Disease Characteristics Research Articles

Sociodemographic inequality in children aged 0–19 years with and without parents diagnosed with heart disease: a Danish nationwide register-based study

ObjectivesThis study aimed to estimate the prevalence of children aged 0–19 years who have a parent with a history of heart disease and investigate their sociodemographic characteristics. Study designA national register-based study. MethodsFrom the Danish Fertility Register and the Danish National Patient Register information on children of parents with ischemic heart disease, arrhythmia, heart failure and heart valve disease in the period 1981–2018 were obtained. Statistical analyses including descriptive statistics, logistic and linear regression were used to illuminate associations between parental heart disease and sociodemographic characteristics. ResultsThe study population consisted of 142,480 children aged 0–19 years with at least one parent diagnosed with heart disease, corresponding to every 9th child in Denmark in 2018. The number increased from 4.5% in 2002 to 11.1% in 2018. In the study population most had a father with heart disease (57.8%) and 4.6% had two parents with heart disease. Parents with heart disease had significantly higher odds of being out of work (OR 1.68, 95% CI 1.64; 1.72), in a single-parent household (OR 1.09, 95% CI 1.07; 1.11), divorced or widowed (OR: 1.10, 95% CI 1.08; 1.12), having a lower educational level (OR 1.35, 95% CI 1.33; 1.37), and a lower family income (−42,410 DKR, 95% CI -50,306; −34,514, P < 0.0001) compared to those without heart disease. ConclusionChildren affected by parental heart disease comprise a substantial part of the Danish population. These have significantly different sociodemographic characteristics than children in families without parental heart disease, which might affect social heritage and parental capacity.

Prevalence of skin problems caused by insulin pump therapy and associated factors in children with type 1 diabetes mellitus: A large cross-sectional survey in China

AimsTo document the prevalence of skin problems associated with insulin pump use and identify contributing factors among children with type 1 diabetes mellitus in China. MethodsIn total, 461 children were recruited from an online community (i.e., a Wechat group) of pediatric patients with T1DM. A self-developed questionnaire was filled in by parents, collecting the information on social demographics, disease, and insulin pump therapy related characteristics and skin problems. We applied the Mann–Whitney U test, Chi square test and logistic regression analysis to identify the factors associated with skin problems. ResultsOf the 461 responders, 308 (66.8 %) children were reported to have skin problems. More specifically, 38.8 % had pigmentation changes, 22.3 % allergy/dermatitis, 20.2 % scaring, 11.5 % pain, 10.8 % infection, 10.6 % subcutaneous lipohypertrophy, and 6.1 % lipoatrophy. Logistic regression analysis showed that independent associated factors of skin problems were the caregiver’s educational level as college or above, patient having skin allergies, and using the Brand 2 insulin pump (p values < 0.05). ConclusionsThe present study documents the prevalence of skin problems and identifies associated factors, such as caregiver’s education, patients skin allergies, and using a specific brand of pump. Health education should address these factors in addition to the traditionally emphasized factors.

Rifaximin plus lactulose versus lactulose alone for reducing the risk of HE recurrence.

The aim was to examine rifaximin plus lactulose efficacy in patients with cirrhosis at a risk of developing overt HE who were stratified by important baseline characteristics such as comorbid ascites or diabetes. Pooled post hoc subgroup analysis of adults receiving rifaximin 550mg twice daily plus lactulose or lactulose alone for 6 months in a phase 3 randomized, double-blind trial and a phase 4 open-label trial was conducted. Rifaximin plus lactulose was more efficacious than lactulose alone for reducing the risk of overt HE recurrence and HE-related hospitalization in adults grouped by select baseline disease characteristics.

Red blood cell distribution width as a surrogate biomarker of damage and disease activity in patients with systemic lupus erythematosus.

Red blood cell distribution width (RDW) is a measure of variability in mean corpuscular volume. Alterations in RDW can be observed in a variety of human disorders, including inflammatory, cardiovascular, and hepatic or renal diseases. Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect virtually any organ in the body. In this work, our objective was to analyse how a complete characterisation of disease characteristics in a large series of patients with SLE is related to RDW values. 284 patients with SLE and 181 age- and sex-matched healthy controls were recruited. Complete blood count including RDW was assessed. Multivariable analysis was performed to analyse the relationship between RDW and SLE disease characteristics, including composite scores of disease activity and damage. After multivariable adjustment, RDW was higher in patients with SLE compared to controls (beta coefficient 0.8 [95% confidence interval: 0.3-1] %, p=0.003). Several disease characteristics, such as the presence of extractable nuclear antibodies and antiphospholipid syndrome, and the use of prednisone and azathioprine, were significantly associated with higher levels of RDW after adjustment for confounders. Of note, cumulative disease damage and disease activity scores were associated with higher RDW values after controlling for covariates. RDW may serve as a surrogate biomarker of accrual disease damage and activity in patients with SLE.

An Investigative Analysis of Therapeutic Strategies in Hepatocellular Carcinoma: A Raetrospective Examination of 23 Biopsy-Confirmed Cases Emphasizing the Significance of Histopathological Insights

Background: The Liver Imaging Reporting and Data System (LI-RADS) combines standardized terminology with a classification system for imaging findings in patients with HCC, therefore rendering diagnostic biopsy unnecessary in many cases. This retrospective study included 23 patients with a biopsy diagnosis of HCC, performed either before or after local interventional procedures, in order to evaluate the histopathologic changes induced by previous procedures and their potential influence on the response to immune therapy. Material and Methods: The study encompassed a cohort of patients diagnosed with Hepatocellular Carcinoma (HCC). Diagnosis was established via contrast-enhanced computer tomography or magnetic resonance imaging that identified LI-RADS-5 nodules in conjunction with historical liver disease and elevated alpha-fetoprotein (AFP) levels or via histological examination confirming positivity for glypican3, heat shock protein 70, and glutamine synthetase. The study detailed the liver disease etiology, LI-RADS scores, characteristics and dimensions of HCC nodules, serum AFP concentrations, Edmondson–Steiner grading, and the expression of programmed cell death ligand 1 (PD-L1) in the tumor cells. Results: Among the study’s cohort of Hepatocellular Carcinoma (HCC) patients, a portion had not received any prior treatments, while the remainder experienced local HCC recurrence following trans-arterial chemoembolization or radiofrequency ablation. Observations indicated elevated alpha-fetoprotein (AFP) levels in those who had not undergone any previous interventions, showing statistical significance. The Edmondson–Steiner classification predominantly identified grade III differentiation across patients, irrespective of their treatment history. Furthermore, an increase in intra-tumoral programmed cell death ligand 1 (PD-L1) expression was noted in patients who had not been subjected to previous therapies. Conclusion: Liver biopsy offers valuable insights for patients with Hepatocellular Carcinoma (HCC), assisting in the tailoring of immune therapy strategies, particularly in cases of recurrence following prior local interventions.

Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper.

The landscape of oncology drug development has witnessed remarkable advancements over the last few decades, significantly improving clinical outcomes and quality of life for patients with cancer. Project Optimus, introduced by the U.S. Food and Drug Administration, stands as a groundbreaking endeavor to reform dose selection of oncology drugs, presenting both opportunities and challenges for the field. To address complex dose optimization challenges, an Oncology Dose Optimization IQ Working Group was created to characterize current practices, provide recommendations for improvement, develop a clinical toolkit, and engage Health Authorities. Historically, dose selection for cytotoxic chemotherapeutics has focused on the maximum tolerated dose, a paradigm that is less relevant for targeted therapies and new treatment modalities. A survey conducted by this group gathered insights from member companies regarding industry practices in oncology dose optimization. Given oncology drug development is a complex effort with multidimensional optimization and high failure rates due to lack of clinically relevant efficacy, this Working Group advocates for a case-by-case approach to inform the timing, specific quantitative targets, and strategies for dose optimization, depending on factors such as disease characteristics, patient population, mechanism of action, including associated resistance mechanisms, and therapeutic index. This white paper highlights the evolving nature of oncology dose optimization, the impact of Project Optimus, and the need for a tailored and evidence-based approach to optimize oncology drug dosing regimens effectively.

Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN.

Treatment optimization may require dosing flexibility. The Phase 3 JADE REGIMEN trial (NCT03627767) evaluated maintenance of abrocitinib 200 mg-induced response in patients with moderate-to-severe atopic dermatitis (AD) randomly assigned to subsequent maintenance with continuous-dose abrocitinib (200 mg), reduced-dose abrocitinib (100 mg) or placebo. Maintenance with continuous-dose abrocitinib was associated with a stronger prevention of disease flares, but also with a higher occurrence of adverse events, compared with the reduced dose. This post hoc analysis of JADE REGIMEN aimed to identify predictors of not flaring during the maintenance period and to generate tools that can be used to assess probability of not flaring. Data were analysed from patients who responded to abrocitinib 200 mg induction therapy (12 weeks) and were randomly assigned to receive abrocitinib (200 mg or 100 mg) or placebo in the 40-week maintenance period. Demographic and baseline disease characteristics and level of response to induction were evaluated for association with not flaring using logistic regression. Parameters with a significant (p < 0.15) interaction with the treatment arm were fitted into a multivariable regression model, which was used to assess probability of not flaring. Lower percentage body surface area affected at baseline (p = 0.09), absence of prior exposure to systemic agents (p = 0.02) and greater percentage change in EASI from baseline to randomization (p < 0.001) were identified as predictors of not flaring with abrocitinib. In both abrocitinib arms, percentage change in EASI from baseline to end of induction (Week 12) was the major contributor to the probability of not flaring in the maintenance period. Maintenance of response using reduced-dose abrocitinib 100 mg may be feasible for patients with lower baseline disease severity and strong response to abrocitinib 200 mg induction treatment.

Patient Burden of Nonsegmental Vitiligo: A US Real-World Survey of Dermatologists and Their Patients.

Vitiligo is a chronic autoimmune disease characterized by destruction of melanocytes, leading to skin depigmentation. Vitiligo can have a high quality-of-life burden and profound impact on psychosocial well-being. The objectives of this study were to describe the self-reported patient burden among patients with nonsegmental vitiligo with≤10% affected body surface area, summarize the physician-reported psychosocial and psychological impact of vitiligo on patient lives, and describe disease characteristics and treatment history, goals, and satisfaction. Data were drawn from the Adelphi Vitiligo Disease Specific Programme™, a real-world, cross-sectional survey with retrospective data collection of physicians and patients with vitiligo, collected in the United States between October 2021 and April 2022. Separate surveys for dermatologists and patients contained questions on clinical and demographic characteristics of patients with vitiligo and burden of vitiligo. Treatment history, goals, and satisfaction were assessed together with the impact of vitiligo on quality of life. Sixty-one dermatologists provided data for 326 patients with≤10% affected body surface area (adults, n=221; adolescents, n=105); 90 of those patientsalso responded to the survey. The most common treatments were topical corticosteroids, topical calcineurin inhibitors, and narrow-band ultraviolet-B phototherapy, with the main treatment goal being repigmentation. Physician-reported treatment satisfaction was 56%; 25% of patients reported frustration with treatment options. Physicians reported impact of vitiligo on everyday life in 46% of patients. Patients reported 12.7% overall work impairment; mean scores for Hospital Anxiety and Depression Scale anxiety and depression domains were 3.5 and 2.2, respectively, and mean Vitiligo-specific Quality of Life index score was 26.9. Patients with facial involvement experienced higher burden than those without. A high patient burden was reported by dermatologists and their patients with vitiligo who had≤10% affected body surface area, including psychosocial and psychological consequences. Thesefindings highlight an unmet need in the treatment of vitiligo.

Myasthenia Gravis Disease Burden and Its Impact on Satisfaction with Life: A Qualitative Survey of Patients' Perspectives in Japan.

Myasthenia gravis (MG) has a negative impact on patients' health-related quality of life; however, many clinicians do not fully understand their patients' lived experience of the disease. To understand the actual conditions of patients with MG and clarify the problems they perceive, we conducted a survey to evaluate the effects of the disease on patients' daily life and work. A questionnaire-based, qualitative, cross-sectional, non-interventional survey was conducted in Japan between April and May 2022 in patients with MG who were receiving regular outpatient treatment. The questionnaire included items regarding the patients' disease characteristics and experience, satisfaction with life, current treatment status, and treatment satisfaction. In total, 452 patients were included in the survey population (66.6% aged ≥ 60years; 64.6% with MG disease duration ≥ 10years; 76.6% acetylcholine receptor [AChR] autoantibody positive). The symptoms of MG had a significant impact on the patients' daily lives, with the most common symptoms being fatigability (74.8%), ptosis (59.7%), diplopia (54.2%), and weakness in the arms and/or legs (50.9%). Patients commonly identified exercise (73.7%), work 68.0%), hobbies (60.4%), travel (60.0%), and socializing with friends (59.7%) as being difficult to perform, with approximately 50% of patients reporting that hospitalization sometimes interfered with their ability to work. In total, 27.2% of patients were dissatisfied with life, with the highest rates of dissatisfaction among patients who were either positive for muscle-specific kinase (MuSK) autoantibodies or seronegative for both AChR and MuSK autoantibodies. In Japanese patients with MG, over 25% are dissatisfied with life, indicating several unmet needs in this population.

Comparison of the upper and lower airway microbiome in early postoperative lung transplant recipients.

Lung transplantation is the only therapeutic option for patients with end-stage lung disease, but its outcome is much worse than other solid organ transplants. Little is known about the NS and BALF microbiome of early postoperative LTRs. Here, we compared paired samples of the nasal and lung microbiome from 17 early postoperative LTRs and showed both difference and homogeneity between the two samples. Most of the "core" microbiome in both NS and BALF samples were recognized respiratory pathogens, suggesting that both samples can reflect the diseases characteristics of transplanted lung. We also found that the differences between upper and lower airway microbiome in early postoperative LTRs mainly come from sampling sites instead of sampling individuals.

Comment on: Immune checkpoint inhibitor-mediated polymyalgia rheumatica versus primary polymyalgia rheumatica: comparison of disease characteristics and treatment requirement. Reply.

Comment on: Immune checkpoint inhibitor-mediated polymyalgia rheumatica versus primary polymyalgia rheumatica: comparison of disease characteristics and treatment requirement. Reply.

Risk Factors for Delayed Atrioventricular Block after Aortic Valve Surgery: A Retrospective Study

Objective: This study aimed to examine the potential factors that contribute to the occurrence of delayed high-grade atrioventricular block (DHAVB) following transcatheter aortic valve replacement (TAVR). Methods: A retrospective analysis was conducted on the clinical data of 115 patients who underwent TAVR at Jiaozhou Central Hospital of Qingdao Hospital between January 2018, and June 2023. A follow-up period of 30 days post-operation was observed for all patients. The patients were categorized into two groups on the basis of the occurrence of DHAVB: DHAVB group (n = 35) and control group (n = 80). The general clinical data preoperative and postoperative heart disease characteristics of the groups were compared. The risk factors associated with DHAVB after TAVR were analyzed. Results: The mean systolic blood pressure (SBP) level of the DHAVB group significantly increased compared with that of the control group, whereas the heart rate (HR) level significantly reduced (p &lt; 0.05). The average preoperative left ventricular ejection fraction (LVEF) was significantly lower in the DHAVB group than in the control group (p &lt; 0.05). The control group exhibited a significantly higher prevalence of preoperative QRS wave broadening, severe calcification of the aortic valve, and right bundle branch block than the control group (p &lt; 0.05). Spearman's correlation and logistic regression analyses identified increased SBP, decreased HR, diminished LVEF, the presence of preoperative and postoperative right bundle branch block, and thickened interventricular septum were as risk factors for DHAVB in patients undergoing TAVR (p &lt; 0.05). Conclusion: Close surveillance of blood pressure, heart rate, and cardiac function is recommended for individuals undergoing TAVR. Pre-operative and post-operative electrocardiography and echocardiography are valuable tools in identifying potential risk factors for DHAVB, offering a solid foundation for effective patient prognostic management.

Impella vs Veno-arterial extracorporeal membrane oxygenation in cardiogenic shock: a systematic review and meta-analysis of propensity score matched studies

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abiomed Singapore PTE. Ltd. Background/Introduction Cardiogenic shock is a life-threatening condition associated with multi-organ failure and death. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is well-established in the management of cardiogenic shock; however, mortality rates have remained relatively consistent over the past two decades. Impella is a transluminal microaxial ventricular assist device that improves haemodynamics by unloading the left ventricle and represents an alternative to VA-ECMO. No randomised controlled trials exist to date comparing Impella versus VA-ECMO given difficulties in recruiting patients due to the acute nature of the condition. Whilst a plethora of non-randomised, comparative studies have been published, many are confounded by underlying differences in baseline disease characteristics. Propensity score matched / adjusted studies may mitigate confounding by accounting for differences in important covariates that impact outcomes. Purpose The objective of this study was to conduct a systematic review and meta-analysis of propensity score matched / adjusted studies to assess the clinical outcomes of Impella versus VA-ECMO in cardiogenic shock patients. Methods A systematic review was undertaken to identify all comparative studies of Impella and VA-ECMO in cardiogenic shock which performed propensity score matching / adjustment of outcomes to account for important covariates. The study limitations were assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach. In-hospital/30-day survival and bleedings requiring transfusion were meta-analysed using the random effects method. Results Six propensity score matched / adjusted studies comparing Impella versus VA-ECMO in cardiogenic shock were included in the meta-analysis. A statistically significant difference in in-hospital/30-day mortality was detected between patients treated with Impella (39.6%) versus VA-ECMO (53.8%) (odds ratio [OR] 95% confidence interval [95% CI]: 0.57 [0.44, 0.74]; p&amp;lt;0.0001). Similarly, Impella (19.9%) was associated with statistically significantly fewer bleeding events requiring transfusion compared with VA-ECMO (28.8%) (OR=0.61 [0.46, 0.80]; p=0.0004). Conclusion(s) This systematic review identified no randomised controlled trials of Impella versus VA-ECMO. The meta-analysis of propensity matched observational trials, represents the highest level of evidence available to date, and suggests that Impella may be associated with increased survival rates and decreased bleeding. Randomised controlled trials are urgently needed to assess cardiac support modalities in cardiogenic shock.

Outpatient psychosocial screening in askin cancer center: acceptance, psychosocial distress and utilization of support : Aposthoc analysis in aquality management program

Psychosocial care of cancer patients is an important aspect throughout the entire course of oncological treatment. Since 2015, psychosocial screening has been implemented in the outpatient clinics of the Skin Cancer Center in Freiburg. We present here apost hoc analysis in the context of aquality management program. Acceptance, psychosocial distress and desire for counseling were evaluated. Exploratively, we investigated which patient and disease characteristics are related to increased subjective distress. In afull survey from 06/2015 to 12/2015, we evaluated acceptance, psychosocial distress by distress thermometer (DT), and desire for counseling. Of 753 patients, 345 (45.8%) participated in psychosocial screening and data from 310 (174men, 136women; 89.7% melanoma patients, mean time since initial diagnosis 4.7 ± 3.9years) could be analyzed. The mean burden on the DT was 2.97 ± 2.83 (median2, range 0-10). High distress (DT ≥ 5) was reported by 84patients (28.8%). Thirty-four patients (11%) indicated adesire for counseling, and 23patients took up the counseling offer. The patient group with high distress was younger, more often under ongoing or recently completed systemic therapy, and had more often adesire for counseling. In addition to assessing psychosocial distress with validated screening instruments, the survey of the subjective desire for care represents an important parameter for the identification of patients in need of care. Young patients and patients with ongoing systemic therapy should be the focus of attention.

Association of systemic lupus erythematosus standard of care immunosuppressants with glucocorticoid use and disease outcomes: a multicentre cohort study

BackgroundThis study examines the association of standard-of-care systemic lupus erythematosus (SLE) medications with key outcomes such as low disease activity attainment, flares, damage accrual, and steroid-sparing, for which there is current paucity of data.MethodsThe Asia Pacific Lupus Collaboration (APLC) prospectively collects data across numerous sites regarding demographic and disease characteristics, medication use, and lupus outcomes. Using propensity score methods and panel logistic regression models, we determined the association between lupus medications and outcomes.ResultsAmong 1707 patients followed over 12,689 visits for a median of 2.19 years, 1332 (78.03%) patients achieved the Lupus Low Disease Activity State (LLDAS), 976 (57.18%) experienced flares, and on most visits patients were taking an anti-malarial (69.86%) or immunosuppressive drug (76.37%). Prednisolone, hydroxychloroquine and azathioprine were utilised with similar frequency across all organ domains; methotrexate for musculoskeletal activity. There were differences in medication utilisation between countries, with hydroxychloroquine less frequently, and calcineurin inhibitors more frequently, used in Japan. More patients taking leflunomide, methotrexate, chloroquine/hydroxychloroquine, azathioprine, and mycophenolate mofetil/mycophenolic acid were taking ≤ 7.5 mg/day of prednisolone (compared to > 7.5 mg/day) suggesting a steroid-sparing effect. Patients taking tacrolimus were more likely (Odds Ratio [95% Confidence Interval] 13.58 [2.23–82.78], p = 0.005) to attain LLDAS. Patients taking azathioprine (OR 0.67 [0.53–0.86], p = 0.001) and methotrexate (OR 0.68 [0.47–0.98], p = 0.038) were less likely to attain LLDAS. Patients taking mycophenolate mofetil were less likely to experience a flare (OR 0.79 [0.64–0.97], p = 0.025). None of the drugs was associated with a reduction in damage accrual.ConclusionsThis study suggests a steroid-sparing benefit for most commonly used standard of care immunosuppressants used in SLE treatment, some of which were associated with an increased likelihood of attaining LLDAS, or reduced incidence of flares. It also highlights the unmet need for effective treatments in lupus.

Comment on: Immune checkpoint inhibitor-mediated polymyalgia rheumatica versus primary polymyalgia rheumatica: comparison of disease characteristics and treatment requirement.

Comment on: Immune checkpoint inhibitor-mediated polymyalgia rheumatica versus primary polymyalgia rheumatica: comparison of disease characteristics and treatment requirement.

Disease characteristics, effectiveness, and safety of vestronidase alfa for the treatment of patients with mucopolysaccharidosis VII in a novel, longitudinal, multicenter disease monitoring program

BackgroundMucopolysaccharidosis VII (MPS VII) is an ultra-rare, autosomal recessive, debilitating, progressive lysosomal storage disease caused by reduced activity of β-glucuronidase (GUS) enzyme. Vestronidase alfa (recombinant human GUS) intravenous enzyme replacement therapy is an approved treatment for patients with MPS VII.MethodsThis disease monitoring program (DMP) is an ongoing, multicenter observational study collecting standardized real-world data from patients with MPS VII (N ≈ 50 planned) treated with vestronidase alfa or any other management approach. Data are monitored and recorded in compliance with Good Clinical Practice guidelines and planned interim analyses of captured data are performed annually. Here we summarize the safety and efficacy outcomes as of 17 November 2022.ResultsAs of the data cutoff date, 35 patients were enrolled: 28 in the Treated Group and seven in the Untreated Group. Mean (SD) age at MPS VII diagnosis was 4.5 (4.0) years (range, 0.0 to 12.4 years), and mean (SD) age at DMP enrollment was 13.9 (11.1) years (range, 1.5 to 50.2 years). Ten patients (29%) had a history of nonimmune hydrops fetalis. In the 23 patients who initiated treatment prior to DMP enrollment, substantial changes in mean excretion from initial baseline to DMP enrollment were observed for the three urinary glycosaminoglycans (uGAGs): dermatan sulfate (DS), -84%; chondroitin sulfate (CS), -55%; heparan sulfate (HS), -42%. Also in this group, mean reduction from initial baseline to months 6, 12, and 24 were maintained for uGAG DS (-84%, -87%, -89%, respectively), CS (-70%, -71%, -76%, respectively), and HS (+ 3%, -32%, and − 41%, respectively). All adverse events (AEs) were consistent with the known vestronidase alfa safety profile. No patients discontinued vestronidase alfa. One patient died.ConclusionsTo date, the DMP has collected invaluable MPS VII disease characteristic data. The benefit-risk profile of vestronidase alfa remains unchanged and favorable for its use in the treatment of pediatric and adult patients with MPS VII. Reductions in DS and CS uGAG demonstrate effectiveness of vestronidase alfa to Month 24. Enrollment is ongoing.

Clustering of Cardiovascular Risk Factors and Heart Failure in Older Adults from the Brazilian Far North.

Given the aging global population, identifying heart failure (HF) phenotypes has become crucial, as distinct disease characteristics can influence treatment and prognosis in older adults. This study aimed to analyze the association between clustering of cardiovascular risk factors and HF in older adults. A cross-sectional epidemiological study was conducted with 1322 older adults (55% women, mean age 70.4) seen in primary health care. Diagnosis of HF was performed by a cardiologist based on diagnostic tests and medical history. Cardiovascular risk factors included hypertension, diabetes, hypercholesterolemia, and smoking. Using logistic regression, potential associations were tested. Individual risk factor analysis showed that older adults with hypertension, diabetes, or hypercholesterolemia had up to 7.6 times higher odds to have HF. The cluster where older adults had only one risk factor instead of none increased the odds of HF by 53.0%. Additionally, the odds of older patients having HF ranged from 3.59 times for the two-risk factor cluster to 20.61 times for the simultaneous presence of all four factors. The analysis of clusters substantially increasing HF risk in older adults revealed the importance of individualizing subgroups with distinct HF pathophysiologies. The clinical significance of these clusters can be beneficial in guiding a more personalized therapeutic approach.

Association between coffee and caffeine intake and risk of COPD: Findings based on NHANES 2007–2012

BackgroundThe association between coffee and caffeine intake and the risk of COPD and lung function has not been thoroughly discussed in Americans, with subgroup and threshold effects remaining unclear. ObjectivesThis study investigated the association between coffee and caffeine consumption and the risk of chronic obstructive pulmonary disease (COPD) as well as lung function utilizing data from the NHANES 2007–2012. MethodsWe assessed the associations of coffee and caffeine consumption with the risk of COPD and lung function parameters, including FEV1 and FVC, adjusting for common demographic and disease characteristics in a cross-sectional analysis of NHANES data. ResultsA total of 9763 participants were included in the study, and 592 were diagnosed with COPD. Multivariate regression models revealed positive associations between coffee and caffeine consumption and the risk of COPD and lung function. Subgroup analyses stratified by sex, DM, hypertension status, and smoking habits identified potential effect modifiers as well as inflection points from threshold effect examinations. ConclusionsThe results of this cross-sectional study indicated significant positive correlations between coffee and caffeine consumption and the risk of COPD. Additionally, positive correlations between exposure variables and FEV1 and FVC were detected. Among the stratification factors, smoking status exhibited the most potential for modifying effects. Future practices and research are needed to validate the results and explore the underlying mechanisms

Abstract PO5-12-07: Analyzing Patient Experiences with Adjuvant Hormone Therapy for Early Breast Cancer Treatment via NLP/ML on Social Media: Symptoms and Their Mitigation

Abstract Understanding the early breast cancer (eBC) patient experience of disease and treatment is critical to addressing unmet patient needs, improving outcomes, and informing the next wave of drug development. Traditional approaches, such as interviews or focus group studies, are resource intensive and have limitations in reflecting the diverse experiences of patients with different disease characteristics, treatments, and sociodemographic backgrounds, and in detecting rare severe events that could potentially lead to therapy discontinuation. To overcome these limitations, we have developed a semi-automated approach utilizing Natural Language Processing (NLP) and Machine Learning (ML) methods in application to public patient forums to extract patient insights. Specifically, we analyzed 500,000 anonymized posts from the BreastCancer.org forum, utilizing Transformer-based methods to identify posts related to eBC patient experiences treated with standard hormonal therapies (HT). First, a novel ML-based model identified posts related to eBC adjuvant HT. For those, patient demographics, symptoms and their severity, and symptom management strategies such as exercise and yoga were subject to further analysis. Out of 362,074 relevant eBC posts, 32 symptoms and 9 impacts were significantly associated with at least one of the six hormonal therapies we considered. Hot flushes (relative risk [RR]: 6.70; 95% CI: 3.36–13.36), arthralgia (RR: 6.67; 95% CI: 3.53–12.59), weight increase (RR: 4.83; 95% CI: 3.20–7.28), mood swings (RR: 7.36; 95% CI: 5.75–9.42), insomnia (RR: 4.76; 95% CI: 3.14–7.22), and depression (RR: 3.05; 95% CI: 1.71–5.44) demonstrated the strongest associations. Severe headache, dizziness, back pain, and muscle spasms showed significant associations with ≥1 HT despite their low overall prevalence in eBC posts. Notably, posts contained a wide range of symptoms severity, including rarely seen symptoms in smaller patient pools, such as severe night hot flashes leading to treatment discontinuation. Symptoms/impacts mentioned in association with exercise and yoga as a way for symptom mitigation included hot flashes, arthralgia, fatigue, anxiety, depression, and pain. Of those posts, 53.3% to 82.5% reported positive or neutral sentiments for exercise, and 22.2% to 100.0% for yoga. For posts specifically mentioning the management of side effects of HT, between 50.0% and 63.5% had a positive sentiment associated with exercise concerning each of the symptoms/impacts with a lower positive impact related to yoga (between 11.1% and 43.0% of posts). Posts discussing pain management and exercise included a higher proportion of negative feedback, versus positive sentiment for depression. Posts related to yoga as an HT symptom mitigation strategy had a higher prevalence of negative sentiments for anxiety and depression. Our proposed ML/NLP-based approach to collecting patient feedback from publicly available forums complements standard qualitative methods by enabling the scalable extraction of insights from hundreds of thousands of online conversations that could span a broad diversity of symptoms and well-being reflections. Furthermore, our findings suggest the potential value of informing clinical outcome assessment (COA) measurement for clinical trials, alone and in combination with standard qualitative research approaches to guide the next clinical development. Overall, our study highlights the significant potential of NLP and ML to address the critical need to better understand the eBC patient experience of disease and treatment to improve outcomes for patients. Citation Format: Sameet Sreenivasan, Chao Fang, Emuella Flood, Natasha Markuzon, Jasmine Sze. Analyzing Patient Experiences with Adjuvant Hormone Therapy for Early Breast Cancer Treatment via NLP/ML on Social Media: Symptoms and Their Mitigation [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-12-07.