Search

ObjectivesTo disseminate and assess the level of acceptability and applicability of the European Alliance of Associations for Rheumatology (EULAR) recommendations for patient education among professionals in rheumatology across Europe and three Asian countries and identify potential barriers and facilitators to their application.MethodsA parallel convergent mixed-methods design with an inductive approach was used. A web-based survey, available in 20 different languages, was distributed to health professionals by non-probability sampling. The level of agreement and applicability of each recommendation was assessed by (0–10) rating scales. Barriers and facilitators to implementation were assessed using free-text responses. Quantitative data were analysed descriptively and qualitative data by content analysis and presented in 16 categories supported by quotes.ResultsA total of 1159 completed the survey; 852 (73.5%) were women. Most of the professionals were nurses (n=487), rheumatologists (n=320), physiotherapists (n=158). For all recommendations, the level of agreement was high but applicability was lower. The four most common barriers to application were lack of time, lack of training in how to provide patient education, not having enough staff to perform this task and lack of evaluation tools. The most common facilitators were tailoring patient education to individual patients, using group education, linking patient education with diagnosis and treatment and inviting patients to provide feedback on patient education delivery.ConclusionsThis project has disseminated the EULAR recommendations for patient education to health professionals across 23 countries. Potential barriers to their application were identified and some are amenable to change, namely training patient education providers and developing evaluation tools.

A clinical guideline is a document with the aim of guiding decisions based on evidence regarding diagnosis, management and treatment in specific areas of healthcare. Specific to rheumatic and musculoskeletal diseases (RMDs), adherence to clinical guidelines recommendations impacts the outcomes of people with these diseases. However, currently, the implementation of recommendations is less than optimal in rheumatology.The WHO has described the implementation of evidence-based recommendations as one of the greatest challenges facing the global health community and has identified the importance of scaling up these recommendations. But closing the evidence-to-practice gap is often complex, time-consuming and difficult. In this context, the implementation science offers a framework to overcome this scenario.This article describes the principles of implementation science to facilitate and optimise the implementation of clinical recommendations in RMDs. Embedding implementation science methods and techniques into recommendation development and daily practice can help maximise the likelihood that implementation is successful in improving the quality of healthcare and healthcare services.

ObjectivesTo compare outcomes of different treatment schedules from the care in early rheumatoid arthritis (CareRA) trial over 5 years.MethodsPatients with RA completing the 2-year CareRA randomised controlled trial were eligible for the 3-year observational CareRA-plus study. 5-year outcomes after randomisation to initial methotrexate (MTX) monotherapy with glucocorticoid bridging (COBRA-Slim) were compared with MTX step-up without glucocorticoids or conventional synthetic disease-modifying antirheumatic drug (DMARD) combinations with glucocorticoid bridging, per prognostic patient group. Disease activity (Disease Activity Score based on 28 joints calculated with C reactive protein (DAS28-CRP)) and functionality (Health Assessment Questionnaire (HAQ)) were compared between treatment arms using longitudinal models; safety and drug use were detailed.ResultsOf 322 eligible patients, 252 (78%) entered CareRA-plus, of which 203 (81%) completed the study. Treatments for high-risk patients resulted in comparable DAS28-CRP (p=0.539) and HAQ scores over 5 years (p=0.374). Low-risk patients starting COBRA-Slim had lower DAS28-CRP (p3 months and 17% for >6 months outside the bridging period.ConclusionsAll intensive treatments with glucocorticoids bridging demonstrated excellent 5 year outcomes. Initiating COBRA-Slim was comparably effective as more complex treatments for high-risk patients with early RA and more effective than initial MTX monotherapy for low-risk patients with limited need for biologics and chronic glucocorticoid use.

Objective: Pain interference and pain behavior are highly relevant outcomes in patients with rheumatoid arthritis (RA). The Patient-Reported Outcomes Measurement Information System (PROMIS) is a universally applicable set of item banks measuring patient-reported health, and if applied as computerized adaptive tests (CATs), more efficiently and precisely than current instruments. The objective was to study the psychometric properties of the Dutch-Flemish PROMIS pain interference (PROMIS-PI) and the PROMIS pain behavior (PROMIS-PB) item banks in patients with RA. Methods: A total of 2,029 patients with RA completed the full PROMIS-PI (version 1.1, 40 items), and 1,554 patients completed the full PROMIS-PB (version 1.1, 39 items). The following psychometric properties were studied: unidimensionality, local dependence, monotonicity and graded response model (GRM) fit, cross-cultural validity (differential item functioning [DIF] for language [Dutch versus Flemish]), other forms of measurement invariance, construct validity, reliability, and floor and ceiling effects. Results: The PROMIS-PI and PROMIS-PB banks were sufficiently unidimensional (Omega-hierarchical [Omega-H] 0.99, 0.95, and explained common variance 0.95, 0.78, respectively), had negligible local dependence (0.3–1.4% of item pairs), good monotonicity (H 0.75, 0.46), and a good GRM model fit (no misfitting items). Furthermore, both item banks showed good cross-cultural validity (no DIF for language), measurement invariance (no DIF for age, sex, administration mode, and disease activity), good construct validity (all hypotheses met), high reliability (>0.90 in the range of patients with RA), and an absence of floor and ceiling effects (0% minimum or maximum score, respectively). Conclusion: Both PROMIS-PI and PROMIS-PB banks showed good psychometric properties in patients with RA and can be used as CATs in research and clinical practice.

ObjectivesTo evaluate the cost-effectiveness of treat-to-target strategies among recently diagnosed patients with rheumatoid arthritis (RA) using methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim) compared with (1) this combination with either sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde) in high-risk patients and (2) MTX without GCs (Tight-Step-Up, TSU) in low-risk patients.MethodsThe incremental cost-utility was calculated from a healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial. Healthcare costs were collected prospectively through electronic trial records. Quality-adjusted life years (QALYs) were estimated using mapping algorithms for EuroQoL-5 Dimension. Multiple imputation was used to handle missing data and bootstrapping to calculate CIs. Robustness was tested with biological disease-modifying antirheumatic drugs at biosimilar prices.ResultsIn the high-risk group, Classic (∆k€1.464, 95% CI −0.198 to 3.127) and Avant-Garde (∆k€0.636, 95% CI −0.987 to 2.258) were more expensive compared with Slim and QALYs were slightly worse for Classic (∆−0.002, 95% CI −0.086 to 0.082) and Avant-Garde (∆−0.009, 95% CI −0.102 to 0.084). This resulted in the domination of Classic and Avant-Garde by Slim. In the low-risk group, Slim was cheaper (∆k€−0.617, 95% CI −2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated. Results were robust against the price of biosimilars.ConclusionsThe combination of MTX with a GC bridging scheme is less expensive with comparable health utility than more intensive step-down combination strategies or a conventional step-up approach 2 years after initial treatment.Trial registration numberNCT01172639.

ObjectivesTo explore patients’ agreement and reasons for agreement or disagreement with the EULAR recommendations for patient education (PE) for people with inflammatory arthritis (IA).MethodsThis mixed-method survey collected data using snowball sampling. The survey had been translated into 20 languages by local healthcare professionals, researchers and patient research partners. It explored the degree to which patients with IA agreed with each recommendation for PE (0=do not agree at all and 10=agree completely) and their rationale for their agreement level in free text questions. Descriptive statistics summarised participants’ demographics and agreement levels. Qualitative content analysis was used to analyse the free text data. Sixteen subcategories were developed, describing the reasons for agreement or disagreement with the recommendations, which constituted the categories.ResultsThe sample comprised 2779 participants (79% female), with a mean (SD) age 55.1 (13.1) years and disease duration 17.1 (13.3) years. Participants strongly agreed with most recommendations (median 10 (IQR: 9–10) for most recommendations). Reasons for agreement with the recommendations included the benefit of using PE to facilitate collaborative care and shared decision making, the value of flexible and tailored PE, and the value of gaining support from other patients. Reasons for disagreement included lack of resources for PE, not wanting information to be tailored by healthcare professionals and a reluctance to use telephone-based PE.ConclusionThe EULAR recommendations for PE have been disseminated among patients with IA. Overall, agreement levels were very high, suggesting that they reflect patients’ preferences for engaging in collaborative clinical care and using PE to facilitate and supplement their own understanding of IA. Reasons for not completely agreeing with the recommendations can inform implementation strategies and education of healthcare professionals.

We thank Dr Dhir et al for their kind words and would like to address some of the points raised.1 First, in patients without markers of poor prognosis, the COBRA-Slim scheme with methotrexate (MTX) and prednisone bridging led to a more rapid response than initial MTX monotherapy in the first 16 weeks.2 Subsequently, remission rates did not differ until year 5, but patients starting a COBRA-Slim scheme had a lower disease activity and better functionality longitudinally over 5 years.3–5 This long-term effect of prednisone bridging seems counterintuitive to Dr Dhir, given the results of the 'BehandelStrategieen in Reumatoide Arthritis' (BeSt) study and the 'Treatment of Early Aggressive Rheumatoid Arthritis' (TEAR) trial, showing that long-term outcomes were essentially determined by treating-to-target.6 7 Unfortunately, differences in design and follow-up duration hamper direct comparisons of the Care in early Rheumatoid Arthritis (CareRA) study with these trials. The 2-year TEAR trial did not include a glucocorticoid bridging scheme in its MTX step-up arms, but 40% of patients were already on low-dose oral glucocorticoids at baseline, which was prohibited per protocol in the MTX-Tight-Step-Up (TSU) arm of CareRA. Moreover, only about one in …

ObjectivesRheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (SpA) are chronic inflammatory rheumatic conditions with high levels of comorbidity requiring additional therapeutic attention. We aimed to compare the 3-year comorbidity incidence and pain medication prescription in patients diagnosed with RA, PsA or SpA versus controls.MethodsData between 1999 and 2012 were obtained from Intego, a general practitioner (GP) morbidity registry in Flanders, Belgium. Cases were identified by International Classification of Primary Care (ICPC-2) codes representing ‘rheumatoid/seropositive arthritis (L88)’ or ‘musculoskeletal disease other (L99)’. The registered keywords mapped to these ICPC-2 codes were further verified and mapped to a RA/SpA/PsA diagnosis. Controls were matched on age, gender, GP practice and diagnosis date. We analysed the 3-year comorbidity burden in cases and controls, measured by the Rheumatic Diseases Comorbidity Index (RDCI). All electronically GP-prescribed drugs were registered.ResultsIn total, 738, 229 and 167 patients were included with a diagnosis of RA, SpA or PsA, respectively. Patients with RA or PsA had comparable median RDCI scores at baseline, but higher scores at year 3 compared with controls (RA: p=0.010; PsA: p=0.008). At baseline, depression was more prevalent in PsA patients vs controls (pConclusionsThis study highlights the increasing comorbidity burden of patients with chronic inflammatory rheumatic conditions, especially for individuals with RA or PsA. The high opioid use in all populations was remarkable.

Objectives RA should be treated to target in a process of shared decision-making with patients. Person-centred care is essential to meeting specific patient needs. Nurse-led clinics, where a nurse is responsible for care, have demonstrated added value in some countries but are still not implemented widely. This study aimed to explore stakeholders’ perceptions of advantages, disadvantages and conditions for the implementation of nurse-led clinics for RA in Belgium. Methods We performed a cross-sectional qualitative study consisting of five semi-structured focus group interviews. Rheumatology nurses, patients with RA and rheumatologists were interviewed as stakeholders. The analysis was carried out by three researchers according to the Qualitative Analysis Guide of Leuven (QUAGOL), formulating a conceptual framework of overarching themes and deconstructing this into perceived advantages, disadvantages and conditions. Results Two focus groups with nurses (total n = 16), two with patients (n = 17) and one with rheumatologists (n = 9) were conducted. The interview synthesis resulted in five overarching themes across stakeholders: efficiency of care, disease management, legal and organizational requirements, the conventional role of the nurse and the extended role of the nurse. All stakeholders perceived additional education for nurses as essential, but rheumatologists debated nurses’ abilities to lead a rheumatology clinic. Furthermore, patients preferred care protocols to guide nurses, and care providers approached this reluctantly. Generally, patients with a well-controlled disease were perceived as the ideal candidates for nurse-led care. Conclusion Nurse-led clinics could provide many benefits but require additional nurse education and a legal and organizational framework before being implemented widely and successfully.

Objective.To explore the possibility of integrating patient-important outcomes like pain, fatigue, and physical function into the evaluation of disease status in early rheumatoid arthritis (ERA) without compromising correct disease activity measurement.Methods.Patients from the 2-year Care in Early Rheumatoid Arthritis (CareRA) trial were included. Pain and fatigue (visual analog scales), Health Assessment Questionnaire (HAQ), standard components of disease activity [swollen/tender joint counts (SJC/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), physician (PhGH) and patient (PaGH) global health] were recorded at every visit (n = 10). Pearson correlation and exploratory factor analyses (EFA), using multiple imputation (15×) and outputation (1000×), were performed per timepoint and overall, on standard components of disease activity scores with and without pain, fatigue, and HAQ. Each of the 15,000 datasets was analyzed using EFA with principal component extraction and oblimin rotation to determine which variables belong together.Results.We included 379 patients. EFA on standard composite score components extracted 2 factors with no substantial cross-loadings. Still, pain (0.83), fatigue (0.65), and HAQ (0.59) were strongly correlated with PaGH. When rerunning the EFA with the inclusion of pain, fatigue, and HAQ, the 2-factor model had substantial cross-loadings between factors. However, a 3-factor model was optimal, with Factor 1: patient assessment, Factor 2: clinical assessment (PhGH, SJC, and TJC), and Factor 3: laboratory assessment (ESR/CRP).Conclusion.PaGH, pain, fatigue, and physical function represent a separate aspect of the disease burden of patients with ERA, which could be further explored as a target for care apart from disease activity. [ClinicalTrials.gov: NCT01172639].

BackgroundSystemic sclerosis (SSc) is a severe autoimmune disease often leading to fibrotic cutaneous involvement of the face. Reduced oral aperture is associated with impaired food intake, oral hygiene and secondary dental problems. Stretching and oral augmentation exercises can increase oral aperture but are often hampered by low adherence rates. The aim of this mixed method study was to explore feasibility, patient satisfaction and effectiveness of two exercise programs in SSc-associated microstomia.MethodsAdult patients (ResultsWe included 6 women and 3 men, median age 60 years (range 40-75) and median disease duration 8 years (range 3-22). At 6 months, all patients in group A (n=4) and 4 in group B (n=5) improved with a median of 9mm (range 2-10) and 7mm (range 4-11), respectively. The proportion of executed to the planned number of exercises ranged between 63.7% and 98,9% in group A and between 48.5% and 97,4% in group B. Maintenance of the increase in oral aperture was noted in patients that continued to exercise daily. All 9 patients attended the interview that revealed three themes: drivers, challenges and perceived improvement. ConclusionBoth interventions improve maximal oral aperture. The adherence to therapy was high but none of the patients considered it feasible to continue practicing 3 times/day. Future studies are needed in order to define feasible long-term exercise programs.

INTRODUCTION/OBJECTIVES: Evidence regarding the effectiveness of step-down strategies for patients with well-controlled early rheumatoid arthritis (RA) on a combination of methotrexate (MTX) and leflunomide (LEF) is currently lacking. METHOD: The Care in early RA (CareRA) trial is a 2-year randomized pragmatic trial comparing different remission induction strategies in treatment-naïve patients with early RA. For this study, we included participants who achieved low disease activity (LDA) (DAS28-CRP ≤ 3.2) between 40 to 52 weeks after starting a combination of MTX, LEF, and a prednisone bridging scheme followed by a treat-to-target approach. Patients were re-randomized to a maintenance monotherapy of either MTX 15 mg weekly or LEF 20 mg daily. Remission rates (DAS28-CRP

ObjectivesTo explore treatment outcomes preferred by patients with early rheumatoid arthritis (RA) and how these change throughout the early disease stage across three European countries.MethodsA longitudinal, qualitative, multicentre study was conducted in Belgium, the Netherlands and Sweden. 80 patients with early RA were individually interviewed 3–9 months after treatment initiation and 51 of them participated again in either a focus group or an individual interview 12–21 months after treatment initiation. Data were first analysed by country, following the Qualitative Analysis Guide of Leuven (QUAGOL). Thereafter, a meta-synthesis, inspired by the principles of meta-ethnography and the QUAGOL, was performed, involving the local research teams.ResultsThe meta-synthesis revealed 11 subthemes from which four main themes were identified: disease control, physical performance, self-accomplishment and well-being. ‘A normal life despite RA’ was an overarching patient-preferred outcome across countries. Belgian, Dutch and Swedish patients showed many similarities in terms of which outcomes they preferred throughout the early stage of RA. Some outcome preferences (eg, relief of fatigue and no side effects) developed differently over time across countries.ConclusionsThis study on patient-preferred outcomes in early RA revealed that patients essentially want to live a normal life despite RA. Our findings help to understand what really matters to patients and provide specific insights into the early stage of RA, which should be addressed by clinicians of different disciplines from the start of treatment onwards.

To quantify the prevalence of co-morbidities in patients with early RA and determine their prognostic value for effectiveness outcomes in a randomized trial.We included patients from the 2-year pragmatic randomized CareRA trial, who had early RA (diagnosis 1 year), were DMARD naïve and then treated-to-target with different remission induction schemes. Prevalence of co-morbidities was registered at baseline and the Rheumatic Diseases Comorbidity Index (RDCI; range 0-9) was calculated. We tested the relation between baseline RDCI and outcomes including disease activity (DAS28-CRP), physical function (HAQ index), quality of life (SF-36 domains) and hospitalizations over 2 years, using linear mixed models or generalized estimating equations models.Of 379 included patients, 167 (44%) had a RDCI of minimum 1. RDCI scores of 1, 2 or ≥3 were obtained in 65 (17%), 70 (19%), and 32 (8%) participants, respectively. The most frequent co-morbidity was hypertension (22%). Patients with co-morbidities had significantly higher HAQ (β = 0.215; 95% CI: 0.071, 0.358), DAS28-CRP (β = 0.225; 95% CI: 0.132, 0.319) and lower SF-36 physical component summary scores (β =-3.195; 95% CI: -4.844, -1.546) over 2 years than patients without co-morbidities, after adjusting for possible confounders including disease activity and randomized treatment. Patients with co-morbidities had over time lower chances of achieving remission (OR = 0.724; 95% CI: 0.604, 0.867) and a higher risk of hospitalization (OR = 3.725; 95% CI: 2.136, 6.494).At disease onset, almost half of RA patients had at least one clinically important co-morbidity. Having co-morbidities was associated with worse functionality and disease activity outcomes over 2 years, despite intensive remission induction treatment.Clinical trials NCT01172639.

ObjectivesTo identify and characterise a subgroup of patients with early rheumatoid arthritis (RA) reporting not feeling well 1 year after treatment initiation despite achieving optimal disease control according to current treatment standards.MethodsThis observational study included participants of the Care in early RA trial with a rapid and sustained response (DAS28CRPResultsAnalyses revealed three clusters. Of 140 patients, 77.9% were assigned to the ‘concordant to disease activity’ cluster, 9.3% to the ‘dominant fatigue’ cluster and 12.9% to the ‘dominant pain and fatigue’ cluster. Large differences in pain and fatigue reporting were found at week 16 when comparing the ‘concordant’ with the ‘dominant pain and fatigue’ or the ‘dominant fatigue’ cluster. Small differences in reporting were found for the other PROs. Illness perceptions and coping style also differed in the ‘concordant’ cluster.ConclusionsAlthough most patients reported PRO scores in concordance with their well-controlled disease activity, one in five persistent treatment responders reported not feeling well at year 1. These patients reported higher pain and fatigue, and different illness perceptions and coping strategies early in the disease course.

Purpose To explore patients’ preferred treatment outcomes during their first two years with rheumatoid arthritis (RA). Patients and Methods A qualitative, longitudinal, multicenter study with interviews at two time points was performed in Sweden. Individual interviews were conducted at time point 1 with 31 patients with RA, defined as disease duration of ≤1 year and treatment for 3–7 months. Seven focus group interviews and five individual interviews were conducted at time point 2 with 22 patients 12–20 months after treatment initiation. The interviews were analyzed using the Qualitative Analysis Guide of Leuven. A core category with four related concepts emerged. Results The core finding of patient-preferred treatment outcomes was “mastering a new life situation”. Patients preferred to experience control of the disease by controlling the symptoms and by experiencing absence of disease. To experience autonomy by regaining former activity level, experiencing independence, and being empowered was another preferred outcome. Patients preferred to regain identity through being able to participate, experience well-being, and regain former self-image. To experience joy in everyday life through vitality and believing in the future was another preferred outcome. Patients’ preferences developed over time from the acute phase of controlling the symptoms and wanting to return to the life they lived prior to diagnosis, to a more preventive way of self-management and empowerment to master the new life situation. Conclusion The patients’ preferred treatment outcomes during the first two years with RA were to master their new life situation and changed from a preference to return to a life lived prior disease onset, to a preference of living with quality of life, despite RA. This study increases the understanding of patients’ preferred treatment outcomes in the early disease course and can be a foundation for tailoring interventions to be more person-centered and to improve long-term treatment outcomes.

OBJECTIVES To quantify the prevalence of co-morbidities in patients with early RA and determine their prognostic value for effectiveness outcomes in a randomized trial. METHODS We included patients from the 2-year pragmatic randomized CareRA trial, who had early RA (diagnosis

OBJECTIVE: Treating early, intensively, and to target leads to rapid disease control, preventing joint damage and loss of function in early rheumatoid arthritis (RA). We report the effect of such an approach on patient-reported outcomes and explore the contribution of rapid and persistent disease control to well-being after 1 year of treatment. METHODS: This study is part of the Care in Early RA trial, a prospective, 2-year, investigator-initiated, randomized controlled trial rooted in daily practice and implementing the treat-to-target principle. Short Form 36 (SF-36) health survey and Revised Illness Perception Questionnaire (IPQ-R) data were collected prospectively. We defined 4 clinical response profiles based on speed and consistency of the treatment response within the first year, defined as the Disease Activity Score in 28 joints using the C-reactive protein level

BackgroundPatients recently diagnosed with rheumatoid arthritis (RA) have specific educational and supportive needs. These could partly be addressed with mentoring by other patients living with RA. This qualitative study explores stakeholder perceptions towards peer mentoring in early RA care.MethodsTwo focus groups with patients with early RA (n=10), one with patient organisation representatives (n=5), one with rheumatologists (n=8) and one with rheumatology nurses (n=5) were held. Two patient research partners supported analysis and interpretation.ResultsFour overarching themes were found: added value, experience with peer mentoring, concerns and need in daily care. Patients and patient organisation representatives confirmed the potential of peer mentoring especially regarding sensitive topics not easily discussed with professionals. Patients felt it could provide additional understanding and recognition. Nurses and rheumatologists were less convinced of the added value of peer mentoring because patients never mentioned it and they were concerned about the loss of control over correct information provision. The need for peer mentoring was perceived as person and disease phase-dependent and should therefore be optional, rather than a care standard. The requirements for a peer mentorship programme remained challenging to define for stakeholders. However, all expressed the need for supervision by healthcare professionals and that peer mentors should be carefully selected, educated and matched to newly diagnosed patients.ConclusionPeer mentoring and its implementation remain vague concepts, especially for healthcare providers. However, patients are interested in mentoring by peers, and the current results may support in effectively implementing such programmes early in the disease.

Objectives Timely treatment of patients with Early Rheumatoid Arthritis (ERA) favors a beneficial disease outcome. However, individuals often delay their contact with a healthcare professional (HCP) after ERA-related symptom onset. This study investigates the patients’ perspective on the patient’s journey from RA symptom onset until referral to a specialist. Methods A subgroup of patients with ERA from the Care in ERA (CareRA) trial were retrospectively interviewed to discuss their initial ERA-related experiences preceding diagnosis, using a bespoke assessment form. The form’s first section focused on initial symptoms and patients’ help-seeking behavior. The second part probed the consulted HCPs’ actions. Additional notes derived from the patient stories were thematically analyzed. Results Among 94 patients, pain (97%), swelling (73%) and stiffness (52%), typically in multiple joints, were reported as initial ERA-symptoms. The general practitioner (GP) was generally the first contacted HCP (87%). Frequently reported reasons to visit a HCP were too intense pain (90.4%) and difficulties in performing daily activities (69%). In 44.1% of patients, the HCP suspected ERA at the first visit. Approximately 25% of patients needed >5 visits before ERA detection. GPs mainly referred patients to rheumatologists (71%). Thematic analysis uncovered that often multiple HCPs were involved in the journey to RA detection and referral. Conclusion Pain is the most commonly reported initial symptom of ERA and the main reason to visit a HCP, mostly a GP. These GPs play a pivotal role in early detection and correct referral. Furthermore, the patient’s journey seems complex with often multiple HCPs involved.

Background Seronegative rheumatoid arthritis (RA) patients have been historically considered to have a milder disease. This confers a potential risk for under treatment. The quality of their response to early intensive therapies has not been thoroughly studied. Objectives To compare the disease course in seronegative and seropositive patients from the Care in early RA (CareRA) trial treated with COBRA Slim. Methods The CareRA trial included 379 patients with early RA (≤1 year) fulfilling 1987 or 2010 ACR criteria and naive to disease modifying anti-rheumatic drugs (DMARDs). Patients were randomized to one of four different intensive treatment strategies based on methotrexate (MTX) monotherapy or synthetic (cs)DMARD combinations with or without glucocorticoid (GC) bridging. Before randomization, stratification into a high- or low-risk group according to classical poor prognostic markers (presence of erosions, positivity to rheumatoid factor (RF) and/or anti-citrullinated protein antibody (ACPA), and elevated disease activity) was conducted. One of these strategies, COBRA Slim, a combination of MTX and a prednisone remission induction scheme stepping-down from 30 mg QD, was initiated in 141 patients from both risk strata, of which 38 were negative for both RF and ACPA (seronegative). Following the treat-to-target principle, using the disease activity score in 28 joints with C-reactive protein (DAS28CRP), treatment adaptations were steered at low disease activity (≤3.2), while aiming for remission ( The “as observed” population was analysed for differences in disease activity and radiographic progression between seronegative and seropositive patients at several time points during the 2-year study using independent sample t-test, Man Whitney-U or adjusted X2 (Yate’s correction for small samples). Survival analysis using Kaplan Meier was employed for time to first response to treatment. First response to treatment was defined as achieving first remission (DAS28CRP 1.2) after screening. Sensitivity analyses were applied on the complete CareRA cohort. Results Seronegative patients starting COBRA Slim (n=38), had similar age (53 vs 51 years, p=0.52), body mass index (25.5 vs 26.7, p=0.08), symptom duration (7.9 vs 7.2 months, p=0.23), presence of erosions (24% vs 23%, p=0.99) and gender distribution (82% vs 63%, p=0.06), compared to seropositive patients (n=103). However, parameters of disease activity were higher in seronegative patients at screening: DAS28CRP (5.1 vs 4.5, p=0.01), 28 swollen joint count (8.2 vs 5.7, p=0.02) and 28 tender joint count (10.3 vs 6.9, p=0.006). These results were corroborated when analysing the entire CareRA cohort. The mean disease activity was significantly higher in seronegative patients at the first stages (week 8 and 16), but became comparable by year 1 and 2 (Table 1). There was a significant difference in time to first treatment response between seronegative and seropositive patients, despite being treated with the same strategy, as depicted in the inverted Kaplan Meier plot (Figure 1). Conclusion In conclusion, CareRA participants with seronegative RA had a higher initial disease activity, longer time to experience a first treatment response, but achieve comparable remission status as seropositive patients with COBRA Slim, a combination of MTX with moderate dose GC bridging. This provides further evidence that, seronegative RA can no longer be considered a milder form of disease and requires an equally intensive initial treat-to-target therapy as seropositive RA. Disclosure of Interests Sofia Pazmino: None declared, Annelies Boonen: None declared, Veerle Stouten: None declared, Diederik De Cock: None declared, Delphine Bertrand: None declared, Kristien Van der Elst: None declared, Johan Joly: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Increasing emphasis has been placed on the concept of multi-morbidity or the coexistence of two or more chronic diseases in adult patients with rheumatic conditions. A few years ago a EULAR initiative raised some points to consider for management of comorbidities, such as cardiovascular diseases and depression, in chronic inflammatory rheumatic diseases in daily practice (1). Nevertheless, improved management of comorbidities, including prevention, remains a commonly identified unmet need in rheumatology (2). Multi-morbidity can be quite challenging to manage, while the perspective of the individuals having to cope with multiple chronic diseases could differ from that of health professionals taking care of them. Awareness and regular assessment are key, as well as a collaboration between health professionals and well-informed patients. This lecture aims to provide practical information about how to manage more than the rheumatic disease as such, focussing as well on topics of specific interest to young people. References: [1] Baillet, et al. Points to consider for reporting, screening for and preventing selected comorbidities in chronic inflammatory rheumatic diseases in daily practice: a EULAR initiative. Ann Rheum Dis. 2016 [2] Winthrop, et al. Unmet need in rheumatology: reports from the Targeted Therapies meeting 2018. Ann Rheum Dis. 2019 Disclosure of Interests: None declared

Background Systemic sclerosis (SSc) is a severe autoimmune disease and fibrotic cutaneous involvement of hands and face is a typical characteristic. Oral involvement with reduced oral aperture is frequent and associated with impaired food intake, oral hygiene and secondary dental problems. Several studies have shown that stretching (placing the thumbs in opposite corners of the mouth hand, pulling outward) and oral augmentation (tongue depressors between the back molars) exercises can increase oral aperture but is often hampered by low adherence rates. Objectives The aim of this descriptive explorative mixed method study was to explore feasibility, patient satisfaction and effectiveness of two exercise programs, Therabite and orofacial exercises, in systemic sclerosis associated microstomia. Methods We included adult patients suffering from systemic sclerosis (fulfilling the ACR/EULAR 2013 criteria) and microstomia (maximal oral aperture Results We included 6 women and 3 men, with a median age of 60 years (range 40-75) and a median disease duration of 8 years (range 3-22). At time point 6 months, all patients in group A (n=4) and 4 patients in group B (n=5) improved with a median of 9mm (range 2-10) and 7mm (range 4-11), respectively. One patient had a decrease of 2mm. The compliance, measured as the ratio of executed exercises relative to the planned number of exercises ranged between 63.7% and 98,9% in group A and between 48.5% and 97,4% in group B. Details are shown in Table 1. In the follow-up period, we documented maintenance of the observed increase in oral aperture in those patients that continued exercising daily. In all others, maximal oral aperture declined again. All 9 patients attended the interview. Three main themes emerged from the data: drivers, challenges and perceived improvement. Patients highlighted several drivers to perform the exercises at home, such as the motivation to improve current disability cause by microstomia. Furthermore, they equally highlighted several challenges regarding feasibility, such as the struggle to exercise multiple times a day. Most of the patients were hoping that they could keep their improvement. They were willing to continue practicing if necessary, but with a lower frequency. Conclusion This study suggests that both types of intervention can improve maximal oral aperture. The adherence to therapy was higher than expected but none of the patients considered it feasible to continue practicing 3 times/day in the long-term resulting in a decline of improvement post intervention. This is the first study to report the feasibility of the exercises for the patients and can be very useful for health professionals giving guidance. Future studies are needed in order to define exercise programs that are feasible and can be sustained in the long term. Disclosure of Interests Ellinor Sydow: None declared, Sabien Severi: None declared, Kristien Van der Elst: None declared, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research, Jan Lenaerts: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Ellen De Langhe: None declared

Background Patients with autoimmune inflammatory rheumatic diseases (AIIRD) have an increased risk for acquiring infections. Vaccines were developed to diminish the prevalence of vaccine-preventable infections. The EULAR recommendations for vaccination in adult patients with AIIRD emphasise the importance of assessing the vaccination status of patients with AIIRD. Objectives To determine the vaccination status of patients with AIIRD, the reason for non-vaccination and the proportion of patients that are vaccinated according to the EULAR recommendations. Methods The single-centre cross-sectional COLOSSeUM study was conducted in a tertiary referral centre. Between August and December 2018, all consecutive patients with AIIRD including Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Juvenile Idiopathic Arthritis (JIA) who visited the outpatient clinic were included. The vaccination status (influenza winter season 2017-2018, pneumococcal, tetanus toxoid and hepatitis B vaccine) and history of varicella zoster virus infection was determined using a one-page questionnaire which was completed by the treating rheumatologist after discussion with the patient. The patients’ reason for non-vaccination was registered if applicable. Patients were classified as vaccinated according to the EULAR recommendations if they had a yearly influenza, an every-five-year pneumococcal and a decennial tetanus toxoid vaccine, the latter as recommended in the general population. Results The vaccination status of 633 consecutive patients was obtained. The group consisted of 489 (77.2%) patients with RA, 73 (11.5%) patients with PsA, 58 (9.2%) patients with AS and 13 (2.1%) patients with JIA with a mean ± standard deviation age of 59.8 ± 13.6, 55.8 ± 13.5, 45.2 ± 14.0 and 35.0 ± 13.9 respectively. Of all included patients with AIIRD, 69.2% were vaccinated for influenza, followed by vaccination rates of 55.0%, 32.1% and 30.5% for tetanus toxoid, pneumococcal and hepatitis B vaccination, respectively (Table 1). In addition, 70.6% of patients with AIIRD had a history of varicella zoster virus infection. Various reasons for non-vaccination were reported, of which ‘No specific reason’ was the most common, closely followed by non-awareness of the need for pneumococcal vaccination. The compliance with EULAR recommendations was 18.5%. Of the 429 patients with AIIRD not vaccinated according to the EULAR recommendations, 68 (15.9%) patients were not compliant with all three of the vaccines, 136 (31.7%) were not compliant with 2 vaccines (1: pneumococcal and 2: influenza or tetanus toxoid vaccine), 148 (34.5%) were not compliant with 1 vaccine (103 pneumococcal, 41 tetanus toxoid and 4 influenza vaccine) and 77 (17.9%) patients were unaware of their vaccination status for at least 1 vaccine. Conclusion In our patients with AIIRD, the highest vaccination rate for recommended vaccines was observed for influenza (nearly 70%). Not being vaccinated for pneumococcus was the main reason why patients did not comply with the EULAR recommendations. More attention is needed to determine and optimise the vaccination status of AIIRD patients and to increase the awareness regarding the pneumococcal vaccine. Disclosure of Interests: Delphine Bertrand: None declared, Sofie Coenen: None declared, Sofia Pazmino: None declared, Veerle Stouten: None declared, Diederik De Cock: None declared, Kristien Van der Elst: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Marc Ferrante Grant/research support from: Janssen, Pfizer, Takeda, Consultant for: Abbvie, Boehringer-Ingelheim, Ferring, Janssen, Mitsubishi Tanabe, Takeda, MSD, Pfizer, Speakers bureau: Abbvie, Boehringer-Ingelheim, Chiesi, Ferring, Janssen, Lamepro, Mitsubishi Tanabe, MSD, Pfizer, Takeda, Tramedico, Tillotts, Zeria, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research DOI: 10.1136/annrheumdis-2019-eular.3060

Background: Management and support by an interdisciplinary rheumatology team are essential for achieving optimal disease outcomes in rheumatoid arthritis (RA). Nevertheless, health professionals generally do not experience the disease themselves, and patients may have specific educational needs that can only be provided by other patients having gone through the same experience. Furthermore, patients with RA may benefit most from such additional care interventions in the early disease stage when they are particularly faced with threats to their normal life. Peer mentoring has been studied and successfully implemented in other chronic conditions, however, this is rather a new care concept in the field of rheumatology. Objectives: Among four key stakeholders in the management of early RA, we aimed (1) to uncover the current experience with, need for and attitude towards implementing peer mentoring in the care for patients with early RA in Flanders; (2) to gather ideas for the content and format of a peer mentor program. Methods: We conducted an explorative qualitative focus group study. In total, five focus groups were organized to capture the perspective of each of the following stakeholders: patients with early RA (n=10), representatives of patient organizations (n=5), rheumatologists (n=10) and rheumatology nurses (n=5). Data were analyzed using the constant comparison method as presented in the Qualitative Analysis Guide of Leuven. Two patient research partners helped to analyze and interpret the data. Results: Most stakeholders perceived a potential need for peer mentoring in early RA. However, they underscored that this would be largely person and disease phase dependent suggesting that peer mentoring should be presented as an option to patients, rather than a standard of care. The additional value of peer mentors would be foremost situated in providing disease perspective and a sense of recognition to newly diagnosed patients. For some stakeholders, it was difficult to get a clear picture of such a program, which made it difficult for them to formulate an opinion on a specific format. The health professionals particularly mentioned the current lack of a formal framework for collaborating with patient experts, and the need for carefully selected and well-trained peer mentors. Stakeholders shared the view that the development of a peer mentor program and its integration within the current care context should ideally take place in co-operation with and under supervision of health professionals. Conclusion: Our results underline that peer mentoring in early RA holds potential for certain patients under certain circumstances, yet a clear framework for all stakeholders is a prerequisite to ensure a chance for success of this complex intervention. Future research should thus focus on unfolding the facilitators and barriers of collaborating with patient experts in the daily care of patients with early rheumatoid arthritis. Acknowledgement: This work was supported by Fonds Wetenschappelijk Reuma Onderzoek (FWRO). Disclosure of Interests: Kristien Van der Elst: None declared, Lore Bangels: None declared, Lianne Peerlings: None declared, Lies De Caluwe: None declared, Ilse Langers: None declared, Veerle Stouten: None declared, Diederik De Cock: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background: Rheumatology care strives to identify and meet the needs of the patients, and to understand disease and treatment impact from the patients’ perspective. A better understanding of patien ...

Background Treating to a predefined target is a principle adopted in guidelines to treat rheumatoid arthritis (RA). It is currently the most efficient strategy to control disease activity, but its implementation in daily clinical practice remains challenging. Objectives To evaluate rheumatologists’ adherence to a treat-to-target (T2T) approach at a threshold of low disease activity (DAS28CRP≤3.2) in patients with early RA during the 2-year Care in early RA (CareRA) study. Methods CareRA is an investigator-initiated pragmatic multicentre trial, in which patients with early RA and naive to conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) were included (n=379). Participants were randomized to different remission induction schemes consisting of a csDMARD combination or methotrexate (MTX) monotherapy with and without a prednisone tapering down scheme. Following the T2T approach, specific treatment adaptations had to be performed in case of DAS28CRP>3.2 during the first study year, unless a predefined reason not to intensify treatment was provided. As first step, dose of MTX had to be increased from 15mg to 20mg weekly. As second step, dose of the other csDMARD was escalated in the combination arms and leflunomide was added in the MTX monotherapy arms. From week (w)52 onwards, further T2T was advised but type of treatment adaptation was left at the rheumatologists’ discretion. Adherence to this T2T approach was defined as performing a dose escalation or changing/adding DMARD medication in case of DAS28CRP>3.2 and was evaluated at every study visit during 2 years. Additionally, remission (DAS28CRP Results The proportion of patients with DAS28CRP>3.2 was 26% (93/365) at w8, but decreased to a stable average of 16% on the following visits and further diminished to 10% (30/303) at w104. The frequency of T2T adherence in these patients varied from 59% (55/93) at w8 to 17% (5/30) at w104 (Figure 1). The most frequent reason not to intensify treatment during the first study year was that rheumatologists considered the disease already well-controlled. This reason was reported in 50% of non-adherent cases at w8, in 15% at w16, 14% at w28, and 24% at w40. The second most frequently given reason for non-adherence during the first study year was that giving glucocorticoids or NSAIDs temporarily was preferred over changing DMARDs, as reported in 3% of cases at w8, 15% at w16, 27% at w28, and 35% at w40. T2T was applied at all visits in 41 out of 110 (37%) patients needing at least 1 adaptation during the 2-year trial. Of these 41 patients, 36 (88%) were in remission at w104, while of the 69 patients not always treated to the T2T principle, 40 (58%) were in remission at the end of the 2-year trial (p=0.001). Conclusion This study shows the difficulty of applying T2T strictly, both with and without a fixed protocol to follow. In less than half of patients theoretically in need of a treatment adaptation, treatment was intensified at all visits during the first 2 years of treatment. In the majority of cases rheumatologists gave as reason for overruling the T2T guidance that they estimated disease activity to be sufficiently controlled. However, patients in which the T2T principle was applied strictly, showed higher remission rates after 2 years of treatment. Disclosure of Interests Veerle Stouten: None declared, Diederik De Cock: None declared, Sofia Pazmino: None declared, Kristien Van der Elst: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research

Background In rheumatoid arthritis (RA), good disease control without major joint damage, loss of function or disability can be achieved. Still, a substantial number of patients report poor wellbeing. A better understanding is needed on why some patients still feel unwell despite good disease control. Specific attention to this mismatch, especially early in the disease, could help to further optimize the clinical course of new patients with RA. Objectives To identify and characterize patients with early RA treated optimally to current standards but reporting not feeling well after 1 year of treatment. Methods We included participants of the Care in early RA trial with an early and persistently favorable treatment response, defined as having a disease activity score (DAS28CRP) Results Analyses revealed 3 distinct clusters. Details are depicted in Table 1. Of 140 patients, 77.9% were assigned to the ‘concordant to disease activity’ cluster, 9.3% to the ‘dominant fatigue’ cluster and 12.9% to the ‘dominant pain and fatigue’ cluster. When comparing the concordant cluster with both discordant clusters, differences at BL and w16 were shown, with small effects on patients’ evaluation of their disease at year 1, such as more negative beliefs about the consequences of RA at w16 in patients reporting dominant pain and fatigue at year 1. Few differences with medium effects were identified, such as a moderately higher use of avoidance as a coping style at w16 and a stronger belief that symptoms can be explained by RA at w16, in patients reporting dominant fatigue at year 1 compared to patients in the concordant cluster. Large differences between patients in concordant and discordant clusters were found for pain and fatigue levels, which were already higher after 4 months of treatment for those patients reporting persistent pain and fatigue at year 1. Conclusion Three distinct groups of persistent responders with early RA were identified based on their 1-year PRO profile. The majority of patients were well-synchronized, reporting very low pain and fatigue levels in concordance with their well-controlled disease activity. One in 5 persistent responders, however, seemed to have unmet needs. In view of early identification of patients at risk of poor wellbeing despite good disease control, early pain and fatigue levels and certain coping behavior and illness perceptions were recognized as potential targets for future interventions. Disclosure of Interests Kristien Van der Elst: None declared, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research, Diederik De Cock: None declared, An De Groef: None declared, Veerle Stouten: None declared, Sofia Pazmino: None declared, Johanna Vriezekolk: None declared, Johan Joly: None declared, Philip Moons: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead DOI: 10.1136/annrheumdis-2019-eular.3629

Objective To unravel the perspective of patients with rheumatoid arthritis (RA) on preferred health and treatment outcomes at 2 time points during the early stage of their disease and treatment. Methods In a longitudinal, qualitative, explorative study, we individually interviewed 26 patients with early RA (ERA) 4–6 months after the start of initial RA treatment. Fourteen of these participants took part in 1 of 3 focus groups at least 1 year after treatment initiation. Interviews were audiotaped, transcribed verbatim, and analyzed using the constant comparison method. Two patient researchers completed the interdisciplinary research team. Results Patients with ERA ultimately strive to be normal again, literally and figuratively. Outcome preferences inherent to this urge for normality were related to aspects of disease control, physical aspects, aspects of participation, and mental aspects. Initially, patient outcome preferences in ERA were primarily related to pain relief, medication side effects and burden, and emotional well-being. Patient-preferred outcomes evolved over the ERA disease course, with subtle changes in terminology used by participants and with pain relief staying in the foreground. Conclusion From a patient perspective, normality is the ultimate outcome to target in ERA. Our study produced knowledge for designing more targeted therapeutic interventions aimed at normalizing patients’ health and life in all its aspects during a crucial phase of RA.

ObjectivesCombining disease-modifying antirheumatic drugs (DMARDs) with glucocorticoids (GCs) is an effective treatment strategy for early rheumatoid arthritis (ERA), yet the ideal schedule and feasibility in daily practice are debated. We evaluated different DMARD combinations and GC remission induction schemes in poor prognosis patients; and methotrexate (MTX) with or without GC remission induction in good prognosis patients, during the first treatment year.MethodsThe Care in ERA (CareRA) trial is a 2-year investigator-initiated randomised pragmatic open-label superiority trial comparing remission induction regimens in a treat-to-target approach. DMARD-inexperienced patients with ERA were stratified into a high-risk or low-risk group based upon presence of erosions, disease activity, rheumatoid factor and anticitrullinated protein antibodies. High-risk patients were randomised to a COBRA Classic (MTX + sulfasalazine + prednisone step-down from 60 mg), COBRA Slim (MTX + prednisone step-down from 30 mg) or COBRA Avant Garde (MTX + leflunomide + prednisone step-down from 30 mg) scheme. Low-risk patients were randomised to MTX tight step-up (MTX-TSU) or COBRA Slim. Primary outcome was the proportion of patients in 28 joint disease activity score calculated with C-reactive protein remission at week 52 in an intention-to-treat analysis. Secondary outcomes were safety and effectiveness (ClinicalTrial.gov identifier NCT01172639).Results98 COBRA Classic, 98 COBRA Slim (high risk), 93 COBRA Avant Garde, 47 MTX-TSU and 43 COBRA Slim (low risk) patients were evaluated. Remission was achieved in 64.3% (63/98) COBRA Classic, 60.2% (59/98) COBRA Slim (high risk) and 62.4% (58/93) COBRA Avant Garde patients at W52 (p=0.840); and in 57.4% (27/47) MTX-TSU and 67.4% (29/43) COBRA Slim (low risk) patients (p=0.329). Less adverse events occurred per patient with COBRA Slim (high risk) compared with COBRA Classic or COBRA Avant Garde (p=0.038). Adverse events were similar in MTX-TSU and COBRA Slim (low risk) patients (p=0.871). At W52, 76.0% patients were on DMARD monotherapy, 5.2% used GCs and 7.5% biologicals.ConclusionsMTX with a moderate-dose GC remission induction scheme (COBRA Slim) seems an effective, safe, low-cost and feasible initial treatment strategy for patients with ERA regardless of their prognostic profile, provided a treat-to-target approach is followed.Trial registration numbersEudraCT-number 2008-007225-39 and NCT01172639; Results.

Background: The World Health Organization defines health as ”a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. Health changes dramatica ...

Item does not contain fulltext The objectives of the study were to determine the relative importance of barriers related to the provision of intensive combination treatment strategies with glucocorticoids (ICTS-GCs) in early rheumatoid arthritis (ERA) from the rheumatologists' perspective and to explore the relation between rheumatologists' characteristics and importance scores. A maximum difference scaling (MDS) survey was administered to 66 rheumatologists in Flanders and the Brussels-Capital Region. The survey included 25 barriers, previously being discovered in a qualitative study. The survey included 25 choice sets, each of which contained a different set of four barriers. In each choice situation, respondents were asked to choose the most important barrier. The mean relative importance score (RIS) for each barrier was calculated using hierarchical Bayes modeling. The potential relation between rheumatologists' characteristics and the RIS was examined using Spearman's correlation coefficient, Mann-Whitney U test, and Kruskal-Wallis H test. The three highest ranked barriers included "contraindicated for some patients (e.g., patients with comorbidities, older patients)," "an increased risk of side effects and related complications," and "patients' resistance" with a mean +/- SD RIS of 9.76 +/- 0.82, 8.50 +/- 1.17, and 7.45 +/- 1.22, respectively. Comparing the RISs based on rheumatologists' characteristics, a different ranking was found for three barriers depending on the age, university location, and/or frequency of prescribing ICTS-GCs. The dominant barriers hindering ICTS-GCs prescription from a rheumatologists' perspective are patient-related barriers and barriers related to the complexity of prescribing a combination therapy including GCs. A tailored improvement intervention is needed to overcome these barriers and should focus on the familiarity of rheumatologists with ICTS-GC and patient education.

Objective.To investigate sleep problems, and the relationship between sleep and disease activity, in Belgian patients with established rheumatoid arthritis (RA).Methods.This cross-sectional, observational, multicenter study assessed sleep quality using the Athens Insomnia Scale (AIS) and Pittsburgh Sleep Quality Index (PSQI), and daytime sleepiness using the Epworth Sleepiness Scale (ESS). Additional patient-reported outcomes included visual analog scales (VAS) for fatigue and pain, the Medical Outcomes Study Short Form-36 Health Survey, the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the Positive and Negative Affect Schedule. Multivariate regression and structural equation modeling identified factors associated with sleep quality, with the 28-joint Disease Activity Score [DAS28-C-reactive protein (CRP)] as a continuous or categorical variable. Analyses were performed on the total population and on patients stratified by disease activity status: remission/low (DAS28-CRP ≤ 3.2) or moderate to high (DAS28-CRP > 3.2).Results.Among 305 patients, mean (SD) age was 57.00 (12.38) years and mean (SD) disease duration was 11.77 (9.94) years. Mean (SD) AIS, PSQI, and ESS scores were 6.8 (4.79), 7.8 (4.30), and 7.3 (4.67), respectively. Mean (SD) VAS fatigue, VAS pain, and HAQ-DI were 45.22 (26.29), 39.04 (26.21), and 1.08 (0.75), respectively. There were significant positive relationships between DAS28-CRP and AIS/PSQI, but a significant negative relationship between DAS28-CRP and ESS. Several potentially confounding factors were identified.Conclusions.Poor control of RA is associated with a reduction in sleep quality and decreased daytime sleepiness, which is likely explained by pain-related alertness. Future prospective studies are needed to confirm potential relationships between sleep quality, sleepiness, and RA treatment.

Adolescents with juvenile idiopathic arthritis (JIA) are transferred from paediatrics to adult-oriented healthcare when they reach early adulthood. Research on the extent to which patients' expectations about the adult healthcare setting match their actual experience after transfer, may promote successful transfer from paediatrics to adult care. As part of the 'Don't Retard' project ( http://www.kuleuven.be/switch2/rheuma.html ), experiences and expectations of young adults regarding their transfer from paediatric rheumatology to adult rheumatology were explored. A qualitative study was conducted using semi-structured, in-depth interviews of 11 patients with JIA, aged 18 to 30. Data were analysed using procedures inherent to the content analysis approach. For both concepts, experiences and expectations, three main themes emerged: 'preparation', 'parental involvement' and an 'adapted setting for the late-adolescent or early adult'. The need for a gradual process covered the themes 'preparation' and 'parental involvement'. Young people with JIA prefer to have a say in the moment of transfer and in the reduction of parental involvement. The majority of the participants like their parents' presence at the first consultation at the adult rheumatology department. They expect a healthcare setting adapted to their needs and the possibility to meet peers in this setting. Sudden confrontation with older patients with severe rheumatoid arthritis at adult rheumatology was an unsettling experience for some of the young patients and they declared that better preparation is needed. This study enabled us to define three main themes important in transfer. These themes can facilitate healthcare professionals in developing specific interventions to prepare the young people to transfer, to regulate parental involvement and to arrange an adapted setting for them. Since we included patients who were in follow-up at one tertiary care centre, in which both paediatric and adult rheumatology care are located, the results of the study cannot be generalised to the entire population of patients with JIA.

BACKGROUND: General practitioners (GPs) may play a crucial role in early recognition, rapid referral and intensive treatment follow-up of patients with rheumatoid arthritis (RA). To improve early RA management, perceived barriers in general practice must be addressed. However, the general practice perspective on early RA management remains understudied. OBJECTIVE: To explore GPs' experiences, beliefs and attitudes regarding detection, referral, and intensive treatment for early RA. METHODS: In 2014, a qualitative study was conducted by means of individual, in depth, face-to-face interviews of a purposive sample of 13 Flemish GPs. Interviews were audio-recorded, transcribed verbatim and coded using the constant comparative method. RESULTS: GPs applied multiple assessment techniques for early RA detection and regularly prescribed non-steroidal anti-inflammatory drugs if they suspected early RA. However, GPs felt unconfident about their detection skills because early RA symptoms are often unclear, diagnostic tests could provide inconclusive results and the incidence is low in general practice. GPs mentioned various approaches and multiple factors determining their referral decision. Perceived referral barriers included limited availability of rheumatology services and long waiting times. GPs considered intensive treatment initiation to be the expertise of rheumatologists. Reported key barriers to intensive treatment included patients' resistance and non-adherence, lack of GP involvement and unsatisfactory collaboration with rheumatology services. CONCLUSION: GPs acknowledge the importance of an early and intensive treatment, but experience various barriers in the management of early RA. GPs should enhance their skills to detect early RA and should actively be involved in early RA care.

To unravel the perspective of patients with rheumatoid arthritis (RA) on preferred health and treatment outcomes at 2 time points during the early stage of their disease and treatment.In a longitudinal, qualitative, explorative study, we individually interviewed 26 patients with early RA (ERA) 4-6 months after the start of initial RA treatment. Fourteen of these participants took part in 1 of 3 focus groups at least 1 year after treatment initiation. Interviews were audiotaped, transcribed verbatim, and analyzed using the constant comparison method. Two patient researchers completed the interdisciplinary research team.Patients with ERA ultimately strive to be normal again, literally and figuratively. Outcome preferences inherent to this urge for normality were related to aspects of disease control, physical aspects, aspects of participation, and mental aspects. Initially, patient outcome preferences in ERA were primarily related to pain relief, medication side effects and burden, and emotional well-being. Patient-preferred outcomes evolved over the ERA disease course, with subtle changes in terminology used by participants and with pain relief staying in the foreground.From a patient perspective, normality is the ultimate outcome to target in ERA. Our study produced knowledge for designing more targeted therapeutic interventions aimed at normalizing patients' health and life in all its aspects during a crucial phase of RA.

Objectives To investigate patients’ experiences with intensive combination-treatment strategies with glucocorticoids (ICTS-GCs) in the early phase of early rheumatoid arthritis (ERA) treatment. Methods We interviewed 26 participants individually, 4–6 months after initiation of ICTS-GCs ( t 1 ). Fourteen participants from the same sample took part in one of three focus groups at least 1 year after treatment initiation ( t 2 ). Each interview was audio-recorded, literally transcribed and thematically coded. Results The participants described concerns and feelings about ICTS-GCs that changed over time; for example, a fear of side effects diminished when the treatment effects were beneficial or expected side effects did not materialize. Moreover, participants indicated additional information needs at t 1 and t 2 . The most used sources of information were healthcare professionals, relatives, and the Internet. Furthermore, participants reported on their relationship with healthcare professionals and the need for trust and reassurance, especially at t 1 . Lastly, participants described their personal self-management strategies. Conclusion Despite their concerns at treatment initiation, most participants had positive experiences with ICTS-GCs. Practice implications Healthcare professionals should be aware that, in the early phase of treatment, they can address patients’ concerns, they are the most important information source, they need to create a relationship of trust, and guide patients in self-management strategies.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune condition traditionally viewed as a severe destructive disease affecting physical health and global wellbeing. The treatment strategies for RA have changed in the last decades from mainly symptomatic towards a more vigorous and targeted approach. AREA COVERED: Reviewing recent literature enhanced by own expertise and research, a case is made for starting early with an intensive combination treatment with glucocorticoids, followed by a treat to target approach in a tight control setting. Implementation issues that need to be addressed to make optimal use of the 'window of opportunity' are highlighted. EXPERT OPINION: There is strong evidence in favor of traditional synthetic disease-modifying anti-rheumatic drugs (DMARDs) combined with a remission induction scheme of glucocorticoids to achieve adequate efficacy in controlling early rheumatoid arthritis with good safety and feasibility in daily clinical practice. Furthermore, the most optimal RA treatment should address not only the physician-oriented clinical disease outcomes but also the patient perspective. There is still a need for working on improving implementation of this approach in daily practice in order to provide optimal treatment benefit to more patients.

Objective To investigate the clinical impact of a brief transition programme for young people with JIA. Methods The Devices for Optimization of Transfer and Transition of Adolescents with Rheumatic Disorders (DON'T RETARD) project is a mixed method project in which we first conducted a quasi-experimental study employing a one-group pre-test-post-test with a non-equivalent post-test-only comparison group design. In this quantitative study, we investigated clinical outcomes in patients with JIA and their parents who participated in the transition programme (longitudinal analyses). The post-test scores of this intervention group were compared with those of patients who received usual care (comparative analyses). Second, a qualitative study was conducted to explore the experiences of adolescents with JIA and their parents regarding their participation in the transition programme. Results The primary hypothesis of improved physical (effect size 0.11), psychosocial (effect size 0.46) and rheumatic-specific health status (effect size ranging from 0.21 to 0.33), was confirmed. With respect to the secondary outcomes, improved quality of life (effect size 0.51) and an optimized parenting climate (effect size ranging from 0.21 to 0.28) were observed. No effect was measured in medication adherence (odds ratio 1.46). Conclusion Implementation of a transition programme as a brief intervention can improve the perceived health and quality of life of adolescents with JIA during the transition process, as well as the parenting behaviours of their parents. Based on the present study, a randomized controlled trial can be designed to evaluate the effectiveness of the transition programme.

Background In the assessment of patients with rheumatoid arthritis (RA) it is important to measure fatigue. The National Institutes of Health9s Patient-Reported Outcomes Measurement Information System (PROMIS) initiative developed an item bank for measuring fatigue. This item bank was translated into Dutch-Flemish language according to the FACIT methodology. Objectives The aim of current study was to validate the Dutch-Flemish translation of the PROMIS Fatigue item bank (DF-PROMIS-Fatigue) in Dutch and Flemish RA patients. This is the first validation study of the PROMIS Fatigue item bank in RA patients. Methods 2030 RA patients (1370 Dutch and 660 Flemish RA patients) completed a paper-and-pencil or web-based survey, including the full DF-PROMIS-Fatigue (95 items, 5-point Likert scale). One-factor confirmatory factor analysis assessed unidimensionality. Item response theory (IRT) models evaluated the item characteristics of the item bank, to facilitate future development of a computer adaptive test (CAT). A graded item response model (GRM) was fitted and construct validity was studied. Ordinal regression models evaluated Differential Item Functioning (DIF) for e.g. language (Dutch-Flemish vs. English and Dutch vs. Flemish), to analyse cross-cultural validity. Results The analyses support unidimensionality of the DF-PROMIS-Fatigue (CFI=0.996 and TLI=0.996). Only 45 out of 4465 (1%) item pairs were marked as possibly locally dependent. The data of the item bank fit the GRM, and showed good coverage across the fatigue continuum (threshold-parameters ranged from -3.8 to 5.8). The item bank showed good cross-cultural validity: none of the DF-PROMIS-Fatigue items showed DIF between Dutch and Flemish language. Furthermore, the item bank showed good reliability (Cronbach9s alpha=0.993). Analyses of construct validity are in progress and will be presented at the conference. Conclusions The results indicate that the items of the DF-PROMIS-Fatigue fit a GRM. The DF-PROMIS-Fatigue can be used to develop a CAT for measuring fatigue in Dutch and Flemish RA patients. Disclosure of Interest None declared

Objectives: To describe (1) the content of a transition programme for young people with juvenile idiopathic arthritis (JIA) designed as a brief intervention, (2) the rationale and design of a mixed-methods study evaluating the clinical impact of this transition programme and (3) to provide baseline data of the intervention group. Design: An 'embedded experimental' design is used for the evaluation of the transition programme. A 'one-group pretest-posttest, with a non-equivalent posttest-only comparison group design' is used to quantitatively evaluate the impact of the transition programme, applying both longitudinal and comparative analyses. Subsequently, experiences of adolescents and their parents who participated in the experimental group will be analysed qualitatively using content analysis. Setting: Participants in the intervention are recruited at a tertiary care centre in Belgium. The comparison group participants are recruited from one tertiary and three secondary care centres in Belgium. Participants: The intervention group consists of 33 young people (25 females; 8 males) with a median age of 16 years. Main diagnoses are persistent or extended oligoarticular JIA (33%), polyarticular JIA (30%), enthesitis-related JIA (21%) or systemic arthritis (15%). Intervention: The transition programme comprises eight key components: (1) transition coordinator; (2) providing information and education; (3) availability by telephone; (4) information about and contact with an adult care programme; (5) guidance of parents; (6) meeting with peers; (7) transfer plan; and (8) actual transfer to adult care. Primary and secondary outcomes: The primary outcome is health status, as perceived by the adolescents. Secondary outcomes are health status, as perceived by the parents; medication adherence; illness-related knowledge; quality of life; fatigue; promotion of independence; support of autonomy; behavioural control and psychological control. Results: At baseline, the median score was 69.2 (Q1=60.0; Q3=92.9) on psychosocial health and 68.8 (Q1=56.3; Q3=89.1) on physical health. Rheumatic-specific health scores ranged from 62.5 to 100. Conclusions: We present the rationale and design of a study intended to evaluate a transition programme for adolescents with JIA as a brief intervention.

Background The current recommendations for early Rheumatoid Arthritis (eRA) management focus on achieving clinical remission as soon as possible with an early and intensive treatment. Understanding patients’ experiences and ideas regarding their treatment could make healthcare professionals (HPs) more aware of and timely responsive to patients’ preferences, which might result in a better treatment adherence, an improved health status and higher satisfaction with care.