16,334 results on '"Severity of Illness Index"'
Search Results
2. The severity of nutrition and pneumonia predicts survival in patients with aspiration pneumonia: A retrospective observational study
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Yorihide Yanagita, Shinichi Arizono, Yuichi Tawara, Masaki Oomagari, Hikaru Machiguchi, Koshi Yokomura, Norimasa Katagiri, and Yuki Iida
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aspiration pneumonia ,mortality ,nutritional status ,severity of illness index ,Diseases of the respiratory system ,RC705-779 - Abstract
Abstract Introduction Aspiration pneumonia is a common problem among older adults; it has a high mortality rate and the prevalence is increasing. Reports on the risk factors for mortality in patients with aspiration pneumonia are limited. This study aimed to evaluate the risk factors for 90‐day survival in patients with aspiration pneumonia. Methods This retrospective observational study was conducted at Seirei Mikatahara General Hospital between 1 April 2015 and 31 March 2016. Patients with aspiration pneumonia who had dysphagia or aspiration confirmed by modified water swallow test or VideoEndoscopic examination of swallowing were included. The primary endpoint was 90‐day survival. We performed univariate and multivariate logistic regression analyses with survival and non‐survival at 90 days as the independent variables. Results A total of 276 patients were recruited for this study. The A‐DROP score (odds ratio [OR] = 2.440; 95% confidence interval [CI], 1.400–4.270; p
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- 2022
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3. The effects of long‐term continuous positive airway pressure on apnea–hypopnea index change following short‐term that withdrawal in patients with obstructive sleep apnea
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Longlong Wang, Minxia Pan, and Qiong Ou
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cohort study ,continuous positive airway pressure ,early diagnosis ,severity of illness index ,sleep apnea, obstructive ,Diseases of the respiratory system ,RC705-779 - Abstract
Abstract The effect of long‐term continuous positive airway pressure (CPAP) treatment on apnea–hypopnea index (AHI) after CPAP withdrawal remains unclear, especially in obstructive sleep apnea (OSA) patients screened from the population. To examine that, 1241 civil servants who participated in the annual physical examination were screened for OSA between September and December 2017. Screened OSA firstly underwent 1‐week CPAP adherence assessment. Then, patients with good CPAP adherence would be freely provided CPAP to continued treatment. All OSA patients were followed for 2 years. At study end, all OSA patients underwent home sleep testing (HST) again within 1 week of CPAP withdrawal. The effect of 2‐year CPAP treatment on OSA severity was investigated by using linear regression and multinominal logistic regression. In total, 103 OSA patients were screened, including 41 cases (39.8%) in CPAP treatment group and 62 cases (60.2%) in non‐CPAP treatment group. At 2‐year follow‐up, compared with baseline, in CPAP treatment group, following CPAP withdrawal, a significant decrease in AHI was observed in patients with severe OSA (P = 0.014); in non‐CPAP treatment group, a significant increase in AHI was observed in patients with moderate OSA (P = 0.028). After adjustment for confounding factors, multivariate linear regression showed that △AHI was negatively associated with CPAP treatment (β = −4.930, 95% confidence interval [CI] [−9.361, −0.500], P = 0.030). Multinominal logistic regression showed that the AHI of patients not treated with CPAP tended to be unchanged or worsened with the AHI improvement group as a reference (OR [odds ration] [95% CI], 4.555 [1.307, 15.875], P = 0.017; 6.536 [1.171, 36.478], P = 0.032). In conclusion, active OSA screening and long‐term CPAP intervention may improve the severity of severe OSA patients following short‐term CPAP withdrawal in the general population.
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- 2022
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4. Prostate cancer in transgender women: A propensity score-matched analysis of disease severity and survival.
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Meagher M, Morgan K, Deshler L, Riviere P, Dolendo I, Rose B, Jamieson C, Morris S, Nik-Ahd F, Freedland S, Anger J, and Salmasi A
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- Humans, Male, Female, Aged, Middle Aged, United States epidemiology, Aged, 80 and over, Severity of Illness Index, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Transgender Persons statistics & numerical data, Propensity Score, SEER Program
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Background: Despite the rise in gender-affirming care, our understanding of prostate cancer (PCa) in transgender women (TGW) remains in its infancy. Health disparities and lack of PCa awareness and screening are possible barriers to providing quality care for this population. In addition, the implication of hormonal manipulation for the aggressiveness of PCa in TGW is yet to be determined. Here, this study sought to compare oncological characteristics and survival outcomes between transgender and cisgender (CG) patients with PCa via two national data sets., Methods: The Veterans Affairs Informatics and Computing Infrastructure database (1999-2020) and the Surveillance, Epidemiology, and End Results-Medicare database (2010-2017) were reviewed. Demographic and clinical details were analyzed. Logistic regression analysis was performed on propensity score-matched groups to identify predictors of high-risk disease and metastasis in patients with PCa. Groups were matched 5:1 (CG:TGW) on the basis of age, race, year of diagnosis, and Charlson Comorbidity Index score. Primary outcomes included metastatic presentation, high-risk localized disease, overall survival (OS), and prostate cancer-specific mortality (PCSM)., Results: A total of 1194 patients were included (199 TGW; 995 CG). Associations between transgender identity and metastatic presentation (odds ratio [OR], 0.38; p = .2), high-risk localized disease (OR, 1.19; p = .50), or PCSM (hazard ratio [HR], 0.65; p = .3) were not detected. Transgender identity was associated with improved OS (HR, 0.67; p = .014)., Conclusions: PCa-specific outcomes seem comparable between TGW and CG men, although the study was underpowered to detect modest differences. Further investigation into the incidence and outcomes of PCa in TGW is warranted., (© 2024 American Cancer Society.)
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- 2024
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5. A scoping review and narrative synthesis of neonatal skin injury severity scales.
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August D, Hall S, Marsh N, and Coyer F
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- Humans, Infant, Newborn, Injury Severity Score, Severity of Illness Index, Pressure Ulcer classification, Pressure Ulcer diagnosis, Skin injuries
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Background: Mechanical force skin injuries are common for critical care patients, especially neonates. Currently, identification and severity assessments of injuries are dependent on clinical experience and/or utilization of severity tools. Compared with adults, neonates sustain skin injuries in different anatomical locations and have decreased layers of healthy tissue (from 0.9 to 1.2 mm) creating questions around direct application of adult injury severity scales reliant on visual assessment., Aim: The aim of this scoping review (ScR) was to investigate severity scales used to report hospital acquired skin injuries for neonates., Methods: This study utilized the 2015 Joanna Briggs Institute methodology for scoping reviews and is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews extension. PubMed, CINAHL, COCHRANE Central, Scopus, and the reference lists of included studies were searched for studies published between 2001 and 2023, that included severity scales use within neonatal population. Two authors independently identified studies for full review, data extraction, and quality assessment., Results: A systematic database search returned 1163 records. After full test review of 109 studies, 35 studies were included. A majority of studies included were cohort or action research and conducted in the United States of America. Most studies (57%, n = 20) reported skin injuries acquired throughout the body, 14 (40%) of the studies reported the nasal area alone and one study reported no anatomical location. A total of nine severity scales or combination of scales were utilized within studies (n = 31) and four studies did not report a scale. Various versions of scales from the National Pressure Ulcer Advisory Panel (n = 16), European Pressure Ulcer Advisory Panel (n = 8) or Neonatal Skin Condition Score (n = 4) were reported, compared with locally developed classifications/scales (n = 4). Scales were predominantly of ordinal grouping (74%, n = 26) or categorical assessment (14%, n = 5). Only one scale from 2004 was validated for neonates., Conclusion: Neonatal skin injuries will continue to be reported subjectively until severity scales are consistently applied or other measurements are identified to support assessment. Additionally, without skin injury assessment uniformity, critical examination of effectiveness of skin care treatment practices will have subjective comparison. This review suggests there is a need for consistent skin assessment and severity scales that are valid for the neonatal population and their unique skin considerations., Relevance to Clinical Practice: In the context of neonatal skin, with its unique characteristics and heightened risk for injury, clinicians must stage, categorise, and describe injury locations to provide objective information on injury severity. Given the risk for injuries across the entire body, including mucous membranes, describing the depth of the injury is essential regardless of the anatomical site. Although not originally designed for this population, a modified version of the National Pressure Injury Advisory Panel (NPIAP) classification system, which incorporates additional classifications (e.g., skin tears), remains the most applicable severity assessment system currently available. This should be supplemented by clinical images or detailed descriptive language (e.g., subtle redness) until rigorously validated severity and assessment scales, based on neonatal data, are developed-particularly for infants born at less than 27 weeks gestation. [Correction added on 25 October 2024, after first online publication: The Relevance to Clinical Practice subsection in Abstract has been added on this version.]., (© 2024 The Authors. Nursing in Critical Care published by John Wiley & Sons Ltd on behalf of British Association of Critical Care Nurses.)
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- 2024
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6. Prediction of mortality in ICU patients: A comparison between the SOFA score and other indicators.
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Shafigh N, Hasheminik M, Shafigh E, Alipour H, Sayyadi S, Kazeminia N, Khoundabi B, and Salarian S
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- Humans, Male, Female, Middle Aged, Prognosis, Aged, Severity of Illness Index, Predictive Value of Tests, Intensive Care Units statistics & numerical data, C-Reactive Protein analysis, Hospital Mortality, Organ Dysfunction Scores, Critical Illness mortality
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The intensive care unit (ICU) is the most important department for critically ill patients. Different scoring systems are used to assess the severity of the disease and evaluate organ failure during the patient's stay in ICU. Our purpose was to evaluate the C-reactive protein/Albumin (CRP/Alb) ratio and SOFA score as indicators of 28-day mortality in ICU patients. A total of 55 patients were enrolled in this study. CRP and CRP/Alb rates, SOFA scores, and demographic data were used to evaluate 28-day mortality in a referral hospital. Survived and dead patients were significantly different in the CRP, CRP/Alb rates, and SOFA scores. However, in the adjusted model, the SOFA score was the predictor of 28-day mortality in ICU patients. SOFA score was also confirmed as a predictor of mortality in ICU patients. Besides, the role of CRP and CRP/Alb in the prediction of disease prognosis or mortality requires further studies., (© 2023 British Association of Critical Care Nurses.)
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- 2024
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7. Development and Initial Validation of the Novel Scleroderma Clinical Trials Consortium Activity Index.
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Ross L, Hansen D, Proudman S, Khanna D, Herrick AL, Stevens W, Baron M, and Nikpour M
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- Humans, Consensus, Quality of Life, Female, Male, Middle Aged, Australia, Reproducibility of Results, Proportional Hazards Models, Clinical Trials as Topic, Scleroderma, Systemic physiopathology, Severity of Illness Index, Delphi Technique
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Objective: Accurate measurement of disease activity in systemic sclerosis (SSc) remains a significant clinical challenge. The Scleroderma Clinical Trials Consortium (SCTC) convened an Activity Index (AI) Working Group (WG) to develop a novel measure of disease activity (SCTC-AI)., Methods: Using consensus methodology, we developed a conceptual definition of disease activity. Literature review and expert consensus generated provisional SCTC-AI items, which were reduced by Delphi survey. Provisional items were weighted against a combined endpoint of morbidity and mortality, using time-dependent Cox proportional hazards regression analysis of the Australian Scleroderma Cohort Study (ASCS) (n = 1,254). External validation of the SCTC-AI was performed using data collected from 1,103 Canadian Scleroderma Research Group Study participants., Results: Disease activity in SSc was defined using consensus methodology as "aspects of disease that are reversible, or can be arrested, with time and, or effective therapy." One-hundred and forty-one provisional SCTC-AI items were generated and reduced using three rounds of Delphi survey and statistical reduction and weighting, against mortality and quality of life measures, yielding a final 24-item index with a maximum possible score of 140. Survival analysis in an external cohort showed a graded relationship between disease activity scores and survival (P < 0.01)., Conclusion: We present a novel instrument to quantify the burden of disease activity in SSc. We have employed a rigorous consensus-based process in combination with data-driven methods to develop an instrument that has face, content, and criterion validity. Further work is required to fully validate and confirm the construct and discriminative validity of the SCTC-AI., (© 2024 The Author(s). Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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8. Prediction of COVID-19 severity using machine learning.
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Karaduzovic-Hadziabdic K, Adilovic M, Zhang L, Lumley AI, Shah P, Shoaib M, Satagopam V, Srivastava PK, Emanueli C, Greco S, Madè A, Padro T, Domingo P, Lustrek M, Scholz M, Rosolowski M, Jordan M, Benczik B, Ágg B, Ferdinandy P, Baker AH, Fagherazzi G, Ollert M, Michel J, Sanchez G, Firat H, Brandenburger T, Martelli F, Badimon L, and Devaux Y
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- Humans, SARS-CoV-2, Male, Female, Middle Aged, COVID-19 diagnosis, COVID-19 epidemiology, Machine Learning, Severity of Illness Index
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- 2024
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9. Archimedes Spiral Ratings: Determinants and Population-Based Limits of Normal.
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Hopfner F, Tietz A, D'Elia Y, Pattaro C, Becktepe JS, Gögele M, Barin L, Pramstaller PP, Kuhlenbäumer G, and Melotti R
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- Humans, Male, Female, Middle Aged, Aged, Adult, Aged, 80 and over, Severity of Illness Index, Young Adult, Age Factors, Sex Factors, Reference Values, Hand physiology, Functional Laterality physiology, Adolescent, Tremor physiopathology, Tremor diagnosis
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Background: Tremor is commonly found among healthy humans or prevalently a symptom of neurological dysfunctions. However, the distinction between physiological and pathological tremor is dependent on the examiner's competence. Archimedes Spiral Rating (ASR) is a valid and reproducible semi-quantitative method to assess the severity of action tremor., Objectives: (1) To assess the range and percentiles of ASR in a large sample seemingly free of tremor-related conditions or symptoms from the population-based CHRIS-study. (2) To analyze the influence of sex, age, and the drawing hand on ASR. (3) To define ASR limits of normal. (4) To supply exemplary Archimedes spiral drawings by each rating to favor consistent and proficient clinical evaluation., Methods: Accurately investigated participants were randomly sampled over 14 sex-age strata. 2686 paired spirals drawn with both hands by 1343 participants were expertly assessed on a tremor rating scale from 0 to 9., Results: ASR had a quadratic increase with age in both sexes, while it was relatively lower in the dominant compared to the non-dominant hand and in women compared to men. ASRs above sex-age specific 97.5th percentiles of 4 and 5, below and above 60 years of age, respectively, were conceivably of non-physiological nature., Conclusions: In a large population-based sample we show a steeper increase of action tremor by age as age progresses. Relatively higher ratings among the elderly, males and the non-dominant hands, appear compatible with ASR limits of "normal" across sex-age groups. The current operational evidence may support practitioners differentiating physiological and pathological hand tremor., (© 2024 The Author(s). Movement Disorders Clinical Practice published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
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- 2024
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10. An artificial intelligence-driven scoring system to measure histological disease activity in ulcerative colitis.
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Peyrin-Biroulet L, Adsul S, Stancati A, Dehmeshki J, and Kubassova O
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- Humans, Observer Variation, Algorithms, Deep Learning, Image Processing, Computer-Assisted methods, Machine Learning, Colon pathology, Colon diagnostic imaging, Image Interpretation, Computer-Assisted methods, Female, Male, Reproducibility of Results, Colitis, Ulcerative pathology, Colitis, Ulcerative diagnosis, Artificial Intelligence, Severity of Illness Index
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Background and Aims: Assessment and scoring of histological images in Ulcerative colitis (UC) is prone to inter- and intra-observer variability. This study aimed to investigate whether an artificial intelligence (AI) system developed using image processing and machine learning algorithms could measure histological disease activity based on the Nancy index., Methods: A total of 200 histological images of patients with UC were used in this study. A novel AI algorithm was developed using state-of-the-art image processing and machine learning algorithms based on deep learning and feature extraction. The cell regions of each image, followed by the Nancy index, were manually annotated and measured independently by four histopathologists. Manual and AI-automated measurements of the Nancy index score were conducted and assessed using the intraclass correlation coefficient (ICC)., Results: The 200-image dataset was divided into two groups (80% was used for training and 20% for testing). Intraclass correlation coefficient statistical analyses were performed to evaluate the AI tool and used as a reference to calculate the accuracy. The average ICC among the histopathologists was 89.3 and the average ICC between histopathologists and the AI tool was 87.2. The AI tool was found to be highly correlated with histopathologists., Conclusions: The high correlation of performance of the AI method suggests promising potential for inflammatory bowel disease clinical applications. A standardized automated histological AI-driven scoring system can potentially be used in daily inflammatory bowel disease practice to reduce training needs and resource use, eliminate the subjectivity of the pathologists, and assess disease severity for treatment decisions., (© 2024 Takeda Development Center Americas, Inc. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
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- 2024
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11. A history of abuse is associated with more severe migraine- and pain-related disability: Results from the American Registry for Migraine Research.
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Trivedi M, Dumkrieger G, Chong CD, Leibovit-Reiben Z, and Schwedt TJ
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- Humans, Male, Female, Adult, Cross-Sectional Studies, Middle Aged, United States epidemiology, Depression epidemiology, Anxiety epidemiology, Severity of Illness Index, Disability Evaluation, Migraine Disorders epidemiology, Registries
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Background: Prior studies have established an association between a history of abuse and more severe migraine presentation., Objectives: This cross-sectional, observational study of a clinic-based migraine population used validated measures to elucidate migraine-specific and migraine-related burdens among patients with a history of abuse., Methods: Patients with migraine (n = 866) from the American Registry for Migraine Research self-reported if they had a history of emotional, physical, and/or sexual abuse and completed questionnaires assessing migraine-related burden: Migraine Disability Assessment, Subjective Cognitive Impairment Scale for Migraine Attacks, Work Productivity and Activity Impairment, Patient-Reported Outcomes Measurement Information System Pain Interference, Patient Health Questionnaire-2, and Generalized Anxiety Disorder-7. Migraine-related burden in patients with versus without a history of abuse was compared. Subsequently, a mediation analysis evaluated the impact of depression and anxiety symptoms in the relationship between abuse history and migraine burden., Results: A history of abuse was reported by 36.5% (n = 316/866) of participants. After controlling for patient age, sex, years lived with headache, and headache frequency, a history of abuse was significantly associated with more severe migraine-related disability. The combined burden of depression and anxiety symptoms mediated the relationship., Conclusion: A history of abuse is associated with greater migraine-related disability. Future studies should determine if identification and management of the psychological and physical sequelae of abuse reduce migraine burden., (© 2024 American Headache Society.)
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- 2024
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12. Shoulder dystocia by severity in families: A nationwide population study.
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Rasmussen S, Ebbing C, Baghestan E, and Linde LE
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- Humans, Female, Pregnancy, Norway epidemiology, Adult, Recurrence, Severity of Illness Index, Risk Factors, Registries, Cohort Studies, Infant, Newborn, Male, Shoulder Dystocia epidemiology, Cesarean Section statistics & numerical data
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Introduction: Previous studies have established a history of shoulder dystocia as an important risk factor for shoulder dystocia, but studies on shoulder dystocia by severity are scarce. It is unknown if shoulder dystocia tends to be passed on between generations. We aimed to assess the recurrence risk of shoulder dystocia by severity in the same woman and between generations on both the maternal and paternal side. We also assessed the likelihood of a second delivery and planned cesarean section after shoulder dystocia., Material and Methods: This was a population-based cohort study, using data from the Medical Birth Registry of Norway. To study recurrence in the same mother, we identified 1 091 067 pairs of first and second, second and third, and third and fourth births in the same mother. To study intergenerational recurrence, we identified an individual both as a newborn and as a mother or father in 824 323 mother-offspring pairs and 614 663 father-offspring pairs. We used Bayesian log-binomial multilevel regression to calculate relative risks (RR) with 95% credible intervals., Results: In subsequent deliveries in the same woman the unadjusted RR of recurrence was 7.05 (95% credible interval 6.39-7.79) and 2.99 (2.71-3.31) after adjusting for possible confounders, including current birthweight. The RRs were higher with severe shoulder dystocia as exposure or outcome. With severe shoulder dystocia as both exposure and outcome, unadjusted and adjusted RR was 20.42 (14.25-29.26) and 6.29 (4.41-8.99), respectively. Women with severe and mild shoulder dystocia and those without had subsequent delivery rates of 71.1, 68.9 and 69.0%, respectively. However, the rates of planned cesarean section in subsequent deliveries for those without shoulder dystocia, mild and severe were 1.3, 5.2 and 16.0%, respectively. On the maternal side the unadjusted inter-generational RR of recurrence was 2.82 (2.25-3.54) and 1.41 (1.05-1.90) on the paternal side. Corresponding adjusted RRs were 1.90 (1.51-2.40) and 1.19 (0.88-1.61), respectively., Conclusions: We found a strong recurrence risk of shoulder dystocia, especially severe, in subsequent deliveries in the same woman. The inter-generational recurrence risk was higher on the maternal than paternal side. Women with a history of shoulder dystocia had more often planned cesarean section., (© 2024 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)
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- 2024
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13. Efficacy and Safety of Upadacitinib or Elsubrutinib Alone or in Combination for Patients With Systemic Lupus Erythematosus: A Phase 2 Randomized Controlled Trial.
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Merrill JT, Tanaka Y, D'Cruz D, Vila-Rivera K, Siri D, Zeng X, Saxena A, Aringer M, D'Silva KM, Cheng L, Mohamed MF, Siovitz L, Bhatnagar S, Gaudreau MC, Doan TT, and Friedman A
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- Humans, Female, Male, Adult, Middle Aged, Treatment Outcome, Janus Kinase Inhibitors therapeutic use, Janus Kinase Inhibitors adverse effects, Double-Blind Method, Heterocyclic Compounds, 4 or More Rings therapeutic use, Heterocyclic Compounds, 4 or More Rings adverse effects, Heterocyclic Compounds, 4 or More Rings administration & dosage, Agammaglobulinaemia Tyrosine Kinase antagonists & inhibitors, Heterocyclic Compounds, 3-Ring therapeutic use, Heterocyclic Compounds, 3-Ring administration & dosage, Heterocyclic Compounds, 3-Ring adverse effects, Severity of Illness Index, Pyridines, Triazoles, Lupus Erythematosus, Systemic drug therapy, Drug Therapy, Combination
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Objective: The 48-week, phase 2 SLEek study (NCT03978520) evaluated the efficacy and safety of upadacitinib (JAK inhibitor) and elsubrutinib (BTK inhibitor) alone or in combination (ABBV-599) in adults with moderately to severely active systemic lupus erythematosus (SLE)., Methods: Patients were randomized 1:1:1:1:1 to elsubrutinib 60 mg and upadacitinib 30 mg once daily (ABBV-599 high dose), elsubrutinib 60 mg and upadacitinib 15 mg once daily (ABBV-599 low dose), elsubrutinib 60 mg once daily (QD), upadacitinib 30 mg QD, or placebo QD. The primary endpoint was the proportion of patients achieving both Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and glucocorticoid dose ≤10 mg QD at week 24. Additional assessments through week 48 included British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) and Lupus Low Disease Activity State (LLDAS) responses, number of flares, time to first flare, and adverse events., Results: The study enrolled 341 patients. The ABBV-599 low dose and elsubrutinib arms were discontinued after a planned interim analysis showed lack of efficacy (no safety concerns). More patients achieved the primary endpoint with upadacitinib (54.8%; P = 0.028) and ABBV-599 high dose (48.5%; P = 0.081) versus placebo (37.3%). SRI-4, BICLA, and LLDAS response rates were higher for both upadacitinib and ABBV-599 high dose versus placebo at weeks 24 and 48. Flares were reduced, and time to first flare through week 48 was substantially delayed with both upadacitinib and ABBV-599 high dose versus placebo. No new safety signals were observed beyond those previously reported for upadacitinib or elsubrutinib., Conclusion: Upadacitinib 30 mg alone or in combination with elsubrutinib (ABBV-599 high dose) demonstrated significant improvements in SLE disease activity and reduced flares and were well tolerated through 48 weeks., (© 2024 The Author(s). Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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14. Pilot study evaluating treatment with sumatriptan for moderate to severe post-traumatic headache: A phase 2 open-label study.
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Sharma TL, Lucas S, Barber J, and Hoffman JM
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- Humans, Male, Female, Adult, Pilot Projects, Middle Aged, Prospective Studies, Serotonin 5-HT1 Receptor Agonists pharmacology, Serotonin 5-HT1 Receptor Agonists administration & dosage, Severity of Illness Index, Feasibility Studies, Sumatriptan administration & dosage, Sumatriptan pharmacology, Post-Traumatic Headache drug therapy, Post-Traumatic Headache etiology
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Objective: Our primary outcome was to determine the feasibility of patients with post-traumatic headache (PTH) keeping a daily headache diary and using sumatriptan as directed. Secondary outcomes include determining if sumatriptan is effective in aborting PTH and whether headache resolution is dependent on PTH phenotype., Background: PTH is prevalent and persistent after traumatic brain injury, yet there have been few studies evaluating the effects of pharmacological treatments in individuals with PTH., Methods: This is a single-arm, prospective, non-randomized phase 2 clinical trial registered at Clinicaltrials.gov (NCT01854385) and conducted from 2013 to 2017. Data analysis was completed in 2022. Of the 299 participants screened, 40 were enrolled in the study. Participants kept a headache diary documenting headache characteristics and severity. Headache characteristics were used to determine PTH phenotypes of migraine-like, probable migraine-like, or non-migraine-like. Participants reported whether sumatriptan was used for their headache, their response to the medication, if a second dose was taken, and their response to the second dose., Results: A total of 15 participants out of the 40 enrolled (mean [SD] age, 41.9 [14.2] years, and 53% [21/40] male), met the criteria for the use of sumatriptan, and completed all assessments. Average headache diary compliance rate for the final month of the study was 80% (372/465). While sumatriptan was used for only 19% (122/654) of all reported headaches, 72% (88/122) of those headaches resolved within 2 h of taking the medication. Resolution of headaches with sumatriptan was not significantly different among headache phenotypes (migraine-like: 22/38 [58%], probable migraine-like: 24/29 [83%], non-migraine-like: 6/15 [40%]; p = 0.154)., Conclusions: A daily headache diary is feasible for tracking headache symptoms. Preliminary results also suggest that sumatriptan, a migraine-specific medication, may be beneficial for the treatment of PTH of different clinical phenotypes. Future studies, such as a phase 3 clinical trial with a larger sample size, are needed to better understand the efficacy of sumatriptan in the treatment of PTH., (© 2024 American Headache Society.)
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- 2024
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15. Effect of hysteroscopic surgery on IVF/ICSI pregnancy outcomes for different cesarean scar diverticulum severity: A retrospective cohort study.
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Pan X, Xu L, Liu Z, Li N, Liu Q, Shi H, and Yang X
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- Humans, Female, Pregnancy, Retrospective Studies, Adult, Diverticulum surgery, Severity of Illness Index, Pregnancy Rate, Embryo Transfer methods, Hysteroscopy methods, Sperm Injections, Intracytoplasmic methods, Cicatrix etiology, Fertilization in Vitro methods, Pregnancy Outcome, Cesarean Section adverse effects
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Objective: To investigate associations between hysteroscopic surgery for patients with varying cesarean scar diverticulum (CSD) severity and in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) embryo transfer (ET) pregnancy outcomes, focusing also on the correlation between the CSD size with its severity, and pregnancy outcomes., Methods: A retrospective study was conducted on patients with CSD who underwent IVF/ICSI-ET at a university-based hospital between January 2017 and July 2023. Patients were categorized into four groups based on CSD severity and whether they received hysteroscopic surgery: a mild surgical group (Group A, n = 86), a mild non-surgical group (Group B, n = 30), a moderate-to-severe surgical group (Group C, n = 173), and a moderate-to-severe non-surgical group (Group D, n = 96). Baseline characteristics and pregnancy outcomes were compared among these groups. Correlation assessments were conducted to explore relationships between CSD size with its severity, and pregnancy outcomes., Results: Compared with Group D, Group C exhibited significantly increased rates of biochemical pregnancy (odds ratio [OR] 1.90; 95% confidence interval [CI] 1.03-3.51, P = 0.041), clinical pregnancy (OR 2.30; 95% CI1.18-4.45; P = 0.014), and live birth (OR 2.77; 95% CI 1.10-7.00, P = 0.031). However, no differences in pregnancy outcomes were observed between Groups A and B. Correlation analyses revealed significant positive associations between CSD severity and its depth, length, width, and volume., Conclusions: Patients with moderate-to-severe CSD achieved favorable IVF/ICSI pregnancy outcomes following hysteroscopic surgery. The CSD size was significantly related to its severity., (© 2024 International Federation of Gynecology and Obstetrics.)
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- 2024
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16. Influence of Economic Connectedness on Pediatric Obstructive Sleep Apnea Severity and Adenotonsillectomy Outcomes.
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Kim J, Nwaogu C, Mitchell RB, and Johnson RF
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- Humans, Male, Child, Female, Retrospective Studies, Treatment Outcome, Child, Preschool, Sleep Apnea, Obstructive surgery, Tonsillectomy, Adenoidectomy, Severity of Illness Index, Polysomnography
- Abstract
Objective: To examine the influence of economic connectedness (EC), a measure of social capital, on obstructive sleep apnea (OSA) severity and adenotonsillectomy outcomes in children., Study Design: Retrospective study., Setting: Single tertiary medical center., Methods: The study population included 286 children who were referred for full-night polysomnography for OSA and underwent adenotonsillectomy. The primary outcome was the relationship between EC and the presence of severe OSA, and secondary outcomes included postoperative emergency room visits and residual OSA after adenotonsillectomy. Linear regression, Kruskal-Wallis test, Pearson's χ
2 test, and multiple logistic regression were used for categorical and continuous data as appropriate., Results: In this population, the median age was 9.0 (interquartile range [IQR] = 6.9-11.7) and 144 (50.3%) were male. The majority were white (176, 62.0%), black (60, 21.1%), and/or of Hispanic ethnicity (173, 60.9%). The median EC of this population was 0.64 (IQR = 0.53-0.86). Higher EC was associated with decreased odds of having severe OSA (odds ratio: 0.17, 95% confidence interval = 0.05-0.61). However, EC was not associated with either postoperative emergency room visits or residual OSA., Conclusion: EC was significantly associated with severe OSA (ie, apnea-hypopnea index ≥ 10) but not with postoperative emergency room visits or residual OSA after adenotonsillectomy. Further research is needed to understand the effects of various social capital measures on pediatric OSA and adenotonsillectomy outcomes., (© 2024 American Academy of Otolaryngology–Head and Neck Surgery Foundation.)- Published
- 2024
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17. Association of Baseline Depression and Anxiety with Longitudinal Health Outcomes in Parkinson's Disease.
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Shi Y, Dobkin R, Weintraub D, Cho HR, Caspell-Garcia C, Bock M, Brown E, Aarsland D, and Dahodwala N
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- Humans, Male, Female, Aged, Middle Aged, Longitudinal Studies, Severity of Illness Index, Disease Progression, Treatment Outcome, Parkinson Disease psychology, Parkinson Disease drug therapy, Parkinson Disease complications, Anxiety epidemiology, Depression epidemiology, Depression drug therapy
- Abstract
Background: Anxiety and depression are common non-motor symptoms in Parkinson's disease (PD) but remain under-recognized and under-treated., Objectives: To evaluate functional outcomes associated with baseline anxiety or depression and effects related to the initiation of new psychiatric treatment., Methods: We analyzed 7 years of data from patients with de novo PD enrolled in the Parkinson's Progression Markers Initiative. Longitudinal regression models evaluated the association between baseline anxiety and depression with Schwab and England (SE) and MDS-UPDRS total scores over time. Cox proportional hazard models assessed effects of baseline anxiety and depression on time to initiation of dopaminergic therapy. Piecewise linear regression models examined the association of treatment initiation for anxiety and depression with SE and MDS-UPDRS., Results: 490 participants with baseline depression and anxiety data were included. Anxiety and depression were associated with lower SE (anxiety: β = -1.31, P = 0.038, depression: β = -1.96, P = 0.012, co-morbid: β = -2.70, P = 0.003) and higher MDS-UPDRS scores (anxiety: β = 5.37, P < 0.001, depression: β = 9.17, P < 0.001, co-morbid: β = 10.50, P < 0.001) longitudinally. Anxiety was associated with faster time to dopamine replacement therapy initiation (HR 1.30, 95% CI 1.03-1.66, P = 0.03). 16 participants with anxiety initiated treatment for anxiety, which was associated with subsequent lower levodopa daily dose (slope change = -218.49, P = 0.018). 10 participants with depression initiated treatment of depression, which was associated with reduced MDS-UPDRS total scores (slope change = -8.3, P < 0.001) and higher SE scores (slope change = 5.99, P = 0.004)., Conclusions: Anxiety and depression at PD onset are associated with multiple negative longitudinal trajectories. However, preliminary findings suggest that anxiety and depression treatment may be linked with improved motor and non-motor outcomes., (© 2024 The Author(s). Movement Disorders Clinical Practice published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
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- 2024
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18. Acarbose might be associated with reduced risk of gastric cancer in patients with diabetes mellitus: A nationwide population-based cohort study.
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Mao PC, Chung MI, Hung YM, Chen HM, and Chen CL
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- Humans, Female, Male, Middle Aged, Retrospective Studies, Taiwan epidemiology, Aged, Cohort Studies, Adult, Diabetes Mellitus epidemiology, Databases, Factual, Proportional Hazards Models, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents adverse effects, Risk Factors, Severity of Illness Index, Acarbose therapeutic use, Acarbose administration & dosage, Stomach Neoplasms epidemiology
- Abstract
Background: Several epidemiologic studies have revealed a higher risk of cancer in patients with diabetes mellitus (DM) relative to the general population. To investigate whether the use of acarbose was associated with higher/lower risk of new-onset cancers., Method: We conducted a retrospective cohort study, using a population-based National Health Insurance Research Database of Taiwan. Both inpatients and outpatients with newly onset DM diagnosed between 2000 and 2012 were collected. The Adapted Diabetes Complications Severity Index (aDCSI) was used to adjust the severity of DM. The Cox proportional hazards regression model was used to estimate the hazard ratio (HR) of disease., Results: A total of 22 502 patients with newly diagnosed DM were enrolled. The Cox proportional hazards regression model indicating acarbose was neutral for risk for gastroenterological malignancies, when compared to the acarbose non-acarbose users group. However, when gastric cancer was focused, acarbose-user group had significantly lowered HR than non-acarbose users group (p = 0.003). After adjusted for age, sex, cancer-related comorbidity, severity of DM, and co-administered drugs, the HR of gastric cancer risk was 0.43 (95% CI = 0.25-0.74) for acarbose-user patients., Conclusion: This long-term population-based study demonstrated that acarbose might be associated with lowered risk of new-onset gastric cancer in diabetic patients after adjusting the severity of DM., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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19. Examining Identity Functioning in Anorexia Nervosa Across Illness and Recovery Stages.
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Croce SR, Malcolm AC, Ralph-Nearman C, and Phillipou A
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- Humans, Female, Adult, Adolescent, Young Adult, Severity of Illness Index, Anorexia Nervosa psychology, Self Concept
- Abstract
Objective: Research suggests that identity functioning (i.e., sense of self) issues may be a core feature of anorexia nervosa (AN). We aimed to investigate differences in identity functioning among women with AN at varying illness and recovery stages, and women with no history of eating disorders (non-ED controls). It was hypothesized that those with current AN (AN-C), weight-restored (AN-WR), and partial recovered individuals (AN-PR) would show poorer identity functioning than fully recovered individuals (AN-FR) and non-ED controls., Method: Women (334) with AN-C (n = 74), AN-WR (n = 90), AN-PR (n = 19), AN-FR (n = 22), and non-ED controls (n = 129) completed online self-report measures of identity functioning and ED symptom severity., Results: The AN-C group showed significantly poorer overall identity functioning, poorer consolidated identity, and significantly worse disturbed and lack of identity, than the AN-PR, AN-FR, and non-ED Control groups. The AN-WR group showed significantly poorer overall identity function, and worse lack of identity, than the AN-FR and non-ED Controls, and poorer consolidated identity and disturbed identity than non-ED Controls. Identity scores did not significantly differ between AN-PR, AN-FR, and non-ED Controls., Discussion: Differences in identity functioning are identifiable among individuals at different AN recovery stages, and thus may represent an important state-based feature of AN, making it an important area of consideration in treatment., (© 2024 The Author(s). International Journal of Eating Disorders published by Wiley Periodicals LLC.)
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- 2024
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20. SERENE ER Analysis Part 1-SERENE CD: Exposure-Response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients With Moderately to Severely Active Crohn Disease.
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Chen MJ, Ponce-Bobadilla AV, Stodtmann S, Song AP, Finney-Hayward TK, and Mostafa NM
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- Humans, Adult, Female, Male, Models, Biological, Severity of Illness Index, Remission Induction methods, Middle Aged, Treatment Outcome, Young Adult, Double-Blind Method, Adalimumab administration & dosage, Adalimumab pharmacokinetics, Crohn Disease drug therapy, Dose-Response Relationship, Drug
- Abstract
SERENE CD (NCT02065570) evaluated whether a higher adalimumab induction dose would improve patients with Crohn disease response and suggested a flat dose-response relationship for efficacy in the induction study. We investigated exposure-response relationships in induction and maintenance studies considering patients' baseline characteristics. Adalimumab exposures were simulated using the established population pharmacokinetic model. Efficacy end points (clinical remission/endoscopic response) at Weeks 4, 12, and 56 were evaluated in exposure-response analyses using multivariable logistic regression. Analyses showed an increasing trend with heterogeneity between induction regimens, which suggested that average concentration has an impact on coprimary efficacy end points within each group, but data did not fit a single-response curve. Although higher concentrations within arms were associated with improved outcomes, increasing the concentration through a higher induction dose was not associated with increasing clinical remission/endoscopic response at Week 4/12. A model including inverse effective clearance eliminated heterogeneity and described trends across induction regimens with a single curve. In the maintenance study, the response rates at Week 56 showed no heterogeneity. In the induction study, patients with lower effective adalimumab clearance responded better, whereas in the maintenance study average concentration drove primary efficacy end points at Week 56. Research extending these findings to other indications is needed., (© 2024, The American College of Clinical Pharmacology.)
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- 2024
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21. An examination of state and trait urgency in individuals with binge-eating disorder.
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Wonderlich JA, Forester G, Crosby RD, Engel SG, Crow SJ, Peterson CB, and Wonderlich SA
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- Humans, Female, Adult, Male, Ecological Momentary Assessment, Severity of Illness Index, Middle Aged, Affect physiology, Binge-Eating Disorder psychology, Impulsive Behavior physiology
- Abstract
Objective: Negative urgency (i.e., acting rashly when experiencing negative affect; NU), is a theorised maintenance factor in binge-eating type eating disorders. This study examined the association between trait NU and eating disorder severity, momentary changes in state NU surrounding episodes of binge eating, and the momentary mechanistic link between affect, rash action, and binge-eating risk., Methods: Participants were 112 individuals with binge-eating disorder (BED). Baseline measures included the UPPS-P Impulsive Behaviour Scale to assess trait NU and the Eating Disorders Examination to assess binge-eating frequency and global eating disorder severity. Ecological momentary assessment captured real-time data on binge eating, negative affect, and state NU., Results: Multiple regression analysis revealed a strong association between trait NU and eating disorder severity. Generalised estimating equations showed that state NU increased before and decreased after binge-eating episodes, and that this pattern was not moderated by trait-level NU. Finally, a multilevel structural equation model indicated that increases in rash action mediated the momentary relationship between states of high negative affect and episodes of binge eating., Conclusion: These findings underscore the importance of both trait and state NU in binge-eating type eating disorders, and suggest NU as a potential key target for intervention., (© 2024 Eating Disorders Association and John Wiley & Sons Ltd.)
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- 2024
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22. Thrombectomy improves functional independence in severe basilar artery occlusion with favorable collateral circulation.
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Luo C, Tao C, Li R, Nguyen TN, Jing X, Yuan S, Wang A, Abdalkader M, Gao F, Chen L, Hao P, Cai M, Liu X, and Hu W
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- Humans, Male, Female, Aged, Middle Aged, Treatment Outcome, Severity of Illness Index, Recovery of Function physiology, Aged, 80 and over, Functional Status, Computed Tomography Angiography, Basilar Artery surgery, Basilar Artery diagnostic imaging, Basilar Artery physiopathology, Thrombectomy methods, Collateral Circulation physiology, Vertebrobasilar Insufficiency surgery, Vertebrobasilar Insufficiency diagnostic imaging, Vertebrobasilar Insufficiency physiopathology
- Abstract
Background and Purpose: This study aimed to investigate the effect of collateral circulation on the outcomes of thrombectomy versus medical management alone in basilar artery occlusion (BAO) patients with varying stroke severities., Methods: Data from the ATTENTION cohort were used to perform a post-hoc analysis comparing the outcomes of thrombectomy with medical management in BAO patients with varying degrees of collateral circulation and stroke severity. Basilar Artery on Computed Tomography Angiography (BATMAN) scores were used to quantify the collateral circulation, and the effect was estimated through a primary outcome of 90-day functional independence (modified Rankin Scale score, mRS ≤2). Favorable versus unfavorable BATMAN scores were analyzed as both continuous and categorical variables, and an adjusted multivariate regression model was applied., Results: Among 221 BAO patients, thrombectomy significantly improved functional independence compared to medical management in patients with favorable BATMAN scores (aOR 7.75, 95% CI 2.78-26.1), but not in those with unfavorable BATMAN scores (aOR 1.33, 95% CI 0.28-6.92; p
interaction = 0.028). When treated as a continuous variable, increased BATMAN score was found to be associated with a higher likelihood of functional independence in the thrombectomy group (aOR 1.97, 95% CI 1.44-2.81; pinteraction = 0.053). In severe stroke patients with higher BATMAN scores (National Institutes of Health Stroke Scale (NIHSS) ≥21), we identified a significant interaction for treatment effect with thrombectomy compared to medical management (pinteraction = 0.042)., Conclusion: An increased BATMAN score was significantly associated with a higher probability of functional independence after thrombectomy than after medical management, particularly in patients with severe BAO., (© 2024 The Author(s). European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)- Published
- 2024
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23. Prevalence of Myofascial Trigger Points in Isolated Idiopathic Cervical Dystonia: A Possible Contributor to Pain, Movement and Disability.
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de-la-Hoz-López D, Gómez-Mayordomo V, Cuadrado ML, García-Ramos R, Alonso-Frech F, de-la-Hoz JL, Fernández-de-Las-Peñas C, and López-Valdés E
- Subjects
- Humans, Female, Middle Aged, Male, Aged, Prevalence, Pain Measurement methods, Pain epidemiology, Pain physiopathology, Pain diagnosis, Disability Evaluation, Severity of Illness Index, Torticollis physiopathology, Torticollis epidemiology, Trigger Points physiopathology, Myofascial Pain Syndromes epidemiology, Myofascial Pain Syndromes physiopathology
- Abstract
Background: Myofascial trigger points (TrPs) are hypersensitive points located in a tight band of muscle that, when palpated, produce not only local pain but also referred (distant) pain. The role of TrPs in patients with cervical dystonia (CD) has not been investigated., Objective: To identify the presence of TrPs in patients with isolated idiopathic CD and their association with pain., Methods: Thirty-one patients (74.2% women; age: 61.2 years, SD: 10.1 years) participated. TrPs were explored in the sternocleidomastoid, upper trapezius, splenius capitis, levator scapulae, anterior scalene, suboccipital, and infraspinatus muscles. Clinical features of CD were documented as well as the presence of pain. The severity of dystonia and its consequences were assessed using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)., Results: The mean number of TrPs for each patient was 12 (SD:3), with no differences between patients with pain (n = 20) and those without pain (n = 11). Active TrPs were only found in patients with pain (mean: 7.5, SD:4). Latent TrPs were found in both groups but were more prevalent (P < 0.001) in patients without pain (mean: 11, SD:3.5) than in those with pain (mean: 5, SD:3.5). The number of active TrPs or latent TrPs was positively associated with the TWSTRS disability subscale and the TWSTRS total score. The number of active, but not latent, TrPs was associated with worse scores on the TWSTRS pain subscale., Conclusion: Active TrPs were present in patients with CD reporting pain, while latent TrPs were present in all CD patients, irrespective of their pain status. The numbers of active/latent TrPs were associated with disability. TrPs could act as pain generators in CD and also contribute to the involuntary muscle contractions characteristic of dystonia., (© 2024 The Author(s). Movement Disorders Clinical Practice published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
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- 2024
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24. The association between endometrial cancer and subsequent diabetic retinopathy severity: A retrospective nationwide study.
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Lee CY, Lin CW, Sun YH, Wang PH, Lee CY, Huang JY, and Yang SF
- Subjects
- Humans, Female, Retrospective Studies, Middle Aged, Taiwan epidemiology, Aged, Incidence, Adult, Proportional Hazards Models, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 complications, Severity of Illness Index, Databases, Factual, Risk Factors, Endometrial Neoplasms epidemiology, Endometrial Neoplasms pathology, Diabetic Retinopathy epidemiology, Diabetic Retinopathy etiology
- Abstract
Objective: The endometrial cancer is a disorder with elevated oxidative stress. The high oxidative stress resulting from hyperglycemia can lead to diabetic retinopathy (DR) development which is a complication of type 2 diabetes mellitus. Accordingly, we aim to evaluate the potential relationship between the endometrial cancer and following DR development., Methods: A retrospective cohort study was conducted using the National Health Insurance Research Database (NHIRD) of Taiwan. Individuals diagnosed with endometrial cancer were matched to the non-endometrial cancer patients in a 1:4 ratio. The major outcomes are the presence of DR, diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) according to diagnostic codes. Cox proportional hazard regression was used to show the adjusted hazard ratio (aHR) with 95% confidence interval (CI) of major outcomes between groups., Results: There were 99 (2.3%), 20 (0.5%), and 14 (0.3%) cases with DR, DME and PDR in the endometrial cancer group, respectively. Another 303 (1.8%), 35 (0.2%), and 27 (0.2%) with DR, DME and PDR were observed in the control group, respectively. The endometrial cancer group revealed a significantly higher incidence of DR compared with the control group (aHR 1.51, 95% CI 1.20-1.90, P < 0.001). The cumulative probability of DR was also higher in the endometrial cancer group than in the control group (P < 0.001). The relationship between endometrial cancer and DR was significantly higher in patients aged over 70 years (P = 0.008). In addition, a higher incidence of DR was found during the first 5 years after the endometrial cancer diagnosis (P < 0.001)., Conclusions: The endometrial cancer correlates to a higher incidence of subsequent DR, especially within first 5 years of endometrial cancer diagnosis., (© 2024 International Federation of Gynecology and Obstetrics.)
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- 2024
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25. Differences in treatment trajectory following brief paediatric inpatient admissions for children and young people with eating disorders.
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El-Salahi S, Anderson C, McDaid A, Lunn A, Ralph E, and Holliday J
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- Humans, Child, Adolescent, Female, Male, Retrospective Studies, Hospitalization, Inpatients psychology, Severity of Illness Index, Parents psychology, Patient Admission statistics & numerical data, Feeding and Eating Disorders therapy
- Abstract
Objective: Little is known about factors associated with treatment trajectory following brief paediatric admissions for children and young people (CYP) admitted for medical complications of their eating disorder (ED). This project aimed to identify possible factors and ways to improve the usefulness of paediatric admissions., Method: Retrospective NHS data was analysed to explore differences between paediatric admissions followed by community-based care or inpatient psychiatric care. Twelve parents were interviewed to seek feedback about paediatric admissions., Results: Patients who received subsequent inpatient psychiatric care were unwell for longer, had longer paediatric admissions and more crisis team input, were more likely to have had previous admissions, and had higher parent-reported anxiety and depression. However, the groups did not significantly differ in ED severity. The interviews identified recommendations for improving paediatric admissions, which included improving understanding of EDs, enhancing communication channels, and providing psychological support to parents., Conclusions: Factors linked with illness severity (but not illness severity itself) appear to be associated with the difference between CYP either returning to community-based care or requiring more intensive psychiatric input. These factors may help clinicians understand who requires subsequent inpatient care, allowing clinicians to target more intensive support earlier and facilitate smoother transitions between services., (© 2024 The Author(s). European Eating Disorders Review published by Eating Disorders Association and John Wiley & Sons Ltd.)
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- 2024
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26. SERENE ER Analysis Part 2 SERENE-UC: Exposure-response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis.
- Author
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Stodtmann S, Chen MJ, Ponce-Bobadilla AV, Finney-Hayward TK, Kalabic J, and Mostafa NM
- Subjects
- Humans, Adult, Female, Male, Middle Aged, Severity of Illness Index, Models, Biological, Treatment Outcome, Remission Induction methods, Double-Blind Method, Anti-Inflammatory Agents administration & dosage, Anti-Inflammatory Agents pharmacokinetics, Young Adult, Adalimumab administration & dosage, Adalimumab pharmacokinetics, Colitis, Ulcerative drug therapy, Dose-Response Relationship, Drug
- Abstract
SERENE UC (NCT02065622) evaluated whether a higher adalimumab induction regimen improved patients with ulcerative colitis (UC) response, but a flat dose-response relationship was found in the induction study. We investigated exposure-response (ER) relationships in induction and maintenance studies considering patients' baseline characteristics. Adalimumab exposures were simulated using the established population pharmacokinetic model. Multivariable logistic regressions were used to assess the efficacy endpoints (clinical remission, endoscopic remission, endoscopic improvement) at weeks 8 and 52. In the induction study, an increasing ER trend with heterogeneity between induction regimens was shown, suggesting average concentration (C
avg ) had a significant impact on primary efficacy endpoints within each group. However, data were not described by a single ER curve. Using inverse effective clearance as the exposure metric described trends across induction regimens with a single curve. Patients with inherently lower effective adalimumab clearance responded better. The patient response rates at week 52 showed no heterogeneity. A short-term increase in adalimumab dose did not drive better responses for induction, and apparent ER relationships were better explained by patient-inherent lower clearance. Conversely, during maintenance up to week 52, increasing the concentration via dose translated to better responses more robustly. The ER findings for SERENE UC were consistent with SERENE CD., (© 2024, The American College of Clinical Pharmacology.)- Published
- 2024
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27. Model-Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate-to-Severe Ulcerative Colitis.
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Wojciechowski J, Mukherjee A, Banfield C, and Nicholas T
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- Humans, Treatment Outcome, Severity of Illness Index, Female, Male, Adult, Middle Aged, Models, Biological, Probability, Double-Blind Method, Colitis, Ulcerative drug therapy
- Abstract
Ritlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor, was evaluated in patients with ulcerative colitis (UC) in a phase 2b trial. Model-informed drug development strategies were applied to bridge observations from phase 2b to predictions for a proposed phase 3 study design to assess the probability of achieving the target efficacy outcome. A longitudinal exposure-response model of the time course of the 4 Mayo subscores (rectal bleeding, stool frequency, physician's global assessment, and endoscopic subscore) in patients with UC receiving placebo or ritlecitinib was developed using population modeling approaches and an item response theory framework. The quantitative relationships between the 4 Mayo subscores accommodated the prediction of composite endpoints such as total Mayo score and partial Mayo score (key endpoints from phase 2b), and modified clinical remission and endoscopic remission (proposed phase 3 endpoints). Clinical trial simulations using the final model assessed the probability of candidate ritlecitinib dosing regimens (including those tested in phase 2b and alternative) and phase 3 study designs for achieving target efficacy outcomes benchmarked against an approved treatment for moderate-to-severe UC. The probabilities of achieving target modified clinical remission and endoscopic improvement outcomes at both weeks 8 and 52 for ritlecitinib 100 mg once daily was 74.8%. Model-based assessment mitigated some of the risk associated with proceeding to pivotal phase 3 trials with dosing regimens of which there was limited clinical experience., (© 2024 Pfizer Inc. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
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- 2024
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28. Suicidal thoughts and attempts in a transdiagnostic eating disorder sample: Do diagnostic severity criteria predict risk?
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Schmidt K, Fitzgerald E, and Keel P
- Subjects
- Humans, Female, Adult, Severity of Illness Index, Body Mass Index, Adolescent, Risk Factors, Diagnostic and Statistical Manual of Mental Disorders, Young Adult, United States epidemiology, Suicide, Attempted statistics & numerical data, Suicidal Ideation, Feeding and Eating Disorders diagnosis
- Abstract
Objective: Eating disorders (EDs) are associated with elevated suicide. Low body mass index (BMI) and frequency of purging and binge eating represent severity criteria for EDs and distinguish full-threshold EDs from other specified feeding and eating disorders (OSFED). However, no work has taken a transdiagnostic approach to studying whether severity of these or other features is associated with suicidal ideation (SI) and attempts., Method: We examined diagnostic status, ED features, and SI and attempts in a large, transdiagnostic, community sample of 257 women with EDs and 45 controls without a current or past ED in the United States using the EDs Examination interview and the Structured Clinical Interview for the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders)., Results: SI and suicide attempts (SA) were elevated in OSFED compared to controls but did not differ between OSFED and full-threshold EDs. Higher BMI predicted increased SI. Number of purging methods, but not frequency, was related to history of SA. Binge episode frequency and size were not significant predictors., Conclusions: OSFED presents with elevated SI and SA, and ED severity criteria that distinguish OSFED from full-threshold EDs do not predict SI or SA. Suicide risk assessments should be implemented universally across EDs in clinical practice., (© 2024 Eating Disorders Association and John Wiley & Sons Ltd.)
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- 2024
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29. Prognostic clinical decision support for pneumonia in the emergency department: A randomized trial.
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Williams DJ, Nian H, Suresh S, Slagle J, Gradwohl S, Johnson J, Stassun J, Reale C, Just SL, Rixe NS, Beebe R, Arnold DH, Turer RW, Antoon JW, Sartori LF, Freundlich RE, Grijalva CG, Smith JC, Weitkamp AO, Weinger MB, Zhu Y, and Martin JM
- Subjects
- Humans, Male, Female, Child, Child, Preschool, Prognosis, Electronic Health Records, Infant, Hospitalization, Severity of Illness Index, Adolescent, Length of Stay, Decision Support Systems, Clinical, Emergency Service, Hospital, Pneumonia diagnosis
- Abstract
Background: Hospitalization rates for childhood pneumonia vary widely. Risk-based clinical decision support (CDS) interventions may reduce unwarranted variation., Methods: We conducted a pragmatic randomized trial in two US pediatric emergency departments (EDs) comparing electronic health record (EHR)-integrated prognostic CDS versus usual care for promoting appropriate ED disposition in children (<18 years) with pneumonia. Encounters were randomized 1:1 to usual care versus custom CDS featuring a validated pneumonia severity score predicting risk for severe in-hospital outcomes. Clinicians retained full decision-making authority. The primary outcome was inappropriate ED disposition, defined as early transition to lower- or higher-level care. Safety and implementation outcomes were also evaluated., Results: The study enrolled 536 encounters (269 usual care and 267 CDS). Baseline characteristics were similar across arms. Inappropriate disposition occurred in 3% of usual care encounters and 2% of CDS encounters (adjusted odds ratio: 0.99, 95% confidence interval: [0.32, 2.95]). Length of stay was also similar and adverse safety outcomes were uncommon in both arms. The tool's custom user interface and content were viewed as strengths by surveyed clinicians (>70% satisfied). Implementation barriers include intrinsic (e.g., reaching the right person at the right time) and extrinsic factors (i.e., global pandemic)., Conclusions: EHR-based prognostic CDS did not improve ED disposition decisions for children with pneumonia. Although the intervention's content was favorably received, low subject accrual and workflow integration problems likely limited effectiveness. Clinical Trials Registration: NCT06033079., (© 2024 Society of Hospital Medicine.)
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- 2024
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30. Outcomes of patients with acute severe autoimmune hepatitis: Predictors of non-response to corticosteroids and need for liver transplantation.
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Eshraghian A, Taghavi A, and Nikeghbalian S
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- Humans, Female, Male, Retrospective Studies, Middle Aged, Adult, Treatment Outcome, Acute Disease, Severity of Illness Index, Aged, Liver Transplantation, Hepatitis, Autoimmune drug therapy, Hepatitis, Autoimmune blood, Hepatitis, Autoimmune mortality, International Normalized Ratio, Adrenal Cortex Hormones therapeutic use, Adrenal Cortex Hormones administration & dosage
- Abstract
Background and Aims: Acute severe autoimmune hepatitis (AS-AIH) is an evolving concept and the outcomes and optimal treatment have been less studied. In this study, we aimed to investigate the outcomes of patients with AS-AIH and predictors of non-response to corticosteroid therapy and need for liver transplantation., Methods: In a retrospective cohort, we included patients with AS-AIH admitted to our liver center. We defined AS-AIH based on the international autoimmune hepatitis group score as acute presentation of AIH with an international normalized ratio (INR) ≥ 1.5 and without liver cirrhosis and hepatic encephalopathy. All patients received high dose corticosteroid therapy. Treatment response was defined as liver transplant free survival at 4 months after presentation. Factors associated with response to corticosteroids and survival of patients were studied., Results: In total, 61 patients with AS-AIH were included. Forty-seven patients responded to corticosteroid therapy. In the multivariate regression model, baseline INR (odds ratio [OR]: 0.184; 95% confidence interval [CI]: 0.048-0.699; p = 0.013) and delayed versus early initiation of corticosteroid (after vs. before 5 days of presentation) (OR: 0.189; 95% CI: 0.039-0.919; p = 0.039) were independent predictors of clinical non-response to corticosteroid therapy. In the multivariable Cox regression model, baseline INR level (hazard ratio [HR]: 2.542; 95% CI: 1.188-5.440; p = 0.016) and delayed initiation of corticosteroids (HR: 3.578; 95% CI: 1.084-11.812; p = 0.036) were independent predictors of liver transplant free survival at 6 months after diagnosis., Conclusion: Delayed initiation of corticosteroid therapy might be predictive of clinical non-response to medical therapy and need for liver transplantation in patients with AS-AIH., (© 2024 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
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- 2024
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31. Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Avacopan, a Small-Molecule Complement C5a Receptor Antagonist, for the Treatment of Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis.
- Author
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Miao S, Suso P, Furst JA, Hudson MG, and Trivedi A
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- Humans, Male, Female, Middle Aged, Aged, Adult, Area Under Curve, Severity of Illness Index, Cytochrome P-450 CYP3A metabolism, Administration, Oral, Liver Diseases metabolism, Aniline Compounds, Nipecotic Acids, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis drug therapy, Receptor, Anaphylatoxin C5a antagonists & inhibitors
- Abstract
Avacopan is currently approved in several regions of the world as an oral treatment in combination with standard therapy, including glucocorticoids, for adult patients with severe active antineutrophil cytoplasmic autoantibody-associated vasculitis. In vitro and clinical studies have established that avacopan is primarily eliminated through cytochrome P450 3A4 metabolism. This Phase 1, open-label, single-dose study (ClinicalTrials.gov identifier: NCT06004934) was conducted to evaluate the effect of mild (n = 8) or moderate (n = 8) hepatic impairment compared with normal hepatic function (n = 8) on the pharmacokinetics, safety, and tolerability of a single oral dose of 30 mg of avacopan in patients without active antineutrophil cytoplasmic autoantibody-associated vasculitis. Relative to participants with normal hepatic function, in participants with mild or moderate hepatic impairment, the avacopan area under the plasma concentration-time curve from time 0 to infinity geometric mean ratios (90% confidence intervals) were 1.3 (0.9-2.0) and 1.1 (0.6-2.0), respectively, and the avacopan maximum plasma concentration geometric mean ratios (90% CIs) were 1.0 (0.8-1.3) and 0.8 (0.6-1.1), respectively. The geometric mean ratios of metabolite M1 also revealed no pharmacokinetically relevant increase in the peak exposure of M1 in participants with mild or moderate hepatic impairment. Thus, no avacopan dosage adjustment is necessary for patients with mild or moderate hepatic impairment., (© 2024, The American College of Clinical Pharmacology.)
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- 2024
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32. The sepsis coding intensity measure: Is this the scalpel that will dissect out illness severity or is it still too blunt for the task?
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Carmichael HL, Bhasin A, and Ruhnke GW
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- Humans, Clinical Coding, Sepsis diagnosis, Severity of Illness Index
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- 2024
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33. Social media use among adolescents with acne: A cross-sectional survey study.
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Finan CF, Leon P, Midani L, Hill DA, and Smidt AC
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- Humans, Adolescent, Cross-Sectional Studies, Male, Female, Child, Quality of Life, Surveys and Questionnaires, Severity of Illness Index, Adolescent Behavior psychology, Social Media, Acne Vulgaris psychology
- Abstract
Social media is increasingly used by patients for the management of skin conditions like acne, despite the potential risk for low-quality information. This study surveyed 45 participants between the ages of 12 and 17 years to investigate factors that could be associated with social media use among adolescents with acne. The likelihood of social media use was not significantly increased by clinical severity of acne, more severe physical barriers (greater than or equal to 20 miles to the dermatology clinic), more severe temporal barriers (waiting 12 or more weeks for a first dermatology appointment), or worsened quality of life (assessed via the Skindex-Teen score). This study increases understanding of adolescents' social media behaviors, particularly as a way to seek information for skin conditions like acne., (© 2024 Wiley Periodicals LLC.)
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- 2024
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34. The degree of bowel remission predicts phenotype progression in Crohn's disease.
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Fernandes SR, Bernardo S, Saraiva S, Gonçalves AR, Moura Santos P, Valente A, Araújo Correia L, Cortez-Pinto H, and Magro F
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- Humans, Male, Female, Retrospective Studies, Adult, Middle Aged, Young Adult, Severity of Illness Index, Crohn Disease diagnostic imaging, Crohn Disease pathology, Crohn Disease diagnosis, Disease Progression, Remission Induction, Phenotype, Colonoscopy, Magnetic Resonance Imaging
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Background: Patients with Crohn's disease (CD) are at risk of progressing from inflammatory to stricturing and penetrating phenotypes. The influence of the depth of remission on the risk of progression has not been adequately evaluated., Methods: A retrospective cohort study including surgically naïve CD patients with inflammatory phenotype evaluated concomitantly by magnetic resonance enterography and colonoscopy. The degree of remission was correlated with the risk of progressing to stricturing and penetrating phenotypes., Results: Three hundred nineteen CD patients were included: 27.0% with transmural remission, 16.0% with isolated endoscopic remission, 14.4% with isolated radiologic remission, and 42.6% without remission. Patients with transmural remission presented the lowest rates of phenotype progression (1.2%), with a significant difference compared to isolated radiologic remission (10.9%, p = 0.019), to isolated endoscopic remission (19.6%, p ≤ 0.001), and to no remission (46.3%, p ≤ 0.001). In multivariate regression analysis, transmural remission (OR 0.017 95% CI 0.002-0.135, p < 0.001), isolated radiologic remission (OR 0.139 95% CI 0.049-0.396, p < 0.001), and isolated endoscopic remission (OR 0.301 95% CI 0.123-0.736, p = 0.008) resulted in lower rates of phenotype progression compared to no remission. No patient with transmural or isolated radiologic remission progressed to penetrating phenotypes., Conclusion: The degree of bowel remission correlates with the risk of phenotype progression. Patients with transmural remission are at the lowest risk of progressing to stricturing and penetrating phenotypes., (© 2024 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
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- 2024
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35. Defining Criteria for Disease Activity States in Systemic Juvenile Idiopathic Arthritis Based on the Systemic Juvenile Arthritis Disease Activity Score.
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Rosina S, Rebollo-Giménez AI, Tarantola L, Pistorio A, Vyzhga Y, El Miedany Y, Lotfy HM, Abu-Shady H, Eissa M, Osman NS, Hassan W, Mahgoub MY, Fouad NA, Mosa DM, Adel Y, Mohamed SEM, Radwan AR, Abu-Zaid MH, Tabra SAA, Shalaby RH, Nasef SI, Khubchandani R, Khan A, Maldar NP, Ozen S, Bayindir Y, Alsuweiti M, Alzyoud R, Almaaitah H, Vilaiyuk S, Lerkvaleekul B, Alexeeva E, Dvoryakovskaya T, Kriulin I, Bracaglia C, Pardeo M, De Benedetti F, Licciardi F, Montin D, Robasto F, Minoia F, Filocamo G, Rossano M, Simonini G, Marrani E, Abu-Rumeileh S, Kostik MM, Belozerov KE, Pal P, Bathia JN, Katsicas MM, Villarreal G, Marino A, Costi S, Sztajnbok F, Silva RM, Maggio MC, El-Ghoneimy DH, El Owaidy R, Civino A, Diomeda F, Al-Mayouf SM, Al-Sofyani F, Dāvidsone Z, Patrone E, Saad-Magalhães C, Consolaro A, and Ravelli A
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- Humans, Child, Male, Female, Adolescent, Child, Preschool, Cohort Studies, ROC Curve, Arthritis, Juvenile physiopathology, Severity of Illness Index
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Objective: Our objective was to develop and validate cutoff values in the systemic Juvenile Arthritis Disease Activity Score 10 (sJADAS10) that distinguish the states of inactive disease (ID), minimal disease activity (MDA), moderate disease activity (MoDA), and high disease activity (HDA) in children with systemic juvenile idiopathic arthritis, based on subjective disease state assessment by the treating pediatric rheumatologist., Methods: The cutoff definition cohort was composed of 400 patients enrolled at 30 pediatric rheumatology centers in 11 countries. Using the subjective physician rating as an external criterion, six methods were applied to identify the cutoffs: mapping, calculation of percentiles of cumulative score distribution, the Youden index, 90% specificity, maximum agreement, and receiver operating characteristic curve analysis. Sixty percent of the patients were assigned to the definition cohort, and 40% were assigned to the validation cohort. Cutoff validation was conducted by assessing discriminative ability., Results: The sJADAS10 cutoffs that separated ID from MDA, MDA from MoDA, and MoDA from HDA were ≤2.9, ≤10, and >20.6, respectively. The cutoffs discriminated strongly among different levels of pain, between patients with and without morning stiffness, and among patients whose parents judged their disease status as remission or persistent activity or flare or were satisfied or not satisfied with current illness outcome., Conclusion: The sJADAS cutoffs revealed good metrologic properties in both definition and validation cohorts and are therefore suitable for use in clinical trials and routine practice., (© 2024 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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36. Psychometric Properties and Concurrent Validity of a 10-Item Questionnaire for Patients With Vestibular Disorders.
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Knapstad MK, Heggdal PO, Berge JE, Nordahl SHG, and Goplen FK
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- Humans, Male, Female, Surveys and Questionnaires, Cross-Sectional Studies, Middle Aged, Reproducibility of Results, Aged, Adult, Severity of Illness Index, Factor Analysis, Statistical, Vestibular Diseases diagnosis, Vestibular Diseases psychology, Psychometrics, Dizziness psychology, Dizziness diagnosis
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Objective: This study aimed to investigate the psychometric properties and concurrent validity of the Haukeland Dizziness Questionnaire (HDQ-10), a 10-item questionnaire designed for simplified assessment of symptom severity and emotional effects in patients with vestibular disorders., Study Design: Cross-sectional study., Setting: Secondary referral hospital., Methods: Out of 238 consecutive patients examined for suspected vestibular disease at an otolaryngology clinic, 201 completed the questionnaire. The psychometric properties of the HDQ-10 were examined by exploratory factor analysis and analysis of internal consistency. Concurrent validity was determined in comparison with the Dizziness Handicap Inventory (DHI), Vertigo Symptom Scale-Short Form (VSS-SF), and the Hospital Anxiety and Depression Scale., Results: The factor analysis revealed 3 subscales of the questionnaire covering "function," "unsteadiness," and "emotion." The examination of the total scale (α = .866) and its subscales indicated satisfactory psychometric properties. The HDQ-10 correlated highly with both DHI (r = .732. P < .001) and VSS-SF (r = .720. P < .001) indicating good concurrent validity., Conclusion: The HDQ-10 is a 10-item questionnaire designed for simplified assessment of symptom severity and emotional effects in patients with vestibular disorders. It has satisfactory psychometric properties and good concurrent validity compared to existing dizziness questionnaires., (© 2024 The Authors. Otolaryngology–Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology–Head and Neck Surgery Foundation.)
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- 2024
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37. Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses.
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FitzGerald O, Gladman DD, Mease PJ, Ritchlin C, Smolen JS, Gao L, Hu Y, Nowak M, Banerjee S, and Catlett I
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- Humans, Male, Female, Middle Aged, Adult, Treatment Outcome, beta-Defensins, Severity of Illness Index, Matrix Metalloproteinase 3 blood, Double-Blind Method, Chemokine CXCL10 blood, Interleukin-23 blood, Arthritis, Psoriatic drug therapy, Arthritis, Psoriatic blood, Biomarkers blood, Interleukin-17 blood
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Objective: Our objective was to evaluate the association of serum biomarkers with baseline psoriatic arthritis (PsA) disease activity, pharmacodynamic effects of deucravacitinib on biomarker levels, and the relationship between biomarkers and clinical responses to deucravacitinib., Methods: The phase 2 trial (ClinicalTrials.gov identifier: NCT03881059) randomly assigned 203 patients with PsA 1:1:1 to placebo, deucravacitinib at 6 mg once daily (QD), or deucravacitinib at 12 mg QD. Serum biomarkers associated with the interleukin 23 (IL-23) pathway (IL-17A, β-defensin [BD-2], and IL-19), type I interferon pathway, inflammation, and collagen matrix turnover were measured by immunoassay. Clinical responses (≥75% improvement from baseline in the Psoriasis Area and Severity Index [PASI75] and ≥20% improvement from baseline in American College of Rheumatology criteria [ACR20] responses) were measured at week 16. Hematologic variables were also assessed., Results: IL-17A, BD-2, and IL-19 had a modest association with PASI scores (r = 0.4, r = 0.56, and r = 0.5, respectively) at baseline. In deucravacitinib groups, IL-17A, BD-2, IL-19, C-X-C motif ligand 9 (CXCL9), CXCL10, C-reactive protein, matrix metalloproteinase 3, and collagen type 4 degradation marker levels were significantly reduced at week 16 versus baseline (P < 0.01); higher levels of IL-23 pathway-associated biomarkers predicted higher PASI75 and ACR20 response rates in deucravacitinib-treated patients. Significantly higher PASI75 response rates were seen in patients with high baseline IL-17A (odds ratio 15.76) and BD-2 levels (odds ratio 15.41) versus low baseline IL-17A and BD-2 levels. Changes in hematologic variables that are characteristic of JAK inhibition were not observed with deucravacitinib., Conclusion: Deucravacitinib significantly impacted biomarkers associated with Tyk2 signaling pathways of key inflammatory cytokines, including IL-23 and type I interferon, and those related to collagen matrix turnover. These biomarkers may predict treatment responses to deucravacitinib., (© 2024 The Author(s). Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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38. Clinical factors associated with day-to-day peak pain severity in individuals with chronic migraine: A cohort study using daily prospective diary data.
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Vives-Mestres M, Casanova A, Silberstein SD, Hershey AD, and Orr SL
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- Humans, Female, Male, Adult, Middle Aged, Prospective Studies, Pain Measurement, Cohort Studies, Diaries as Topic, Chronic Disease, Migraine Disorders physiopathology, Severity of Illness Index
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Objective: To describe the association between day-to-day peak pain severity and clinical factors in individuals with chronic migraine (CM)., Background: Little is known about how clinical factors relate to day-to-day pain severity in individuals with CM., Methods: Adults with CM were enrolled into this observational prospective cohort study that collected daily data about headache, associated symptoms, and lifestyle factors using a digital health platform (N1-Headache™) for 90 days. "Migraine days" were defined as days in which a headache occurred that had features described by the International Classification of Headache Disorders criteria. On these days, peak pain severity was recorded on a 4-point scale; on non-headache days peak pain severity was imputed as "0/none". The associations between peak pain severity and 12 clinical factors were modeled and adjusted for sex, age, daily headache, presence of menstrual bleeding, day of the week, and disability. All numerical and Likert scale variables were standardized prior to analysis., Results: Data were available for 392 participants (35,280 tracked days). The sample was predominantly female (90.6%), with a mean (standard deviation) age of 39.9 (12.8) years. In the final multivariable model with random intercept and slopes, higher than typical self-reported levels of standardized stress (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.04-1.11), standardized irritability (OR 1.05, 95% CI 1.02-1.08), standardized sadness (OR 1.05, 95% CI 1.02-1.07), fatigue (OR 1.25, 95% CI 1.15-1.36), eyestrain (OR 1.38, 95% CI 1.26-1.52), neck pain (OR 1.94, 95% CI 1.76-2.13), skin sensitivity (OR 1.61, 95% CI 1.44-1.80), and dehydration (OR 1.29, 95% CI 1.18-1.42) were associated with higher reported peak pain severity levels, while standardized sleep quality (OR 0.96, 95% CI 0.93-0.99) and standardized waking feeling refreshed (OR 0.84, 95% CI 0.81-0.88) were associated with lower reported peak pain severity levels. The inclusion of a random intercept and random slopes improved upon more parsimonious models and illustrated large differences in individuals' reporting of peak severity according to the levels of the associated clinical factors., Conclusion: Our data showed that the experience of CM, from a pain severity perspective, is complex, related to multiple clinical variables, and highly individualized. These results suggest that future work should aim to study a personalized approach to both medical and behavioral interventions for CM based on which clinical factors relate to the individual's experience of pain severity., (© 2024 The Author(s). Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.)
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- 2024
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39. Severity of illness and risk of mortality from all patient refined-diagnosis related groups: Two scales of different concepts or two sides of the same coin?
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Santos JV, Viana J, Pinto C, Souza J, Lopes F, Freitas A, and Lopes S
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All patient refined-diagnosis related groups (APR-DRGs) includes severity of illness (SOI) and risk of mortality (ROM) subclasses. For predictions, both subscales are used together or interchangeably. We aimed to compare SOI and ROM by evaluating the reliability and agreement between both. We performed a retrospective observational study using mainland Portuguese public hospitalisations of adult patients from 2011 to 2016. Reliability (quadratic weighted kappa) and agreement (proportion of agreement) between SOI and ROM were analysed overall and by APR-DRG. While overall reliability and agreement between SOI and ROM were high (weighted kappa: 0.717, 95% CI 0.717-0.718; proportion of agreement: 69.0%, 95% CI 69.0-69.0) there was high heterogeneity across APR-DRGs, ranging from 0.016 to 0.846 on reliability and from 23.1% to 94.8% on agreement. Most of APR-DRGs (263 out of 284) showed a higher proportion of episodes with ROM level above the SOI level than the opposite. In conclusion, SOI and Risk of Mortality measures must be clearly distinguished and are 'two scales of different concepts' rather than 'two sides of the same coin'. However, this is more evident for some APR-DRGs than for others., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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40. Liver fibrosis stage based on the four factors (FIB-4) score or Forns index in adults with chronic hepatitis C.
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Huttman M, Parigi TL, Zoncapè M, Liguori A, Kalafateli M, Noel-Storr AH, Casazza G, and Tsochatzis E
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- Humans, Biopsy, Adult, Severity of Illness Index, Liver pathology, Biomarkers blood, Case-Control Studies, Bias, Cross-Sectional Studies, Platelet Count, Alanine Transaminase blood, Sensitivity and Specificity, Aspartate Aminotransferases blood, Liver Cirrhosis pathology, Liver Cirrhosis blood, Liver Cirrhosis diagnosis, Hepatitis C, Chronic complications, Hepatitis C, Chronic pathology
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Background: The presence and severity of liver fibrosis are important prognostic variables when evaluating people with chronic hepatitis C (CHC). Although liver biopsy remains the reference standard, non-invasive serological markers, such as the four factors (FIB-4) score and the Forns index, can also be used to stage liver fibrosis., Objectives: To determine the diagnostic accuracy of the FIB-4 score and Forns index in staging liver fibrosis in people with chronic hepatitis C (CHC) virus, using liver biopsy as the reference standard (primary objective). To compare the diagnostic accuracy of these tests for staging liver fibrosis in people with CHC and explore potential sources of heterogeneity (secondary objectives)., Search Methods: We used standard Cochrane search methods for diagnostic accuracy studies (search date: 13 April 2022)., Selection Criteria: We included diagnostic cross-sectional or case-control studies that evaluated the performance of the FIB-4 score, the Forns index, or both, against liver biopsy, in the assessment of liver fibrosis in participants with CHC. We imposed no language restrictions. We excluded studies in which: participants had causes of liver disease besides CHC; participants had successfully been treated for CHC; or the interval between the index test and liver biopsy exceeded six months., Data Collection and Analysis: Two review authors independently extracted data. We performed meta-analyses using the bivariate model and calculated summary estimates. We evaluated the performance of both tests for three target conditions: significant fibrosis or worse (METAVIR stage ≥ F2); severe fibrosis or worse (METAVIR stage ≥ F3); and cirrhosis (METAVIR stage F4). We restricted the meta-analysis to studies reporting cut-offs in a specified range (+/-0.15 for FIB-4; +/-0.3 for Forns index) around the original validated cut-offs (1.45 and 3.25 for FIB-4; 4.2 and 6.9 for Forns index). We calculated the percentage of people who would receive an indeterminate result (i.e. above the rule-out threshold but below the rule-in threshold) for each index test/cut-off/target condition combination., Main Results: We included 84 studies (with a total of 107,583 participants) from 28 countries, published between 2002 and 2021, in the qualitative synthesis. Of the 84 studies, 82 (98%) were cross-sectional diagnostic accuracy studies with cohort-based sampling, and the remaining two (2%) were case-control studies. All studies were conducted in referral centres. Our main meta-analysis included 62 studies (100,605 participants). Overall, two studies (2%) had low risk of bias, 23 studies (27%) had unclear risk of bias, and 59 studies (73%) had high risk of bias. We judged 13 studies (15%) to have applicability concerns regarding participant selection. FIB-4 score The FIB-4 score's low cut-off (1.45) is designed to rule out people with at least severe fibrosis (≥ F3). Thirty-nine study cohorts (86,907 participants) yielded a summary sensitivity of 81.1% (95% confidence interval (CI) 75.6% to 85.6%), specificity of 62.3% (95% CI 57.4% to 66.9%), and negative likelihood ratio (LR-) of 0.30 (95% CI 0.24 to 0.38). The FIB-4 score's high cut-off (3.25) is designed to rule in people with at least severe fibrosis (≥ F3). Twenty-four study cohorts (81,350 participants) yielded a summary sensitivity of 41.4% (95% CI 33.0% to 50.4%), specificity of 92.6% (95% CI 89.5% to 94.9%), and positive likelihood ratio (LR+) of 5.6 (95% CI 4.4 to 7.1). Using the FIB-4 score to assess severe fibrosis and applying both cut-offs together, 30.9% of people would obtain an indeterminate result, requiring further investigations. We report the summary accuracy estimates for the FIB-4 score when used for assessing significant fibrosis (≥ F2) and cirrhosis (F4) in the main review text. Forns index The Forns index's low cut-off (4.2) is designed to rule out people with at least significant fibrosis (≥ F2). Seventeen study cohorts (4354 participants) yielded a summary sensitivity of 84.7% (95% CI 77.9% to 89.7%), specificity of 47.9% (95% CI 38.6% to 57.3%), and LR- of 0.32 (95% CI 0.25 to 0.41). The Forns index's high cut-off (6.9) is designed to rule in people with at least significant fibrosis (≥ F2). Twelve study cohorts (3245 participants) yielded a summary sensitivity of 34.1% (95% CI 26.4% to 42.8%), specificity of 97.3% (95% CI 92.9% to 99.0%), and LR+ of 12.5 (95% CI 5.7 to 27.2). Using the Forns index to assess significant fibrosis and applying both cut-offs together, 44.8% of people would obtain an indeterminate result, requiring further investigations. We report the summary accuracy estimates for the Forns index when used for assessing severe fibrosis (≥ F3) and cirrhosis (F4) in the main text. Comparing FIB-4 to Forns index There were insufficient studies to meta-analyse the performance of the Forns index for diagnosing severe fibrosis and cirrhosis. Therefore, comparisons of the two tests' performance were not possible for these target conditions. For diagnosing significant fibrosis and worse, there were no significant differences in their performance when using the high cut-off. The Forns index performed slightly better than FIB-4 when using the low/rule-out cut-off (relative sensitivity 1.12, 95% CI 1.00 to 1.25; P = 0.0573; relative specificity 0.69, 95% CI 0.57 to 0.84; P = 0.002)., Authors' Conclusions: Both the FIB-4 score and the Forns index may be considered for the initial assessment of people with CHC. The FIB-4 score's low cut-off (1.45) can be used to rule out people with at least severe fibrosis (≥ F3) and cirrhosis (F4). The Forns index's high cut-off (6.9) can be used to diagnose people with at least significant fibrosis (≥ F2). We judged most of the included studies to be at unclear or high risk of bias. The overall quality of the body of evidence was low or very low, and more high-quality studies are needed. Our review only captured data from referral centres. Therefore, when generalising our results to a primary care population, the probability of false positives will likely be higher and false negatives will likely be lower. More research is needed in sub-Saharan Africa, since these tests may be of value in such resource-poor settings., (Copyright © 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)
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- 2024
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41. Accuracy of routine laboratory tests to predict mortality and deterioration to severe or critical COVID-19 in people with SARS-CoV-2.
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De Rop L, Bos DA, Stegeman I, Holtman G, Ochodo EA, Spijker R, Otieno JA, Alkhlaileh F, Deeks JJ, Dinnes J, Van den Bruel A, McInnes MD, Leeflang MM, and Verbakel JY
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- Humans, Biomarkers blood, Prognosis, Clinical Deterioration, Bias, Pandemics, Sensitivity and Specificity, Severity of Illness Index, COVID-19 Testing methods, COVID-19 mortality, COVID-19 blood, COVID-19 diagnosis, SARS-CoV-2, C-Reactive Protein analysis
- Abstract
Background: Identifying patients with COVID-19 disease who will deteriorate can be useful to assess whether they should receive intensive care, or whether they can be treated in a less intensive way or through outpatient care. In clinical care, routine laboratory markers, such as C-reactive protein, are used to assess a person's health status., Objectives: To assess the accuracy of routine blood-based laboratory tests to predict mortality and deterioration to severe or critical (from mild or moderate) COVID-19 in people with SARS-CoV-2., Search Methods: On 25 August 2022, we searched the Cochrane COVID-19 Study Register, encompassing searches of various databases such as MEDLINE via PubMed, CENTRAL, Embase, medRxiv, and ClinicalTrials.gov. We did not apply any language restrictions., Selection Criteria: We included studies of all designs that produced estimates of prognostic accuracy in participants who presented to outpatient services, or were admitted to general hospital wards with confirmed SARS-CoV-2 infection, and studies that were based on serum banks of samples from people. All routine blood-based laboratory tests performed during the first encounter were included. We included any reference standard used to define deterioration to severe or critical disease that was provided by the authors., Data Collection and Analysis: Two review authors independently extracted data from each included study, and independently assessed the methodological quality using the Quality Assessment of Prognostic Accuracy Studies tool. As studies reported different thresholds for the same test, we used the Hierarchical Summary Receiver Operator Curve model for meta-analyses to estimate summary curves in SAS 9.4. We estimated the sensitivity at points on the SROC curves that corresponded to the median and interquartile range boundaries of specificities in the included studies. Direct and indirect comparisons were exclusively conducted for biomarkers with an estimated sensitivity and 95% CI of ≥ 50% at a specificity of ≥ 50%. The relative diagnostic odds ratio was calculated as a summary of the relative accuracy of these biomarkers., Main Results: We identified a total of 64 studies, including 71,170 participants, of which 8169 participants died, and 4031 participants deteriorated to severe/critical condition. The studies assessed 53 different laboratory tests. For some tests, both increases and decreases relative to the normal range were included. There was important heterogeneity between tests and their cut-off values. None of the included studies had a low risk of bias or low concern for applicability for all domains. None of the tests included in this review demonstrated high sensitivity or specificity, or both. The five tests with summary sensitivity and specificity above 50% were: C-reactive protein increase, neutrophil-to-lymphocyte ratio increase, lymphocyte count decrease, d-dimer increase, and lactate dehydrogenase increase. Inflammation For mortality, summary sensitivity of a C-reactive protein increase was 76% (95% CI 73% to 79%) at median specificity, 59% (low-certainty evidence). For deterioration, summary sensitivity was 78% (95% CI 67% to 86%) at median specificity, 72% (very low-certainty evidence). For the combined outcome of mortality or deterioration, or both, summary sensitivity was 70% (95% CI 49% to 85%) at median specificity, 60% (very low-certainty evidence). For mortality, summary sensitivity of an increase in neutrophil-to-lymphocyte ratio was 69% (95% CI 66% to 72%) at median specificity, 63% (very low-certainty evidence). For deterioration, summary sensitivity was 75% (95% CI 59% to 87%) at median specificity, 71% (very low-certainty evidence). For mortality, summary sensitivity of a decrease in lymphocyte count was 67% (95% CI 56% to 77%) at median specificity, 61% (very low-certainty evidence). For deterioration, summary sensitivity of a decrease in lymphocyte count was 69% (95% CI 60% to 76%) at median specificity, 67% (very low-certainty evidence). For the combined outcome, summary sensitivity was 83% (95% CI 67% to 92%) at median specificity, 29% (very low-certainty evidence). For mortality, summary sensitivity of a lactate dehydrogenase increase was 82% (95% CI 66% to 91%) at median specificity, 60% (very low-certainty evidence). For deterioration, summary sensitivity of a lactate dehydrogenase increase was 79% (95% CI 76% to 82%) at median specificity, 66% (low-certainty evidence). For the combined outcome, summary sensitivity was 69% (95% CI 51% to 82%) at median specificity, 62% (very low-certainty evidence). Hypercoagulability For mortality, summary sensitivity of a d-dimer increase was 70% (95% CI 64% to 76%) at median specificity of 56% (very low-certainty evidence). For deterioration, summary sensitivity was 65% (95% CI 56% to 74%) at median specificity of 63% (very low-certainty evidence). For the combined outcome, summary sensitivity was 65% (95% CI 52% to 76%) at median specificity of 54% (very low-certainty evidence). To predict mortality, neutrophil-to-lymphocyte ratio increase had higher accuracy compared to d-dimer increase (RDOR (diagnostic Odds Ratio) 2.05, 95% CI 1.30 to 3.24), C-reactive protein increase (RDOR 2.64, 95% CI 2.09 to 3.33), and lymphocyte count decrease (RDOR 2.63, 95% CI 1.55 to 4.46). D-dimer increase had higher accuracy compared to lymphocyte count decrease (RDOR 1.49, 95% CI 1.23 to 1.80), C-reactive protein increase (RDOR 1.31, 95% CI 1.03 to 1.65), and lactate dehydrogenase increase (RDOR 1.42, 95% CI 1.05 to 1.90). Additionally, lactate dehydrogenase increase had higher accuracy compared to lymphocyte count decrease (RDOR 1.30, 95% CI 1.13 to 1.49). To predict deterioration to severe disease, C-reactive protein increase had higher accuracy compared to d-dimer increase (RDOR 1.76, 95% CI 1.25 to 2.50). The neutrophil-to-lymphocyte ratio increase had higher accuracy compared to d-dimer increase (RDOR 2.77, 95% CI 1.58 to 4.84). Lastly, lymphocyte count decrease had higher accuracy compared to d-dimer increase (RDOR 2.10, 95% CI 1.44 to 3.07) and lactate dehydrogenase increase (RDOR 2.22, 95% CI 1.52 to 3.26)., Authors' Conclusions: Laboratory tests, associated with hypercoagulability and hyperinflammatory response, were better at predicting severe disease and mortality in patients with SARS-CoV-2 compared to other laboratory tests. However, to safely rule out severe disease, tests should have high sensitivity (> 90%), and none of the identified laboratory tests met this criterion. In clinical practice, a more comprehensive assessment of a patient's health status is usually required by, for example, incorporating these laboratory tests into clinical prediction rules together with clinical symptoms, radiological findings, and patient's characteristics., (Copyright © 2024 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.)
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- 2024
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42. A Dynamic Prognostic Model for Identifying Vulnerable COVID-19 Patients at High Risk of Rapid Deterioration.
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Anand P, D'Andrea E, Feldman W, Wang SV, Liu J, Brill G, DiCesare E, and Lin KJ
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- Humans, Female, Male, Middle Aged, Prognosis, Aged, Massachusetts epidemiology, Electronic Health Records statistics & numerical data, Clinical Deterioration, Cohort Studies, Hospitalization statistics & numerical data, Severity of Illness Index, COVID-19 Vaccines administration & dosage, Models, Statistical, Adult, Risk Assessment, COVID-19 epidemiology, COVID-19 prevention & control, COVID-19 diagnosis
- Abstract
Purpose: We aimed to validate and, if performance was unsatisfactory, update the previously published prognostic model to predict clinical deterioration in patients hospitalized for COVID-19, using data following vaccine availability., Methods: Using electronic health records of patients ≥18 years, with laboratory-confirmed COVID-19, from a large care-delivery network in Massachusetts, USA, from March 2020 to November 2021, we tested the performance of the previously developed prediction model and updated the prediction model by incorporating data after availability of COVID-19 vaccines. We randomly divided data into development (70%) and validation (30%) cohorts. We built a model predicting worsening in a published severity scale in 24 h by LASSO regression and evaluated performance by c-statistic and Brier score., Results: Our study cohort consisted of 8185 patients (Development: 5730 patients [mean age: 62; 44% female] and Validation: 2455 patients [mean age: 62; 45% female]). The previously published model had suboptimal performance using data after November 2020 (N = 4973, c-statistic = 0.60. Brier score = 0.11). After retraining with the new data, the updated model included 38 predictors including 18 changing biomarkers. Patients hospitalized after Jun 1st, 2021 (when COVID-19 vaccines became widely available in Massachusetts) were younger and had fewer comorbidities than those hospitalized before. The c-statistic and Brier score were 0.77 and 0.13 in the development cohort, and 0.73 and 0.14 in the validation cohort., Conclusion: The characteristics of patients hospitalized for COVID-19 differed substantially over time. We developed a new dynamic model for rapid progression with satisfactory performance in the validation set., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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43. Lack of Evidence for Vaccine-Associated Enhanced Disease From COVID-19 Vaccines Among Adults in the Vaccine Safety Datalink.
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Boyce TG, McClure DL, Hanson KE, Daley MF, DeSilva MB, Irving SA, Jackson LA, Klein NP, Lewin B, Williams JTB, Duffy J, McNeil MM, Weintraub ES, and Belongia EA
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- Adult, Aged, Female, Humans, Male, Middle Aged, Cross-Sectional Studies, Intensive Care Units statistics & numerical data, United States epidemiology, Vaccination adverse effects, COVID-19 prevention & control, COVID-19 epidemiology, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, Hospitalization statistics & numerical data, Severity of Illness Index
- Abstract
Purpose: Vaccine-associated enhanced disease (VAED) is a theoretical concern with new vaccines, although trials of authorized vaccines against SARS-CoV-2 have not identified markers for VAED. The purpose of this study was to detect any signals for VAED among adults vaccinated against coronavirus disease 2019 (COVID-19)., Methods: In this cross-sectional study, we assessed COVID-19 severity as a proxy for VAED among 400 adults hospitalized for COVID-19 from March through October 2021 at eight US healthcare systems. Primary outcomes were admission to an intensive care unit (ICU) and severe illness (score ≥6 on the World Health Organization [WHO] Clinical Progression Scale). We compared the risk of outcomes among those who had completed a COVID-19 vaccine primary series versus those who were unvaccinated. We incorporated inverse propensity weights for vaccination status in a doubly robust regression model to estimate the causal average treatment effect., Results: The causal risk ratio in vaccinated versus unvaccinated was 0.36 (95% confidence interval [CI], 0.15-0.94) for ICU admission and 0.46 (95% CI, 0.25-0.76) for severe illness., Conclusion: Among hospitalized patients, reduced disease severity in those vaccinated against COVID-19 supports the absence of VAED., (© 2024 John Wiley & Sons Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)
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- 2024
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44. Mirikizumab Exposure-Response Relationships in Patients with Moderately-to-Severely Active Ulcerative Colitis in Randomized Phase II and III Studies.
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Friedrich S, Chua L, Adams DH, Crandall W, and Zhang XC
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- Humans, Male, Female, Adult, Antibodies, Monoclonal pharmacokinetics, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal administration & dosage, Treatment Outcome, Middle Aged, Gastrointestinal Agents adverse effects, Gastrointestinal Agents pharmacokinetics, Gastrointestinal Agents therapeutic use, Gastrointestinal Agents administration & dosage, Interleukin-23 Subunit p19 antagonists & inhibitors, Remission Induction, Antibodies, Monoclonal, Humanized pharmacokinetics, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage, Colitis, Ulcerative drug therapy, Dose-Response Relationship, Drug, Severity of Illness Index
- Abstract
Mirikizumab is a humanized anti-interleukin-23p19 monoclonal antibody being developed for ulcerative colitis (UC) and Crohn's disease. We characterized the relationship of mirikizumab systemic exposure with efficacy and safety end points in patients with UC using phase II (NCT02589665) and III (NCT03518086, NCT03524092) trial data. Exposure-response models were developed for clinical remission, clinical response, endoscopic remission, and change in modified Mayo score following induction (50-1,000 mg i.v. every 4 weeks) and maintenance (200 mg s.c. every 4 or 12 weeks) treatment. These models evaluated observed and pharmacokinetic model-predicted mirikizumab exposures as the exposure measure. Key safety event rates were compared across mirikizumab exposure quartiles in the phase III trial. Mirikizumab efficacy in patients with UC showed an apparent positive association with systemic exposure following both induction and maintenance. However, further analysis found this relationship to be overstated by the presence of confounding factors that were not among the tested patient covariates. While prior biologic experience and baseline disease severity showed statistically significant influences on estimated placebo effect, no patient factors affected the mirikizumab effect parameters in any of the phase III exposure-response models. There was no apparent mirikizumab concentration relationship with any adverse event of special interest. When the phase II and III data and confounding are considered together, efficacy was unlikely to be strongly affected by variation in exposures across individual patients at the phase III dose. Together with the previously demonstrated mirikizumab exposure insensitivity to patient factors, these findings indicate that mirikizumab dose adjustment to patient characteristics is not required., (© 2024 Eli Lilly and Company. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
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- 2024
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45. Surviving maternal sepsis: Clinical, laboratory, and treatment features.
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Ribeiro-do-Valle CC, Luz AG, Pacagnella RC, and Cecatti JG
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- Humans, Female, Pregnancy, Retrospective Studies, Adult, Brazil, Shock, Septic, Tertiary Care Centers, Young Adult, Urinary Tract Infections drug therapy, Severity of Illness Index, Anti-Bacterial Agents therapeutic use, Pregnancy Complications, Infectious drug therapy, Sepsis
- Abstract
Objective: To describe clinical, laboratory, and antibiotic treatment characteristics in pregnant or recently pregnant women diagnosed with maternal sepsis., Methods: A retrospective cohort study was conducted in a Brazilian tertiary hospital from March 2014 until February 2018. The hospital implemented a Sepsis Protocol, based on the Brazilian Ministry of Health recommendation. All women who were pregnant or recently pregnant (up to 42 days postpartum), and who presented with suspected sepsis were included. Unconfirmed infections were excluded. Three hundred sixty-five women were included and divided into three groups according to sepsis severity (SEPSIS-2): sepsis, severe sepsis, and septic shock. Clinical, laboratory, and management characteristics were described and compared., Results: Pregnancy-related and respiratory tract infections were the greater causes of maternal sepsis, and the urinary tract was the major cause of septic shock. We found almost total compliance with blood culture sample collection, and samples were positive in 10.8% of the cases, and in 41% of septic shock patients. Escherichia coli was the most common pathogen found and it was resistant to third-generation cephalosporins in none of the blood cultures and 3.3% of the urine cultures. Using the AWaRe (Access, Watch and Reserve) classification groups of antibiotics, Access and Watch antibiotics were used in virtually all women. We did not find any fatal maternal outcomes., Conclusion: Maternal sepsis is seldom the result of resistant microorganisms in this setting and the use of Access group antibiotics is widely possible. Health professionals' awareness of and institutional policies for maternal sepsis are crucial to its adequate treatment and better outcomes., (© 2024 International Federation of Gynecology and Obstetrics.)
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- 2024
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46. Risk factors for early postpartum hemorrhage: A retrospective, population-based, cohort analysis.
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Abecassis A, Wainstock T, Sheiner E, Miodownik S, and Pariente G
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- Humans, Female, Pregnancy, Risk Factors, Retrospective Studies, Adult, Logistic Models, Delivery, Obstetric adverse effects, Delivery, Obstetric statistics & numerical data, Cesarean Section statistics & numerical data, Pre-Eclampsia epidemiology, Severity of Illness Index, Uterine Rupture epidemiology, Uterine Rupture etiology, Placenta Previa epidemiology, Young Adult, Fertilization in Vitro, Postpartum Hemorrhage epidemiology, Postpartum Hemorrhage etiology
- Abstract
Objective: To identify risk factors for developing early postpartum hemorrhage (PPH) and to examine whether risk factors vary according to severity and mode of delivery., Methods: A population-based cohort study was conducted in which all deliveries at a tertiary medical center were included. Risk factors for developing early PPH were compared based on the severity of bleeding as well as the mode of delivery. Multiple logistic regression models were used to control for confounders., Results: Among 322 497 deliveries included in the analysis, early PPH complicated 1811 (0.56%) of all deliveries. Among all cases of early PPH, 505 deliveries (28%) were complicated with severe PPH. Using a logistic regression model, in vitro fertilization (IVF) pregnancy, previous cesarean delivery (CD), pre-eclampsia, placental abruption, and uterine rupture were independently associated only with severe early PPH, while non-progressive second stage of labor, induction of labor, and large for gestational age were independently associated with both severe and mild early PPH. When applying an additional logistic regression model, whereas IVF pregnancy, pre-eclampsia, and large for gestational age were independently associated with early PPH among vaginal deliveries only, placenta previa was independently associated with early PPH among CD only., Conclusions: Independent risk factors for developing severe PPH solely include IVF pregnancy, previous CD, pre-eclampsia, placental abruption, and uterine rupture. IVF pregnancy, pre-eclampsia, and large for gestational age are independent risk factors for early PPH following vaginal delivery, while placenta previa is independently associated with early PPH after CD only. Due to the recognition of the importance of both the provider and institutional planning and preparation for PPH, the study's results should be viewed within the scope of its retrospective cohort design., (© 2024 International Federation of Gynecology and Obstetrics.)
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- 2024
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47. Disordered eating behaviors in pediatric patients with inflammatory bowel disease in remission or mild-moderate disease activity.
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Vickers M, Whitworth J, Alvarez LM, and Bowden M
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- Humans, Adolescent, Female, Male, Child, Surveys and Questionnaires, Longitudinal Studies, Young Adult, Prevalence, Risk Factors, Feeding Behavior psychology, Severity of Illness Index, Crohn Disease psychology, Crohn Disease complications, Crohn Disease epidemiology, Body Mass Index, Colitis, Ulcerative psychology, Colitis, Ulcerative complications, Feeding and Eating Disorders epidemiology, Feeding and Eating Disorders psychology, Inflammatory Bowel Diseases psychology, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases epidemiology
- Abstract
Background: Inflammatory bowel disease (IBD) is a chronic, autoimmune disorder that affects the gastrointestinal tract. Disordered eating describes irregular eating behaviors that may be a precursor to an eating disorder diagnosis. Higher rates of disordered eating have been described in chronic diseases. Screening for disordered eating is not performed in pediatric patients with IBD. The goal of this longitudinal study was to use the Eating Attitudes Test (EAT-26) to screen pediatric patients with IBD for disordered eating, estimate our population's prevalence, identify potential risk factors, and correlate positive EAT-26 screen results with evaluation in adolescent medicine clinic., Methods: Eighty patients with IBD between 10 and 21 years completed the EAT-26 questionnaire during gastroenterology clinic visit. Disease activity was measured using Pediatric Ulcerative Colitis Activity Index (PUCAI) and Pediatric Crohn's Disease Activity Index (PCDAI). Patients also rated their own disease activity on a numerical scale., Results: Five patients had a positive EAT-26 screen and were evaluated in the adolescent medicine clinic. One hundred percent of those who screened positive were diagnosed with a concomitant eating disorder once evaluated. Only 20% of those who screened positive had active IBD. Higher weight, body mass index, and patient perception of disease activity were associated with increased EAT-26 score., Conclusion: Pediatric patients with IBD are at risk for disordered eating, with a prevalence of 6% in our population, which is twice the prevalence of disordered eating in the general population. The EAT-26 questionnaire is a feasible tool to screen pediatric IBD patients for disordered eating., (© 2024 American Society for Parenteral and Enteral Nutrition.)
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- 2024
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48. Narcissistic personality disorder in the ICD-11: Severity and trait profiles of grandiosity and vulnerability.
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Day NJS, Green A, Denmeade G, Bach B, and Grenyer BFS
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- Humans, Female, Adult, Male, Middle Aged, Severity of Illness Index, Self Concept, Young Adult, Narcissistic Personality Disorder, Personality Disorders diagnosis, Personality Disorders classification, International Classification of Diseases, Narcissism
- Abstract
Modern diagnostic and classification frameworks such as the ICD-11 and DSM-5-AMPD have adopted a dimensional approach to diagnosing personality disorder using a dual "severity" and "trait" model. As narcissistic personality has historically struggled to be adequately captured in dominant diagnostic systems, this study investigated the utility of the new ICD-11 framework in capturing diverse narcissistic expressions. Participants were mental health clinicians (N = 180, 67% female, age = 38.9), who completed ratings of ICD-11 personality severity, trait domains and a clinical reflection for two hypothetical case vignettes reflecting either prototypical "grandiose" or "vulnerable" narcissism. The majority of clinicians (82%) endorsed a diagnosis of personality disorder for both grandiose and vulnerable vignettes. Discriminant elements of personality impairment included rigid, unrealistically positive self-view, low empathy and high conflict with others for grandiosity, and incoherent identity, low self-esteem and hypervigilant, avoidant relations with others for vulnerability. Regarding trait profile, grandiose narcissism was predominately dissocial whereas vulnerable narcissism was primarily associated with negative affectivity and detachment. Qualitative responses highlight distinct clinical themes for each presentation. These findings suggest that clinicians using the ICD-11 framework are able to identify common core elements of personality dysfunction in grandiose and vulnerable narcissism while also recognizing their distinctive differences., (© 2024 The Authors. Journal of Clinical Psychology published by Wiley Periodicals LLC.)
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- 2024
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49. Association of severity of menstrual dysfunction with cardiometabolic risk markers among women with polycystic ovary syndrome.
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Li X, Yang J, Blockeel C, Lin M, Tian X, Wu H, Cao Y, Deng L, Zhou X, Xie J, Hu Y, and Chen X
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- Humans, Female, Adult, Cross-Sectional Studies, Prospective Studies, Insulin Resistance, Metabolic Syndrome epidemiology, Oligomenorrhea epidemiology, Severity of Illness Index, Dyslipidemias epidemiology, Biomarkers blood, Young Adult, Risk Factors, Polycystic Ovary Syndrome complications, Polycystic Ovary Syndrome blood, Polycystic Ovary Syndrome epidemiology, Cardiometabolic Risk Factors, Menstruation Disturbances epidemiology
- Abstract
Introduction: Polycystic ovary syndrome (PCOS) is associated with a wide range of unfavorable cardiometabolic risk factors, including obesity, hypertension, insulin resistance, impaired glucose metabolism, dyslipidemia, and metabolic syndrome. Compared with women with regular menstrual cycles, women with a history of irregular menstrual periods have an increased unfavorable cardiometabolic risk. Recently, the association between the severity of oligomenorrhea and hyperinsulinemia and insulin resistance has been demonstrated. However, evidence linking the severity of menstrual cyclicity with cardiometabolic risk in PCOS women is scarce., Material and Methods: This work was a prospective cross-sectional study. A total of 154 women diagnosed with PCOS by the Rotterdam criteria were recruited from July 2021 to September 2022. PCOS women with eumenorrheic (eumeno group), oligomenorrhea (oligo group), and amenorrhea (ameno group) underwent history and physical examination, gonadal steroid hormone measurement, lipid profile, oral glucose tolerance test, and homeostasis model assessment of insulin resistance., Results: A trend toward an increase in unfavorable cardiometabolic risk markers including obesity, hypertension, prevalence of insulin resistance, prediabetes, dyslipidemia, and metabolic syndrome was observed in the ameno group (n = 57) as compared with the eumeno (n = 24) or oligo group (n = 73). A higher prevalence of insulin resistance (odds ratio [OR]: 3.02; 95% confidence interval [CI]: 1.03-8.81) and prediabetes (OR: 3.94; 95% CI: 1.01-15.40) was observed in the ameno group than in the eumeno group, and a higher proportion of dyslipidemia (OR: 2.44; 95% CI: 1.16-5.15) was observed in the ameno group than in the oligo group in the binary logistic regression analysis after adjusting for confounding factors., Conclusions: PCOS women with amenorrhea show a higher prevalence of insulin resistance, prediabetes, and dyslipidemia compared with those with oligomenorrhea or eumenorrhea. The severity of menstrual dysfunction could be used as a readily obtainable marker for the identification of PCOS women at greatest risk of cardiometabolic diseases., (© 2024 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)
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- 2024
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50. Disease severity versus pain severity: Range of motion differences during single- and multiplanar tasks in women with carpometacarpal osteoarthritis.
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Ordonez Diaz T, Licht S, Wright TW, and Nichols JA
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- Humans, Female, Middle Aged, Aged, Biomechanical Phenomena, Osteoarthritis physiopathology, Osteoarthritis diagnostic imaging, Range of Motion, Articular, Carpometacarpal Joints physiopathology, Carpometacarpal Joints diagnostic imaging, Severity of Illness Index
- Abstract
In carpometacarpal osteoarthritis (CMC OA) of the thumb, to what extent treatments should be directed by radiographic disease severity versus pain-based indicators remains an open question. To address this gap, this study investigated the relative impact of disease severity and pain severity on the range of motion in participants with CMC OA. We hypothesized larger differences would exist between extremes in the pain severity cohort than the disease severity cohort, suggesting pain modulates movement to a greater extent than joint degradation. Thirty-one female participants (64.6 ± 10.9 years) were grouped as symptomatic or asymptomatic (pain severity cohort) and early stage OA or end-stage OA (disease severity cohort) using radiographs and questionnaires. Kinematics were measured during single-planar and multiplanar range of motion tasks. Joint angle differences between groups were statistically compared. Differences in self-reported pain, function, and disability were evident in both participant cohorts. Notably, substantial distinctions emerged exclusively during multiplanar tasks, with a greater prevalence in the disease severity cohort compared to the pain severity cohort. Participants with end-stage OA also exhibited similar overall area covered during circumduction in comparison to those with early-stage OA, despite having a decreased range of motion at the CMC joint. The study underscores the importance of assessing multiplanar tasks, potentially leading to earlier identification of CMC OA. While movement compensations such as employing the distal thumb joints over the CMC joint were observed, delving deeper into the interplay between pain and movement could yield greater insight into the underlying factors steering these compensatory mechanisms., (© 2024 Orthopaedic Research Society.)
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- 2024
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