108 results on '"Danila MI"'
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2. Sonochemically synthetized ZnO-Graphene nanohybrids and its characterization
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Cobianu Cornel, Dumbravescu Niculae, Serban Bogdan-Catalin, Buiu Octavian, Romanitan Cosmin, Comanescu Florin, Danila Mihai, Marinescu Roxana, Avramescu Viorel, and Ionescu Octavian
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zno-graphene nanocomposite ,nano-flower architecture ,sonochemistry ,colloids ,zeta potential ,hydroz-incite ,Technology ,Chemical technology ,TP1-1185 - Abstract
The paper presents the morphological, structural and compositional properties of the sonochemically prepared ZnO-1.4wt% Graphene (Z-G) nanocomposites as a function of pH value of suspension varying from 8.5 to 14 and thermal annealing at 450°C in nitrogen or air ambient. The SEM analysis of the Z-G hybrids dried at 150°C in air has shown a nano-flower like nanostructure for a pH value of 14. The XRD analysis of dried Z-G hybrids revealed a crystallite size increase from 3.5 nm to 18.4 nm with pH increase, and this result was explained in terms of colloids zeta potential evolution with pH value. The Raman and EDS spectroscopy have shown a split of the G band (1575 cm−1) of graphene into two bands (1575 cm−1 and 1605 cm−1), an increased height of D (1323 cm−1) band, and an additional amount of carbon due to CO2 absorption from the air, respectively. The carbon incorporation increased with the decrease of pH, and was associated with a hydrozincite phase, Zn5(CO3)2(OH)6. The formation of dried Z-G nanocomposite was clearly demonstrated only at a pH value equal to 14, where two ZnO Raman active bands at 314.9 cm−1 and 428.2 cm−1 appeared. This result may indicate the sensitivity of the Raman spectroscopy to the nanoflower-like nanostructure of dried Z-G hybrids prepared at pH=14. The thermal treatment of Z-G hybrids in N2at 450°C has increased the number of ZnO Raman bands as a function of pH value, it has decreased the amount of additional carbon by conversion of hydrozincite to ZnO and preserved the graphene profile. The thermal treatment in air at 450°C has increased the crystalline symmetry and stoichiometry of the ZnO as revealed by high and narrow Raman band from 99 cm−1 specific to Zn optical phonons, but it has severely affected the graphene profile in the Z-G hybrid, due to combustion of graphene in oxygen from the ambient.
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- 2020
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3. Widely Accepted Credibility Criteria for Online Health-related Information Are Not Correlated with Content Quality of Stroke Webpages in Two Languages of Central and Eastern European Countries
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Popescu Septimiu Daniel, Popescu Alex Otniel, Maior David, Dănilă Mihaela, Dobria Mihaela, and Nădăşan Valentin
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stroke ,credibility criteria ,proxy quality indicators ,health-related internet ,consumer health ,Medicine - Abstract
Background: Finding accurate health-related information on the Internet may be a real challenge for users lacking the critical skills necessary to assess the validity of online content, even if they browse websites that are compliant with credibility criteria. The aim of the study was to check whether an overall high website credibility or compliance to any of the individual criteria for credibility are correlated/associated with a higher quality of health-related information on a sample of Romanian and Hungarian stroke-related websites.
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- 2018
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4. Bisphosphonate-associated osteonecrosis of the jaw, with healing after teriparatide: a review of the literature and a case report.
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Narongroeknawin P, Danila MI, Humphreys LG Jr, Barasch A, Curtis JR, Narongroeknawin, Pongthorn, Danila, Maria I, Humphreys, Lewis G Jr, Barasch, Andrei, and Curtis, Jeffrey R
- Abstract
This paper reports the case history of a patient who had bisphosphonate-associated osteonecrosis of the jaw (ONJ) in which adjunctive treatment with teriparatide was used. The patient was treated for 5 years with alendronate for osteoporosis and developed ONJ after extraction of maxillary teeth. An implant was placed at the site of the extracted teeth. The pathology report confirmed the clinical diagnosis of ONJ; treatment was changed from alendronate to teriparatide and the ONJ resolved. To our knowledge, this is the third case history reported in the literature in which teriparatide was successfully used as adjunct therapy in ONJ because it has an anabolic effect and presumed role in accelerating bone healing. ONJ is a serious but infrequent condition that has been recently associated with nitrogen-containing bisphosphonate therapy. Teriparatide may be a useful adjunctive therapy when ONJ develops. [ABSTRACT FROM AUTHOR]
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- 2010
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5. Biologics and heart failure in rheumatoid arthritis: are we any wiser?
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Danila MI, Patkar NM, Curtis JR, Saag KG, Teng GG, Danila, Maria I, Patkar, Nivedita M, Curtis, Jeffrey R, Saag, Kenneth G, and Teng, Gim Gee
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- 2008
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6. Online Information about Stroke – A Soft Challenge for Critical Care Professionals
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Popescu Septimiu-Daniel, Dănilă Mihaela, and Nădășan Valentin
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stroke-related websites ,consumer health ,health literacy ,stroke recognition ,pre-hospital delay time ,Medical emergencies. Critical care. Intensive care. First aid ,RC86-88.9 - Published
- 2018
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7. Modified Diamide and Phosphine Oxide Extracting Compounds as Membrane Components for Cross-Sensitive Chemical Sensors
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Maria Khaydukova, Danila Militsyn, Mikhail Karnaukh, Bohumir Grüner, Pavel Selucký, Vasily Babain, Andreas Wilden, Dmitry Kirsanov, and Andrey Legin
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diamides of diglycolic acid ,CMPO ,potentiometric sensors ,lanthanides ,multisensor system ,Biochemistry ,QD415-436 - Abstract
This research is devoted to the development and study of novel cross-sensitive sensors based on modified extracting ligands. According to the previous results of liquid extraction studies, the chemical modification of membrane active components would change the analytical characteristics of a sensor comprising them. The sensing elements of the studied sensors consisted of various derivatives of N,N,N′,N′-tetraoctyldiamide of diglycolic acid (TODGA) and di-phenyl-N,N-di-i-sobutylcarbamoylmethylen phoshine oxide (CMPO) used as neutral carriers, CCD (chlorinated cobalt dicarbollide) as a lipophilic additive, different plasticizers, and poly(vinyl chloride) (PVC) as a polymer. TODGA-based sensors demonstrated a stable and reproducible response towards rare earth cations in acidic media (pH = 2). Changing the concentrations and ratio of neutral carriers and the lipophilic additive, it is possible to modify the sensitivity and selectivity of the sensors towards the same target ions. Bonded ligands, such as cobalt dicarbollide covalently attached to TODGA and CMPO, exhibited lower selectivity and sensitivity to rare earth cations. A possibility to vary the cross-sensitivity patterns of the sensors in a wide range might be of great interest for the development of multisensor systems allowing the simultaneous determination of several analytes in multicomponent solutions.
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- 2019
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8. Microstructures and growth characteristics of polyelectrolytes on silicon using layer-by-layer assembly
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Bragaru Adina, Kusko Mihaela, Radoi Antonio, Danila Mihai, Simion Monica, Craciunoiu Florea, Pascu Razvan, Mihalache Iuliana, and Ignat Teodora
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layer-by-layer ,polyelectrolytes ,microanalysis ,nanocomposite structures ,Chemistry ,QD1-999 - Published
- 2013
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9. LIDAR Measurements Comparison Of Two Volcanic Eruptions: Environmental Influences Upon The Romanian Territory
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Dănilă Mihai Nicolae, Unga Florin, Cazacu Marius Mihai, Timofte Adrian, Strat Mitachi, Dimitriu Dan Gheorghe, and Gurlui Silviu
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volcanic ash ,lidar ,satellite imagery ,42.68.wt ,42.79.qx ,Physics ,QC1-999 - Abstract
The eruption of both the Eyjafjallajokull (April 2010) and Grimsvotn (May 2011) volcanoes cumulated with two moments that gave headaches to the authorities and air traffic, and their impact on the environment upon Iasi region have been studied by means of different tools evidencing the complexity of the phenomena. In order to evidence the intrusion of pollutants in the cloud systems and to obtain additional data on the intrusion when the ash cloud was over our country, LIDAR measurements, meteorological (NMA), Satellite data (EUMETSAT), and various forecasting models (ECMWF, VAAC-Met Office, HYSPLIT) have been used. The new 3D Atmospheric Observatory Site of the Alexandru Ioan Cuza University of Iasi, as part of RADO (Romanian Atmospheric 3D Observatory) is presented, too.
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- 2012
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10. The value of transabdominal ultrasound for assessment of the severity of liver steatosis as compared to liver biopsy
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Sporea Ioan, Şirli Roxana, Başa Elena, Cornianu Maria, Popescu Alina, Dănilă Mirela, and Focşa Mircea
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“fatty liver” ,ultrasound ,hepatic biopsy ,Medicine - Published
- 2009
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11. Leveraging the Consolidated Framework for Implementation Research to Develop the American College of Rheumatology's Toolkit for Implementation of Rheumatoid Arthritis Outcome Measures in Clinical Practice: A Qualitative Study.
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Nasrallah C, Schmajuk G, Hamblin A, Wilson C, Kersey E, Young C, Katz P, Bajaj P, Downey C, Bartels C, Zell J, Danila MI, Ferguson S, Barton JL, DeQuattro K, and Yazdany J
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- Humans, United States, Male, Interviews as Topic, Registries, Female, Workflow, Rheumatologists, Patient Reported Outcome Measures, Middle Aged, Treatment Outcome, Arthritis, Rheumatoid therapy, Arthritis, Rheumatoid diagnosis, Rheumatology, Qualitative Research, Implementation Science
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Objective: Despite the recognized benefits of collecting rheumatoid arthritis (RA) outcomes measures, their use in routine care is inconsistent. Using the Consolidated Framework for Implementation Research (CFIR), we conducted semistructured interviews with US rheumatologists and practice personnel to assess workflows, opportunities, and challenges in collecting RA outcome measures. Using insights from interviews, we developed the RA Measures Toolkit to enhance their use in clinical practice., Methods: We invited 138 Rheumatology Informatics System for Effectiveness (RISE) registry practices and 5 academic medical centers with ≥30 patients eligible for RA outcome measures to participate in the study. Practices were classified based on their performance in quality payment programs. Recorded interviews were transcribed verbatim and analyzed thematically using deductive and inductive techniques. The findings were used to create the RA Measures Toolkit., Results: We conducted 20 interviews with 38 participants across 20 practices. Key themes within the CFIR domains highlighted the challenges and best practices in RA outcome measure collection and included (1) process: the variability in practices' use of RA outcome measures and the importance of streamlined workflows; (2) intervention: challenges of integrating patient-reported outcomes into electronic health records; and (3) individual characteristics: importance of clinic culture around quality improvement. Using these data, we developed the RA Measures Toolkit, a multimedia online resource, featuring guidelines, best practices, and educational resources to improve the efficiency of current workflows and to enhance patient care., Conclusion: This study identifies critical gaps in the collection of RA outcome measures in US rheumatology practices and provides actionable recommendations and resources to address challenges via the RA Measures Toolkit., (© 2024 American College of Rheumatology.)
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- 2024
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12. Reply to Ganda and colleagues' Letter to the Editor regarding "Defining the Key Clinician Skills and Attributes for Competency in Managing Patients with Osteoporosis and Fragility Fractures".
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Jackson LE, Saag KG, Johnson SR, and Danila MI
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- 2024
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13. Identification of Gaps in Quality of Care and Good Practice Interventions in Rheumatoid Arthritis: Insights From a Literature Review and Qualitative Study of Nine Centers in North America.
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Curtis JR, Bykerk VP, Crow MK, Danila MI, Haraoui B, Karpouzas GA, Newman ED, Norton H, Peterson J, Thorne C, Wright GC, and Bain L
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Objective: Quality of care (QoC) delivery in rheumatoid arthritis (RA) continues to suffer from various challenges (eg, delay in diagnosis and referral) that can lead to poor patient outcomes. This study aimed to identify good practice interventions that address these challenges in RA care in North America., Methods: The study was conducted in three steps: (1) literature review of existing publications and guidelines (April 2005 to April 2021) on QoC in RA; (2) in-person visits to >50 individual specialists and health care professionals across nine rheumatology centers in the United States and Canada to identify challenges in RA care and any corresponding good practice interventions; and (3) collation and organization of findings of the two previous methods by commonalities to identify key good practice interventions, followed by further review by RA experts to ensure key challenges and gaps in RA care were captured., Results: Several challenges and eight good practice interventions were identified in RA care. The interventions were prioritized based on the perceived positive impact on the challenges in care and ease of implementation. High-priority interventions included the use of technology to improve care, streamlining specialist treatment, and facilitating comorbidity assessment and care. Other interventions included enabling patient access to optimal medication regimens and improving patient self-management strategies., Conclusion: Learnings from the study can be implemented in other rheumatology centers throughout North America to improve RA care. Although the study was completed before the COVID-19 pandemic, the findings remain relevant., (© 2024 The Author(s). ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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14. Which Educational Topics and Smartphone App Functions Are Prioritized by US Patients With Rheumatic and Musculoskeletal Diseases? A Mixed-Methods Study.
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Nowell WB, Gavigan K, Garza K, O'Beirne R, Safford M, George M, Ogdie A, Walsh JA, Danila MI, Venkatachalam S, Stradford L, Rivera E, and Curtis JR
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- Humans, Male, Female, Middle Aged, Adult, United States, Aged, Surveys and Questionnaires, Rheumatic Diseases physiopathology, Mobile Applications, Musculoskeletal Diseases physiopathology, Musculoskeletal Diseases diagnosis, Smartphone, Patient Education as Topic methods
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Objective: We sought to identify (1) what types of information US adults with rheumatic and musculoskeletal diseases (RMD) perceive as most important to know about their disease, and (2) what functions they would use in an RMD-specific smartphone app., Methods: Nominal groups with patients with RMD were conducted using online tools to generate a list of needed educational topics. Based on nominal group results, a survey with final educational items was administered online, along with questions about desired functions of a smartphone app for RMD and wearable use, to patients within a large community rheumatology practice-based research network and the PatientSpot registry. Chi-square tests and multivariate regression models were used to determine differences in priorities between groups of respondents with rheumatic inflammatory conditions (RICs) and osteoarthritis (OA), and possible associations., Results: At least 80% of respondents considered finding a rheumatologist, understanding tests and medications, and quickly recognizing and communicating symptoms to doctors as extremely important educational topics. The highest-ranked topic for both RIC and OA groups was "knowing when the medication is not working." The app functions that most respondents considered useful were viewing laboratory results, recording symptoms to share with their rheumatology provider, and recording symptoms (eg, pain, fatigue) or disease flares for health tracking over time. Approximately one-third of respondents owned and regularly used a wearable activity tracker., Conclusion: People with RMD prioritized information about laboratory test results, medications, and disease and symptom monitoring, which can be used to create educational and digital tools that support patients during their disease journey., (Copyright © 2024 by the Journal of Rheumatology.)
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- 2024
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15. Long-Term Mortality Following SARS-CoV-2 Infection in Rural Versus Urban Dwellers With Autoimmune or Inflammatory Rheumatic Disease: A Retrospective Cohort Analysis From the National COVID Cohort Collaborative.
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Anzalone AJ, Jackson LE, Singh N, Danila MI, Reisher E, Patel RC, and Singh JA
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Objective: Autoimmune or inflammatory rheumatic diseases (AIRDs) increase the risk for poor COVID-19 outcomes. Although rurality is associated with higher post-COVID-19 mortality in the general population, whether rurality elevates this risk among people with AIRD is unknown. We assessed associations between rurality and post-COVID-19 all-cause mortality, up to two years post infection, among people with AIRD using a large nationally sampled US cohort., Methods: This retrospective study used the National COVID Cohort Collaborative, a medical records repository containing COVID-19 patient data. We included adults with two or more AIRD diagnostic codes and a COVID-19 diagnosis documented between April 2020 and March 2023. Rural residency was categorized using patient residential zip codes. We adjusted for AIRD medications and glucocorticoid prescription, age, sex, race and ethnicity, tobacco or substance use, comorbid burden, and SARS-CoV-2 variant-dominant periods. Multivariable Cox proportional hazards with inverse probability treatment weighting assessed associations between rurality and two-year all-cause mortality., Results: Among the 86,467 SARS-CoV-2-infected persons with AIRD, we observed a higher risk for two-year post-COVID-19 mortality in rural versus urban dwellers. Rural-residing persons with AIRD had higher two-year all-cause mortality risk (adjusted hazard ratio 1.24, 95% confidence interval 1.19-1.29). Glucocorticoid, immunosuppressive, and rituximab prescriptions were associated with a higher risk for two-year post-COVID-19 mortality, whereas risk with nonbiologic or biologic disease-modifying antirheumatic drugs was lower., Conclusion: Rural residence in people with AIRD was independently associated with higher two-year post-COVID-19 mortality in a large US cohort after adjusting for background risk factors. Policymakers and health care providers should consider these findings when designing interventions to improve outcomes in people with AIRD following SARS-CoV-2 infection, especially among high-risk rural residents., (Published 2024. This article is a U.S. Government work and is in the public domain in the USA.)
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- 2024
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16. Vitamin B12 status and hyperhomocysteinemia in patients with Rheumatoid arthritis treated with methotrexate and folic acid.
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Patel AV, Morgan SL, Green R, Danila MI, Merriman TR, Wanzeck K, Ahmed H, and Gaffo AL
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- Humans, Female, Male, Middle Aged, Cross-Sectional Studies, Aged, Homocysteine blood, Adult, Methylmalonic Acid blood, Methotrexate therapeutic use, Methotrexate adverse effects, Folic Acid blood, Folic Acid therapeutic use, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid blood, Hyperhomocysteinemia blood, Hyperhomocysteinemia chemically induced, Hyperhomocysteinemia epidemiology, Vitamin B 12 blood, Antirheumatic Agents therapeutic use, Antirheumatic Agents adverse effects, Vitamin B 12 Deficiency chemically induced, Vitamin B 12 Deficiency blood, Vitamin B 12 Deficiency epidemiology
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Background: Rheumatoid arthritis (RA) is an inflammatory arthritis in which the immune system targets synovial joints. Methotrexate serves as the mainstay of treatment for RA due to its efficacy. However, patients treated with methotrexate are uniquely at risk for vitamin B12 deficiency and hyperhomocysteinemia due to coincident disease risk factors and the fact that methotrexate use is associated with malabsorption. The objective of this study was to assess for vitamin B12 deficiency among patients with RA treated with methotrexate and folic acid., Methods: This cross-sectional study included 50 patients with RA treated with methotrexate and folic acid and 49 patients with RA treated with other therapies. Patients were matched by age, sex, race, renal function, and disease activity. We compared plasma vitamin B12, methylmalonic acid, and homocysteine levels between these two groups utilizing quantitative and categorical analyses., Results: Thirty-seven (74%) RA patients on methotrexate and folic acid had elevated plasma homocysteine levels compared with only 27 (55%) RA patients receiving other therapies (P < 0.05). The proportion of patients with low vitamin B12 and high methylmalonic acid levels did not differ between the two groups., Conclusions: Our data show high plasma homocysteine levels among RA patients treated with methotrexate and folic acid. While plasma vitamin B12 levels were similar between the two groups, high plasma homocysteine is also a sensitive marker of vitamin B12 deficiency. Additional studies should evaluate for the presence of clinical features of vitamin B12 deficiency and hyperhomocysteinemia among RA patients treated with methotrexate and folic acid., Competing Interests: Declaration of competing interest Dr. Maria Danila: Pfizer: Research grants UCB: Consultant, ad hoc advisory board, (Published by Elsevier Inc.)
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- 2024
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17. Defining the key clinician skills and attributes for competency in managing patients with osteoporosis and fragility fractures.
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Jackson LE, Saag KG, Johnson SR, and Danila MI
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- Humans, Female, Male, Osteoporotic Fractures therapy, Middle Aged, Adult, Clinical Competence, Osteoporosis therapy
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Osteoporosis and fragility fractures are managed by clinicians across many medical specialties. The key competencies of clinicians delivering bone health care have not been systematically established. We aimed to develop a decision rule to define the threshold of adequate skills and attributes associated with clinical competency in bone health for a clinician serving as a referral source for bone health care. Using a modified-Delphi method, we invited clinicians with expertise in treating osteoporosis and representatives of patient advocacy groups focused on bone health to create a list of desirable characteristics of a clinician with bone health competency. Characteristics were defined as "attributes" with "levels" within each attribute. Participants prioritized levels by perceived importance. To identify the cut points for defining adequate competency, participants next ranked 20 hypothetical clinicians defined by various levels of attributes from highest to lowest likelihood of having adequate bone health competency. Lastly, we conducted a discrete choice experiment (DCE) to generate a weighted score for each attribute/level. The threshold for competency was a priori determined as the total weighted score at which ≥70% of participants agreed a clinician had adequate bone health competency. Thirteen participants generated lists of desirable characteristics, and 30 participants ranked hypothetical scenarios and participated in the DCE. The modified-Delphi exercise generated 108 characteristics, which were reduced to 8 categories with 20 levels with associated points. The maximum possible score was 25 points. A summed threshold score of >12 points classified a clinician as having adequate bone health competency. We developed a numeric additive decision rule to define clinicians across multiple specialties as having adequate competency in managing bone health/osteoporosis. Our data provide a rigorously defined criteria for a clinician with competency in bone health and can be used to quantitate the skills of clinicians participating in bone health research and clinical care., (Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research 2024.)
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- 2024
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18. An Emergency Department-based system intervention to improve osteoporosis screening for older adults at high-risk of fracture.
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Jackson LE, Skains RM, Mudano A, Techarukpong N, Booth JS, Saag KG, Fraenkel L, and Danila MI
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Falls and osteoporosis are risk factors for fragility fractures. Bone mineral density (BMD) assessment is associated with better preventative osteoporosis care, but it is underutilized by those at high fracture risk. We created a novel electronic medical record (EMR) alert-driven protocol to screen patients in the Emergency Department (ED) for fracture risk and tested its feasibility and effectiveness in generating and completing referrals for outpatient BMD testing after discharge. The EMR alert was configured in 2 tertiary-care EDs and triggered by the term "fall" in the chief complaint, age (≥65 years for women, ≥70 years for men), and high fall risk (Morse score ≥ 45). The alert electronically notified ED study staff of potentially eligible patients. Participants received osteoporosis screening education and had BMD testing ordered. From November 15, 2020 to December 4, 2021, there were 2,608 EMR alerts among 2,509 patients. We identified 558 patients at high-risk of fracture who were screened for BMD testing referral. Participants were excluded for: serious illness ( N = 141), no documented health insurance to cover BMD testing ( N = 97), prior BMD testing/recent osteoporosis care ( N = 58), research assistant unavailable to enroll ( N = 53), concomitant fracture ( N = 43), bedridden status ( N = 38), chief complaint of fall documented in error ( N = 38), long-term care residence ( N = 34), participation refusal ( N = 32), or hospitalization ( N = 3). Of the 16 participants who had BMD testing ordered, 7 scheduled and 5 completed BMD testing. EMR alerts can help identify subpopulations who may benefit from osteoporosis screening, but there are significant barriers to identifying eligible and willing patients for screening in the ED. In our study targeting an innovative venue for osteoporosis care delivery, only about 1% of patients at high-risk of fracture scheduled BMD testing after an ED visit. Adequate resources during and after an ED visit are needed to ensure that older adults participate in preventative osteoporosis care., Competing Interests: None to report., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)
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- 2024
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19. Cardiovascular disease in spondyloarthritis: a narrative review of risk factors and the effect of treatments.
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Sen R, Caplan L, and Danila MI
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- Humans, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Risk Factors, Cardiovascular Diseases epidemiology, Cardiovascular Diseases etiology, Spondylarthritis complications, Spondylarthritis drug therapy, Spondylarthritis diagnosis, Arthritis, Psoriatic drug therapy
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Purpose of Review: This review summarizes the recent evidence available regarding the epidemiology of cardiovascular disease in spondyloarthritis (SpA), including the effect of disease modifying drugs on cardiovascular risk., Recent Findings: People with SpA suffer from an increased risk of cardiovascular disease compared to the general population. This elevated risk is explained by the high prevalence of traditional cardiovascular risk factors and inflammation from disease activity leading to endothelial dysfunction and accelerated atherosclerosis. Consequently, the American College of Cardiology/American Heart Association and the European League Against Rheumatism recommend enhanced cardiovascular risk screening in SpA patients. There is evidence from observational studies that methotrexate and tumor necrosis factor inhibitors reduce the risk of cardiovascular events in SpA. Unlike what is observed in the general population, the use of nonsteroidal anti-inflammatory drugs does not appear to increase cardiovascular disease risk in SpA., Summary: Cardiovascular diseases are increasingly recognized in patients suffering from SpA, especially axial SpA and psoriatic arthritis. Cardiovascular diseases can cause significant morbidity, mortality, and add to the overall disease burden. Disease modifying drugs may mitigate some of the cardiovascular risk; however, a multidisciplinary team is needed to monitor patients and improve cardiovascular health status., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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20. COVID-19 Vaccine Uptake, Hesitancy, and Flare in a Large Rheumatology Practice Network.
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Holladay EE, Mudano AS, Xie F, Stewart P, Jackson LE, Danila MI, Gavigan K, Nowell WB, Venkatachalam S, and Curtis JR
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- Humans, Odds Ratio, Physicians, Vaccination, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Rheumatology
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Objective: The goal of this study was to ascertain COVID-19 vaccine uptake, reasons for hesitancy, and self-reported flare in a large rheumatology practice-based network., Methods: A tablet-based survey was deployed by 108 rheumatology practices from December 2021 to December 2022. Patients were asked about COVID-19 vaccine status and why they might not receive a vaccine or booster. We used descriptive statistics to explore the differences between vaccination status and vaccine and booster hesitancy, comparing patients with and without autoimmune and inflammatory rheumatic diseases (AIIRDs). We used multivariable logistic regression to examine the association between vaccine uptake and AIIRD status and self-reported flare and AIIRD status. We reported adjusted odds ratios (aORs)., Results: Of the 61,158 patients, 89% reported at least one dose of vaccine; of the vaccinated, 68% reported at least one booster. Vaccinated patients were less likely to have AIIRDs (44% vs 56%). A greater proportion of patients with AIIRDs were vaccine hesitant (14% vs 10%) and booster hesitant (21% vs 16%) compared to patients without AIIRDs. Safety concerns (28%) and side effects (23%) were the main reasons for vaccine hesitancy, whereas a lack of recommendation from the physician was the primary factor for booster hesitancy (23%). Patients with AIIRD did not have increased odds of self-reported flare or worsening disease compared to patients without with AIIRD (aOR 0.99, 95% confidence interval [CI] 0.94-1.05). Among the patients who were vaccine hesitant and booster hesitant, 12% and 39% later reported receiving a respective dose. Patients with AIIRD were 32% less likely to receive a vaccine (aOR 0.68, 95% CI 0.65-0.72) versus patients without AIIRD., Conclusion: Some patients who are vaccine and booster hesitant eventually receive a vaccine dose, and future interventions tailored to patients with AIIRD may be fruitful., (© 2023 American College of Rheumatology.)
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- 2024
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21. Sociodemographic profiles and organ damage accural in the Black Women's Experience Living with Lupus study.
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Martz CD, Webb-Detiege T, Danila MI, and Chae DH
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- Humans, Female, Racial Groups, Black or African American, Severity of Illness Index, Patient Acuity, Lupus Erythematosus, Systemic epidemiology, Lupus Erythematosus, Systemic complications
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Objective: Black/African American women with systemic lupus erythematosus (SLE) experience greater organ damage and at younger ages than white women. The objective of this study was to advance research on SLE inequities by identifying sociodemographic risk profiles associated with organ damage accrual specifically among Black/African American women., Methods: Latent profile analysis was conducted among 438 Black/African American women with SLE living in Atlanta, GA and enrolled in the Black Women's Experiences Living with Lupus (BeWELL) Study (May 2015 to April 2017). Proportional hazard and Poisson regression models examined prospective associations between sociodemographic profiles and the timing and degree of organ damage accrual over 2 years., Results: Four profiles emerged: (1) "Younger/Lower SES with Uncontrolled SLE" (44.8%), (2) "Older/Lower SES with Uncontrolled SLE" (23.3%), (3) "Mid-SES with Controlled SLE" (19.6%), and (4) "Higher SES with Controlled SLE" (11.2%). Approximately 42% of participants experienced new organ damage during the follow-up period. Proportional hazard models indicated that "Older/Lower SES with Uncontrolled SLE" participants were at greatest risk of new organ damage (HR = 2.41; 95% CI = 1.39, 4.19), followed by "Younger/Lower SES with Uncontrolled SLE" participants (HR = 1.56; 95% CI = 0.92, 2.67), compared to those in the "Higher SES with Controlled SLE" profile. Poisson regression models revealed that these two groups also exhibited greater organ damage accrual (b = 0.98, SE = 0.24, 95% CI = 0.52, 1.44 and b = 0.72, SE = 0.23, 95% CI = 0.27, 1.17, respectively)., Conclusions: Black/African American women with fewer socioeconomic resources and uncontrolled SLE are at greatest risk for increasing disease severity over time. Social inequities likely contribute to racial inequities in SLE progression., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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22. 2022 American College of Rheumatology Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis.
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Humphrey MB, Russell L, Danila MI, Fink HA, Guyatt G, Cannon M, Caplan L, Gore S, Grossman J, Hansen KE, Lane NE, Ma NS, Magrey M, McAlindon T, Robinson AB, Saha S, Womack C, Abdulhadi B, Charles JF, Cheah JTL, Chou S, Goyal I, Haseltine K, Jackson L, Mirza R, Moledina I, Punni E, Rinden T, Turgunbaev M, Wysham K, Turner AS, and Uhl S
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- Adult, Child, Humans, United States, Glucocorticoids adverse effects, Bone Density, Rheumatology, Osteoporosis chemically induced, Osteoporosis diagnosis, Osteoporosis drug therapy
- Abstract
Objective: The objective is to update recommendations for prevention and treatment of glucocorticoid-induced osteoporosis (GIOP) for patients with rheumatic or nonrheumatic conditions receiving >3 months treatment with glucocorticoids (GCs) ≥2.5 mg daily., Methods: An updated systematic literature review was performed for clinical questions on nonpharmacologic, pharmacologic treatments, discontinuation of medications, and sequential therapy. Grading of Recommendations Assessment, Development and Evaluation approach was used to rate the certainty of evidence. A Voting Panel achieved ≥70% consensus on the direction (for or against) and strength (strong or conditional) of recommendations., Results: For adults beginning or continuing >3 months of GC treatment, we strongly recommend as soon as possible after initiation of GCs, initial assessment of fracture risks with clinical fracture assessment, bone mineral density with vertebral fracture assessment or spinal x-ray, and Fracture Risk Assessment Tool if ≥40 years old. For adults at medium, high, or very high fracture risk, we strongly recommend pharmacologic treatment. Choice of oral or intravenous bisphosphonates, denosumab, or parathyroid hormone analogs should be made by shared decision-making. Anabolic agents are conditionally recommended as initial therapy for those with high and very high fracture risk. Recommendations are made for special populations, including children, people with organ transplants, people who may become pregnant, and people receiving very high-dose GC treatment. New recommendations for both discontinuation of osteoporosis therapy and sequential therapies are included., Conclusion: This guideline provides direction for clinicians and patients making treatment decisions for management of GIOP. These recommendations should not be used to limit or deny access to therapies., (© 2023 American College of Rheumatology. 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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- 2023
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23. Clinical Features Associated With Rate of Fractures in Patients With Systemic Sclerosis: A US Cohort Study.
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Rogers B, Famenini S, Perin J, Danila MI, Wipfler K, Michaud K, and McMahan ZH
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- Humans, Female, Middle Aged, Male, Cohort Studies, Risk Factors, Comorbidity, Scleroderma, Systemic complications, Scleroderma, Systemic diagnosis, Scleroderma, Systemic epidemiology, Osteoporotic Fractures diagnosis, Osteoporotic Fractures epidemiology, Osteoporotic Fractures etiology
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Objective: Systemic sclerosis (SSc) is associated with several specific risk factors for fracture due to the complications of the disease and related medications. The present study was undertaken to examine the relationship between SSc-associated clinical features and fracture rate in a large US cohort., Methods: Participants with SSc in FORWARD, The National Databank for Rheumatic Diseases, were included (1998-2019). Age- and sex-matched individuals with osteoarthritis (OA) from the same database were included as comparators. The primary end point was self-reported major osteoporotic fracture. Cox proportional hazards models were used to study the associations between risk factors and fractures., Results: The study included 922 individuals (SSc patients, n = 154; OA patients, n = 768). Eighty-seven percent were female, with a mean age of 57.8 years. Fifty-one patients developed at least 1 fracture during a median of 4.2 years (0.5-22.0 years) of follow-up. Patients with SSc had more frequent fractures compared to OA comparators (hazard ratio [HR] 2.38 [95% confidence interval (95% CI) 1.47-3.83]). Among patients with SSc, a higher Rheumatic Disease Comorbidity Index score (HR 1.45 [95% CI 1.20-1.75]) and a higher Health Assessment Questionnaire disability index score (HR 3.83 [95% CI 2.12-6.93]) were associated with more fractures. Diabetes mellitus (HR 5.89 [95% CI 2.51-13.82]) and renal disease (HR 2.43 [95% CI 1.10-5.37]) were independently associated with fracture among SSc patients relative to SSc patients without these comorbidities., Conclusion: Our findings highlight factors associated with fracture among patients with SSc. Disability as measured by the HAQ DI is a particularly strong indicator of fracture rate in SSc. Improving SSc patients' functional status, where possible, may lead to better long-term outcomes., (© 2023 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2023
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24. Development and Validation of an Emergency Department Electronic Medical Record Gout Flare Alert.
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Jackson LE, Annapureddy N, Hansen ME, Saag KG, Booth J, Rosas G, Foster PJ, Mudano A, Sun D, Osborne JD, Bongartz T, Hess E, Lawrence C, Dunkel L, and Danila MI
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- Humans, Electronic Health Records, Symptom Flare Up, Sensitivity and Specificity, Emergency Service, Hospital, Gout diagnosis, Gout epidemiology
- Abstract
Objective: Patients with acute gout are frequently treated in the emergency department (ED) and represent a typically underresourced and understudied population. A key limitation for gout research in the ED is the timely ability to identify acute gout patients. Our goal was to refine a multicriteria, electronic medical record alert for gout flares and to determine its diagnostic characteristics in the ED., Methods: The gout flare alert used electronic medical record data from ED nursing notes and was triggered by the term 'gout' preceding past medical history in the chief complaint, the term 'gout' and a musculoskeletal problem in the chief complaint, or the term 'gout' in the problem list and a musculoskeletal chief complaint. We validated its diagnostic properties to assess presence/absence of gout through manual medical record review using adjudicated expert consensus as the gold standard., Results: In January 2020, we analyzed 202 patient records from 2 university-based EDs; from these records, 57 patients were identified by our gout flare alert, and 145 were identified by other means as potentially having an acute gout flare. The gout flare alert's positive predictive value was 47% (95% confidence interval [95% CI] 34-60%), negative predictive value was 94% (95% CI 90-98%), sensitivity was 75% (95% CI 61-89%), and specificity was 82% (95% CI 76-88%). The diagnostic properties were similar at both institutions., Conclusion: Our multicomponent gout flare alert had reasonable sensitivity and specificity, albeit a modest positive predictive value. An electronic gout flare alert may help enable the conduct of gout research in the ED setting., (© 2022 American College of Rheumatology.)
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- 2023
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25. Balancing COVID-19 Risk With Physical and Mental Wellness: Perspectives of Patients With Autoimmune Rheumatic Diseases Throughout the Pandemic.
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Rapoport C, Wells C, Torres G, Ortiz-Maldonado R, Venkatachalam S, Stradford L, Gavigan K, Boyd-Floering B, Danila MI, Nowell WB, and Carandang K
- Abstract
Objective: Patients with autoimmune rheumatic diseases (ARDs) are at greater risk of COVID-19 infection and hospitalization, increasing the stress and uncertainty already associated with unpredictable conditions. These may be heightened for patients with ARDs from underrepresented minority backgrounds. This study aimed to explore patient experiences and ARD-related challenges during the first year of the pandemic., Methods: Between December 2020 and May 2021, 60-minute semistructured interviews were conducted with English- and Spanish-speaking adults, aged 18 years or older with self-reported diagnosis of ARD, via phone or videoconferencing using an interview guide on living with an ARD during the pandemic. Analysis combined methods of phenomenology and content analysis through three steps: 1) summarizing interviews, 2) iteratively refining units of meaning, and 3) axial and selective coding to determine cross-cutting themes. Study procedures were conducted by a multidisciplinary team, a majority also diagnosed with ARDs., Results: The research team interviewed 22 patients (39.8 ± 15.7 years old; 82.8% female; 31.8% Hispanic or Latino/a/x) with ARDs. Themes included 1) information access and understanding, 2) problem solving access to health care, 3) balancing risks, and 4) mental health implications. Within these themes, patients from underrepresented minority backgrounds faced unique challenges., Conclusion: Patients with ARDs require direct and timely communication about their risk of COVID-19 morbidity and mortality and require increased support for psychosocial and ARD-related implications of the pandemic. Health care systems must consider ways to support patients who are balancing chronic disease management with risk reduction for contracting emerging COVID-19 variants., (© 2023 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2023
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26. A multi-step approach to develop a "storytelling" intervention to improve patient gout knowledge and improve outpatient follow-up.
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Jackson LE, Saag KG, Chiriboga G, Lemon SC, Allison JJ, Mudano A, Rosas G, Foster PJ, and Danila MI
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Background: "Storytelling" interventions influence knowledge, attitudes and behavior to promote chronic disease management. We aimed to describe the development of a video "storytelling" intervention to increase gout knowledge and promote adherence to medications and follow-up care after an acute gout flare visit in the emergency department., Methods: We developed a direct-to-patient storytelling intervention to mitigate modifiable barriers to gout care and promote outpatient follow-up and medication adherence. We invited adult patients with gout as storytellers. We utilized a modified Delphi process involving gout experts to identify key themes to guide development of an intervention. Using a conceptual model, we selected stories to ensure delivery of evidence-based concepts and to maintain authenticity., Results: Our video-based storytelling intervention consisted of segments addressing modifiable barriers to gout care. Four diverse gout patients were recruited as storytellers and interviewed with questions that covered gout diagnosis and care. Eleven international gout experts from diverse geographic locations generated and ranked items they considered important messages to promote outpatient gout care follow-up and treatment adherence. Filmed videos were truncated into segments and coded thematically. Distinct segments that captured desired messages were combined to form a cohesive narrative story based on gout patient experiences that conveyed evidence-based strategies to manage gout., Conclusions: Using the Health Belief Model, we developed a culturally appropriate narrative intervention containing "storytelling" that can be tested as an approach to improve gout outcomes. The methods we describe may be generalizable to other chronic conditions requiring outpatient follow-up and medication adherence to improve outcomes., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 Published by Elsevier Inc.)
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- 2023
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27. Supporting International Medical Graduates in Rheumatology: A Call to Action.
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Fernandez-Ruiz R, Duarte-García A, Rolle NA, Sattui SE, Saygin D, Dowell S, Alexander SA, Kumar B, Danila MI, and Singh N
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- Humans, Career Choice, Emigrants and Immigrants, Rheumatology education
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- 2023
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28. Satisfaction with modes of telemedicine delivery during COVID-19: A randomized, single-blind, parallel group, noninferiority trial.
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Danila MI, Sun D, Jackson LE, Cutter G, Jackson EA, Ford EW, DeLaney E, Mudano A, Foster PJ, Rosas G, Melnick JA, Curtis JR, and Saag KG
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- Humans, Aged, United States, Adult, Female, Middle Aged, Male, Single-Blind Method, Personal Satisfaction, Medicare, COVID-19 epidemiology, Telemedicine methods
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Background: Little is known about satisfaction with different modes of telemedicine delivery. The objective of this study was to determine whether patient satisfaction with phone-only was noninferior to video visits., Methods: We conducted a parallel group, randomized (1:1), single-blind, noninferiority trial in multispecialty clinics at a tertiary academic medical center. Adults age ≥ 60 years or with Medicare/Medicaid insurance were eligible. Primary outcome was visit satisfaction rate (9 or 10 on a 0-10 satisfaction scale). Noninferiority was determined if satisfaction with phone-only (intervention) versus video visits (comparator) was no worse by a -15% prespecified noninferiority margin. We performed modified intent-to-treat (mITT) and per protocol analyses, after adjusting for age and insurance., Results: 200 participants, 43% Black, 68% women completed surveys. Visit satisfaction rates were high. In the mITT analysis, phone-only visits were noninferior by an adjusted difference of 3.2% (95% CI, -7.6% to 14%). In the per protocol analysis, phone-only were noninferior by an adjusted difference of -4.1% (95% CI, -14.8% to 6.6%). The proportion of participants who indicated they preferred the same type of telemedicine visit as their next clinic visit were similar (30.2% vs 27.9% video vs phone-only, p = 0.78) and a majority said their medical concerns were addressed and would recommend a telemedicine visit., Conclusions: Among a group of diverse, established older or underserved patients, the satisfaction rate for phone-only was noninferior to video visits. These findings could impact practice and policies governing telemedicine., Competing Interests: Declaration of Competing Interests The authors do not have any conflict of interest to disclose related to this work., (Published by Elsevier Inc.)
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- 2022
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29. Heavy Chain Constant Region Usage in Antibodies to Peptidylarginine Deiminase 4 as a Marker of Disease Subsets in Rheumatoid Arthritis.
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Gómez-Bañuelos E, Shi J, Wang H, Danila MI, Bridges SL Jr, Giles JT, Sims GP, Andrade F, and Darrah E
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- Humans, Protein-Arginine Deiminases, Protein-Arginine Deiminase Type 4, Autoantibodies, Biomarkers, Immunoglobulin G, Immunoglobulin E, Arthritis, Rheumatoid
- Abstract
Objective: The study of autoantibody isotypes in autoimmune diseases is useful for identifying clinically relevant endotypes. This study was undertaken to study the prevalence and clinical significance of different isotypes and IgG subclasses of anti-peptidylarginine deiminase 4 (anti-PAD4) autoantibodies in individuals with rheumatoid arthritis (RA)., Methods: In 196 RA subjects and 64 healthy controls, anti-PAD4 antibody types were determined using enzyme-linked immunosorbent assay. We investigated associations between anti-PAD4 antibodies and clinical outcomes, and relevant features were confirmed in an independent RA cohort., Results: Anti-PAD4 IgG1, anti-PAD4 IgG2, anti-PAD4 IgG3, anti-PAD4 IgG4, anti-PAD4 IgA, and anti-PAD4 IgE antibodies were more frequent in RA patients than healthy controls (P < 0.001). Anti-PAD4 IgG1, anti-PAD4 IgG3, and anti-PAD4 IgE were associated with distinct clinical features. Anti-PAD4 IgG1 was predictive of progressive radiographic joint damage (odds ratio [OR] 4.88, P = 0.005), especially in RA patients without baseline joint damage (40% versus 0%, P = 0.003) or in those negative for anti-cyclic citrullinated peptide and/or rheumatoid factor (OR 32; P = 0.009). IgG1 was also associated with higher levels of C-reactive protein (P = 0.006) and interleukin-6 (P = 0.021). RA patients with anti-PAD4 IgG3 had higher baseline joint damage scores (median Sharp/van der Heijde score 13 versus 7, P = 0.046), while those with anti-PAD4 IgE had higher Disease Activity Score in 28 joints (median 4.0 versus 3.5, P = 0.025), more frequent rheumatoid nodules (31% versus 16%, P = 0.025), and more frequent interstitial lung disease (ground-glass opacification) (24% versus 9%, P = 0.014). Anti-PAD4 IgG1 antibody associations with joint damage were corroborated in an independent RA cohort., Conclusion: Anti-PAD4 IgG1, anti-PAD4 IgG3, and anti-PAD4 IgE antibodies identify discrete disease subsets in RA, suggesting that heavy chain usage drives distinct effector mechanisms of anti-PAD4 antibodies in RA., (© 2022 American College of Rheumatology.)
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- 2022
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30. Telemedicine in rheumatology care: A systematic review.
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Jackson LE, Edgil TA, Hill B, Owensby JK, Smith CH, Singh JA, and Danila MI
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- Humans, Pandemics, Quality of Life, Autoimmune Diseases, COVID-19, Rheumatic Diseases diagnosis, Rheumatic Diseases therapy, Rheumatology, Telemedicine
- Abstract
Objective: The COVID-19 pandemic led to a sudden uptake of telemedicine in rheumatology. We analyzed the recent published literature on telemedicine for the diagnosis and management of inflammatory, non-inflammatory and/or autoimmune rheumatic diseases., Methods: We performed a registered systematic search (CRD42020202063) for interventional or observational studies published between August 2015 and January 2022. We included studies of telemedicine that reported outcomes (e.g., satisfaction, disease activity, quality of life) in ten or more people with rheumatic disease. Reviewers screened manuscripts, extracted data, and assessed bias., Results: Of the 2,988 potentially eligible studies, 36 reports were included: 27 observational studies, 7 randomized clinical trials, and 2 controlled clinical trials. Studies focused on general rheumatology (n = 18), rheumatoid arthritis (n = 9), gout (n = 3), osteoarthritis (n = 2), unspecified inflammatory arthritis (n = 1), osteoporosis (n = 2), and systemic lupus erythematosus (n = 1). Patient satisfaction with telemedicine was the most common reported outcome (n = 23) with majority of studies demonstrating high levels of satisfaction. Among interventional studies, the effect of telemedicine on the primary outcomes varied, with most finding that telemedicine was as good as usual / in-person care for disease activity control, patient satisfaction, total societal costs, and other patient reported outcomes. Effectiveness and feasibility were high across studies, though most demonstrated a high risk of bias. Meta-analysis was not feasible given the heterogeneity of interventions and outcome instruments utilized., Conclusion: Although the number of studies to date is low, telemedicine may be an effective mode to deliver care for people with rheumatic diseases. Most studies demonstrated limitations due to study design and risk of bias. Randomized clinical studies are needed to determine best uses of telemedicine for the diagnosis and management of rheumatic conditions., Competing Interests: Declaration of Competing Interests MD has received research support from Horizon and Pfizer for unrelated work. JS has received consultant fees from Crealta/Horizon, Medisys, Fidia, PK Med, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, Jupiter Life Science, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JAS owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JAS is on the speaker's bureau of Simply Speaking. JAS is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JAS serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS previously served as a member of the following committees: member, the American College of Rheumatology's (ACR) Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee and the co-chair of the ACR Criteria and Response Criteria subcommittee., (Copyright © 2022. Published by Elsevier Inc.)
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- 2022
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31. Environmental and societal factors associated with COVID-19-related death in people with rheumatic disease: an observational study.
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Izadi Z, Gianfrancesco MA, Schmajuk G, Jacobsohn L, Katz P, Rush S, Ja C, Taylor T, Shidara K, Danila MI, Wysham KD, Strangfeld A, Mateus EF, Hyrich KL, Gossec L, Carmona L, Lawson-Tovey S, Kearsley-Fleet L, Schaefer M, Al-Emadi S, Sparks JA, Hsu TY, Patel NJ, Wise L, Gilbert E, Duarte-García A, Valenzuela-Almada MO, Ugarte-Gil MF, Ljung L, Scirè CA, Carrara G, Hachulla E, Richez C, Cacoub P, Thomas T, Santos MJ, Bernardes M, Hasseli R, Regierer A, Schulze-Koops H, Müller-Ladner U, Pons-Estel G, Tanten R, Nieto RE, Pisoni CN, Tissera YS, Xavier R, Lopes Marques CD, Pileggi GCS, Robinson PC, Machado PM, Sirotich E, Liew JW, Hausmann JS, Sufka P, Grainger R, Bhana S, Gore-Massy M, Wallace ZS, and Yazdany J
- Abstract
Background: Differences in the distribution of individual-level clinical risk factors across regions do not fully explain the observed global disparities in COVID-19 outcomes. We aimed to investigate the associations between environmental and societal factors and country-level variations in mortality attributed to COVID-19 among people with rheumatic disease globally., Methods: In this observational study, we derived individual-level data on adults (aged 18-99 years) with rheumatic disease and a confirmed status of their highest COVID-19 severity level from the COVID-19 Global Rheumatology Alliance (GRA) registry, collected between March 12, 2020, and Aug 27, 2021. Environmental and societal factors were obtained from publicly available sources. The primary endpoint was mortality attributed to COVID-19. We used a multivariable logistic regression to evaluate independent associations between environmental and societal factors and death, after controlling for individual-level risk factors. We used a series of nested mixed-effects models to establish whether environmental and societal factors sufficiently explained country-level variations in death., Findings: 14 044 patients from 23 countries were included in the analyses. 10 178 (72·5%) individuals were female and 3866 (27·5%) were male, with a mean age of 54·4 years (SD 15·6). Air pollution (odds ratio 1·10 per 10 μg/m
3 [95% CI 1·01-1·17]; p=0·0105), proportion of the population aged 65 years or older (1·19 per 1% increase [1·10-1·30]; p<0·0001), and population mobility (1·03 per 1% increase in number of visits to grocery and pharmacy stores [1·02-1·05]; p<0·0001 and 1·02 per 1% increase in number of visits to workplaces [1·00-1·03]; p=0·032) were independently associated with higher odds of mortality. Number of hospital beds (0·94 per 1-unit increase per 1000 people [0·88-1·00]; p=0·046), human development index (0·65 per 0·1-unit increase [0·44-0·96]; p=0·032), government response stringency (0·83 per 10-unit increase in containment index [0·74-0·93]; p=0·0018), as well as follow-up time (0·78 per month [0·69-0·88]; p<0·0001) were independently associated with lower odds of mortality. These factors sufficiently explained country-level variations in death attributable to COVID-19 (intraclass correlation coefficient 1·2% [0·1-9·5]; p=0·14)., Interpretation: Our findings highlight the importance of environmental and societal factors as potential explanations of the observed regional disparities in COVID-19 outcomes among people with rheumatic disease and lay foundation for a new research agenda to address these disparities., Funding: American College of Rheumatology and European Alliance of Associations for Rheumatology., Competing Interests: MID reports research support from Pfizer for unrelated work. AS reports grants from a consortium of 13 companies (AbbVie, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Lilly, Mylan, Hexal, Merck, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB) supporting the German RABBIT register, and personal fees from lectures for AbbVie, Merck, Roche, Bristol Myers Squibb, and Pfizer, outside of the submitted work. EFM reports that the Portuguese League Against Rheumatic Diseases received support for specific activities: grants from Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal SA, Merck, Celgene, Medac, Pharmakern, the Global Alliance for Patient Access; grants and non-financial support from Pfizer; and non-financial support from Grünenthal GmbH, outside of the submitted work. KLH reports receiving speaker fees from Abbvie and grant income from Bristol Myers Squibb, UCB, and Pfizer, unrelated to this work. KLH is also supported by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre. LG reports research grants from Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, and Sanofi; and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, and UCB, all unrelated to this work. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, SA Pharma, Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi, Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH, and UCB Pharma. JAS has performed consultancy for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, Inova Diagnostics, Janssen, and Optum, unrelated to this work. LW has received consulting or speaking fees from Aurinia Pharma, outside of the submitted work. MFU-G reports grant or research support from Jannsen and Pfizer, unrelated to this work. The Swedish Rheumatology Quality Register, with LL as register holder, has agreements with Abbvie, Amgen, Eli Lilly, Gilead, Novartis, Pfizer, Sanofi, Sobi, and UCB for register data analyses, unrelated to this work. CR has received consulting or speaker fees from Abbvie, Amgen, AstraZeneca, BMS, Biogen, Eli Lilly, Glenmark, GlaxoSmithKline, Merck, Mylan, and Pfizer; and grants from Biogen, Lilly, and Nordic Pharma, all unrelated to this work. MJS has received speaker fees from Abbvie, AstraZeneca, Novartis, and Pfizer. AR has received speaker fees from Janssen, Pfizer, and Novartis. GP-E reports reports personal consulting fees, speaking fees, or both from Pfizer, GlaxoSmithKline, Janssen, Sandoz, and Sanofi, outside of the submitted work. PCR reports personal consulting fees, speaking fees, or both from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and travel assistance from Roche. PMM has received consulting fees, speaker fees, or both from Abbvie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, and UCB, unrelated to this work. PMM is supported by the NIHR University College London Hospitals Biomedical Research Centre. ES is a Board Member of the Canadian Arthritis Patient Alliance, a patient-run, volunteer-based organisation whose activities are largely supported by independent grants from pharmaceutical companies. JWL has received research funding from Pfizer, outside of the submitted work. JSH is supported by grants from the Rheumatology Research Foundation and has salary support from the Childhood Arthritis and Rheumatology Research Alliance. JSH has performed consulting for Novartis, Sobi, and Biogen, unrelated to this work. PS reports honorarium for doing social media for American College of Rheumatology journals. RG reports personal fees, speaking fees, or both from Abbvie, Janssen, Novartis, Pfizer, and Cornerstones; and travel assistance from Pfizer. SB reports non-branded consulting fees for AbbVie, Horizon, and Novartis; and is employed by Pfizer. ZSW reports grant support from Bristol Myers Squibb and Principia–Sanofi; and performed consultancy for Viela Bio and MedPace, outside of the submitted work. ZSW's work is supported by grants from the National Institutes of Health. JY has performed consulting for Eli Lilly, Pfizer, Aurinia, and AstraZeneca, outside of the submitted work. All other authors declare no competing interests., (Published by Elsevier Ltd.)- Published
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32. Patient Perceptions and Preferences Regarding Telemedicine for Autoimmune Rheumatic Diseases Care During the COVID-19 Pandemic.
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Danila MI, Gavigan K, Rivera E, Nowell WB, George MD, Curtis JR, Christopher-Stein L, Banerjee S, Merkel PA, Young K, Shaw DG, Gordon J, and Venkatachalam S
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- Aged, Female, Humans, Middle Aged, Pandemics, Patient Satisfaction, Telephone, COVID-19 epidemiology, Rheumatic Diseases diagnosis, Rheumatic Diseases therapy, Telemedicine
- Abstract
Objective: To assess the perceptions and preferences of telemedicine among patients with autoimmune rheumatic diseases during the COVID-19 pandemic., Methods: We conducted an online survey among patients with autoimmune rheumatic diseases. Attitudes about telemedicine (i.e., telemedicine acceptability), evaluated using the validated Telemedicine Perception Questionnaire (TMPQ), and visit satisfaction were assessed for different telemedicine experiences and types of autoimmune rheumatic disease., Results: Of 3,369 invitations, 819 responses were received. Participants had a mean ± SD age of 58.6 ± 11.6 years and were mostly White (n = 759, or 92.7%) and female (n = 702, or 85.7%). Of the 618 participants who said that telemedicine was available to them, 449 (72.7%) reported having a telemedicine visit, with 303 (67.5%) reporting attending a telemedicine video visit. On a 0 to 10 scale, the mean ± SD visit satisfaction score was 7.3 ± 1.8, with 25.8% of respondents being very satisfied (scores of 9 or 10). Video visits and higher TMPQ scores were associated with higher satisfaction. Compared to those who did not experience a telemedicine visit, patients who did were more likely to prefer telemedicine (video or phone) for routine visits (73.7% versus 44.3%; P < 0.001), reviewing test results (64.8% versus 53.8%; P < 0.001), when considering changing medications (40.5% versus 26.8%; P < 0.001), and when starting a new injectable medication (18.9% versus 12.7%; P = 0.02)., Conclusion: During the COVID-19 pandemic, patients with autoimmune rheumatic diseases frequently had telemedicine visits, with the majority held via video, and were satisfied with these visits. These results suggest that because patients prefer telemedicine for certain visit reasons, maximizing effective use of telemedicine will require personalized patient scheduling., (© 2022 American College of Rheumatology.)
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- 2022
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33. COVID-19 vaccine uptake and vaccine hesitancy in rheumatic disease patients receiving immunomodulatory therapies in community practice settings.
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Ledbetter SS, Xie F, Cutter G, Saag KG, Jackson L, Danila MI, Stewart P, George M, Nowell WB, Mikuls T, Winthrop K, and Curtis JR
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- COVID-19 Vaccines, Humans, Immunomodulation, Vaccination, Vaccination Hesitancy, COVID-19 prevention & control, Rheumatic Diseases drug therapy
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- 2022
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34. Experience with telemedicine among rheumatology clinicians during the COVID-19 pandemic: an international survey.
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Chock EY, Putman M, Conway R, Danila MI, Hoyer B, Hsieh E, Jayatilleke A, Kilian A, Leipe J, Liew JW, Machado PM, Robinson PC, Singh N, Ung N, Yeoh SA, Wallace ZS, Grainger R, and Cappelli LC
- Abstract
Objective: The aim was to assess rheumatology clinicians' perceptions of telemedicine and their experiences before and during the coronavirus disease 2019 (COVID-19) pandemic., Methods: We conducted a cross-sectional online survey and collected responses from rheumatology clinicians worldwide, between November 2020 and February 2021, regarding use and perceptions of telemedicine in rheumatology. We summarized data with descriptive statistics and qualitative analysis for free-text responses., Results: The survey was completed by 349 rheumatology clinicians from 49 countries; 59% were female and about two-thirds were in the 30-50 years age group. Academic affiliations were held by 55% of participants, and 44% were from North America. Before the pandemic, 24% of participants had experience with telemedicine, whereas about three-quarters used telemedicine for the first time during the pandemic. Overall, 56% thought they provided less adequate care with telemedicine. More than half of clinicians felt that telemedicine was adequate for evaluating crystalline arthritis, inflammatory arthritis and lupus flares. Telemedicine was felt to be inadequate for flares of myositis, vasculitis and scleroderma. Technical problems were reported in 29% of telemedicine encounters and were most commonly related to patient-encountered difficulties., Conclusion: Most rheumatology clinicians used telemedicine for the first time during the pandemic. The quality of care provided was thought to be inferior to that provided in person for specific clinical situations. Additional efforts are needed to address barriers to effective telemedicine, such as patient-related technology issues, challenges with building rapport and performing a physical examination, and to define the appropriate scope of clinical scenarios conducive to telemedicine., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2022
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35. Healthcare disparities in telemedicine for rheumatology care.
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Jackson LE and Danila MI
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- Ethnicity, Healthcare Disparities, Humans, Minority Groups, Pandemics, COVID-19 epidemiology, Rheumatology, Telemedicine
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Purpose of Review: We summarize the recent literature published in the last 2 years on healthcare disparities observed in the delivery of rheumatology care by telemedicine. We highlight recent research dissecting the underpinnings of healthcare disparities and identify potentially modifiable contributing factors., Recent Findings: The COVID-19 pandemic has had major impacts on care delivery and has led to a pronounced increase in telemedicine use in rheumatology practice. Telemedicine services are disproportionately underutilized by racial/ethnic minority groups and among patients with lower socioeconomic status. Disparities in telemedicine access and use among vulnerable populations threatens to exacerbate existing outcome inequalities affecting people with rheumatic disease., Summary: Telemedicine has the potential to expand rheumatology services by reaching traditionally underserved communities. However, some areas lack the infrastructure and technology to engage in telemedicine. Addressing health equity and the digital divide may help foster more inclusive telemedicine care., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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36. Medication Interruptions and Subsequent Disease Flares During the COVID-19 Pandemic: A Longitudinal Online Study of Patients With Rheumatic Disease.
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Dharia T, Venkatachalam S, Baker JF, Banerjee S, Curtis D, Danila MI, Gavigan K, Gordon J, Merkel PA, Shaw DG, Young K, Curtis JR, Nowell WB, and George MD
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- Female, Humans, Longitudinal Studies, Male, Middle Aged, Pandemics, Symptom Flare Up, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid diagnosis, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, COVID-19 epidemiology, Vasculitis drug therapy
- Abstract
Objective: We aimed to assess trends in anxiety and interruptions in disease-modifying antirheumatic drug (DMARD) use among patients with rheumatic diseases during the COVID-19 pandemic and to evaluate whether DMARD interruptions were associated with disease flares., Methods: ArthritisPower, the Vasculitis Patient-Powered Research Network, and other patient organizations invited members to join a 52-week longitudinal study, with baseline surveys completed March 29 to June 30, 2020, with follow-up through May 2021. Logistic regression incorporating generalized estimating equations evaluated associations between interruptions in DMARD use and self-reported disease flares at the next survey, adjusting for demographic characteristics, medications, disease, and calendar time., Results: Among 2,424 patients completing a median of 5 follow-up surveys, the mean age was 57 years, 87% were female, and the most common conditions were rheumatoid arthritis, vasculitis, and psoriatic arthritis. Average Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety T scores decreased from April 2020 (58.7) to May 2021 (53.7) (P < 0.001 for trend). Interruptions in DMARD use decreased from April (11.2%) to December 2020 (7.5%) (P < 0.001) but increased through May 2021 (14.0%) (P < 0.001). Interruptions in DMARD use were associated with a significant increase in severe flares (rated ≥6 of 10) at the next survey (12.9% versus 8.0% [odds ratio (OR) 1.71 (95% confidence interval [95% CI 1.23, 2.36]) although not any flare (OR 1.18 [95% CI 0.89, 1.58])]., Conclusion: Anxiety and interruptions in DMARD use initially decreased over time, but DMARD interruptions increased during 2021, possibly related to an increase in COVID-19 cases or vaccine availability. Interruptions in DMARD use were associated with increased rates of severe disease flares, highlighting the importance of avoiding unnecessary DMARD interruptions., (© 2021 American College of Rheumatology.)
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- 2022
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37. Integration of stakeholder engagement from development to dissemination in genomic medicine research: Approaches and outcomes from the CSER Consortium.
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O'Daniel JM, Ackerman S, Desrosiers LR, Rego S, Knight SJ, Mollison L, Byfield G, Anderson KP, Danila MI, Horowitz CR, Joseph G, Lamoure G, Lindberg NM, McMullen CK, Mittendorf KF, Ramos MA, Robinson M, Sillari C, and Madden EB
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- Genomics, Humans, Population Groups, Research Design, Genomic Medicine, Stakeholder Participation
- Abstract
Purpose: There is a critical need for genomic medicine research that reflects and benefits socioeconomically and ancestrally diverse populations. However, disparities in research populations persist, highlighting that traditional study designs and materials may be insufficient or inaccessible to all groups. New approaches can be gained through collaborations with patient/community stakeholders. Although some benefits of stakeholder engagement are recognized, routine incorporation into the design and implementation of genomics research has yet to be realized., Methods: The National Institutes of Health-funded Clinical Sequencing Evidence-Generating Research (CSER) consortium required stakeholder engagement as a dedicated project component. Each CSER project planned and carried out stakeholder engagement activities with differing goals and expected outcomes. Examples were curated from each project to highlight engagement strategies and outcomes throughout the research lifecycle from development through dissemination., Results: Projects tailored strategies to individual study needs, logistical constraints, and other challenges. Lessons learned include starting early with engagement efforts across project stakeholder groups and planned flexibility to enable adaptations throughout the project lifecycle., Conclusion: Each CSER project used more than 1 approach to engage with relevant stakeholders, resulting in numerous adaptations and tremendous value added throughout the full research lifecycle. Incorporation of community stakeholder insight improves the outcomes and relevance of genomic medicine research., Competing Interests: Conflict of Interest The authors declare no conflict of interest., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2022
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38. Evaluation of an Intervention to Support Patient-Rheumatologist Conversations About Escalating Treatment in Patients with Rheumatoid Arthritis: A Proof-of-Principle Study.
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Danila MI, Chen L, Ruderman EM, Owensby JK, O'Beirne R, Melnick JA, Harrold LR, Curtis D, Nowell WB, and Curtis JR
- Abstract
Objective: This study's objective was to test whether an online video intervention discussing appropriate treatment escalation improves willingness to change treatment in people living with rheumatoid arthritis (RA)., Methods: We conducted a controlled, randomized trial among patients with RA enrolled in ArthritisPower, a United States patient registry. We recruited participants by email and surveyed their assessment of disease activity (patient global), satisfaction with disease control (patient acceptable symptom state), attitudes about RA medications, decisional conflict (decisional conflict scale), and willingness to modify RA treatment (choice predisposition scale, higher scores are better) if or when recommended by their rheumatologist. Intervention groups watched educational videos relevant to a treat-to-target (T2T) strategy, whereas control groups viewed vaccination-related videos as an "attention control." We compared the between-group difference in patients' willingness to modify RA treatment (primary outcome) and difference in decisional conflict about changing RA treatment (secondary outcome) after watching the videos using t tests., Results: Participants with self-reported RA (n = 208) were 90% White and 90% women, with a mean (standard deviation) age of 50 (11) years, and 52% reported familiarity with the RA T2T strategy. We found a significant improvement in between-group difference in willingness to change RA treatment among intervention versus control participants (0.49 [95% confidence interval 0.09-0.88], P = 0.02). The effect size (Glass's delta) for the intervention was 0.48. Decisional conflict about treatment change decreased, but the between-group difference was not significant., Conclusion: This novel educational patient-directed intervention discussing appropriate treatment escalation was associated with improved willingness to change RA treatment if or when recommended by a rheumatologist. Further studies should evaluate whether this change in patients' predisposition translates into actual treatment escalation., (© 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2022
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39. Osteoporosis in 10 years time: a glimpse into the future of osteoporosis.
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Adami G, Fassio A, Gatti D, Viapiana O, Benini C, Danila MI, Saag KG, and Rossini M
- Abstract
Patients living with osteoporosis are projected to increase dramatically in the next decade. Alongside the forecasted increased societal and economic burden, we will live a crisis of fractures. However, we will have novel pharmacological treatment to face this crisis and, more importantly, new optimized treatment strategies. Fracture liaison services will be probably implemented on a large scale worldwide, helping to prevent additional fractures in high-risk patients. In the next decade, novel advances in the diagnostic tools will be largely available. Moreover, new and more precise fracture risk assessment tools will change our ability to detect patients at high risk of fractures. Finally, big data and artificial intelligence will help us to move forward into the world of precision medicine. In the present review, we will discuss the future epidemiology and costs of osteoporosis, the advances in early and accurate diagnosis of osteoporosis, with a special focus on biomarkers and imaging tools. Then we will examine new and refined fracture risk assessment tools, the role of fracture liaison services, and a future perspective on osteoporosis treatment., Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: G.A. reports personal fees from Theramex and Galapagos outside the submitted work. A.F. reports personal fees from Abiogen, Novartis, and Neopharmed, outside the submitted work. D.G. has received advisory board honoraria, consultancy fees, and/or speaker fees from Abiogen, Celgene, Eli-Lilly, Neopharmed-Gentili, Pfizer, and UCB. M.I.D. reports research grants from Pfizer and Horizon. K.G.S. reports research grants from Amgen, Mereo, and Radius and has received consultancy fees from Amgen, outside the submitted work. O.V. has received advisory board honoraria and speaker fees from Gilead, Fresenius Kabi, Biogen, Ely-Lilly, UCB, AbbVie, MSD, and BMS. M.R. reports advisory board honoraria, consultancy fees, and/or speaker fees from AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Galapagos, Theramex, and UCB, outside the submitted work., (© The Author(s), 2022.)
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- 2022
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40. Education and Training of Non-Genetics Providers on the Return of Genome Sequencing Results in a NICU Setting.
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East KM, Cochran ME, Kelley WV, Greve V, Finnila CR, Coleman T, Jennings M, Alexander L, Rahn EJ, Danila MI, Barsh G, Korf B, and Cooper G
- Abstract
To meet current and expected future demand for genome sequencing in the neonatal intensive care unit (NICU), adjustments to traditional service delivery models are necessary. Effective programs for the training of non-genetics providers (NGPs) may address the known barriers to providing genetic services including limited genetics knowledge and lack of confidence. The SouthSeq project aims to use genome sequencing to make genomic diagnoses in the neonatal period and evaluate a scalable approach to delivering genome sequencing results to populations with limited access to genetics professionals. Thirty-three SouthSeq NGPs participated in a live, interactive training intervention and completed surveys before and after participation. Here, we describe the protocol for the provider training intervention utilized in the SouthSeq study and the associated impact on NGP knowledge and confidence in reviewing, interpreting, and using genome sequencing results. Participation in the live training intervention led to an increased level of confidence in critical skills needed for real-world implementation of genome sequencing. Providers reported a significant increase in confidence level in their ability to review, understand, and use genome sequencing result reports to guide patient care. Reported barriers to implementation of genome sequencing in a NICU setting included test cost, lack of insurance coverage, and turn around time. As implementation of genome sequencing in this setting progresses, effective education of NGPs is critical to provide access to high-quality and timely genomic medicine care.
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- 2022
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41. Validation of an algorithm to identify incident interstitial lung disease in patients with rheumatoid arthritis.
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Meehan M, Shah A, Lobo J, Oates J, Clinton C, Annapureddy N, Xie F, Zhuo J, Danila MI, England BR, and Curtis JR
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- Aged, Algorithms, Cohort Studies, Humans, Medicare, United States, Arthritis, Rheumatoid complications, Arthritis, Rheumatoid diagnosis, Arthritis, Rheumatoid epidemiology, Lung Diseases, Interstitial diagnosis, Lung Diseases, Interstitial epidemiology
- Abstract
Background/purpose: Interstitial lung disease (ILD) is an important problem for patients with rheumatoid arthritis (RA). However, current approaches to ILD case finding in real-world data have been evaluated only in limited settings and identify only prevalent ILD and not new-onset disease. Our objective was to develop, refine, and validate a claims-based algorithm to identify both prevalent and incident ILD in RA patients compared to the gold standard of medical record review., Methods: We used administrative claims data 2006-2015 from Medicare to derive a cohort of RA patients. We then identified suspected ILD using variations of ILD algorithms to classify both prevalent and incident ILD based on features of the data that included hospitalization vs. outpatient setting, physician specialty, pulmonary-related diagnosis codes, and exclusions for potentially mimicking pulmonary conditions. Positive predictive values (PPV) of several ILD algorithm variants for both prevalent and incident ILD were evaluated., Results: We identified 234 linkable RA patients with sufficient data to evaluate for ILD. Overall, 108 (46.2%) of suspected cases were confirmed as ILD. Most cases (64%) were diagnosed in the outpatient setting. The best performing algorithm for prevalent ILD had a PPV of 77% (95% CI 67-84%) and for incident ILD was 96% (95% CI 85-100%)., Conclusion: Case finding in administrative data for both prevalent and incident interstitial lung disease in RA patients is feasible and has reasonable accuracy to support population-based research and real-world evidence generation., (© 2021. The Author(s).)
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- 2022
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42. Remote Management of Osteoporosis.
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Saag JL and Danila MI
- Abstract
Purpose of Review: Osteoporosis management has evolved significantly over the past decade, with telehealth emerging as an effective tool to manage bone health in a growing patient population. This review explores the advantages and disadvantages of telehealth use for osteoporosis management while highlighting recent studies of clinical importance., Recent Findings: A wide variety of telehealth approaches are used today, from phone or video telemedicine appointments with physicians and advanced practice providers, to electronic systems for triage and consultation with osteoporosis specialists. Contemporary studies show that telehealth can facilitate health care access to underserved communities and enhance physician-patient communication, as well as provide patient education. However, barriers such as inexperience or lack of access to technology, suboptimal patient-clinician relationship building process, and difficulties with follow-up have limited the use of telehealth to certain situations., Summary: Telehealth has proven to be an effective resource for managing and treating osteoporosis patients. As its use continues to grow, important limitations must be accounted for to avoid lapses in care. Further research should keep these factors in mind as the use of this technology progresses., Competing Interests: Conflict of interestJordan Saag declares no conflicts of interest. Maria I. Danila declares no conflicts of interest., (© This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2022.)
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- 2022
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43. The Development of the Rheumatology Informatics System for Effectiveness Learning Collaborative for Improving Patient-Reported Outcome Collection and Patient-Centered Communication in Adult Rheumatology.
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Subash M, Liu LH, DeQuattro K, Choden S, Jacobsohn L, Katz P, Bajaj P, Barton JL, Bartels C, Bermas B, Danila MI, Downey C, Ferguson S, Reiter K, Wahl E, Weinstein E, Zell J, Schmajuk G, and Yazdany J
- Abstract
Objective: Patient-reported outcomes (PROs) are an integral part of treat-to-target approaches in managing rheumatoid arthritis (RA). In clinical practice, however, routine collection, documentation, and discussion of PROs with patients are highly variable. The RISE LC (Rheumatology Informatics System for Effectiveness Learning Collaborative) was established to develop and share best practices in PRO collection and use across adult rheumatology practices in the United States METHODS: The goals of the RISE LC were developed through site surveys and in-person meetings. Participants completed a baseline survey on PRO collection and use in their practices. RISE LC learning sessions focused on improving communication around PROs with patients and enhancing shared decision-making in treatment plans. During the coronavirus disease 2019 (COVID-19) pandemic, the RISE LC pivoted to adapt PRO tools for telehealth., Results: At baseline, all responding sites (n = 15) had established workflows for collecting PROs. Most sites used paper forms alone. PRO documentation in electronic health records was variable, with only half of the sites using structured data fields. To standardize and improve the use of PROs, participants iteratively developed a Clinical Disease Activity Index-based RA Disease Activity Communication Tool to solicit treatment goals and improve shared decision-making across sites. The COVID-19 pandemic necessitated developing a tool to gauge PROs via telehealth., Conclusion: The RISE LC is a continuous, structured method for implementing strategies to improve PRO collection and use in rheumatological care, initially adapting from the Learning Collaborative model and extending to include features of a learning network. Future directions include measuring the impact of standardized PRO collection and discussion on shared decision-making and RA outcomes., (© 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2021
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44. Disruptions in Rheumatology Care and the Rise of Telehealth in Response to the COVID-19 Pandemic in a Community Practice-Based Network.
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George MD, Danila MI, Watrous D, Reddy S, Alper J, Xie F, Nowell WB, Kallich J, Clinton C, Saag KG, and Curtis JR
- Subjects
- Adult, Aged, COVID-19 prevention & control, Delivery of Health Care trends, Female, Follow-Up Studies, Humans, Longitudinal Studies, Male, Middle Aged, COVID-19 epidemiology, Community Health Services trends, Office Visits trends, Patient Acceptance of Health Care, Rheumatology trends, Telemedicine trends
- Abstract
Objective: The effect of the COVID-19 pandemic on community-based rheumatology care and the use of telehealth is unclear. We undertook this study to investigate the impact of the pandemic on rheumatology care delivery in a large community practice-based network., Methods: Using a community practice-based rheumatologist network, we examined trends in in-person versus telehealth visits versus canceled visits in 3 time periods: pre-COVID-19, COVID-19 transition (6 weeks beginning March 23, 2020), and post-COVID-19 transition (May-August). In the transition period, we compared patients who received in-person care versus telehealth visits versus those who cancelled all visits. We used multivariable logistic regression to identify factors associated with canceled or telehealth visits., Results: Pre-COVID-19, there were 7,075 visits/week among 60,002 unique rheumatology patients cared for by ~300 providers practicing in 92 offices. This number decreased substantially (24.6% reduction) during the COVID-19 transition period for in-person visits but rebounded to pre-COVID-19 levels during the post-COVID-19 transition. There were almost no telehealth visits pre-COVID-19, but telehealth increased substantially during the COVID-19 transition (41.4% of all follow-up visits) and slightly decreased during the post-COVID-19 transition (27.7% of visits). Older age, female sex, Black or Hispanic race/ethnicity, lower socioeconomic status, and rural residence were associated with a greater likelihood of canceling visits. Most factors were also associated with a lower likelihood of having telehealth versus in-office visits. Patients living further from the rheumatologists' office were more likely to use telehealth., Conclusion: COVID-19 led to large disruptions in rheumatology care; these disruptions were only partially offset by increases in telehealth use and disproportionately affected racial/ethnic minorities and patients with lower socioeconomic status. During the COVID-19 era, telehealth continues to be an important part of rheumatology practice, but disparities in access to care exist for some vulnerable groups., (© 2021, American College of Rheumatology.)
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- 2021
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45. Reducing Immunogenicity of Pegloticase With Concomitant Use of Mycophenolate Mofetil in Patients With Refractory Gout: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.
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Khanna PP, Khanna D, Cutter G, Foster J, Melnick J, Jaafar S, Biggers S, Rahman AKMF, Kuo HC, Feese M, Kivitz A, King C, Shergy W, Kent J, Peloso PM, Danila MI, and Saag KG
- Subjects
- Double-Blind Method, Drug Therapy, Combination, Female, Gout immunology, Gout Suppressants immunology, Humans, Male, Middle Aged, Mycophenolic Acid immunology, Proof of Concept Study, Treatment Outcome, Urate Oxidase immunology, Adaptive Immunity drug effects, Gout drug therapy, Gout Suppressants administration & dosage, Mycophenolic Acid administration & dosage, Polyethylene Glycols administration & dosage, Urate Oxidase administration & dosage
- Abstract
Objective: Pegloticase is used for the treatment of severe gout, but its use is limited by immunogenicity. This study was undertaken to evaluate whether mycophenolate mofetil (MMF) prolongs the efficacy of pegloticase., Methods: Participants were randomized 3:1 to receive 1,000 mg MMF twice daily or placebo for 14 weeks, starting 2 weeks before receiving pegloticase and continuing while receiving intravenous pegloticase 8 mg biweekly for 12 weeks. Participants then received pegloticase alone from week 12 to week 24. The primary end points were the proportion of patients who sustained a serum urate level of ≤6 mg/dl at 12 weeks and the rate of adverse events (AEs). Secondary end points included 24-week durability of serum urate level ≤6 mg/dl. Fisher's exact test and Wilcoxon's 2-sample test were used for analyses, along with Kaplan-Meier estimates and log rank tests., Results: A total of 32 participants received ≥1 dose of pegloticase. Participants were predominantly men (88%), with a mean age of 55.2 years, mean gout duration of 13.4 years, and mean baseline serum urate level of 9.2 mg/dl. At 12 weeks, a serum urate level of ≤6 mg/dl was achieved in 19 (86%) of 22 participants in the MMF arm compared to 4 (40%) of 10 in the placebo arm (P = 0.01). At week 24, the serum urate level was ≤6 mg/dl in 68% of MMF-treated patients versus 30% of placebo-treated patients (P = 0.06), and rates of AEs were similar between groups, with more infusion reactions occurring in the placebo arm (30% versus 0%)., Conclusion: Our findings indicate that MMF therapy with pegloticase is well tolerated and shows a clinically meaningful improvement in targeted serum urate level of ≤6 mg/dl at 12 and 24 weeks. This study suggests an innovative approach to pegloticase therapy in gout., (© 2021, American College of Rheumatology.)
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- 2021
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46. Use of path modeling to inform a clinical decision support application to encourage osteoporosis medication use.
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Miller MJ, Jou T, Danila MI, Mudano AS, Rahn EJ, Outman RC, and Saag KG
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- Aged, Female, Humans, Medication Adherence, Trust, Decision Support Systems, Clinical, Fractures, Bone, Health Literacy, Osteoporosis drug therapy
- Abstract
Background: Osteoporosis medication use is suboptimal. Simple interventions personalized to a patients' stage of readiness are needed to encourage osteoporosis medication use., Objectives: To estimate interrelationships of sociodemographic factors, perceived fracture risk, health literacy, receipt of medication information, medication trust and readiness to use osteoporosis medication; and apply observed relationships to inform design specifications for a clinical decision support application that can be used for personalized patient counseling., Methods: Data from a national sample of older women (n = 1759) with self-reported history of fractures and no current use of osteoporosis medication treatment were used to estimate an acceptable path model that describes associations among key sociodemographic characteristics, health literacy, perceived fracture risk, receipt of osteoporosis medication information within the past year, trust in osteoporosis medications, and readiness to use osteoporosis medication. Path model results were used to inform an application for personalized patient counseling that can be easily integrated into clinical decision support systems., Results: Increased age (β = 0.13), trust for medications (β = 0.12), higher perceived fracture risk (β = 0.21), and having received medication information within the past year (β = 0.21) were all positively associated with readiness to use osteoporosis medication (p < 0.0001). Whereas, health literacy (β = -0.09) was inversely associated with readiness to use osteoporosis medication (p < 0.0001). Using these results, a brief 6-item question set was constructed for simple integration into clinical decision support applications. Patient responses were used to inform a provider dashboard that integrates a patient's stage of readiness for osteoporosis medication use, predictors of readiness, and personalized counseling points appropriate to their stage of readiness., Conclusion: Content of counseling strategies must be aligned with a patient's stage of readiness to use treatment. Path modeling can be effectively used to identify factors for inclusion in an evidenced-based clinical decision support application designed to assist providers with personalized patient counseling and osteoporosis medication use decisions., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2021
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47. Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research.
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Danila MI, Allison JJ, Goins KV, Chiriboga G, Fischer M, Puliafico M, Mudano AS, Rahn EJ, Merchant J, Lawrence CE, Dunkel L, Israel T, Barton B, Jenoure F, Alexander T, Cruz D, Douglas M, Sims J, Richmond A, Roberson ED, Chambless C, Harris PA, Saag KG, and Lemon SC
- Abstract
Introduction: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups., Methods: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components., Results: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process., Conclusions: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants., Competing Interests: The authors have no conflicts of interest to declare., (© The Association for Clinical and Translational Science 2021.)
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- 2021
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48. Social Distancing, Health Care Disruptions, Telemedicine Use, and Treatment Interruption During the COVID-19 Pandemic in Patients With or Without Autoimmune Rheumatic Disease.
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George MD, Baker JF, Banerjee S, Busch H, Curtis D, Danila MI, Gavigan K, Kirby D, Merkel PA, Munoz G, Nowell WB, Stewart P, Sunshine W, Venkatachalam S, Xie F, and Curtis JR
- Abstract
Background: We aimed to compare concerns, social distancing, health care disruptions, and telemedicine use in patients with autoimmune rheumatic disease (ARD) and non-ARD and to evaluate factors associated with immunomodulatory medication interruptions., Methods: Patients in a multistate community rheumatology practice network completed surveys from April 2020 to May 2020. Adults with common ARD (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus) or non-ARD (gout, osteoarthritis, osteoporosis) were evaluated. Concerns about coronavirus disease 2019 (COVID-19), social distancing, health care disruptions, and telemedicine use were compared in patients with ARD versus non-ARD, adjusting for demographics, rural residence, and zipcode-based measures of socioeconomic status and COVID-19 activity. Factors associated with medication interruptions were assessed in patients with ARD., Results: Surveys were completed by 2319/36 193 (6.4%) patients with non-ARD and 6885/64 303 (10.7%) with ARD. Concerns about COVID-19 and social distancing behaviors were similar in both groups, although patients receiving a biologic or Janus kinase (JAK) inhibitor reported greater concerns and were more likely to avoid friends/family, stores, or leaving the house. Patients with ARD were less likely to avoid office visits (45.2% vs. 51.0%, odds ratio [OR] 0.79 [0.70-0.89]) with similar telemedicine use. Immunomodulatory medications were stopped in 9.7% of patients with ARD, usually (86.9%) without a physician recommendation. Compared with patients with an office visit, the likelihood of stopping medication was higher for patients with a telemedicine visit (OR 1.54 [1.19-1.99]) but highest for patients with no visits (OR 2.26 [1.79-2.86])., Conclusion: Patients with ARD and non-ARD reported similar concerns about COVID-19 and similar social distancing behaviors. Missed office visits were strongly associated with interruptions in immunomodulatory medication., (© 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2021
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49. Concerns, Healthcare Use, and Treatment Interruptions in Patients With Common Autoimmune Rheumatic Diseases During the COVID-19 Pandemic.
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George MD, Venkatachalam S, Banerjee S, Baker JF, Merkel PA, Gavigan K, Curtis D, Danila MI, Curtis JR, and Nowell WB
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- Adult, Aged, Delivery of Health Care, Female, Humans, Male, Middle Aged, Pandemics, Patient Acceptance of Health Care statistics & numerical data, United States, Antirheumatic Agents therapeutic use, COVID-19, Rheumatic Diseases drug therapy, Rheumatic Diseases epidemiology
- Abstract
Objective: To assess concerns and healthcare-related behaviors of patients with autoimmune rheumatic diseases during the coronavirus disease 2019 (COVID-19) pandemic., Methods: Adults from the United States with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and systemic lupus erythematosus (SLE) from the ArthritisPower Patient-Powered Research Network and CreakyJoints patient community completed surveys. Concerns and behaviors were compared among patients with different autoimmune conditions, disease-modifying antirheumatic drug (DMARD) use, and geographic measures of urban status, income, education, and COVID-19 activity., Results: Among 1517 participants (925 RA, 299 PsA, 185 AS, 108 SLE), mean age was 55.1 years, 88.3% were female, and 89.5% were White. COVID-19 concerns were similar across the country and were higher in biologic users ( P < 0.001). Avoidance of doctor's office visits (56.6%) or laboratory testing (42.3%) and use of telehealth (29.5%) were more common in urban areas. Among participants receiving a DMARD without COVID-19 or other respiratory illness, 14.9% stopped a DMARD, with 78.7% of DMARD interruptions not recommended by a physician. DMARD stopping was more common in participants with lower socioeconomic status (SES) and in participants who avoided an office visit (OR 1.46, 95% CI 1.04-2.04) or reported lack of telehealth availability OR 2.26 (95% CI 1.25-4.08)., Conclusion: In the early months of the COVID-19 pandemic, patients with RA, PsA, AS, and SLE frequently avoided office visits and laboratory testing. DMARD interruptions commonly occurred without the advice of a physician and were associated with SES, office visits, and telehealth availability, highlighting the need for adequate healthcare access and attention to vulnerable populations during the pandemic., (Copyright © 2021 by the Journal of Rheumatology.)
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- 2021
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50. Identification of Gout Flares in Chief Complaint Text Using Natural Language Processing.
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Osborne JD, Booth JS, O'Leary T, Mudano A, Rosas G, Foster PJ, Saag KG, and Danila MI
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- Algorithms, Humans, Retrospective Studies, Text Messaging, Triage, Emergency Service, Hospital, Gout diagnosis, Natural Language Processing, Symptom Flare Up
- Abstract
Many patients with gout flares treated in the Emergency Department (ED) often do not receive optimal continuity of care after an ED visit. Thus, developing methods to identify patients with gout flares in the ED and referring them to appropriate outpatient gout care is required. While Natural Language Processing (NLP) has been used to detect gout flares retrospectively, it is much more challenging to identify patients prospectively during an ED visit where documentation is usually minimal. We annotate a corpus of ED triage nurse chief complaint notes for the presence of gout flares and implement a simple algorithm for gout flare ED alerts. We show that the chief complaint alone has strong predictive power for gout flares. We make available a de-identified version of this corpus annotated for gout mentions, which is to our knowledge the first free text chief complaint clinical corpus available., (©2020 AMIA - All rights reserved.)
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- 2021
Catalog
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