Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases.

BACKGROUND: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight, fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise definitions of all mandatory domains within the core domain set. METHODS: OMERACT methodology was applied with the use of evidence and consensus-based decision making of all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry members and methodologists) to develop detailed definitions for the broad domain, target domain and domain components, taking into consideration sources of variability that could affect measurement of the domain.  The working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to develop a rich definition of 'what' is to be measured. RESULTS: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain / concept match and content validity in the OMERACT pillar of 'truth' before moving on to feasibility and discrimination. CONCLUSION: The OMERACT GC Impact Working Group has developed and agreed upon detailed domain definitions for core domains. Future steps of the working group are to select instruments and develop the core outcome measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.

Joining forces to understand what matters most: qualitative insights into the patient experience of outpatient rheumatology care.

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.

Incidence of biopsy-proven giant cell arteritis (GCA) in South Australia 2014-2020.

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.

Mortality estimates and excess mortality in rheumatoid arthritis.

OBJECTIVES: To determine long-term (20 year) survival in RA patients enrolled in the Australian Rheumatology Association Database (ARAD). METHODS: ARAD patients with RA and data linkage consent who were diagnosed from 1995 onwards were included. Death data were obtained through linkage to the Australian National Death Index. Results were compared with age-, gender- and calendar year-matched Australian population mortality rates. Analysis included both the standardized mortality ratio (SMR) and relative survival models. Restricted mean survival time (RMST) at 20 years was calculated as a measure of life lost. Cause-specific SMRs (CS-SMRs) were estimated for International Classification of Diseases, Tenth Revision cause of death classifications. RESULTS: A total of 1895 RA patients were included; 74% were female, baseline median age 50 years (interquartile range 41-58), with 204 deaths. There was no increase in mortality over the first 10 years of follow up, but at 20 years the SMR was 1.49 (95% CI 1.30, 1.71) and the relative survival was 94% (95% CI 91, 97). The difference between observed (18.41 years) and expected (18.68 years) RMST was 4 months. Respiratory conditions were an important underlying cause of death in RA, primarily attributable to pneumonia [CS-SMR 5.2 (95% CI 2.3, 10.3)] and interstitial lung disease [CS-SMR 7.6 (95% CI 3.0, 14.7)], however, coronary heart disease [CS-SMR 0.82 (95% CI 0.42, 1.4)] and neoplasms [CS-SMR 1.2 (95% CI 0.89, 1.5)] were not. CONCLUSION: Mortality risk in this RA cohort accrues over time and is moderately increased at 20 years of follow-up. Respiratory diseases may have supplanted cardiovascular diseases as a major contributor to this mortality gap.

Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure.

OBJECTIVES: Glucocorticoids (GCs) ('steroids') are used to treat rheumatic diseases but adverse effects are common. We aimed to explore the impact of GC therapy on health-related quality of life (HRQoL), to inform the development of a treatment-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS: Semi-structured qualitative interviews were conducted with patients from the UK, USA and Australia, treated for a rheumatic condition with GCs in the last 2 years. Purposive sampling was used to select participants with a range of demographic and disease features. An initial conceptual framework informed interview prompts and cues. Interviews elicited GC-related physical and psychological symptoms and salient aspects of HRQoL in relation to GC therapy. Interview data were analysed inductively to develop initial individual themes and domains. Candidate questionnaire items were developed and refined. RESULTS: Sixty semi-structured qualitative interviews were conducted (UK n = 34, USA n = 10, Australia n = 16). The mean age was 58 years; 39/60 were female; and 18 rheumatic diseases were represented. Some 126 individual themes were identified and organized into six domains: physical symptoms; psychological symptoms; psychological impact of steroids; impact of steroids on participation; impact of steroids on relationships; and benefits of steroids. Candidate questionnaire items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews and linguistic translatability assessment, informing a draft questionnaire. CONCLUSION: We describe an international qualitative study to develop candidate items for a treatment-specific PROM for patients with rheumatic diseases. A future survey will enable the validation of a final version of the PROM.

Socioeconomic Status and Medication Use in Rheumatoid Arthritis: A Scoping Review.

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.

COVID-19 vaccine hesitancy in inflammatory arthritis patients: serial surveys from a large longitudinal national Australian cohort.

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.

Diagnosis of giant cell arteritis by temporal artery biopsy is associated with biopsy length.

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.

Patient-Reported Experience Measures in outpatient rheumatology care: a systematic review.

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.

Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set.

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.

The patient's perspective of the adverse effects of glucocorticoid use: A systematic review of quantitative and qualitative studies. From an OMERACT working group.

INTRODUCTION: Glucocorticoids (GCs) remain widely used. However, the impact of GCs from the perspective of the patient, rather than of the clinician, remains relatively unexplored. Additionally, no general patient reported outcome measure has been developed to assess the effects of GCs across rheumatological conditions. The aim of this literature review was to identify the adverse effects of systemic GC use that are of importance to patients. METHODS: OVID EMBASE, OVID MEDLINE, PsycINFO and CINAHL was searched relating to three concepts: GCs, the patient perspective and adverse effects. A meta-synthesis of the qualitative data was performed separately by two independent researchers before qualitative metasummary was utilized to quantitatively aggregate the findings (combining quantitative and qualitative results), including the derivation of frequency and intensity effect sizes to identify those outcomes most prominently featured across all reviewed articles. RESULTS: The initial search retrieved 1,356 articles, of which 25 (18 quantitative, 7 qualitative) were deemed suitable for quality assessment and data extraction. Four major themes emerged amongst the 71 discrete outcomes: physical symptoms (44), psychological symptoms (18), effect on participation (6) and contextual factors (3). CONCLUSIONS: Patients with a broad range of inflammatory diseases and demographic features describe key cross-cutting themes in relation to GCs and their impact on health-related quality of life. This work will inform the development of a core domain set for clinical trials involving GCs and a patient reported outcome to measure impact of GCs from the patient's perspective.

A qualitative study of patient perspectives related to glucocorticoid therapy in polymyalgia rheumatica and giant cell arteritis.

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.

Factors associated with commencing and ceasing opioid therapy in patients with rheumatoid arthritis.

OBJECTIVE: To determine factors associated with opioid use in rheumatoid arthritis (RA) patients. METHODS: Adult RA patients (n = 3225, 73% female, mean age 57 years, median follow-up 54 months) were recruited into the Australian Rheumatology Association Database (ARAD) between 2001-2015. A logistic regression examining both within- and between-patient effect sizes for time-varying covariates, and transition-state analysis for covariates associated with opioid commencement or cessation were used to examine determinants of current opioid use. RESULTS: The population-averaged prevalence of any opioid use was 33% (95%CI 32-34), 9% (95% CI 8, 10) for high potency opioid use, and 62% (95% 60, 64) of patients reported opioid ever-use after five years of follow-up. Opioid use was higher in females and decreased with older baseline age. Within-patients opioid use was associated with higher self-reported pain and HAQ scores (p < 0.001), and NSAID (OR 1.88; 1.67-2.10), oral glucocorticoid (2.23;1.93-2.58), csDMARD (2.08;1.78-2.44) and bDMARD (1.22;1.06-1.40) treatment. Younger baseline age, higher pain scores, HAQ scores and oral GC use were important determinants of change in opioid use, associated with both a higher probability of commencing opioid use, and a lower probability of cessation. Paradoxically, NSAID and DMARD treatments were associated with both a lower probability of commencing opioids, and a lower probability of cessation. CONCLUSIONS: There was a high prevalence of opioid use among RA patients, which was associated with pain, function and GC treatment. NSAID, and DMARD treatments obviate the need for opioids in some, but not all, patients.

The OMERACT Emerging Leaders Program: The Good, the Bad, and the Future.

OBJECTIVE: To describe the experience of the first OMERACT Emerging Leaders Program (ELP). METHODS: A Delphi process identified positive aspects, areas for improvement, and future directions. Core items were defined as essential if they received ≥ 70% ratings. RESULTS: Participants valued relatable/accessible mentors (100%), including an OMERACT Executive mentor (100%), and a support network of peers (90%). Key items for future development were funding support (100%) and developing knowledge about OMERACT processes (90%) and politics (80%). CONCLUSION: The ELP has the potential to provide targeted training for early career researchers to develop relevant skills for future leadership roles within OMERACT.

Toward a Core Domain Set for Glucocorticoid Impact in Inflammatory Rheumatic Diseases: The OMERACT 2018 Glucocorticoid Impact Working Group.

OBJECTIVE: To understand the effects of glucocorticoids (GC), which are of importance to patients. METHODS: The results of 2 literature reviews, a patient survey, and a qualitative study were presented. RESULTS: No validated instrument exists to evaluate GC effect on patients. Survey data revealed skin thinning/bruising, sleep disturbance, and weight gain as the most frequent adverse effects. The qualitative research yielded rich data covering rapid benefits and physical and emotional consequences of GC. CONCLUSION: It was agreed that a patient-reported outcome to measure GC effect was required and a research agenda was developed for this goal.

Factors associated with oral glucocorticoid use in patients with rheumatoid arthritis: a drug use study from a prospective national biologics registry.

BACKGROUND: Glucocorticoids (GCs) are used in ~ 60% of patients with rheumatoid arthritis (RA). Although disease-modifying, they also have significant adverse effects. Understanding factors associated with GC use may help minimise exposure. The aims of the present study were to describe oral GC use in RA; determine any change in use over time; and determine factors associated with oral GC use, commencement or cessation. METHODS: Adult patients with RA were identified in the Australian Rheumatology Association Database (ARAD), a national Australian registry that collects long-term outcome data from patients with inflammatory arthritis. Patients were categorised by their ARAD date of entry (DOE), with population-averaged logistic regression and transition state analysis used to determine any change in GC use over time. Fixed-effects panel regression was used to examine whether GC current use was associated with pain/arthritis activity/Health Assessment Questionnaire (HAQ) scores or medication use. Transition state analysis was used to assess whether these factors influenced the commencement or cessation of GCs. RESULTS: A total of 3699 patients with RA completed a baseline ARAD questionnaire (73% female, mean age 57 years). The probability of GC use decreased over time according to ARAD DOE: September 2001 to March 2005, 55% (95% CI 52-58%); March 2005 to September 2008, 47% (45-49%); September 2008 to March 2012, 42% (39-45%); and March 2012 to October 2015, 39% (34-43%) (p < 0.001). Conventional synthetic disease-modifying anti-rheumatic drugs (OR 10.13; 95% CI 8.22-12.47), non-steroidal anti-inflammatory drugs (1.18; 1.02-1.37) and opioids (2.14; 1.84-2.48) were associated with GC current use, as were lower pain scores (0.94; 0.90-0.98), higher arthritis activity scores (1.09; 1.05-1.14) and poorer HAQ scores (1.52; 1.30-1.79). Use of biologic disease-modifying anti-rheumatic drugs (bDMARDs) was not associated with GC current use (0.98; 0.83-1.15) or GC cessation (HR 0.87; 95% CI 0.75-1.01), but it was associated with GC commencement (0.54; 0.47-0.62). CONCLUSIONS: The probability of oral GC use decreased over time, with reduced commencement and increased cessation of GCs. The modest effect of bDMARDs on GC cessation was not statistically significant.

A Survey of Glucocorticoid Adverse Effects and Benefits in Rheumatic Diseases: The Patient Perspective.

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.

The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica.

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.

A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group.

OBJECTIVE: The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has been well documented in the literature. The aim of the first GC Special Interest Group was to define a research agenda around the development of a patient-reported outcome measure (PROM) in this area. METHODS: The results of a background literature search and the preliminary results of a pilot survey and 2 qualitative studies were presented to facilitate the development of a research agenda. RESULTS: It was agreed that there was a need for a data-driven PROM that identified both positive and negative effects of GC therapy to be used across all inflammatory indications for systemic GC use in adults. A research agenda was developed, consisting of further qualitative work to assess the effect of GC across different groups including various indications for GC use, different age groups, different dosages, and duration of treatment. CONCLUSION: There was agreement on the need for a PROM in this area and a research agenda was set.

Risk of mortality in patients with giant cell arteritis: A systematic review and meta-analysis.

BACKGROUND: Previous studies of mortality associated with GCA have shown conflicting results. We conducted a systematic review and meta-analysis to determine the mortality risk in GCA patients compared to the general population. METHODS: We searched for published studies indexed in MEDLINE and EMBASE and the Cochrane database from inception to June 18, 2015 using the terms "giant cell arteritis" and "temporal arteritis" combined with the terms for death, mortality, and survival. A manual search of citations from retrieved articles was also performed. The inclusion criteria were as follows: (1) observational studies of mortality in GCA and (2) comparison of mortality to the general population. Studies published only in abstract form were excluded. Study eligibility and quality (Newcastle-Ottawa scale) were independently assessed by at least two investigators. Random effects meta-analysis of the mortality ratio (MR) was performed by the inverse variance method. RESULTS: Out of 435 potentially relevant articles, 64 studies were reviewed, 19 studies were included in the review and 17 studies were included in the meta-analysis. Mortality was not increased in GCA patients ascertained from a population base (MR = 1.03, 95% CI: 0.96-1.10), but was increased in patients ascertained from a hospital setting (MR = 1.61, 95% CI: 1.19-2.19). There was no difference in MR by gender, and two studies provided evidence that mortality was increased in the early years following diagnosis. CONCLUSION: At a population level, long-term mortality is not increased in GCA. However, mortality risk may be increased in some patients, and may vary over time.