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New and effective treatment for acute kidney injury remains a challenge. Here, we induced mouse hematopoietic stem and progenitor cells (HSPC) to differentiate into cells that partially resemble a renal cell phenotype and tested their therapeutic potential. We sequentially treated HSPC with a combination of protein factors for 1 wk to generate a large number of cells that expressed renal developmentally regulated genes and protein. Cell fate conversion was associated with increased histone acetylation on promoters of renal-related genes. Further treatment of the cells with a histone deacetylase inhibitor improved the efficiency of cell conversion by sixfold. Treated cells formed tubular structures in three-dimensional cultures and were integrated into tubules of embryonic kidney organ cultures. When injected under the renal capsule, they integrated into renal tubules of postischemic kidneys and expressed the epithelial marker E-cadherin. No teratoma formation was detected 2 and 6 mo after cell injection, supporting the safety of using these cells. Furthermore, intravenous injection of the cells into mice with renal ischemic injury improved kidney function and morphology by increasing endogenous renal repair and decreasing tubular cell death. The cells produced biologically effective concentrations of renotrophic factors including VEGF, IGF-1, and HGF to stimulate epithelial proliferation and tubular repair. Our study indicates that hematopoietic stem and progenitor cells can be converted to a large number of renal-like cells within a short period for potential treatment of acute kidney injury. [ABSTRACT FROM AUTHOR]

Objective: Individuals with inflammatory arthritis (IA) require long-term rheumatologist care for optimal outcomes. We sought to determine if socioeconomic status (SES) influences general practitioner (GP) and specialist physician visit frequency and out of pocket (OOP) visit costs., Methods: We linked data from Australian Rheumatology Association Database (ARAD) participants with rheumatoid arthritis or psoriatic arthritis to the Pharmaceutical Benefits (PBS) and Medicare Benefits Schedule (MBS) from 2011-2018. Small-area SES was approximated as quintiles of the Index of Relative Socieconomic Advantage and Disadvantage. A comorbidity index (Rx-Risk) was determined from PBS data. Analysis was performed using panel regression methods., Results: We included 1916 ARAD participants (76.3% rheumatoid arthritis, 71.1% women, mean [SD] age 54 [12] years and disease duration 6 [4] years). Participants averaged 9.0 (95% CI 8.6, 9.4) annual GP visits and 3.9 (3.8 to 4.1) annual specialist physician visits. After adjustment for sex, age, education, remoteness and comorbidity, there was an inverse relationship between annual GP visit frequency and higher SES quintile (-0.6 [-0.9, -0.3] visits/quintile) and a direct relationship between more frequent specialist visits and higher SES (linear slope 0.3 [0.2, 0.5] visits/quintile). Average OOP costs/visit were higher for specialist physician (AUD$38.43 [37.34, 39.53] versus GP visits (AUD$7.86 [7.42, 8.31], and higher SES was associated with greater OOP cost., Conclusion: Higher SES patients have relatively fewer GP visits and more specialist physician visits compared with lower SES patients, suggesting lower SES patients may receive suboptimal specialist physician care. OOP costs may be a contributing factor., (This article is protected by copyright. All rights reserved.)

Objectives: To evaluate the reliability and validity of an adapted Commissioning for Quality in Rheumatoid Arthritis-RA-Patient-Reported Experience Measure (CQRA-RA-PREM) for assessing care experience in an Australian rheumatology outpatient cohort., Methods: Individual patient interviews were performed to check the language and completion time of the CQRA-RA-PREM before modification. Australian Rheumatology Association Database (ARAD) participants completed the CQRA-PREM-Australian version (CQRA-PREM-AU) (22 items, 5 domains), disease activity measure (RAPID-3, BASDAI) and Assessment of Quality of Life (AQOL-6D) index. Exploratory factor analysis (EFA) assessed item correlation. Cronbach's α assessed internal consistency., Results: Individual patient interviews ( n  = 8, 62% male, mean age 50 years, mean disease duration 4.5 years) informed CQRA-RA-PREM modification. The ARAD survey response rate was 707/1124 (63%); 459 (65%) RA, 134 (19%) PsA, 114 (16%) AS; 67% female, mean age 62 years, mean disease duration 22 years. The median instrument completion time was 299 s (interquartile range 284-414). Scoring of responses allowed an averaged overall score. EFA extracted five factors: all items loading similarly onto factor 1, indicating validity of the overall score. The CQRA-PREM-AU score correlated with the AQOL-6D score (ρ = 0.23, P  < 0.01); partial correlation with disease activity was not significant (ρ = 0.03, P  = 0.45), indicating divergent validity. Reliability was comparable across disease subgroups (Cronbach's α >0.94). The mean overall score did not differ by disease subgroup [4.1 (s.d. 0.6, P  = 0.73) and there was no floor/ceiling effect., Conclusion: CQRA-PREM-AU is a valid and reliable instrument to measure self-reported care experience in Australian rheumatology patients and may be interpreted as an average overall numerical score., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: People with rheumatic diseases are frequent, long-term attenders of health-care services. Their care experiences are central to improving services. The aim of this study was to explore real-world experiences and priorities of people attending outpatient rheumatology care and those of health-care professionals (HCPs) providing care., Methods: This qualitative study consisted of five semi-structured focus groups. Participants included rheumatology outpatients ( n  = 16) of two tertiary teaching hospitals and HCPs ( n  = 14; rheumatologists, rheumatology trainees, physiotherapists, a specialty nurse and a pharmacist). Participants explored priorities when attending outpatient services, real experiences and aspirations for improving future care. Transcripts were coded using inductive and deductive thematic analysis., Results: Seven key themes were identified: smooth flow of technical processes, care coordination, individualized care, information sharing, clinical excellence, patient empowerment and comprehensive care. The findings were aligned conceptually with quality standards in Australia and worldwide. Different sub-themes and prioritization of concerns emerged from patient and HCP subgroups. Highly prioritized themes for patients pertained to processes and technical aspects of care. HCPs focused on themes relating to non-technical aspects of service provision: information sharing, individualization of care, patient advocacy and empowerment., Conclusion: This study captured valuable insights into the current experience of outpatient rheumatology care from the perspective of patients and HCPs. It informs a collective understanding of differing and shared priorities, positives of current care and areas requiring change. Themes derived from the study data can be conceptualized in terms of the process, content and impact of care. Such domains can be measured longitudinally by routine implementation of validated patient-reported experience measures in rheumatology., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: To provide the best clinical practice guidance for surfactant use in preterm neonates with respiratory distress syndrome (RDS). The RDS-Neonatal Expert Taskforce (RDS-NExT) initiative was intended to add to existing evidence and clinical guidelines, where evidence is lacking, with input from an expert panel., Study Design: An expert panel of healthcare providers specializing in neonatal intensive care was convened and administered a survey questionnaire, followed by 3 virtual workshops. A modified Delphi method was used to obtain consensus around topics in surfactant use in neonatal RDS., Result: Statements focused on establishing RDS diagnosis and indicators for surfactant administration, surfactant administration methods and techniques, and other considerations. After discussion and voting, consensus was achieved on 20 statements., Conclusion: These consensus statements provide practical guidance for surfactant administration in preterm neonates with RDS, with a goal to contribute to improving the care of neonates and providing a stimulus for further investigation to bridge existing knowledge gaps., (© 2023. The Author(s).)

Objective: To determine distinct trajectories of self-reported pain-related health status in rheumatoid arthritis (RA), their relationship with sociodemographic factors and medication use., Methods: 988 Australian Rheumatology Association Database participants with RA (71% female, mean age 54 years, mean disease duration 2.3 years) were included. Distinct multi-trajectories over 15-year follow-up for five different self-reported pain-related health outcome measures (Health Assessment Questionnaire Disability Index, visual analogue scores for pain, arthritis, global health and the Assessment of Quality of Life utility index) were identified using latent variable discrete mixture modelling. Random effects models were used to determine associations with medication use and biologic therapy modification during follow-up., Results: Four, approximately equally sized, pain/health status groups were identified, ranging from 'better' to 'poorer', within which changes over time were relatively small. Important determinants of those with poorer pain/health status included female gender, obesity, smoking, socioeconomic indicators and comorbidities. While biologic therapy use was similar between groups during follow-up, biologic therapy modifications (p linear <0.001) and greater tendency of non-tumour necrosis factor inhibitor use (p linear <0.001) were observed in those with poorer pain/health status. Similarly, greater use of opioids, prednisolone and non-steroidal anti-inflammatory drugs was seen in those with poorer pain/health status., Conclusion: In the absence of disease activity information, distinct trajectories of varying pain/health status were seen from the outset and throughout the disease course in this RA cohort. More biologic therapy modifications and greater use in anti-inflammatories, opioids and prednisolone were seen in those with poorer pain/health status, reflecting undesirable lived experience of persistent pain in RA., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Long-acting injectable antipsychotic (LAIA) medications offer an effective treatment option for patients with serious mental illness. Despite demonstrated clinical safety and efficacy as well as increased adherence and less frequent administration compared with daily oral regimens, LAIAs remain underutilized in clinical practice. With legislation allowing pharmacists to administer injectable medications in 48 U.S. states, community pharmacies are uniquely positioned to serve as an access point for patients with serious mental illnesses to receive LAIA injections., Objective: This study aimed to conduct a systematic review of the health and economic benefits and costs of community pharmacist administration of LAIA medications., Methods: A systematic search of the literature published from January 1996 to April 2022 was conducted across 3 databases (Embase, PubMed, and Scopus Plus). Publications describing pharmacist administration of LAIA medications in outpatient settings were included. Publications that examined the use of LAIAs but did not involve a pharmacist administering the medication were excluded., Results: Of 2261 publications reviewed, we identified 8 publications (4 articles and 4 abstracts) that met our inclusion criteria, of which only 7 included results. Four studies reported high medication adherence achieved by patients receiving pharmacist-administered LAIAs. Two publications surveyed patient satisfaction with pharmacist administration of LAIAs in community pharmacy settings. One study found pharmacists' mixed attitudes regarding LAIA administration and time and safety barriers to offering the service., Conclusion: We found very little evidence on the impact of pharmacist administration of LAIAs on patient outcomes. This review highlights the need to generate greater evidence on the health and economic benefits as well as financial models for pharmacists to administer LAIA medications in outpatient and community pharmacy settings. Such evidence could support more community pharmacists to offer LAIA medications and contribute to the shift toward value-based care., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Objective: To determine the incidence of biopsy proven giant cell arteritis (GCA) in South Australia., Methods: Patients with biopsy-proven GCA were identified from pathology reports of temporal artery biopsies at state-based pathology laboratories, from 1 January 2014 to 31 December 2020. Incidence rates for biopsy-proven GCA were calculated using Australian Bureau of Statistics data for South Australian population sizes by age, sex, and calendar year. Seasonality was analyzed by cosinor analysis., Results: There were 181 cases of biopsy-proven GCA. The median age at diagnosis of GCA was 76 years (IQR 70, 81), 64% were female. The estimated population incidence for people over 50 was 5.4 (95% CI 4.7, 6.1) per 100,000-person years. The female: male incidence ratio was 1.6 (95% CI 1.2, 2.2). There was no ordinal trend in GCA incidence rates by calendar year ( p = 0.29). The incidence was, on average, highest in winter, but not significantly ( p = 0.35). A cosinor analysis indicated no seasonal effect ( p = 0.52)., Conclusion: The incidence of biopsy-proven GCA remains low in Australia. A higher incidence was noted compared to an earlier study. However, differences in ascertainment and methods of GCA diagnosis may have accounted for the change., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Ninan, Ruediger, Dyer, Dodd, Black, Lyne, Shanahan, Proudman, Lester, McNeil and Hill.)

Objectives: To determine COVID-19 vaccine hesitancy rates in inflammatory arthritis patients and identify factors associated with changing vaccine hesitancy over time., Methods: This investigation was a prospective cohort study of inflammatory arthritis patients from community and public hospital outpatient rheumatology clinics enrolled in the Australian Rheumatology Association Database (ARAD). Two surveys were conducted, one immediately prior to (pre-pandemic) and another approximately 1 year after the start of the pandemic (follow-up). Coronavirus disease 2019 (COVID-19) vaccine hesitancy was measured at follow-up, and general vaccine hesitancy was inferred pre-pandemic; these were used to identify factors associated with fixed and changing vaccine beliefs, including sources of information and broader beliefs about medication., Results: Of the 594 participants who completed both surveys, 74 (12%) were COVID-19 vaccine hesitant. This was associated with pre-pandemic beliefs about medications being harmful (P < 0.001) and overused (P = 0.002), with stronger beliefs resulting in vaccine hesitancy persistent over two time points (P = 0.008, P = 0.005). For those not vaccine hesitant pre-pandemic, the development of COVID-19 vaccine hesitancy was associated with a lower likelihood of seeking out vaccine information from health-care professionals (P < 0.001). COVID-19 vaccine hesitancy was not associated with new influenza vaccine hesitancy (P = 0.138)., Conclusion: In this study of vaccine beliefs before and during the COVID-19 pandemic, factors associated with COVID-19 vaccine hesitancy in inflammatory arthritis patients varied, depending on vaccine attitudes immediately prior to the start of the pandemic. Fixed beliefs reflected broader views about medications, while fluid beliefs were highly influenced by whether they sought out information from health-care professionals, including rheumatologists., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: To determine vaccination rates, perceptions, and information sources in people with inflammatory arthritis., Methods: Participants enrolled in the Australian Rheumatology Association Database were invited to participate in an online questionnaire, conducted in January 2020, prior to the COVID-19 pandemic. Included questions were about vaccination history, modified World Health Organization Vaccination Hesitancy Scale, views of the information sources consulted, the Beliefs About Medicines Questionnaire, education, and the Single-Item Health Literacy Screener., Results: Response rate was 994 of 1498 (66%). The median age of participants was 62 years, with 67% female. Self-reported adherence was 83% for the influenza vaccine. Participants generally expressed positive vaccination views, particularly regarding safety, efficacy, and access. However, only 43% knew which vaccines were recommended for them. Vaccine hesitancy was primarily attributable to uncertainty and a perceived lack of information about which vaccines were recommended. Participants consulted multiple vaccination information sources (median 3, interquartile range 2-7). General practitioners (89%) and rheumatologists (76%) were the most frequently used information sources and were most likely to yield positive views. Negative views of vaccination were most often from internet chatrooms, social media, and mainstream media. Factors of younger age, male gender, and having more concerns about the harms and overuse of medicines in general were associated with lower adherence and greater uncertainty about vaccinations, whereas education and self-reported literacy were not., Conclusion: Participants with inflammatory arthritis generally held positive views about vaccination, although there was considerable uncertainty as to which vaccinations were recommended for them. This study highlights the need for improved consumer information about vaccination recommendations for people with inflammatory arthritis., (© 2023 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objective: Socioeconomic status (SES) influences disease outcomes in rheumatoid arthritis (RA) patients. Differences in medication use may partly explain this association. A scoping review was used to identify research conducted on this topic and determine what knowledge gaps remain., Methods: Medline, Embase, and PsychInfo were searched from their inception until February 2022 for studies that assessed SES and medication use as an outcome variable. Data was extracted on the use of specific SES measures, medication use, and whether differences in SES variables were associated with differences in medication use., Results: We identified 2,103 studies, of which 81 were selected for inclusion. Included studies originated most frequently from the US (42%); the mean ± SD age of participants was 55.9 ± 6.8 years, and most were female (75%). Studies measured a median of 4 SES variables (interquartile range 3-6), with educational, area-level SES, and income being the most frequent measurements used. Patients' race and/or ethnicity were documented by 34 studies. Studies primarily assessed the likelihood of prescription of disease-modifying antirheumatic drugs or dispensation, medication adherence, or treatment delays. A majority of studies documented at least 1 SES measure associated with a difference in medication use., Conclusion: There is some evidence that SES affects use of medications in patients with RA; however, multiple definitions of SES have been utilized, making comparisons between studies difficult. Prospective studies with consistently defined SES will be needed to determine whether differences in medication use accounts for the poorer outcomes experienced by patients of lower SES., (© 2022 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Aims: Temporal artery biopsy (TAB) is a widely used method for establishing a diagnosis of Giant Cell Arteritis (GCA). The optimal TAB length for accurate histological GCA diagnosis has been suggested as 15 mm post-fixation (15-20 mm pre-fixation). The aim of this study was to determine the relationship between a histological GCA diagnosis and optimal TAB length in the South Australian (SA) population., Materials and Methods: Pre-fixation TAB length (mm) was reported in 825/859 of all samples submitted to SA Pathology between 2014 and 2020 from people aged 50 and over. When more than one biopsy was taken, the longest length was recorded. Analyses of both TAB length and TAB positive proportions were performed by multivariable linear and logistic regression analysis, including covariates sex, age, and calendar year., Results: The median age of participants was 72 (IQR 65, 79) years, 549 (66%) were female. The TAB positive proportion was 172/825 (21%) with a median biopsy length of 14 mm (IQR 9, 18). Biopsy length (mm) was shorter in females ( p = 0.001), increased with age ( p = 0.006), and a small positive linear trend with calendar year was observed ( p = 0.015). The TAB positive proportion was related to older age (slope/decade: 6, 95% CI 3.6, 8.3, p < 0.001) and to TAB length (slope/mm 0.6, 95% CI 0.2, 0.9, p = 0.002), but not sex or calendar year. Comparison of models with TAB length cut-points at 5, 10, 15, 20 mm in terms of diagnostic yield, receiver operating characteristics and Akaike Information Criteria confirmed ≥ 15 mm as an appropriate, recommended TAB length. However, only 383 (46%) of the biopsies in our study met this criteria. The diagnostic yield at this cut-point was estimated as 25% which equates to an expected additional 30 histologically diagnosed GCA patients., Conclusion: This study confirms that TAB biopsy length is a determinant of a histological diagnosis of temporal arteritis, and confirms that a TAB length ≥ 15 mm is optimal. Approximately half the biopsies in this study were shorter than this optimal length, which has likely led to under-diagnosis of biopsy-proven GCA in SA. Further work is needed to ensure appropriate TAB biopsy length., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Ruediger, Ninan, Dyer, Lyne, Tieu, Black, Dodd, Lester and Hill.)

Objectives: To investigate the knowledge and beliefs of Australian patients with inflammatory arthritis regarding biologic/targeted synthetic DMARDs (b/tsDMARDs) and biosimilars and their sources of information., Methods: Participants enrolled in the Australian Rheumatology Association Database (ARAD) with RA, PsA and axial SpA were sent an online survey. They were asked about information sources for b/tsDMARDs and how positive or negative this information was. The Beliefs about Medicine Questionnaire (BMQ) was used to measure beliefs about b/tsDMARDs with scores ranging from 1 (strongly disagree) to 5 (strongly agree). Participants were asked about their knowledge of biosimilars and willingness to switch to biosimilar., Results: There was a response rate of 66% (994/1498; 67% female, median age 62 years). Participants currently taking b/tsDMARDs ( n  = 794) had a high b/tsDMARD-specific BMQ 'necessity' score {median 4.2 [interquartile range (IQR) 3.6-4.8]}, with a lower specific 'concerns' score [median 2.4 (IQR 2.0- 3.0)]. Participants consulted multiple information sources [median 3 (IQR 2-5)]. Positive sources were rheumatologists and educational websites and negative were chat rooms and social media. Only 18% were familiar with biosimilars, with half knowing of availability in Australia. Following a short paragraph describing biosimilars, 75% (744) of participants indicated they would consider switching if recommended by their rheumatologist, with nearly half identifying safety and efficacy of biosimilars as an important concern., Conclusion: Australian patients have positive attitudes towards b/tsDMARDs overall, although little knowledge of biosimilars specifically. They have a high degree of trust in their rheumatologist regarding treatment decisions, even if they are unfamiliar with the medication recommended., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: Absence status epilepticus (ASE) is a form of generalized nonconvulsive status epilepticus. ASE is characterized by impairment in consciousness, which can vary widely, making the diagnosis more difficult. The typical patient with ASE will be confused yet responsive and in a "trance-like state" with delayed speech, clumsy gait, and the ability to perform simple tasks after prompting. With treatment, typical ASE has an excellent prognosis and does not appear to be associated with significant neuronal damage., Case Presentation: An 11-year-old boy with history of febrile seizures presented to the emergency department (ED) with altered mental status without trauma or ingestion. His vital signs and physical examination were normal, with the exception of appearing intoxicated with sparse verbalization and inappropriate emotional responses. All laboratory results and imaging were unremarkable. While in the ED, his neurologic examination trended toward normal, returning almost to baseline. He was admitted to the hospital for video electroencephalogram, which revealed status epilepticus. After benzodiazepine therapy, epileptic electrical activity ceased and the patient's symptoms resolved. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: ASE is a rare condition that is uncommonly described in the pediatric population. These patients are frequently misdiagnosed on initial presentation as their alteration in mental status can be easily confused with ingestion, trauma, psychiatric illness, or infectious etiologies. Overturning the long-standing emergency dogma of "if they're talking to you, it's not a seizure" is undoubtedly difficult, but both pediatric and adult providers should be aware of this clinical entity., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objectives: There is a growing acceptance of the need for routine implementation of patient-reported experience measures (PREMs) in health care. Rheumatology patients, as frequent and long-term users of care, stand to benefit from collection of experience-related data. The aim of this study was to perform a systematic review to identify and critically appraise the development and psychometric validation of PREMs in rheumatology., Methods: Six databases were searched systematically from inception to 14 December 2020: MEDLINE, EMBASE, PsycINFO, SCOPUS, Cochrane and Google Scholar. We included articles in English that described the use or development of PREMs, with results of psychometric testing, in an adult outpatient rheumatology context. This study is registered with PROSPERO (CRD42021233819). Articles were appraised using the COnsensus Based Standards for the selection of health status Measurement Instruments (COSMIN) (i) Risk of Bias checklist and (ii) criteria for good measurement properties., Results: The search yielded 3809 publications, and six studies met inclusion criteria. All the included studies on PREM development fulfilled COSMIN standards for 'doubtful' or 'inadequate' quality of instrument development. One study fulfilled a 'sufficient' rating for content validity, and the remainder fulfilled 'inconsistent' ratings. During validity testing, studies fulfilled between one and four of the eight COSMIN checklist criteria for good measurement properties., Conclusion: Methodological concerns regarding instrument development and validation limit the generalizability of the existing six validated PREMs in use in rheumatology contexts. There is a need for further well-designed studies to validate existing and new PREMs in this area., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions., Methods: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set., Results: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders., Conclusion: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials., Competing Interests: Declaration of Competing Interest MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. M de Witt reports being a collaborating partner in the EU/IMI funded trial to investigate the efficacy and safety of low-dose GC in the elderly. M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work. JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh 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. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh 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. JA Singh 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. R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work. A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work. S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work. C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. H Keen reports personal fees from Roche and Pfizer, outside the submitted work. P Tugwell is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center. J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. No disclosures: A Makol, L King, A Hinojosa-Azaola, O Russell, S Lyne, K Toupin-April, S Decary, M Whitstock, L Gupta, M Alba Garibay, K Yip, C Mukhtyar, C Uhunmwangho, WM Oo, C Ruediger, L Yue, LS Simon, RJ Black, JTL Cheah, N Ghosh, C Campochiaro, B Shea, P Richards. MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. M de Witt reports being a collaborating partner in the EU/IMI funded trial to investigate the efficacy and safety of low-dose GC in the elderly. M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work. JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh 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. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh 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. JA Singh 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. R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work. A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work. S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work. C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. H Keen reports personal fees from Roche and Pfizer, outside the submitted work. P Tugwell is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center. J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. No disclosures: A Makol, L King, A Hinojosa-Azaola, O Russell, S Lyne, K Toupin-April, S Decary, M Whitstock, L Gupta, M Alba Garibay, K Yip, C Mukhtyar, C Uhunmwangho, WM Oo, C Ruediger, L Yue, LS Simon, RJ Black, JTL Cheah, N Ghosh, C Campochiaro, B Shea, P Richards., (Copyright © 2021. Published by Elsevier Inc.)

Peri-implantitis is becoming a frequent complication observed around dental implants. An endodontic infection of a nearby tooth or an immediate implant placement in an inflamed bone socket from failing endodontic therapy has been associated with retrograde peri-implantitis (RPI), a condition that presents with radiographic lucency at the "apex" of an implant. However, current classification schemes do not capture endodontic lesions that may manifest as coronal or intrabony lesions associated with dental implants. As a result, such cases may be mistreated. Here we present for the first time 2 cases in which peri-implant bone loss occurred in the coronal half of the implant adjacent to a tooth with an endodontic-periodontic lesion and was resolved via endodontic therapy or tooth extraction as indicated. This proof of concept report aimed to introduce endodontic peri-implant ("endo-implant") defects and increase vigilance, which may help prevent overtreatment or mistreatment of such cases., (Copyright © 2019 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.)

Objective: To determine patient experiences of glucocorticoid (GC) therapy in polymyalgia rheumatica (PMR) and giant cell arteritis (GCA)., Methods: Patients with a diagnosis of PMR or GCA were invited to participate in this qualitative study that used focus groups to explore: symptoms onset, process of diagnosis, treatment, adverse effects (AEs), and ongoing condition/s management. Data were transcribed verbatim and a "framework" approach was used for analysis and interpretation., Results: Fourteen patients participated. Weight gain, changes in face and neck shape, and bruising were commonly reported and impacts of these AEs on quality of life were highlighted. Dealing with uncertainties associated with long-term experiences of the condition/s and cycles of GC treatment were raised as were workload demands for patients in managing both the condition and other people's expectations and recommendations related to GC therapy., Conclusion: These findings demonstrate that the patient experience of GC use is poorly captured by usual physician monitoring for GC AEs. These findings suggest that development of a patient-reported outcome instrument for inflammatory conditions treated with GCs is required., Competing Interests: Through the data collection and analysis period of this study, Elizabeth Hoon was supported by an Arthritis South Australian Florey Research Fellowship.  Tiffany K Gill reports grants from Arthritis Australia, during the conduct of the study. The authors report no other conflicts of interest in this work., (© 2019 Hoon et al.)

Objective: The aim of this study was to explore, from the patient's perspective, the beneficial and adverse effects (AEs) of glucocorticoids (GCs) in patients with rheumatic diseases, to be used in the development of a patient-reported outcome measure., Methods: A cross-sectional survey, capturing benefits and AEs of GC use, was administered to 2 groups of patients: (1) those attending a tertiary rheumatology clinic with various rheumatic diseases who had used GCs within the past year and (2) patients from the Hospital for Special Surgery rheumatoid arthritis database., Results: Cohort 1 had 55 GC users, and cohort 2 had 95 GC users and 29 nonusers. The majority of GC users in both cohorts reported at least 1 AE (100%, 86%). The AE prevalence per person was 50% higher in cohort 1 compared with GC users in cohort 2 (7.7 vs. 5.3; AE ratio, 1.5; 95% confidence interval, 1.3-1.7) and 2-fold greater in cohort 2 GC users compared with GC nonusers (5.3 vs. 2.6; AE ratio, 2.0; 95% confidence interval, 1.6-2.6). In both cohorts, AEs identified as "worst" by GC users included skin thinning/easy bruising, sleep disturbance, mood disturbance, and change in facial shape. Most felt GCs helped their disease "a lot" (78%/62%) and that the benefits were greater than the AEs (55%/64%). Many AEs were more frequent in GC users than in nonusers., Conclusions: Patients receiving GC therapy for rheumatic conditions report a large number of AEs and those that have the greatest life impact are often difficult for physicians to measure. These results will inform the development of a patient-reported outcome measure to capture the effects of GCs from the patient's perspective.

Objective: To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies., Methods: Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary., Results: Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic inflammation, pain, stiffness, and physical function. Patient's global and fatigue were considered important but not mandatory (outer core). The research agenda included psychological impact, weakness, physical activity, participation, sleep, imaging, and health-related quality of life., Conclusion: This core domain set was considered sufficiently well-defined that the next step will be to apply the OMERACT Filter 2.0 Instrument Selection Algorithm to select candidate instruments for a subsequent "deeper dive" into the data. This will allow instruments to be mapped onto each of our core domains to derive a core outcome set for PMR.

Giant cell arteritis (GCA) is one of the commonest forms of vasculitis in the elderly, and may result in blindness and stroke. The pathogenesis of GCA is not understood, although environmental, infectious and genetic risk factors are implicated. One gene of interest is PTPN22, encoding lymphoid protein tyrosine phosphatase (Lyp), expressed exclusively in immune cells, which is proposed to be an 'archetypal non-HLA autoimmunity gene'. The minor allele of a functional PTPN22 single nucleotide polymorphism (rs2476601, R620W), which disrupts an interaction motif in the protein, was originally reported to be associated with biopsy-proven GCA in Spanish patients, with supporting data from three replicate Northern European studies. Recently, this observation was extended with additional patients and controls, and studies encompassing European, Scandinavian, UK and American patients. The aim of our study was to determine the association between PTPN22 rs2476601 (R620W) and biopsy-proven GCA in an Australian case cohort.

Objective. To determine the relationship between FCGR3B gene copy number variation (CNV) and biopsy proven giant cell arteritis (GCA). Methods. FCGR3B CNV was determined in 139 Australian biopsy proven GCA patients and 162 population matched controls, using a duplex qPCR assay and RNase P as the reference gene. Copy number was determined using Copy Caller software (v.1.0, Applied Biosystems, USA). CNV genotypes were classified into 3 groups (<2, 2, 3+) for analysis purposes, and analysis was performed using logistic regression. Results. All GCA patients had a positive temporal artery biopsy, and the most common presenting symptoms were visual disturbance and temporal headache. The mean age of patients at biopsy was 74 years (range 51-94) and 88/139 (63%) were female. The frequency of low (<2) FCGR3B copy number was comparable between GCA patients (9/139 = 6.5%) and controls (10/162 = 6.2%), as was the frequency of high (3+) FCGR3B copy number (15/130 (10.8%) in GCA patients versus 13/162 (8.0%) in controls). Overall there was no evidence that FCGR3B CNV frequencies differed between GCA patients and controls (χ (2) = 0.75, df = 2, P = 0.69). Conclusion. FCGR3B CNV is not associated with GCA; however, replicate studies are required.

New and effective treatment for acute kidney injury remains a challenge. Here, we induced mouse hematopoietic stem and progenitor cells (HSPC) to differentiate into cells that partially resemble a renal cell phenotype and tested their therapeutic potential. We sequentially treated HSPC with a combination of protein factors for 1 wk to generate a large number of cells that expressed renal developmentally regulated genes and protein. Cell fate conversion was associated with increased histone acetylation on promoters of renal-related genes. Further treatment of the cells with a histone deacetylase inhibitor improved the efficiency of cell conversion by sixfold. Treated cells formed tubular structures in three-dimensional cultures and were integrated into tubules of embryonic kidney organ cultures. When injected under the renal capsule, they integrated into renal tubules of postischemic kidneys and expressed the epithelial marker E-cadherin. No teratoma formation was detected 2 and 6 mo after cell injection, supporting the safety of using these cells. Furthermore, intravenous injection of the cells into mice with renal ischemic injury improved kidney function and morphology by increasing endogenous renal repair and decreasing tubular cell death. The cells produced biologically effective concentrations of renotrophic factors including VEGF, IGF-1, and HGF to stimulate epithelial proliferation and tubular repair. Our study indicates that hematopoietic stem and progenitor cells can be converted to a large number of renal-like cells within a short period for potential treatment of acute kidney injury.

Purpose: To estimate patient satisfaction with telephone follow-up and compare the frequencies of postoperative complications between patients undergoing telephone and those undergoing clinical follow-up after ambulatory office-based dentoalveolar procedures., Materials and Methods: Using a retrospective study design, the investigators enrolled a cohort of subjects who had had at least 1 tooth extracted during a 2-year period. The primary study variable was subject self-report of satisfaction with the telephone follow-up. For additional analyses, the predictor variable was follow-up type grouped as telephone versus clinical. The outcome variable was postoperative complications. To measure the relationships between the follow-up type and postoperative complications, bivariate and multiple logistic regression statistics were computed. P ≤ .05 was considered significant., Results: The sample was composed of 364 subjects, of whom 155 (42.6%) had received telephone follow-up. The sample's mean age was 28.6 ± 11.7 years, included 220 females (60.4%), and had had an average of 3.4 ± 2.1 teeth removed. The self-reported patient satisfaction rate with telephone follow-up was 95.9%. The subjects who experienced postoperative complications were 90% less likely to be satisfied relative to those without complications (P = .04). The overall complication frequency was 19.2%, with telephone follow-up subjects having a lower complication frequency (12.9%) than the clinical follow-up subjects (23.4%) (P < .01). After adjusting for differences between the 2 samples, no significant difference was found in the complication frequencies according to the method of follow-up (P = .7)., Conclusion: Patient satisfaction with telephone follow-up was high. The subjects scheduled for telephone follow-up had a complication rate that was similar to that of the clinical follow-up subjects., (Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)