The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review.

PURPOSE: Although the use of Patient-Reported Outcomes Measurement Information System (PROMIS) measures is widely advocated, little is known on their use in patients with inflammatory arthritis. We systematically describe the use and outcomes of PROMIS measures in clinical studies involving people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). METHODS: A systematic review was conducted according to the PRISMA guidelines. Through a systematic search of nine electronic databases, clinical studies including patients with RA or axSpA and reporting the use of PROMIS measure were selected. Study characteristics, details of PROMIS measures and their outcomes, if available, were extracted. RESULTS: In total, 29 studies described in 40 articles met the inclusion criteria, of which 25 studies included RA patients, three studies included axSpA patients and one study included both RA and axSpA patients. The use of two general PROMIS measures (PROMIS Global Health, PROMIS-29) and 13 different domain-specific PROMIS measures was reported, of which the PROMIS Pain Interference (n = 17), Physical Function (n = 14), Fatigue (n = 13), and Depression (n = 12) measures were most frequently used. Twenty-one studies reported their results in terms of T-scores. Most T-scores were worse than the general population mean, indicating impairments of health status. Eight studies did not report actual data but rather measurement properties of the PROMIS measures. CONCLUSION: There was considerable variety regarding the different PROMIS measures used, with the PROMIS Pain interference, Physical function, Fatigue, and Depression measures being the most frequently used. In order to facilitate the comparisons across studies, more standardization of the selection of PROMIS measures is needed.

Barriers and facilitators for physical activity in rheumatic and musculoskeletal disease: a European-based survey.

Physical activity (PA) is a key strategy for improving symptoms in people with rheumatic and musculoskeletal diseases (RMDs). The aim of this study was to investigate and rank the importance of known barriers and facilitators for engaging in PA, from the perspective of people living with RMD. Five hundred thirty-three people with RMD responded to a survey (nine questions) disseminated by the People with Arthritis and Rheumatism (PARE) network of the European Alliance of Associations for Rheumatology (EULAR). The survey required participants to rank - based on their perceived importance - known PA barriers and facilitators from the literature, and specifically RMD symptoms as well as healthcare and community factors that may affect PA participation. Of the participants, 58% reported rheumatoid arthritis as their primary diagnosis, 89% were female, and 59% were between 51 and 70 years of age. Overall, participants reported fatigue (61.4%), pain (53.6%) and painful/swollen joints (50.6%) as the highest ranked barriers for engaging in PA. Conversely, less fatigue (66.8%) and pain (63.6%), and being able to do daily activities more easy (56.3%) were identified as the most important facilitators to PA. Three literature identified PA barriers, i.e., general health (78.8%), fitness (75.3%) and mental health (68.1%), were also ranked as being the most important for PA engagement. Symptoms of RMDs, such as pain and fatigue, seem to be considered the predominant barriers to PA by people with RMD; the same barriers are also the ones that they want to improve through increasing PA, suggesting a bi-directional relationship between these factors. Key Points • Symptoms of rheumatic and musculoskeletal disease (RMD) are the predominant barriers for lack of physical activity engagement. • RMD symptoms are the factors that people with RMDs want to improve when engaging in PA. • The barriers that stop people living with RMDs to do more PA are the ones that can be significantly improved through PA engagement.

Reporting quality of interventions using a wearable activity tracker to improve physical activity in patients with inflammatory arthritis or osteoarthritis: a systematic review.

To assess the reporting quality of interventions aiming at promoting physical activity (PA) using a wearable activity tracker (WAT) in patients with inflammatory arthritis (IA) or hip/knee osteoarthritis (OA). A systematic search was performed in eight databases (including PubMed, Embase and Cochrane Library) for studies published between 2000 and 2022. Two reviewers independently selected studies and extracted data on study characteristics and the reporting of the PA intervention using a WAT using the Consensus on Exercise Reporting Template (CERT) (12 items) and Consolidated Standards of Reporting Trials (CONSORT) E-Health checklist (16 items). The reporting quality of each study was expressed as a percentage of reported items of the total CERT and CONSORT E-Health (50% or less = poor; 51-79% = moderate; and 80-100% = good reporting quality). Sixteen studies were included; three involved patients with IA and 13 with OA. Reporting quality was poor in 6/16 studies and moderate in 10/16 studies, according to the CERT and poor in 8/16 and moderate in 8/16 studies following the CONSORT E-Health checklist. Poorly reported checklist items included: the description of decision rule(s) for determining progression and the starting level, the number of adverse events and how adherence or fidelity was assessed. In clinical trials on PA interventions using a WAT in patients with IA or OA, the reporting quality of delivery process is moderate to poor. The poor reporting quality of the progression and tailoring of the PA programs makes replication difficult. Improvements in reporting quality are necessary.

Patient involvement in basic rheumatology research at Nijmegen: a three year's responsive evaluation of added value, pitfalls and conditions for success.

BACKGROUND: Empirical evidence for effective patient-researcher collaboration in basic research is lacking. This study aims to explore good working models and impact of patient involvement in basic rheumatology research and to identify barriers and facilitators. METHOD: A responsive evaluation of a three years' participatory research project in a basic and translational laboratory research setting. Several working models for patient involvement were piloted and adapted if considered necessary. The study comprised surveys, interviews, training days, meeting reports, Q-sort exercises and field notes, and regular reflective team sessions with participant involvement. A qualitative analysis using thematic coding focused on impact, barriers and facilitators. RESULTS: Thirteen patient research partners (PRPs) and fifteen basic researchers participated. PRPs experienced basic research as fascinating though complex to understand. Their initial role was mostly listening and asking questions. After several meetings equal and more meaningful relationships emerged. Researchers' motivation increased by listening to patient stories. They learned about disease impact on daily life and to speak in understandable language. This enabled PRPs to learn about research and the pathogenesis of their disease. It inspired them to stay involved over a longer period. After three years, both parties preferred 1:1 contacts over collaboration in team meetings. A common language and respectful communication were important facilitators. Limitations were the complexity of disease processes for patients and the time commitment for researchers. Impact was reported as a sincere dialogue with multiple advantages for patients and researchers, and to a lesser extent than expected on the research process and outcomes. CONCLUSION: Patient involvement contributes to motivating young scientists in performing basic research projects. Patients and researchers valued the benefits of long-term one-on-one collaboration. These benefits outweigh the lack of direct impact on basic research goals and performance. A plain language summary of the abstract is available (as) online Additional file 1.

Quality of knee osteoarthritis care in the Netherlands: a survey on the perspective of people with osteoarthritis.

BACKGROUND: Quality indicators (QIs) are used to monitor quality of care and adherence to osteoarthritis (OA) standards of care. Patient reported QIs can identify the most important gaps in quality of care and the most vulnerable patient groups. The aim of this study was to capture the perspective of people with knee OA (KOA) in the Netherlands on the quality of care received, and explore determinants related to lower achievement rates. METHODS: We sent an online survey to all members of The Dutch Knee Panel (n = 622) of the Sint Maartenskliniek Nijmegen, the Netherlands between September and October 2019. The survey consisted of a slightly adapted version of the "OsteoArthritis Quality Indicator" (OA-QI) questionnaire (18 items; yes, no, N/A); a rating of quality of KOA care on a 10-point scale; a question on whether or not one wanted to see change in the care for KOA; and an open-ended question asking recommendations for improvement of OA care. Furthermore, sociodemographic and disease related characteristics were collected. Pass rates for separate QIs and pass rates on patient level were calculated by dividing the number of times the indicator was achieved by the number of eligible persons for that particular indicator. RESULTS: A total of 434 participants (70%) completed the survey. The mean (SD) pass rate (those answering "Yes") for separate QIs was 49% (20%); ranging from 15% for receiving referral for weight reduction to 75% for patient education on how to manage knee OA. The mean (SD) pass rate on patient level was 52% (23%). Presence of OA in other joints, comorbidities, and having a knee replacement were associated with higher pass rates. On average, a score of 6.5 (1.6) was given for the quality of care received, and the majority of respondents (59%) wanted change in the care for KOA. Of 231 recommendations made, most often mentioned were the need for tailoring of care (14%), more education (13%), and more empathy and support from healthcare providers (12%). CONCLUSION: This study found patients are only moderately satisfied with the OA care received, and showed substantial gaps between perceived quality of care for OA and internationally accepted standards. Future research should focus on the underlying reasons and provide strategies to bridge these gaps.

Effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial.

OBJECTIVE: To evaluate the short-term effects of use of the dr. Bart app, compared to usual care, on the number of secondary health care consultations and clinical outcomes in people with knee/hip OA in the Netherlands. METHOD: A randomized controlled design involving participants ≥50 years with self-reported knee and/or hip OA recruited from the community. The number of secondary health care consultations (primary outcome) and secondary outcomes were assessed at baseline, 3 and 6 months via online questionnaires. Data were analyzed using longitudinal mixed models, corrected for baseline values. Due to the design of this study, blinding of participants and researchers was not possible. RESULTS: In total, 427 eligible participants were allocated to either the dr. Bart group (n = 214) or usual care (n = 213). We found no difference between groups in the number of secondary (i.e., orthopaedic surgeon, rheumatologist, or physician assistant) health care consultations (incidence rate ratio (IRR) 1.20 (95% CI: 0.67; 2.19)). We found positive treatment effects of the dr. Bart app on symptoms (2.6 (95% CI: 0.4; 4.9)), pain (3.5 (95% CI: 0.9; 6.0)), and activities of daily living (2.9 (95% CI: 0.2; 5.6)) on a 0-100 scale, higher score indicating less complaints, but not in any other secondary outcome. CONCLUSION: The dr. Bart app did not change the number of secondary health care consultations compared to usual care. However, we found small positive effects (not clinically relevant) on pain, symptoms, and activities of daily living in people with knee/hip OA. TRIAL REGISTRATION: Dutch Trial Register (Trial Number NTR6693/NL6505) (https://www.trialregister.nl/trial/6505).

The effects of exercise on cardiovascular disease risk factors and cardiovascular physiology in rheumatoid arthritis.

Cardiovascular disease (CVD) morbidity and mortality is highly prevalent in patients with rheumatoid arthritis (RA) with debilitating effects for the individual as well as significant healthcare impact. Current evidence demonstrates that engaging in aerobic and resistance exercise (i.e. structured physical activity) can significantly improve patient-reported and clinical index-assessed outcomes in RA. In addition to this, engagement in exercise programmes improves, in a dose-dependent manner, the risk of developing CVD as well as CVD symptoms and outcomes. The present narrative review uses evidence from systematic reviews and meta-analyses as well as controlled trials, to synthesize the current state-of-the-art on the potential effects of aerobic and resistance exercise on CVD risk factors as well as on cardiac and vascular function and structure in people with RA. Where there is a lack of evidence in RA to explain potential mechanisms, relevant studies from the general population are also discussed and linked to RA.

Implicit and explicit attitudes towards disease-modifying antirheumatic drugs as possible target for improving medication adherence.

OBJECTIVE: This study aims to explore the contribution of implicit attitudes and associations towards conventional disease-modifying antirheumatic drugs (cDMARDs), alongside explicit measures, on medication-taking behaviour and clinical outcomes in adult patients with rheumatoid arthritis (RA). METHODS: In this observational study, implicit attitudes (positive-negative) and health-related associations (health-sickness) were measured with Single Category Implicit Association Tests, whereas explicit outcomes were measured with a bipolar evaluative adjective scale and the Beliefs about Medicines Questionnaire Specific. The primary outcome of this study was medication-taking behaviour subjectively measured by self-report (i.e. validated Compliance Questionnaire on Rheumatology) and objectively measured with electronic drug monitors over a 3 month period. Spearman rank correlations were used to describe correlations between implicit and explicit outcomes. Nested linear regression models were used to assess the additional value of implicit measures over explicit measures and patient-, clinical-, and treatment-related characteristics. RESULTS: Of the 1659 initially-invited patients, 254 patients with RA agreed to participate in this study. Implicit attitudes correlated significantly with necessity-concerns differential (NCD) scores (ρ = 0.13, P = 0.05) and disease activity scores (ρ = -0.17, P = 0.04), whereas implicit health-related associations correlated significantly with mean scores for explicitly reported health-related associations (ρ = 0.18, P = 0.004). Significant differences in age, number of DMARDs, biologic DMARD use, NCD-scores, and self-reported correct dosing were found between the four attitudinal profiles. Nested linear regression models revealed no additional value of implicit measures in explaining self-reported medication-taking behaviour and clinical outcomes, over and above all other variables. CONCLUSION: Implicit attitudes and associations had no additional value in explaining medication-taking behaviour and clinical outcomes over and above often used explicitly measured characteristics, attitudes and outcomes in the studied population. Only age and NCD scores contributed significantly when the dependent variable was correct dosing measured with self-report.

Exploring longitudinal associations of histologically assessed inflammation with symptoms and radiographic damage in knee osteoarthritis: combined results of three prospective cohort studies.

OBJECTIVE: To explore the associations between different histologically assessed, inflammatory synovial characteristics and subsequent clinical and structural aspects in knee osteoarthritis (OA). DESIGN: Knee OA patients, ranging in stage from early to advanced, were recruited from three different ongoing studies. Synovial tissue biopsies were taken and histologically assessed for six features (four inflammatory related aspects, fibrosis and fibrin deposition). Clinical aspects (WOMAC pain, functioning and stiffness and SF-36 vitality) and structural aspects (Kellgren and Lawrence (KL)-grade, joint space narrowing (JSN; 0-3) and osteophytes (0-3), and reception of total knee replacement (TKR)) were repeatedly assessed during follow-up. Associations between histology and clinical and structural aspects were analysed using linear mixed model analyses and cox proportional hazards analysis. RESULTS: Biopsies of 83 patients (median complaint duration: 5 [2-8] years) were analysed. Follow-up was a median of 1.4 [0.8-2.7] years for clinical and 1.8 [0.2-5.2] years for structural aspects. Fibrosis and fibrin deposition were inversely correlated with the inflammatory features. A higher fibrosis score was associated with a lower scores for KL-grade, JSN and osteophytes, while higher scores for perivascular oedema, synovial lining thickness and vascularisation were associated with higher scores for structural aspects during follow-up. No associations were found between each of the histological features and any of the clinical aspects or the chance for TKR during follow-up. CONCLUSIONS: Inflammatory related histological aspects are associated with subsequent increased radiological severity in knee OA, while fibrosis seems to protect against this, providing a potential therapeutic target for OA treatment.

Lack of beneficial effects of low-dose radiation therapy on hand osteoarthritis symptoms and inflammation: a randomised, blinded, sham-controlled trial.

OBJECTIVES: Low-dose radiation therapy (LDRT) is widely used as treatment for osteoarthritis (OA) in some countries, while relatively unknown in others. Systematic literature review displayed a lack of high-level evidence for beneficial effects in clinical practice. The aim was to assess the efficacy of LDRT on symptoms and inflammation in hand OA patients in a randomised, blinded, sham-controlled trial, using validated outcome measures. DESIGN: Hand OA patients, ≥50 years, with pain ≥5 (scale 0-10) and non-responding to conservative therapy were included and randomised 1:1 to receive LDRT (6 × 1 Gy in 2 weeks) or sham (6 × 0 Gy in 2 weeks). Primary outcome was the proportion of OMERACT-OARSI responders, 3 months post-intervention. Secondary outcomes were pain and functioning (Australian/Canadian Hand Osteoarthritis Index; AUSCAN), quality of life (Short Form Health Survey; SF36) and inflammatory outcomes: erythrocyte sedimentation rate and C-reactive protein serum levels, effusion, synovial thickening and power Doppler signal on ultrasound (range 0-3). RESULTS: Fifty-six patients were included. After 3 months, no significant difference in responders was observed between groups (LDRT: 8 (29%); sham: 10 (36%); difference -7% (95%CI -31-17%)). Also, differences in clinical and inflammatory outcomes between groups were small and not significant. CONCLUSIONS: We were unable to demonstrate a substantial beneficial effect of LDRT on symptoms and inflammation in patients with hand OA, compared to sham treatment. Although a small effect can not be excluded, a treatment effect exceeding 20% is very unlikely, given the confidence interval. Therefore, in the absence of other high-level evidence, we advise against the use LDRT as treatment for patients with hand OA. CLINICAL TRIAL REGISTRATION NUMBER: NTR4574 (Dutch Trial Register).

Responsiveness of four patient-reported outcome measures to assess physical function in patients with knee osteoarthritis.

OBJECTIVES: The aim of this study was to evaluate the responsiveness of four patient-reported outcome measures (PROMs) to measure change in physical function simultaneously in patients with knee osteoarthritis (OA) following currently recommended COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) standards. METHOD: Patients with knee OA receiving conservative treatment following a stepped care approach were invited to complete a set of questionnaires at baseline and 3 months. Questionnaires included four widely used measures of physical function: the Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), the Lequesne algofunctional index (LAI), the Lower Extremity Functional Scale (LEFS), and the Western Ontario and McMaster University Osteoarthritis Index Physical Function subscale (WOMAC-PF). Responsiveness of physical function was investigated according to the COSMIN standards by testing 15 a priori defined hypotheses. Responsiveness was considered positive if > 75% of the hypotheses could be confirmed. RESULTS: A total of 161 patients participated [61% female, mean (sd) age 59 (9) years and body mass index 29.7 (5.0) kg/m2]. Baseline values of the four PROMs were, mean (sd): KOOS-PS 53.6 (16.8), LAI 11.0 (4.0), LEFS 40.6 (14.1), and WOMAC-PF 51.8 (19.4). We could confirm 12 out of 15 predefined hypotheses (80%) about expected correlations for the WOMAC-PF whereas for the KOOS-PS, LAI, and LEFS < 75% hypotheses could be confirmed (73, 67, and 73%. respectively). CONCLUSIONS: Our results suggest that the WOMAC-PF is able to detect changes over time in physical function and therefore should be the measure of first choice in clinical trials evaluating the effectiveness of an intervention on physical function in knee OA patients.

The efficacy and safety of low-dose radiotherapy on pain and functioning in patients with osteoarthritis: a systematic review.

Low-dose radiotherapy (LD-RT) has been widely used for treatment of non-malignant disorders since its introduction and animal studies show anti-inflammatory effects in osteoarthritis (OA). However, the evidence for its effect in clinical practice remains unclear. Therefore, the aim of this study is to systematically summarise the literature on effectiveness of LD-RT on pain and functioning in patients with OA and its safety. Broad search terms were used to search PubMed, EMBASE and Web of Science. Primary inclusion criteria were osteoarthritis as indication, radiotherapy as intervention, written in English, German or Dutch and published since 1980. Study quality was assessed using the EPHPP Quality Assessment Tool for Quantitative Studies (scale: strong, moderate, weak). Seven studies were suitable for inclusion, all with retrospective uncontrolled observational design. Methodological quality of all studies was judged as weak. Most studies used 2-3 RT sessions per week for 2 weeks, some with booster session after 6 weeks. Generally, non-validated single-item measurement instruments were used to evaluate the effect of LD-RT on pain and function. Across the studies, in 25-90 and 29-71 % of the patients pain and functioning improved, respectively. Side effects were described in one study, none were reported. Our results show that there is insufficient evidence for efficacy or to confirm the safety of LD-RT in treatment of OA, due to absence of high-quality studies. Therefore, a well-designed, sham-controlled and blinded randomised trial, using validated outcome measures is warranted to demonstrate the value of LD-RT for OA in clinical practice.

Characterizing the concept of activity pacing as a non-pharmacological intervention in rheumatology care: results of an international Delphi survey.

OBJECTIVE: To develop a consensual list of the most important aspects of activity pacing (AP) as an intervention within the context of non-pharmacological rheumatology care. METHOD: An international, multidisciplinary expert panel comprising 60 clinicians and/or healthcare providers experienced in AP across 12 different countries participated in a Delphi survey. Over four Delphi rounds, the panel identified and ranked the most important goals of AP, behaviours of AP (the actions people take to meet the goal of AP), strategies to change behaviour in AP, and contextual factors that should be acknowledged when instructing AP. Additionally, topics for future research on AP were formulated and prioritized. RESULTS: The Delphi panel prioritized 9 goals, 11 behaviours, 9 strategies to change behaviour, and 10 contextual factors of AP. These items were integrated into a consensual list containing the most important aspects of AP interventions in non-pharmacological rheumatology care. Nine topics for future research on AP with the highest ranking were included in a research agenda highlighting that future research should focus on the effectiveness of AP interventions and on appropriate outcome measures to assess its effectiveness, as selected by 64% and 82% of the panellists, respectively. CONCLUSIONS: The diversity and number of items included in the consensual list developed in the current study reflect the heterogeneity of the concept of AP. This study is an important first step in achieving more transparency and homogeneity in the concept of AP in both rheumatology daily clinical practice and research.

Randomized trial of the effectiveness of a non-pharmacological multidisciplinary face-to-face treatment program on daily function compared to a telephone-based treatment program in patients with generalized osteoarthritis.

OBJECTIVE: To compare the effectiveness of a non-pharmacological multidisciplinary face-to-face self-management treatment program with a telephone-based program on daily function in patients with generalized osteoarthritis (GOA). DESIGN: A pragmatic single-blind randomized clinical superiority trial involving 147 patients clinically diagnosed with GOA, randomly allocated to either a 6 week non-pharmacological multidisciplinary face-to-face treatment program comprising seven group sessions or a 6 week telephone-based treatment program comprising two group sessions combined with four telephone contacts. Both programs aimed to improve daily function and to enhance self-management to control the disease. The programs critically differed in mode of delivery and intensity. Daily function (primary outcome) and secondary outcomes were assessed at baseline, 6, 26 and 52 weeks. Data were analyzed using linear or logistic multilevel regression models corrected for baseline, sex and group-wise treatment. RESULTS: No differences in effectiveness between both treatment programs were observed on the primary outcome (group difference (95% CI): -0.03 (-0.14, 0.07)) or on secondary outcome measures, except for a larger improvement in pain in the face-to-face treatment group (group difference (95% CI): 1.61 (0.01, 3.21)). Within groups, significant improvements were observed on several domains, especially in the face-to-face group. However, these benefits are relatively small and unlikely to be of clinical importance. CONCLUSIONS: We found no differences in treatment effect between patients with GOA who followed a non-pharmacological multidisciplinary face-to-face self-management program and those who received a telephone-delivered program. Besides, our findings demonstrated limited benefits of a self-management program for individuals with GOA. Dutch Trial Register trial number: NTR2137.

Effect of Aerobic Exercise Training on Fatigue in Rheumatoid Arthritis: A Meta-Analysis.

OBJECTIVE: Rheumatoid arthritis (RA) fatigue is not being well-managed currently, and evidence of effective interventions is limited. Aerobic exercise may provide benefit to treat fatigue in RA. Therefore, the purpose of this meta-analysis is to analyze the effect of aerobic land-based exercise on fatigue in RA. METHODS: A literature search was conducted using PubMed, Cochrane Library, Embase, and trial registers to identify randomized controlled trials (RCTs) with a supervised land-based aerobic exercise program performed with an intensity between 50% and 90% of maximal heart rate, of at least 15 minutes' duration, performed at least 2 times a week, and lasting for a time period of at least 4 consecutive weeks. Risk of bias was assessed using the Cochrane tool. A meta-analysis of fatigue outcomes was performed by calculating the standardized mean difference (SMD) using a random-effects model. RESULTS: Five RCTs were included. None of the trials selected patients with RA for having fatigue. Risk of bias was low in 3 RCTs and unclear in 2. Land-based aerobic exercise programs had a positive effect on fatigue in RA compared to no exercise at 12 weeks, SMD -0.31 (95% confidence interval [95% CI] -0.55, -0.06). At 24 weeks, the effect of aerobic land-based exercise was smaller and not statistically significant: SMD -0.15 (95% CI -0.33, 0.02). CONCLUSION: There is evidence with low risk of bias that an aerobic exercise program is effective in reducing fatigue among patients with RA, especially in the short term; however, effects are small. To substantiate the evidence, RCTs should be performed in patients with RA selected for having fatigue.

Association between serum levels of the proinflammatory protein S100A8/A9 and clinical and structural characteristics of patients with established knee, hip, and hand osteoarthritis.

OBJECTIVES: To explore the association between S100A8/A9 serum levels with clinical and structural characteristics of patients with established knee, hip, or hand osteoarthritis (OA). METHOD: A cross-sectional exploratory study was conducted with 162 OA patients. Measures for pain, stiffness, and function included the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire or the Australian Canadian Osteoarthritis Hand (AUSCAN) Index and for structural abnormalities, osteophytes and joint space narrowing grades. The association between S100A8/A9 and clinical or structural characteristics was analysed using linear regression or logistic regression where appropriate. RESULTS: The mean age of the OA patients was 56 years, 71% were female, and 61% had a Kellgren and Lawrence (K&L) score ≥ 2. The serum S100A8/A9 level did not differ between knee, hip, and hand OA patients and no association was found between serum S100A8/A9 and clinical characteristics. The serum S100A8/A9 level was negatively associated with the sum score of osteophytes after adjusting for sex and body mass index (BMI) [adjusted ß -0.015, 95% confidence interval (CI) -0.030 to 0.001, p = 0.062] and positively associated with erythrocyte sedimentation rate (ESR) > 12 mm/h (adjusted OR 1.002, 95% CI 1.000-1.004 p = 0.049) for each increase in S100A8/A9 of 1 ng/mL. For hand OA patients, a negative association of S100A8/A9 with sum score of joint space narrowing was found (adjusted ß -0.007, 95% CI -0.016 to 0.001, p = 0.099). CONCLUSIONS: The results from this cross-sectional exploratory study do not support an important role for serum S100A8/A9 levels as a biomarker for clinical and structural characteristics in established knee, hip, and hand OA patients. The inverse association with structural abnormalities and the positive association with ESR may reflect inflammatory synovial processes in patients with OA before structural abnormalities occur.

Frequency and impact of disease symptoms experienced by patients with systemic sclerosis from five European countries.

OBJECTIVES: Knowledge about the nature and impact of symptoms faced by patients with systemic sclerosis (SSc) is needed to identify targets for research and treatment. The aim of this study was to assess and compare the frequency and impact on everyday activities of SSc symptoms among patients from five European countries. METHODS: European patients with SSc were invited through announcements by patient associations to complete an online survey. The survey included items assessing the frequency of 40 SSc symptoms and the impact on daily activities, if present. Chi-square tests were utilised to assess the differences in frequency and impact of symptoms across countries. RESULTS: In total, 537 patients were included from France (n=111), the Netherlands (n=229), Spain (n=61), Switzerland (n=50), and the United Kingdom (n=86). Symptoms experienced by ≥ 70% of patients in all countries were fatigue, Raynaud's phenomenon, joint pain, and muscle pain. Twenty symptoms were experienced by ≥ 50% of patients in all countries. Thirty symptoms had an impact on daily activities in ≥ 50% of patients who reported that the symptom was present in all countries. There were significant differences among countries in the prevalence of 17 out of 40 symptoms. Furthermore, in 24 out of 40 symptoms significant differences in the proportion of patients reporting impact of a specific symptom on everyday activities were observed. CONCLUSIONS: European patients with SSc experience a broad range of symptoms that have an impact on everyday activities. International research initiatives should target common SSc symptoms cooperatively. Further research is needed to better understand the differences in SSc symptoms among countries.