Y. El Miedany

THU0597 Flipped learning: can rheumatology lead the shift in medical education?

Background Flipped Classroom is a model that is quickly gaining recognition as a novel teaching approach among health science. Flipped learning turns the usual teaching model on its head. The idea is that students learn new content outside the classroom (usually online) and then tackle assignments in lessons, giving tutors more time to help them with aspects they dont understand. Objectives 1. to implement a flipped classroom teaching for rheumatology topics for both under and postgraduate education. 2. to evaluate outcomes of teaching using a post-flipped classroom assessment and a student perceived effectiveness and satisfaction questionnaire. Methods Ten online videos on topics of how to take rheumatology history, individual joint examination, handling cases of monoarthritis and polyarthritis, and metabolic bone disease were made available for the students. 39 undergraduate 35 postgraduate trainees were included in this educational activity. The students were exposed to online lecture content prior to the class-time active learning session. The teaching session adopted an interactive learning environment and the course instructor served as a facilitator rather than a dominator for the instructional process, provided in-class applied learning opportunities and offered timely feedback/guidance to students. Evaluation of the teaching session was assessed using a scenario based learning and an evaluation check list. The students were asked to complete a questionnaire based on a 5-point Likert scale: 1 (strongly disagree) to 5 (strongly agree) to assess for their perceived effectiveness and satisfaction. The outcomes of the evaluation sheet and students questionnaire, were compared to 40 undergraduate and 34 postgraduate trainees who were taught in the last year on the same topics in a lecture-based model using the standard teaching protocols, followed by scenario based learning sessions, student evaluation and satisfaction survey. Results There was no significant difference regarding socio-demographics between the 2 students groups included in this study. Outcomes of the flipped learning revealed that 94% of the students viewed the videos prior to the class session, and 96% attended the education sessions in comparison to 86% attendance in the traditional teaching group. Students reported an increase in knowledge, a positive learning experiences and perceptions of the flipped classroom model. Students perceived effectiveness and satisfaction scores were significantly higher among the flipped learning in contrast to the traditional teaching comparative group (4.9 vs 4.3, p<0.05). Similarly, analysis of the students assessment scores after the scenario based learning sessions was higher in the flipped learning group compared to the students taught by traditional methods (p<0.01). Conclusions Implementation of the flipped learning for the rheumatology topics demonstrated a successful and promising platform for using technology to make better use of the students time, and for increasing their satisfaction with the necessary didactic learning. Active learning increases student engagement and can lead to improved retention of knowledge. Disclosure of Interest None declared

OP0091 Psoriatic Arthritis Comorbidity Index: Development and Validation of A New Specific Tool for Classifying Prognostic Comorbidity in Psoriatic Arthritis Patients

Background Specific comorbidity index can guide the management of psoriatic arthritis (PsA) patients and optimize their outcomes. So far, no disease-specific models are currently available for this purpose. Objectives 1. identify comorbidities with greatest impact on PsA patients health status. 2. develop and validate a prospectively applicable comorbidity index for classifying PsA patients according to their comorbid conditions which might alter their risk of hospitalization and mortality. Methods This was a retrospective multicenter cohort analysis of PsA patients in a rheumatology clinical registry, assessing the effect of different comorbidities measured at patients visits over 10-years period, on predicting future death and hospitalization. A weighted index that takes into account the number and seriousness of comorbid disease was developed in a cohort of 1707 PsA patients monitored over 10-years. Logistic and Cox Regression analyses were implemented to estimate the risk of mortality. Regression coefficients were used to develop the morbidity index score. ROC curve for the invented index was used to evaluate the discriminating ability of the index and identify different cutoff values that can delineate patients at different stages for risk of death. Disease activity parameters were considered. Results PsA patients who had higher incidence of comorbid condition and were at high risk of hospitalization were men, with older age at disease onset, high BMI at baseline (p<0.05). The most prevalent comorbidities strongly associated with the 10-year death risk or hospitalization in PsA patients were: Cardiovascular (7 comorbidities), osteoporosis, falls, depression/ anxiety, diabetes mellitus, renal and liver diseases, lung and GIT affection, as well as infection (p<0.001). Multivariate regression analysis identified Multidimensional Disease Relapse score (including 5 parameters: DAPSA, PASI, Functional disability score, ESR and CRP) as independent predictor for disease status associated with the 10-year death risk or hospitalization (Wald χ2=9.2, p=0.002, OR=24.6). Binary regression analysis revealed that: male gender, cardiovascular diseases, evident fall risk, diabetes, infection, anxiety, and the multidimensional relapse score were significant independent factors affecting the 10-years outcome of the disease. A comorbidity index weighted according to the regression coefficient of the variables extracted through the logistic regression analysis was developed. The score ranges from 0 to 38. A cut off point of 14.5 was associated with a sensitivity of 97.5% and a specificity of 87%. Validation using ROC curve revealed AUC of 98.5%. Conclusions The PsA-comorbidity index is a valid method for estimating risk of death in PsA patients. It enables the clinicians to include comorbidities assessment and management in their standard practice. It can be used to predict resource utilization, identify targets for reducing high costs, by prospectively identifying PsA patients at high risk. Rigorous application of systematic evaluation of comorbidities may permit earlier detection, which may ultimately result in an improved outcome of patients with PsA. Disclosure of Interest None declared

SAT0073 Physician VS Patient Global Assessment in Early Rheumatoid Arthritis: Putting the CART before the Horse

Background With the introduction of Treat-to-Target approach for inflammatory arthritis, adoption of patient reported outcome measures (PROMs) as part of the standard clinical practice has been emphasized by both clinicians and regulatory bodies as changes in these measures reflect changes most important to the patients. Objectives To assess the concurrence and non-concurrence of patient and physician global assessment in Early rheumatoid arthritis (eRA) patients both in disease activity and in remission; 2. To identify the independent related variables for positive (PtGA >PhGA) and negative (PhGA>PtGA) discordance. Methods Retrospective analysis of 480 patients diagnosed according to the 2010 ACR/EULAR criteria for eRA and included in the USACAS study [1]. Before clinical assessment every patient completed a Patient reported outcome measures questionnaire [2]. This includes assessment for functional disability, Quality of life; pain, PtGA and fatigue scores using 0-100 VAS, duration of morning stiffness, self-reported joint tenderness and helplessness as well as systemic affection. The treating physician reviewed the patients answers, before clinical assessment and calculation of disease activity score (DAS-28). Non-concurrence was defined as a difference of 20% (2 or more units) on the VAS between the physician and patient global scores. The patients were stratified into 3 categories: patients with similar (within 20/100 units) scores (PtGA = PhGA); patients with PtGA >20 units or more higher than PhGA (PtGA > PhGA); and those with PhGA >20 or more units higher than PtGA (PhGA > PtGA). Bivariate analysis was carried out as well as multinominal logistic regression analysis. Results In patients with Moderate- highly active disease (DAS-28 >3.2), mean PtGA was 8.6 whereas mean PhGA was 6.7 (P<0.05). Analysis of the scores revealed, PtGA > PhGA in 56% of the patients, PtGA = PhGA in 31% whereas PhGA > PtGA was reported in 13% of the patients. On the other hand, in patients with low disease activity (DAS-28 <3.2) or in remission (DAS-28 <2.6), mean PtGA was 2.3 and mean PhGA was 1.9. Analysis of the scores revealed, PtGA > PhGA 12%, PtGA = PhGA in 79%, PhGA > PtGA in 9%. PtGA > PhGA was associated significantly with scores of DAS-28, pain, fatigue, quality of life, functional disability, duration of morning stiffness, patient self-reported joint tenderness, systemic manifestations, work ability and self-helplessness. PhGA > PtGA was associated with DAS-28, physician reported joint tenderness, swollen joint count, functional disability, ESR and CRP levels. There was no correlation with age, sex, level of education or marital status. Conclusions Global estimates of both patients and physicians vary according to disease activity status. Parameters such as sleep, fatigue, self-helplessness and work ability have a significant impact on the patients with active disease and should be considered by the treating physician. Whilst HAQ assess the patients functional ability, quality of life assessment should be also added to the standard clinical assessment. References US guided treat to target approach in early RA. Arthritis Rheum 2013; 65(10): S966 Incorporating patient reported outcome measures in clinical practice. Clin Exp Rheumatol. 2010; 28(5):734. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.1408

THU0358 Gray Scale and Power Doppler Ultrasound Assessment of the Median Nerve: A Biomarker That Can Help in Setting A Treat to Target Approach Tailored for Carpal Tunnel Syndrome Patients

Background Though there are various carpal tunnel syndrome (CTS) treatment options, their outcomes and long-term effects are still debatable. An accurate understanding of the predictive factors of CTS management outcomes would enable physicians and patients to make more informed decisions about an approach tailored to the patients condition and develop more accurate expectations of outcomes. Objectives 1. To assess the median nerve both by Gray-scale US and intra-neural vascular flow (using Power Doppler (PD) before and after management in subjects with CTS, and 2. to verify the feasibility of initial US parameters for prediction of management outcome. Methods 233 subjects, mean age 55.6 years, diagnosed with CTS established by clinical and electrophysiological (NCS) findings. Baseline clinical, electrophysiological severity (grade 1-6 score) and self-assessment scoring of symptoms (using the modified Boston questionnaire were recorded. US measures included: the median nerve area at tunnel inlet, the flexor retinaculum, and the flattening ratio as well as Intra-neural PD signals (grades 0-3). Surgical decompression was offered to the patients who had neurological deficit or severe NCS outcome (grade 5/6) whereas the rest were given the choice of being treated either conservatively (including local steroid injection) or surgically. The main outcome variable was improvement >25% in CTS symptoms questionnaire score and >50% of the patients overall satisfaction score. US assessments were performed at baseline, 1-week, 1-months and 6-months post treatment (whether conservative or surgically). Logistic regression analyses was used to assess the best predictive combination of preoperative findings. Results There was an inverse relation between intra-neural vasculature in the median nerve (PD score) and increasing CTS severity based on nerve conduction results (r= - 0.648). In the patients cohort treated conservatively, US measures of the median nerve started to improve within a week of local injection, whereas in those treated surgically there was an initial phase of post-operative increase of the median nerve measures, before settling at 1-month time of follow up. The risk of a poor outcome was significantly higher in the patients with high median nerve flattening ratio at the CT inlet (relative risk 3.3, 95% CI 1.73-6.43, P=0.0004). This risk was most marked in the cohort with nerve flattening associated with longer duration of illness (relative risk 4.3, 95% CI 1.82-10.29, P=0.006) and low PD signal (relative risk 4.1, 95% CI 1.71-9.47, P=0.005). Clinical predictors of poor outcome included: neurological deficit and predisposing medical conditions. Nerve conduction testing did not show significant response to management. Conclusions In addition to the diagnostic value of US in CTS, the detection of increased intra-neural vasculature of the median nerve is an indicator of early median nerve affection and has a good prognostic value. Increased flattening of the median nerve with low vascularity assessed by PD has a poor prognostic impact. Nerve conduction studies are not a good tool to monitor response to therapy, whereas US can be used to monitor median nerve changes as early as 1 week of management. Acknowledgements To Omar El Miedany for Data Recording and admin support Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.1410

SAT0072 Functional Disability: A Parameter Fit to BE A Biomarker for Inflammatory Arthritis

Background The search for markers identifying key targets for the assessment of major outcomes in Rheumatoid Arthritis (RA) has become one of the hot issues in rheumatology. Possible markers should help to identify (in early RA) the patients who are going to respond quickly to therapy with the opportunity to tailor management to the patient status. So far this target has not been achieved. Objectives To assess whether Functional Disability can be used as a valid biomarker enabling the physicians to optimally match patient with disease progression and response to treatment. Methods Retrospective study which included 481 subjects suffering from early inflammatory arthritis (Disease duration <6-months) diagnosed according to the ACR/EULAR criteria 2010. Changes from baseline to week 76 in clinical variables, patient reported outcome measures [1], including functional disability, and measures of radiographic progression were assessed in early RA patients diagnosed according to the 2010 EULAR/ACR criteria for RA and treated to Target. Radiographic progression was scored at baseline and at 76-weeks using modified Sharp score as well as US scores for number of erosions, synovial hypertrophy and vascularity (using Power Doppler). Biochemical laboratory measures included ESR, CRP and rheumatoid factor. Correlation of functional disability score to response to therapy at 3, 6 and 12 months of management as well as to work ability, development of erosions and joint affection were studied. The sensitivity and specificity of Functional disability as an indicator of prognosis was also assessed using ROC curve analysis. Results The crude functional disability score as well as the percentage changes at 3 and 6 months showed a statistically significant increase in the group with persistent inflammatory synovitis compared to the self-limiting arthritis group. Using binary logistic regression analyses to assess the association between functional disability and disease activity flare up revealed that a flare was associated with poor baseline function and quality of life measures: Functional disability [OR per 0.1 unit=1.8 (1.06–1.54), p=0.004] and Quality of Life [OR=1.12 (1.01–1.23), p=0.024]. Changes in functional disability scores were not significantly correlated to changes in inflammatory biochemical markers (ESR and CRP) levels. However, changes in the functional disability scores correlated significantly to changes in PD scores (p<0.01). In multiple conditional logistic regression analysis, factors associated with the development of joint space narrowing were worsening of functional disability score by >0.5/3, synovial thickening and synovial PD score ≥2 at both baseline and 6-months of treatment. The discriminative power had an AUC of 0.864 (95% CI 0.765 - 0.937), with Sensitivity 84%, Specificity 92% and LR + 5.6. Conclusions Functional disability met the criteria of a valid marker for rheumatoid arthritis, being objectively measured, indicator of normal and pathologic joint affection, as well as a sensitive and specific marker for response to therapy and poor prognosis. References Incorporating patient reported outcome measures in clinical practice: development and validation of a questionnaire for inflammatory arthritis. Clin Exp Rheumatol. 2010; 28(5):734. Acknowledgements To Omar El Miedany for help in data recording and admin support. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.1470

AB1129-HPR Cross-Cultural Adaptation and Validation of The Patient Reported Outcome Measures Questionnaire for Inflammatory Arthritis for Bulgarian-Speaking Individuals

Background The PROMs-Arthritis questionnaire [1] was developed to evaluate the patient reported outcomes in individuals with inflammatory arthritis. Translation of the questionnaire to other languages will provide a standard outcome measure across populations. Objectives To translate the English version of the Patient Reported Outcome Measures for inflammatory arthritis (PROMs-Arthritis) to Bulgarian; and evaluate the psychometric properties of the Bulgarian version. Methods The PROMs-Arthritis questionnaire was cross-culturally adapted to Bulgarian, according to established guidelines. The validity and reliability of the Bulgarian version were assessed in 110 patients with rheumatoid arthritis (RA) as well as 44 healthy control. The questionnaire includes assessment for functional disability, quality of life, VAS for joint pain, patient global status, fatigue, duration of morning stiffness, assessment of co-morbidities, patient activation as well as self-reported joint pain. Results The expert committee and the participants considered the questionnaire to have good face and content validity. Dimensionality analysis revealed a 1-factor solution, explaining 97% of the total variance. Known group validity was demonstrated by significant differences between patients compared with the asymptomatic group (P<0.001). An item analysis showed a high degree of internal consistency (Cronbach α=0.805).The Bulgarian version exhibited excellent test-retest reliability (intraclass correlation coefficient =0.805 for the arthritis group). The questionnaire items correlated significantly (p<0.01) with clinical parameters of disease activity (DAS-28), physician global assessment, ESR and CRP levels. RA patient self-reported tender joints correlated significantly with the physicians scores (0.893). Changes in functional disability, quality of life as well as Patient Activation scores showed significant (p<0.01) variation, with diseases activity status (DAS-28). The questionnaire showed also a high degree of comprehensibility (9.4). Conclusions Integrating patient reported outcome measures into standard clinical practice is feasible and applicable. The Bulgarian version, adapted from the original English PROMs-Arthritis questionnaire, shows a considerable validity and reliability, and its psychometric properties are comparable with the original version. References El Miedany Y et al. Clin Exp Rheumatol. 2010 Sep-Oct;28(5):734–44. Disclosure of Interest None declared

FRI0114 Development of The Patient Motivation Questionnaire: Conceptualizing and Measuring Motivation in Patients with Inflammatory Arthritis

Background Motivation is literally the desire to do things, and patient motivation was reported to play an important role in determining the outcome of therapy. Measuring patients motivation reflects their proactivity, engagement and activation to self-manage their disease which is of value both at the individual level (e.g. tailoring management and interventions) and at the educational program evaluation (e.g. monitor efficacy in enhancing activation). Objectives to develop a questionnaire for evaluating the patients “motivation” and assess the psychometric properties of that measure in patients with chronic inflammatory arthritis. Methods the conceptualization stage identified that inflammatory arthritic patients who are likely to have better health outcomes are those who: (1) Understand the nature of their disease, 2. Are involved in treatment and diagnostic choices through a shared decision process; 3. Are aware of the patients health-engagement role; 4. Able to self-manage symptoms/problems; 5. Able to collaborate with providers; 6. Can find solutions; 7. Able to maintain functioning and reduce health declines; 8. Can engage in activities; 9. Able to administer medications; 10. Able to find resources and select providers based on performance or quality. Using Rasch analysis and 76 questions item pool; content analysis and semi structured group discussion, the questionnaire was developed including: 10-items scale (0–10 on VAS scale). Construct validity was assessed by correlating the score of the questionnaire to parameters of disease activity (DAS-28, ASDAS and DAPSA scores), functional disability, quality of life, patient self-helplessness measure [1] as well as the patients compliance to therapy [2]. Reliability and comprehensibility and sensitivity to change were also assessed. Results The questionnaire was assessed in 432 RA, 415 Psoriatic arthritis patients, and 232 Ankylosing spondylitis patients. Dimensionality analysis revealed a 1-factor solution, explaining 98% of the total variance. It showed acceptable validity as it correlated significantly with disease activity measures: DAS-28: r = -0.85; ASDAS: r = -0.86, DAPSA: r= -0.89. It also correlated significantly with Functional disability score: r= -0.91, and QoL: r= -0.90 as well as patient self-helplessness r= -0.88. The questionnaire was reliable (Cronbachs alpha 0.958) and had no misfitting items. In addition, it was comprehensible (9.4) and sensitive to change (p<0.01). The patient motivation score showed significant (p<0.01) variation with the medication compliance. Conclusions The Patient Motivation Measure is a patient-reported tool that is valid, reliable, comprehensible and unidimensional scale that reflects the patients: (1) awareness of their role in their disease management, (2) confidence and knowledge necessary to take action, (3) actual ability of taking action to maintain and improve ones health, and (4) staying the course even under stress, (5) ability to find reliable resources. The measure has good psychometric properties indicating that it can be used at the individual patient level to tailor management and monitor changes. References El Miedany et al. Clin Exp Rheumatol 2010; 28(5):734–44. El Miedany et al. Rheumatol Int (2012) 32:3061–3068 Acknowledgement Omar El Miedany: Data Entry and Analysis Disclosure of Interest None declared

THU0330 Towards Tailored Patient's Management Approach: Integrating the Modified 2010 ACR Criteria for Fibromyalgia in Multidimensional Patient Reported Outcome Measures Questionnaire

Background The modified 2010 ACR criteria for fibromyalgia shifted the role of somatic symptoms assessment from the physician to the patient and allowed subjects to rate specific self-reported symptoms. Yet, fibromyalgia patients need further assessment in particular for associated co-morbidities and impact of the disease on the patients life. Objectives To assess the validity, reliability and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and co-morbidities assessment in fibromyalgia patients. Methods The PROMs was conceptualized based on frameworks used by the WHO Quality of Life tool and the PRO measurement information system (PROMIS). Initially, cognitive interviews were conducted with 51 fibromyalgia patients (diagnosed according to modified ACR criteria 2010), with a range of severity to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of physicians, nurses, and health educators, in addition to clinometric and psychometric methods. The latter included Rasch and internal consistency reliability analyses. The questionnaire included the modified ACR criteria main items (symptoms severity score and widespread pain index); in addition to assessment of functional disability, quality of life, review of the systems, falls and cardiovascular risks, as well as self-helplessness. In addition, every patient completed SF-36 and Euro QoL 5D questionnaires. Results A total of 146 fibromyalgia patients and 101 subjects suffering from widespread pain completed the questionnaire. The modified ACR criteria were satisfied by 91.2% of fibromyalgia patients with and by 10.8% of subjects who had widespread pain (sensitivity and specificity are 91.2% and 89.2%, respectively). The PROMs questionnaire was reliable as demonstrated by a high-standardized alpha (0.893-0.967). Content construct assessment of the PROMs-functional disability and QoL revealed significant correlation (p<0.01) with both SF-36 and Euro QoL. Changes in functional disability, quality of life as well as self-helplessness scores showed significant (p<0.01) variation with diseases activity status and response to therapy. Mean time to complete the questionnaire was 8.04 ± 0.92 min.There was higher prevalence of autonomic symptoms in fibromyalgia patients (cold hands, p=0.039; flatulence, p=0.022; tiredness, p=0.001); CVS risk (44.8%, p=0.01), sexual dysfunction (64.4%, p=0.01) and falling (61.6%, p=0.01). Conclusions The diagnosis of fibromyalgia can be self-reported of the typical symptom complex. The developed PROMs questionnaire is a reliable and valid instrument for assessment of patients suffering from fibromyalgia. Being short, rapid and comprehensive, this adds more to its applicability. The data support the value of completion of the simple 2 pages patient questionnaire, which provides a quantitative written documented record by the patient, at each visit to the clinic. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.1405

FRI0156 The Combined Spondylo-Arthritis Questionnaire for Assessment of Functional Disability and Quality of Life: Assessment of the Minimal Clinically Important Difference and REAL Clinically Important Difference in Patients with Spondyloarthritis

Background The Combined Spondylo- Arthritis Questionnaire for functional disability (CASQ-Fn) and Quality of life (CASQ-QoL) Questionnaire [1] is used to assess these parameters in Spondyloarthritis (SpA) patients. Objectives 1. To estimate the minimal clinically important differences (MCID) of the CASQ-Fn and CASQ-QoL for worsening and improvement that were experienced in SpA patients. 2. To define Real Clinical Important Difference (RCID) which reflect the degree of improvement consistent with responsiveness to therapy. Methods 334 SpA patients (122 AS, 212 Psoriatic arthritis), starting their Biologic/DMARDs therapy and managed according to Treat-to-Target approach, completed a copy of the CASQ questionnaire at 0, 3, 6 and 12 months of therapy. Assessment of both ASDAS (for AS patients) and the ACR response criteria (for psoriatic patients) was carried out at baseline, 3, 6 and 12 months of therapy. Each of the disease activity parameters was calculated and used as external standards as follows: ([final score-baseline score]/baseline score x 100). Four categories of change were derived. 1. patients with no change or a worsening in their scores, 2. patients with a net improvement of <20%, 3. patients with a net improvement of <50%, 4. patients with a net improvement >50%. MCID was determined by estimating the mean changes in CASQ-Fn and -QoL scores in patients who showed 1 level of improvement on the disease activity parameters. RCID was determined by estimating the mean changes in CASQ-Fn and -QoL scores in patients who showed 2 levels of improvement on the disease activity parameters. Results Depending on the external standards used, the MCID for improvement of the CASQ-Fn was -0.20 at most, whilst the MCID for worsening was +0.22 at most. Regarding CASQ-QoL the MCID for improvement was -0.21, and for worsening was +0.22 at most. RCID for improvement of the CASQ-Fn was -0.52 and for CASQ-QoL was -0.56. With adjustment for age, sex, and race, the MANOVA results linking score changes of both CASQ-Fn and CAsQ-QoL to changes in disease severity were statistically significant (p<0.01). Differences in categorical changes among both scores were also significant across the levels of change in the disease activity parameters. Logistic regression analysis revealed significant differences (p<0.01) in categorical changes (% better, %same, % worse) of both CASQ-Fn and -QoL scores across the groups that differed in the level of change in severity. Conclusions Both CASQ-Fn and –QoL are responsive to change. The MCID of both scores for improvement as well as worsening were sensitive to important short term changes in SpA patients. The results provide insight into patient satisfaction with changes in function and expectations for therapy. RCID values are 2 to 3 times greater than MCID values. This range of MICD and RICD changes will help investigators interpret changes in CASQ-Fn and –QoL scores in clinical trials both at the group level (average change) and individual patient level (categorical change). References Development and validation of a new questionnaire for functional impairment and quality of life assessment. Clin Exp Rheumatol. 2011; 29(5):801. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.1407