D. Palmer

Toward electronic health recording: evaluation of electronic patient reported outcome measures (e-PROMs) system for remote monitoring of early systemic lupus patients

The study aimed to assess the value of evaluation of electronic patient reported outcome measures (e-PROMs) in the assessment and management of SLE disease activity flares, its association with adherence to therapy as well as organ damage. A randomized, controlled crossover study was carried out over a 24-month duration. One hundred forty-seven SLE patients meeting the revised American College of Rheumatology (ACR) criteria were enrolled. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) was used to assess disease activity, whereas organ damage was scored using the Systemic Lupus International Collaborating Clinics (SLICC)/ACR Damage Index. In the first 12xa0months, the patients were assessed every 3 months. At 12xa0months, the patients were randomized into a cohort of 73xa0patients who continued their care in the same style and 74xa0patients who completed an online e-PROMs questionnaire on monthly basis for another 12-month period. The data captured were then retrospectively analyzed at the end of the 24-month study period. At the end of the first year of the study, the mean SLEDAI and SDI scores were 8.72 (6.1) and 1.9 (2.2). At the end of the second year, the mean SLEDAI and SDI scores in the e-PROMs cohort were 3.1 (2.6) and 1.2 (1.3), whereas in the control group, the scores were 7.63 (6.7) and 1.8 (2.3), respectively (pxa0<xa00.01). Adjusting for possible confounding variables, the number of flares, regardless of their severity, was associated with damage accrual (OR 2.03, 95% CI 1.34 to 2.83, pxa0<xa00.001). Adherence to therapy was significantly (pxa0<xa00.1) higher in the e-PROMs group. e-PROMs was equivalent to PROMs paper format and has a potential disease-modifying effect as it facilitated close monitoring of disease activity with an option of management escalation whenever indicated.

Nurses' Role in Cardiovascular Risk Assessment and Management in People with Inflammatory Arthritis: A European Perspective

INTRODUCTIONnCardiovascular risk (CVR) assessment and management in patients with inflammatory arthritis (IA) is recommended but European nurses involvement in this role has not been well studied.nnnAIMnThe aim of the present study was to explore European nurses role in assessing and managing CVR, in order to suggest topics for practice development and research in this area regarding persons with IA.nnnMETHODSnWe searched Embase, Cinahl, Cochrane, PsycInfo and PubMed databases and included European articles from the past ten years if they described how nurses assess and/or manage CVR. In addition to the systematic review, we provided case studies from five different countries to illustrate national guidelines and nurses role regarding CVR assessment and management in patients with IA.nnnRESULTSnThirty-three articles were included. We found that trained nurses were undertaking CVR assessment and management in different settings and groups of patients. The assessments include blood pressure, body mass index, waist circumference, glucose and lipid-profile, adherence to medication and behavioural risk factors (unhealthy diet, physical inactivity, alcohol and smoking). Different tools were used to calculate patients risk. Risk management differed from brief advice to long-term follow-up. Nurses tended to take a holistic and individually tailored approach. Clinical examples of inclusion of rheumatology nurses in these tasks were scarce.nnnCONCLUSIONnNurses undertake CVR assessment, communication and management in different types of patients. This is considered to be a highly relevant task for rheumatology nursing, especially in patients with IA. Further studies are needed to assess patients perspective, effectiveness and cost-effectiveness of nurse-led CVR. Copyright

AB0324 Shared Decision Making in Standard Rheumatology Practice: From Policy to Practice

Background Shared decision making (SDM) is based on setting up a good relationship between the patient and the treating doctor. To accomplish this, we adopted a SDM model based on 3 pillars: a)Presenting choice, b) defining options, and c) supporting patients discover preferences and make decisions. The model is centered on respecting “what matters most” to the patients and respecting their “informed choice” Objectives To assess 1. The patients perception and impact of SDM on drug compliance in RA patients. 2. the cost effectiveness of shared decision making in standard practice. Methods A double-blind randomized controlled study which included early arthritis patients diagnosed according to ACR/EULAR criteria. The patients were randomly stratified into: Active group (69 patients) who were given a Shared Decision aid to read whilst waiting outside the clinic room, entailing their choices and treatment options. The patient was then reviewed in the clinic where decision talk phase was carried out towards making a decision regarding the preferred treatment. The control group included 68 patients. The standard drug information leaflets were given to the patient prior to having a thorough discussion in the clinic. Disease activity status and DMARDs therapy were monitored over 1-year period during which PROMs, compliance to medications and co-morbidity scores were also recorded. Primary outcome was the patients adherence to their medications; change in disease activity score (DAS-28) and PROMs after 1-year of management. Secondary outcomes were: 1. the outcome of a copy of SURE questionnaire completed by every patient in both the active group and control group at time zero and at 1-year of treatment to rate the patients perspective regarding their condition and treatment. 2. Time taken by each patient in the clinic to discuss their queries regarding the DMARDs medication. Results There was no significant difference on comparing the disease activity parameters in both groups whereas there was significant improvement of the patients adherence to anti-rheumatic therapy (p<0.01) in favour of the active group. Medication compliance in the active group was significantly (P<0.01) correlated with changes in PROMs parameters with significant less contact to the advice line in comparison to the control group. Stopping the DMARDs therapy because of intolerance was significantly less in the active group. The improvement of disease activity parameters was associated with improvement in functional disability and quality of life scores as well as less absence days from work. There was no significant difference on comparing the time taken for discussion with the patient to explain their DMARDs therapy and options available. Conclusions SDM did facilitate a longer term positive impact on the patients management. SDM was cost effective as it led to reduced health service use over a 1-year period as well as better patients adherence to therapy and less number of sick leaves. Furthermore, SDM was not found to be time consuming. The shared partnership had a direct impact on the patients management as it allowed the patients to have a better attitude toward their management, self-efficacy/self-confidence which were both correlated with improved clinical outcomes. 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

PROMs and Patient Education

Patient education is a core activity in the management of inflammatory arthritic conditions. However, it may be challenging to decide which educational approach is most appropriate to fit with the individual patient’s needs. This is in parallel with the new trend of empowering patients, providing them with the environment to develop the skills, confidence, and knowledge to move from being a passive recipient of care to an active partner in their own healthcare. The scope of patient-reported outcome measures (PROMs) has gone beyond disease activity assessment and moved toward a dynamic role in the evaluation of the impact of the disease on the patients’ lives and their educational needs to enable them to cope with their illness. This chapter discusses how PROMs can help to deliver an educational program tailored to the patient’s needs, assessing its outcomes as well as identifying new targets to facilitate patients’ empowerment.

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

Incorporating motivational interviewing into rheumatology care

Deborah Palmer, Advanced Nurse Practitioner, North Middlesex University Hospital, and Yasser El Miedany, Consultant Rheumatologist, discuss ways to close the gap between disease control and patient empowerment.

Comorbidity and Patient-Reported Outcomes

Although it has been well recognised that comorbid conditions are common among patients living with inflammatory as well as noninflammatory arthritic conditions, little is known about the specific impact of comorbidities on the patients’ experiences, including their perception of pain, function, insomnia, depression and fatigue. Understanding such association and whether a cumulative number of chronic health conditions or certain specific health problems may have a stronger negative influence on patient-reported outcomes (PROs), can guide clinical care by identifying aspects of comorbidity that have the greatest impact on the arthritis-related PROs and therefore should be emphasised in treatment and care models. This chapter will provide a comprehensive evaluation of the interplay between comorbidities and patient-reported outcomes as well as its impact on the patients’ management.

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