The capture of patient baseline characteristics in randomized controlled trials (RCTs) is essential for assessing external validity and for exploring treatment effect heterogeneity. Yet, the capture of such information is highly inconsistent across trials with limited harmonization efforts to date. The International Consortium for Health Outcomes Measurement (ICHOM) has issued expert recommendations for baseline characteristics to capture in clinical practice, as part of Sets of Patient-Centered Outcome Measures ("Sets"). We reviewed which characteristics were recommended across different conditions, and how they were to be measured. We systematically retrieved and included all ICHOM Sets that were published in peer-reviewed journals and issued measurement recommendations for adult populations. For each Set, we extracted measurement recommendations pertaining to patients' individual baseline characteristics ("case-mix factors") from the Set's data collection reference guide. We used inductive thematic coding to harmonize variable names, and group them into thematic factors and domains. Two reviewers independently coded factors and resolved disagreements. We also extracted the recommended approach to measuring each factor. We identified 32 eligible ICHOM Sets covering a range of conditions that make important contributions to the global disease burden (e.g. coronary artery disease, diabetes, depression). These Sets identified 616 original baseline variables for measurement, which we mapped onto 89 thematic factors. We identified factors that were repeatedly recommended across conditions, with a focus on sixteen factors appearing in at least 15% of Sets. These included demographics such as age, sex, gender, race/ethnicity; clinical factors such as comorbidities and disease onset; and psychosocial factors such as education, tobacco and alcohol consumption, employment, relationship status, and physical activity. For most of these factors, ICHOM recommended brief assessments via one or two questions. Only for comorbidities and physical activity did the recommended approaches include multi-item instruments, namely the Self-administered Comorbidity Questionnaire and the International Physical Activity Questionnaire Short Form, respectively. Only six factors were recommended in more than 50% of Sets. There is scope to harmonize baseline measurement in RCTs both within conditions, drawing on clinical and physiological patient characteristics with condition-specific relevance, and across conditions, based on recurrent demographic and psychosocial factors. Clinical trials need to collect clear and consistent information about the people who take part. This information is essential for understanding who the trial findings apply to and whether different groups of people may respond differently to a treatment. However, this type of information is currently collected in very inconsistent and incomplete ways across trials. In this study, we examined recommendations for patient characteristics to capture that have been developed by expert groups convened by the International Consortium for Health Outcomes Measurement (ICHOM). Although these expert recommendations were designed for measurement in everyday clinical settings rather than research studies, they can potentially inform future efforts to identify similar recommendations specifically for research studies. We reviewed 32 sets of ICHOM measurement recommendations that covered a range of different health conditions. Across these Sets, we found 616 individual baseline variables, which we grouped into 89 thematic factors. Many of these factors were specific to particular diseases, for example clinical measurements or the clinical history of a patient's condition. However, we also identified some demographic and psychosocial factors that were recommended repeatedly for measurement in the context of different conditions. Sixteen such factors were found in at least 15% of Sets, including, for example, age, sex and gender, race and ethnicity, co-occurring health problems, when the disease began, education level, smoking and alcohol use, employment and relationship status, living situation, and physical activity. Most of this information can be obtained from patients using only one or two questions. These findings suggest that it may be possible to develop guidance on what patient information to collect in clinical trials and how, both in terms of information that is relevant for specific conditions and information that has general relevance across diseases. If differences in measurement approaches could be reduced, this would make it easier to interpret, compare, and combine research findings, and could improve our understanding of which treatments work best for which groups of patients.
Acquired hypothalamic obesity (aHO) is a disease characterized by rapid, clinically significant, and persistent weight gain resulting from damage to hypothalamic structures. aHO is associated with substantial morbidity, increased mortality, and marked impairment in quality of life. Etiologies include craniopharyngioma and other space-occupying lesions of the sellar/parasellar region, neurosurgical procedures, cranial irradiation, and traumatic brain injury. A multidisciplinary panel comprising ten specialists in neuroendocrinology, neurooncology, and neurosurgery from Germany, Austria, and Switzerland convened in Frankfurt am Main, Germany, on November 10, 2025, to discuss contemporary challenges and advances in this field. aHO should be conceptualized and treated within the broader clinical entity of hypothalamic syndrome, a complex disorder involving multiple neuroendocrine deficiencies, disturbances of circadian regulation, impaired control of hunger, satiety, and thirst, altered thermoregulation, and a range of cognitive, sleep-related, and psychosocial dysfunctions. Long-term outcomes for affected individuals are frequently unfavorable, largely due to increased risks of metabolic syndrome, cardiovascular disease, profound reductions in health-related quality of life, and elevated rates of premature mortality. The management of hypothalamic syndrome remains particularly challenging. Pharmacological strategies, including dextroamphetamine and glucagon-like peptide-1 receptor agonists, have demonstrated potential benefits for weight and hyperphagia-related outcomes. Recently, preliminary findings from a prospective, randomized, placebo-controlled clinical trial (TRANSCEND) provided encouraging evidence for the efficacy of setmelanotide, a melanocortin-4 receptor agonist. This perspectives report reviews clinical advances in epidemiology, diagnostics, treatment, and follow-up of patients with aHO and outlines key directions for future research aimed at improving outcomes in this vulnerable population.
Social determinants of health (SDoH) have emerged as a critical focus of research due to their significant impact on clinical outcomes; however, there is a gap in research specific to women's health. Understanding the factors underlying trends in gynecologic emergency diagnoses requires a more comprehensive examination of SDoH. In this study we characterize the demographic and clinical profile of patients with documented SDoH International Classification of Diseases, 10th revision (ICD-10), Z codes (Z55-Z65) who presented to the emergency department (ED) with salpingitis and oophoritis, and explore patterns of healthcare utilization and management. In this retrospective cohort study we used TriNetX Research Network data to compare adult females (18-49 years of age) presenting to the ED with diagnosed salpingitis and oophoritis between January 1, 2000-January 1, 2024, by presence or absence of SDoH Z codes. Propensity score matching balanced baseline demographics and comorbidities. The outcomes assessed one year from ED presentation included surgical intervention, hospital admission, ED revisits, utilization of critical care service, analgesic use, and new mental health diagnoses such as anxiety, post-traumatic stress disorder, and depression. Risk analyses compared outcome proportions between cohorts, reported as risk ratios (RR) with 95% confidence intervals. Before propensity score matching, the proportion of the initial cohort that had at least one SDoH Z code was 11.9%. Following propensity score matching, we analyzed 5,570 patients, 50% of whom had documented SDoH Z codes. We found that 10.2% of patients with documented SDoH Z codes received surgery compared to 15.0% of patients without (RR, 0.679; 95% CI, 0.577-0.799, P < .001). On the contrary, 45.7% of patients with Z codes were hospitalized compared to 34.3% without (RR, 1.333; 95% CI, 1.248-1.423, P < .001). Of patients with SDoH Z codes, 58.1% revisited the ED compared to 45.2% without (RR, 1.287; 95% CI, 1.222-1.355, P < .001). 4.4% of patients with Z codes required critical care services compared to 2.5% without (RR, 1.757; 95% CI, 1.317-2.345, P < .001). Lastly, patients with SDoH Z codes experienced new mental health diagnoses. This included 8.4% with Z codes diagnosed with depression (RR, 1.890; 95% CI, 1.432-2.495, P < .001) compared to 4.6% without, 11.1% with Z codes diagnosed with anxiety (RR, 1.565; 95% CI, 1.241-1.973, P < .001) compared to 7.1% without, and 2.7% with Z codes diagnosed with post-traumatic stress disorder (RR, 3.026; 95% CI, 1.897-4.826, P < .001) compared to 0.9% in patients without documented Z codes. Patients with documented ICD-10 Z codes for social determinants of health were less likely to receive surgery but were associated with increased ED repeat visits, hospitalization, need for critical care, and mental health conditions. These findings highlight the clinical relevance of SDoH in acute care utilization and patient outcomes, underscoring the importance of routine screening and documentation of SDoH in electronic health records. Addressing underlying social needs may be a key strategy in reducing healthcare burden and improving long-term outcomes for vulnerable populations.
Mental health conditions such as depression, anxiety, and post-traumatic stress disorder (PTSD) are highly prevalent among forcibly displaced populations. Prevalence rates of common mental health conditions have been studied in refugee groups. However, research is sparse regarding the heterogeneity of psychiatric symptoms and quality of life (QoL) profiles among individuals with recent displacement experiences. The current study employed Latent Profile Analysis (LPA) to identify profiles of psychopathology and QoL in a sample of 510 recently arrived refugees in Sweden. The associations of profile membership with socio-demographic factors were thereafter investigated. Three distinct profiles were identified: a severe psychopathology/low QoL profile (36.27%), a PTSD-dominant/preserved QoL profile (33.14%) and a mild psychopathology/high QoL profile (30.59%). Nationality and residence status were moderately associated with profile membership. Individuals with Afghan nationality were over-represented, and those with Syrian nationality under-represented, in the severe psychopathology/low QoL profile. This association is likely explained by residence status: 82% of individuals in the severe psychopathology/low QoL profile lacked a residence permit, with only 3.6% of Afghans having received a residence permit, compared to 59.1% of Syrians. The results underscore the heterogeneity of psychopathological symptoms and QoL in individuals with recent displacement experiences, as well as a significant influence of contextual factors like residence status on their mental health and QoL. These findings may have implications for informing psychological treatments and migration policies.
Intrahepatic cholestasis of pregnancy (IHCP) is the most common pregnancy-specific liver disease. This study aimed to determine the prevalence of proteinuria in patients with IHCP and to evaluate its association with adverse pregnancy outcomes. This retrospective cohort study included pregnant patients with gestational age > 24 weeks who were diagnosed with IHCP and completed 24-hour urine protein collection at Haseki Training and Research Hospital (January 2018-December 2024). Proteinuria was defined as ≥300 mg/24-h urine collection. Patients were categorized into 3 groups: non-proteinuric, isolated proteinuria (proteinuria ≥ 300 mg/24 h in the absence of hypertension), and preeclampsia (defined according to the American College of Obstetricians and Gynecologists [ACOG] criteria). The primary outcome was a composite adverse pregnancy outcome, including preterm delivery at <34 weeks, umbilical artery pH < 7.1, and emergency cesarean delivery due to fetal distress. Group comparisons were performed using the Kruskal-Wallis test for continuous variables and the chi-square or Fisher exact test for categorical variables. Multivariate logistic regression was performed adjusting for maternal age, twin gestation, and in vitro fertilization conception. Among 341 patients, 207 (60.7%) had no proteinuria, 105 (30.8%) had isolated proteinuria, and 29 (8.5%) had preeclampsia. Overall, 39.3% of IHCP patients demonstrated proteinuria. The distribution of IHCP severity, as classified by maximum total bile acid (TBA) concentration, was comparable among the 3 groups (P = .976). The demographic parameters were comparable between the groups. The preeclampsia group exhibited significantly higher composite adverse outcome rates (P < .001). Multivariate logistic regression demonstrated that preeclampsia was independently associated with composite adverse outcomes (adjusted odds ratio: 6.96, 95% confidence interval: 2.69-18.01; P < .001), whereas isolated proteinuria showed no significant association (adjusted odds ratio: 1.54, 95% confidence interval: 0.95-2.50; P = .079). Approximately 39% of IHCP patients exhibited proteinuria. Isolated proteinuria without hypertension was not an independent predictor of adverse pregnancy outcomes. In the absence of hypertension or other features of preeclampsia, the presence of proteinuria alone may not warrant escalation of care or accelerated delivery decisions in IHCP. However, prospective validation of these findings is needed before definitive clinical recommendations can be established.
Sickle cell disease (SCD) disproportionately affects racial and ethnic minority groups in the US and is associated with high levels of morbidity and health care utilization. However, population-level geographic differences and temporal variation in SCD hospitalization outcomes remain incompletely characterized. To assess temporal and regional patterns of SCD hospitalizations in New York State from 2009 through 2022. This retrospective cross-sectional study analyzed inpatient SCD hospitalizations recorded in the New York State Statewide Planning and Research Cooperative System deidentified database between January 1, 2009, and December 31, 2022. The analytic sample included 42 271 hospitalizations after exclusion of records with missing demographic, cost, or facility information. Data analysis was conducted from July 17, 2024, to February 14, 2025. Hospitalization with SCD across 8 state-defined health service areas. Outcomes included regional distribution of hospitalizations, mean length of stay, mean total charges, and trends in severity of illness and risk of mortality as defined by the All Patient Refined Diagnosis Related Groups classification system. Demographic and regional distributions were compared across years and regions. Among 42 271 SCD hospitalizations (21 777 female [51.5%]), most occurred among individuals identified as Black (35 318 [83.6%) compared with White (750 [1.8%]), multiracial (242 [0.6%]), and other race or ethnicity 5956 (14.1%) and were aged 18 to 29 (16 794 [39.7%]) or 30 to 49 years (13 480 [31.8%]). New York City accounted for the largest proportion of hospitalizations statewide. There were significant differences in the length of stay and total charges across service areas; Central New York had the longest mean (SD) length of stay of 6.3 (7.3) days, followed by the Hudson Valley (6.2 [7.2]) days, while Long Island had the highest mean (SD) total charges at $59 476.3 ($63 823.5). The proportion of hospitalizations classified as major severity increased from 751 of 5897 (12.7%) in 2009 to 1011 of 3709 (27.3%) in 2022, and the proportion classified as major risk of mortality increased from 170 of 5897 (2.9%) to 469 of 3709 (12.6%) during the same period. Long Island had the highest proportion of hospitalizations with major risk of mortality (93 of 970 [9.6%]), whereas New York City exhibited one of the lower proportions of major risk of mortality (1531 of 27 923 [5.5%]) despite high hospitalization volume. In this cross-sectional study, geographic and temporal differences in SCD hospitalization outcomes were observed across New York State during a 14-year period. These findings suggest the need for region-specific strategies to improve access to specialized care, reduce severe outcomes, and optimize health care resource use for individuals living with SCD.
Postpartum hemorrhage (PPH) remains a leading cause of maternal morbidity and mortality globally, particularly in women with antepartum hemorrhage (APH). Current risk assessment methods lack standardized predictive tools that are both simple and reliable for clinical application. We conducted a secondary analysis of a prospectively collected cohort of 100 pregnant women presenting with APH at ≥28 weeks' gestation at a tertiary care centre in northern India. Multivariable logistic regression was used to identify significant predictors of PPH. A point-based clinical risk score was then developed based on the multivariable model and internally validated using bootstrap techniques with 1000 replicates. PPH occurred in 30% of patients (n=30). Multivariable analysis identified four independent predictors of PPH: maternal age (adjusted odds ratio [OR] 1.29 per year; 95% confidence interval [CI] 1.10-1.51; p=0.002), gravidity (OR 2.11 per unit; 95% CI 1.00-4.43; p=0.049), gestational age at delivery (OR 0.64 per week; 95% CI 0.44-0.94; p=0.021), and antepartum blood transfusion (OR 2.44; 95% CI 1.02-5.84; p=0.045). The prediction model demonstrated excellent discrimination with an area under the receiver operating characteristic (ROC) curve of 0.86 (95% CI 0.80-0.92) and good calibration (slope 0.95). Bootstrap internal validation yielded an optimism-corrected AUC of 0.84. The resulting four-factor risk score stratified patients into four risk categories with PPH rates ranging from 4% (low risk) to 100% (very high risk). The four-variable score provides an accurate, easily applicable tool with excellent predictive performance. The score is a promising tool that, pending external validation, may facilitate early identification of high-risk patients and improve maternal outcomes. Further research should focus on external validation of this tool in diverse populations and its integration into clinical practice.
People with lived experience are increasingly involved in guideline development. There is limited research about the experiences of lived experience engagement in guideline development from the perspective of guideline developers and people with lived experience. The aim of this study is to explore the experiences and perspectives of people with lived experience and guideline developers about lived experience engagement in Australian guidelines. Participants included guideline developers and people with lived experience who had developed (or contributed to the development of) an Australian guideline in the last five years. We conducted 15-30-minute online interviews and one 50-minute online focus group, with an inductive thematic analysis of the data. Fifteen guideline developers and 22 people with lived experience participated. We found that many people in both participant groups described positive experiences with engagement, with few weaknesses. Guideline developers described how helpful it was to have an established practice of consumer engagement and the supported of colleagues to draw upon. Some people with lived experience described receiving insufficient support (e.g. lack of orientation) to participate in the guideline development process. Both participant groups wanted more people with lived experience involved in the development of guidelines and greater diversity in contributors. The need for adequate funding and resources was highlighted by guideline developers and the importance of remuneration was emphasised by both groups. Both participant groups advocated for having separate meetings with only people with lived experience. Guideline developers who had not involved people with lived experience wanted to do so in the future. Australian guideline developers and people with lived experience report many positive experiences working together on guidelines, and identified some areas for improvement. Lived experience engagement would be improved by guideline developers being able to access sufficient funding and resources for engagement.
To compare accuracy, precision, recall, F1 and time spent using commercial tools to identify physiotherapy trials based on title and abstract, compared with a human approach. This study compared two approaches for title and abstract screening of 10,793 newly published records. In the reference standard human approach, two reviewers independently screened records using pre-specified rules to assess relevance to physiotherapy. A third person resolved disagreements. We evaluated three LLMs (gpt-4o, gpt-4.5, gpt-4-turbo) within two commercial, web-based tools (ChatGPT and Co-pilot). Outcomes were accuracy (proportion of records that model correctly identified as relevant or irrelevant), precision (proportion of records identified as relevant that were considered as relevant by human approach), recall (the proportion of all actual relevant records that the model successfully identified), F1 (harmonic mean of precision and recall) and time spent. Exploratory analyses compared the performance of the commercial tools with local approaches, including local LLMs implementation, machine learning and natural language processing. Commercial tools showed comparable performance across all metrics (ChatGPT vs Copilot: accuracy: 83% vs 86%; precision: 44% vs 48%; recall: 88% vs 87%; F1: 59% vs 62%). The total time spent using commercial tools with a labelled dataset was equivalent to 37% of the time required for the human-only screening process. Exploratory analysis showed that the API-based implementation has comparable performance (accuracy: 82%; precision: 42%; recall: 93%; F1: 58%). Yet, LLM-based models demonstrated lower performance compared with other local, custom-adapted automation approaches such as machine learning and natural language processing. This proof-of-concept study demonstrates that commercial web-based LLMs may have sufficient accuracy to support title and abstract screening and substantially reduce the time to identify field-specific trials. However, alternative approaches, including machine learning or natural language processing, could achieve screening performance similar to or slightly higher than that of commercial tools, yet they require a series of pre-processing steps for implementation.
To explore the risk factors and predictive value of Mycoplasma pneumoniae (MP) infection in children. A total of 2042 children with suspected Mycoplasma pneumoniae infection who were treated for the first time at Civil Aviation General Hospital from October 2023 to December 2023 were selected as the study subjects. Among them, 1637 cases were confirmed as Mycoplasma pneumonia-infected and were included in the pneumonia group, while the remaining 405 cases were non-Mycoplasma pneumonia-infected and were included in the non-Mycoplasma pneumonia group. The clinical data of the 2 groups of children (including gender, age, initial symptoms, laboratory indicators, etc) and the risk factors of MP infection in children were compared, and the receiver operating characteristic curve was analyzed. This study showed that the percentage of neutrophils in the non-MP infection group was significantly lower than that in the MP infection group, and the difference was statistically significant (P < .001). When comparing the percentages of lymphocyte percentage (LY) and hemoglobin in the 2 groups of children, the Mycoplasma pneumonia-infected group was lower than the non-Mycoplasma pneumonia-infected group, and the differences were both statistically significant (P < .05). Logistic regression analysis revealed that white blood cell and neutrophil-to-lymphocyte ratio (NLR) might be valuable markers for predicting MP infection. The Spearman correlation indicated that LY was collinear with the occurrence of MP infection, and Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis demonstrated that both LY and NLR might be valuable markers for predicting MP infection (P < .05). Receiver operating characteristic curve analysis revealed that the area under the curve of the NLR for diagnosing MP infection was 0.624, with a cutoff value of 1.36 (sensitivity of 0.798 and specificity of 0.558). In the diagnosis of MP infection, the consistency between the RNA method and the immunogold colloidal method was poor (Kappa = 0.108, P < .05). The consistency between the RNA method and the immunogold colloidal method in the diagnosis of MP infection is poor. Both the white blood cell and NLR are valuable markers for MP infection.
Pre-procedural anxiety in patients with intravitreal injections shows a significant negative association with vision-related quality of life. This study determines the effect of telenursing with self-care education podcasts on anxiety and quality of life in patients with diabetes undergoing intravitreal injections. A randomized clinical trial was conducted in 2022 in Mashhad, Iran on 68 patients assigned to two groups. After informed consent were obtained, patients completed a demographic questionnaire, the Spielberger State-Trait Anxiety Inventory, and the SF-36 quality of life questionnaire. Relevant podcasts were delivered individually via WhatsApp once a week over an 8-week period to the intervention group (n=34), while the control group (n=34) received routine education via pamphlets. Anxiety levels were measured before the commencement of the intervention and each injection; the quality-of-life questionnaire was administered before and after the completion of the intervention. Data were analyzed using SPSS version 26. The statistical tests included the t-test, Chi square, repeated measures ANOVA, ANCOVA, and Mann-Whitney U test. The intervention group demonstrated a significantly greater reduction in both state anxiety (P<0.001) and trait anxiety (P<0.001) over the eight-week study period compared to the control group. Furthermore, the intervention group comparison with the control group showed statistically significant improvement in the total score of quality-of-life (P<0.001). A telenursing program delivered via self-care podcasts, a feasible task for community nurses, significantly reduced anxiety and improved quality of life in patients with diabetic retinopathy undergoing intravitreal injections.Trial Registration Number: IRCT20220611055134N.
The COVID-19 pandemic created unprecedented ethical challenges for nurses, often culminating in moral distress. The aim of this study was to explore the experiences of Spanish nurses in relation to moral distress and ethical conflicts experienced during the COVID-19 pandemic. Qualitative phenomenological study. Nurses who had tended COVID-19 patients were given a semi-structured interview via the Zoom application. Thematic analysis was carried out, identifying units of meaning and assigning codes that were grouped into the different categories using Open Code software. Seventeen nurses participated and four categories emerged: (i) Difficulties in the general management of the pandemic on the institutional level, (ii) Limitation of patients' rights in a pandemic situation, (iii) Influence on the humanization of healthcare, (iv) Impact on professionals and on the profession. Restrictions on patients' and families' rights during the pandemic generated ethical conflicts for healthcare professionals. In addition, the scarcity of both human and material resources, together with limited access to information, intensified value conflicts in clinical practice. This project provides evidence on ethical conflicts experienced by nurses during the pandemic, both in the quality of care and professionals' well-being. Findings will contribute to and have an impact on future action protocols and public policies aimed at better managing ethical challenges in health emergency situations.
Comorbidity is prevalent among people with multiple sclerosis (pwMS) and may contribute to disease progression. Physical exercise (PE) reduces symptoms in pwMS and also benefits comorbidities. Digital (e)-based PE has been proposed as a tool to support the integration of PE. To describe a protocol for a randomized controlled trial (RCT) based on a structured approach and the results from a controlled feasibility study of an e-based PE intervention in pwMS with and without comorbidities. In a RCT following a feasibility study (n=50), patients will be randomly assigned in a 1:1 ratio to receive either usual care (n=150) or usual care plus an e-based PE program at home (n=150). The exercise program consists of resistance training with resistance bands targeting the lower extremities. The sessions will enable participants to engage in group exercises from their homes, supervised online by physiotherapists, two 60-minute sessions per week for 6 months (24 weeks and 48 sessions). The primary endpoint is change of walking capacity using the 6-minutes' walk test. Secondary endpoints include "no evidence of disease activity" (NEDA)-3 scale, measures of quality of life and fatigue as well as levels of neurofilament light chain in blood and cerebrospinal fluid.Results of the feasibility study: Fifty individuals were eligible and randomized to an intervention group (n = 23) or to a usual care control group (n = 27). A total of 24 sessions were conducted for three months in groups of 6, supervised by the physiotherapist. In the intervention group, two pwMS did not begin the PE program due to occupational constraints with a resulting recruitment rate of 91.3% (21/23). Of the remaining 21 individuals, 16 (76.2%) completed the follow-up assessments with a mean attendance of 15.2 (range 6-22) sessions per participant, corresponding to a 63% adherence rate. No intervention-related adverse events were reported. This protocol describes a prospective RCT study and the supporting feasibility data of an e-based PE performed at home. The effects of e-based PE performed at home will be evaluated, offering a significant contribution to the field of digital healthcare solutions and MS. https://clinicaltrials.gov/, identifier NCT06298201.
The prevalence of leg ulcers (LUs) increases with age. Nevertheless, a significant number of working-age individuals are affected by hard-to-heal (chronic) wounds that last throughout their adult lives, impacting work capacity and leading to absenteeism, unemployment and subsequent financial burden. A retrospective observational study was carried out between January 2022 and June 2024 at a Portuguese tertiary hospital, which included working-age patients living with LUs. Patients who were unemployed and retired for reasons other than LUs were excluded from the study. Clinical data on wound care and work activity were registered, and the Work Productivity and Activity Impairment questionnaire General Health version 2 (WPAI-GH) was applied. Results: A total of 24 patients were included, with a mean age of 53.6±11.0 years. LUs had a median evolution of six years (interquartile range: 3-20) and 19 (79%) patients had recurrent ulcers. A total of 11 (46%) patients were unemployed or had retired early due to their LUs. A reduction of monthly income after developing the ulcer was noted in 43.5% of patients. The median number of work days missed by employed patients in the previous year was 39 (interquartile range: 2.5-317.5); three patients were on leave for ≥1 year. LU was related to incapacity for work and loss of income in almost half of the study cohort. Longer duration of the ulcers, recurrence rates and work that required prolonged standing were positively associated with unemployment and retirement. By establishing earlier and more efficient treatment plans, clinicians can reduce duration of treatment and work incapacity in people with LUs.
Sepsis, a critical condition caused by dysregulated host responses to infection, frequently involves cardiac complications. Electrocardiogram (ECG) provides valuable insights into the cardiovascular status of sepsis patients and may guide early interventions. However, comprehensive data on ECG patterns in sepsis patients within the emergency department (ED) is limited. In this study we aimed to identify common ECG rhythms and patterns in sepsis patients presenting to the ED and analyze their association with poor clinical outcomes, including intensive care unit (ICU) admission, prolonged hospital stay (> 14 days), and in-hospital mortality. We conducted a retrospective observational study using data from 3,598 adult sepsis patients presenting to the ED of Srinagarind Hospital, Khon Kaen, Thailand, between January-December 2023. ECG abnormalities were extracted from the automated ECG interpretation system. Cardiologists reviewed only ECGs flagged as potential acute infarction or ST elevation to confirm acute coronary syndrome patterns. We analyzed associations between ECG abnormalities and clinical outcomes using univariate logistic regression models. Common ECG rhythms in sepsis patients included sinus rhythm (41.7%), sinus tachycardia (39.0%), and atrial fibrillation/flutter (8.8%). The automated algorithm identified prolonged QT intervals (54.4%) and ST elevation in 10.4% of patients; however, only 1.7% met cardiologist-confirmed criteria for acute coronary syndrome. Compared with patients with better outcomes, those with poor outcomes more frequently had atrial fibrillation/flutter (14.9 vs. 7.5%), new-onset atrial fibrillation/flutter (6.0 vs. 2.8%), QT prolongation (61.6 vs. 52.9%), and abnormal T waves (10.9 vs. 8.4%), corresponding to odds ratios of 2.19 (95% CI, 1.77-2.69), 2.24 (1.50-3.28), 1.43 (1.20-1.70), and 1.34 (1.01-1.76), respectively. Certain ECG abnormalities in sepsis patients are associated with adverse clinical outcomes. Incorporating ECG assessments into sepsis protocols may enhance the early identification of high-risk patients and improve management strategies in the ED.
Background: Chronic spontaneous urticaria (CSU) presents with unpredictable, often debilitating symptoms, yet detailed clinical characterization, particularly in pediatric populations, remains limited. Improved understanding of clinical profiles and comorbidities may guide management strategies. Objective: The objective was to characterize clinical presentation, comorbid type 2 inflammatory diseases, and treatment responses in a large cohort of pediatric and adult patients with CSU across multiple allergy practices. Methods: A retrospective observational cohort study was conducted across four U.S. allergy clinics, including two pediatric- and two adult-focused practices. Medical records of 400 patients with CSU (189 pediatric patients, 211 adults) with ≥ 6 months of follow-up between 2013 and 2023 were reviewed for demographic data, comorbidities, clinical presentation, clinician-documented disease severity, and treatment outcomes. Results: Disease severity spanned mild (24%), moderate (28%), and severe (48%) disease; adults more often presented with severe disease (65% versus 32% in pediatric patients). Atopic comorbidities were common, including allergic rhinitis (72%), asthma (38%), and atopic dermatitis (17%), with 43% of patients having two or more type 2 inflammatory comorbidities. H1-antihistamines were the most frequently used therapies, with cetirizine being most common. Omalizumab showed effectiveness in most patients, although ∼31% experienced partial or no response. Systemic corticosteroids and cyclosporine were used infrequently. Sparse documentation of physical findings and laboratory analysis limited further objective analysis. Conclusion: This U.S. multicenter study highlights the substantial burden of atopic disease and refractory CSU in both pediatric and adult populations. These findings emphasize the need for prospective studies with standardized clinical documentation to better understand CSU phenotypes and optimize individualized treatment strategies.
To examine the association between prenatal exposure to benzodiazepines or Z-hypnotics and a spectrum of psychiatric disorders in children. Population based cohort study with sibling controlled analysis. National Health Information Database of South Korea, 2009-23. All liveborn children between 2010 and 2022 were followed until 2023. Pregnancies exposed to benzodiazepines or Z-hypnotics were compared with unexposed pregnancies and with pregnancies in women with previous use of these drugs (past users). Overall and 12 specific psychiatric disorders in offspring. Propensity score overlap weighting was applied to balance covariates, and hazard ratios with 95% confidence intervals were estimated using Cox proportional hazards models. Sibling controlled analyses were conducted to account for shared familial factors. Among 3 809 949 liveborn children, 94 482 (2.5%) were exposed to benzodiazepines or Z-hypnotics during pregnancy, 3 715 467 were unexposed, and 147 307 were born to past users. During the follow-up period, a total of 10 060, 311 997, and 15 645 events occurred in the exposed, unexposed, and past user groups, respectively. Prenatal exposure was associated with a higher risk of psychiatric disorders compared with unexposed pregnancies and past users; however, this association was attenuated in the sibling controlled analysis (hazard ratio 0.99, 95% confidence interval 0.94 to 1.04). No increased risk was observed for individual psychiatric disorders. In subgroup analyses, modestly elevated hazard ratios were observed for exposure during the second half of pregnancy (sibling controlled hazard ratios: 1.27 (0.95 to 1.71) for benzodiazepine; 1.81 (0.57 to 5.74) for Z-hypnotic), during both the first and second half of pregnancy (sibling controlled hazard ratios: 1.35 (0.93 to 1.96) for benzodiazepine; 1.44 (0.93 to 2.21) for Z-hypnotic), and for 30 or more days of Z-hypnotic exposure (sibling controlled hazard ratio 1.31, 0.96 to 1.78), although the confidence intervals in sibling analyses were wide and included the null. In this large population based cohort, prenatal exposure to benzodiazepines or Z-hypnotics was not associated with an increased risk of psychiatric disorders in offspring after familial factors were accounted for. However, given the modest elevations in point estimates observed in certain subgroups-particularly with benzodiazepine and Z-hypnotic exposure during the latter half of pregnancy, as well as with exposure in both early and late pregnancy, and with longer durations of Z-hypnotic use-the potential for a slightly increased risk in these specific contexts could not be ruled out.
Diabetic neuropathy (DN) is the most common chronic complication of Type 2 diabetes mellitus (T2DM), with reported prevalence ranging from 23% to 54.5%. This study evaluated the prevalence, clinical characteristics, and treatments of DN using Korean National Health Insurance Service (NHIS) data from 2012 to 2017. We analyzed NHIS sample data for 8.7 million individuals stratified by age, sex, eligibility, and income. DN was defined using ICD-10 codes (E10.4-E14.4, G59.0, G63.2, G99.0) and concurrent prescriptions for diabetes and DN. Annual DN prevalence among diabetes patients was calculated, and treatment patterns and patient characteristics were compared between those with and without DN. DN prevalence declined from 23.4% in 2012 to 21.5% in 2017. About half of DN patients received pharmacologic treatment-mainly monotherapy (up to 82%), followed by dual (15%) and triple therapy (3%). The most prescribed drugs were α-lipoic acid (52.1%-55.0%), anticonvulsants (30.4%-34.5%), tricyclic antidepressants, SNRIs, and γ-linolenic acid. DN patients were generally older, more often female, and had more comorbidities such as hypertension, dyslipidemia, cardiovascular disease, diabetic foot, and amputations. They were also more likely to use insulin or multiple oral agents. About one-quarter of patients with T2DM had DN, and half received treatment, mostly α-lipoic acid monotherapy. DN patients tended to be older and had multiple comorbidities, resulting in higher hospitalization rates.
Accurately differentiating severe from nonsevere COVID-19 clinical types is critical for the health care system to optimize workflow. Current techniques lack the ability to accurately classify COVID-19 clinical types in patients, especially as SARS-CoV-2 continues to mutate. We explore the predictability and interpretability of multiple state-of-the-art machine learning (ML) techniques trained and tested under different biomedical data types and SARS-CoV-2 variants. Comprehensive patient-level data were collected from 362 patients (severe COVID-19: n=148; nonsevere COVID-19: n=214) infected with the original SARS-CoV-2 strain in 2020 and 1000 patients (severe COVID-19: n=500; nonsevere COVID-19: n=500) infected with the Omicron variant in 2022-2023. The data included 26 biochemical features from blood testing and 26 clinical features from patients' clinical characteristics and medical history. Different ML techniques, including penalized logistic regression, random forest, k-nearest neighbors, and support vector machines, were applied to build predictive classification models based on each data modality separately and together for each variant. Fifty randomized train-test splits were conducted per scenario, and performance results were recorded. The fusion (hybrid) characteristic modality yielded the highest mean area under the curve (AUC) in this study, achieving 0.915, while the biochemical and clinical modalities had AUCs of 0.862 and 0.818, respectively. All ML models performed similarly under different testing scenarios and were consistent when cross-tested with data of patients infected with the original strain and those infected with the Omicron variant. Our models ranked elevated d-dimer (biochemical), elevated high sensitivity troponin I (biochemical), and age greater than 55 years (clinical) as the most positively predictive features of severe COVID-19. These results are compatible with the hypothesis that ML is a useful tool for predicting severe COVID-19 based on comprehensive individual patient-level data. Further, ML models trained on the biochemical and clinical modalities together show patterns consistent with enhanced predictive performance. The improved performance observed with Omicron variant data agrees with the hypothesis that ML approaches may retain utility across variants in this study setting, although further validation is required before clinical application. Future work using larger datasets with more ethnic variation and investigating unbiased ML interpretation methods may be able to provide further validation.
The burden and clinical correlates of dementia are unknown in Uganda. We therefore determined the prevalence and factors associated with dementia among older persons in Northern Uganda. In a cross-sectional study, adults aged 60 years and above attending the medical outpatient clinic at a tertiary Hospital from March 2022 to April 2022 were enrolled. The prevalence of dementia was determined using the Intervention for Dementia in Elderly Africans (IDEA) and the Instrumental Activities of Daily Living (IADL) tool henceforth presented as IDEA-IADL. Factors of association were collected using a standardized questionnaire. A total of 271 eligible participants were enrolled into the study. Majority were age 60-69 years (153/271) and of male gender (165/271). The prevalence of dementia was 17.7% (48/271), severe dementia 7.4%, (20/271), moderate dementia 10.3%, (28/271). Factors independently associated with dementia were: participants aged between 80-89 years; (adjusted odds ratio (aOR): 9.7; 95% Confidence Interval (CI): 4.08-23.07, p< 0.001), family history of dementia (aOR: 3.4, 95CI: 1.62-7.04, p=0.001). history of depression (aOR: 2.7, 95CI: 1.40-5.02, p=0.003). Physical activity and cognitive exercise were associated protective factors with (aOR 0.1, 95CI: 0.03-0.24, p< 0.001) and (aOR 0.2, 95CI: 0.06-0.53, p<0.002) respectively. There burden of dementia among older persons in Northern Uganda is significant. Enhanced screening and early identification of dementia is recommended in this setting.