BackgroundThe advances in paediatric rheumatology management have mandated a drastic change in the way children with juvenile arthritis are assessed and monitored. As a consequence, there has been a call for new outcome measures that reflect a more holistic approach to day to day standard management. Such an emphasis reflects contemporary views about the relation between mind and body, and acknowledges the critical link between physical and psychological health as well as adherence to therapy amongst the children living with inflammatory arthritis.ObjectivesTo assess validity; reliability and responsiveness to change of an illustrated child/parent Multidimensional Patient Reported Outcome Measures questionnaire which can assess construct outcome measures of children with juvenile inflammatory arthritis.Methods106 children with juvenile inflammatory arthritis were included in this work in a multicentre study. The questionnaire was developed by integrating information obtained from children living with JIA as well as their parents. The questionnaire included 5 main categories which are patient-centred: Health related quality of life: functional ability (children health assessment questionnaire) and quality of life (10-items reflecting psychological, social, school and behavioural issues as well as the patient’s own perception). 2. Disease activity measure: pain intensity, the child’s overall well-being, measure of fatigue and morning stiffness using (0–10 numerical visual analogue scale), 3. self-reported joint tenderness and swelling. 4. Current medication, side effects as well as adherence to therapy (2 questions using 0–10 numerical visual analogue scale); 4. Comorbidities as well as 5. Patient motivation. All the items were supported by illustrations to explain the question and make it easier to understand. The questionnaire has parent and patient versions. The disease activity status was assessed using JADAS-27.ResultsThe questionnaire was reliable as demonstrated by a high-standardised alpha (0.890–0.978). The questionnaire items correlated significantly (p<0.01) with clinical parameters of disease activity. The patient reported tender joints correlated significantly with the physician’s scores (0.842). Changes in functional disability, quality of life as well as the motivation score showed significant variation (p<0.01) with diseases activity status in response to therapy. The illustrated PROMs questionnaire showed also a high degree of comprehensibility (9.6).ConclusionsIntegrating patient reported outcome measures into standard clinical practice is feasible and applicable. This version of illustrated multidimensional questionnaire was found to be valid and reliable. It provides informative quantitative measure for the disease activity core set data, and in the meantime, facilitates assessing the children’s health related quality of life measure, adherence to therapy, comorbidities as well as motivation on individual basis.Disclosure of InterestNone declared
BackgroundGlucocorticoid-induced tumor necrosis factor receptor related protein (GITR) is a member of the tumor necrosis factor receptor superfamily that is activated by its specific ligand (GITRL). GITR is mainly expressed in immature and mature T cells especially regulatory (Treg) cells (CD4+ CD25+) and effector T cells (CD25–) [1]. GITRL is mainly expressed in endothelial cells, dendritic cells, macrophages and B cells but not in T cells. GITR-GITRL system is known to have important regulatory role on inflammatory response and immune reactivity.ObjectivesThis study aimed to measure serum and synovial fluid (SF) levels of GITRL in patients with recent onset rheumatoid arthritis (RA) before and after initiation of therapy and to evaluate the relationship between GITRL and RA clinical and laboratory characteristics, disease activity and response to therapy.MethodsWe measured GITRL in the serum (n=48) and SF samples (n=21) from 48 recent onset RA patients and in the serum from 20 healthy control (n=20) at baseline and 6 months after initiation therapy with non-biological disease modifying anti-rheumatic drugs (DMARDS). In the patients Disease activity was calculated by the 28 joint counts (DAS28) and musculoskeletal ultrasound examination (MSUS) was performed at baseline and after 6 months using a 12-joint score (bilateral elbow, wrist, 2nd metacarpophalangeal (MCP), 3rd MCP, knee, ankle) [2]; immunoglobulin-M rheumatoid factor (IgM-RF) titre, anti-cyclic citrullinated peptide (anti-CCP) antibodies titre and C-reactive protein (CRP) levels were measured and the health assessment questionnaire (HAQ) score were recorded.ResultsSerum and SF GITRL levels were highly significantly increased in RA (39.38±16.78 ng/mL and 30.6±16.79 ng/mL respectively) compared to serum level in the healthy controls (10.3±5.46 ng/mL) (p<0.001). In RA patients, baseline serum and SF levels of GITRL significantly correlated with DAS28 (r=0.52 and 0.56 respectively, p<0.05), anti-CCP titres (r=0.46 and 0.51 respectively, p<0.05), grey scale (GS) (r=0.5 and 0.52 respectively, p<0.05) and power Doppler (PD) (r=0.65 and 0.68 respectively, p<0.001) synovitis scores. Also, serum and SF levels of GITRL at 6 months follow up significantly correlated with the DAS28 (r=0.42 and 0.48 respectively, p<0.05), GS score (r=0.46 and 0.51 respectively, p<0.05), PD signal (r=0.43 and 0.45 respectively, p<0.05). Logistic regression analysis showed that baseline serum levels of GITRL were predictive of follow up DAS 28 and PD synovitis score (p=0.009 and 0.03 respectively).ConclusionsRheumatoid arthritis patients have significantly increased serum and synovial levels of GITRL that remarkably correlated with the DAS28 and MSUS parameters of inflammations suggesting that it could be a useful marker to reflect RA disease activity. GITRL could be a useful biomarker to predict treatment outcome in RA patients.References Kim SH, Youn J. Rheumatoid Fibroblast-like Synoviocytes Downregulate Foxp3 Expression by Regulatory T Cells Via GITRL/GITR Interaction. Immune Netw. ...
BackgroundShared decision making (SDM) is an emerging trend in paediatrics. Currently available SDM interventions are mere information on the disease or medication and often fail to engage the children in the medical decision process. It has been suggested that future decision aids should consider developing separate more appropriate tools in order to better engage the children.ObjectivesTo develop, and evaluate an illustrated and interactive evidence-based SDM aid for children living with inflammatory arthritis, able to inform them about the pros and cons of their disease as well as the available treatment options, and help them to make an informed shared decision.MethodsA multidisciplinary team defined criteria for the SDM as to design, medical content and functionality, for children. Development was according to the international standard (IPDAS). Eight categories emerged as highly important for shared decision making: 1. What is arthritis; 2. Why do we treat arthritis; 3. What are my targets?; 4. What are the available treatment options?; 5. Progressometer/my chances of improvement; 6. How soon will the medications kick in and how to take them; 7. Potential side effects; 8. For how long shall I take the medication. Each category is supported by simple illustrations showing the state of the joint in the different scenarios whether the child take treatment or not, whereas at the end of each category the child is asked to make a decision in view of the information given. 94 children with juvenile idiopathic arthritis, evaluated the tool, in a randomised controlled study, in comparison to control group composed of 95 patients treated according to standard protocols.ResultsThe shared decision making aid was developed to offer information about the disease, the risks and benefits of treatment. 97.5% of the children included reported comprehensibility of >90/100. the progressometer helped the children identify the importance of taking treatment for their disease. The patients’ adherence to anti-rheumatic therapy was significantly (p<0.01) higher in the SDM group, whereas stopping DMARDs for intolerability was significantly (p<0.01) higher in the control group at 12 months of treatment. There was significant improvement in the functional ability as well as quality of life measures in the SDM group (p<0.01), whilst absence from school was significantly higher in the control group (p<0.01)ConclusionsThis Illustrated-interactive SDM aid for children living with idiopathic inflammatory arthritis was found to be a simple, user-friendly tool which can be implemented in standard clinical practice. The illustration and interactive style made it more attractive to the children. The developed SDM offered the children evidence-based information about the pros and cons of treatment options, improved their understanding of the disease, communication with their treating clinician as well as their ability to make an informed decision.Disclosure of InterestNone declared
BackgroundGiant Cell Arteritis (GCA) is the commonest form of systemic vasculitis in people over the age of 50. In 2017, the OMERACT Vasculitis Working Group published a core set of domains and outcome measures for use in clinical trials in large vessel vasculitis [1] and highlighted the lack of a disease-specific patient reported outcomes (PROMs) for GCA. The OMERACT group proposed a draft core set of domains for GCA, including disease specific domains, organ and arterial function, psychosocial impact and physical function biomarkers, fatigue, pain, as well as death.ObjectivesTo assess the validity, reliability and responsiveness to change of a patient self-reported questionnaire to assess for the construct outcome measures, co-morbidities and the impact of GCA and its treatment on health-related quality of life in GCA patients.MethodsThe PROMs-GCA was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the GCA specific physical and psychological symptoms, sense of self, symptoms severity using numerical visual analogue scale (0-10) in addition to assessment of functional disability, quality of life (QoL), review of the systems, glucocorticoids benefit:risks, comorbidities as well as motivation [2]. In addition, every patient completed HAQ and EQ-5D questionnaires.ResultsA total of 52 GCA patients completed the questionnaire. The PROMs-GCA questionnaire was reliable as demonstrated by a high standardized alpha (0.867-0.941). Content construct assessment of the PROMs-GCA/functional disability and QoL revealed significant correlation (p< 0.01) with both HAQ and EQ-5D. Changes in functional disability, QoL showed significant (p< 0.01) variation with diseases activity status in response to therapy.ConclusionThe developed PROMs-GCA questionnaire is a reliable and valid instrument for assessment of patients living with GCA. A phased treatment regimen depending on the severity of GCA as well as the patient’s preferences and comorbidities are the best approach to tailored patient management.References[1]Sreih AG, et al. Development of a core set of outcome measures for large-vessel vasculitis: report from OMERACT 2016. J Rheumatol. 2017;44(12):1933–7[2]El Miedany et al. Meaningful patient engagement in inflammatory arthritis: Development of the patient motivation questionnaire. Clin Rheumatol. 2017 doi: 10.1007/s10067-017-3605-x.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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