703, generic mean 0.9482, p < 0.0001). Consistency in irAE diagnosis varied across models. Conclusions and Relevance Despite high proficiency in name-matching, LLMs exhibit inconsistencies when processing brand versus generic drug names in more complex tasks. These findings highlight the need for increased awareness, improved robustness assessment methods, and the development of more consistent systems for handling nomenclature variations in clinical applications of LLMs.

medrxiv

10.1101/2024.11.07.24316948

Variable-Interval Temporal Feathering to Optimize Organ-at-Risk Repair for Head and Neck Adaptive Radiotherapy

Karagoz, A.; Hemmati, M.; Nosrat, F.; Mavroidis, P.; Dede, C.; McCullum, L. B.; Garcia, R.; Hosseinian, S.; Scott, J. G.; Bates, J. E.; Enderling, H.; Mohamed, A. S. R.; Brock, K. K.; Schaefer, A. J.; Fuller, C. D.; Rice/MD Anderson Center for Operations Research in Cancer (CORC), ; MD Anderson Head and Neck Cancer Symptom Working Group,

Mehdi Hemmati

School of Industrial and Systems Engineering, University of Oklahoma, Norman, OK

2024-11-08

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oncology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316948.source.xml

Purpose: Temporally feathered radiation therapy (TFRT) for head-and-neck cancer (HNC) radiotherapy combines variable-dose daily subplans to increase the rest time of organs-at-risk (OARs) as sought in intensity modulated radiation therapy (IMRT). While the standard TFRT recommends uniform rest time for each OAR, improved toxicity outcomes may be achieved through variable rest time for OARs by incorporating the OARs' variable radiosensitivity profiles. Methods and Materials: A decision-making model was constructed to maximize the combined recovery of OARs by determining OARs' optimal rest times. Two main components were incorporated: the cumulative biologically effective dose based on the linear-quadratic model; and a dynamical model capturing the adjusted recovery of OARs as a function of delivered dose. Further, variable radiosensitivity profiles were allowed across the OARs to capture their variable recovery time. Individual recoveries of each OAR under IMRT and the standard TFRT (sTFRT) was compared against optimized TFRT (oTFRT). Results: Five OARs (larynx, esophagus, parotid, spinal cord, brainstem) were considered. When the cumulative dose delivered under TFRT and IMRT remains the same, three OARs exhibited higher recovery under oTFRT compared to the second-best approach (larynx (81.8% vs. 74.1%), esophagus (95.9% vs. 93.9%), parotid (85.6% vs. 83.5%), while the recovery of spinal cord (90.5% vs. 90.8%) and brainstem (96.2% vs. 96.6%) remained comparable under TFRT and IMRT approaches. With different cumulative dose under TFRT and IMRT, oTFRT achieved significantly higher recovery for larynx (95.5% vs. 81.8%) and parotid (92.9% vs. 85.6%), while it is slightly outperformed by IMRT for esophagus (93.4% vs. 95.9%), spinal cord (87.1% vs. 90.5%), and brainstem (90.2% vs. 96.6%). When considering the minimum end-of-treatment recovery, oTFRT always achieved higher recovery among the other two approaches. Conclusions: By considering non-identical radiosensitivity profiles of OARs in HNC radiotherapy, TFRT can optimize their rest time to enhance recovery at the end of treatment, potentially reducing patient toxicities.

medrxiv

10.1101/2024.11.06.24316625

Assessing Language Barriers in Health Facilities in Malawi

Taylor, A.; Kazembe, P.

Amelia Taylor

Malawi University of Business and Applied Sciences

2024-11-08

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health systems and quality improvement

https://www.medrxiv.org/content/early/2024/11/08/2024.11.06.24316625.source.xml

Background Language barriers in healthcare lead to miscommunication between professionals and patients, thereby reducing the quality of and equitable access to healthcare. In African countries, the recognition and formal study of these barriers is severely limited despite Africa having more languages than any other continent. Our study investigates language barriers in healthcare facilities in Zomba district in Malawi, where three major local languages are spoken. Methods We employed a mixed methods approach and conducted a questionnaire-led study. Data were gathered at 22 health facilities, from 79 healthcare professionals and 312 outpatients using a semi-structured questionnaire. Findings were corroborated using document analysis to review legislation and policies, curriculum documents and patient notes. Results Language discordance emerged as a problem for professionals and patients. Both faced challenges due to vocabulary limitations for medical terms in English and Chichewa. Professionals did not receive training on how to effectively communicate medical concepts in local languages. Most patients did not speak English, which was used for all written records. Patient understanding of the information given to them verbally during consultations or in written health notes was very low, and this diminished their confidence in the diagnosis or treatment they received. Social factors including gender, age or patient experience, as well as patient literacy or perceived low literacy, poor rapport between healthcare professionals and patients, and a lack of privacy during consultations all exacerbated communication issues. Consequences of language barriers included unsatisfactory care experiences and compromised exchanges of health information. Strategies used by professionals to cope with these challenges were flexibility in the choice of language, reliance on physical checks and non-verbal communication indicators and the occasional use of ad-hoc interpretations. Conclusion Language barriers in healthcare facilities in Malawi have serious implications on the quality of healthcare provided. We propose solutions such as the development of dictionaries with phrases for symptoms and conditions, sensitisation courses that incorporate language considerations for both professionals and patients. Policies such as the provision of interpreters and staff allocation are discussed. We recognise that coordinated efforts at national and international levels are key to securing significant funding for effective interventions.

medrxiv

10.1101/2024.11.06.24316625

Assessing Language Barriers in Health Facilities in Malawi

Taylor, A.; Kazembe, P.

Amelia Taylor

Malawi University of Business and Applied Sciences

2024-11-09

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health systems and quality improvement

https://www.medrxiv.org/content/early/2024/11/09/2024.11.06.24316625.source.xml

Background Language barriers in healthcare lead to miscommunication between professionals and patients, thereby reducing the quality of and equitable access to healthcare. In African countries, the recognition and formal study of these barriers is severely limited despite Africa having more languages than any other continent. Our study investigates language barriers in healthcare facilities in Zomba district in Malawi, where three major local languages are spoken. Methods We employed a mixed methods approach and conducted a questionnaire-led study. Data were gathered at 22 health facilities, from 79 healthcare professionals and 312 outpatients using a semi-structured questionnaire. Findings were corroborated using document analysis to review legislation and policies, curriculum documents and patient notes. Results Language discordance emerged as a problem for professionals and patients. Both faced challenges due to vocabulary limitations for medical terms in English and Chichewa. Professionals did not receive training on how to effectively communicate medical concepts in local languages. Most patients did not speak English, which was used for all written records. Patient understanding of the information given to them verbally during consultations or in written health notes was very low, and this diminished their confidence in the diagnosis or treatment they received. Social factors including gender, age or patient experience, as well as patient literacy or perceived low literacy, poor rapport between healthcare professionals and patients, and a lack of privacy during consultations all exacerbated communication issues. Consequences of language barriers included unsatisfactory care experiences and compromised exchanges of health information. Strategies used by professionals to cope with these challenges were flexibility in the choice of language, reliance on physical checks and non-verbal communication indicators and the occasional use of ad-hoc interpretations. Conclusion Language barriers in healthcare facilities in Malawi have serious implications on the quality of healthcare provided. We propose solutions such as the development of dictionaries with phrases for symptoms and conditions, sensitisation courses that incorporate language considerations for both professionals and patients. Policies such as the provision of interpreters and staff allocation are discussed. We recognise that coordinated efforts at national and international levels are key to securing significant funding for effective interventions.

medrxiv

10.1101/2024.11.07.24316777

Relationship between plasma cortisol concentration and Long COVID symptoms in the post-acute phase of COVID-19: a cross-sectional study and recommendations for future research

Dalhuisen, T.; Grebe, H.; Anglin, K.; Lu, S.; Goldberg, S. A.; Kallas-Silva, L.; Hauser, J.; Conway, E.; Ewing, M.; Chen, J. Y.; Fehrman, E. A.; Kelly, J. D.; Martin, J. N.; Hunt, P. W.; Henrich, T. J.; Durstenfeld, M. S.; Deeks, S. G.; Murphy, E.; Schambelan, M.; Peluso, M. J.

Michael J. Peluso

Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, USA

2024-11-08

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infectious diseases

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316777.source.xml

BACKGROUND: Low cortisol concentrations have been reported in some people with Long COVID (LC), but more data from diverse cohorts are needed to validate this observation. A subset of people with LC present with symptoms resembling those of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The objective of this study was to compare cortisol concentrations in those with and without Long COVID, with a particular focus on people experiencing ME/CFS-like Long COVID. METHODS: We measured plasma cortisol in 200 individuals 3-6 months following a SARS-CoV-2 infection. Banked biospecimens collected between 8 AM-12 PM were used. Participants met the case definition for Long COVID if they had >=1 COVID-attributed symptom at least 3 months after symptom onset. People who did not report any symptoms at least 3 months after symptom onset served as recovered controls. Adapting the 2015 Institute of Medicine criteria for ME/CFS, we further defined those with LC resembling ME/CFS (LC-ME). RESULTS: We found no difference in overall morning cortisol concentrations between people with LC (n=144) and those who fully recovered (n=56) (median 8.9 g/dL vs. 8.8 g/dL, p=0.97). Analyses of samples collected between 8-10 AM, however, revealed that, compared to those who fully recovered, cortisol concentrations were lower between 8-9 AM for those with LC-ME (median 8.2 vs. 14.8, p=0.02), but higher between 9-10 AM for those with severe LC (>=5 symptoms) (median 12.4 vs. 8.5, p=0.009) and those with LC-ME (median 13.7 vs. 8.5, p=0.02). CONCLUSION: We found no difference in overall morning plasma cortisol concentrations between those with and without Long COVID. Although our data could be suggestive of altered morning cortisol dynamics in a subset of people with Long COVID, longitudinal measures of cortisol in individuals with Long COVID will be critical to further inform the biology of the condition.

medrxiv

10.1101/2024.11.08.24316976

Post-SARS-CoV-2 Onset Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Symptoms in Two Cohort Studies of COVID-19 Recovery

Jamal, A.; Dalhuisen, T.; Gallego Marquez, N.; Dziarski, A. D.; Uy, J.; Walch, S. N.; Thomas, S. A.; Fehrman, E. A.; Romero, A. E.; Zelaya, A. S.; Akasreku, E. A.; Adeagbo, T. V.; Pasetes, E. C.; Akbas, S. Y.; Azola, A. M.; Deeks, S. G.; Kelly, J. D.; Martin, J. N.; Henrich, T. J.; Landay, A. L.; Peluso, M. J.; Antar, A. A. R.

Annukka A. R. Antar

Johns Hopkins University

2024-11-08

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infectious diseases

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24316976.source.xml

Objective: To determine how many people with long COVID also meet diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Methods: We identified which participants with long COVID also met the Institute of Medicine (IOM) or the 2003 Canadian Consensus Criteria (CCC) for ME/CFS at approximately 6-8 months post-SARS-CoV-2 infection in two cohorts: (1) the JHU COVID Recovery cohort, which enrolled participants within 4 weeks of infection and (2) the Long-term Impact of Infection with Novel Coronavirus (LIINC) cohort, which enriched for participants with long COVID. Neither study administered ME/CFS-specific surveys, so available data elements were mapped onto each ME/CFS diagnostic criteria. Results: Of 97 JHU participants with long COVID, 5 met IOM criteria and 2 met CCC criteria. Of 281 LIINC participants with long COVID, 51 met the IOM criteria and 29 met the CCC criteria. In LIINC, participants with long COVID meeting ME/CFS criteria were more likely to be female and report a greater number of post-COVID symptoms (p<0.001). Conclusions: The co-occurrence of ME/CFS symptoms and long COVID suggests that SARS-CoV-2 is a cause of ME/CFS. ME/CFS-specific measures should be incorporated into studies of post-acute COVID-19 to advance studies of post-SARS-CoV-2 onset ME/CFS.

medrxiv

10.1101/2024.11.08.24316961

Sex-specific risk of smoking for abdominal aortic aneurysm and exploration of potential mechanism: meta-analysis and prospective cohort study

Powell, J. T.; Pouncey, A. L.; Welsh, P.

Janet T Powell

Imperial College London

2024-11-08

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cardiovascular medicine

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24316961.source.xml

Objective: Smoking is the strongest modifiable risk factor for abdominal aortic aneurysm (AAA). This study aims to confirm whether smoking is a stronger risk factor in women than men and identify contributory reasons, including inflammation, for any sex-specific difference observed. Methods: Systematic review and meta-analysis, conducted according to PRISMA guidance (Prospero registration (CRD2024586609)). Data sources were Medline, Embase, and CENTRAL. Population-based studies reporting risk of AAA, adjusted for age and cardiovascular risk factors, for women versus men, were included. These were complemented by data from the UK Biobank (UKB) cohort, which also were assessed for sex-specific effects of smoking on incident atherosclerotic cardiovascular disease (ASCVD). Results: Meta-analysis of 6 studies (including UKB), 2001-2024) showed that the relative risk ratio of current versus never-smokers for incident AAA in women versus men was 1.78 [95%CI 1.32, 2.38]. Comparison of the sex-specific relative risks of current smoking and number of cigarettes/day were similar in the UKB cohort and these risks were much higher for AAA than for ASCVD, but the risks of pack-years were similar. Sex-specific risks of current smoking for AAA were not significantly modified by inflammatory markers (including C-reactive protein, alkaline phosphatase and white blood cell count), lung function or physical activity. Stopping smoking reduced the risk of AAA by almost half in both sexes. Conclusion: The risk of developing AAA by current smokers is almost twice as high in women versus men. Inflammation was not a major modifier and other reasons for the disparity must be sought.

medrxiv

10.1101/2024.11.08.24316954

A systematic review of the methodological considerations in Campylobacter burden of disease studies

Tumulty, M.; Di Bari, C.; Devleesschauwer, B.; M. Pires, S.; Kabir, Z.

Megan Tumulty

University College Cork

2024-11-08

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epidemiology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24316954.source.xml

Background: Campylobacteriosis is a major zoonotic and foodborne disease (FBD), posing a substantial social and health economic burden on human health. Burden of disease (BoD) studies, which increasingly use the disability-adjusted life years (DALYs) metric, provide comprehensive insights into disease effects. However, the complexity of DALY calculations, combined with diverse causative agents and research gaps, complicates cross-regional comparisons. This review evaluates existing Campylobacter BoD studies and interrogates their methodological approaches and assumptions in quantifying DALYs. Methods/Principal Findings: A systematic search of PubMed, EMBASE, Web of Science, and selected grey literature databases was conducted to identify existing CampylobacterBoD studies. Studies assessing the BoD methodology and calculation using the DALY framework were considered. In total, 23 studies met the predefined inclusion criteria. Of these, 19 were single-country studies, while 4 were multi-country analyses. A significant data gap exists, with limited or no studies from low- and middle-income countries, exemplified by just one study obtained from Rwanda. Most studies used an incidence- and pathogen-based approach to estimate DALYs, excluding social weighting, in line with the Global Burden of Disease (GBD) study. Methodological discrepancies were noted, especially in disability weight (DW) assignment, health state classification, and life expectancy table usage. Most single-country studies (n=8) used national life tables rather than universal ones, challenging cross-country comparisons due to a lack of standardisation. Conclusion: Significant variations in the methodological approaches and assumptions for Campylobacter BoD studies exist. Addressing these disparities is essential for harmonising methodological design choices using the DALYs metric to inform evidence-based public health policies and interventions. PROSPERO Registration Number: The protocol for this study was registered with the International Prospective Register of Systematic Reviews (PROSPERO), which can be accessed under the registration number CRD42023414973.

medrxiv

10.1101/2024.11.05.24316808

Comparison of Tooth Wear Among Young Sports Persons Involved in Individual and Team Sports- A Cross-Sectional Study

Rangasamy, R.; KenniyanKumar, S.; Harikrishnan, P.; Muthusamy, R.; Perumal, P.; Thuckanickenpalayam Ragunathan, Y.; Sivanandhan, S.

SriChinthu KenniyanKumar

KSR Institute of Dental Science and Research

2024-11-08

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sports medicine

https://www.medrxiv.org/content/early/2024/11/08/2024.11.05.24316808.source.xml

BACKGROUND: Tooth wear has multifactorial etiology & defined as non-self-reparable loss of hard tissue in the absence of dental caries or trauma. One of the valid aetiologies for pathological tooth wear is stress. During sports activity, athletes tend to clench their teeth involuntarily which results in tooth wear, especially in young sportspersons. Hence, we designed a study to evaluate and compare tooth wear among young sportspersons involved in individual and team sports. METHODS: The study population comprised 300 subjects and were divided into two groups, group 1 (150 individuals involved in individual sports activity) & group 2 (150 individuals involved in team sport activity) The Tooth wear index was assessed based on Smith & Knight scoring criteria (1984). RESULTS: 88.6% of study participants showed tooth wear in individual sports & 84% in team sports. Tooth wear was highest in the mandibular & maxillary central incisor of both individual & team sports individuals. CONCLUSION: We found that both individual and team sports players showed tooth wear, especially in the incisal surface of mandibular & maxillary incisors, which might reflect the underlying stress or anxiety. This study is the first of its kind to evaluate and compare tooth wear among young sportspersons involved in individual and team sports in India. Keywords: Tooth wear, Individual Sports, Team sports, Young, Athlete

medrxiv

10.1101/2024.11.08.24315876

The impact of psychological treatment on catastrophization and pharmacological response in chronic migraine: A single-center experience

Sepe, F. N.; Lanni, C.; Lancia, G.; De Michelis, D.

Federica Nicoletta Sepe

IRCCS C. Mondino Foundation, Stroke Unit Department

2024-11-08

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neurology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24315876.source.xml

Background: We aimed to assess the impact of pain catastrophizing, measured using the Italian version of the Pain Catastrophizing Scale (PCS), on the clinical response of patients with chronic migraine to anti-CGRP monoclonal antibodies combined with a multidisciplinary approach, including psychological treatment. Methods: Twenty-five outpatients from the SS. Antonio e Biagio e Cesare Arrigo headache clinic were randomly assigned to receive Galcanezumab, Erenumab, or Fremanezumab. Their clinical response was evaluated over six months using several measures, including the reduction in the number of migraine days per month and quality of life assessments via the Headache Impact Test (HIT-6), Migraine Disability Assessment Score questionnaire (MIDAS), and Beck Inventory Scale (BDI-II) for comorbid depression. Results: We established a strong correlation between HIT-6 and PCS, with coefficients of 0.81 and 0.88 at T1 and T2, respectively. Additionally, there was no significant correlation between PCS and other scales, such as MIDAS, nor with any pharmacological therapies. Conclusion: This study underscores the importance of a multidisciplinary approach, including psychological follow-up, for a specific clinical phenotype of chronic migraine patients prone to catastrophizing. However, further data are needed to support these findings.

medrxiv

10.1101/2024.11.07.24316940

ELABELA as a Potential Diagnostic Biomarker and Therapeutic Target of Atherosclerosis

Tang, L.; Yi, X.; Yang, H.; Song, S.; Tan, W.; Xiong, J.; Liu, C.; Zhang, Y.; Wang, M.; Zhu, M.; Zheng, L.; Yu, J.; Xu, C.

Chuanming Xu

Jiangxi University of Chinese Medicine

2024-11-08

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cardiovascular medicine

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316940.source.xml

Atherosclerosis (AS) is a progressive arterial disease characterized by chronic inflammation and plaque formation in blood vessel walls. ELABELA, an endogenous ligand for the G protein-coupled receptor APJ (apelin peptide jejunum, apelin receptor), has multiple pharmacological activities for protecting the cardiovascular system. This study aimed to determine the potential anti-atherosclerotic effect of ELABELA and reveal the underlying mechanisms. Plasma ELABELA levels were significantly reduced and negatively correlated with plasma MMP2 and MMP9 levels in AS patients and high-fat diet-induced atherosclerotic ApoE-/- mice. Plasma ELABELA levels exhibited a potential diagnostic value for AS patients. Application of ELABELA-21 (ELA-21) significantly decreased atherosclerotic plaque area and inflammation in the aortas from the ApoE-/- mice. ELA-21 administration modulated the balance between M1 and M2 macrophages in the abdominal cavity and aorta roots toward a more anti-inflammatory status, accompanied by reduced MMP2, MMP9, and PRR and enhanced APJ, ACE, and ACE2 protein expression in plaques within aortic roots and decreased plasma sPRR levels. In vitro, ELA-21 effectively suppressed oxidized-low-density lipoprotein-induced foam cell formation and LPS/IFN-{gamma}-induced M1 polarization in THP-1 cells. Interestingly, the anti-inflammatory effect of ELA-21 was further enhanced by APJ inhibitor ML221, accompanied by elevated ACE and ATP6AP2 and reduced ACE2 mRNA levels. Collectively, our data highlighted the diagnostic and therapeutic potential of ELABELA on AS. ELA-21 protects against AS by inhibiting atherosclerotic plaque formation and promoting a more stable plaque phenotype, possibly via restoring the M1/M2 macrophage balance, enhancing macrophage ACE and ACE2 expression, and inhibiting the PRR system. ELABELA may be a novel biomarker and candidate therapeutic target for treating AS.

medrxiv

10.1101/2024.11.07.24316896

Quality of life of Type II Diabetic patients

Ghimire, S.; Neupane, G.; Sah, C.; Ghimire, M. R.; Soti, B.

Sulochana Ghimire

Universal College of Medical Sciences and Teaching Hospital: Universal College of Medical Sciences

2024-11-08

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endocrinology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316896.source.xml

Objective Diabetes mellitus poses significant challenges to individuals' well-being, affecting various aspects of their lives beyond the physical symptoms of the disease. Understanding the multidimensional aspects of QoL among diabetic patients is crucial for providing holistic healthcare interventions and improving overall health outcomes. The study aims to evaluate the quality of life of Type II Diabetes Mellitus patients. Research Design and Methods Descriptive cross-sectional study was conducted among 334 diagnosed cases of Type 2 Diabetes Mellitus for more than or equal to 6 months attending the outpatient department of UCMS-TH. Non-probability purposive sampling technique was used to select samples for the study. The WHOQOL-BREF questionnaire was used to measure QoL. Data were analyzed with descriptive statistics (frequency, percentage, mean, standard deviation) and inferential statistics (t-tests or one way ANOVA) to explore associations between QoL domains and sociodemographic characteristics. Results More than half (56.6%) of the respondents were between the age group of 41-60 years with mean age of 58.42. Highest mean score {+/-} SD was found in social domain (60.77 {+/-} 13.83) followed by environmental domain (56.05 {+/-} 10.38) and psychological domain (55.67 {+/-}8.44) with least mean domain score in physical domain (49.99 {+/-} 14.53). The results show that diabetic patients, particularly women and those with comorbid conditions, report lower quality of life in all domains. Additionally, no significant association was found between having a family history of diabetes and quality of life. There was high positive correlation between physical and environmental domain of quality of life (r = 0.70, p < 0.001). Conclusion Comprehensive management strategies focusing on all dimensions of health is necessary to improve the quality of life of patients with Diabetes Mellitus.

medrxiv

10.1101/2024.11.07.24316898

Reference interval of optimal vitamin D level for an adult population of Bangladesh

Haque, W. M. M. U.; Haq, J. A.; Pathan, M. F.; Sayeed, M. A.

Wasim Md Mohosin Ul Haque

BIRDEM: Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrines and Metabolic Disorders

2024-11-08

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endocrinology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316898.source.xml

Vitamin D deficiency presents a significant public health concern, especially in regions where reference intervals from Western populations may not apply due to differences in sun exposure and ethnicity. This study aimed to establish population-specific reference intervals for serum 25-hydroxyvitamin D [25(OH)D] and to determine a deficiency cutoff for healthy adults in Bangladesh. In a cross-sectional design, we assessed serum 25(OH)D and intact parathyroid hormone (iPTH) levels in 125 coastal fishermen (Group 1) and 371 urban residents (Group 2), comprising healthy adults aged 18 years or older. Group 1 served as a reference to establish baseline vitamin D levels, while Group 2 data aided in determining the deficiency cutoff. Measurements were conducted using chemiluminescent immunoassay, and reference intervals were calculated according to Clinical and Laboratory Standards Institute (CLSI) Guidelines C28-A3. The deficiency cutoff was identified at the deflection point of iPTH levels. Results indicate a reference interval for serum 25(OH)D of 15.88-45.27 ng/ml among coastal fishermen. Among urban residents, mean serum 25(OH)D was 21.53 {+/-} 15.98 ng/ml, with iPTH levels showing significant increases below 12.16 ng/ml (95% CI: 11.04-13.28), establishing this as the deficiency cutoff. Urban residents exhibited significantly lower vitamin D levels than coastal fishermen (21.53 ng/ml vs. 27.36 ng/ml, p < 0.001). Limitations include potential selection bias due to convenience sampling and the use of chemiluminescent immunoassay instead of the gold-standard LC-MS/MS assay. This study provides the first population-specific reference intervals for serum 25(OH)D in Bangladesh, accounting for unique sun exposure patterns and ethnic factors, and sets a deficiency threshold at 12.16 ng/ml. These findings are critical for guiding targeted interventions against vitamin D deficiency in this region.

medrxiv

10.1101/2024.11.08.24316965

The impact of Option B+ policy on engagement in HIV care and viral suppression among pregnant women living with HIV in South Africa

Nattey, C.; Maskew, M.; Jinga, N.; Wise, A.; van Dongen, N.; Ferreira Brizido, T.; Mudau, M.; Technau, K.-G.; Clouse, K.

Kate Clouse

Vanderbilt University School of Nursing

2024-11-08

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public and global health

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24316965.source.xml

Background: Early access to HIV care impacts maternal outcomes and the risk of vertical transmission of HIV Option B+, a policy that mandates offering all pregnant women living with HIV (PWLH) lifelong antiretroviral therapy (ART) irrespective of their CD4 count, has been adopted across sub-Saharan Africa, including South Africa since 2015. This study aimed to assess the impact of Option B+ on engagement in HIV care and viral suppression among pregnant women in South Africa. Methods: This observational study used data from pregnant women living with HIV who delivered at Rahima Moosa Mother and Child Hospital in Johannesburg, South Africa from 2013-2017. Linkage to a national HIV laboratory cohort (the NHLS National HIV cohort) was used to ascertain engagement in HIV care prior to antenatal care (ANC) entry and viral load outcomes. Analyses were stratified by the pre-Option B+ (2013-2015) and Option B+ (2016-2017) eras. We compared engagement rates before and during the Option B+ era and assessed factors associated with HIV care engagement and viral suppression. Risk ratios were estimated using log-binomial regression. Results: Among 4,865 PWLH, 65% had evidence of prior engagement in HIV care. Prior engagement in care was higher during the Option B+ era (66%) compared to the pre-Option B+ era (55%) (p<0.001). Younger women (18-24 years) were less likely to engage in HIV care than those aged 25-34 years (aRR 0.8, 95% CI: 0.6-0.9). Women with CD4 counts <200 cells/mm3 were less likely to have been engaged in care prior to pregnancy compared to those with CD4 [&ge;]500 (aRR 0.6, 95% CI: 0.6-0.7). Primigravid women had a 30% lower likelihood of earlier HIV care engagement compared to those with 2-3 pregnancies (aRR 0.7, 95% CI: 0.5-0.8). Overall viral suppression was higher in women reporting prior ART use compared to those with no prior HIV care (33% vs. 19%, p<0.001). During the four-year study period, the proportion of PWLH who had a viral load recorded but were not virally suppressed ranged from 22-36%. Conclusion: The Option B+ policy led to increased engagement in HIV care prior to pregnancy. However, high prevalence of unsuppressed viral load during the Option B+ era highlights the need for continued monitoring and support to sustain the benefits of this policy. Pregnancy and antenatal care services remain an essential portal of entry to HIV care among PWLH in South Africa. Interventions to improve early ANC attendance and maternal engagement in HIV care prior to pregnancy are critical to eliminate vertical HIV transmission.

medrxiv

10.1101/2024.11.08.24316963

A protocol for high-dose quadrivalent influenza vaccine effectiveness in the community and long-term care facilities using electronic health records

Soares, P.; Gomez, V.; Gaio, V.; Santos, J. A.; Rodrigues, A. P.; Machado, A.

Patrícia Soares

National School of Public Health: Escola Nacional de Saude Publica

2024-11-08

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public and global health

https://www.medrxiv.org/content/early/2024/11/08/2024.11.08.24316963.source.xml

Since the 2022-2023 season in Portugal, a high-dose quadrivalent influenza vaccine is freely available for individuals living in long-term care facilities (LTCF). In 2024-2025, vaccination was extended to community-dwelling individuals aged [&ge;]85 years. Given the scarcity of reported high-dose influenza vaccine effectiveness (IVE) estimates for this population, this study aims to estimate the high-dose relative and absolute IVE. A retrospective cohort study using data from electronic health records databases (EHR) will be implemented, using two cohorts, one of individuals vaccinated with influenza vaccine (to estimate relative IVE) and another of individuals eligible for the high-dose quadrivalent influenza vaccine (to estimate absolute IVE). We will consider two subgroups for both cohorts: individuals living in LTCF and community-dwelling individuals aged [&ge;]85. We will use a fixed cohort approach, defining the eligible population by age at the vaccination campaign(s) start and living status. The outcomes are based on the primary cause of hospital admission. The reference population database will be defined by linking EHR on vaccination, comorbidities, and hospitalisations using a unique identifier through a deterministic data linkage procedure, and influenza vaccination status will be assessed retrospectively. We will use Cox proportional hazards regression models to estimate the hazard ratio (HR), considering as event the first hospitalisation due to influenza-like-illness and as exposure the vaccination status. IVE will be estimated as one minus the confounder-adjusted HR of vaccinated with the high-dose quadrivalent influenza vaccine vs vaccinated with standard dose (to estimate relative IVE) or unvaccinated (to estimate absolute IVE). While challenges such as EHR constraints and potential reporting bias pose limitations, using routinely collected data has successfully estimated COVID-19 VE and enables precise monitoring of VE with higher representativeness. The results of this study will inform the Health Ministry on the future influenza vaccine programme in Portugal.

medrxiv

10.1101/2024.11.07.24316941

Genetically predicted plasma levels of amino acids and stroke risk: a Mendelian randomization study

Li, Z.; Zhang, Y.; Zhou, H.; Xu, Y.; Sun, L.; Zhang, Z.; Gao, Z.; Wang, S.; Ni, J.; Miao, Z.

Zhigang Miao

Soochow University

2024-11-08

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neurology

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316941.source.xml

Stroke, including ischemic stroke (IS) and small vessel stroke (SVS), is a major cause of morbidity and mortality globally. The role of amino acids in stroke risk and outcomes is not well understood. This study investigates the causal effects of genetically determined amino acid levels on stroke and its functional outcomes using Mendelian randomization (MR). We analyzed data by single nucleotide polymorphisms (SNPs), Inverse-variance weighted (IVW) and so on. After False discovery rate (FDR) correction, we found that Higher genetically determined levels of CSF glycine (odds ratio [OR] per standard deviation [SD] increase, 1.34; 95% confidence interval [CI], 1.14-1.56; P=2.46x10-4), glutamate (odds ratio [OR] per standard deviation [SD] increase, 1.48; 95% confidence interval [CI], 1.17-1.87; P=9.50x10-4), glutamine (odds ratio [OR] per standard deviation [SD] increase, 1.58; 95% confidence interval [CI], 1.29-1.94; P=1.30x10-5), and phenylalanine (odds ratio [OR] per standard deviation [SD] increase, 1.58; 95% confidence interval [CI], 1.32-1.89; P=7.37x10-7) were associated with increased risks of SVS. Higher phenylalanine (odds ratio [OR] per standard deviation [SD] increase, 1.79; 95% confidence interval [CI], 1.26-2.55; P=1.15x10-3) was linked to increased risks of worse IS functional outcomes (modified Rankin Scale score[&ge;]3). These findings suggest amino acids as potential biomarkers and therapeutic targets for stroke.

medrxiv

10.1101/2024.11.04.24316576

Early Life Safety Profiling of Gene Therapy for Spinal Muscular Atrophy: A Case Series Analysis

Spellman, R. G.; Ha, L. L.; Duarte Lepez, S. D. S.; Arruda, E. A.; Rodrigues, E.; Swoboda, K. J.; Alves, C. R. R.

Christiano R. R. Alves

Massachusetts General Hospital / Harvard Medical School

2024-11-08

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genetic and genomic medicine

https://www.medrxiv.org/content/early/2024/11/08/2024.11.04.24316576.source.xml

The present study examines the safety profile of intravenous onasemnogene abeparvovec gene therapy in a real world setting, both alone or in combination with intrathecal antisense oligonucleotide nusinersen therapy in two cohorts of patients with spinal muscular atrophy (SMA). The first cohort included 8 presymptomatic infants treated solely with onasemnogene abeparvovec, while the second cohort comprised 6 symptomatic infants receiving onasemnogene abeparvovec and nusinersen co-therapy. All patients received the corticosteroid prednisolone coincident with gene therapy. Circulating alanine aminotransferase (ALT) and aspartate transaminase (AST) levels were measured to determine potential hepatoxicity, the primary focus of this study. Elevated ALT and AST levels, but no change in GGT levels were observed in 1 pre-symptomatic and 3 symptomatic patients post-treatment. However, all values normalized within three months of onasemnogene abeparvovec injection. Nusinersen treatment received previously or coincident with gene therapy did not impact the elevation of liver transaminases, which was transient. This study highlights the importance of early intervention with molecular treatments for SMA and indicates that prior or coincident treatment with nusinersen is unlikely to impact safety of onasemnogene apoparvovec and could theoretically improve clinical outcomes in symptomatic infants or in those with gene therapy delayed beyond the immediate neonatal period.

medrxiv

10.1101/2024.11.07.24316943

Using evidence-based strategies, including coverage of remote cardiac rehabilitation, to increase cardiac rehabilitation participation -a community health insurance plan's experience

Magdon-Ismail, Z.; Murphy, S.; Gauthier, V.; Wyrick, T.; Rowe, C.; Austin, R.; Cuevas, P.; Pickreign, J.; Coplin, B.

Zainab Magdon-Ismail

Capital District Physicians\' Health Plan

2024-11-08

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health systems and quality improvement

https://www.medrxiv.org/content/early/2024/11/08/2024.11.07.24316943.source.xml

Background: Barriers to referral, enrollment, and participation in cardiac rehabilitation (CR) contribute to low rates of completion despite known benefits. Barriers are system, provider and patient related. In this observational cohort quality improvement study, we examined the impact a community-based, not-for-profit health insurance plan had on barriers to CR participation. Methods: The Capital District Physicians' Health Plan (CDPHP) in Albany, New York developed and implemented a cardiac rehabilitation initiative (CRI) to increase CR rates using evidence-based strategies. CDPHP: 1) eliminated patient cost-share, 2) covered remote CR (RCR), 3) implemented physician valued-based incentives, 4) presented metrics to providers, 5) educated providers and patients, and 6) dedicated staff to facilitating enrollment. Chi-square tests were used to identify differences among patients who enrolled in facility-based CR (FBCR), RCR and no CR. CR enrollment rate distributions were evaluated between Q1, 2021 and Q2, 2022. Results: A total of 1,736 patients with varying cardiac conditions were eligible for CR in the study period. Between Q1, 2021 and Q2, 2022, enrollment went from 11.1% (32/286) to 16.2% (50/308) in FBCR; 0.7% (2/286) to 10.7% (33/308) in RCR; and 11.9% (34/286) to 26.9% (83/308) overall (P<.0001). Time to enrollment went from 40 to 47 days for FBCR (P=0.1792), 53 to 20 days for RCR (P<.0001) and 43 to 36 days overall (P=0.3348). Older patients were more likely to enroll in CR as were patients who underwent cardiac procedures. Conclusions: The CRI created a call-to-action among providers to address CR referral and enrollment. RCR increased CR rates and were additive to FBCR rates, suggesting that the introduction of RCR will not displace FBCR. Time to enrollment improved overall, driven by improvement in those enrolling in RCR. Increasing CR engagement requires coordinated effort from stakeholders' cardiology providers, hospitals, CR providers and health plans.

medrxiv