M. El Gaafary

Sexual dysfunction in rheumatoid arthritis patients: arthritis and beyond

Rheumatoid arthritis treatment has been shown to improve quality of life. There is little data regarding the impact of the disease and treatments on sexual function. The aim of this study was to describe the results of an assessment of sexual activity/sexual satisfaction of rheumatoid arthritis patients, identify the sexual dysfunction features, and assess their association with disease activity/disease activity parameters and other systemic risk factors/comorbidities. Consecutive rheumatoid arthritis patients attending the outpatient rheumatology clinic completed the multidimensional patient-reported outcome measures questionnaire. There are three questions screening for sexual dysfunction: patients who ticked any of the boxes were further assessed. Men completed the Sexual Health Inventory for Men; whereas women completed the Female Sexual Function Index. All patients underwent clinical assessment of disease activity parameters and cardiovascular risk. Among 231 rheumatoid arthritis patients included in this study, 49/91 (53.8%) men and 64/140 (45.7%) women reported sexual dysfunction. Among men, erectile dysfunction significantly correlated (p < 0.01) with pain score, cardiovascular disease, age, disease activity, fatigue score, intramuscular steroid injection, and tender joint count. Among women, sexual dysfunction was significantly correlated (p < 0.01) with occurrence of secondary Sjogrens syndrome, pain score, cardiovascular disease, hip joint involvement, disease activity, and tender joint count. Sexual dysfunction is common among rheumatoid arthritis patients. Erectile dysfunction in men, and problems with orgasm, arousal, and satisfaction in women, were the most prevalent manifestations. The significant correlation of sexual dysfunction with CVD may help to identify patients at high risk of cardiovascular disorders.

Psoriatic arthritis comorbidity index: development and validation of a new specific tool for classifying prognostic comorbidity in psoriasis and psoriatic arthritis patients

Objective: 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. 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. Outcomes of interest included functional ability, quality of life, medications induced complications, hospitalization/ death. A weighted index that was developed in a cohort of 1707 PsA patients. Internal and external validation were carried out. 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 (p < 0.05). Multivariate regression analysis identified 29 comorbidities. A comorbidity index weighted according to the regression coefficient of the variables was developed (the score range: 0-37). A cut off point of 8 was associated with a sensitivity of 97.5% and a specificity of 87%. The developed PsACI correlated significantly with the 4 tested comorbidity indices: Charlson comorbidity index, Functional comorbidity index, Rheumatic Diseases comorbidity index, and Multimorbidity index at 1-, 3-, 5and 10-years. Similar significant correlation was seen on external validation assessment. Conclusion: The PsA-comorbidity index is a valid method for estimating comorbidity risk in PsA patients. It enables the clinicians to include comorbidities assessment and management in their practice. It can be used to predict resource utilization, identify targets for reducing costs, by prospectively identifying PsA patients at high risk. Correspondence to: Y. El Miedany, Rheumatology, Darent Valley Hospital, Dartford, United Kingdom, E-mail: drelmiedany@rheumatology4u.com Received: March 14, 2017; Accepted: April 10, 2017; Published: April 13, 2017 Introduction Rheumatic diseases are chronic progressive conditions which may result in significant physical disability and, in several cases, accelerated mortality [1-3]. While the primary disease accounts for much of the heightened death risk and the majority of morbidity, other factors such as comorbid conditions play a major contributing role [4, 5]. A widely accepted definition of comorbidity is “the existence or occurrence of any distinct additional entity during the clinical course of a patient who has the index disease under study” [6]. These additional entities are categorized according to the comorbidity ‘three Cs’ classification scheme: causality, complication, and coincidence. Causality is when an inflammatory disease like rheumatoid (RA), psoriatic arthritis (PsA) or systemic lupus erythematosus (SLE) is followed by patho-physiologically linked abnormalities, such as cardiovascular disorders; complications are comorbidities therapeutically linked to illnesses such as diabetes mellitus or osteoporosis (glucocorticoid-induced) or peptic ulcer (NSAIDinduced). Coincidence means that comorbidities occur independently and are unrelated to the index disease (for example, inflammatory arthritis and appendicitis) [7,8]. Separate patterns of comorbidity have been identified in patients with rheumatic diseases whether they have inflammatory arthritic conditions (such as RA, PsA, and SLE); or those with non-inflammatory rheumatic disorders such as fibromyalgia or osteoarthritis [9]. As these comorbidities contribute to increased early mortality, affect disease activity, response to treatments, and generate costs in these populations, they should be considered when managing patients with inflammatory arthritic conditions [10-12]. Furthermore, medications used to manage the underlying inflammatory condition, including diseasemodifying antirheumatic drugs (whether synthetic (sDMARD), or biologic therapy (bDMARD), corticosteroids, and NSAID, may also increase or, conversely, decrease the likelihood of comorbidities. People with psoriasis (PsO) and PsA were reported to have an elevated risk of developing comorbidities. A recent review noted that over half of the PsA patients have more than one comorbidity; which had a significant negative impact on their functional ability as well as quality of life [13]. There is currently no standardized, and validated instrument for recording and collecting comorbidity data in patients with PsO and PsA, which is relevant to contemporary and routine rheumatology practice. El Miedany Y (2017) Psoriatic arthritis comorbidity index: development and validation of a new specific tool for classifying prognostic comorbidity in psoriasis and psoriatic arthritis patients Volume 2(2): 2-7 Rheumatol Orthop Med, 2017 doi: 10.15761/ROM.1000117 The purpose of the study is to identify comorbidities with greatest impact on PsO and PsA patients’ health status. Also, to develop and validate a prospectively applicable comorbidity index for classifying these patients according to their comorbid conditions which might alter their risk of hospitalization and mortality.

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

AB0197 The arthritic patients’ perspective of measuring treatment efficacy: patient reported experience measures (prems) as a quality tool

Background Patients have an important role to play in communicating the impact of disease and the effectiveness of healthcare. Well-developed patient-reported experience measures (PREMs) can provide a clinically relevant and scientifically rigorous resource for including the patients’ perspective of their disease activity in decisions about their management. Objectives Assess the validity and reliability of a Patient Reported Experience Measures (PREMs) questionnaire that can be used to measure self-defined important experiences and perspectives of inflammatory arthritis (RA) patients. Methods The PREMs questionnaire was conceptualized based on frameworks used by the WHO Quality of Life tool, as well as the PRO measurement information system (PROMIS). Cognitive interviews were conducted with 94 inflammatory arthritis patients (diagnosed according to EULAR/ACR criteria 2010), with a range of severity and disease activity to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of physicians, nurses, health educators and OTs feedback, in addition to clinometric and psychometric methods. The latter included Rasch and internal consistency reliability analyses. The PREMs questionnaire was developed centered around 5 main categories: 1. Journey to diagnosis, 2. Impact of the disease on the patients’ everyday life, 3. knowledge about the disease, 4. the care in the hospital, and 5. patient education and aftercare (including what to do in case of exacerbation). After analysis for ordered response options, content analysis and semi-structured group discussion to cover these 5 categories, 36 questions were identified as the final item set. The routine clinic was used as a setting for the questionnaire evaluation. In a multicenter study, 264 patients were asked to complete the PROMs [1] as well as the PREMs questionnaires whilst sitting in the waiting area before being examined by the treating physician. Comprehensibility and reliability (using the Test-retest reliability (reproducibility) were assessed. Results The tool was derived from RA patients, therefore establishing its face validity. The PREMs questionnaire was reliable as demonstrated by a high-standardized alpha (0.891-0.963). The questionnaire items correlated significantly (P< 0.01) with clinical parameters of disease activity, PROMs, self-helplessness and DAS-28 score supporting its construct validity. The domain of impact of arthritis correlated significantly (P< 0.01) with HRQOL score as well as disease activity and damage measures, establishing its criterion validity. Patient education and aftercare correlated significantly (P< 0.01) with adherence to therapy. The PREMs questionnaire showed also a high degree of comprehensibility (9.4). Conclusions The studied PREMs questionnaire was valid as well as reliable. The patients were able to comprehend varying response options on a categorical scale, and could accurately respond to items using a 7-day recall period. It provides informative measure for the patients’ experience with their disease, and in the meantime, facilitates incorporating the patients’ feedback into the patients’ management algorithm. References El Miedany et al. Clin Exp Rheumatol 2010; 28: 734-744. Disclosure of Interest None Declared

AB0287 Mutual assent towards comprehensive disease control: the relationship between us measures and patient reported outcomes in early rheumatoid arthritis

Objectives Assessment of the relationship between US measures of joint inflammation/damage and patient reported outcomes (PROs): HAQ, pain and patient global assessment in early rheumatoid arthritis (early RA) patients over 5-years follow up period. Methods This longitudinal cohort of 261 patients with early RA was derived from the US monitoring study [1]. Adopting OMERACT definitions; correlations between total US scores (synovial hypertrophy, synovial fluid, Power Doppler, bone erosion and tenosynovitis) and PROs [2] namely functional disability (HAQ), pain and patient global scores were determined at 0, 1, and 5years. Radiological damage was assessed using modified Total Sharp score (mTSS). Univariate correlations as well as correlations between interval changes were assessed. Multivariable regression models were used to evaluate the associations over all time-points and their relationship to clinical disease activity measures. Results There were significant correlations (p<0.01) between total US score and HAQ (r=0.71), pain (r=0.69) and patient global scores (r=0.66) at all timepoints. The association tends to be stronger with increase disease duration (Spearman correlation 0.12 at baseline, 0.22 at 1-year and 0.41 at 5-years). Change in mTSS score at 5-years was not associated with changes in PROs. Improvements in US scores were also associated with improvements in PROs. Multivariate models revealed that synovial hypertrophy and Power Doppler scores were associated (p<0.01) with functional disability, pain and patient global assessment, controlling for clinical disease activity measures. Studying the pattern of joint involvement, it was associated significantly (p<0.01) with the US score of the affected joints. US total score at 1-year predicted subsequent 5-year HAQ score (R2=0.17). At 0, 1- and 5-years, total US scores were higher in patients whose HAQ score was >1 (9.26) compared to those below 1 (4.16, p<0.01). Conclusions the link between joint inflammation/structural damage and PROs is of critical importance to the care of patients with inflammatory arthritis. US measures of inflammation and structural damage correlated independently with physical function, pain and patient global assessments. A clear relationship between radiographic structure damage and the patients perceived remission/flare provide the basis for comprehensive disease assessment and management. References El Miedany et al. Current Rheumatology Reviews 2015; 11, 18–27. El Miedany et al. Clin Exp Rheumatol 2010; 28(5):734–44. Disclosure of Interest None declared

AB0325 Biomarkers and Patient Tailored Approach in Rheumatoid Arthritis: Can Proms be the Missing Biomarker?

Background In many chronic diseases, there is usually a single “gold standard” biomarker measure which is applicable to diagnosis, management, prognosis, and analyses of outcomes in all individual patients in clinical trials, clinical care, and long-term databases (such as blood pressure in hypertension, and HbA1c in diabetes). In contrast, in most rheumatic diseases, there is none. This absence of a gold standard measure resulted in the suggestion of pooled indices, which are complex, and used in clinical trials but not in clinical care. Objectives To assess the feasibility of using PROMs and its individual components as a valid biomarker enabling the treating doctor to optimally measure disease progression, severity and joint damage in patients with inflammatory arthritis. Methods Changes from baseline to week 76 of clinical variables, patient reported outcome measures [1], and measures of radiographic progression were assessed in 481 subjects suffering from early inflammatory arthritis (Disease duration <6-months) diagnosed according to the ACR/EULAR criteria 2010 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 changes in PROMs individual components scores 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. Linear regression analysis was used to assess the significance of correlations for changes in disease activity and PROMs components over time. Results The crude functional disability score as well as the percentage changes at 3 and 6 months showed a 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]. Patient global assessment and pain score were associated significantly with scores of DAS-28, ACR response, systemic manifestations and work ability. 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 PROMs 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 El Miedany et al. Clin Exp Rheumatol 2010; 28: 734. Disclosure of Interest None declared

OP0312 Simulated Teaching in Rheumatology: Assessment of an Interactive E-Learning Postgraduate Rheumatology Teaching Module

Background Computer-assisted learning has several privileges in contrast to the conventional teaching methods. An inventive, online learning atmosphere can have a significant impact on the students ability for learning and problem solving. Advantages of internet based learning include universal availability, easiness to update its content, and the option of adding hyperlinks which facilitate cross-referencing to other resources. Objectives To assess the outcome of a series of interactive cyber-based self-study program for post-graduate rheumatology trainees involving problem solving and decision analysis. Methods An initial needs assessment online survey was carried out to assess the learning requirements and attitude towards e-learning and the topics of interest. From these results a series of 10 interactive case studies and problem solving were designed for simulated teaching from a web-server. The topics included: PASI scoring, PROMs in inflammatory arthritis and spondyloarthritis, assessment of co-morbidities, treat to target of arthritis, ankylosing spondylitis and psoriatic arthritis, SLE and Scleroderma as well as management and assessment of falls and fracture risk in osteoporosis patients. Before and after completing the module every participant was asked to complete a copy of the Satisfaction and Self-Confidence in Learning questionnaire to assess the outcome the teaching module. Results At baseline, a survey of 49 postgraduate students revealed that 41/49 (84%) reported that e-learning teaching modules were a valuable enhancement to existing teaching and they could see a positive use for e-learning. This percentage increased in the post module survey up to 48/49 (98%). Results of the Satisfaction with Current Learning questionnaire revealed significant improvement (p<0.01) of the trainees perceived confidence and competence levels for handling the patients in the clinic. There was significant improvement in the trainees perception of usefulness of skills and knowledge acquired and the ability to transfer this into clinical enviroment. Several web-based technologies were voted to be important for the teaching modules. These included digital videos (88%), animation and graphics (84%), interactivity (97%), pictures (100%) and links to articles and research (92%). Conclusions The interactive case studies and problem solving e-learning program was well received by a wide range of trainees with different abilities and backgrounds. Reflection on the module revealed that the program was realistic and clearly presented in an intuitive manner. Simulated teaching approach may provide a way to increase the exposure of postgraduate trainees to interactive diagnostic and treatment procedures, that mimic real-world scenarios, but with fewer resource implications. Acknowledgements To Omar El Miedany for contribution in preparing the web-based technologies and electronic formatting of the module 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