22 results on '"Morris HL"'
Search Results
2. High Concordance Between Nonalcoholic Fatty Liver Disease and Metabolic Dysfunction-Associated Steatotic Liver Disease in the TARGET-NASH Real-World Cohort.
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Barritt AS 4th, Yu F, Mospan AR, Newsome PN, Roden M, Morris HL, Loomba R, and Neuschwander-Tetri BA
- Subjects
- Humans, Female, Male, Middle Aged, Adult, Terminology as Topic, Liver Cirrhosis complications, Cohort Studies, Aged, Fatty Liver complications, United States epidemiology, Non-alcoholic Fatty Liver Disease complications
- Abstract
Introduction: This study investigates the applicability of the new metabolic dysfunction-associated steatotic liver disease (MASLD) nomenclature to the real-world TARGET-NASH US adult cohort., Methods: The new MASLD/metabolic steatohepatitis nomenclature was applied to patients enrolled with pragmatic diagnoses of nonalcoholic fatty liver and nonalcoholic steatohepatitis (NASH), and NASH cirrhosis and concordance were determined between the definitions., Results: Approximately 99% of TARGET-NASH participants met the new MASLD diagnostic criteria. Approximately 1,484/1,541 (96.3%, kappa 0.974) nonalcoholic fatty liver patients (metabolic dysfunction-associated steatotic liver), 2,195/2,201 (99.7%, kappa 0.998) NASH patients (metabolic steatohepatitis), and 1,999/2,003 (99.8%, kappa 0.999) NASH cirrhosis patients met the new criteria., Discussion: The new MASLD nomenclature is highly concordant with the previous TARGET-NASH pragmatic definitions., (Copyright © 2024 by The American College of Gastroenterology.)
- Published
- 2024
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3. Factors Predicting Loss of Remission in Crohn's Disease Patients in Endoscopic Remission in the Real World: Results From TARGET-IBD.
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Ahmad H, Click B, Morris HL, Crawford JM, Choi J, and Long MD
- Abstract
Background: There is limited evidence that histologic remission improves outcomes in Crohn's disease (CD). We aimed to characterize a cohort of patients with CD in endoscopic remission and explore factors associated with subsequent loss of remission (LOR)., Methods: In total, 4474 patients were enrolled in TARGET-IBD, a longitudinal, observational cohort study. Patients with a normal steroid-free colonoscopy (index) were defined as "in endoscopic remission" and were followed for LOR, defined as presence of inflammation, erosion, ulceration, or stricturing on a subsequent colonoscopy or commencement of steroids. Histologic activity was dichotomized using standard of care reports for active inflammation. Unadjusted and multivariable-adjusted Cox proportional hazards regression models were used to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs) of LOR in relation to independent variables., Results: Of 658 patients with CD with steroid-free endoscopic remission, the majority were female (57%), white (83%), non-Hispanic (93%); 20% had ileal and 20% isolated colonic disease. Inflammatory (B1) disease was the most common phenotype (43%). Of these 658 patients, 257 (39%) had histologic inflammation on index colonoscopy. Histologic inflammation at index colonoscopy was associated with nearly twice the LOR risk (HR 1.96, 95% CI: 1.50-2.57) with median time to relapse of 1.20 years. Biologic use at index was associated with lower LOR risk (monotherapy, HR 0.61, 95% CI: 0.45-0.82; combination therapy, HR 0.43, 95% CI: 0.28-0.66)., Conclusions: Active histologic inflammation despite endoscopic remission, and lack of biologic use were independently associated with risk of subsequent LOR, providing evidence that histologic remission may impart improved outcomes in patients with CD., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2024
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4. Correction to: Impact of Pruritus on Quality of Life and Current Treatment Patterns in Patients with Primary Biliary Cholangitis.
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Mayo MJ, Carey E, Smith HT, Mospan AR, McLaughlin M, Thompson A, Morris HL, Sandefur R, Kim WR, Bowlus C, and Levy C
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- 2023
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5. Impact of Pruritus on Quality of Life and Current Treatment Patterns in Patients with Primary Biliary Cholangitis.
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Mayo MJ, Carey E, Smith HT, Mospan AR, McLaughlin M, Thompson A, Morris HL, Sandefur R, Kim WR, Bowlus C, and Levy C
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- Humans, Quality of Life, Liver Cirrhosis, Pruritus diagnosis, Pruritus drug therapy, Pruritus epidemiology, Fatigue epidemiology, Fatigue etiology, Liver Cirrhosis, Biliary complications, Liver Cirrhosis, Biliary drug therapy, Liver Cirrhosis, Biliary diagnosis
- Abstract
Background and Aims: Patients with primary biliary cholangitis (PBC) often suffer with pruritus. We describe the impact of pruritus on quality of life and how it is managed in a real-world cohort., Methods: TARGET-PBC is a longitudinal observational cohort of patients with PBC across the USA. Data include information from medical records for three years prior to the date of consent up to 5 years of follow-up. Enrolled patients were asked to complete patient-reported outcome surveys: PBC-40, 5-D itch, and the PROMIS fatigue survey. Kruskal-Wallis tests were used to compare differences in symptoms between groups., Results: A total of 211 patients with completed PRO surveys were included in the current study. PRO respondents were compared with non-respondents in the TARGET-PBC population and were broadly similar. Pruritus was reported in 170 patients (81%), with those reporting clinically significant pruritus (30%) scoring worse across each domain of the PBC-40 and 5-D itch, more frequently having cirrhosis, and having significantly greater levels of fatigue. Patients reporting clinically significant pruritus were more likely to receive treatment, but 33% had never received treatment (no itch = 43.9%, mild itch = 38.3%)., Conclusions: The prevalence of pruritus was high in this population, and those reporting clinically significant pruritus had a higher likelihood of having advanced disease and worse quality of life. However, this study found that pruritus in PBC is under-treated. This may be due in part to ineffectiveness of current treatments, poor tolerance, or the lack of FDA-approved medications for pruritus., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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6. Noninvasive Diagnosis of Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis Using Machine Learning Methods: Comparative Study With Existing Quantitative Risk Scores.
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Wu Y, Yang X, Morris HL, Gurka MJ, Shenkman EA, Cusi K, Bril F, and Donahoo WT
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Background: Nonalcoholic steatohepatitis (NASH), advanced fibrosis, and subsequent cirrhosis and hepatocellular carcinoma are becoming the most common etiology for liver failure and liver transplantation; however, they can only be diagnosed at these potentially reversible stages with a liver biopsy, which is associated with various complications and high expenses. Knowing the difference between the more benign isolated steatosis and the more severe NASH and cirrhosis informs the physician regarding the need for more aggressive management., Objective: We intend to explore the feasibility of using machine learning methods for noninvasive diagnosis of NASH and advanced liver fibrosis and compare machine learning methods with existing quantitative risk scores., Methods: We conducted a retrospective analysis of clinical data from a cohort of 492 patients with biopsy-proven nonalcoholic fatty liver disease (NAFLD), NASH, or advanced fibrosis. We systematically compared 5 widely used machine learning algorithms for the prediction of NAFLD, NASH, and fibrosis using 2 variable encoding strategies. Then, we compared the machine learning methods with 3 existing quantitative scores and identified the important features for prediction using the SHapley Additive exPlanations method., Results: The best machine learning method, gradient boosting (GB), achieved the best area under the curve scores of 0.9043, 0.8166, and 0.8360 for NAFLD, NASH, and advanced fibrosis, respectively. GB also outperformed 3 existing risk scores for fibrosis. Among the variables, alanine aminotransferase (ALT), triglyceride (TG), and BMI were the important risk factors for the prediction of NAFLD, whereas aspartate transaminase (AST), ALT, and TG were the important variables for the prediction of NASH, and AST, hyperglycemia (A
1c ), and high-density lipoprotein were the important variables for predicting advanced fibrosis., Conclusions: It is feasible to use machine learning methods for predicting NAFLD, NASH, and advanced fibrosis using routine clinical data, which potentially can be used to better identify patients who still need liver biopsy. Additionally, understanding the relative importance and differences in predictors could lead to improved understanding of the disease process as well as support for identifying novel treatment options., (©Yonghui Wu, Xi Yang, Heather L Morris, Matthew J Gurka, Elizabeth A Shenkman, Kenneth Cusi, Fernando Bril, William T Donahoo. Originally published in JMIR Medical Informatics (https://medinform.jmir.org), 06.06.2022.)- Published
- 2022
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7. Factors Associated With Readmission in the United States Following Hospitalization With Coronavirus Disease 2019.
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Verna EC, Landis C, Brown RS, Mospan AR, Crawford JM, Hildebrand JS, Morris HL, Munoz B, Fried MW, and Reddy KR
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- Hospitalization, Humans, Patient Readmission, Retrospective Studies, Risk Factors, United States epidemiology, COVID-19 epidemiology, COVID-19 therapy, Cardiovascular Diseases epidemiology, Kidney Failure, Chronic
- Abstract
Background: Patients hospitalized for coronavirus disease 2019 (COVID-19) may experience complications following hospitalization and require readmission. In this analysis, we estimated the rate and risk factors associated with COVID-19-related readmission and inpatient mortality., Methods: In this retrospective cohort study, we used deidentified chargemaster data from 297 hospitals across 40 US states on patients hospitalized with COVID-19 from 15 February 2020 through 9 June 2020. Demographics, comorbidities, acute conditions, and clinical characteristics of first hospitalization are summarized. Multivariable logistic regression was used to measure risk factor associations with 30-day readmission and in-hospital mortality., Results: Among 29 659 patients, 1070 (3.6%) were readmitted. Readmitted patients were more likely to have diabetes, hypertension, cardiovascular disease (CVD), or chronic kidney disease (CKD) vs those not readmitted (P < .0001) and to present on first admission with acute kidney injury (15.6% vs 9.2%), congestive heart failure (6.4% vs 2.4%), or cardiomyopathy (2.1% vs 0.8%) (P < .0001). Higher odds of readmission were observed in patients aged >60 vs 18-40 years (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.48-2.50) and those admitted in the Northeast vs West (OR, 1.43; 95% CI, 1.14-1.79) or South (OR, 1.28; 95% CI, 1.11-1.49). Comorbidities including diabetes (OR, 1.34; 95% CI, 1.12-1.60), CVD (OR, 1.46; 95% CI, 1.23-1.72), CKD stage 1-5 (OR, 1.51; 95% CI, 1.25-1.81), and CKD stage 5 (OR, 2.27; 95% CI, 1.81-2.86) were associated with higher odds of readmission; 12.3% of readmitted patients died during second hospitalization., Conclusions: Among this large US population of patients hospitalized with COVID-19, readmission was associated with certain comorbidities and acute conditions during first hospitalization. These findings may inform strategies to mitigate risks of readmission due to COVID-19 complications., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
- Published
- 2022
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8. Variation in Alanine Aminotransferase in Children with Non-Alcoholic Fatty Liver Disease.
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Castillo-Leon E, Morris HL, Schoen C, Bilhartz J, McKiernan P, Miloh T, Palle S, Kabbany MN, Munoz B, Mospan AR, Rudolph B, Xanthakos SA, Vos MB, and Target-Nash Investigators
- Abstract
Background: Pediatric non-alcoholic fatty liver disease (NAFLD) is a major public health concern. Aminotransferase (ALT) is frequently used for screening and monitoring, but few studies have reported typical patterns of ALT elevation in children. Methods: TARGET-NASH is a real-world longitudinal observational cohort of patients with NAFLD receiving care across the United States. Analyses included children enrolled between 1 August 2016, and 12 October 2020, with at least one ALT measurement after enrollment. Peak ALT was based on the first and last available record and categorized into clinical cut points: <70 IU/L, >70−<250 IU/L, and >250 IU/L. A chi-squared test was used to compare differences in proportions, and a Kruskal−Wallis test was used to compare the medians and distributions of continuous responses. Results: Analyses included 660 children with a median age of 13 years. Of the 660, a total of 187 had undergone a biopsy and were more likely to be Hispanic or Latino (67% vs. 57%, p = 0.02) and to have cirrhosis (10% vs. 1%, p < 0.001). The highest ALT scores ranged from 28 U/L to 929 U/L; however, these scores varied across time. The prevalence of cirrhosis or any liver fibrosis stage was most common among children with a peak ALT > 70 U/L. Conclusions: Large variability was seen in ALT among children, including many values > 250 U/L. Higher levels of ALT were associated with increased prevalence of comorbidities and more advanced stages of NAFLD. These findings support an increased need for therapeutics and disease severity assessment in children with peak ALT > 70 U/L.
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- 2022
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9. Host-biomaterial interactions in mesh complications after pelvic floor reconstructive surgery.
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Abhari RE, Izett-Kay ML, Morris HL, Cartwright R, and Snelling SJB
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- Female, Foreign-Body Reaction immunology, Foreign-Body Reaction prevention & control, Gynecologic Surgical Procedures adverse effects, Gynecologic Surgical Procedures instrumentation, Humans, Postoperative Complications immunology, Postoperative Complications prevention & control, Risk Factors, Urologic Surgical Procedures adverse effects, Urologic Surgical Procedures instrumentation, Biocompatible Materials adverse effects, Foreign-Body Reaction etiology, Pelvic Organ Prolapse surgery, Polypropylenes adverse effects, Postoperative Complications etiology, Surgical Mesh adverse effects, Urinary Incontinence, Stress surgery
- Abstract
Polypropylene (PPL) mesh is widely used in pelvic floor reconstructive surgery for prolapse and stress urinary incontinence. However, some women, particularly those treated using transvaginal PPL mesh placement for prolapse, experience intractable pain and mesh exposure or extrusion. Explanted tissue from patients with complications following transvaginal implantation of mesh is typified by a dense fibrous capsule with an immune cell-rich infiltrate, suggesting that the host immune response has a role in transvaginal PPL mesh complications through the separate contributions of the host (patient), the biological niche within which the material is implanted and biomaterial properties of the mesh. This immune response might be strongly influenced by both the baseline inflammatory status of the patient, surgical technique and experience, and the unique hormonal, immune and microbial tissue niche of the vagina. Mesh porosity, surface area and stiffness also might have an effect on the immune and tissue response to transvaginal mesh placement. Thus, a regulatory pathway is needed for mesh development that recognizes the roles of host and biological factors in driving the immune response to mesh, as well as mandatory mesh registries and the longitudinal surveillance of patients., (© 2021. Springer Nature Limited.)
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- 2021
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10. Real-world evidence in hepatocellular carcinoma.
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Mospan AR, Morris HL, and Fried MW
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- Humans, Longitudinal Studies, Carcinoma, Hepatocellular therapy, Liver Neoplasms therapy
- Abstract
Real-world evidence includes all health-related information, such as electronic health records, insurance claims, pharmacy records and wearables that are obtained outside of clinical trials. These data can provide critical insights into the natural history of disease and evaluate the safety and effectiveness of treatment regimens used in clinical practice. Real-world data have been applied to varying degrees by global regulatory agencies to inform and expedite many phases of drug development and help refine the use of therapeutic regimens after marketing, especially in populations that are under-represented in registration trials. For the management of hepatocellular carcinoma, early detection provides the best chance for curative therapies, whose success has been evaluated in numerous cohorts. The availability of novel systemic therapies, including kinase inhibitors and immunotherapies, has provided new treatment options and improved survival in patients with advanced stage hepatocellular carcinoma. Real-world longitudinal observational studies can help understand the long-term safety and effectiveness of these agents., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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- 2021
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11. Cost-Effectiveness of the Wellness Incentives and Navigation (WIN) Program.
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Vogel WB, Morris HL, Muller K, Huo T, Parish A, Stoner D, and Shenkman E
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- Adult, Cost-Benefit Analysis, Female, Health Promotion economics, Health Status, Humans, Longitudinal Studies, Male, Medicaid economics, Motivational Interviewing organization & administration, Patient Navigation organization & administration, Quality-Adjusted Life Years, Self Care, Self Concept, Socioeconomic Factors, Texas epidemiology, United States, Young Adult, Health Knowledge, Attitudes, Practice, Health Promotion organization & administration, Medicaid statistics & numerical data, Multiple Chronic Conditions epidemiology
- Abstract
Objectives: Promoting patient involvement in managing co-occurring physical and mental health conditions is increasingly recognized as critical to improving outcomes and controlling costs in this growing chronically ill population. The main objective of this study was to conduct an economic evaluation of the Wellness Incentives and Navigation (WIN) intervention as part of a longitudinal randomized pragmatic clinical trial for chronically ill Texas Medicaid enrollees with co-occurring physical and mental health conditions., Methods: The WIN intervention used a personal navigator, motivational interviewing, and a flexible wellness expense account to increase patient activation, that is, the patient's knowledge, skills, and confidence in managing their self-care and co-occurring physical and mental health conditions. Regression models were fit to both participant-level quality-adjusted life years (QALYs) and total costs of care (including the intervention) controlling for demographics, health status, poverty, Medicaid managed care plan, intervention group, and baseline health utility and costs. Incremental costs and QALYs were calculated based on the difference in predicted costs and QALYs under intervention versus usual care and were used to calculate the incremental cost-effectiveness ratios (ICERs). Confidence intervals were calculated using Fieller's method, and sensitivity analyses were performed., Results: The mean ICER for the intervention compared with usual care was $12 511 (95% CI $8971-$16 842), with a sizable majority of participants (70%) having ICERs below $40 000. The WIN intervention also produced higher QALY increases for participants who were sicker at baseline compared to those who were healthier at baseline., Conclusion: The WIN intervention shows considerable promise as a cost-effective intervention in this challenging chronically ill population., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)
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- 2021
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12. Diabetes medication regimens and patient clinical characteristics in the national patient-centered clinical research network, PCORnet.
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Bachmann KN, Roumie CL, Wiese AD, Grijalva CG, Buse JB, Bradford R, Zalimeni EO, Knoepp P, Dard S, Morris HL, Donahoo WT, Fanous N, Fonseca V, Katalenich B, Choi S, Louzao D, O'Brien E, Cook MM, Rothman RL, and Chakkalakal RJ
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- Adult, Aged, Comorbidity, Diabetes Mellitus, Type 2 ethnology, Dipeptidyl-Peptidase IV Inhibitors therapeutic use, Drug Therapy, Combination, Electronic Health Records, Female, Glucagon-Like Peptide-1 Receptor agonists, Humans, Insulin therapeutic use, Male, Metformin therapeutic use, Middle Aged, Patient-Centered Care, Retrospective Studies, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Sulfonylurea Compounds therapeutic use, Thiazolidinediones therapeutic use, United States epidemiology, Diabetes Mellitus, Type 2 drug therapy, Hyperlipidemias epidemiology, Hypertension epidemiology, Hypoglycemic Agents classification, Hypoglycemic Agents therapeutic use
- Abstract
We used electronic medical record (EMR) data in the National Patient-Centered Clinical Research Network (PCORnet) to characterize "real-world" prescription patterns of Type 2 diabetes (T2D) medications. We identified a retrospective cohort of 613,203 adult patients with T2D from 33 datamarts (median patient number: 12,711) from 2012 through 2017 using a validated computable phenotype. We characterized outpatient T2D prescriptions for each patient in the 90 days before and after cohort entry, as well as demographics, comorbidities, non-T2D prescriptions, and clinical and laboratory variables in the 730 days prior to cohort entry. Approximately half of the individuals in the cohort were females and 20% Black. Hypertension (60.3%) and hyperlipidemia (50.5%) were highly prevalent. Most patients were prescribed either a single T2D drug class (42.2%) or had no evidence of a T2D prescription in the EMR (42.4%). A smaller percentage was prescribed multiple T2D drug types (15.4%). Among patients prescribed a single T2D drug type, metformin was the most common (42.6%), followed by insulin (18.2%) and sulfonylureas (13.9%). Newer classes represented approximately 13% of single T2D drug type prescriptions (dipeptidyl peptidase-4 inhibitors [6.6%], glucagon-like peptide-1 receptor agonists [2.5%], thiazolidinediones [2.0%], and sodium-glucose cotransporter-2 inhibitors [1.6%]). Among patients prescribed multiple T2D drug types, the most common combination was metformin and sulfonylureas (63.5%). Metformin-based regimens were highly prevalent in PCORnet's T2D population, whereas newer agents were prescribed less frequently. PCORnet is a novel source for the potential conduct of observational studies among patients with T2D., (© 2020 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.)
- Published
- 2020
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13. An Iterative Process for Identifying Pediatric Patients With Type 1 Diabetes: Retrospective Observational Study.
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Morris HL, Donahoo WT, Bruggeman B, Zimmerman C, Hiers P, Zhong VW, and Schatz D
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Background: The incidence of both type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in children and youth is increasing. However, the current approach for identifying pediatric diabetes and separating by type is costly, because it requires substantial manual efforts., Objective: The purpose of this study was to develop a computable phenotype for accurately and efficiently identifying diabetes and separating T1DM from T2DM in pediatric patients., Methods: This retrospective study utilized a data set from the University of Florida Health Integrated Data Repository to identify 300 patients aged 18 or younger with T1DM, T2DM, or that were healthy based on a developed computable phenotype. Three endocrinology residents/fellows manually reviewed medical records of all probable cases to validate diabetes status and type. This refined computable phenotype was then used to identify all cases of T1DM and T2DM in the OneFlorida Clinical Research Consortium., Results: A total of 295 electronic health records were manually reviewed; of these, 128 cases were found to have T1DM, 35 T2DM, and 132 no diagnosis. The positive predictive value was 94.7%, the sensitivity was 96.9%, specificity was 95.8%, and the negative predictive value was 97.6%. Overall, the computable phenotype was found to be an accurate and sensitive method to pinpoint pediatric patients with T1DM., Conclusions: We developed a computable phenotype for identifying T1DM correctly and efficiently. The computable phenotype that was developed will enable researchers to identify a population accurately and cost-effectively. As such, this will vastly improve the ease of identifying patients for future intervention studies., (©Heather Lynne Morris, William Troy Donahoo, Brittany Bruggeman, Chelsea Zimmerman, Paul Hiers, Victor W Zhong, Desmond Schatz. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 04.09.2020.)
- Published
- 2020
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14. Polydioxanone implants: A systematic review on safety and performance in patients.
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Martins JA, Lach AA, Morris HL, Carr AJ, and Mouthuy PA
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- Device Approval, Humans, Inflammation etiology, Medical Device Recalls, Absorbable Implants adverse effects, Biocompatible Materials adverse effects, Biocompatible Materials chemistry, Polydioxanone adverse effects, Polydioxanone chemistry
- Published
- 2020
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15. Addressing health disparities in type 1 diabetes through peer mentorship.
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Walker AF, Haller MJ, Gurka MJ, Morris HL, Bruggeman B, Miller K, Foster N, Anez Zabala C, and Schatz DA
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- Adolescent, Age Factors, Blood Glucose Self-Monitoring, Child, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 psychology, Feasibility Studies, Female, Glycated Hemoglobin metabolism, Hope, Humans, Male, Peer Group, Socioeconomic Factors, Young Adult, Diabetes Mellitus, Type 1 therapy, Health Promotion methods, Health Status Disparities, Mentors
- Abstract
Pronounced health disparities exist in type 1 diabetes (T1D) based on socioeconomic status (SES) yet there are a lack of programs designed to promote health equity for vulnerable communities. The All for ONE (Outreach, Networks, and Education) mentoring program was piloted pairing college students and publicly insured teenagers with T1D to assess feasibility as a possible intervention. There were 22 mentors recruited (mean age 20 ± 2 years; 17 [77%] females; mean HbA1c 8.4 ± 1.5%) and matched with mentees based on gender. There were 42 teens randomized to treatment and control groups including 22 teens in the treatment group (age 14 ± 2 years; 17 [77%] females; HbA1c 9.8 ± 2.3%) and 20 teens in the control group (age 14 ± 2 years; 15 [75%] females; HbA1c 8.9 ± 2.0%) followed over 9 months. Outcome measures included HbA1c and the Children's Hope Scale. The intervention included automated text reminders for blood glucose monitoring, text exchanges, social events with education, and clinic visits with mentors/mentees. Mean change in HbA1c for teens was +0.09% in the intervention group, compared with +0.28% in the control group (P = .61); college students had a reduction in HbA1c of -0.22% (P = .38). Treatment group teens had marked improvement in their hope for the future compared to control group teens (P = .04) and were more likely to attend clinic visits (P = .02). This program established feasibility for a model that could be replicated and modified for other types of settings. Additional research is warranted to study the potential long-term benefits of participating in the All for ONE mentoring program., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
- Published
- 2020
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16. Performance of a computable phenotype for identification of patients with diabetes within PCORnet: The Patient-Centered Clinical Research Network.
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Wiese AD, Roumie CL, Buse JB, Guzman H, Bradford R, Zalimeni E, Knoepp P, Morris HL, Donahoo WT, Fanous N, Epstein BF, Katalenich BL, Ayala SG, Cook MM, Worley KJ, Bachmann KN, Grijalva CG, Rothman RL, and Chakkalakal RJ
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Algorithms, Cohort Studies, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Female, Humans, Incidence, Information Storage and Retrieval, International Classification of Diseases, Male, Middle Aged, Retrospective Studies, United States, Young Adult, Comparative Effectiveness Research methods, Computer Communication Networks, Diabetes Mellitus, Type 2 epidemiology, Electronic Health Records statistics & numerical data, Patient-Centered Care
- Abstract
Purpose: PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites., Methods: We adapted existing computable phenotypes (CP) for the identification of patients with T2DM and evaluated their performance across four PCORnet sites (2012-2016). Patients entered the cohort on the earliest date they met one of three CP categories: (CP1) coded T2DM diagnosis (ICD-9/ICD-10) and an antidiabetic prescription, (CP2) diagnosis and glycosylated hemoglobin (HbA1c) ≥6.5%, or (CP3) an antidiabetic prescription and HbA1c ≥6.5%. We required evidence of health care utilization in each of the 2 prior years for each patient, as we also developed an incident T2DM CP to identify the subset of patients without documentation of T2DM in the 365 days before t
0 . Among a systematic sample of patients, we calculated the positive predictive value (PPV) for the T2DM CP and incident-T2DM CP using electronic health record (EHR) review as reference., Results: The CP identified 50 657 patients with T2DM. The PPV of patients randomly selected for validation was 96.2% (n = 1572; CI:95.1-97.0) and was consistently high across sites. The PPV for the incident-T2DM CP was 5.8% (CI:4.5-7.5)., Conclusions: The T2DM CP accurately and efficiently identified patients with T2DM across multiple sites that participate in PCORnet, although the incident T2DM CP requires further study. PCORnet is a valuable data source for future epidemiological and comparative effectiveness research among patients with T2DM., (© 2019 John Wiley & Sons, Ltd.)- Published
- 2019
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17. Pyridine as an additive to improve the deposition of continuous electrospun filaments.
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Lach AA, Morris HL, Martins JA, Stace ET, Carr AJ, and Mouthuy PA
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- Electric Conductivity, Humans, Polydioxanone chemistry, Polyesters chemistry, Solutions chemistry, Sutures, Tissue Scaffolds chemistry, Biophysical Phenomena, Nanofibers chemistry, Pyridines chemistry, Tensile Strength
- Abstract
Electrospun filaments are leading to a new generation of medical yarns that have the ability to enhance tissue healing through their biophysical cues. We have recently developed a technology to fabricate continuous electrospun filaments by depositing the submicron fibres onto a thin wire. Here we investigate the influence of pyridine on the fibre deposition. We have added pyridine to polydioxanone solutions at concentrations ranging from 0 to 100 ppm, increasing the conductivity of the solutions almost linearly from 0.04 uS/cm to 7 uS/cm. Following electrospinning, this led to deposition length increasing from 1 cm to 14 cm. The samples containing pyridine easily underwent cold drawing. The strength of drawn filaments increased from 0.8 N to 1.5 N and this corresponded to a decrease in fibre diameter, with values dropping from 2.7 μm to 1 μm. Overall, these findings are useful to increase the reliability of the manufacturing process of continuous electrospun filaments and to vary their biophysical properties required for their application as medical yarns such as surgical sutures., Competing Interests: The authors have declared that no competing interests exist.
- Published
- 2019
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18. Geographic access to endocrinologists for Florida's publicly insured children with diabetes.
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Walker AF, Hall JM, Shenkman EA, Gurka MJ, Morris HL, Haller MJ, Rohrs HJ, Salazar KR, and Shatz DA
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- Child, Diabetes Mellitus, Type 1 epidemiology, Diabetes Mellitus, Type 2 epidemiology, Female, Florida epidemiology, Humans, Male, Diabetes Mellitus, Type 1 therapy, Diabetes Mellitus, Type 2 therapy, Endocrinologists statistics & numerical data, Health Services Accessibility, Insurance, Health statistics & numerical data
- Published
- 2018
19. Synthetic sutures: Clinical evaluation and future developments.
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Abhari RE, Martins JA, Morris HL, Mouthuy PA, and Carr A
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- Absorbable Implants adverse effects, Animals, Biocompatible Materials adverse effects, Biocompatible Materials chemistry, Biocompatible Materials metabolism, Device Approval, Humans, Infections etiology, Inventions, Regenerative Medicine, Sutures adverse effects
- Abstract
Today's sutures are the result of a 4000-year innovation process with regard to their materials and manufacturing techniques, yet little has been done to enhance the therapeutic value of the suture itself. In this review, we explore the historical development, regulatory database and clinical literature of sutures to gain a fuller picture of suture advances to date. First, we examine historical shifts in suture manufacturing companies and review suture regulatory databases to understand the forces driving suture development. Second, we gather the existing clinical evidence of suture efficacy from reviewing the clinical literature and the Food and Drug Administration database in order to identify to what extent sutures have been clinically evaluated and the key clinical areas that would benefit from improved suture materials. Finally, we apply tissue engineering and regenerative medicine design hypotheses to suture materials to identify routes by which bioactive sutures can be designed and passed through regulatory hurdles, to improve surgical outcomes. Our review of the clinical literature revealed that many of the sutures currently in use have been available for decades, yet have never been clinically evaluated. Since suture design and development is industry driven, incremental modifications have allowed for a steady outflow of products while maintaining a safe regulatory position and limiting costs. Until recently, there has been little academic interest in suture development, however the rise of regenerative medicine strategies is shifting the suture paradigm from an inert material, which mechanically approximates tissue, to a bioactive material, which also actively promotes cell-directed repair and a positive healing response. These materials hold significant therapeutic potential, but could be associated with an increased regulatory burden, cost, and clinical evaluation compared with current devices.
- Published
- 2017
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20. Development and validation of an instrument to measure collaborative goal setting in the care of patients with diabetes.
- Author
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Morris HL, Dumenci L, and Lafata JE
- Abstract
Objective: Despite known benefits of patient-perceived collaborative goal setting, we have a limited ability to monitor this process in practice. We developed the Patient Measure of Collaborative Goal Setting (PM-CGS) to evaluate the use of collaborative goal setting from the patient's perspective., Research Design and Methods: A random sample of 400 patients aged 40 years or older, receiving diabetes care from the Virginia Commonwealth University Health System between 8/2012 and 8/2013, were mailed a survey containing potential PM-CGS items (n=44) as well as measures of patient demographics, perceived self-management competence, trust in their physician, and self-management behaviors. Confirmatory factor analysis was used to evaluate construct validity. External validity was evaluated via a structural equation model (SEM) that tested the association of the PM-CGS with self-management behaviors. The direct and two mediated (via trust and self-efficacy) pathways were tested., Results: A total of 259 patients responded to the survey (64% response rate), of which 192 were eligible for inclusion. Results from the factor analysis supported a 37-item measure of patient-perceived CGS spanning five domains: listen and learn; share ideas; caring relationship; measurable objective; and goal achievement support (χ=4366.13, p<0.001; RMSEA=0.08). Results from the SEM supported the external validity of the PM-CGS. The relationship between CGS and self-management was partially mediated by perceived competence (p<0.05). The direct effect between the PM-CGS and self-management was significant (p<0.001)., Conclusions: CGS can be validly measured by the 37-item PM-CGS. Use of the PM-CGS can help illustrate actionable deficits in goal-setting discussions., Competing Interests: Competing interests: None declared.
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- 2017
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21. Adding the patient's voice to our understanding of collaborative goal setting: How do patients with diabetes define collaborative goal setting?
- Author
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Morris HL, Carlyle KE, and Elston Lafata J
- Subjects
- Aged, Cooperative Behavior, Female, Focus Groups, Humans, Male, Middle Aged, Outcome Assessment, Health Care, Physician-Patient Relations, Qualitative Research, Trust, Communication, Diabetes Mellitus therapy, Patient Care Planning, Patient Participation
- Abstract
Background: Patient reports of collaborative goal setting have repeatedly been associated with improved health outcomes, and the American Diabetes Association specifically encourages collaborative goal setting as a component of high quality care. Current limitations in our understanding of what needs to transpire for patients to denote goal setting as "collaborative", remain a barrier to fostering collaborative goal setting in practice., Methods: Four focus groups were conducted among 19 patients with diabetes. A semi-structured focus group guide was used to explore patient perceptions of collaborative goal setting and what needed to happen for goals to be considered collaboratively set. Focus group transcripts were coded using thematic analysis., Results: Collaborative goal setting was described by patients as occurring within the context of a caring relationship where patients and health care providers: (1) listen and learn from each other; (2) share ideas; (3) agree on a measurable objective; and (4) support goal achievement. Patients also articulated clear responsibilities for themselves and clinicians and described collaborative goal setting as a process that occurs over time., Conclusions: Patients perceived collaborative goal setting as a multidimensional process that occurs over time within the context of a caring relationship and encompasses distinct patient and clinician responsibilities., (© The Author(s) 2016.)
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- 2016
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22. Genetic Deletion of the Stromal Cell Marker CD248 (Endosialin) Protects against the Development of Renal Fibrosis.
- Author
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Smith SW, Croft AP, Morris HL, Naylor AJ, Huso DL, Isacke CM, Savage CO, and Buckley CD
- Subjects
- Animals, Antigens, Neoplasm genetics, Fibrosis, Kidney chemistry, Male, Mice, Mice, Knockout, Pericytes physiology, Receptors, Platelet-Derived Growth Factor physiology, Stromal Cells chemistry, Antigens, Neoplasm metabolism, Kidney pathology, Kidney Diseases genetics, Kidney Diseases pathology, Stromal Cells physiology
- Abstract
Background: Tissue fibrosis and microvascular rarefaction are hallmarks of progressive renal disease. CD248 is a transmembrane glycoprotein expressed by key effector cells within the stroma of fibrotic kidneys including pericytes, myofibroblasts and stromal fibroblasts. In human disease, increased expression of CD248 by stromal cells predicts progression to end-stage renal failure. We therefore, hypothesized that the genetic deletion of the CD248 gene would protect against fibrosis following kidney injury., Methods: Using the unilateral ureteral obstruction (UUO) model of renal fibrosis, we investigated the effect of genetic deletion of CD248 on post obstructive kidney fibrosis., Results: CD248 null mice were protected from fibrosis and microvascular rarefaction following UUO. Although the precise mechanism is not known, this may to be due to a stabilizing effect of pericytes with less migration and differentiation of pericytes toward a myofibroblast phenotype in CD248-/- mice. CD248-/- fibroblasts also proliferated less and deposited less collagen in vitro., Conclusion: These studies suggest that CD248 stromal cells have a pathogenic role in renal fibrosis and that targeting CD248 is effective at inhibiting both microvascular rarefaction and renal fibrosis through modulation of pericyte and stromal cell function., (© 2015 S. Karger AG, Basel.)
- Published
- 2015
- Full Text
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