Validation of the Rheumatoid and Arthritis Outcome Score (RAOS) for the lower extremity

BACKGROUND: Patients with inflammatory joint diseases tend due to new treatments to be more physically active; something not taken into account by currently used outcome measures. The Rheumatoid and Arthritis Outcome Score (RAOS) is an adaptation of the Knee injury and Osteoarthritis Outcome Score (KOOS) and evaluates functional limitations of importance to physically active people with inflammatory joint diseases and problems from the lower extremities. The aim of the study was to test the RAOS for validity, reliability and responsiveness. METHODS: 119 in-patients with inflammatory joint disease (51% RA) admitted to multidisciplinary care, mean age 56 (±13), 73% women, mean disease duration 18 (±14) yr were consecutively enrolled. They all received the RAOS, the SF-36, the HAQ and four subscales of the AIMS2 twice during their stay for test of validity and responsiveness. Test-retest reliability of the RAOS questionnaire was calculated on 52 patients using the first or second administration and an additional mailed questionnaire. RESULTS: The RAOS met set criteria of reliability and validity. The random intraclass correlation coefficient (ICC (2,1)) for the five subscales ranged from 0.76 to 0.92, indicating that individual comparisons were possible except for the subscale Sport and Recreation Function. Inter-item correlation measured by Cronbach's alpha ranged from 0.78 to 0.95. When measuring construct validity the highest correlations occurred between subscales intended to measure similar constructs. Change over time (24 (± 7) days) due to multidisciplinary care was significant for all subscales (p < 0.001). The effect sizes ranged from 0.30–0.44 and were considered small to medium. All the RAOS subscales were more responsive than the HAQ. Some of the SF-36 subscales and the AIMS2 subscales were more responsive than the RAOS subscales. CONCLUSION: It is possible to adapt already existing outcome measures to assess other groups with musculoskeletal difficulties in the lower extremity. The RAOS is a reliable, valid and responsive outcome instrument for assessment of multidisciplinary care. To fully validate the RAOS further studies are needed in other populations

Sick leave patterns in common musculoskeletal disorders – a study of doctor prescribed sick leave

Comparative data on sick leave within musculoskeletal disorders (MSDs) is limited. Our objective was to give a descriptive overview of sick leave patterns in different MSDs

Evaluation of hand bone loss by digital X-ray radiogrammetry as a complement to clinical and radiographic assessment in early rheumatoid arthritis: results from the SWEFOT trial

BACKGROUND: To investigate hand bone loss (HBL) measured by digital X-ray radiogrammetry (DXR) in patients with early rheumatoid arthritis (RA) receiving different treatment regimens, and to evaluate if DXR change rates during the first 12 months correlate with radiological damage after 24 months. METHODS: From the total SWEFOT trial population, 159 patients had hand radiographs correctly timed and taken with same modality to be analyzed with DXR. All patients started treatment with methotrexate. After 3–4 months, patients with DAS28 > 3.2 were randomized to add sulfasalazine and hydroxychloroquine (triple therapy) or infliximab (MTX + INF). Those with DAS28 ≤3.2 were followed in regular care. Radiographic progression over 24 months was scored according to the Sharp van der Heijde score (SHS) and defined as >5 increase in T-SHS over 24 months. Hand bone mineral density (BMD) was measured by DXR at inclusion and 12 months and a change ≥2.5 mg/cm(2)/month was used as a cut-off for HBL. RESULTS: In the MTX responders, triple therapy, and MTX + INF groups, the proportions with HBL were 4.1%, 22.2% and 16.4%, respectively (p = 0.01), and the mean (SD) radiological progression in these groups was 3.91 (6.72), 7.40 (14.63) and 2.72 (4.55) respectively (p = 0.06). Patients with HBL had significantly greater risk for radiographic progression, compared with patients without HBL (odds ratio 3.09, 95% CI =1.20–7.79, p = 0.02). CONCLUSIONS: Non-responders to MTX had a significantly greater risk of HBL than MTX-responders, despite the add-on therapies. Patients with HBL during the 12 months had greater risk of radiographic progression after 24 months. Evaluation of HBL may help to identify patients who are at risk of radiographic progression

The nature stroke study; NASTRU: A randomized controlled trial of nature-based post-stroke fatigue rehabilitation

Objective: To determine whether nature-based rehabilitation, as an add-on to standard care, has a long-term influence on post-stroke fatigue, perceived value of everyday occupations, disability, health-related quality of life, anxiety, and depression at follow-up 8 and 14 months after randomization. Design: Single-blinded, 2-armed, randomized controlled trial. Methods: Stroke survivors, identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke >1 year previously), were randomized to standard care + nature-based rehabilitation (intervention group) or standard care alone (control group). Blinded evaluations were conducted at follow-up 8 and 14 months after randomization, for the following outcomes: post-stroke fatigue (Mental Fatigue Scale; MFS), perceived value of everyday occupations (Occupational value instrument with predefined items), disability (modified Rankin Scale; mRS), health-related quality of life (Euro-QoL-5 Demension Questionnaire), anxiety (Hospital Anxiety and Depression Scale; HAD) and depression (HAD). Results: Approximately one-quarter of the screened patients were eligible for inclusion in the study; of these, half agreed to participate; a final total of 101 patients were randomized (mean age 67 years, 60% female). The patients with sub-acute stroke were highly compliant with the intervention. The participants in both the intervention and control groups improved, However, no statistically significant differences in improvement were found between the intervention and control groups for any of the outcome measures. Fatigue decreased to a value below the suggested cut-off for mental fatigue (&lt;10.5) in the intervention group, but not in the control group. Conclusion: Nature-based rehabilitation is feasible and well tolerated. A larger randomized controlled trial is warranted

Decrease in the incidence of total hip arthroplasties in patients with rheumatoid arthritis - results from a well defined population in south Sweden

To access publisher full text version of this article. Please click on the hyperlink in Additional Links field.INTRODUCTION: One aim of modern pharmacologic treatment in rheumatoid arthritis (RA) is to prevent joint destruction and reduce the need for surgery. Our purpose was to investigate secular trends in the incidence of primary total hip and knee arthroplasties in a well defined sample of patients with RA. METHODS: Prevalent cases with RA in 1997 and incident cases from 1997 to 2007 in a community based register in Malmö, south Sweden, were included. Based on a structured review of the medical records, patients were classified according to the 1987 ACR criteria for RA. This cohort was linked to the Swedish Hip Arthroplasty Register (through December 2006) and the Swedish Knee Arthroplasty Register (through October 2007). Patients with a registered total hip or knee arthroplasty before 1997 or before RA diagnosis were excluded. Incidence rates for the period of introduction of TNF inhibitors (1998 to 2001) were compared to the period when biologics were part of the established treatment for severe RA (2002 to 2006/2007). RESULTS: In the cohort (n = 2,164; 71% women) a primary hip arthroplasty was registered for 115 patients and a primary knee arthroplasty for 82 patients. The incidence of primary total hip arthroplasties decreased from the period 1998 to 2001 (12.6/1,000 person-years (pyr)) to 2002 to 2006 (6.6/1,000 pyr) (rate ratio (RR) 0.52; 95% confidence interval (CI) 0.35 to 0.76). There was a trend towards an increase of primary knee arthroplasties (incidence 4.8/1,000 pyr vs. 6.8/1,000 pyr; RR 1.43; 95% CI 0.89 to 2.31). CONCLUSIONS: Our investigation shows a significant decrease in the incidence of total hip arthroplasties in patients with RA after 2001. Possible explanations include a positive effect on joint damage from more aggressive pharmacological treatment.The Swedish Research Council Lund University Crafoord Foundation Swedish Rheumatism Associatio

TNF inhibitors and extraarticular RA Personal non-commercial use only

ABSTRACT. Objective. The aims of this study were to evaluate whether treatment with tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA) affects the risk of developing severe extraarticular rheumatoid arthritis (ExRA) manifestations and to investigate potential predictors for developing ExRA. Methods. A dynamic community-based cohort of patients with RA was studied (n = 1977). Clinical records were reviewed and cases of severe ExRA were identified. Information on exposure to TNF inhibitors was obtained from a regional register. Exposure to TNF inhibitors was analyzed in a time-dependent fashion and the incidence of severe ExRA in exposed patients was compared with the incidence in unexposed patients. Cox regression models were used to assess potential predictors of severe ExRA. Results. During treatment with TNF inhibitors, there were 17 patients with new onset of severe ExRA in 2400 person-years at risk (PY; 0.71/100 PY, 95% CI 0.41-1.13) compared with 104 in 15,599 PY (0.67/100 PY, 95% CI 0.54-0.81) in patients without TNF inhibitors. This corresponded to an incidence rate ratio of 1.06 (95% CI 0.60-1.78). The age-and sex-adjusted HR for ExRA in anti-TNF-treated patients was 1.21 (95% CI 1.02-1.43), with similar findings in models adjusted for time-dependent Health Assessment Questionnaire and propensity for anti-TNF treatment. Male sex, positive rheumatoid factor (RF), long disease duration, and greater disability were predictors for ExRA. Conclusion. This study suggests that patients treated with TNF inhibitors are at a slightly increased risk of developing severe ExRA. RF-positive patients with disabling disease of long duration were more likely to develop sever

The revised Bristol Rheumatoid Arthritis Fatigue measures and the Rheumatoid Arthritis Impact of Disease scale: Validation in six countries

© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. Objective. To evaluate the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAFMDQ), the revised Bristol Rheumatoid Arthritis Numerical Rating Scales (BRAF-NRS V2) and the Rheumatoid Arthritis Impact of Disease (RAID) scale in six countries. Methods. We surveyed RA patients in France, Germany, The Netherlands, Spain, Sweden and the UK, including the HAQ, 36-item Short Form Health Survey (SF-36) and potential revisions of the BRAF-NRS coping and Spanish RAID coping items. Factor structure and internal consistency were examined by factor analysis and Cronbach's α and construct validity by Spearman's correlation. Results. A total of 1276 patients participated (76% female, 25% with a disease duration < 5 years, median HAQ 1.0). The original BRAF-MDQ four-factor structure and RAID single-factor structure were confirmed in every country with ≥66% of variation in items explained by each factor and all item factor loadings of 0.71-0.98. Internal consistency for the BRAF-MDQ total and subscales was a Cronbach's α of 0.75-0.96 and for RAID, 0.93-0.96. Fatigue construct validity was shown for the BRAF-MDQ and BRAF-NRS severity and effect scales, correlated internally with SF-36 vitality and with RAID fatigue (r = 0.63-0.93). Broader construct validity for the BRAFs and RAID was shown by correlation with each other, HAQ and SF-36 domains (r = 0.46-0.82), with similar patterns in individual countries. The revised BRAF-NRS V2 Coping item had stronger validity than the original in all analyses. The revised Spanish RAID coping item performed as well as the original. Conclusion. Across six European countries, the BRAF-MDQ identifies the same four aspects of fatigue, and along with the RAID, shows strong factor structure and internal consistency and moderate-good construct validity. The revised BRAF-NRS V2 shows improved construct validity and replaces the original

Serum levels of Cartilage Oligomeric Matrix Protein (COMP) increase temporarily after physical exercise in patients with knee osteoarthritis

BACKGROUND: COMP (Cartilage oligomeric matrix protein) is a matrix protein, which is currently studied as a potential serum marker for cartilage processes in osteoarthritis (OA). The influence of physical exercise on serum COMP is not fully elucidated. The objective of the present study was to monitor serum levels of COMP during a randomised controlled trial of physical exercise vs. standardised rest in individuals with symptomatic and radiographic knee OA. METHODS: Blood samples were collected from 58 individuals at predefined time points before and after exercise or rest, one training group and one control group. The physical exercise consisted of a one-hour supervised session twice a week and daily home exercises. In a second supplementary study 7 individuals were subjected to the same exercise program and sampling of blood was performed at fixed intervals before, immediately after, 30 and 60 minutes after the exercise session and then with 60 minutes interval for another five hours after exercise to monitor the short-term changes of serum COMP. COMP was quantified with a sandwich-ELISA (AnaMar Medical, Lund, Sweden). RESULTS: Before exercise or rest no significant differences in COMP levels were seen between the groups. After 60 minutes exercise serum COMP levels increased (p < 0.001). After 60 minutes of rest the serum levels decreased (p = 0.003). Median serum COMP values in samples obtained prior to exercise or rest at baseline and after 24 weeks did not change between start and end of the study. In the second study serum COMP was increased immediately after exercise (p = 0.018) and had decreased to baseline levels after 30 minutes. CONCLUSION: Serum COMP levels increased during exercise in individuals with knee OA, whereas levels decreased during rest. The increased serum COMP levels were normalized 30 minutes after exercise session, therefore we suggest that samples of blood for analysis of serum COMP should be drawn after at least 30 minutes rest in a seated position. No increase was seen after a six-week exercise program indicating that any effect of individualized supervised exercise on cartilage turnover is transient

Protocol for evaluating and implementing a pragmatic value-based healthcare management model for patients with inflammatory arthritis:A Danish population-based regional cohort and qualitative implementation study

Introduction The provision of healthcare for patients with inflammatory arthritis occurs in the context of somewhat conflicting targets, values and drivers. Therefore, there is a need for introducing 'value-based healthcare' defined as the value of patient relevant health outcomes in relation to costs. This term is a central part of tomorrow's healthcare sector, especially for rheumatic diseases, yet the transition is a huge challenge, as it will impact the development, delivery and assessment of healthcare. Aims The aim of this study is to compare medical and patient evaluated impact of the traditional settlement and financing production (DAGS) controlled healthcare setting with a value-based and patient-centred adjunctive to standard care. Methods and analysis Patients with inflammatory arthritis receiving treatment in routine care at the outpatient clinics in the Capital Region of Denmark will prospectively and consecutively be enrolled in a Non-Intervention-Study framework providing a pragmatic value-based management model. A Danish reference cohort, used for comparison will be collected as part of routine clinical care. The enrolment period will be from 1 June 2018 until 31December 2023. Baseline and follow-up visits will be according to routine clinical care. Registry data will be obtained directly from patients and include personal, clinical and outcomes information. The study results will be reported in accordance with the STROBE statement. Ethics and dissemination The study has been notified to the Danish Data Protection Agency and granted authorisation for the period June 2018 to January 2025 (pending). Informed consent will be obtained from all patients before enrolment in the study. The study is approved by the ethics committee, Capital Region of Denmark (H-18013158). Results of the study will be disseminated through publication in international peer-reviewed journals