Search

Background: With the help of a measurement feedback system, the treatment strategy for individual patients with rheumatoid arthritis (RA) can be adjusted to achieve optimal control of disease activity. Objective: To study whether a measurement feedback system is effective in reducing disease activity in patients with RA. Methods: Forty eight rheumatologists and 264 patients participated in a controlled clinical trial. A three month control period was followed by a 12 month period, where feedback on disease activity, disability, and damage was provided to the rheumatologist. The primary outcome measure was the rheumatoid arthritis disease activity index (RADAI). Results: The feedback system was used for 142/228 (62%) patients. Disease modifying antirheumatic drug changes occurred in 69/169 (41%) patients. In patients with high disease activity and feedback use (n=70), the RADAI decreased in the feedback period by –0.27 points per 30 days (p

Our aim was to determine several indexes of reproducibility for strength measurements with a hand-held pull-gauge dynamometer (MFB50K) in cancer patients. Two independent testers performed repeated measurements of maximal isometric elbow and knee strength. The measurements were gathered in a convenience sample of 40 patients (27 men, age 20–72 years) with various types and stages of cancer. These patients were recruited from the medical oncology clinic of a university hospital. The Pearson product moment correlation coefficient, the intraclass correlation coefficient (ICC), the standard error of measurement (SEM) and its associated 95% confidence interval, the smallest detectable difference (SDD) and the limits of agreement were determined as outcome measures for reproducibility. The results for the Pearson product moment correlation and the ICC were 0.90 for elbow and 0.96 for knee extension strength. The results in terms of the SDDs were 29.4 newton (N) for elbow and 54.8 N for knee strength. The limits of agreement for elbow strength were –21.7 N and 38.5 N (mean 8.4 N). For knee strength the limits of agreement were –49.8 N and 59.8 N (mean 5 N). The Pearson product moment correlation and the ICC suggested good reproducibility. However, the more informative indices of reproducibility, i.e. the SEM and the SDD, showed relatively large measurement error between the testers. Therefore, the current use of the MFB50K for the measurement of muscle strength is not supported in cancer patients.

Background The Rheumatoid Arthritis Disease Activity Index (RADAI) is a self-administered questionnaire on signs and symptoms of rheumatoid arthritis (RA). The main goal of the RADAI is to evaluate the course of RA disease activity over time. The RADAI consists of 5 items and produces a single index from 0–10; higher scores are indicating higher levels of disease activity. The RADAI has shown to be cross-sectionally valid1 and responsive to clinical important worsening of disease activity.2 Objectives The study objectives are: 1) to determine the test-retest reliability of the RADAI, and 2) to determine if the RADAI is responsive to clinical important improvements in disease activity, using an intervention of known efficacy (Infliximab) as external standard. Methods Until now, 12 RA patients (ACR criteria) have been included (1 male), having high or moderate disease activity (DAS28 >3.2);3 10 patients already had a 6-week follow-up. The intervention consisted of treatment with Infliximab and Methotrexate, which is likely to induce a relatively large improvement after 6 weeks. The RADAI was self-administered 1 week before the first infusion with Infliximab (T0). At the first infusion (T1), the patient filled in the RADAI again and the physician assessed the DAS28. After 6 weeks (T2), the RADAI and the DAS28 were again assessed. For analysis of reliability (T0 and T1) the ICC3,1 and the Limits-of Agreement [4] were used. Responsiveness was studied by judging the change in RADAI at T2 in relation to the Limits-of-Agreement and the DAS28 response criteria.3 Results The RADAI scores at T0 and T1 were mean (sd) 5.0 (1.7) and 4.8 (1.9). The mean (sd) difference was -0.2 (0.8), (paired t-test, p = 0.41). The ICC3,1 was 0.89 (p Conclusion The data collection is ongoing till N = 20. The first results on reliability and responsiveness are promising. However, if the Limits-of-Agreement turn out to be much wider than -1 and +1, the reliability of the RADAI should be improved. References Fransen J, et al. Rheumatology 2000;39(3):321–7 Fransen J, et al. Arthritis Rheum., in press Van Gestel AM, et al. Arthritis Rheum. 1998;41(10):1845–50 Bland J, Altman D. Lancet 1986;1(8476):307–10

Background Management of patients with RA is challenging and poses specific problems. With the help of a decision-support system (Swiss Clinical Quality Management in RA) that gives the rheumatologist feedback on treatment outcomes, the treatment strategy can be adjusted. It is assumed that control of disease activity avoids or reduces signs and symptoms in the short term, and reduces the development of joint damage and disability in the long term. Objectives To study if the decision-support system is effective in a) reducing disease activity, and b) maintaining the level of joint damage and disability in RA patients. Methods 264 RA patients from 63 rheumatologists were included in a longitudinal evaluation, starting with a 3 month control period P0 (no feedback) followed by a 12 month intervention period P1 (with provision of feedback). Patients are nested in physicians, crossed with time nested in period. The main outcome variable is the Rheumatoid Arthritis Disease Activity Index (RADAI), a questionnaire on signs and symptoms in RA. The RADAI ranges from 0–10, higher scores indicate more disease activity. Disease activity (DAS28), disability (HAQ), and joint damage (X-ray score) were additionally measured in P1. To compare the development of the RADAI in P0 with P1, multilevel analysis (linear regression with random coefficients) was used; the unit of time is 30 days. For analysing differences in P1 for DAS28, HAQ and X-ray score, the paired t-test was used. Results All patients had at least 1 feedback report at start of P1, 40% had 2, 23% had 3–6 reports. The regression model shows no time effect for RADAI in P0: -0.02 (p = 0.75) and a small time effect in P1: -0.04 (p Conclusion These results point to a significant but small effect of a decision-support system in reducing disease activity in RA. Over 12 months, the medication strategy was changed in only a minority of patients. The SCQM may increase its efforts to stimulate physicans to adjust treatment, e.g. by the implementation of explicit treatment guidelines. Other possible reasons for suboptimal effectiveness need to be explored, including limited treatment options and medication compliance.

Objective. The goal of the Rheumatoid Arthritis Disease Activity Index (RADAI) is to provide an easy to use assessment of disease activity. It is a self-administered questionnaire that combines five items into a single index: current and past global disease activity, pain, morning stiffness and a joint count. Methods. A sample of 484 rheumatoid arthritis (RA) patients was used to assess the internal consistency and the convergent validity of the RADAI. This was achieved by calculating Cronbach's alpha and RADAI item and total score correlations with core set measures and DAS28. Results. Cronbach's alpha was 0.87, supporting the summation of the items into a single index. The index correlated best with physicians' global assessment (r = 0.59; P < 0.0001), the Health Assessment Questionnaire (r = 0.55; P < 0.0001) and the number of tender joints (r = 0.55; P < 0.0001), Correlation with the erythrocyte sedimentation rate was low (r = 0.27; P < 0.0001). The RADAI and the DAS28 were correlated (r = 0.53; P < 0.0001), but there was low agreement. Conclusions. The RADAI is valid to assess disease activity in RA patients. However, the RADAI may not automatically replace other measures of disease activity, such as the DAS28.

Background Treat-to-target (T2T) has proven to be more effective in achieving remission in early rheumatoid arthritis (RA) patients than usual care [1]. However, T2T has not been fully implemented in daily clinical practice yet. Moreover, it is unknown whether T2T is cost-effective. Objectives To analyse the cost-effectiveness and cost-utility of a T2T strategy aiming at remission (Disease Activity Score in 28 joints (DAS28) Methods Two early RA inception cohorts including patients who fulfilled the ACR 1987 criteria were compared. The T2T group (n=261) consisted of patients from the DREAM remission induction cohort and was treated according to a protocolized treatment strategy aiming at DAS28 remission. The usual care group (n=213) consisted of patients from the Nijmegen early RA inception cohort and was treated without DAS28-guided, protocolized treatment decisions. For both groups, direct medical costs were collected and compared with gain in effectiveness (DAS28 remission) and quality adjusted life years (QALYs) (EQ-5D utility estimated from the HAQ) over two years of follow-up. Results T2T produced a higher remission percentage (64.4% vs. 34.7%) and a larger gain in QALYs (median (IQR) 1.45 (1.24-1.55) vs. 1.39 (1.18-1.53), p=0.037) than usual care. The total mean (SD) costs per patient were €4.807 (7.434) in the T2T group and €3.806 (5.761) in the usual care group. The incremental cost-effectiveness ratio was €3.340 per patient in remission. The incremental cost-utility ratio was €18.259 per QALY. The figure presents the cost planes which show the relation between A) the differences in effectiveness and costs and B) the differences in utility and costs of T2T versus usual care. Anti-TNF therapy was given to more T2T patients (21.5% vs. 15.0%) and was prescribed earlier in the disease process, compared to usual care. Conclusions This quasi-experiment showed that over the first two years of treatment, T2T is associated with higher costs but also with substantial higher effectiveness. We conclude that T2T is cost-effective in daily clinical practice. References [1]Schipper et al, Ann Rheum Dis. 2011 (In press). Disclosure of Interest None Declared

Background Both early and long-standing rheumatoid arthritis (RA) patients have a low prevalence of work participation, 60% and 40% respectively. Not only is this an economic loss for society, it is also a burden for patients. Studies demonstrate that paid work is associated with better health-related quality of life in patients with RA. TNF blocking agents have a proven effectiveness in the treatment of RA but are expensive. For reasons of cost-effectiveness it is important to know whether the use of TNF blocking agents is associated with increased work participation and to know how it can be predicted. Objectives The objectives of our study were: 1) To analyze the disease related determinants of work participation at the start of TNF blocking agents 2) To verify whether treatment of RA patients with TNF blocking agents leads to changes in work participation 3) To analyze the determinants for changes in work participation in patients who changed in working status after two years of treatment with TNF blocking agents. Methods Data were used from 2002-2011 of a large observational cohort of RA patients on biologics (DREAM). Patients were included when starting a TNF blocking agent (t=0) and were 0.2) were performed followed by multivariate analyses with logistic regression (excluded if p-value >0.1). Results N=1259 patients started on TNF blocking agents and their work participation status was available. N=537 patients were also Conclusions It did appear that in this RA cohort work participation on average did not change during treatment with TNF blocking agents: equal proportions of patients lost or gained work. Work participation increased most in younger, better functioning RA patients without co morbidities. Disclosure of Interest S. Manders Grant/Research support from: the Dutch affiliation of Abbott Pharmaceuticals, W. Kievit: None Declared, A. Braakman: None Declared, L. Hendriks: None Declared, H. Brus: None Declared, J. Fransen: None Declared, M. van de Laar: None Declared, P. van Riel: None Declared

Background The existing 1980 classification criteria for systemic sclerosis (SSc) are suboptimal for patients with early SSc and some patients with limited cutaneous SSc (lcSSc) where an important subset do not meet those criteria. Objectives To develop and test new classification criteria for SSc by a joint EULAR and ACR committee. Methods Delphi exercises and a nominal group technique were used to create a set of potential items for classification of SSc. Twenty cases were prospectively collected to represent the spectrum of SSc (low probability to high probability) which were ranked by SSc experts and conjoint analysis (1000 Minds®) was used to assign weights to the items and reduce the number of items. Experts agreed that all patients with sclerodactyly and scleroderma skin involvement proximal to the MCPs were considered SSc; patients with skin involvement due another scleroderma-like disorder (e.g. scleromyxedema) or skin thickening sparing the fingers were not regarded to have SSc. The provisional classification system was tested in a random sample of SSc cases and controls of 100 from North America and 100 from Europe (derivation sample). The system was simplified and calibrated to real cases. The classification system was re-analyzed in another sample of SSc cases and controls (validation set; n=405). Results The table provides the final items with the proposed weights. Only the maximum score in each domain is counted. A cut-off of >= 9 (out of 19) had a sensitivity of 91% and specificity of 92% in the validation cohort (n=405). The sensitivity and specificity of the former 1980 ARA criteria in this database were 75% and 72%, respectively. These results are preliminary and not yet approved by the organizational sponsors. Conclusions The preliminary results of the classification criteria for SSc performed better than 1980 Preliminary ARA Criteria for SSc. These criteria can be endorsed for epidemiological studies and clinical trials after approval by ACR and EULAR. Disclosure of Interest None Declared

Background Trials of tight control strategies have shown additional effectiveness over usual care. Despite this, in daily clinical practice medication is not always escalated according to guidelines. It is hypothesized that, additional to attained disease activity level, other clinical factors or patient related factors might explain divergence from tight control. Objectives To investigate factors predicting escalation of medication in rheumatoid arthritis (RA) patients. Methods All RA patients with regular monitoring visits to the Nijmegen outpatient clinic received standard clinical assessment including DAS28 assessment and registration of medication changes. In addition, patients were asked 4 questions regarding: perceived health state transition, satisfaction with their current health state, willingness to change therapy and expected health state transition in the near future. To investigate explanatory factors, three models predicting escalation of medication were compared by means of ROC analyses. Predictors for the respective models were: model 1 (reflecting tight control) DAS28>3.2 (yes/no), model 2 gender, age, rheumatoid factor, disease duration, DAS28 response since last visit + attained DAS28 level, model 3 predictors in model 2 + the above mentioned patient perception parameters. Escalation of medication was defined as an increase in frequency and/or dose of medication, or starting a new drug, between the current and next visit. Results In total 337 RA patients; 65.9% female, 71.5% rheumatoid factor positive were included in the analysis. Mean (SD) DAS28 at visit, age and disease duration in years were: 3.11 (1.24), 59.2 (13.17), 11.2 (9.03), respectively. In total 146 (43.3%) patients had a DAS28>3.2, of whom 79 (54.1%) were satisfied with their health status if this would not change until the next visit and a majority of 96 (65.8%) did not want to change their medication. Figure 1 shows sub specifications of patients according to satisfaction an willingness to change medication. Figure 2 shows clear improvement in the predictive capacity of the models by adding additional clinical and patient related factors. Conclusions Including a broader range of clinical and patient related parameters clearly improves the prediction of escalation of care. These results reflect that the decision process to escalate medication in daily clinical practice is more complex than is suggested by tight control guidelines. Interventions aimed at increasing tight control should address additional clinical and patient related factors rather than attained disease activity level alone. Disclosure of Interest None Declared

Background Prevention of joint damage is a main goal of treatment in Rheumatoid Arthritis (RA). However, not all patients have the same risk for joint damage during the course of disease. This is partly dependent on the level of disease activity over time, but also on three main prognostic factors at baseline: presence of anti-CCP, elevated ESR and presence of erosions. Therefore, in establishing a treatment target to prevent joint damage, the presence of these risk factors may be taken into account. A differentiation can be made in the one-size-fits-all treatment target of clinical remission and individualized treatment targets can be defined. Objectives To define DAS treatment targets for the prevention of joint damage for four different baseline risk profiles, based on the presence of anti-CCP, increased ESR and erosions. Methods Data were used from year 0 to 3 of patients of the Nijmegen Early RA cohort. Presence or absence of the three main prognostic factors anti-CCP, high ESR and erosions at baseline was combined in an individual risk profile, with a risk score of 0 to 3, representing the number of risk factors. Joint damage progression was assessed with the Ratingen score at 0 and 3 years and the Disease Activity Score (DAS) was calculated every 3 months. Logistic regression models were used for analyses. Based on the probability for joint damage progression after 3 years, treatment targets were defined for each risk profile. A probability cut point of Results An increasing number of risk factors, as well as an increasing level of DAS over time resulted in a higher probability for joint damage progression after three years. The combination of these two associations showed that a higher baseline risk score corresponded with a lower acceptable level of disease activity for the same probability for joint damage progression. Table 1 shows the treatment targets for each risk profile, based on the cut point for acceptable probability of Conclusions Personalized risk profiles can be translated to personalized DAS treatment targets. Personalized risk profiles can be defined, based on presence of the three main baseline prognostic factors for joint damage in RA: anti-CCP, high ESR and erosions. The probability for joint damage is higher for patients with a higher risk profile. The higher the risk profile, the lower the acceptable level of disease activity to prevent joint damage. Disclosure of Interest None Declared

Background Cardiovascular risk is increased in rheumatoid arthritis (RA) patients. Algorithms for cardiovascular (CV) risk stratification as SCORE or Framingham’s score are used in the general population. Before they can be used for (CV) risk assessment in RA, validation by calibration and updating of these algorithms, is needed. It would be an advantage if long lasting RA cohorts could be used for this purpose. However, it is unclear if cholesterol levels in frozen serum samples can be used. There is no data available regarding the validity of cholesterol measurements in samples after long-term storage (>10 years). Objectives To assess the stability of serum total cholesterol (TC), HDL- and LDL-cholesterol (HDL-c, LDL-c) over time, by estimating the effect of storage time on cholesterol levels in frozen serum samples of RA patients. Methods In the Nijmegen early RA cohort that started in 1985, non-fasting blood samples were taken annually during follow-up and stored at -20oC. After thawing in 2011, TC and HDL-c were measured enzymatically. LDL-c was calculated using the Friedewald formula. Serum samples from year 0, 1, 2, 3, 5, 7 and 10, during follow-up were used. The cohort was divided into 5 sub-cohorts, starting at 1985 up to 2009 covering 5 years of calendar time each. Per subcohort, 30 RA patients were randomly selected. The data were analyzed for differences between subcohorts in cholesterol levels using longitudinal regression (linear mixed models) while age, gender, smoking, BMI, blood pressure, statin use, DAS28 score, rheumatoid factor positivity at baseline, were considered potential confounders. Results In total, 1002 serum samples were used from 152 patients, evenly distributed across sub-cohorts, with a mean±SD age 54±13.8 years, 65% were female and 80% were rheumatoid factor positive. In all sub-cohorts, the course of cholesterol levels over time was non-linear. Age and gender were added to the regression model as covariates with BMI at baseline being the only confounder. There was a significant storage effect for LDL-c levels (p=0.047), but not for TC (fig. 1) and HDL-c (p=0.099 and p=0.175 respectively). The differences between the youngest and oldest subcohorts were -0.17 mmol/L/year for LDL-c, -0.17 mmol/L/year for TC, and -0.02 mmol/L/year for HDL-c. Conclusions There was no storage effect in frozen serum on HDL-c and TC, but there was a significant storage effect on LDL. Although the found effects per additional year of storage are small, over time this effect could accumulate to a clinically relevant change and a correction factor can adjust for this effect. Therefore, serum samples stored for longer periods of time under stable conditions can be considered suitable for cholesterol measurements. Disclosure of Interest None Declared

Background The POEET (Potential Optimalisation of Expediency of TNFi) study is an ongoing study investigating TNFi cessation in RA patients on TNFi and conventional DMARD. Part of this study is the POET-US, investigating whether ultrasonography (US) can predict flare. (1) Objectives To present preliminary data of the POET-US study in which prediction of flare, defined as DAS28>3.2 and at least > 0.6 increase compared to baseline DAS28, by US at baseline is investigated. Methods The POETUS study is a multicenter (n=14) randomized prospective cohort study in the Netherlands. Participating patients have RA according to ACR 1987 criteria, DAS28 low disease activity low disease activity ( 6 months and have been treated with stable dose TNF-i and conventional DMARD > 1 year. Patients are randomized to continue or stop TNFi; of those who stop US is performed at baseline (MCP 1-5 dorsal & volar, wrists and MTP 2-5 dorsal, all bilaterally). All US-scans are performed with an Esaote MyLab 60 machine and high-frequency, linear transducer. A semi-quantitative synovitis scoring system is used for Grey Scale (GS) and Power Doppler (PD). Grey scale: Grade 0: normal; Grade 1: elevated capsule, below the joint boundaries; Grade 2: elevated capsule above the joint boundaries, Grade 3: elevated capsule above the joint boundaries, > 50% convex. Power Doppler: Grade 0: no PD signal; Grade 1: few single PD signals; Grade 2: merging PD signals, Grade 3: PD signal in > 50% of the synovial space. GS and PD scores of individual joints were summed; as grade 1 GS occured very frequently this was recoded to grade 0. Also baseline laboratory parameters and RA characteristics are recorded. The presented data are preliminary data from 2 centers (Utrecht, Nijmegen). Results 53 patients were included, 9 (17%) flared. Mean (sd) follow-up of all patients was 106 (79) days; mean (sd) time until flare was 77 (46) days. Conclusions Our preliminary results with limited data show that PD US and CRP, both assessed at cessation of TNFi in low disease activity RA, may predict future flare. Analysis of all data at completion of the study is necessary to corroborate these results. References Disclosure of Interest F. Lamers-Karnebeek Grant/research support from: Abbott, H. Jacobs: None Declared, J. Fransen: None Declared, J. Luime: None Declared, P. Riel: None Declared, T. Jansen: None Declared

Background Randomized clinical trials (RCTs) are accepted as the ‘gold standard’ to evaluate the efficacy/effectiveness of treatment. However, generalizing results from RCTs to daily practice poses a challenge with treatment effectiveness often being different. Pragmatic clinical trials have been posed as a solution. Objectives To identify whether pragmatic clinical trials are indeed generalizable to clinical practice and investigate how efficacy estimates from RCTs can be translated into effectiveness estimates for daily practice populations. Methods Data from pragmatic clinical trials of the Utrecht Rheumatoid Arthritis Study Cohort and the observational Nijmegen inception cohort study with comparable inclusion criteria (RA Results Age, higher disease activity and response to treatment were higher in patients included in the pragmatic trial as compared to daily practice and rheumatoid factor positive patients were lower. DAS28 and HAQ generally improved more in trial patients as compared to daily practice. Using EULAR response as outcome, the relative effect of treatment (relative risk) was not found to be different. For extrapolating RCT results, glucocorticoid use, disease duration and co treatment with DMARD increased the RR in the study. Higher values of baseline DAS28 and HAQ decreased RD and the use of corticosteroids increased RD. Conclusions Pragmatic clinical trials might be directly generalizable only regarding relative treatment effects. In extrapolating RCT results to daily practice, population characteristics associated with disease activity, disease duration and treatment history or co-treatment need to be taken into account, regardless whether the treatment effect is expressed absolute or relative. Extrapolations of RCT results could also considerably impact costs-effectiveness results. Disclosure of Interest None Declared

Background Fatigue in rheumatoid arthritis (RA) could be related to several factors. 1 The disease process, as well as its consequences such as pain, mental health problems and activity limitations are contributed to fatigue in RA. 1 It is reasonable to assume that increased fatigue may limit physical activity, or vice versa that increased physical activity may reduce fatigue. However, so far as we know the association between daily physical activity level and fatigue in RA patients has not been studied before. Objectives The objective of this study was to investigate whether there is an association between objectively measured physical activity and fatigue in RA patients. Methods Consecutive RA patients of the rheumatology clinic of the Radboud University Nijmegen Medical Centre (N=152) were enrolled. Fatigue severity was measured using the fatigue severity subscale (CIS-fatigue) of the Checklist Individual Strength (CIS20), asking about fatigue the last two weeks. Physical activity was measured during 12 consecutive days with the actometer, an ankle worn motion sensing device that registers and quantifies physical activity. A general physical activity score (DOM) reflected the average physical activity over the total 12-day time period and was expressed in the average number of accelerations per 5-min period. The individuals’ activity patterns were based on the 12 daily physical activity scores. Patients with at least 90% of the daily activity scores below the DOM were classified as pervasively passive. Patients with at least 90% of the daily scores above the DOM were classified as pervasively active while the remaining patients were labeled as fluctuating active. An one-way ANOVA with Scheffe’s post-hoc test was performed to investigate whether there was a difference in fatigue between the three physical activity patterns. Linear regression analysis was performed with CIS-fatigue as dependent and DOM as independent variable with correction for confounders. Results The mean (±SD) CIS-fatigue increased with activity pattern (p=0.020): in pervasively active patients it was 26.29 (11.81), in fluctuating active it was 31.49 (11.94) and in pervasively passive patients it was 35.50 (12.94). This difference between the pervasively active patients and pervasively passive patients was significant (p=0.022) but both the difference between the pervasively active and the fluctuating active patients (p=0.214) and pervasively passive and fluctuation active patients (p=0.227) was not significant. Lineair regression analysis confirmed that the relation between activity (DOM) and fatigue was significant (p=0.002) and non-linear, with correction for age and gender. Conclusions In RA, a higher level of physical activity was associated with less fatigue. Pervasively active patients had a significantly lower CIS-fatigue score than the pervasively passive patients. So, increased fatigue may limit physical activity, or vice versa increased physical activity may reduce fatigue. References Hewlett S, Chalder T, Choy E, et al. Fatigue in rheumatoid arthritis: time for a conceptual model. Rheumatology (Oxford, England) 2011;50:1004-1006. Disclosure of Interest None Declared

Background Classification criteria for systemic sclerosis (SSc) are being developed. Twenty-three candidate criteria have been identified and validated. Standardized cases need to be developed for criteria reduction and possible weighting. Objectives To develop and test SSc-specific case forms for clarity and feasibility. We secondarily explored the agreement between SSc experts on the probability that cases were classified as SSc. Methods Standardized forms were developed using: skin thickening; nailfold capillary pattern; finger tip ulcers/pitting scars; Raynaud’s phenomenon; interstitial lung disease; renal crisis; reduced DLCO; reduced FVC; dysphagia, esophageal dilation; telangiectasia; flexion contractures; pulmonary hypertension; puffy fingers; pulp loss/acro-osteolysis; gastroesophageal reflux; calcinosis; tendon/bursal friction rubs; topoisomerase-I, centromere, RNA polymerase III, antinuclear or PM-ScL antibodies. Six experts tested 6 cases and the ranking procedure for clarity of the instructions, response option and time-to-completion. The forms were applied to purposively sampled SSc cases from international cohorts covering a wide range of probabilities that each case had SSc. Eight experts rank-ordered 20 cases from 1 (highest) to 20 (lowest). The consistency in rankings was evaluated using an intraclass correlation coefficient (ICC). Results 83% (5/6) endorsed clarity of the form, 100% (6/6) clarity of the instructions, and 100% (6/6) clarity of the response option. The median time-to-completion was 10 minutes (range 10–20). The ICC for agreement across experts was 0.73 (95% CI 0.58, 0.86). Conclusions Our SSc-specific forms have demonstrable clarity and feasibility. Using these cases, the expert panel had substantial agreement in rank order. Our methods reflect the rigors of modern psychometric science, and serves as a template for groups developing classification criteria. Disclosure of Interest None Declared

Background Joint inflammation in Rheumatoid Arthritis is strongly associated with the development of joint damage. However, this association is highly different between patients, which may be explained by the presence of anti-CCP. Therefore it can be hypothesized that anti-CCP modifies the effect of joint inflammation on progression of joint damage. Objectives To analyze whether the association between joint damage progression and Swollen Joint Count (SJC44), Erythrocyte Sedimentation Rate (ESR) or Disease Activity Score (DAS) is different for anti-CCP positive versus negative RA patients in the first three years of the disease. Methods Follow-up data were used of the first three years from a subset of patients from the Nijmegen Inception Cohort with rated X-rays. Joint damage progression was assessed 1) as the absolute difference in Ratingen score and 2) dichotomized as erosive progression in at least one previously unaffected joint. Time averaged SJC44, ESR and DAS over three years were calculated. Anti-CCP titer ≥25 u/l was regarded as positive. Linear and logistic regression were used for analyses. Results Data of 264 RA-patients were used, 180 (68%) were anti-CCP positive. In linear regression, anti-CCP was an effect modifier for the relationship between SJC44 and absolute joint damage progression (p=0.031). Stratification by anti-CCP resulted in beta’s of 0.46 and 1.12 for respectively anti-CCP negative and anti-CCP positive patients (see [figure][1] left). With up to five swollen joints, the probability of erosive progression in a previously unaffected joint was 70% in anti-CCP positive patients (see [figure][1] right). The relationship between DAS and joint damage progression was modified by anti-CCP concerning the chance on progression in at least one new joint. The relationship between ESR and joint damage was not influenced by anti-CCP. ![Figure][2] Conclusions The relationship between SJC44 and joint damage progression is different for anti-CCP positive and anti-CCP negative RA-patients (effect modification). For clinical practice, this means that the treatment target regarding swollen joint count should be lower for anti-CCP positive patients than for anti-CCP negative patients to prevent joint damage progression. Disclosure of Interest None Declared [1]: #F1 [2]: pending:yes

To the Editor: Standardized assessment of outcomes has become increasingly important in the comprehensive physical therapy and rehabilitation management of patients. Health care professionals measure outcomes to adjust treatments and to improve processes and results of care. Outcomes measurement has been substantially improved in the past decade by the creation of psychometrically sound, condition-specific and generic health status instruments. Although these instruments are now commonly included in clinical research, in our opinion they are not yet widely used in patient care. Possible reasons are the additional administrative load and difficulty in the interpretation of end scores.1–3 Health status instruments, therefore, should be brief and yield scores that are easy to interpret. Among the currently available instruments, the 36-Item Short-Form Health Survey (SF-36), covering physical, psychological, and social aspects of health status, has found wide acceptance, in part because of its brevity.…

The Disease Activity Score using 28 joint counts (DAS28) has been developed in a cohort of patients with rheumatoid arthritis in which only conventional anti-rheumatic treatments were used. It has extensively been validated to monitor disease activity in daily clinical practice as well as in clinical trials. The study of Vander Cruyssen and colleagues showed that the DAS28 correlated best with the decisions of rheumatologists to increase the infliximab dose because of insufficient response. This result once more confirms the validity of the DAS28 to monitor disease activity in patients with rheumatoid arthritis and to titrate treatment with biologicals.