To adapt and cross-culturally validate the Foot Impact Scale for Rheumatoid Arthritis (FIS-RA) using Rasch analysis.

The FIS-RA was translated from English to German, Hungarian and Dutch target languages and administered to 653 rheumatoid arthritis (RA) patients. Rasch analysis was undertaken on the impairment/footwear (FIS-RA_IF) and activity/participation (FIS-RA_AP) subscales for each language version separately and for pooled data. Overall fit to the Rasch model, item and person fit, unidimensionality, differential item function (DIF), and local response dependency were tested. To meet Rasch model assumptions, item deletion, subtests analysis and item splitting strategies were adopted.

With the exception of the Hungarian FIS-RA_IF subscale, preliminary fit to the Rasch model was unsuccessful for all target languages individually and pooled data. Multidimensionality, misfitting items, local dependency and DIF by age, gender, disease duration, and language were observed. With adjustment, fit to the Rasch model was satisfactorily achieved for all language versions. For the pooled data the Rasch model assumptions for cross-cultural validity were met following item deletion, subtest analysis and item splitting for language DIF.

With adaptations, FIS-RA was successfully translated and cross-culturally validated for use in 4 European languages. The two subscales can be used at the individual level for patient assessment and at the group level for research purposes. © 2012 by the American College of Rheumatology.

To report a single-center experience with use of TNF inhibitors (TNFi) in patients with Takayasu arteritis (TA).

We retrospectively studied a cohort of patients with refractory TA evaluated at our institution, and treated with TNFi. ACR criteria for TA were used for inclusion. Disease activity was assessed according to the NIH criteria.

We included 20 patients (19 women, 16 Caucasians), with a mean age of 33 years (± 10.2), and a median disease duration of 15.9 months [2-32.7] prior to use of TNFi.

Before use of TNFi, all 20 patients received prednisone. Other medication-use included methotrexate (18 patients), azathioprine (5 patients), mycophenolate mofetil (3 patients), and cyclophosphamide (3 patients). Seventeen patients (85%) received infliximab, 2 patients adalimumab (10%) and 1 patient etanercept (5%). The median duration of treatment with TNFi was 23.0 months [10.2-41.3]. Treatment with TNFi resulted in disease remission in 18/20 patients (90%), and sustained remission in 10 patients (50%). Ten of 12 patients (83%) were able to taper prednisone below 10 mg, and 7 patients discontinued prednisone. However, 6 of the 18 patients achieving remission experienced relapse while on TNFi.

Eleven patients (55%) discontinued TNFi for the following reasons: relapse, persistently active disease, lack of corticosteroid sparing effect, adverse effects (4 patients), other reasons (4 patients).

In this study, treatment with TNFi induced remission, including sustained remission in patients with refractory TA. However, 33% of patients experienced disease relapse while on TNFi, and 20 % discontinued treatment because of adverse events. © 2012 by the American College of Rheumatology.

To compare quality of life in adults diagnosed with Juvenile Dermatomyositis (JDM) with that of matched controls; and to analyze the association with other disease parameters in patients.

39 JDM patients (aged ≥ 18 years) were clinically examined, and compared with 39 age- and sex-matched controls. Global and health-related quality of life were assessed by the Norwegian version of Quality of Life Scale (QoLS-N) and the Short Form 36 (SF-36) respectively. For patients, disease parameters were assessed by Disease activity score (DAS), Health assessment questionnaire (HAQ) and Myositis damage index (MDI).

Compared to the controls, JDM patients assessed median 22.2(range 1.8 – 36.1) years after disease onset had reduced health-related quality of life (HRQoL) in general health (p = 0.009) measured by SF-36. In patients, a moderate correlation was found between the physical component summary score (PCS) and DAS (r_s = - 0.422,) and MDI (r_s = -0.381,) and a strong correlation between PCS and HAQ (r_s =-0.516). There were no differences between patients and controls in the SF-36 mental component scores. Patients and controls had similar total scores of QoLS-N, but differences existed within certain items.

Adult patients with JDM had, compared to controls, reduced HRQoL in general health measured by SF-36, but not in the other subscales of SF-36 nor in global quality of life measured by QoLS-N. An association was found between disease parameters and reduced HRQoL in physical domains. © 2012 by the American College of Rheumatology.

Our objective was to evaluate adherence among new users of zoledronate and IV ibandronate among U.S. Medicare enrollees.

We used data from the Medicare 5% random sample to evaluate new users of IV zoledronate and IV ibandronate with continuous Part A+B fee-for-service coverage. The outcome was adherence as quantified by the proportion of days covered (PDC), measured continuously and dichotomously (>= 80%). Follow-up time extended from 18-27 months for all individuals. Factors associated with low adherence with zoledronate were evaluated with logistic regression.

We identified 775 new users of zoledronate and 846 new users of IV ibandronate. For both drugs, 30-48% of first infusions were given in an outpatient infusion center, not in a physician office. The mean PDC for zoledronate users was 82%, which was greater than the mean PDC for the IV Ibandronate users (58-62%, depending on time period, p < 0.0001). Approximately 30% of zoledronate users did not receive a second infusion. Factors associated with low adherence to zolendronate included older age and receipt of the first infusion in an outpatient infusion center rather than a physician's office.

Less frequently dosed IV bisphosphonates have not resolved the problem of suboptimal adherence with prescription osteoporosis medications. Interventions continue to be warranted to improve long term adherence with osteoporosis treatments. © 2012 by the American College of Rheumatology.

To estimate the relationship between physical activity and health-related utility for people with knee OA and implications for designing cost effective interventions.

Use GEE regression analysis to estimate partial association of accelerometer-measured physical activity levels with health-related utility after controlling for demographics, health status, knee OA severity level, pain and functioning.

Moving from lowest to middle tertile of physical activity levels is associated with .071 (p<.01) increase in health-related utility after controlling for demographics and .036 (p<.05) increase in utility after controlling for demographics, health status, knee OA severity level, weight, pain, and functional impairments.

Intervention programs that move individuals out of the lowest tertile of physical activity have the potential to be cost effective. © 2012 by the American College of Rheumatology.

Rheumatoid arthritis (RA) is associated with an increased risk of cardiovascular (CV) disease. CV risk can be estimated using established clinical risk scores; however traditional risk factors do not perform as well in RA patients. Reliable CV risk stratification remains an unmet clinical need in the RA population. It is unknown whether emergent biomarkers increase the predictive ability of clinical scores for CV risk in RA.

To determine whether adding C-reactive protein, anti-citrullinated peptide antibodies, rheumatoid factor, N-terminal pro-Brain Natriuretic peptide (NT-proBNP), oxidized LDL (oxLDL) or anti-apolipoprotein A-1 IgG (anti-apoA-1) to the 10 year-Framingham cardiovascular risk score (FRS) could improve its CV prognostic accuracy in RA.

We performed an ancillary study derived from a prospective single center cohort including 118 RA patients without cardiovascular disease at baseline. The FRS and the various biomarkers were assessed at enrollment and their prognostic accuracy was determined using receiver operating characteristic (ROC) curve analysis. The incremental predictive ability of biomarkers was assessed using the integrated discrimination improvement (IDI) statistics.

During a median follow-up of 9 years, the incidence of CV events was 16%. Both the FRS and 3 of the biomarkers (NT-proBNP, oxLDL, anti-apoA-1) were significant predictors of subsequent CV events (area under the ROC curve (AUC) between 0.68 – 0.73). Anti-apoA-1 was the only biomarkers to improve significantly the FRS's prognostic ability, with AUCs increasing from 0.72 to 0.81 and the IDI improving by 175% (p<0.001).

Among the biomarkers tested, only anti-apoA-1 significantly improved the FRS predictive ability. © 2012 by the American College of Rheumatology.

Neuropsychiatric (NP) manifestations attributable to active disease affect up to 30% of individuals with systemic lupus erythematosus (SLE). The short-term impact of neuropsychiatric events includes increased organ damage, fatigue, mortality, and lower health-related quality-of-life. We investigated the impact of NP events attributable to active SLE at presentation on long-term disease activity, organ damage and health-related quality-of-life.

Seventy-two NP cases and 144 matched controls from the Toronto Lupus Cohort, enrolled between 1970 and 2005, were included in the study. NP cases had at least one NP event attributable to active SLE at first clinic visit. Controls did not have NP events at first clinic visit, and were matched to cases on age, sex, disease duration and decade. Paired case-control analyses were performed on measures of disease activity (SLEDAI-2K), disease damage (SDI) and health-related quality-of-life (SF-36), at 1-year, 3-years and 5-years after first clinic visit.

NP cases showed greater disease activity than controls at first clinic visit (p<0.0001) and greater cumulative organ damage at 1-year follow-up (p=0.01). No statistically significant differences were found on 3-year or 5-year outcomes. Mean scores showed a decreasing trend of disease activity, increasing organ damage and persistently low quality-of-life for both cases and controls.

This study shows that early neuropsychiatric events due to active SLE are not major contributors to long-term disease activity, accumulation of damage or health-related quality-of-life. The long-term prognosis and patterns of disease in SLE patients with early NP events are similar to those of SLE patients without these events. © 2012 by the American College of Rheumatology

Fear of movement has important clinical implications for individuals with osteoarthritis. This study aimed to establish a brief fear of movement scale for use in osteoarthritis. Items from the Tampa Scale for Kinesiophobia (TSK) were examined.

The English version of the TSK was examined in a community-based sample (N=1,136) of individuals with osteoarthritis of the hip or knee. Exploratory and confirmatory factor analyses were used to determine the number and content of the dimensions of fear of movement. Factorial invariance was tested across subgroups of gender, race, education, and osteoarthritis severity. Convergent validity with measures of pain, physical functioning, and psychological functioning was examined.

Factor analyses identified a single factor 6-item scale that measures activity avoidance due to pain-related fear of movement (confirmatory factor analysis indices of model fit: RMSEA=.04; SRMR=.01; CFI=.99; TLI=.99). The 6-item scale demonstrated factorialinvariance across gender, race, levels of education, and osteoarthritis severity suggesting that thisscale performs consistently across diverse groups of individuals with osteoarthritis. Convergentvalidity with measures of pain (β=.30 to .41), physical functioning (β=.44 to .48), andpsychological functioning (β=.36 to .37) was also demonstrated.

The brief fear of movement scale identified in this study provides a promising and valid approach for assessing fear of movement in individuals with osteoarthritis. This brief scale demonstrated several important strengths including a small number of items, sound psychometric properties, and consistent performance across diverse groups of individuals with osteoarthritis. © 2012 by the American College of Rheumatology

To investigate the potential public health impact of modifiable risk factors related to physical inactivity in adults with rheumatoid arthritis.

A cross-sectional study used baseline data from 176 adults with rheumatoid arthritis enrolled in a randomized clinical trial assessing the effectiveness of an intervention to promote physical activity. Accelerometer data were assessed for inactivity (i.e. no sustained 10 minute periods of moderate-to-vigorous intensity physical activity during a week's surveillance). The relationships between modifiable risk factors (motivation for physical activity, beliefs related to physical activity, obesity, pain, mental health) with inactivity were assessed using odds ratios (OR) and attributable fractions (AF), controlling for descriptive factors (age, gender, race, education, disease duration, and co-morbidity).

Over two in five adults (42%) with rheumatoid arthritis were inactive. Factors most strongly related to inactivity were lack of strong motivation for physical activity (adjusted OR=2.85, 95% CI: 1.31, 6.20; adjusted AF=53.1%, 95% CI: 21.7, 74.6) and lack of strong beliefs related to physical activity (OR=2.47, 95% CI: 1.10, 5.56; AF=49.2%, 95% CI: 7.0, 76.4). Together, these two factors are related to almost 65% excess inactivity in this sample.

These results support development of interventions that increase motivation for physical activity and that lead to stronger beliefs related to physical activity's benefits should be considered in public health initiatives to reduce the prevalence of physical inactivity in adults with rheumatoid arthritis. © 2012 by the American College of Rheumatology

U.S. national prevalence of Spondyloarthritis (SpA) was estimated for two published sets of classification criteria: Amor et al. (Amor) and the European Spondylarthropathy Study Group (ESSG). These two SpA criteria sets have been the most widely utilized in previous population based studies of SpA.

U.S. SpA prevalence estimates were based on a representative sample of 5013 U.S. adults ages 20-69 years examined in the 2009-10 U.S. National Health and Nutrition Examination Survey (NHANES).

Overall age-adjusted prevalence of definite and probable SpA by the Amor criteria was 0.9% (95% CI 0.7-1.1%). This corresponds to an estimated 1.7 million persons (95%CI 1.4-2.1 million). Age-adjusted prevalence of SpA by the ESSG criteria was 1.4% (95% CI 1.0-1.9%), corresponding to an estimated 2.7 million persons (95%CI 1.9-3.7 million). There were no statistically significant gender differences in SpA prevalence. SpA prevalence among non-Hispanic whites was 1.0% (95%CI 0.7-1.5%) by the Amor criteria and 1.5% (95%CI 1.0-2.3%) by the ESSG criteria. SpA prevalence could not be reliably estimated in other race/ethnicity subgroups due to sample size imitations.

SpA prevalence estimates are in the range of SpA prevalence estimates reported elsewhere in population-based surveys and it is likely that SpA may affect up to 1% of U.S. adults, a prevalence range similar to that reported for rheumatoid arthritis. Current U.S. SpA prevalence estimates may be lower than the true value, because NHANES 2009-10 data collection did not capture a complete set of the elements specified in the two SpA criteria sets. © 2012 by the American College of Rheumatology

TheRhoA/Rho-kinase pathway plays a pivotal role in cold induced vasoconstriction, vascular smooth muscle cells function and vascular homeostasis. This study evaluates the efficacy of fasudil, a RhoA/Rho-kinase inhibitor, to reverse cold-induced vasospasm in patients with Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc).

This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40mg or 80mg) or placebo administered 2 hours before a standardized cold challenge. The fall in skin temperature after the cold challenge and time to recover 50% and 70% of pre-challenge digital skin temperature were used as primary outcomes. Digital blood flow assessed by Laser Doppler, time to minimum skin temperature, and rate of skin cooling were also measured.

Seventeen patients with SSc and RP completed the study. After cold challenge, skin temperatures and the average time (minutes) to recover 50% (placebo: 7.9, fasudil 40mg: 7.5, and fasudil 80mg: 8.2; p=.791) and 70% (placebo: 18.2, fasudil 40mg: 15.0, and fasudil 80mg: 17.1; p=.654) of pre-challenge skin temperaturewerenot significantly different across the three groups. The digital blood flow measurements were higher in fasudil treated groups than placebo but differences were not significant (p=.693).

Fasudil administered at single oral dose of 40mg or 80mg was not associated with significant benefit in term of skin temperature recovery time and digital blood flow after cold challenge. © 2012 by the American College of Rheumatology

To compare the characteristics of traditional cardiovascular risk factors of untreated early arthritis (EA) patients and healthy subjects, and to look for a link between cardiovascular risk factors and inflammation in EA patients.

This Multicentre case-control study enrolled 607 EA patients (ESPOIR cohort) and 1821 age- and gender-matched controls (WHO MONICA survey). Lipid levels, blood pressure, glucose levels and exposure to smoking were characterized in patients and controls. Systemic inflammation was quantified in EA patients. Traditional cardiovascular risk factors characteristics were compared between EA patients and controls. The link between cardiovascular risk factors and inflammation was assessed in EA patients.

Mean (standard error of the mean) total cholesterol 2.14 (0.022) vs 2.34 (0.017) g/l (p<0.001), HDL cholesterol 0.60 (0.011) vs 0.63 (0.007) (p=0.020), and LDL cholesterol 1.28 (0.025) vs 1.51 (0.016) g/l (p<0.001), were lower in EA patients than in controls. Triglycerides, triglyceride/HDL ratio and pulse pressure were higher in EA patients. Diastolic blood pressure and glucose levels were lower in EA patients. Former or current smokers were more frequent in EA patients. Total and HDL cholesterol levels were negatively associated with CRP or serum interleukin-6 levels.

Total, HDL and LDL cholesterol, triglycerides, diastolic blood pressure, pulse pressure, glucose and triglyceride/HDL ratio differ between EA patients and controls. Some of these risk factors appear to be linked to systemic inflammation. Such initial differences could modulate the risk of cardiovascular events later in the course of arthritis. © 2012 by the American College of Rheumatology

To accurately estimate, in France, the prevalence and the factors associated with uveitis in spondyloarthropathies (SpA) patients.

In an observational survey on SpA patients (ESSG and/or Amor's criteria) consulting their rheumatologist for routine follow-up, present and past history of uveitis, with the detailed characteristics of the disease were collected. Factors independently associated with uveitis were determined.

From September 2008 to January 2009, 202 rheumatologists participated in the survey and recruited 902 patients (males: 61%), with a mean age (± standard deviation) of 45.3 ±13.4 years and mean disease duration of 10.4 ± 9.6 years. SpA diagnoses were ankylosing spondylitis (71%), psoriatic arthritis (PsA) (18%) or other SpA (11%). HLA-B27-positivity rate was 76%. Uveitis prevalence was 32.2% (95% confidence interval [CI]: 29.1-35.3%) since psoriasis and inflammatory bowel disease (IBD) were, 22.3% (95% CI: 19.5-25.0%) and 8.6% (95% CI: 6.7-10.5%) respectively. Recurrence of uveitis occurred in 52.3% and complications in 11.7%. Factors independently associated with uveitis were HLA-B27 positivity (adjusted odds ratio [aOR]=2.97 [95% CI: 1.83-4.81]; P<0.0001) and disease duration (≥10 years (aOR= 1.28 [95% CI: 1.16-1.41]; P<0.0001).

Results indicate that uveitis is the most common extra-articular feature of SpAs and that it occurs preferentially in HLA-B27 positive patients and over all the course of the disease.

Although the knee joint is one the most affected joints by osteoarthritis (OA), research on economic implications focussed merely on OA in general. The goal of this study was to identify and quantify knee related productivity and medical costs in knee OA patients in paid employment. Furthermore, we evaluated associations between productivity loss and relevant patient, health and work characteristics.

Consecutive knee OA patients with mild to moderate knee OA, age 18-65 year, conservative treatment ≥ 6 months and paid work were included. Productivity loss and health care consumption were measured by questionnaires. Associations between productivity loss and patient, health and work characteristics were explored with regression analyses.

In total, 117 knee OA patients were included (mean age 53.2, mean body mass index 28.8). Total knee related productivity costs and medical costs are €871 (median (M) €411, interquartile range (IQR) €107-€1200) per patient per month, with total productivity costs being €722 (M €217, IQR €0-€1041) and total medical costs being €149 (M €137, IQR €72-€198). More pain during activity and performing physically intensive work were significantly associated with productivity loss.

The total knee related productivity costs and medical costs of conservatively treated symptomatic knee OA patients with paid work in The Netherlands are €871 per patient per month, with productivity costs accounting for 83% and medical costs for 17%. Productivity loss is associated with having more pain during activity and performing physically intensive work. Developing adequate treatment strategies for knee OA may be cost-beneficial.

The purpose of the present study was to validate the Dutch translation of the Fear of Progression-Questionnaire Short Form (FoP-Q-SF) for patients with systemic sclerosis (SSc, scleroderma). Although concerns about the future are often expressed by patients with SSc, as yet no valid quantitative measure is available to assess the extent to which patients with SSc are troubled by those concerns.

Measurement properties of the FoP-Q-SF were assessed using a cross-sectional design including 215 patients with SSc. Patients completed the FoP-Q-SF as well as questionnaires on physical and psychological functioning. Psychometric properties of the FoP-Q-SF were assessed using the COSMIN checklist.

The mean FoP-Q-SF score in patients with SSc was 30.05 (SD= 8.97). There were no indications of floor or ceiling effects. Confirmatory factor analysis supported the single-factor structure of the questionnaire (χ² (52)=96.84, p<.001, RMSEA = .064, CMIN/DF=1.86). Cronbach's alpha was .86 for the questionnaire. Most of our a priori determined hypotheses (11 out of 12) were confirmed, supporting the construct validity of the questionnaire.

Now a valid measure is available to assess fear of disease progression in patients with SSc, which is important since fear of progression is one of the most important stressors in these patients.

For cost-utility analyses of health technologies, utilities are commonly measured with the EQ-5D or SF-6D. Although most studies in rheumatoid arthritis (RA) concluded the SF-6D to be more responsive than the EQ-5D, evidence is not convincing. The aim of this study was to compare the responsiveness of the EQ-5D and SF-6D to improvement in RA patients treated with tumour necrosis factor (TNF) blockers.

Data of 278 RA patients included in the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry were used. Internal responsiveness over one year was evaluated by using Standardized Response Means (SRMs). External responsiveness was evaluated by using Receiver Operating Characteristic (ROC) curves based on perceived health change (self-reported health transition item SF-36) and change in disease activity (EULAR28 response criteria).

The scores of the EQ-5D and SF-6D changed moderately over one year (SRMs 0.50 and 0.67 respectively). The SF-6D was significantly more responsive to treatment than the EQ-5D. The EQ-5D and SF-6D were moderately able to correctly classify patients according to health transition -area under the curves (AUCs) 0.67 and 0.72 respectively- and change in disease activity (AUCs 0.71 and 0.65 respectively).

The EQ-5D and SF-6D were only moderately responsive to improvement in RA patients treated with TNF-blockers. Overall, the SF-6D was more responsive than the EQ-5D.

To assess the prevalence and risk factors for Raynaud's phenomenon (RP) in a French working population characterized by various levels of exposure to work-related constraints.

The study population comprised 3,710 workers (2,161 men, 1,549 women) followed by 83 occupational physicians and representative of the region's workforce. RP, diagnosed by questionnaire and standardized interview, was defined as the “occurrence of at least occasional attacks of finger blanching triggered by exposure to environmental cold” during the previous 12 months. Personal factors and work exposure were assessed by self-administered questionnaires. Associations between RP and personal and occupational factors were analyzed using logistic regression modeling.

A total of 87 cases of RP (56 women, 31 men) were diagnosed. The population-based annual prevalence rates of RP were 3.6% (95%CI,2.7–4.5) for women and 1.4% (95%CI,0.9–1.9) for men. Women were at higher risk (OR 2.1 [95%CI,1.3-3.4]) and the risk decreased continuously with BMI [OR (for 1-kg/m² increment) 0.87 [95%CI,0.81–0.94]. The risk of RP increased consistently but moderately with age after 35 years (OR ranging from 2.0 [95%CI,1.1-3.8] to 2.9 [95%CI,1.6-5.2]). Among the work-related factors studied, RP was associated with exposure to a cold environment or objects (OR 2.2 [95%CI,1.0-4.6]), high repetitiveness of a task (OR 1.7 [95%CI,1.0-2.7]), high psychological demand at work (OR 1.7 [95%CI,1.0-2.7]) and low support from supervisors (OR 2.4 [95%CI,1.5-3.8]).

Personal and work-related factors were associated with RP, with a clear difference between genders. Work-related psychosocial stressors played a significant role, independently of biomechanical and environmental exposure. © 2012 by the American College of Rheumatology

To determine whether the method of disease severity measurement influences the magnitude of knee extensor force deficits in knee osteoarthritis (OA).

Data from the Osteoarthritis Initiative (n = 659) were analyzed. Knee extensor force was assessed with isometric contractions. Clinical severity was measured with the Western Ontario and McMaster Osteoarthritis Index (WOMAC). Patients were stratified into tertiles of severity (i.e. moderate, mild and severe OA), based on lowest, middle and highest WOMAC scores. Kellgren-Lawrence grading (KLG) was used to assess radiographic severity of the tibiofemoral compartment and patients were again stratified into mild (KLG<2), moderate (KLG = 2) and severe (KLG>2) knee OA.

When stratifying with WOMAC, force was significantly lower in severe compared to mild (∼18% lower, p<0.001) and moderate (∼9% lower, p = 0.03) groups and in moderate compared to mild group (∼10% lower, p = 0.03). When stratifying with KLG, small, non-significant differences were observed in the severe (∼7% lower, p = 0.19) and moderate (∼8% lower, p = 0.08) compared to mild group. Large intra-group variability was observed when comparing WOMAC score across radiographic severity (coefficients of variation were 79.3%, 74.6% and 61.6% for KLG<2, KLG = 2 and KLG>2, respectively).

The method of disease severity stratification influences the magnitude of knee extensor force deficits as no difference in force between disease subgroups was observed when stratifying with KLG. Furthermore, there was large variability in WOMAC score within each radiographic subgroup, highlighting the limitations in using radiographic measures to reflect symptom severity.

We conducted a cross-sectional study to describe the prevalence of tibiofemoral joint space narrowing (JSN) in medial and lateral compartments and assess whether it differs by gender and ethnic groups, and if it does, to what extent such a difference is accounted for by knee malalignment.

The NIH-funded Multicenter Osteoarthritis (MOST) Study is an observational study of persons age 50 to 79 years with either symptomatic knee OA or at high risk of disease. Knee radiographs were assessed for JSN in each tibiofemoral compartment. Mechanical axis angle was measured using full-limb films. We compared the proportion of knees with medial compartment JSN and with lateral JSN between men and women as well as Caucasians (CC) and African Americans (AA) using a logistic regression model adjusting for covariates (race or gender and BMI, age, education, clinic site), and used generalized estimating equations to account for correlation between two knees within a person.

Of 5202 knees (2652 subjects), 1532 (29.5%) had medial JSN, and 427 (8.2%) had lateral JSN. Lateral JSN was more prevalent in women's than in men's knees (OR=1.9, 95% CI 1.5-2.4) and was also higher in knees of AA than in CC (OR=2.4, 95% CI: 1.7-3.3). Further adjustment for malalignment attenuated the OR for gender but not the OR for race.

Women and AA are more likely to have lateral JSN than men and Caucasians. Valgus malalignment may contribute to the higher prevalence in women.

This study aims to examine the secular trend of hip fracture incidence in Belgium between 2000 and 2007 and the concomitant change in the prescriptions of anti-osteoporosis medications.

The incidence of hip fractures and the number of prescriptions were determined using national databases. A logistic regression including years and 5-year age range was performed to assess the secular trend of hip fracture incidence and Pearson' coefficient correlation was calculated to examine the relationship between hip fracture incidence and the prescriptions of anti-osteoporosis medications.

The annual number of hip fractures increased in Belgium from 13,512 in 2000 to 14,744 in 2007, with a more marked increased in men (20.4%) than in women (5.7%). The age-adjusted incidence of hip fractures significantly decreased by 1.12% per year in women, but declined non-significantly by 0.38% per year in men. An increase in the prescriptions of anti-osteoporosis medications in women was observed during the same time period.

Despite an increase in the number of hip fractures in Belgium between 2000 and 2007, there was a significant decrease in age-adjusted incidence in women but not in men. Although our results may suggest that the decrease may be related to the extent of anti-osteoporosis medications, a causal relationship cannot be ascertained and many other factors may have contributed to the decrease in age-adjusted incidence.

Children with Juvenile Idiopathic Arthritis (JIA) experience functional impairment due to joint manifestations of the disease. The aim of our present study was to assess Health Related Quality of Life (HRQoL) and its predictors in a group of children and adolescents with JIA.

The study sample includes all JIA patients (aged 6-18 years) who consulted a pediatric rheumatologist in Amsterdam, the Netherlands, between February 2009 and March 2010. HRQoL was measured using the Paediatric Quality of Life Inventory 4.0 (PedsQL) (6-18 years olds). Functional ability was measured using the Child Health Assessment Questionnaire (CHAQ), and medical and socio-demographic parameters were assessed. The study sample was compared to a Dutch youth norm population including children with other chronic health conditions. The proportion of children with JIA with an impaired HRQoL (< 1 SD) was evaluated and multivariate regression analyses were performed to predict HRQoL outcome.

Of the eligible patients, 64.1% (n = 152) participated. Both children (6-12 years) and adolescents (13-18 years) with JIA reported a significantly lower HRQoL in almost all domains compared to either healthy controls or children with other chronic health conditions. Approximately half of the children with JIA showed an impaired HRQoL. The main predictors of HRQoL were functional ability, pain, subjective burden of medication use and school absence.

The HRQoL is severely affected in children and adolescents with JIA. These findings underline the necessity to systematically monitor HRQoL in daily clinical practice.

To study the prevalence of extra-glandular manifestations (EGM) in primary Sjögren's Syndrome (pSS) among participants enrolled in the Sjögren's International Collaborative Clinical Alliance (SICCA) registry.

1927 participants in the SICCA registry were studied, including 886participants who met the 2002 American-European consensus group (AECG) criteria for pSS, 830 “intermediate” cases who had some objective findings of pSS but did not meet AECG criteria, and 211 control individuals. We studied the prevalence of immunologic and hematologic laboratory abnormalities;specific rheumatologic examination findings; and physician confirmed thyroid, liver, kidney disease and lymphoma among SICCA participants.

Laboratory abnormalities, including hematologic abnormalities, hypergammaglobulinemia and hypocomplementemia, frequently occurred among pSS cases, and were more common among the intermediate cases than among control participants.Cutaneous vasculitis and lymphadenopathy werealso more commonamong pSS cases. In contrast, the frequency of physician confirmed diagnoses of thyroid, liver and kidney disease, and lymphoma was low and only primary biliary cirrhosis was associated with pSS cases status. Rheumatologic and neurologic symptoms were common among all SICCA participants, regardless of case status.

Data from the international SICCA registry support the systemic nature of pSS, manifest primarily in terms of specific immunologic and hematologic abnormalities. The occurrence of other systemic disorders among this cohort is relatively uncommon.Previously reported associations may be more specific to select patient subgroups, such as those referred for evaluation of certain neurologic, rheumatologic or other systemicmanifestations.

To examine the potential impact of a policy of selective referral to high-volume knee replacement hospitals on patient-hospital travel distance and access to care for patients seeking total knee replacement (TKR) in urban and rural settings.

The travel distance required for patients to reach their hospital and the additional travel distance required to reach the nearest high-volume hospital were analyzed using a 100% sample of Medicare fee-for-service patients undergoing TKR in 2001.

Of the 183,174 TKR performed in the US during 2001, 95% of patients selected underwent TKR at a hospital that was located within 50 miles of their residence. There were 11,550 patients who had their TKR performed at a low-volume hospital (LVH) where there was no nearer high-volume hospital. The impact of a policy that would direct patients to high-volume hospitals varied by region. In urban areas, the nearest high-volume hospital was a median 3.8 miles further than LVH of service. Patient factors, race and poverty, were associated with selection of LVHs in urban areas. In rural areas, 1,506 patients would have had to travel more than 50 miles and 259 patients would have had to travel more than 100 miles to reach a high-volume hospital.

A policy to direct patients away from LVHs could increase patient-hospital travel time in rural areas and restrict access of minority and low-income patients in urban areas. Any implementation of selective referral to high-volume centers should address access to hospitals for rural patients, urban minority and poor patients.

To define inactive disease (ID) and clinical remission (CR),and delineate variables that can be used to measure ID/CR in childhood-onset systemic lupus erythematosus (cSLE).

Delphi questionnaires were sent to an international group of pediatric rheumatologists. Respondents provided information about variables to be used in future algorithms to measure ID/CR. The usefulness of these variables was assessed in 35 children in ID and 31 children with minimally activelupus (MAL).

While ID reflects cSLEstatus ata specific point in time, CR requires the presence of ID for > 6 months and considers treatment. There was consensus that patients in ID/CR can have<2 mild non-limiting symptoms (i.e. fatigue, arthralgia, headaches or myalgia) but not Raynaud's phenomenon, chest pain, or objective physical signs of cSLE; ANA positivity and ESR elevation can be present. CBC, renal function testing, and complement C3 all must be within the normal range. Based on consensus, only damage-related laboratory or clinical findings of cSLE are permissible with ID. The aboveparameterswere suitable to differentiate children with ID/CR from those with MAL (area under the receiver operating characteristic curve> 0.85). Disease activity scores with or without the physician global assessment of disease activity and patient symptoms were well suited to differentiatechildren with ID from those with MAL.

Consensus has been reached on common definitionsof ID/CR with cSLE and relevant patient characteristics with ID/CR. Further studies must assess the usefulness of the data-driven candidate criteria for ID in cSLE.

To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep, and patient-rated sleep, tiredness, and pain in fibromyalgia patients.

Randomized, double-blind, placebo-controlled, 2-period crossover PSG study. Patients ≥18y with fibromyalgia satisfied subjective and objective sleep disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300–450mg/day) or placebo for crossover Period 1; and vice versa for Period 2. Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods. In-laboratory PSGs were recorded during 2 consecutive nights at screening and the end of each crossover period. The primary endpoint was difference in sleep maintenance defined by PSG-recorded wake-after-sleep-onset (WASO; minutes) between 4-weeks' treatment with pregabalin and with placebo. Other PSG measures, patient-rated sleep, tiredness, and pain, and tolerability were assessed.

Of 119 patients randomized (103[86.6%] female; 48.4y), 102(85.7%) completed both periods. Treatment with pregabalin showed a reduction in PSG-determined WASO versus treatment with placebo (Week 4 difference [95% confidence interval]:−19.2[−26.7 to −11.6]mins;P<0.0001). Pain score improved (reduced) with pregabalin versus placebo treatment at all 4 weeks (Week 4 difference:−0.52[−0.90 to −0.14];P=0.008). Modest (rho<0.3) but significant correlations were found between PSG sleep assessments and ratings of pain and sleep quality. Frequently reported adverse events (pregabalin vs. placebo) were: dizziness (30.4% vs. 9.9%), somnolence (20.5% vs. 4.5%), and headache (8.9% vs. 8.1%).

Patients with fibromyalgia treated with pregabalin had statistically-significant and meaningful improvements in sleep, as assessed by PSG. Patients with fibromyalgia also reported reduced daily pain. Pregabalin was well tolerated. © 2012 by the American College of Rheumatology

To examine the association between individual- and neighborhood-level disadvantage and self-reported arthritis.

A population-based cross-sectional study conducted in 2007 among 10,757 males and females aged 40-65 years, selected from 200 neighborhoods in Brisbane, Australia using a stratified two-stage cluster design. Data were collected using a mail survey (68.5 % response). Neighborhood disadvantage was measured using a census-based composite index, and individual disadvantage was measured using self-reported education, household income, and occupation. Arthritis was indicated by self-report. Data were analyzed using multilevel modeling.

Overall rate of self-reported arthritis was 23% (95%CI 22-24). After adjustment for sociodemographic factors, arthritis prevalence was greatest for females (OR 1.5, 95%CI 1.4-1.7): in those aged 60-65 (OR 4.4, 95%CI 3.7-5.2): those with a diploma/associate diploma (OR 1.3, 95%CI 1.1-1.6): those who were permanently unable to work (OR 4.0, 95%CI 3.1-5.3): and those with household income <$25,999 (OR 2.1, 95%CI 1.7-2.6). Independent of individual-level factors, residents of the most disadvantaged neighborhoods were 42% (OR 1.4, 95%CI 1.2-1.7) more likely than those in the least disadvantaged neighborhoods to self-report arthritis. Cross-level interactions between neighborhood disadvantage and education, occupation, and household income were not significant.

Arthritis prevalence is greater in more socially disadvantaged neighborhoods. These are the first multilevel data to examine the relationship between individual- and neighborhood-level disadvantage upon arthritis, and have important implications for policy, health promotion, and other intervention strategies designed to reduce the rates of arthritis; indicating that intervention efforts may need to focus on both people and places. © 2012 by the American College of Rheumatology

The objective was to investigate the passiveproperties of the plantar flexors muscle-tendon tissue in patients with the hypermobility type of Ehlers-Danlos syndrome (EDS-HT).

Twenty-five women with EDS-HT and 25 sex- and age-matched healthy control subjects participated in the study.Passive resistive torque (PRT) of the plantar flexors was measured with an isokinetic dynamometer during 2 standardized stretch protocols to obtain the passive muscle tension. Protocol 1 consisted of 4 continuous cycles to a predetermined angle of 10° dorsiflexion. Protocol 2 consisted of a slow stretch to the onset of pain. Torque, angle, and electromyography were simultaneously recorded during the tests. To take muscle thickness into account, muscle cross sectional area (MCSA) was obtained with peripheral quantitative computed tomography. Stiffness of the Achilles tendon was assessed using a dynamometer in combination with ultrasonography.

The results demonstrate a significantly larger maximal joint angle in the EDS-HT patients accompanied by a similar PRT compared to the control subjects (protocol2), indicating a lower passive muscle tension in the patient group. PRT for the predetermined angle (protocol1) was the same for both groupsand there was no difference in MSCA.Further, asignificantly lower Achilles tendon stiffness was seen in the patient group than the control group.

This study is the first to provide evidence for altered passive properties of the muscle-tendon unit in EDS-HT patients. These changes are thought to be associated with structural modifications in connective tissue. © 2012 by the American College of Rheumatology

Develop a clinical risk prediction tool to identify patients most likely to experiencelong-term clinically meaningful functional improvement following total hip arthroplasty (THA).

We studied 282 patients from 2 English health districts (Portsmouth and North Staffordshire), age =45 years receiving THA for primary osteoarthritis. Baseline data were collected by interview and examination, on age, sex, comorbidity, body mass index (BMI), functional status (SF-36), and preoperative radiographic severity. The outcome was a clinically significant (30-point) improvement in SF-36 physical function assessed ∼8-years after THA. Logistic regression modelling was used to identify predictors of functional improvement.

Improvement in physical functioning was less likely in those with better pre-operative functioning[OR 0.73 95%CI (0.60, 0.89)], in older people[0.94 (0.90, 0.98)], women[0.37 (0.19, 0.72)], a previous hip injury[0.14 (0.03, 0.74)], and greater number of painful joint sites[0.61 (0.46, 0.80)]. Patients with worse radiographic grades were most likely to improve[2.15 (1.17, 3.93)]. We found no influence of BMI or patient co-morbidity on functional outcome. Predictors of good outcome were the same as those of bad outcomes, acting in the opposite direction. A clinical risk prediction tool was developed to identify patients who are most likely to receive functional improvement following THA.

Thisprediction tool has the potential to inform healthcare professionals and patients about functional improvement following THA (as distinct from driving rationing or commissioning decisions on who should have surgery); itrequires introduction into clinical practice under research conditions to investigate its impact on decisions made by patients and clinicians. © 2012 by the American College of Rheumatology

There is sparse data on outcome of lupus nephritis from developing countries. This study looks at outcome in Asian-Indians.

Retrospective study included patients at a single center over 20 years. Patients were treated as per standard protocols. Primary outcome measure was chronic renal failure or death; secondary outcome was end stage renal disease or death. Worst-case scenario also calculated considering lost to follow up in 1^st year as events. Kaplan-Meier and log rank test used for survival analysis. Data represented as mean+SD.

Included 188 patients of lupus nephritis, F: M 11:1, age at onset 23.6+/-10.5 years, median follow up 6 years (IQR 3-9). Of 136 patients with biopsy, distribution: class II in 22, class III in 36, class IV in 61, class V in 16 and class VI in 1. Survival with normal renal function was 84, 69 and 57% at 5, 10 and 15 years; in worst-case scenario, 77, 63 and 51%. There was no difference in survival by histological class, however non-biopsied patients had lower survival. Renal Survival was 91, 81 and 76% at 5, 10 and 15 years; in worst-case scenario 79, 70 and 66%. Risk factors for poor outcome was low C3, hematuria, hypertension, creatinine, lack of remission and occurrence of major infection. There was a high rate of major infections – 42.3%, with tuberculosis 11.5%. Infections caused half of all deaths.

Outcome of lupus nephritis in Asian-Indians with standard immunosuppressive regimens is reasonable but immunosuppression is associated with high rate of infection. © 2012 by the American College of Rheumatology

Various methods are utilized in daily practice to obtain optimal information on effusion in the knee. Our aim is to investigate which scanning position provides the best information about synovial fluid in the knee by using ultrasound and to evaluate the magnitude of difference for measuring synovial fluid in three major recesses (suprapatellar, medial- and lateral parapatellar recess) of the knee according to various degrees of flexion.

Sonographers in 14 European centers documented bilateral knee joint ultrasound examinations on a total of 148 knee joints. The largest sagittal diameter of fluid was measured in scans corresponding to the three major recesses at different (0, 15, 30, 45, 60 and 90°) degrees of flexion of the knee. Difference of measurement of effusion according to transducer position, knee position, and interaction between them was investigated by analysis of variance, followed by Tukey's test.

No correlation was noted between patient characteristics and ultrasound detection of effusion. Sagittal diameter of synovial fluid in all three recesses was greatest at 30° flexion. Analysis of variance and Tukey's test revealed that the suprapatellar scan and 30° flexion is the best combination for detecting effusion, confirmed by receiver operator characteristic curve analysis.

The suprapatellar scan of the knee in 30° flexion was the most sensitive position to detect fluid in knee joints. Sagittal diameter of fluid in all three recesses increased with the knee in the 30° flexed position as compared to the extended position. © 2012 by the American College of Rheumatology

To determine the prognostic significance of data collected early after starting certolizumab pegol (CZP) to predict low disease activity (LDA) at Week 52.

Data through Week 12 from 703 CZP-treated patients in the RA PreventIon of structural Damage (RAPID 1) trial were used as variables to predict LDA (DAS28 [ESR] ≤3.2) at Week 52. We identified variables, developed prediction models using classification trees, and tested performance using training and testing datasets. Additional prediction models were constructed using CDAI and an alternate outcome definition (composite of LDA or ACR50).

Using Week 6 and 12 data and across several different prediction models, response (LDA) and nonresponse at 1 year was predicted with relatively high accuracy (70–90%) for most patients. The best performing model predicting nonresponse by 12 weeks was 90% accurate and applied to 46% of the population. Model accuracy for predicted responders (30% of the RAPID1 population) was 74%. The area under the receiver operator curve was 0.76. Depending on the desired certainty of prediction at 12 weeks, ∼12–24% of patients required >12 weeks of treatment to be accurately classified. CDAI-based models, and those evaluating the composite outcome (LDA or ACR50), achieved comparable accuracy.

We could accurately predict within 12 weeks of starting CZP whether most established RA patients with high baseline disease activity would likely achieve/not achieve LDA at 1 year. Decision trees may be useful to guide prospective management for RA patients treated with CZP and other biologics. © 2012 by the American College of Rheumatology

Several genetic risk variants for ankylosing spondylitis (AS) have been identified in genome wide association studies. Our objective was to examine whether familial AS cases have a higher genetic load of these susceptibility variants.

Overall, 502 AS patients were examined, consisting of 312 who had first-degree relatives (FDR) with AS (familial) and 190 who had no FDR with AS or spondyloarthritis (sporadic). All patients and affected FDRs fulfilled the modified New York Criteria for AS. The patients were recruited from two U.S. cohorts (NASC and PSOAS) and from the United Kingdom- Oxford cohort. The frequencies of AS susceptibility loci in IL23R, IL1R2, ANTRX2, ERAP1, two intergenic regions on chromosomes 2p15 and 21q22, and HLA-B27 status as determined by the tag SNP rs4349859 were compared between familial and sporadic cases. Association between SNPs and multiplex status was assessed by logistic regression controlling for sibship size.

HLA-B27 was significantly more prevalent in familial than sporadic cases of AS (p=0.0001, OR:4.44, CI: (2.06-9.55)). Furthermore, the AS risk allele at chromosome 21q22 intergenic region showed a trend towards higher frequency in the multiplex cases (p=0.08).The frequency of the other AS risk variants did not differ significantly between familial and sporadic cases, either individually or combined.

HLA-B27 is more prevalent in familial than sporadic cases of AS, demonstrating higher familial aggregation of AS in patients with HLA-B27 positivity. The frequency of the recently described non-MHC susceptibility loci is not markedly different between the sporadic and familial cases of AS. © 2012 by the American College of Rheumatology

To test the bi-directional hypothesis that depressive symptomatology influences changes in pain over time, and pain influences changes in depressive symptoms.

394 patients attending the University of Toronto PsA clinic were followed over a mean period of 7.5 years with annual assessments, including number of swollen joints (SJC), Health Assessment Questionnaire (HAQ) and the Medical Outcome Survey Short Form 36 (SF-36). Linear mixed effects models were used to examine the cross and lagged associations between the changes in HAQ pain and in SF-36 mental component score (MCS), adjusting for SJC and other covariates.

The strongest predictors of changes in pain, SJC and depressive symptomatology between visits were scores at previous visit of the corresponding variables, with standardized regression coefficients exceeding 0.75 in absolute value. There was, however, evidence of a small, but consequential, bi-directional relationship (i.e., standardized regression coefficients less than 0.3) between depressive symptomatology and pain. Both previous MCS scores and change in MCS scores were associated with change in pain between visits; conversely, previous pain scores and change in pain scores were associated with change in depressive symptomatology between visits.

Even though cross-variable associations between pain and depressive symptoms exist, changes in pain and depressive symptomatology appear to be strongly driven by their measurements at the previous visit. To optimize patient outcomes a clinical approach that assesses and treats clinically significant depressive symptomatology, as well as pain, is required. © 2012 by the American College of Rheumatology

To determine: (1) the distribution of clinically palpable hand interphalangeal (IP) nodes at each finger and thumb joint in a population with nodes; (2) the influence of handedness and gender on the development of nodes; and (3) the association between nodes and underlying radiographic features of osteoarthritis (OA).

Cross-sectional analysis of participants in the Genetics Osteoarthritis and Lifestyle (GOAL) study who had one or more Heberden's or Bouchard's nodes on clinical examination. Frequencies (%) of nodes were described for each IP joint in the hand. Associations between nodes and underlying radiographic OA were presented with odds ratio (OR) and 95% confidence interval (CI). Logistic regression model was used to adjust for confounding factors: age, gender, BMI, handedness, hand trauma, heavy manual occupation and sports.

Of 3170 GOAL participants, 1939 had one or more nodes (mean age 68 years; 54% women). Index DIP joints were the most frequently affected, followed by the thumb IP joint. Nodes were more common in dominant hands and women. There was a significant association between nodes and underlying radiographic OA (OR range: 2.26 – 21.23). This association was stronger for joint space narrowing than for osteophyte. A dose-response relationship was found between clinical severity of Heberden's nodes and underlying radiographic change.

Our study supports the positive association between nodes and radiographic OA, especially narrowing, and the influence of gender and handedness on development of nodes. In this age group presence of nodes may be taken as an indication of underlying small joint OA. © 2011 by the American College of Rheumatology

Experts disagree about the optimal classification of upper limb disorders (ULDs). To explore whether differential response to treatments offers a basis for choosing between case definitions, we analysed previously published research.

We screened 183 randomised controlled trials (RCTs) of treatments for ULDs, identified from the bibliographies of 10 Cochrane reviews, four other systematic reviews, and a search in Medline, Embase, and Google Scholar to June 2010. From these, we selected RCTs which allowed estimates of benefit (expressed as relative risks (RRs)) for >1 case definition to be compared when other variables (treatment, comparison group, follow-up time, outcome measure) were effectively held constant. Comparisons of RRs for paired case definitions were summarised by their ratios, with the RR for the simpler and broader definition as the denominator.

Two RCT reports allowed within-trial comparison of RRs and thirteen others allowed between-trial comparisons. Together these provided 17 ratios of RRs (five for shoulder treatments, 12 for elbow treatments, none for wrist/hand treatments). The median ratio of RRs was 1.0 (range 0.3 to 1.7; interquartile range 0.6 to 1.3).

Although the evidence base is limited, our findings suggest that for musculoskeletal disorders of the shoulder and elbow, clinicians in primary care will often do best to apply simpler and broader case definitions. Researchers should routinely publish secondary analyses for subgroups of patients by different diagnostic features at trial entry, to expand the evidence base on optimal case definitions for patient management. © 2011 by the American College of Rheumatology

It has been proposed that proprioceptive impairments observed in knee osteoarthritis (OA) may be associated with disease-related changes in joint mechanics. The aim of this study was to quantify joint proprioception and stiffness in the frontal plane of the knee in persons with and without knee OA and to report the associations between these two metrics.

Thirteen persons with knee OA and fourteen healthy age-matched subjects participated. Proprioceptive acuity was assessed in varus and valgus using the threshold to detection of movement (TDPM). Passive joint stiffness was estimated as the slope of the normalized torque-angle relationship at 0° joint rotation (neutral) and several rotations in varus and valgus. Analyses of variance were performed to determine the effect of OA and gender on each metric. Linear regression was used to assess the correlation between TDPM and joint stiffness.

TDPM was significantly higher (P<0.05) in the OA group compared to controls for both varus and valgus, but significant gender differences were observed. Passive joint stiffness was significantly reduced (P<0.05) in OA participants compared to the control group in neutral and valgus, but not varus, and significantly reduced in females compared to males. A weak negative correlation was observed between TDPM and stiffness estimates, suggesting that poorer proprioception was associated with less joint stiffness.

While both joint stiffness and proprioception were reduced in the OA population, they were only weakly correlated. This suggests that other neurophysiological factors play a larger role in the proprioceptive deficits in knee OA. © 2011 by the American College of Rheumatology

The objective of this study was to evaluate the recent epidemiology of hip fractures in the United States (U.S.)

We identified hip fracture cases from the 2008 Nationwide Emergency Department Sample, which contains over 28 million Emergency Department (ED) records.

In 2008, approximately 341,000 (95% confidence interval (CI): 339,000–343,000) patients visited EDs with hip fractures. Of those, 90% were 60 years or older. Between ages 60 and 85, the risk of fracture doubled for every five- to six-year increase in age. However, the hip fracture risk increased slowly after age 85. The overall trochanteric-to-cervical fracture ratio was nearly 2:1. The risk of trochanteric fracture increased faster with age compared with the risk of cervical fracture. At the age of 85, the rates of trochanteric and cervical fractures (per 100,000) were: 1,300 and 700, respectively among women; and 800 and 500, respectively among men.

The slowed growth of hip fracture risk after age of 85 suggests that the eldest old group may have a distinct hip fracture risk. Our study showed that trochanteric fractures were twice as common as cervical fractures. Because trochanteric fractures are more closely related to severe and generalized bone loss than cervical fractures, we hypothesize that the high incidence rate of trochanteric fractures in the U.S. suggests that osteoporosis is a health problem that is linked to hip fracture. In addition to improved safety measures to reduce falls, rigorous preventive treatments of osteoporosis may be needed. © 2011 American College of Rheumatology.

To determine the clinical manifestations and disease damage associated with discoid rash in a large multiethnic systemic lupus erythematosus (SLE) cohort.

SLE patients (per ACR criteria), age = 16 years, disease duration = 10 years at enrollment, and defined ethnicity (African American, Hispanic or Caucasian), from a longitudinal cohort were studied. Socioeconomic-demographic features, clinical manifestations and disease damage [as per the Systemic Lupus International Collaborating Clinics Damage Index (SDI)] were determined. The association of DLE with clinical manifestations and disease damage was examined using multivariable logistic regression.

A total of 2,228 SLE patients were studied. The mean (standard deviation, SD) age at diagnosis was 34.3 (12.8) years and the mean (SD) disease duration was 7.9 (6.0) years; 91.8% were women. Discoid lupus was observed in 393 (17.6%) of patients with SLE. In the multivariable analysis, patients with discoid lupus were more likely to be smokers and of African-American ethnicity, and to have malar rash, photosensitivity, oral ulcers, leukopenia and vasculitis. DLE patients were less likely to be of Hispanic (from Texas) ethnicity, and to have arthritis, end-stage renal disease (ESRD), and antinuclear, anti-dsDNA and anti-phospholipid antibodies. Patients with DLE had more damage accrual, particularly chronic seizures, scarring alopecia, scarring of the skin, and skin ulcers.

In this cohort of SLE patients, discoid lupus was associated with several clinical features including serious manifestations such as vasculitis and chronic seizures. © 2011 American College of Rheumatology.

Giant cell arteritis (GCA) is the most frequent form of vasculitis in adults. We sought to estimate the infectious risk associated with GCA and its treatment.

We conducted a matched historical cohort study, using data from The Health Improvement Research Network. Patients with newly diagnosed GCA were matched with up to 6 non-GCA patients by age, sex, general practice and date of entry into the cohort. Random effects Poisson regression models were used to obtain incidence rates and rate ratios for lower respiratory tract infections (LRTI), urinary tract infections (UTI)and sepsis, as well asfor the subset of these that comprised serious infections (pneumonias, upper UTI and sepsis). Effect modification by age, sex and time since diagnosis of GCA was assessed.

1664 patients with GCA were matched to 8078 patients without GCA. Overall, 805(48%) of GCA patients and 3007(37%)non-GCA patients experienced ≥1 episode of systemic infection during follow up, with adjusted rate ratios for LRTI, UTI, and serious infections of 1.48[95%CI:1.34-1.65], 1.27[95%CI:1.10-1.46], and1.55[95%CI:1.22-1.96], all p-values <0.001. The rate ratio for sepsis was 1.63[95%CI:0.78-3.40], p-value 0.20. Rate ratios for infection were highest in the first six months following diagnosis of GCA and in patients younger than 75 years old, but did not vary by sex.

This is the first study to show that patients with GCA are at increased risk of systemic infections, particularly in the first fewmonths following diagnosis. New GCA medications that allow steroid-sparing are needed to treat this condition. © 2011 by the American College of Rheumatology

Translating patient reported outcomes (PRO) into clinical decision making is difficult. We evaluated patient satisfaction with total hip replacement (THR) to establish cut-points of sufficient improvement based on the patient acceptable symptom state (PASS) and receiving operating characteristics (ROC) curves, and compared them with measures derived from the minimal clinically important difference (MCID), taking into account patients' baseline status.

Two cohorts of prospectively recruited patients on waiting lists for THR. Sociodemographic data and comorbidities were recorded. Patients completed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and other PRO questions before THR and 6 months afterward. Cut-points of sufficient improvement were established by the PASS, ROC and MCID and compare among them.

Patients satisfied with THR had, by pre-intervention WOMAC tertiles, gains of 19.1, 34.1 and 49.3 in the WOMAC pain domain and 17.8, 30.8, 41.4 in the WOMAC functional limitation domain. PASS cut-points determined were 20, 25, and 25 for post-intervention WOMAC pain and 28, 35, and 42 for functional limitation (FL). ROC cut-points were 19, 25 and 25 for post-intervention pain and 26.4, 39, and 40 for FL. Agreement among cut-points classifying patients as responders to THR was 1.0 for pain with both PASS and ROC, and 0.85 for functional limitation; 0.6 for pain between MCID and PASS or ROC, and 0.56 and 0.54 for functional limitation.

Cut-points of expected gain after THR can help clinicians, researchers, and managers to identify suitable candidates for THR, although such measures must be used with caution. © 2011 by the American College of Rheumatology

To introduce and evaluate a new standardized ultrasound (US) score developed for large joints in patients with rheumatoid arthritis (RA).

An US score was designed to determine the degree of inflammation in the shoulder, the elbow, the hip and the knee joint in patients suffering from RA (Sonography of Large Joints in Rheumatology, SOLAR). Synovitis and synovial vascularity were scored semiquantitatively (grade 0-3) by grey scale (GSUS) and power Doppler ultrasound (PDUS). RA patients were examined at baseline and 3, 6 and 12 months after initiation of local or systemic therapy (DMARDs / biologics). Erythrocyte sedimentation rate, anti - citrullinated peptide antibodies and the clinical Disease Activity (DAS28) were determined.

A cohort of 199 patients was analyzed, which have been followed over 12 months. At baseline,before modification of the therapy, patients received DMARDs (n = 131), DMARDs plus biologics (n = 46), biologic monotherapy (n = 8) or no DMARD therapy (n = 14). At baseline, the mean DAS28 was 4.6 and decreased to 3.3 after one year of therapy (p < 0.001). All US scores demonstrated a statistically significant improvement except the PDUS scores for the shoulder and the hip. In detail, the mean synovitis score in GSUS for the knee decreased from 5.2 at baseline to 2.2 after 12 months of follow up. For the shoulder GSUS score fell from 2.6 to 1.6, the elbow score from 5.2 to 2.6 and the mean hip GSUS score declined from 2.2 to 0.4 respectively (each p < 0.05).

The SOLAR score is a feasible tool for the qualitative and quantitative evaluation of large joint involvement in RA patients using US. © 2011 American College of Rheumatology.

ANCA-associated vasculitis (AAV) is infrequently seen in women of fertile age. Only a limited number of pregnancies in women with AAV have been reported, often associated with complications.

Single-center retrospective observational study. All pregnancies in women with granulomatosis with polyangiitis (n = 13) and microscopic polyangiitis (n = 1) were included. Women of fertile age were counseled to abstain from pregnancy during or shortly after disease activity or less than 1 year after cyclophosphamide.

We described 22 pregnancies in 14 women with AAV (median age at diagnosis 25 years (range 19-36)diagnosed between 1982 and 2008. The ENT region (71%) and kidneys (50%) were predominantly involved. All women were in remission at conception and cyclophosphamide had been given in 9 women (15 pregnancies). Median gestational age was 39+4 weeks, including two preterm deliveries. Birth weight was 3400 grams (1860-3890). Hypothyroidism occurred in one newborn and a cleft palate in one newborn of a twin pregnancy. Otherwise fetal outcome was excellent. Preeclampsia was diagnosed in two pregnancies. A caesarean section was performed in two patients. Median follow-up after the last conception was 98 months (11-307). Eight women experienced a relapse 21 months (7-62) after conception, one during pregnancy, seven after delivery.

In this study outcome of pregnancy in patients with AAV in remission was excellent. Pregnancy in women with AAV in remission does not seem to be associated with increased risk of relapse. Counseling, careful management and close follow-up are essential in pregnant women with AAV. © 2011 by the American College of Rheumatology

To evaluate the therapeutic effect of infliximab in patients with inflammatory vascular lesions due to Behçet's disease (BD).

Seven patients with clinical evidence of severe vascular BD were analyzed: Three patients with aortic involvement, one with recurrent venous thrombosis of the pelvic veins, one with recurrent venous and arterial thromboses of his thigh and two with retinal vasculitis. Infliximab was initiated with 3-5 mg-kg bodyweight and infusions repeated in intervals of 4 weeks as either first line therapy in three patients or add-on after failure of conventional immunosuppression in the remaining four. Ongoing immunosuppression consists of a various combination of azathioprine (n=2), methotrexate (n=3), cyclosporine (n=3) and low-dose glucocorticoids (n=3).

Control of inflammation was seen 1-5 days after infliximab induction in all patients. CRP reduced from 89 mg-l mean prior to infliximab to 9 mg-l thereafter. Vision increased rapidly in retinal vasculitis patients. Vascular grafts remained patent. Inflamed and dissected aortic wall healed over a period of 6 months. Infliximab could be stopped in two patients; intervals could be extended in four to a maximum of eight weeks. Infliximab and basic immunosuppression were well tolerated; no drug-induced side-effects were recorded.

Infliximab is effective in inducing and maintaining remission of vasculitic activity in BD patients. The rapid effect together with excellent tolerability suggests that infliximab should be considered as first-line agent in severe vascular BD. © 2011 by the American College of Rheumatology

To formulate consensus treatment plans (CTPs) for induction therapy of newly diagnosed proliferative lupus nephritis (LN) in juvenile systemic lupus erythematosus (jSLE).

A structured consensus formation process was employed by the members of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) after considering the existing medical evidence and current treatment approaches.

After an initial Delphi survey (response rate 70%), a 2-day consensus conference, and two follow-up Delphi surveys (response rates 63-79%), consensus was achieved for a limited set of CTPs addressing the induction therapy of proliferative LN. These CTPs were developed for prototypic patients defined by eligibility characteristics, and included immunosuppressive therapy with either mycophenolic acid orally twice per day, or intravenous cyclophosphamide once per month at standardized doses for six months. Additionally, the CTPs describe three options for standardized use of glucocorticoids; including a primarily oral, a mixed oral/intravenous, and a primarily intravenous regimen. There was consensus on measures of effectiveness and safety of the CTPs. The CTPs were well accepted by the pediatric rheumatology providers treating children with LN, and up to 300 children per year in North America are expected to be candidates for the treatment with the CTPs.

CTPs for induction therapy of proliferative LN in jSLE based on the available scientific evidence and pediatric rheumatology group experience have been developed. Consistent use of the CTPs may improve the prognosis of proliferative LN, and support the conduct of comparative effectiveness studies aimed at optimizing therapeutic strategies for proliferative LN in jSLE. © 2011 by the American College of Rheumatology

To identify and critically appraise the evidence for the effectiveness of custom orthoses for the foot and ankle in rheumatoid arthritis (RA).

Studies were identified in appropriate electronic databases (from 1950 to March 2011). Search term ‘rheumatoid arthritis’ with ‘foot’ and ‘ankle’ and related terms were used in conjunction with ‘orthoses’ and synonyms. Included studies were quantitative longitudinal studies and included randomised controlled trials (RCTs), case-control trials (CCTs), cohort studies, and case series studies. All outcome measures were investigated. Quality assessment was conducted using the Cochrane Collaboration criteria with additional criteria for sample population representativeness, quality of statistical analysis, and compliant intervention use and presence of co-interventions. Meta-analyses were conducted for outcome domains with multiple RCTs. Qualitative data synthesis was conducted for remaining outcome domains. Levels of evidence were then assigned to each outcome measure.

The inclusion criteria were met by 17 studies. Two studies had high quality for internal validity and three studies had high quality for external validity. No study had high quality for both internal and external validity. Six outcome domains were identified. There was weak evidence for custom orthoses reducing pain and forefoot plantar pressures. Evidence was inconclusive for foot function, walking speed, gait parameters and reducing hallux abductovalgus (HAV) angle progression.

Custom orthoses may be beneficial in reducing pain and elevated forefoot plantar pressures in the rheumatoid foot and ankle. However, more definitive research is needed in this area. © 2011 by the American College of Rheumatology

While questionnaires have been developed to capture patient reported outcomes (PRO) in rheumatology practice, these instruments are not widely used. We developed a touchscreen interface designed to provide reliable and efficient data collection. Using the touchscreen to obtain PROs, we compared two different workflow models separately implemented in two rheumatology clinics.

The Plan-Do-Study-Act methodology was used in two cycles of workflow redesign. Cycle 1 relied on off-the-shelf questionnaire builder software and Cycle 2 relied on a custom programmed software solution.

During Cycle 1, clinic 1 (private practice model, resource replete, simple flow) demonstrated a high completion rate at the start, averaging between 74% and 92% for the first 12 weeks. Clinic 2 (academic model, resource deficient, complex flow) did not achieve a consistent completion rate above 60%. The revised Cycle 2 implementation protocol incorporated a 15 minute “nurse visit”, an instant messaging system, and a streamlined authentication process, all of which contributed to substantial improvement in touchscreen questionnaire completion rates of ∼80% that were sustained without the need for any additional clinic staff support.

Process redesign techniques and touchscreen technology were used to develop a highly successful, efficient, and effective process for the routine collection of patient reported outcomes (PROs) in a busy, complex, and resource depleted academic practice and in typical private practice. The successful implementation required both a touchscreen questionnaire, human behavioral redesign, and other technical solutions. © 2011 by the American College of Rheumatology

Fatigue is an overwhelming RA symptom caused by interacting clinical and psychosocial factors. Cognitive-behavioural therapy (CBT) addresses links between thoughts, feelings and behaviours and uses cognitive restructuring to facilitate behaviour changes. In an RCT, a group CBT programme for RA fatigue improved fatigue impact, severity and perceived coping, as well as mood and quality of life. The aim of this study was to explore the patient perspective of the programme and impact of behaviour changes.

Ten exit focus groups were held (38 patients). Transcripts were analysed by an independent researcher using a hybrid thematic approach, with a subset analysed by a team member and patient partner.

Three overarching themes were identified:

“They made us work it out ourselves” (programme factors facilitating changes). Patients spontaneously identified elements of group CBT as pivotal, including guided discovery, the impact of metaphors and working as a group.

“Feeling much better about yourself and coping much better” (the nature of changes). Patients described cognitive changes, including enhanced self-efficacy and problem solving, and emotional changes, including being less volatile and fearful of fatigue.

“My life has changed so much it's unbelievable” (benefits beyond fatigue). Patients re-engaged in previously abandoned activities, were more active and enjoyed greater social participation.

Patients highlighted that CBT elements were key to making behaviour changes, and that these had far-reaching impacts on their lives. This suggests it could be beneficial in clinical practice to incorporate cognitive-behavioural approaches into patient education programmes which aim to enhance self-management. © 2011 by the American College of Rheumatology

The objective of this study was to evaluate the occurrence of emergency department (ED) visits due to humerus fractures in the United States (U.S.).

We analyzed the 2008 Nationwide Emergency Department Sample, which contained approximately 28 million ED records. We identified the cases of interest using diagnostic codes for proximal, shaft, and distal humerus fractures.

In 2008, approximately 370,000 ED visits in the U.S. resulted from humerus fractures. Proximal humerus fractures were the most common, accounting for 50% of humerus fractures. The incidence rate of proximal humerus fractures followed the shape of an exponential function in the ages 40-84 for women (R²=97.9%) and 60-89 for men (R²=98.2%). After the exponential increase in these age intervals, the growth rate of proximal humerus fracture slowed and eventually decreased. The peak occurrence of distal humerus fractures was in children aged 5 to 9 years; yet, elderly women had an increased risk. As the baby boomer generation ages, unless fracture prevention programs improve, more than 490,000 ED visits are expected due to humerus fractures in 2030 when the youngest of the baby boomers turn 65 years old.

Compared to epidemiologic studies in Japan and European countries, the incidence rates of humerus fractures are substantially higher in the U.S. The high incidence rate of humerus fractures in the expanding elderly population may contribute to the recent trend of rapid increase in shoulder arthroplasty in the U.S. Rigorous safety measures to reduce falls and improved preventive treatments of osteoporosis are needed. © 2011 by the American College of Rheumatology

Granulomatosis with polyangiitis (GPA), previously known as Wegener's granulomatosis, is a necrotizing granulomatous vasculitis affecting the upper and lower respiratory tract, kidneys, and other small vessels throughout multiple organ systems. Recently, classification criteria for childhood GPA (cGPA) have been proposed and include the addition of airway stenosis. Airway inflammation occurs more frequently in children than adults and often proves difficult to diagnose and treat.

To 1) determine the frequency of airway involvement in a cohort of children with GPA as defined by the European League Against Rheumatism/Pediatric Rheumatology International Trials Organization/Pediatric Rheumatology European Society (EULAR/PRINTO/PRES) criteria, 2) document the frequency of specific airway findings and 3) review our treatment approach to children with GPA-related airway disease.

Retrospective chart review performed on patients under 18 years old with a diagnosis of vasculitis evaluated at the Cleveland Clinic between 2004 and 2010.

28 patients fulfilling EULAR/PRINTO/PRES classification criteria for the diagnosis of cGPA were included in the analysis. Mean follow-up of 3.1 years. The overall prevalence of any airway disease was 86%, with upper airway involvement in 86%, and larynotracheobronchial (LTB) disease in 50% of patients. LTB disease was present at diagnosis in 36%, while in the remaining 14% it developed on immunosuppressive therapy. Ten patients underwent successful endoscopic intervention.

Airway manifestations frequently occur in cGPA. Inflammatory changes can occur at any point in the disease course, necessitating diligent surveillance. Endoscopic interventions for LTB stenotic lesions represent a safe and effective therapeutic option. © 2011 by the American College of Rheumatology

The objective of this study is to determine the validity of standardized screening assessments of cognitive functioning to detect neuropsychological impairment evaluated using a comprehensive battery in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

This is a cross-sectional study using a combined cohort of 138 persons with SLE and 84 persons with RA. Screening cut-points were empirically derived using receiver operating characteristic curves and threshold selection methods. Screening measures included the Hopkins Verbal Learning Test- Revised (HVLT) Learning and Delayed Recall Indices, Phonemic Fluency, a composite measure of the three cognitive screening tests, and the Perceived Deficits Questionnaire (PDQ), a self-report measure of cognitive complaints. A comprehensive neuropsychological battery was administered as the ‘gold standard’ index of neuropsychological impairment.

Rates of neuropsychological impairment were 27% and 15% for the SLE and RA cohorts, respectively. Optimal threshold estimations were derived for 5 screening techniques. The HVLT Learning and phonemic fluency indices yielded the greatest sensitivity at 81%. The PDQ yielded the lowest sensitivity at 52%. All measures were significantly associated with neuropsychological impairment after controlling for relevant sociodemographic covariates and depression.

These results suggest that telephone administered screening techniques may be useful measures to identify persons with neuropsychological impairment. Specifically, measures of phonemic fluency and verbal learning appeared to be most sensitive and least likely to misclassify impaired individuals as cognitively intact. Self-reported questionnaires may have relatively decreased sensitivity compared to standardized interviewer administered cognitive measures. © 2011 by the American College of Rheumatology

SACQ SLE patients' discordance presents a clinical dilemma: does active serology alone warrant treatment? We explore outcomes in patients with and without a prolonged SACQ period, comparing the rate of damage accrual by SLICC/ACR Damage Index (SDI), and incidences of renal damage and coronary artery disease (CAD), over a decade.

SACQ was defined as a ≥2-year sustained period without clinical activity, with persistent serologic activity (increased anti-dsDNA and/or hypocomplementemia); antimalarials were permissible, corticosteroids/immunosuppressives were not. SACQ patients were matched for relevant variables with SLE controls. Change in SDI, and incidences of CAD and renal damage were compared. Descriptive statistics were used; comparisons were made using t- and McNemar tests.

55 SACQ patients and 110 controls were identified. SDI at 3 years from the start of the SACQ period was 0.70±1.27 vs. 1.13±1.54 in controls (p>0.0001), and by 10 years was 1.26±1.68 vs 2.26±2.23 (p=0.001); intergroup difference in damage significantly increased over 10 years. Initially two (3.6%) SACQ patients had CAD vs. 7 (6.4%) controls (p=0.32), with 1 (1.8%) new case in SACQ patients vs 8 (7.3%) in controls over 10 years (p=0.06). Baseline serum creatinine did not differ between groups. By definition, SACQ patients had no baseline proteinuria, versus 13 (12.3%) controls (p>0.0001). By year 10, two (3.6%) SACQ patients, vs 26 (23.6%) controls had renal damage (p>0.0001).

Patients with a prolonged SACQ period accrued less damage over a decade compared to matched controls, supporting management with active surveillance without treatment during a SACQ period. © 2011 by the American College of Rheumatology

Many outcomes have been proposed in the assessment of Psoriatic Arthritis (PsA). The OMERACT core set for PsA evaluation comprises 6 domains: joint, skin, function, pain, patient's global assessment and quality of life. The objective of this work was to assess reporting of outcomes in PsA, including patient-reported outcomes (PROs) in recent publications.

A systematic literature search of clinical trials related to PsA and reporting at least 1 clinical outcome between 2006 and 2010 was performed in PUBMED, i.e., just before to just after publication of the OMERACT core set. All clinical outcomes were noted and subdivided in domains of health. Data analysis was descriptive.

58 articles (12,405 patients) were included in the analysis: 17 (29%) were randomized clinical trials; patients' mean age was 48.2±5.4 years, and the mean disease duration was 9.0±3.1 years. Eighty-four different outcomes were reported, with a mean of 6.9±4.3 per study. Patients were mainly assessed using the 6 core set domains, reported in 37.9% (quality of life) to 55.2% (skin) of articles, however, the core set was rarely completely reported since only 10.3% of studies reported all 6 core domains. Physician-reported outcomes were heterogeneous and in particular there was no consensus regarding number of joints to assess and instruments for dactylitis and enthesitis. PROs were assessed in more than 75% of publications using 28 different instruments.

There is great heterogeneity in PsA assessment, even since publication of the OMERACT core set. Better consensus on instruments to assess each domain of health, and better insight into which outcomes are important for patients is needed. © 2011 by the American College of Rheumatology

To determine the agreement and reliability of Nail Psoriasis Severity Index (NAPSI) in the assessment of nail involvement in patients with PsA when performed by rheumatologists with no experience in using this instrument.

Three women with PsA, satisfying CASPAR criteria, with nail involvement were selected from the outpatient clinic devoted to PsA. The assessors consisted of two groups: a) 8 expert rheumatologists in the field of PsA, members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and with extensive experience >10 years and b) 69 rheumatologists that had never used NAPSI.

A video, showing the nail of each selected patient (A, B, C) with the most nail PsA dystrophy, was administered to these 2 groups.

The 8 assessors of the first group, previously trained on using NAPSI, evaluated independently the 3 videos by using the NAPSI score. The second group scored the NAPSI after an educational session.

This evaluation was repeated after 6 hours with a different sequence of videos (unpaired fashion). Inter and intra-reader reliability was estimated by calculating intraclass correlation coefficients (ICC) and associated 95% confidence intervals (95% CIs).

Results: The inter-reader reliability showed an ICC (95% CIs) of 0.934 (0.7504-0.9983). Intra-reader reliability showed an ICC (95% CIs) of 0.463 (0.134-0.668), 0.148 (0.3767–0.4722), and 0.354 (0.0425-0.600) for patient A, B and C, respectively.

These results show that NAPSI seems to be an unreliable instrument to assess the nail involvement when used by non-trained rheumatologists in clinical practice. © 2011 by the American College of Rheumatology.

Previous studies indicate that flexible footwear, which mimics the biomechanics of walking barefoot, result in a decreased knee loads in patients with knee osteoarthritis (OA) during walking. However, the effect of flexible footwear on other activities of daily living, such as descending stairs, remains unclear.

To evaluate the influence of inexpensive and minimalist footwear (Moleca®) on knee adduction moment (KAM) during stair descent of elderly women with and without knee OA.

Thirty-four elderly women were equally divided into an OA group (OAG) and a control group (CG). Stair descent was evaluated in barefoot condition, while wearing the Moleca®, and wearing heeled shoes. Kinematics and ground-reaction forces were measured to calculate KAM by using inverse dynamics.

The OAG experienced higher KAM during midstance under barefoot condition (233.3%; p=0.028), Moleca® (79.2%, p=0.004) and heeled shoes (217.6%, p=0.007). The OAG had a similar knee load during early, mid, and late stance with Moleca® compared with the barefoot condition. Heeled shoes increased the knee loads during early-stance phase (versus barefoot [16.7%; p<0.001], versus Moleca [15.5%; p<0.001]); mid-stance (versus barefoot [8.6%; p=0.014], versus Moleca [9.5%; p=0.010], and late-stance (versus barefoot [10.6%; p=0.003], versus Moleca [9.2%; p<0.001]. In the CG, Moleca® produced similar knee load to the barefoot condition only during the early-stance phase.

Besides the general foot protection, the inexpensive and minimalist footwear contributes to decreasing knee loads in elderly women with OA during stair descent. The loads are similar to the barefoot condition and effectively decreased when compared with heeled shoes. © 2011 by the American College of Rheumatology.

Use of synthetic vitamin A derivatives (e.g. isotretinoin used for severe acne) and high doses of preformed vitamin A have been implicated in the pathogenesis of hyperuricemia and gout, whereas a trial reported that β-carotene may lower serum uric acid (SUA) levels. We evaluated the potential population impact of these factors on SUA in a nationally representative sample of US adults.

Using data from 14,349 participants aged 20 years and older in the Third National Health and Nutrition Examination Survey (1988-1994), we examined the relation between serum retinol, β-carotene, and uric acid levels using weighted linear regression. Additionally, we examined the relation with hyperuricemia using weighted logistic regression.

SUA levels increased linearly with increasing serum retinol levels, whereas SUA levels decreased with increasing serum β-carotene levels. After adjusting for age, sex, dietary factors, and other potential confounders, the SUA level differences from the bottom (referent) to top quintiles of serum retinol levels were 0, 0.16, 0.31, 0.43, 0.71mg/dL (P for trend < 0.001) and for β-carotene were 0, -0.15, -0.29, -0.27, -0.40 mg/dL (P for trend < 0.001). Similarly, the multivariate odds ratios of hyperuricemia from the bottom (referent) to top quintiles of serum retinol levels were 1.00, 1.30, 1.83, 2.09, and 3.22 (P for trend <0.001) and for β-carotene were 1.00, 0.85, 0.68, 0.73, and 0.54 (P for trend <0.001). The graded associations persisted across subgroups according to cross-classification by both serum retinol and β-carotene levels.

These nationally representative data raise concerns that vitamin A supplementation and food fortification may contribute to the high frequency of hyperuricemia in the US population, whereas β-carotene intake may be beneficial against hyperuricemia. The use of β-carotene as a novel preventive treatment for gout deserves further investigation. © 2011 by the American College of Rheumatology

To identify both provider and organizational characteristics that predicted outcomes following an educational intervention (nine hour workshop and follow-up reinforcement activities) developed to improve the management of arthritis in primary care.

Providers completed a survey at baseline and at six months post workshop, including a case scenario for early RA. Providers' were asked how they would manage the case and their responses were coded to calculate a best practice score, ranging from 0 to 7. Two-level hierarchical linear modeling was used to determine which of the measured provider and organizational factors predicted best practice scores at follow-up.

275 multidisciplinary providers from 131 organizations completed both baseline and follow-up surveys. Best practice scores increased by 17% (P < 0.01); however, the mean score at 6-month follow-up remained relatively low (2.68). Significant predictors of best practice scores at follow-up were discipline of providers and model of primary care in which they worked (P<0.05), adjusting for baseline practice scores and clustering of providers within organizations. Physicians, nurse practitioners and rehabilitation therapists scored higher than nurses, students and other health care providers (P<0.01). Physician networks scored significantly lower than providers from multi-disciplinary oriented models of care (P=0.02).

These results have implications for the education of health professionals and the design of models of care to enhance arthritis care delivery. © 2011 by the American College of Rheumatology.

To use consensus methods and the considerable expertise contained within the Children's Arthritis and Rheumatology Research Alliance (CARRA) organization, to extend the 3 previously developed treatment plans for moderate juvenile dermatomyositis (JDM) to span the full course of treatment.

A consensus meeting was held in Chicago on April 23-24, 2010 involving 30 pediatric rheumatologists and 4 lay participants. Nominal group technique was used to achieve consensus on treatment plans which represented typical management of moderate JDM. A pre-conference survey of CARRA, completed by 151/272 (56%) members, was used to provide additional guidance to discussion.

Consensus was reached on timing and rate of steroid tapering, duration of steroid therapy, and actions to be taken if patients were unchanged, worsening, experiencing medication side effects or disease complications. Of particular importance, a single, consensus steroid taper was developed.

We were able to develop consensus treatment plans which describe therapy for moderate JDM throughout the treatment course. These treatment plans can now be used clinically, and data collected prospectively regarding treatment effectiveness and toxicity. This will allow comparison of these treatment plans and facilitate the development of evidence-based treatment recommendations for moderate JDM. © 2011 by the American College of Rheumatology.

Classification criteria for systemic sclerosis (SSc) are being updated.

To select a set of items potentially useful for the classification of SSc using consensus procedures including the Delphi and nominal group techniques (NGT).

Items were identified through two independent consensus exercises performed by the Scleroderma Clinical Trials Consortium (SCTC) and the EULAR Scleroderma Trials and Research Group (EUSTAR). The first-round items from both exercises were collated and redundancies were removed leaving 168 items. A 3-round Delphi exercise was performed using a 1-9 scale (1=completely inappropriate and 9=completely appropriate) and a consensus meeting using NGT. During the last Delphi, the items were ranked on a 1-10 scale.

Round 1: 106 experts rated the 168 items. Those with a median score <4 were removed, resulting in a list of 102 items. Round 2: The items were again rated for appropriateness and subjected to a consensus meeting using NGT by European and North American SSc experts (n=16), resulting in 23 items. Round 3: SSc experts (n=26) then individually scored each of the 23 items in a last Delphi round, using an appropriateness score (1-9) and ranking their 10 most appropriate items for classification of SSc. Presence of skin thickening, SSc-specific autoantibodies, abnormal nailfold capillary pattern and Raynaud's phenomenon ranked highest in the final list that also included items indicating internal organ involvement.

The Delphi exercise and NGT resulted in a set of 23 items for classification of SSc which will be assessed for their discriminative properties in a prospective study. © 2011 by the American College of Rheumatology

Classification criteria for systemic sclerosis (SSc) are being updated jointly by ACR and EULAR. Potential items for classification were reduced to 23 using Delphi and Nominal Group Techniques. We evaluated the face, discriminant and construct validity of the items to be further studied as potential criteria.

Face validity was evaluated using the frequency of items in patients sampled from the Canadian Scleroderma Research Group, 1000 Faces of Lupus, the Pittsburgh, Toronto, Madrid and Berlin CTD databases. SSc (n=783) were compared to 1071 patients with diseases similar to SSc (mimickers): SLE (n=499), myositis (n=171), Sjögren's syndrome (n=95), Raynaud's phenomenon (RP) (n=228), MCTD (n=29), and idiopathic PAH (n=49). Discriminant validity was evaluated using odds ratios (OR). For construct validity, empiric ranking was compared to expert ranking.

Compared to mimickers, SSc are more likely to have skin thickening (OR=427), telangiectasias (OR=91), anti-RNA polymerase III antibody (OR=75), puffy fingers (OR=35), finger flexion contractures (OR=29), tendon/bursal friction rubs (OR=27), anti-topoisomerase-I antibody (OR=25), RP (OR=24), finger tip ulcers/pitting scars (OR=19), anti-centromere antibody(OR=14), abnormal nailfold capillaries (OR=10), GERD symptoms (OR=8), and ANA, calcinosis, dysphagia, esophageal dilation (all OR=6), interstitial lung disease/pulmonary fibrosis (OR=5) and anti-PM-Scl antibody (OR=2). Reduced DLCO, PAH, and reduced FVC had OR<2. Renal crisis and digital pulp loss/acro-osteolysis did not occur in SSc mimickers (OR not estimated). Empiric and expert ranking were correlated (Spearman rho 0.53, p=0.01).

The candidate items have good face, discriminant and construct validity. Further item reduction will be evaluated in prospective SSc and mimicker cases. © 2011 by the American College of Rheumatology

To review the performance characteristics of the instruments most commonly used to measure clinical outcomes in juvenile idiopathic arthritis (JIA), including global assessments, articular indices, functional/disability assessments, and quality-of-life measures.

As part of an Agency for Healthcare Research and Quality comparative effectiveness review of antirheumatic drugs, we explored the characteristics of commonly used outcome measures for JIA. English-language studies of children with JIA were identified from MEDLINE® and EMBASE®. Two independent reviewers screened titles and abstracts, with subsequent full text review of studies selected based on predetermined criteria.

We included 35 publications describing 34 unique studies and involving 14,831 patients. The Childhood Health Assessment Questionnaire (CHAQ) was the most extensively studied instrument and had high reliability, but only moderate correlations with other indices of disease activity and poor responsiveness to change in disease status. The physician global assessment of disease activity (PGA) and articular indices had the strongest association with disease activity and were most responsive to change. Measures of psychosocial function and quality of life were moderately associated with measures of disease activity, but less responsive to changes in disease status.

In children with JIA, no single instrument was superior in reliability or validity or in describing the impact of JIA. Although the CHAQ has been extensively evaluated, the PGA and articular indices appear to have the highest responsiveness to change and therefore the highest potential for detecting important differences in treatment response. © 2011 by the American College of Rheumatology.

The aim of this study was to evaluate the impact of acute gout on foot pain, impairment and disability.

This prospective observational study recruited 20 patients with acute gout flares. Patients were recruited from emergency departments, hospital wards and rheumatology outpatient clinics throughout Auckland, New Zealand. Patients were recruited at the time of the flare (baseline visit) and then reassessed at a follow-up visit once the acute flare had resolved 6-8 weeks after the initial assessment. Joint counts, C-reactive protein and serum urate were recorded at both visits. General and foot-specific outcome measures were also recorded at each visit including pain visual analogue scale, Health Assessment Questionnaire (HAQ)-II, Lower Limb Tasks Questionnaire, and the Leeds Foot Impact Scale.

The foot was affected by acute gout in 14 (70%) patients. Objective measures of joint inflammation including swollen and tender joint counts and C-reactive protein significantly improved at the follow-up visit, compared with the baseline visit. At baseline, high levels of foot pain, impairment and disability were reported. All patient-reported outcome measures of general and foot-specific musculoskeletal function improved at the follow-up visit compared with the baseline visit. However, pain, impairment and disability scores did not entirely normalise after resolution of the acute gout flare.

Patients with acute gout flares experience severe foot pain, impairment and disability. These data provide further support for improved management of gout to prevent the consequences of poorly controlled disease. © 2011 by the American College of Rheumatology.

The aim of this study was to evaluate the levels of agreement from independent clinical examination by a paediatric rheumatologist and podiatrist, and US examination of articular and peri-articular foot disease in JIA.

Thirty patients with JIA and a history of foot disease underwent clinical (CE) and ultrasound (US) examination of 24 foot joints, 10 tendons and 6 peri-articular soft tissues. Each site was examined independently by a rheumatologist and a podiatrist for synovitis, and tenderness/swelling. The same sites were examined independently by a sonographer for effusion, synovial hypertrophy, power Doppler signal (PS), tenosynovitis, or abnormal tendon thickening. Agreement was estimated using Cohen's un-weighted kappa (κ) with corresponding 95% confidence intervals.

720 joints, 300 tendons and 180 soft tissue sites were examined. Clinically detected synovitis, tenderness and swelling were recorded in 42 (5.8%), 78 (10.8%) and 73 (10.1%) joints respectively. US-detected effusions, synovial hypertrophy and PS were recorded in 88 (12.2%), 47 (6.5%) and 12 (1.7%) joints respectively. Subclinical foot disease was found in 52 (7.2%) joints, 5 (1.6%) tendons and 4 (2.2%) soft tissue sites. Agreement was consistently less than moderate (κ<0.4) for each clinical and US interaction.

This study uniquely demonstrated inter-professional evaluation of foot disease in JIA. Inter-observer agreement was less than acceptable for CE versus US, and sub-clinical foot disease is common in joints and peri-articular soft tissues. US may be a useful tool to aid CE of the foot in JIA patients. © 2011 by the American College of Rheumatology.

Systemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease with a wide spectrum of manifestations, shows considerable variation across the globe, although there is little evidence to indicate its relative prevalence in Asia. This review describes its prevalence, severity, and outcome across countries in the Asia-Pacific region.

We conducted a systematic literature search using 3 groups of terms (SLE, epidemiology, and Asia-Pacific countries) of EMBase and PubMed databases and non–English language resources, including Chinese Wanfang, Korean KMbase, Korean College of Rheumatology, Japana Centra Revuo Medicina, Taiwan National Digital Library of Theses and Dissertations, and Taiwanese, Thai, and Vietnamese journals.

The review showed considerable variation in SLE burden and survival rates across Asia-Pacific countries. Overall crude incidence rates (per 100,000 per year) ranged from 0.9–3.1, while crude prevalence rates ranged from 4.3–45.3 (per 100,000). Higher rates of renal involvement, one of the main systems involved at death, were observed for Asians (21–65% at diagnosis and 40–82% over time) than for whites. While infections and active SLE were leading causes of death, a substantial proportion (6–40%) of deaths was due to cardiovascular involvement. The correlation between the Human Development Index and 5-year survival was 0.83.

This review highlights the need to closely monitor Asian SLE patients in Asian countries for renal and cardiovascular involvement, especially those who may not receive proper treatment and are therefore at greater risk of severe disease. We hope this will encourage further research specific to this region and lead to improved clinical management.

There is increasing evidence of the impact of systemic lupus erythematosus (SLE) on employment, but few studies have had sufficient sample size and longitudinal followup to estimate the impact of specific manifestations or of increasing disease activity on employment.

Data were derived from the University of California, San Francisco, Lupus Outcomes Study, a longitudinal cohort of 1,204 persons with SLE sampled between 2002 and 2009. Of the 1,204 persons, 484 were working at baseline and had at least 1 followup interview. We used the Kaplan-Meier method to estimate the time between onset of thrombotic, neuropsychiatric, or musculoskeletal manifestations, or of increased disease activity, and work loss. We used Cox proportional hazards regression to estimate the risk of work loss associated with the onset of specific manifestations, the number of manifestations, and increased activity, with and without adjustment for sociodemographic, employment, and SLE duration characteristics.

By 4 years of followup, 57%, 34%, and 38% of those with thrombotic, musculoskeletal, and neuropsychiatric manifestations, respectively, had stopped working, as had 42% of those with increased disease activity. On a bivariable basis, the risk of work loss was significantly higher among persons ages 55–64 years and those with increased disease activity and each kind of manifestation. In multivariable analysis, older age, shorter job tenure, thrombotic and musculoskeletal manifestations, greater number of manifestations, and high levels of activity increased the risk of work loss.

Incident thrombosis and musculoskeletal manifestations, multiple manifestations, and increased disease activity are associated with the risk of work loss in SLE.

To examine the productivity of patients with scleroderma (systemic sclerosis [SSc]) both outside of and within the home in a large observational cohort.

One hundred sixty-two patients completed the Work Productivity Survey. Patients indicated whether or not they were employed outside of the home, how many days per month they missed work (employment or household work) due to SSc, and how many days per month productivity was decreased by ≥50%. Patients also completed other patient-reported outcome measures. We developed binomial regression models to assess the predictors of days missed from work (paid employment or household activities). The covariates included: type of SSc, education, physician and patient global assessments, Health Assessment Questionnaire (HAQ) disability index (DI), Functional Assessment of Chronic Illness Therapy–Fatigue, and Center of Epidemiologic Studies Depression Scale Short Form.

The mean age of patients was 51.8 years and 52% had limited cutaneous SSc. Of the 37% of patients employed outside of the home, patients reported missing 2.6 days per month of work and had 2.5 days per month of productivity reduced by half. Of the 102 patients who were not employed, 39.4% were unable to work due to their SSc. When we assessed patients for household activities (n = 162), patients missed an average of 8 days of housework per month and had productivity reduced by an average of 6 days per month. In the regression models, patients with lower education and poor assessment of overall health by a physician were more likely to miss work outside of the home. Patients with limited cutaneous SSc and high HAQ DI scores were more likely to miss work at home.

SSc has a major impact on productivity at home and at work. Nearly 40% of patients reported disability due to their SSc.