Beliefs about medicines in gout patients: results from the NOR-Gout 2-year study.

OBJECTIVE: Adherence to urate-lowering therapy (ULT) in gout is challenging. This longitudinal study aimed to determine 2 year changes in beliefs about medicines during intervention with ULT. METHOD: Patients with a recent gout flare and increased serum urate received a nurse-led ULT intervention with tight control visits and a treatment target. Frequent visits at baseline and 1, 2, 3, 6, 9, 12, and 24 months included the Beliefs about Medicines Questionnaire (BMQ), and demographic and clinical variables. The BMQ subscales on necessity, concerns, overuse, harm, and the necessity-concerns differential were calculated as a measure of whether the patient perceived that necessity outweighed concerns. RESULTS: The mean serum urate reduced from 500 mmol/L at baseline to 324 mmol/L at year 2. At years 1 and 2, 85.5% and 78.6% of patients, respectively, were at treatment target. The 2 year mean ± sd BMQ scores increased for the necessity subscale from 17.0 ± 4.4 to 18.9 ± 3.6 (p < 0.001) and decreased for the concerns subscale from 13.4 ± 4.9 to 12.5 ± 2.7 (p = 0.001). The necessity-concerns differential increased from 3.52 to 6.58 (p < 0.001), with a positive change independent of patients achieving treatment targets at 1 or 2 years. BMQ scores were not significantly related to treatment outcomes 1 or 2 years later, and achieving treatment targets did not lead to higher BMQ scores. CONCLUSION: Patient beliefs about medicines improved gradually over 2 years, with increased beliefs in the necessity of medication and reduced concerns, but this improvement was unrelated to better outcomes. TRIAL REGISTRATION: ACTRN12618001372279.

Psoriatic arthritis, axial spondyloarthritis and rheumatoid arthritis in Norway: nationwide prevalence and use of biologic agents.

OBJECTIVE: To estimate the prevalence of psoriatic arthritis (PsA), axial spondyloarthritis (axSpA) and rheumatoid arthritis (RA) and the use of biologic agents in these diseases in Norway. METHODS: From the Norwegian Patient Registry (NPR), we identified as PsA, axSpA and RA patients ≥18 years those with ≥2 recorded episodes with diagnostic coding for index disease (L40.5, M07.0-M07.3 for PsA; M45, M46.0, M46.1, M46.8 and M46.9 for axSpA; M05-M06 for RA). We calculated the point prevalence of PsA, axSpA and RA as per the 1st of January 2017 in the Norwegian adult population (age ≥18). Dispensed disease-modifying antirheumatic drug (DMARD) prescriptions were obtained from the Norwegian Prescription Database and biologic DMARDs given in hospitals from the NPR. RESULTS: The point prevalence of PsA, axSpA, RA, and any of these diseases in total was 0.46%, 0.41%, 0.78%, and 1.56%, respectively. Among women, the prevalence of PsA, axSpA, and RA was 0.50%, 0.37%, and 1.10%, and among men 0.43%, 0.45%, and 0.46%, respectively. In 2017, 27.3% of RA patients, 25.7% of PsA patients and 35.1% of axSpA patients used biologic DMARDs. Treatment with biologics was more frequent in younger age groups in all three diseases, and became more infrequent especially after age ≥55 years. CONCLUSION: In Norway, the combined prevalence of PsA, axSpA, and RA was over 1.5%. Reflecting the good overall access to highly effective but costly biologic treatments, more than a fourth of these patients used biologic agents, which corresponds to over 0.4% of Norwegian adult population.

Fluctuation and change of serum urate levels and flares in gout: results from the NOR-Gout study.

A gout attack may evolve after a purine-rich diet or alcohol and after starting urate-lowering therapy (ULT). The relationships between fluctuation and change in serum urate (SU) with the occurrence of flares were investigated in this study. In the prospective NOR-Gout study, gout patients with increased SU and a recent flare were treated to target with ULT over 1 year, with follow-up at year 2 with SU and flare as outcomes. SU and flares were assessed at both monthly and 3-monthly intervals until target SU was reached. Fluctuation over periods and changes in SU between two time points were assessed and compared in patients with and without flares. At year 1, 186 patients completed follow-up (88.2%) and 173 (82.0%) at year 2. Mean age (SD) at baseline was 56.4 (13.7) years, disease duration was 7.8 (7.6) years, and 95.3% were men. The first-year SU fluctuation and change were related to flare occurrence during year 1 (both p < 0.05). High fluctuation with an absolute sum of all SU changes during the first 9 months was related to flares over 3-month periods (all p < 0.05), and high fluctuation during the first 3 months was related to flares in months 3-6 (p = 0.04). Monthly and high SU changes or again reaching higher SU levels > 360 µmol/l were not related to flares. Fluctuation and change in SU were related to flare occurrence during the first year of ULT, while changes between visits and reaching SU levels > 360 µmol/L were not related to flares. Key Points • Urate-lowering therapy seeks to achieve a treatment target and prevent gout flares, and changes in serum urate are related to gout flares. • Fluctuation and changes in serum urate were associated with gout flares, suggesting that fluctuation in serum urate is unfavourable during gout treatment. • During urate-lowering therapy in gout in clinical practice, fluctuation of serum urate, for example, due to lack of adherence, should be observed and avoided.

The MCP2 and the wrist plus two extensor compartments are the most affected and responsive joints/tendons out of the US7 score in patients with rheumatoid arthritis-an observational study.

BACKGROUND: There is no international consensus on an optimal ultrasound score for monitoring of rheumatoid arthritis (RA) on patient-level yet. Our aim was to reassess the US7 score for the identification of the most frequently pathologic and responsive joint/tendon regions, to optimize it and contribute to an international consensus. Furthermore, we aimed to evaluate the impact of disease duration on the performance of the score. METHODS: RA patients were assessed at baseline and after 3 and 6 months of starting/changing DMARD therapy by the US7 score in greyscale (GS) and power Doppler (PD). The frequency of pathologic joint/tendon regions and their responsiveness to therapy were analyzed by Friedman test and Cochrane-Q test respectively, including the comparison of palmar vs. dorsal regions (chi-square test). The responsiveness of different reduced scores and the amount of information retained from the original US7 score were assessed by standardized response means (SRM)/linear regression. Analyses were also performed separately for early and established RA. RESULTS: A total of 435 patients (N = 138 early RA) were included (56.5 (SD 13.1) years old, 8.2 (9.1) years disease duration, 80% female). The dorsal wrist, palmar MCP2, extensor digitorum communis (EDC) and carpi ulnaris (ECU) tendons were most frequently affected by GS/PD synovitis/tenosynovitis (wrist: 45%/43%; MCP2: 35%/28%; EDC: 30%/11% and ECU: 25%/11%) and significantly changed within 6 months of therapy (all p ≤0.003 by GS/PD). The dorsal vs. palmar side of the wrist by GS/PD (p < 0.001) and the palmar side of the finger joints by PD (p < 0.001) were more frequently pathologic. The reduced US7 score (GS/PD: palmar MCP2, dorsal wrist, EDC and ECU, only PD: dorsal MCP2) showed therapy response (SRM 0.433) after 6 months and retained 76% of the full US7 score's information. No major differences between the groups of early and established RA could be detected. CONCLUSIONS: The wrist, MCP2, EDC, and ECU tendons were most frequently pathologic and responsive to therapy in both early and established RA and should therefore be included in a comprehensive score for monitoring RA patients on patient-level.

Peptidylarginine deiminase 4 (PAD4) activity in early rheumatoid arthritis.

Objectives: Peptidylarginine deiminases (PADs) are a family of calcium-dependent enzymes catalysing the conversion of arginine residues to citrulline, which may constitute a risk factor in rheumatoid arthritis (RA) pathogenesis. We investigated PAD activation by serum (PADAct) in early RA, and the associations between PAD activation and disease characteristics, treatment response, and progression of radiographic damage.Method: Sera from disease-modifying anti-rheumatic drug (DMARD)-naïve early RA patients (n = 225), classified according to the 2010 American College of Rheumatology/European League Against Rheumatism criteria, and healthy controls (n = 63) were analysed for PAD4 activating capacity at 0, 3, 12, and 24 months using a high-performance liquid chromatography fluorometric method. Associations for PADAct were evaluated by Mann-Whitney U and chi-squared tests. Changes in PADAct levels were compared using the Wilcoxon signed-rank test.Results: PADAct positivity occurred in 42% (n = 95) of the patients and was more prevalent in anti-citrullinated protein antibody (ACPA)-positive vs ACPA-negative patients (47% vs 20%, p = 0.002), but not in rheumatoid factor (RF)-positive vs RF-negative patients (44% vs 38%, p = 0.49). PADAct-positive were younger than PADAct-negative patients [mean ± sd 48.7 ± 13.5 vs 53.2 ± 13.7 years, p = 0.011]. Median [25th, 75th percentile] PADAct levels were higher in patients than in controls (8768 [7491, 11 393] vs 7046 [6347, 7906], p < 0.0001) and decreased after initiation of DMARD treatment, but were not associated with treatment response or progression of radiographic damage after 2 years of follow-up.Conclusion: Serum capacity to activate PAD4 was associated with ACPA and RF positivity and earlier disease onset in early RA patients, and decreased after initiation of DMARD treatment, indicating that anti-PAD treatment could potentially be beneficial in RA.

Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.

BACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. METHODS: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. RESULTS: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. CONCLUSION: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.

NOR-DMARD data management: implementation of data capture from electronic health records.

OBJECTIVES: The use of electronic health records (EHR) is an essential part of modern health care, and electronic data capture (EDC) has become essential for managing clinical trials. Usually, these two entities are independent of each other, and transfer from one system to another is done manually. Our aim was to develop a method to capture data directly from the EHR system and transfer them into an EDC system for the NORwegian Disease-Modifying Anti-Rheumatic Drugs (NOR-DMARD) registry. METHODS: All rheumatology departments contributing to NOR-DMARD had implemented a structured EHR system. Data are extracted locally and securely transferred to the study data management once a month. The study data management then parse the data into a readable format for the EDC and import the data. Once the data is in the EDC, they are available to all authorized researchers and downloadable in a preferred format. RESULTS: From May 2012 to August 2014 almost 6400 visits in 3400 patients treated with biologics have been successfully registered in the EDC system. Previously, NOR-DMARD used standard paper-based case report forms (CRFs), with a substantial cost for data entry. Setting up and maintaining the EDC system required some investments, but the amount saved from avoiding paper handling has made the shift into EDC profitable. In addition to this, gains have been made in administration and data quality. CONCLUSIONS: The transition from paper and pencil format to a fully electronic data management system in NOR-DMARD has had obvious advantages regarding feasibility, cost, data quality and accessibility of the data.

High incidence of vertebral and non-vertebral fractures in the OSTRA cohort study: a 5-year follow-up study in postmenopausal women with rheumatoid arthritis.

UNLABELLED: A 5-year follow-up study was performed in female RA patients with established disease looking at vertebral fractures, scored on spinal X-rays, and non-vertebral fractures. We found a high incidence rate of vertebral and non-vertebral fractures in these patients compared to population-based studies. INTRODUCTION: The aim of this study is to investigate the incidence of vertebral and non-vertebral fractures over a 5-year period in a cohort of postmenopausal patients with established rheumatoid arthritis (RA). METHODS: One hundred and fifty female patients with established RA were included into the OSTRA cohort. The cohort was assessed at baseline and at 5 years for incident vertebral and non-vertebral fractures. Spinal X-rays were taken at baseline and at follow-up and scored using the semi-quantitative method according to Genant. RESULTS: At 5 years, 102 patients (68%) were examined and included in the present analysis. At baseline, the mean age was 61 years, disease duration 17 years, body mass index 25.5 kg/m(2) and 65% of the patients were rheumatoid factor positive. Fifteen percent were treated with bisphosphonates, 25% received calcium supplementation and 20% vitamin-D supplementation at baseline. During the 5-year follow-up, a total of 16 patients out of 102 patients (16%) had a new non-vertebral fracture [annual incidence of 3.2 (95% CI 1.8-5.5) per 100 patients/year]. In 18 patients out of 97 patients (19%), new vertebral fractures were identified on spinal X-ray [annual incidence of 3.7 (95% C.I. 2.2-5.8) per 100 patients/year]. CONCLUSIONS: We found a high incidence of vertebral and non-vertebral fractures in a cohort of women with established RA compared to population-based studies.

Serum IgG antibodies to peptidylarginine deiminase 4 predict radiographic progression in patients with rheumatoid arthritis treated with tumour necrosis factor-alpha blocking agents.

BACKGROUND: Peptidylarginine deiminase 4 (PAD4) may generate epitopes targeted by anticitrullinated protein antibodies in rheumatoid arthritis (RA). A subset of patients with RA has serum autoantibodies to human recombinant PAD4 (hPAD4). Here, we assessed whether anti-hPAD4 status in RA predicted disease outcome after antitumour necrosis factor (anti-TNF)-alpha therapy. METHODS: We analysed RA sera obtained at baseline (n = 40) and after 1 year on anti-TNF-alpha therapy (n = 33) for anti-hPAD4 IgG. Association analyses between baseline anti-hPAD status and disease progression were performed. RESULTS: We found that 17 of 40 patients (42.5%) were serum anti-hPAD4 positive at baseline, and the anti-hPAD4 IgG levels were stable over 1 year on anti-TNF-alpha therapy. At baseline, there were indications that anti-hPAD4 positive patients had more severe disease than the negative patients. After 1 year on anti-TNF-alpha therapy, the anti-hPAD4 positive patients displayed a persistently elevated disease activity score using 28 joint counts score and increased progression in the van der Heijde-modified Sharp erosion score. Accordingly, more anti-hPAD4 positive than negative patients presented an increase in van der Heijde-modified Sharp erosion scores >0 over 1 year. CONCLUSIONS: Anti-hPAD4 IgG can be detected in a subset of RA sera and the levels are stable after initiation of anti-TNF-alpha therapy. Serum anti-hPAD4 may predict persistent disease activity and radiographic progression in patients with RA receiving anti-TNF-alpha therapy.

Monitoring anti-TNFalpha treatment in rheumatoid arthritis: responsiveness of magnetic resonance imaging and ultrasonography of the dominant wrist joint compared with conventional measures of disease activity and structural damage.

OBJECTIVES: To evaluate the responsiveness of magnetic resonance imaging (MRI) and ultrasonography (US) compared with conventional measures of disease activity and structural damage in patients with rheumatoid arthritis (RA) during the first year of treatment with anti-tumour necrosis factor alpha (TNFalpha). METHODS: A cohort of patients with RA (N = 36, median age 53 years, disease duration 7.6 years and disease activity score (DAS28) 5.7) was evaluated by core measures of disease activity, US (one wrist), MRI (one wrist) and conventional radiography (CR, both hands and wrists) at initiation of treatment with anti-TNFalpha agents and after 3, 6 and 12 months. Responsiveness was assessed by standardised response means (SRM). Accepted thresholds were applied to classify responsiveness as trivial, low, moderate or good. RESULTS: MRI synovitis (SRM between -0.79 and -0.92) and the MRI total inflammation score comprising synovitis, tenosynovitis and bone marrow oedema (SRM between -1.05 and -1.24) were highly responsive. Moderate to high responsiveness was found for MRI tenosynovitis and bone marrow oedema, all the composite indices (DAS28, simplified disease activity index (SDAI) and clinical disease activity index (CDAI)) and the 28-swollen joint count. US displayed low to moderate responsiveness. The MRI erosion score displayed low responsiveness but was more responsive than CR measures at 3 and 6 months follow-up. MRI and CR measures of annual progression rates of damage performed similarly and were highly responsive. CONCLUSIONS: The most responsive measure of inflammation when evaluating anti-TNFalpha medication was a composite measure comprising MRI synovitis, tenosynovitis and bone marrow oedema, and this may be a promising outcome measure in clinical studies.

Calprotectin (a major leucocyte protein) is associated with the levels of anti-CCP and rheumatoid factor in a longitudinal study of patients with very early rheumatoid arthritis.

BACKGROUND: Calprotectin is a major granulocyte and monocyte protein, and plasma levels of calprotectin are strongly associated with inflammation in patients with rheumatoid arthritis (RA). OBJECTIVE: To explore the associations between calprotectin and serological, inflammatory, and clinical assessments in a longitudinal study of patients with very early RA. PATIENTS AND METHODS: In 61 RA patients (77% females, mean age 57.9 years, disease duration 132 days), laboratory and clinical assessments were performed at baseline and after 3, 6, and 12 months. RESULTS: Calprotectin levels were higher in patients positive vs. negative for anti-cyclic citrullinated peptide (anti-CCP), immunoglobulin M rheumatoid factor (IgM-RF), and IgA-RF (p<0.001-0.05). The 1-year averaged level of calprotectin correlated significantly with the mean levels of these three serological markers (p<0.05). In multiple regression analyses, adjusting for age, sex, and disease duration, calprotectin was associated with anti-CCP (p = 0.045), and both calprotectin and erythrocyte sedimentation rate (ESR) were associated with IgM-RF (p = 0.003 and 0.03, respectively). Calprotectin correlated significantly with the inflammatory markers at all examinations [C-reactive protein (CRP); r = 0.60-0.70, p<0.001, ESR; r = 0.55-0.57, p<0.001] as well as with the 28-joint disease activity score (DAS28; r = 0.28-0.33, p<0.05). CONCLUSION: This is the first study that shows significant associations between the levels of calprotectin and anti-CCP, IgA-RF, and IgM-RF in very early RA. In addition, significant correlations were found between calprotectin and markers of disease activity.

Magnetic resonance imaging findings in 84 patients with early rheumatoid arthritis: bone marrow oedema predicts erosive progression.

OBJECTIVES: To examine the spectrum and severity of magnetic resonance imaging (MRI) findings in patients with early rheumatoid arthritis (RA), and to investigate the predictive value of MRI findings for subsequent development of conventional radiographic (CR) damage and MRI erosions. METHODS: 84 consecutive patients with RA with disease duration <1 year were enrolled. Patients were treated according to standard clinical practice, and evaluated at baseline, 3, 6 and 12 months by core measures of disease activity, conventional radiographs of both hands and wrists and MRI of the dominant wrist. MR images were scored according to the OMERACT rheumatoid arthritis magnetic resonance imaging score (RAMRIS), and conventional radiographs according to the van der Heijde modified Sharp score. RESULTS: MRI findings reflecting inflammation (synovitis, bone marrow oedema and tenosynovitis) decreased during follow-up, while there was a small increase in MRI erosion score and CR damage. The proportion of patients with erosive progression at 1 year was 48% for conventional radiography and 66% for MRI. Baseline MRI bone marrow oedema (score >2 RAMRIS units) was identified as an independent predictor of both CR (odds ratio = 2.77 (95% confidence interval (CI) 1.06 to 7.21)) and MRI erosive progression (B = 0.21 (95% CI 0.08 to 0.34)). CONCLUSIONS: MRI findings were common in early RA, and MRI bone marrow oedema was an independent predictor of radiographic damage. These results suggest that MRI scans of the dominant wrist may help clinicians to determine which patients need early and aggressive treatment to avoid subsequent joint damage.

High anti-cyclic citrullinated peptide levels and an algorithm of four variables predict radiographic progression in patients with rheumatoid arthritis: results from a 10-year longitudinal study.

OBJECTIVES: New effective therapies with particularly good effect on joint destruction have highlighted the need for reliable predictors of radiographic progression in rheumatoid arthritis (RA). Our objective was to assess the combined predictive role of a set of laboratory markers with regard to 10-year radiographic progression, and to examine the effect of anti-cyclic citrullinated peptide (anti-CCP) level. METHODS: A cohort of 238 patients with RA was followed longitudinally for 10 years with the collection of clinical data and serum samples. 125 patients with radiographs of the hands available at both baseline and after 10 years were included in this study. Radiographs were scored according to the van der Heijde modified Sharp score. Baseline sera were analysed for C-reactive protein, erythrocyte sedimentation rate (ESR), anti-CCP, IgA rheumatoid factor (RF) and IgM RF. Logistic regression analyses were used to identify predictors of radiographic progression and to examine the effect of anti-CCP level. RESULTS: Anti-CCP (OR 4.0; 95% CI 1.6 to 10.0) was the strongest independent predictor of radiographic progression. Female gender (OR 3.3; 95% CI 1.3 to 7.6), high ESR (OR 3.2; 95% CI 1.2 to 7.6) and a positive IgM RF (OR 3.1; 95% CI 1.2 to 7.9) were also independent predictors. Compared with the anti-CCP-negative patients, patients with low to moderate levels of anti-CCP (OR 2.6; 95% CI 0.9 to 7.2) and patients with high levels of anti-CCP (OR 9.9; 95% CI 2.7 to 36.7) were more likely to develop radiographic progression. CONCLUSIONS: Anti-CCP, IgM RF, ESR and female gender were independent predictors of radiographic progression and could be combined into an algorithm for better prediction. Patients with high levels of anti-CCP were especially prone to radiographic progression, indicating that the anti-CCP level may add prognostic information.

Ultrasonography shows increased cross-sectional area of the median nerve in patients with arthritis and carpal tunnel syndrome.

OBJECTIVES: To examine whether patients with arthritic diseases and carpal tunnel syndrome (CTS) have increased cross-sectional areas of the median nerves measured by ultrasonography (US). Enlarged cross-sectional areas have previously been found in non-arthritic patients with idiopathic CTS. METHODS: During 1 yr, all 12 patients with rheumatoid arthritis (RA) or other arthritic diseases hospitalized in our department for surgery for CTS were included. Nine of the patients had bilateral CTS, giving a total of 21 pathological nerves. The median duration of CTS symptoms was 9.5 months. The controls were 30 randomly selected RA patients without symptoms of CTS and 30 healthy persons. Both CTS patients and controls were examined bilaterally by use of US at the entrance of the carpal tunnel, and the cross-sectional areas of the median nerves were calculated. RESULTS: Cross-sectional areas of the median nerves were significantly higher in the CTS patients compared with the RA controls and healthy persons; median (range) areas were 15.7 mm(2) (11.1-21.8), 8.5 mm(2) (5.8-11.0) and 8.0 mm(2) (4.9-12.0), respectively (P<0.0001). No significant differences in cross-sectional areas were observed between the two control groups, or between the right and left hand in the control groups. CONCLUSIONS: Higher cross-sectional areas were found in the arthritic patients with CTS than in RA patients and healthy persons without CTS. This supports previous studies of idiopathic CTS in which increased cross-sectional areas have been found. Thus, as in idiopathic CTS, arthritic patients may be examined by US of the median nerve when CTS is suspected.

Comparison of the Health Assessment Questionnaire (HAQ) and the modified HAQ (MHAQ) in patients with rheumatoid arthritis.

OBJECTIVES: Physical disability in patients with rheumatoid arthritis (RA) is often assessed by questionnaires. We compared the Health Assessment Questionnaire (HAQ) with the modified HAQ (MHAQ) in a cohort of RA patients across various levels of disability, and examined correlations with other measures of physical function. METHODS: Patients with RA (n = 182) completed self-report questionnaires assessing functional capacity. Instruments included the MHAQ and HAQ completed separately, as well as SF-36 and the Arthritis Impact Measurement Scales (AIMS). Scores from unadjusted and adjusted HAQ were compared with MHAQ at various disability levels. RESULTS: A clear ceiling effect with aggregation of normal scores for physical function was observed for MHAQ (23%) and HAQ (12%), but not for SF-36 (4%) or AIMS (5%). The correlations between adjusted/unadjusted HAQ and MHAQ scores were 0.85/0.88. A discrepancy in HAQ and MHAQ scores was observed in patients with high levels of disability, especially when MHAQ was compared with the adjusted final HAQ score. Adjustment of HAQ by aids or help increased the final score by an average of 0.15, and both adjusted and unadjusted HAQ scores were numerically clearly higher (mean 0.45 and 0.30, respectively) than the MHAQ score. CONCLUSION: The present findings indicate that MHAQ and HAQ may be applicable as measures of physical capacity in RA patients, but clinicians and researchers should select the appropriate instrument for the setting, and be aware of differences in scores, especially at different disability levels.

A comparison of agreement and sensitivity to change between AIMS2 and a short form of AIMS2 (AIMS2-SF) in more than 1,000 rheumatoid arthritis patients.

OBJECTIVE: To examine the agreement between and compare the sensitivity to change of the Arthritis Impact Measurement Scale (AIMS2) and AIMS2 Short Form (AIMS2-SF) in a large sample of rheumatoid arthritis (RA) patients examined within the framework of a longitudinal observational study. METHODS: Data were collected from patients in a community based RA register by a postal survey in April 1994 (1,030 respondents) and again in 1996 (1,153 respondents), comprising AIMS2, Modified Health Assessment Questionnaire (MHAQ), Medical Outcome Survey SF-36, and other commonly used health status measures. The degree of agreement was examined by plotting differences between AIMS2 and AIMS2-SF against the mean of the 2 scores for the 5 main components. The upper and lower limits of agreement (mean diff. +/- 1.96 SD) were calculated and plotted. The intraclass correlation coefficients were computed by repeated measurement ANOVA. Validity was assessed on the basis of external indicators of health status, and responsiveness on the basis of standardized response means. RESULTS: The AIMS2 and AIMS2-SF showed substantial to near-perfect agreement. Best agreement was seen for the physical and affect components. Better agreement for the symptom component was obtained when replacing item 42 with item 38. Internal consistency was high in all components. The 2 forms correlated similarly with scores from other instruments within the same domains, showing similar construct validity. There was no difference in responsiveness between the 2 forms when using changes in patient assessed global disease activity as external indicator of change in health status, and responsiveness for the physical and symptom dimension was similar to other instruments (SF-36, MHAQ). CONCLUSION: The AIMS2-SF is amenable for use in large surveys with a modification of one item in the symptom scale.