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Elizabeth Hoon,1 Carlee Ruediger,2,3 Tiffany K Gill,2 Rachel J Black,2,4 Catherine L Hill2–41School of Public Health, University of Adelaide, Adelaide, SA 5000, Australia; 2Adelaide Medical School, University of Adelaide, Adelaide, SA 5000, Australia; 3Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, SA 5011, Australia; 4Rheumatology Unit, The Royal Adelaide Hospital, Adelaide, SA 5000, AustraliaCorrespondence: Catherine L HillAdelaide Medical School, University of Adelaide, Level 7, SAHMRI, North Tc, Adelaide, SA 5000, AustraliaEmail Catherine.Hill@sa.gov.auObjective: 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.Keywords: patient experience, polymyalgia rheumatica, giant cell arteritis, adverse effects, glucocorticoid therapy

Objective.To survey participants with polymyalgia rheumatica (PMR) to evaluate the face validity, acceptability, and domain match of proposed candidate outcome measures.Methods.A structured, online, anonymous survey was disseminated by patient support groups through their networks and online forums. The candidate outcome measures comprised (1) visual analog scale (VAS) and numerical rating score (NRS) to assess pain; (2) VAS, NRS, and duration to assess stiffness; (3) the modified Health Assessment Questionnaire and Health Assessment Questionnaire Disability Index to assess physical function; and (4) C-reactive protein and erythrocyte sedimentation rate to assess inflammation. Free-text answers were analyzed using descriptive thematic analysis to determine respondents’ views of the candidate instruments.Results.Seventy-eight people with PMR from 6 countries (UK, France, USA, Canada, Australia, and New Zealand) participated in the survey. Most respondents agreed candidate instruments were acceptable or “good to go.” Free-text analysis identified 5 themes that participants considered inadequately covered by the proposed instruments. These related to (1) the variability, context, and location of pain; (2) the variability of stiffness; (3) fatigue; (4) disability; and (5) the correlation of inflammatory marker levels and severity of symptoms, sometimes reflecting disease activity and other times not.Conclusion.Participants reported additional aspects of their experience that are not covered by the proposed instruments, particularly for the experience of stiffness and effect of fatigue. New patient-reported outcome measures are required to increase the relevance of results from clinical trials to patients with PMR.

Objective: Outcome Measures in Rheumatology (OMERACT) convened a premeeting in 2018 to bring together patients, regulators, researchers, clinicians, and consumers to build upon previous OMERACT drug safety work, with patients fully engaged throughout all phases. Methods: Day 1 included a brief introduction to the history of OMERACT and methodology, and an overview of current efforts within and outside OMERACT to identify patient-reported medication safety concerns. On Day 2, two working groups presented results; after each, breakout groups were assembled to discuss findings. Results: Five themes pertaining to drug safety measurement emerged. Conclusion: Current approaches have failed to include data from the patient’s perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential.

Objective: Despite the potential burden of foot pain, some of the most fundamental epidemiologic questions surrounding the foot remain poorly explored. The prevalence of foot pain has proven to be difficult to compare across existing studies due to variations in case definitions. The objective of this study was to investigate the prevalence of foot pain in several international population-based cohorts using original data and to explore differences in the case definitions used.Methods: Foot pain variables were examined in 5 cohorts: the Chingford 1000 Women Study, the Johnston County Osteoarthritis Project, the Framingham Foot Study, the Clinical Assessment Study of the Foot, and the North West Adelaide Health Study. One question about foot pain was chosen from each cohort based on its similarity to the American College of Rheumatology pain question.Results: The precise definition of foot pain varied between the cohorts. The prevalence of foot pain ranged from 13% to 36% and was lowest in the cohort in which the case definition specific to pain was used, compared to the 4 remaining cohorts in which a definition included components of pain, aching, or stiffness. Foot pain was generally more prevalent in women and obese individuals and generally increased with age, with the prevalence being much lower in younger participants (ages 20–44 years).Conclusion: Foot pain is common and is associated with female sex, older age, and obesity. Estimates of the prevalence of foot pain are likely to be affected by the case definition used. Therefore, in future population studies, the use of consistent measures of data collection must be considered.

Objective: The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group (SIG) are to characterize stiffness as an outcome in rheumatic disease and to identify and validate a stiffness patient-reported outcome (PRO) in rheumatology. Methods: At OMERACT 2016, international groups presented and discussed results of several concurrent research projects on stiffness: a literature review of rheumatoid arthritis (RA) stiffness PRO measures, a qualitative investigation into the RA and polymyalgia rheumatica patient perspective of stiffness, data-driven stiffness conceptual model development, development and testing of an RA stiffness PRO measure, and a quantitative work testing stiffness items in patients with RA and psoriatic arthritis. Results: The literature review identified 52 individual stiffness PRO measures assessing morning or early morning stiffness severity/intensity or duration. Items were heterogeneous, had little or inconsistent psychometric property evidence, and did not appear to have been developed according to the PRO development guidelines. A poor match between current stiffness PRO and the conceptual model identifying the RA patient experience of stiffness was identified, highlighting a major flaw in PRO selection according to the OMERACT filter 2.0. Conclusion: Discussions within the Stiffness SIG highlighted the importance of further research on stiffness and defined a research agenda.

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.

Cytoplasmic polyhedrosis virus (CPV) is unique among the double-stranded RNA viruses of the family Reoviridae in having a single capsid layer. Analysis by cryo-electron microscopy allows comparison of the single shelled CPV and orthoreovirus with the high resolution crystal structure of the inner shell of the bluetongue virus (BTV) core. This suggests that the novel arrangement identified in BTV, of 120 protein subunits in a so-called 'T=2' organization, is a characteristic of the Reoviridae and allows us to delineate structural similarities and differences between two subgroups of the family--the turreted and the smooth-core viruses. This in turn suggests a coherent picture of the structural organization of many dsRNA viruses.

Objective\ud Lateral wedge insoles are intended to reduce biomechanical risk factors of medial knee osteoarthritis (OA) progression, such as increased knee joint load; however, there has been no definitive consensus on this topic. The aim of this systematic review and meta-analysis was to establish the within-subject effects of lateral wedge insoles on knee joint load in people with medial knee OA during walking.\ud Methods\ud Six databases were searched from inception until February 13th 2015. Included studies reported on the acute biomechanical effects of lateral wedge insoles in people with medial knee osteoarthritis during walking. Primary outcomes of interest relating to the biomechanical risk of disease progression were the 1st and 2nd peak external knee adduction moment (EKAM) and knee adduction angular impulse (KAAI). Eligible studies were pooled using random-effects meta-analysis.\ud Results\ud Eighteen studies were included with a total of 534 participants. Lateral wedge insoles resulted in a small but statistically significant reduction in the 1st peak EKAM (SMD: -0.19; 95% CI -0.23 − -0.15) and 2nd peak EKAM (SMD: -0.25; 95% CI -0.32 − -0.19) with a low level of heterogeneity (I2 = 5% and 30%, respectively). There was a favourable but small reduction in the KAAI with lateral wedge insoles (SMD: -0.14; 95% CI -0.21 − -0.07, I2 =31%). Risk of methodological bias scores (Quality Index) ranged from 8 to 13 out of 16.\ud Conclusions\ud Lateral wedge insoles cause small reductions in the EKAM and KAAI in people with medial knee OA during walking. At present, they appear ineffective at attenuating structural changes in people with medial knee OA as a whole and may be better suited to targeted use in biomechanical phenotypes associated with larger reductions in knee load.

Refereed/Peer-reviewed Background: Colchicine may offer relief in osteoarthritis. This has never been investigated for hand osteoarthritis. Objectives: To investigate the effect of 1 mg daily colchicine vs placebo on hand pain and function over 12 weeks in older adults with hand osteoarthritis. Methods: Community-dwelling adults with diagnosed osteoarthritis of the hand aged 40–80 years were randomised to receive colchicine (0.5 mg twice daily) or matching placebo. Primary outcome measure was VAS hand pain score (0–100 mm). Secondary outcome measures included tender and swollen joint count, grip strength, C-reactive protein, and Michigan Hand Questionnaire total, function and pain scores. In an exploratory assessment, we compared synovial grade and power Doppler. All outcome measures were obtained at baseline and week 12. Stata v16 was used to perform constrained longitudinal data analysis models. Results: 64 adults (54 females, 10 males) aged 48–79 years of age were enrolled. 59 participants completed the study (N = 28 colchicine, N = 31 placebo) (withdrawal rate 8%). Adverse reactions to the study medication occurred in nine patients. VAS score was not significantly different at baseline (61 ± 17 mm in the colchicine, 64 ± 17 mm in the placebo group). Between-group difference for VAS score at week 12 was 7.6 mm (95% CI -3.5-18.7, p-value 0.18). There were no significant differences between groups for any secondary outcomes at baseline or week 12. Conclusions: 1 mg colchicine daily for 12 weeks was not effective for reducing pain, tender and swollen joint count or increasing grip strength in symptomatic hand osteoarthritis. Our results do not support the use of colchicine in hand osteoarthritis.