[Translation of the 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis and linguistic validation in German-speaking countries with healthcare professionals]. / Übersetzung der 2018 EULAR Empfehlungen zu körperlicher Aktivität von Menschen mit entzündlich-rheumatischen und degenerativen Erkrankungen ins Deutsche und sprachliche Validierung im deutschsprachigen Raum mit medizinischen Fachpersonen.

BACKGROUND: Regular physical activity is beneficial for people with rheumatic diseases and one of the cornerstones in its management. Based on the international recommendations of the World Health Organization for the general population, the "2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis" provide evidence-based recommendations on the prescription, performance, and implementation of physical activity exercises in this population for the first time. AIM: Translation of the 2018 EULAR recommendations into German and linguistic validation in Germany, Austria and Switzerland. METHODS: A professional translation of the EULAR recommendations into the German language was performed and revised by German-speaking experts from all three countries. The translation was validated by healthcare professionals consisting of rheumatologists, occupational therapists, physiotherapists, nurses, and medical assistants in a field test. In each of the three countries, eight structured interviews were conducted on comprehensibility, wording, completeness, and feasibility. The experts then discussed changes until consensus was reached and indicated the level of agreement with the final translation. RESULTS: The translation of the EULAR recommendations was substantially revised. Based on the results of the cognitive test, formulations were adapted in order to increase comprehensibility. The level of agreement between 10 (SD 0.0) and 8.9 (SD 1.5) was very high. DISCUSSION: The final German version of the EULAR recommendations is comprehensible and accepted across all three German-speaking countries. It can help to improve the structure and clarity of the handling of physical activity and promote physical activity for healthcare providers and patients.

Improving the measurement of oral health-related quality of life: Rasch model of the oral health impact profile-14.

OBJECTIVES: The 14-item Oral Health Impact Profile (OHIP-14) is the most frequently used instrument to measure oral health-related quality-of-life (OHRQoL) in adults. Despite its popularity, its psychometric properties have been predominantly investigated based on the classical test theory while the fundamental principles of measurement have not been fully assessed. Therefore, our aim was to investigate to what extent the OHIP-14 meets the fundamental requirments of measurements. METHODS: We used the Rasch model to explore person-item-targeting, unidimensionality, local independence of items, invariance (differential-item-functioning, DIF), and the order of thresholds between response-options in the German version OHIP-14. We used data from osteoarthritis patients because hand disabilities and joint pain might influence oral hygiene. Furthermore, osteoarthritis in the temporomandibular-joint directly affects oral functioning. RESULTS: Five-hundred sixteen patients were included (mean age 66.5 years [±10.2; ranging from 34 to 89]; 71.3% [368] females). The OHIP-14 median total score was 0 (interquartile-range from 0 to 4), indicating a right-skewed distribution because many patients reported good OHRQoL. The instrument was found unidimensional. However, there was strong evidence of local dependency, disordered thresholds between response-options, and age-related DIF for item 5. A revised scoring scheme with three instead of five answer-options in all items and eliminating two items resolving local dependency, the newly adapted OHIP-12, showed better reliability and item-fit to the Rasch model than the original OHIP-14. CONCLUSIONS: This study assesses, for the first time, the OHIP-14 in terms of fundamental principles of measurement and proposes an item-reduced OHIP-12 as a psychometrically more accurate version of the instrument. CLINICAL SIGNIFICANCE: The Rasch model is essential to ensure instruments' precision and clinical meaningfulness when measuring OHRQoL in clinical practice and research. The OHIP-12, derived from the OHIP-14 by deleting two items due to local dependency, with a revised scoring scheme for all items distinguishing three answer-options instead of five, represents a psychometrically improved version of the instrument.

Functional consultation and exercises improve grip strength in osteoarthritis of the hand - a randomised controlled trial.

BACKGROUND: Evidence for non-pharmacological interventions in hand osteoarthritis is promising but still scarce. Combined interventions are most likely to best cover the clinical needs of patients with hand osteoarthritis (OA). The aim of this study was to evaluate the effect of a combined, interdisciplinary intervention feasible in both primary and specialist care compared to routine care plus placebo in patients with hand OA. METHODS: This was a randomised, controlled 2-month trial with a blinded assessor. In the combined-intervention group, rheumatology-trained health professionals from different disciplines delivered a one-session individual intervention with detailed information on functioning, activities of daily living, physical activity, nutrition, assistive devices, instructions on pain management and exercises. Telephone follow up was performed after 4 weeks. The primary outcome was grip strength after 8 weeks. Secondary outcomes were self-reported pain, satisfaction with treatment, health status, two of the Jebsen-Taylor Hand Function subtests and the total score of the Australian/Canadian Hand Osteoarthritis Index (AUSCAN). Statistical significance was calculated by Student's t test or the Mann-Whitney U test depending on data distribution. Binominal logistic regression models were fitted, with the primary outcome being the dependent and the group allocation being the independent variable. RESULTS: There were 151 participating patients (74 in the combined-intervention and 77 in the routine-care-plus-placebo group) with 2-month follow-up attendance of 84% (n = 128). Grip strength significantly increased in the combined-intervention group and decreased in the routine-care group (dominant hand, mean 0.03 bar (SD 0.11) versus - 0.03 (SD 0.13), p value = 0.001, baseline corrected values) after 8 weeks. CONCLUSION: The combined one-session individual intervention significantly improved grip strength and self-reported satisfaction with treatment in patients with hand OA. It can be delivered by different rheumatology-trained health professionals and is thus also feasible in primary care. TRIAL REGISTRATION: ISRCTN registry, ISRCTN62513257 . Registered on 17 May 2012.

Use of biological disease modifying antirheumatic drugs in rheumatoid arthritis in Austria from 2008 to 2011 : A retrospective analysis of 72% of the population.

BACKGROUND: Rheumatoid arthritis (RA) is the most prevalent chronic inflammatory joint disease. On a national level in Austria, there are currently no data available on how often and which biological disease modifying antirheumatic drugs (bDMARDs) are prescribed in patients with RA. The aim of the present study was to explore prescription patterns of bDMARDs in RA in Austria with a focus on drug survival. METHODS: A retrospective data analysis of bDMARD courses of individual patients with RA that were extracted from the databases of nine Austrian health insurance funds covering 6.1 million (72%) insured people in a 4-year observation period from January 2008 to December 2011. Only patients with first prescriptions of bDMARDs were included. All patients with diagnoses other than RA were excluded. RESULTS: A total of 2906 first prescriptions of bDMARDs were included in the present analysis and 19.35% of RA patients were on bDMARDs in Austria taking into account a prevalence of RA of 0.5%. Tocilizumab showed the longest drug survival after 1 year (73.2%), followed by abatacept which had the longest drug survival after 2 (68.2%) and 3 years (65.2%). The most frequent second bDMARDs switched to were adalimumab (n = 109, 26%), tocilizumab (n = 83, 20%) and etanercept (n = 82, 20%) and 37% of biological DMARDs were prescribed as monotherapy (ranging from 33% with infliximab to 46% with tocilizumab). CONCLUSIONS: Our analysis is based on the largest health care database available in Austria. Tocilizumab and abatacept showed the longest drug survival. Adalimumab, tocilizumab and etanercept were the most frequent DMARDs switched to. Of interest was the high number of bDMARD monotherapies.

Efficacy and safety of rituximab in rheumatic diseases.

B-cell depleting therapy is now in clinical use for more than 10 years in rheumatology. In 2001, a first report was published on five rheumatoid arthritis patients responding to the chimeric anti-CD20 antibody rituximab. Since then, numerous clinical trials, prospective and retrospective studies, registry data as well as case reports on the use of rituximab in autoimmune rheumatic diseases have been published. This review gives a short overview on clinical data of rituximab in rheumatic diseases currently available.

VCAM-1 serum levels are associated with arthropathy in hereditary haemochromatosis.

OBJECTIVES: The aim of this study was to assess the role of vascular adhesion molecule 1 (VCAM-1) in patients with hereditary haemochromatosis (HH) with or without arthropathy. METHODS: Sera from a large cross-sectional cohort of unselected HH patients (n=147) were obtained and compared to an age-matched and sex-matched control group. Serum levels of VCAM-1 were measured by ELISA and were correlated with clinical measures. RESULTS: VCAM-1 serum levels were elevated in HH patients as compared to matched controls (mean 913±456 vs 654±451 ng/ml, p<0.0001). Within the HH patient group, VCAM-1 levels were much higher in patients with arthropathy and joint replacement surgery. VCAM-1 levels correlated well with radiographic measures of HH arthropathy (r=0.36, p<0.0001). Multivariate regression analysis confirmed a highly significant association of VCAM-1 serum levels and the presence of HH arthropathy, independent from diabetes, body mass index and age. CONCLUSIONS: VCAM-1 serum levels emerge as a biomarker for haemochromatosis arthropathy.

The use of TNF-inhibitors in ankylosing spondylitis in Austria from 2007 to 2009 - a retrospective analysis.

OBJECTIVE: The introduction of anti- tumor necrosis factor-alpha agents (TNF-inhibitors) offered new dimensions in symptom relief and alteration of disease progression for patients with Ankylosing Spondylitis (AS). In 2007, Infliximab, Etanercept and Adalimumab were approved for AS in Austria. Drug reimbursement data of 2007 were retrieved to evaluate frequency of prescription, preferred substance and data on switching therapies. METHODS: Data from eight health insurance funds covering 5.4 million insured people, which corresponds to 64% of the population, was analyzed by linking two databases, combining data on therapy of individual patients and their diagnosis. For those patients on TNF-inhibitors in 2007 reimbursement data from 2008 and 2009 were obtained, respectively. RESULTS: A total of 694 patients with AS on TNF inhibitors in 2007 were identified for data analysis. Yearly costs for TNF-inhibitors were highest for Adalimumab (14,399 € per patient) followed by Infliximab (11,685 € per patient) and Etanercept (10,184 € per patient). In first-time TNF-inhibitor prescriptions, Adalimumab was prescribed most often, with a tendency towards prescription of Adalimumab and Etanercept in the younger and Infliximab in the older population. In the first year of prescription, 12% of patients already switched from the initially prescribed drug to another substance with those started on Etanercept showing the lowest switching rate. One-year drug survival in our data was highest for Etanercept with 83% still on the drug after 1 year, followed by Infliximab and then Adalimumab, while two-year drug survival was also highest for Etanercept (58%), followed by Adalimumab and then Infliximab. CONCLUSIONS: Patients with Ankylosing Spondylitis starting on TNF-inhibiting therapy in Austria in 2007 were treated most often with Adalimumab, while Etanercept showed the lowest switching rate and the longest 1- and 2-year drug survival.

Attending and non-attending patients in a real-life setting of an early arthritis clinic: why do people leave clinics and where do they go?

OBJECTIVES: Rheumatologist assessment as early as possible is considered essential for patients with inflammatory joint disease. In our Very Early Arthritis Clinic (VEAC), a substantial proportion of initially included and followed patients later stop attendance in the clinic. We questioned attending (AP) and non-attending patients (NAP) regarding current health status and satisfaction with care as well as reasons for discontinuation and current care received by NAP. METHODS: VEAC patients first seen between 1996 and 2003 were included. Assessment included the RADAI, HAQ, and visual analogue scales for pain, disease activity, fatigue, satisfaction with current health care. Current (DMARD) treatment was recorded. RESULTS: Among AP, 87% had rheumatoid arthritis (RA) and 13% non-RA. Of NAP, 37% had RA, 23% non-RA and 40% no more rheumatic disease. Satisfaction with health care concerning rheumatic disease was better in AP than NAP. Likewise, most outcome parameters were better in AP. Substantially more RA patients in the AP than NAP group received DMARDs. Apart from the disappearance of arthritis, logistic reasons were given most frequently for discontinuation of attendance. Less than 10% of NAP indicated dissatisfaction with medical care. CONCLUSIONS: We found advantages in both disease activity measures and satisfaction with health care for patients receiving continuous care in a highly specialised Rheumatology clinic. Furthermore, different DMARD usage in RA in AP and NAP may indicate significant deficits in treatment quality outside specialist care. Logistic issues associated with access to continuous Rheumatology care for early arthritis patients need improvement.

Evaluation of the appropriateness of composite disease activity measures for assessment of psoriatic arthritis.

OBJECTIVE: Specific composite indices assessing disease activity in psoriatic arthritis (PsA) have not yet been sufficiently validated. The objective of this study was to identify instruments best reflecting disease activity in PsA. METHODS: Measures for inclusion in clinical trials, as recommended by the OMERACT-7/8 PsA workshops, were assessed. A principal component analysis (PCA) was performed with cross-sectional data of 105 patients with PsA to identify a minimal set of important dimensions for a disease activity assessment tool for PsA. This was compared with components contained in existing composite indices. RESULTS: The PCA revealed four principal components best reflecting disease activity. The first contained patient global and pain assessment; the second contained 66/68 swollen and tender joint counts as main variables; C-reactive protein (CRP) best loaded to the third component; and the fourth was loaded by skin assessment but did not reach significance. When comparing the three significant principal components with items of established composite measures, they were best covered by the Disease Activity Index for Reactive Arthritis (DAREA) which comprises patient pain and global assessments, 66/68 joint counts and CRP. CONCLUSION: Among the currently available indices used in arthritic conditions, the DAREA best reflects the domains found to be important in PsA.

Treatment of osteoporosis with parathyroid hormone and teriparatide.

Nowadays osteoporosis treatment is based primarily on therapy with antiresorptive agents, like the bisphosphonates. Parathyroid hormone (Preotact) and human recombinant parathyroid hormone peptide 1-34 (Teriparatide) are relatively new for the treatment of osteoporosis and belong to the group of anabolic agents. Both agents demonstrated an increase in bone mineral density and a significant reduction in vertebral fractures in postmenopausal women with osteoporosis when given for 18-24 months. Data on nonvertebral fractures are, however, not clear-cut, and so far only bisphosphonates and strontium ranelate have been demonstrated to reduce all types of fractures and therefore remain the front-line option for treatment of osteoporosis. As the safety, tolerability, and cost of the therapy also influence the choice of therapy, Preotact and Teriparatide might be useful additions to the armamentarium for (second-line) treatment of osteoporosis.