Corrigendum to "Study protocol for the follow-up examination of the Nor-Hand study: A hospital-based observational cohort study exploring pain and biomarkers in people with hand osteoarthritis" [Osteoarthr. Cartil. Open 3 (2021) 100198].

[This corrects the article DOI: 10.1016/j.ocarto.2021.100198.].

Differences and similarities between the EULAR/ASAS-EULAR and national recommendations for treatment of patients with psoriatic arthritis and axial spondyloarthritis across Europe.

This is the first report comparing EULAR and national treatment recommendations for PsA patients across Europe, and the first this decade to compare ASAS-EULAR and national treatment recommendations in axSpA patients. An electronic survey was completed from October 2021-April 2022 by rheumatologists in 15 European countries. One and four countries followed all EULAR and ASAS-EULAR recommendations, respectively. Five countries had no national treatment recommendations for PsA and/or axSpA, but followed other regulations. In several countries, national treatment recommendations predated the most recent EULAR/ASAS-EULAR recommendations. Entry criteria for starting biologic/targeted synthetic disease-modifying anti-rheumatic drugs varied considerably. In several countries, for PsA patients with significant skin involvement, interleukin-17 inhibitors were not given preference. The positioning of Janus Kinase inhibitors differed and Phosphodiesterase-4 inhibitors were not in use/reimbursed in most countries. This study may motivate European countries to update their national treatment recommendations, to align them better with the latest international recommendations.

Attainment of the Patient-acceptable Symptom State in 548 patients with rheumatoid arthritis: Influence of demographic factors.

OBJECTIVES: To explore the clinical and socio-demographic factors associated with Patient Acceptable Symptom Status (PASS) in Rheumatoid Arthritis (RA). METHODS: In a post-hoc analyses of a cross-sectional study, RA patients from 11 countries were included. PASS was assessed as acceptable/not acceptable status by the patient. Variables collected included socio-economic (gender, age and country gross domestic product (GDP) per capita) and clinical variables: DAS28-3vESR (28 joint counts and Erythrocyte Sedimentation Rate), the patient-reported Rheumatoid Arthritis Impact of Disease (RAID) score and its seven domains (scored 0 to 10). Patients in PASS or not were compared through univariable tests and factors associated with PASS assessed by multivariable forward conditional logistic regression. A similar analysis was performed in the subgroup patients in DAS28 remission (n=168). RESULTS: A total of 548 patients were included: 80.5% female, mean (±SD) age 55.8±12.8years, disease duration 13.6±10.6 years, DAS28 3.6±1.5. Overall, 360 (65.7%) considered themselves to be in PASS. Independent factors positively associated with being in PASS were age>50 years [odds ratio, OR 1.67; (95% confidence Interval: 1.04-2.67)], a lower DAS28 [OR: 1.28 (1.08-1.52)], lower pain [OR:1.45 (1.27-1.64)] and better emotional well-being [OR:1.28 (1.13-1.45)]. Among patients in remission, being in PASS was positively associated with less severe pain [OR: 2.50 (1.79-3.84)], age>50 years [OR 3.30 (1.03 to10.87)] and living in a country of the low GDP category [OR: 5.08; (1.34-19.23)]. CONCLUSIONS: Being in PASS is related to many factors besides disease activity, including age, perceived impact of the disease and national GDP.

Study protocol for the follow-up examination of the Nor-Hand study: A hospital-based observational cohort study exploring pain and biomarkers in people with hand osteoarthritis.

Objective: This study aims to increase the understanding of pain mechanisms in hand OA and explore potential risk factors for pain development or worsening in a biopsychosocial framework. Another important aim is to validate potential soluble and imaging OA biomarkers. Design: The follow-up examination of the Nor-Hand hospital-based observational cohort study started in October 2019 and was completed in May 2021. In total, 212 of the 300 participants with hand OA who were examined at baseline attended the follow-up study. The participants underwent clinical joint examinations, medical and functional assessments, quantitative sensory testing, fluorescence optical imaging, ultrasound of the hands, acromioclavicular joints, feet, knees and hips, conventional radiographs of the hands and feet and magnetic resonance imaging of the dominant hand. Blood and urine samples were collected, and all participants answered questions about demographic factors and OA-related questionnaires. Associations between disease variables and symptoms will be examined in cross-sectional and longitudinal analyses. Longitudinal analyses will be performed to assess the predictive value of baseline variables on hand OA outcomes. Conclusion: Current knowledge about predictors for disease progression in hand OA is limited, but with longitudinal data we will be able to explore the predictive value of baseline variables on hand OA outcomes, such as changes in patient-reported outcomes or changes in soluble and imaging biomarkers. This provides a unique opportunity to gain more knowledge about the natural disease course of hand OA.

Validity and diagnostic performance of fluorescence optical imaging measuring synovitis in hand osteoarthritis: baseline results from the Nor-Hand cohort.

OBJECTIVE: Fluorescence optical imaging (FOI) demonstrates enhanced microcirculation in finger joints as a sign of inflammation. We wanted to assess the validity and diagnostic performance of FOI measuring synovitis in persons with hand OA, comparing it with magnetic resonance imaging (MRI)- and ultrasound-detected synovitis. METHODS: Two hundred and twenty-one participants with hand OA underwent FOI and ultrasound (gray-scale synovitis and power Doppler activity) of the bilateral hands and contrast-enhanced MRI examination of the dominant hand. Fifteen joints in each hand were scored on semi-quantitative scales (grade 0-3) for all modalities. Four FOI images were evaluated: one composite image (Prima Vista Mode (PVM)) and three images representing phases of fluorescent dye distribution. Spearman's correlation coefficients were calculated between sum scores of FOI, MRI, and ultrasound. Sensitivity, specificity, and area under the curve (AUC) were calculated for FOI using MRI or ultrasound as reference. RESULTS: FOI did not demonstrate enhancement in the thumb base, and the joint was excluded from further analyses. FOI sum scores showed poor to fair correlations with MRI (rho 0.01-0.24) and GS synovitis sum scores (rho 0.12-0.25). None of the FOI images demonstrated both good sensitivity and specificity, and the AUC ranged from 0.50-0.61 and 0.51-0.63 with MRI and GS synovitis as reference, respectively. FOI demonstrated similar diagnostic performance with PD activity and GS synovitis as reference. CONCLUSION: FOI enhancement correlated poorly with synovitis assessed by more established imaging modalities, questioning the value of FOI for the evaluation of synovitis in hand OA.

Joint Distribution and Two-Year Outcome in 347 Patients With Monoarthritis of Less Than Sixteen Weeks' Duration.

OBJECTIVE: The present study was undertaken to investigate the joint distribution and 2-year outcome of patients with recent-onset monoarthritis. METHODS: Adult patients with clinically apparent monoarthritis of ≤16 weeks' duration were included in a multicenter 2-year longitudinal study. Clinical characteristics, joint distribution, development of chronic inflammatory rheumatic disease (CIRD), as well as classification criteria according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for RA were studied. Predictors for development of CIRD were analyzed by multivariable logistic regression analyses. RESULTS: The knee (49.3%), ankle (16.7%), and wrist (14.1%) were the most frequently affected joints among the 347 included patients. A total of 91 patients (26.2%) developed CIRD during follow-up; 21 (6.1%) were diagnosed with RA, and 16 (4.6%) with psoriatic arthritis. Longer duration of joint swelling, joint localization, and anti-citrullinated protein antibody (ACPA) and rheumatoid factor (RF) positivity were independent predictors of CIRD. Six of 58 patients (10.3%) with ankle monoarthritis and 21 of 49 patients (42.9%) with wrist monoarthritis developed CIRD during follow-up. The 2010 ACR/EULAR Criteria for RA identified all patients diagnosed with seropositive RA at an early stage, mostly within 3 months. CONCLUSION: Approximately one-fourth of patients with recent-onset monoarthritis developed CIRD over 2 years. Patients presenting with ankle arthritis rarely developed CIRD, whereas patients presenting with wrist arthritis more frequently did so. Longer duration of joint swelling and ACPA and RF positivity were also predictive of CIRD. Our findings facilitate the early identification of patients with monoarthritis who have an unfavorable prognosis.

Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study.

OBJECTIVES: To identify a therapeutic target interval for certolizumab pegol drug levels and examine the influence of anti-drug antibodies in patients with inflammatory joint diseases. METHODS: Certolizumab pegol and anti-drug antibody levels were measured in serum samples collected after 3 months of certolizumab pegol treatment in 268 patients with inflammatory joint diseases (116 axial spondyloarthritis, 91 rheumatoid arthritis and 61 psoriatic arthritis) in the NOR-DMARD study. Treatment response was defined by Ankylosing Spondylitis Disease Activity Score Clinically important improvement in axial spondyloarthritis, European League Against Rheumatism good/moderate response in rheumatoid arthritis, and improvement in 28-joint Disease Activity Score of ≥ 0.6 in PsA. Serum drug levels and anti-drug antibodies were analysed using automated in-house assays. RESULTS: Certolizumab pegol serum levels varied considerably between individuals (median (IQR) 32.9 (17.3-43.9) mg/L). Certolizumab pegol level ≥ 20 mg/L was associated with treatment response for the total inflammatory joint disease population, with odds ratio (OR) 2.3 (95% CI 1.2-4.5, P = 0.01) and OR 1.9 (95% CI 1.0-3.5, P = 0.05) after 3 and 6 months of treatment, respectively. For individual diagnoses, this association was most consistent for axial spondyloarthritis, with OR 3.4 (95% CI 1.0-11.1, P < 0.05) and OR 3.3 (95% CI 1.0-10.8, P < 0.05), respectively. Certolizumab pegol level > 40 mg/L was not associated with any additional benefit for any of the diagnoses. Anti-drug antibodies were detected in 6.1% (19/310) of samples and were associated with low certolizumab pegol levels (P < 0.01). CONCLUSIONS: Serum certolizumab pegol levels 20-40 mg/L were associated with treatment response in inflammatory joint diseases. Our study is the first to show this association in axial spondyloarthritis and psoriatic arthritis patients. The results suggest a possible benefit of therapeutic drug monitoring in patients with inflammatory joint disease on certolizumab pegol treatment. TRIAL REGISTRATION: NCT01581294, April 2012.

Fibromyalgia in patients with rheumatoid arthritis. A 10-year follow-up study, results from the Oslo Rheumatoid Arthritis Register.

OBJECTIVES: To examine cross-sectional and longitudinal relationships between fibromyalgia (FM) and rheumatoid arthritis (RA) disease activity. METHODS: 636 patients in the observational Oslo RA register (ORAR) were invited to a clinical examination in 1999. 28-tender and swollen joint counts (TJC, SJC) and 18-tender points were assessed, the RA disease activity score (DAS-28) calculated. Fibromyalgia (FM) was diagnosed according to 1990 (FM-1990) and modified 2011 (mFM-2011) ACR criteria. At the 10-year follow-up patients completed the RA Disease Activity Index (RADAI) and Routine Assessment of Patient Index Data 3 (RAPID-3). Baseline and 10-year RA disease activity were compared across presence/absence of FM. Linear regression models were constructed with 10-year RADAI and RAPID-3 as outcome. RESULTS: 502 patients participated at baseline data-collection and 10-year data was available in 236. At baseline, mean (SD) age was 59.5 (12.5) years and 87% were female. 9% and 30% had FM-1990 and mFM-2011 respectively. RA-FM patients were predominantly female with higher SJC, TJC, and DAS-28 at baseline. Baseline RA-FM predicted higher levels of RADAI and RAPID-3 at the 10-year follow-up. CONCLUSIONS: RA-FM was associated with significantly higher levels of cross-sectional and longitudinal RA disease activity. FM should be considered in patients with RA not reaching remission.

Diagnostic spectrum and 2-year outcome in a cohort of patients with very early arthritis.

OBJECTIVES: To describe the diagnostic spectrum, arthritis persistency and clinical outcomes after 2 years in patients with inflammatory arthritis (IA) of less than 16 weeks' duration. METHODS: Data from the Norwegian Very Early Arthritis Clinic, a 2-year longitudinal observational study of adults with IA of ≤16 weeks' duration, were used. Exclusion criteria were arthritis due to crystal deposits, trauma, osteoarthritis and septic arthritis. In all patients who had any follow-up information (population A), clinical diagnoses and persistency of arthritis were described. For patients with 2-year follow-up (population B), we also studied other clinical outcomes (disease activity, pain, fatigue, functional disability and health-related quality of life). RESULTS: In population A (n=1017) median (25th-75th percentile) duration of joint swelling was 35.0 (13.0-66.5) days, mean (SD) age 45.7 (14.8) years, 55.2% were females and 17.8% anticitrullinated protein antibodies positive. The most common final diagnoses were undifferentiated arthritis (UA) (41.7%), rheumatoid arthritis (RA) (24.1%) and reactive arthritis (18.1%). After 2 years, the arthritis had resolved in 59% of the patients. The remaining 41.0% had persistent disease defined by disease modifying antirheumatic drug (DMARD) use (32.1%) or persistent joint swelling without DMARD use (8.9%). In population B (n=669), all clinical outcomes improved significantly (P<0.001). Baseline joint pain and fatigue were similar across diagnoses. CONCLUSIONS: Among 1017 patients with IA of ≤16 weeks' duration, UA was the most common diagnosis after 2 years, and less than one-fourth were diagnosed with RA. Arthritis resolved without DMARDs in the majority of the patients. All clinical parameters improved significantly over a 2-year course.

The comparison of magnetic resonance imaging and radiographs to assess structural progression over 5 years in hand osteoarthritis.

Objective: . The aim was to explore the agreement between 1.0 T MRI and conventional radiography (CR) to detect progression of hand OA over 5 years and the associations between structural progression and incident joint tenderness. Methods: Paired radiographs and paired MRIs of the second-fifth IP joints of the dominant hand from 69 hand OA patients were read for osteophytes, joint space narrowing and erosions. Patients with two or more joints demonstrating progression of any structural feature(s) were classified as progressors per imaging modality. Agreement between methods to detect progressors was evaluated with κ and intraclass correlation coefficients. At the joint level, the associations between methods to detect progression were explored with generalized estimating equations. Likewise, we analysed the associations between progression per imaging modality and incident pain. Results: MRI (58.0%) and CR (62.3%) detected similar numbers of progressors. The agreement between methods to detect progressors was good (κ = 0.61). We found good agreement between methods regarding the number of progressive joints (intraclass correlation coefficient = 0.61, 95% CI: 0.43, 0.76). At the joint level, MRI progression was associated with radiographic progression (P < 0.001). Incident joint tenderness was more common in joints with progression by MRI and CR, but statistically significance was not reached. Conclusion: Both 1.0 T MRI and CR detect a similar amount of progression over 5 years in patients with hand OA, although not in exactly the same joints. As CR assesses more joints for a lower cost, CR should be the imaging modality of choice rather than 1.0 T MRI in observational studies with a long period of follow-up.

Mapping the Effect of Psoriatic Arthritis Using the International Classification of Functioning, Disability and Health.

OBJECTIVE: The effect of a disease can be categorized by a standardized reference system: the International Classification of Functioning, Disability and Health (ICF). The objective was to map the effect of psoriatic arthritis (PsA) from the patient's perspective to the ICF. METHODS: A systematic literature review was performed. Qualitative publications reporting domains of impact important for patients with PsA were identified using the following terms: ("psoriatic arthritis") AND ("quality of life" OR "impact"). Meaningful concepts were extracted from the publications, grouped into domains and linked to the ICF categories. The number of concepts linked to each ICF category and to each ICF level was calculated. The number of concepts not linkable was also calculated. RESULTS: Eleven studies (13 articles) were included in the analysis. Twenty-five domains of impact were cited, of which the ability to work/volunteer and social participation were the most cited (both by 10 studies). In total, 258 concepts were identified, of which 217 could be linked to 136 different ICF categories; 41 concepts, mostly personal factors, could not be precisely linked. The most represented ICF component was activities and participation (42.6%) rather than body structures (10.3%) or body functions (29.4%). Ten studies (90.9%) reported impairments in the ability to work/volunteer and social participation, and 7 (63.6%) reported leisure activities, family and intimacy, pain, skin problems, and body image. CONCLUSION: PsA widely affects all aspects of patients' lives, in particular aspects related to activities and participation. The ICF is a useful approach for the classification of disease effect.

Association of Chest Pain and Risk of Cardiovascular Disease with Coronary Atherosclerosis in Patients with Inflammatory Joint Diseases.

OBJECTIVES: The relation between chest pain and coronary atherosclerosis (CA) in patients with inflammatory joint diseases (IJD) has not been explored previously. Our aim was to evaluate the associations of the presence of chest pain and the predicted 10-year risk of cardiovascular disease (CVD) by use of several CVD risk algorithms, with CA verified by multidetector computed tomography (MDCT) coronary angiography. METHODS: Detailed information concerning chest pain and CVD risk factors was obtained in 335 patients with rheumatoid arthritis and ankylosing spondylitis. In addition, 119 of these patients underwent MDCT coronary angiography. RESULTS: Thirty-one percent of the patients (104/335) reported chest pain. Only six patients (1.8%) had atypical angina pectoris (pricking pain at rest). In 69 patients without chest pain, two thirds had CA, while in those who reported chest pain (n = 50), CA was present in 48.0%. In a logistic regression analysis, chest pain was not associated with CA (dependent variable) (p = 0.43). About 30% (Nagelkerke R (2)) of CA was explained by any of the CVD risk calculators: Systematic Coronary Risk Evaluation, Framingham Risk Score, or Reynolds Risk Score. CONCLUSION: The presence of chest pain was surprisingly infrequently reported in patients with IJD who were referred for a CVD risk evaluation. However, when present, chest pain was weakly associated with CA, in contrast to the predicted CVD risk by several risk calculators which was highly associated with the presence of CA. These findings suggest that clinicians treating patients with IJD should be alert of coronary atherosclerotic disease also in the absence of chest pain symptoms.

The Impact of Newer Biological Disease Modifying Anti-Rheumatic Drugs on Cardiovascular Risk Factors: A 12-Month Longitudinal Study in Rheumatoid Arthritis Patients Treated with Rituximab, Abatacept and Tociliziumab.

OBJECTIVES: To assess whether treatment with one of three novel biological DMARDs; rituximab, abatacept or tocilizumab reduce cardiovascular disease (CVD) risk factors in patients with rheumatoid arthritis (RA). METHODS: This is an open, observational and prospective study with visits at baseline, 3, 6, and 12 months. Patients were assigned to receive rituximab, abatacept or tocilizumab according to clinical indications assessed by an independent rheumatologist. Disease activity was quantified by the disease activity score (DAS28) and extensive ultrasonography. CVD risk was assessed by total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), blood pressure and arterial stiffness measurements [pulse wave velocity (PWV) and augmentation index (AIx)]. Within group change in disease activity and CVD risk over 3 months was explored using paired samples bivariate tests. Predictors of change in CVD risk at 3 months were identified in linear regression models. Changes in CVD risk markers over the 12- month follow-up in patients receiving rituximab were assessed by mixed models repeated analyses. RESULTS: 24 patients on rituximab, 5 on abatacept and 7 on tocilizumab were included. At 3 months PWV was significantly reduced in the tocilizumab group only, but at 12 months rituximab patients showed a significant reduction in PWV. Reduced inflammation at 3 months was associated with increased TC and HDL-c in the entire cohort. CONCLUSION: Treatment with tocilizumab and rituximab reduces PWV, a marker of CVD risk, in patients with RA.

The L-arginine/asymmetric dimethylarginine ratio is improved by anti-tumor necrosis factor-α therapy in inflammatory arthropathies. Associations with aortic stiffness.

BACKGROUND: Anti-Tumor Necrosis Factor (TNF)-α therapy improves vascular pathology in inflammatory arthropathies such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. The l-arginine/ADMA ratio is important for modulation of the nitric oxide synthase activity. We examined the effect of TNF-α antagonists on ADMA and l-arginine/ADMA, and associations between ADMA, L-arginine/ADMA, aortic stiffness and carotid intima media thickness (CIMT) in patients with inflammatory arthropathies. METHODS: Forty-eight patients who started with anti-TNF-α therapy were compared with a non-treated group of 32 patients. Plasma ADMA and L-arginine were assessed at baseline, 3 and 12 months. In a subgroup of 55 patients, aortic pulse wave velocity (aPWV) was measured at baseline, 3 and 12 moths, and CIMT was examined at baseline and 12 months. RESULTS: Anti-TNF-α therapy increased the L-arginine/ADMA ratio (mean [SD]) in the treatment group compared to the control group after 3 months (12 [29] vs. -13 [20], P < 0.001) and 12 months (7 [27] vs. -8 [19], P = 0.008), but did not affect ADMA (3 months: 0.00 [0.09] µmol/L vs. 0.02 [0.07] µmol/L, P = 0.42, 12 months: 0.01 [0.08] µmol/L vs. 0.01 [0.09] µmol/L, P = 0.88). Baseline aPWV was associated with ADMA (P = 0.02) and L-arginine/ADMA (P = 0.02) in multiple regression analyses, and the L-arginine/ADMA ratio was continuously associated with aPWV after initiation of anti-TNF-α therapy (P = 0.03). ADMA and L-arginine/ADMA were not correlated with CIMT. CONCLUSION: Anti-TNF-α therapy improved the L-arginine/ADMA ratio in patients with inflammatory arthropathies. ADMA and the L-arginine/ADMA ratio were associated with aPWV, and might have a mechanistic role in the aortic stiffening observed in these patients.

The AUSCAN subscales, AIMS-2 hand/finger subscale, and FIOHA were not unidimensional scales.

OBJECTIVES: Evaluate the internal construct validity of the Australian/Canadian (AUSCAN) index for hand osteoarthritis (HOA) and identify the physical function instrument with best performance. STUDY DESIGN AND SETTING: AUSCAN, AIMS-2 (Arthritis Impact Measurement Scale 2), and Functional Index of HOA (FIHOA) were self-completed by 209 HOA patients (mean [standard deviation] age 61.6 [5.7] years) at baseline and 128 at follow-up. Rasch analysis was performed. RESULTS: AUSCAN pain, physical function, and stiffness subscales comprised three constructs. AUSCAN scale performance was improved after removal of "Pain at rest" from the pain scale and division of physical function into two scales of high precision and grip strength tasks. AIMS-2 hand/finger subscale and FIHOA were improved after removal of one and two items, respectively and collapse of two AIMS-2 response categories. AUSCAN physical function scale showed better targeting to the sample and higher person reliability compared with FIHOA and especially AIMS-2 because of less "severe" items concerning grip strength tasks as opposed to precision tasks. CONCLUSION: The AUSCAN subscales, AIMS-2 hand/finger scale, and FIHOA were not unidimensional. However, deletion of misfitting items improved scale performance. The revised AUSCAN physical function and FIHOA scales are preferable for measurement of grip strength and precision tasks, respectively.

Changes in arterial stiffness during continued infliximab treatment in patients with inflammatory arthropathies.

Chronic inflammatory arthropathies such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are associated with an increased risk of cardiovascular disease. TNF-α antagonists may improve vascular function in these patients and thus be beneficial with regard to cardiovascular disease. This study evaluated arterial stiffness and disease activity between two infusions with a TNF-α antagonist (infliximab) in patients with inflammatory arthropathies on long-term infliximab therapy. Augmentation index (AIx), aortic pulse wave velocity (aPWV), and disease activity were measured in 17 patients with RA, AS, or PsA who had been treated with infliximab for at least 12 months. The patients were examined immediately before their infliximab infusion and thereafter every 10th day until their next infusion scheduled at week 4-8. AIx and aPWV did not change during the period between two infliximab infusions. The patients had a temporary improvement in the general disease activity assessed on visual analogue scales by the patients (P = 0.04) and the investigator (P = 0.02) after the infusion. In the group of patients with RA, the Disease Activity Score (DAS28) changed significantly in a similar manner (P = 0.003). C-reactive protein and erythrocyte sedimentation rate remained unchanged. Infliximab infusions did not alter aortic pulse wave velocity or augmentation index in patients with inflammatory arthropathies who were on long-term infliximab therapy. Reductions in the general disease activity and DAS28 were not reflected in alterations of aortic stiffness or augmentation index.

Multidisciplinary and multifaceted outpatient management of patients with osteoarthritis: protocol for a randomised, controlled trial.

BACKGROUND: Osteoarthritis (OA) is a prevalent joint disorder with a need for efficient and evidence-based management strategies. OBJECTIVES: The primary purpose of this study is to compare the effects of a multidisciplinary outpatient clinic, including a brief group-based educational programme, with a traditional individual outpatient clinic for patients with hip, knee, hand or generalized OA. A secondary purpose is to investigate the effects of a telephone follow-up call. METHODS: This is a pragmatic randomised single-blind controlled study with a total of 400 patients with hip, knee, hand or generalized OA between 40 and 80 years referred to an outpatient rheumatology hospital clinic. The randomisation is stratified according to the diagnostic subgroups. The experimental group is exposed to a multidisciplinary and multifaceted intervention, including a 3.5 hour group-based patient education programme about OA in addition to individual consultations with members of a multidisciplinary team. The control intervention is based on regular care with an individual outpatient consultation with a rheumatologist (treatment as usual). Primary outcomes are patient satisfaction measured at 4 months and cost-effectiveness measured at 12 months. Secondary outcomes are pain and global disease activity measured on a numeric rating scales (NRS), generic and disease specific functioning and disability using Short Form-36 (SF-36) health survey, the Western Ontario and McMaster Universities Osteoarthritis Index 3 (WOMAC), the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), and a patient-generated measure of disability (Patient-Specific Functional scale, PSFS). Global perceived effect of change in health status during the study period is also reported. At 4-month follow-up, patients in both groups will be randomly allocated to a 10-minute telephone call or no follow-up ("treatment as usual"). After additional 8 months (12-month follow-up) the four groups will be compared in a secondary analysis with regard to health outcomes and health care costs. DISCUSSION: This trial will provide results on how multidisciplinary and multifaceted management of patients with OA affects health outcomes and health care costs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25778426.

Identification of cutpoints for acceptable health status and important improvement in patient-reported outcomes, in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

OBJECTIVE: To identify cutpoints reflecting Patient Acceptable Symptom State (PASS) and Minimal Clinically Important Improvement (MCII) in patient-reported multi-attribute health status classification systems and health status measurements among patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA). METHODS: We identified patients with RA, AS, and PsA from the Norwegian disease-modifying antirheumatic drug (DMARD) register (NOR-DMARD). The patients (n = 4225) had started with DMARD and responded to the PASS and MCII anchoring questions at the 3-month followup examination. Receiver operating characteristics (ROC) curves with 80% specificity and the 75th percentile approach were used to identify PASS and MCII cutpoints in the EuroQol-5 Dimensions (EQ-5D) and the Short-Form-6 Dimensions (SF-6D) indexes, but also in other patient-reported outcomes (joint pain and patient global visual analog scale and Modified Health Assessment Questionnaire). RESULTS: The PASS cutpoints estimated with 80% specificity were around 0.70 in EQ-5D in all diseases and around 0.65 in SF-6D. The cutpoints were around 0.65 and 0.60, respectively, when the 75th percentile approach was used. The MCII cutpoints assessed by 80% specificity varied from 0.10 to 0.19 in EQ-5D and from 0.07 to 0.10 in SF-6D. CONCLUSION: The cutpoints for PASS in EQ-5D and SF-6D indicate that PASS corresponds to a health-related quality of life that is far from perfect health. Somewhat different cutpoints were identified for both PASS and MCII with 80% specificity versus the 75th percentile method.