Wijnanda Hoogland

The patient perspective on remission in rheumatoid arthritis: ‘You've got limits, but you're back to being you again’

OBJECTIVES The aim of rheumatoid arthritis (RA) treatment is remission. As treatment should be targeted at outcomes relevant to patients, it is important to understand how patients perceive remission, and to assess whether the current definition of remission adequately reflects these perceptions. The objective of this study is to explore the patient perspective on remission in RA. METHODS Nine focus-group discussions in Austria, The Netherlands and UK were conducted, including patients in American College of Rheumatology (ACR)/ European League of Rheumatology (EULAR) remission, self-declared remission and in moderate/high disease activity. Moderators employed a prespecified interview guide helped to engage patients in a discussion on their experience with remission. Inductive thematic analysis was performed within each country, and identified themes were discussed across countries. RESULTS 47 RA patients (66% women, disease duration 9 years) participated. Three major themes of patient-perceived remission emerged: (1) symptoms would either be absent or strongly reduced, (2) impact of the disease on daily life would diminish by increased independence, ability to do valued activities, improved mood and ability to cope; (3) leading to a return to normality, including work, family role and perception of others. Patients felt the concept of remission was influenced by ageing, side effects of medication, comorbidities, accrued damage to joints and disease duration. Opinions on duration of state, the role of medication and measurement instruments varied widely. CONCLUSIONS Patients characterise remission by the absence or reduction of symptoms, but more directly by decreased daily impact of their condition and the feeling of a return to normality. The next step is to study whether an additional patient-perceived measure of remission may add value to the ACR/EULAR definition of remission.

Symptom complexes in patients with seropositive arthralgia and in patients newly diagnosed with rheumatoid arthritis: a qualitative exploration of symptom development

OBJECTIVE The aim of this study was to explore symptoms and symptom development during the earliest phases of RA in patients with seropositive arthralgia and patients newly diagnosed with RA. METHODS Interviews were conducted with 15 seropositive patients (anti-CCP positive, and often with arthralgia) and 11 newly presenting RA patients [classified according to the 2010 ACR/European League Against Rheumatism (EULAR) criteria]. Feedback procedures shared the experiences of seropositive arthralgia patients with early RA patients and vice versa. Data were analysed using thematic analysis. RESULTS Symptoms common to both groups included joint pain, psychological distress, muscle cramps, abnormal skin sensations, stiffness, loss of motor control, weakness, fatigue and sleeping difficulties. Also, patterns of symptom evolution and the order of symptom development were described. Seropositive arthralgia patients described pain as annoying, while RA patients described how the severity of pain intensified before diagnosis, to the point where symptoms were psychologically distressing. Patients with seropositive arthralgia described reddening of the skin and burning sensations that they felt were indicative of the onset of swelling. Intense pain appeared to precede the onset of swelling for those with RA, which was often palindromic and travelled between joints until it later became persistent. CONCLUSION This study highlights the breadth of symptoms that constitute the earliest phases of RA. Further research is needed to develop measures of symptom patterns and clusters to allow the predictive utility of symptoms to be assessed and to allow the integration of aspects of the patients history into evidence-based investigative and management algorithms for use in primary and secondary care.

Patient Perspective on Remission in Rheumatoid Arthritis

Absence of disease activity, or remission, is the most important treatment goal for patients with rheumatoid arthritis (RA). Since a new preliminary definition of remission in RA for clinical trials has been proposed, we investigated what determinants of disease activity patients associate with a state of remission and whether dimensions of impact of disease on daily life are involved. Our report summarizes progress of a workshop at OMERACT 10 on the patient perspective on remission in RA, including the results of a short pre-conference survey among patients, the discussions among the participants and a research agenda resulting from these discussions. This initial OMERACT workshop on remission from the patient perspective showed that there is a great interest among patients, physicians, and researchers to study the concept of remission, taking into account measures that patients indicate as important, but that there is a lack of data on appropriate measures, resulting in a considerable research agenda.

Remission in Rheumatoid Arthritis: Working Toward Incorporation of the Patient Perspective at OMERACT 12

Objective. The treatment of rheumatoid arthritis (RA) should target patient-relevant outcomes, making patient perspective on remission essential. In 2010, patients, physicians, health professionals, and researchers at the Outcome Measures in Rheumatology (OMERACT) conference developed an ambitious research agenda to study the concept of remission. Qualitative research has since helped us understand the concept of remission from the patient perspective. Methods. During OMERACT 12, the OMERACT working group on patient perspective on remission in RA elaborated on data generated to date and discussed the methodological challenges ahead. Challenges included (1) selection of domains, (2) choice of a patient remission definition or a single domain to add to the current remission definition, and (3) the importance of pain in defining remission from a patient perspective. Results. Focus in the coming years will be on increasing our understanding by identifying the most important domains from the patient perspective regarding remission and investigating how these domains can be measured. Investigation into the Rheumatoid Arthritis Impact of Disease questionnaire, disease flare, as well as the concordance of domains from our ongoing remission survey is appropriate. More data and further discussions are needed to decide on the next steps. Conclusion. Progress summarized over 4 years highlights the main methodological challenges discussed within the working group on patient perspective on remission in RA during OMERACT 12.

Impact of Symptoms on Daily Life in People at Risk of Rheumatoid Arthritis

Objectives: To explore the impact on daily life of symptoms experienced by those with systemic autoimmunity associated with rheumatoid arthritis (RA). Methods: Fifteen people took part in focus groups to explore the impact of symptoms on daily life. Results: Core themes included: 1) physical impact of limited hand function and mobility; 2) psychological distress experienced included a fear of symptoms progressing into RA, uncertainty about the future, feelings of despair, shame and frustration. Conclusion: People with arthralgia at risk of developing RA experienced considerable physical and psychological impact of symptoms. Greater consideration should be given to the needs of people at risk of developing RA.

Validating Rheumatoid Arthritis Remission Using the Patients’ Perspective: Results from a Special Interest Group at OMERACT 2016

Objective. The Outcome Measures in Rheumatology (OMERACT) working group on the patients’ perspective on remission in rheumatoid arthritis (RA) has been working on this topic since 2010. At OMERACT 2016, progress and preliminary data on validity of measurement instruments for pain, fatigue, and independence in remission in RA were presented, and future directions were explored. Methods. A special interest group was organized, in which the current data on the patients’ perspective on remission were presented. The ongoing study that aimed to validate measurement instruments for pain, fatigue, and independence in a state of low disease activity or remission was presented, and preliminary data on construct validity and discriminative capacity were evaluated cross-sectionally. Results. At OMERACT 2016, the progress of the working group and preliminary data from 142 of the anticipated 300 patients were presented. Selected instruments significantly correlated with the Disease Activity Score in 28 joints (construct validity) and all instruments except 1 discriminated between patients in and patients not in remission. The subsequent discussion mainly focused around 3 points: (1) the formulation of patient perceived remission, (2) the duration of remission, and (3) the measurement of the domain independence. An informal vote indicated a slight preference for working toward modifying the current remission criteria by adding patient-reported outcomes (PRO), or by substituting the patient’s global assessment with 1 or more PRO. Conclusion. More evidence on measuring patients’ perspective on remission in RA is needed before an informed decision can be made regarding development or modification of remission definitions.

Initial validation and results of the Symptoms in Persons At Risk of Rheumatoid Arthritis (SPARRA) questionnaire: a EULAR project

Objectives To describe the development and assess the psychometric properties of the novel ‘Symptoms in Persons At Risk of Rheumatoid Arthritis’ (SPARRA) questionnaire in individuals at risk of rheumatoid arthritis (RA) and to quantify their symptoms. Methods The questionnaire items were derived from a qualitative study in patients with seropositive arthralgia. The questionnaire was administered to 219 individuals at risk of RA on the basis of symptoms or autoantibody positivity: 74% rheumatoid factor and/or anticitrullinated protein antibodies positive, 26% seronegative. Validity, reliability and responsiveness were assessed. Eighteen first degree relatives (FDR) of patients with RA were used for comparison. Results Face and content validity were high. The test-retest showed good agreement and reliability (1 week and 6 months). Overall, construct validity was low to moderate, with higher values for concurrent validity, suggesting that some questions reflect symptom content not captured with regular Visual Analogue Scale pain/well-being. Responsiveness was low (small subgroup). Finally, the burden of symptoms in both seronegative and seropositive at risk individuals was high, with pain, stiffness and fatigue being the most common ones with a major impact on daily functioning. The FDR cohort (mostly healthy individuals) showed a lower burden of symptoms; however, the distribution of symptoms was similar. Conclusions The SPARRA questionnaire has good psychometric properties and can add information to currently available clinical measures in individuals at risk of RA. The studied group had a high burden and impact of symptoms. Future studies should evaluate whether SPARRA data can improve the prediction of RA in at risk individuals.

FRI0529 Initial Validation of The Symptoms in Persons at Risk of Rheumatoid Arthritis (SPARRA) Questionnaire

Background A range of clinical symptoms can be present in people at risk of rheumatoid arthritis (RA). However, information on location, timing, severity and predictive value of symptoms is still largely lacking. The Symptoms in Persons At Risk of Rheumatoid Arthritis (SPARRA) questionnaire has been developed with support of EULAR to provide more insight into these symptoms1,2. Objectives To validate the SPARRA questionnaire in an international group of arthralgia patients at risk of RA. Methods Questions on presence, severity, impact and location of 13 symptoms were derived from a qualitative study in seropositive arthralgia patients1. The items are: joint pain or swelling, joint stiffness, burning and tingling sensations, numbness, change in skin colour, muscle cramps, weakness, fatigue, emotional distress, concentration difficulties and sleep problems. Answers are given on an ordinal scale. The number of days with a symptom per month (0, 1–5, 6–15, 16–30 days), severity (none, mild, moderate and severe) and influence on daily activities (no, small, moderate or high impact) were recorded. Finally, patients were asked to describe the pattern of symptom development over time. For this initial analysis of validity, patients were selected from the Dutch arthralgia cohort. We first administered the questionnaire to 30 patients to ask for ambiguities. Thereafter, 46 patients did a test-retest within one week to assess intra-rater agreement using the % agreement and the kappa score. Results Feedback on the questionnaire was received from 5/30 patients. There were only minor comments that did not lead to adaptations, such as difficulty distinguishing pain from stiffness (n=1) and difficulty describing muscle cramps (n=1). 46 arthralgia patients were assessed at 2 time points. The rater agreement was moderate to good for most items with kappas of 0.42 to 0.93. We also found acceptable percentages of agreement of 65 to 91 (Table 1). Only tingling sensations and numbness scored low in agreement, with kappas of 0.37 and 0.15, respectively. The kappas were good across the presence, severity and impact of the item categories. Data on clinical variables and follow-up questionnaires to assess the construct and criterion validity will be presented at the congress.Table 1. Test-retest analysis of the SPARRA questionnaire (N=46) Items % agreement1 Prevalence of the complaint2 Joint pain 78% 83% Joint swelling 91% 37% Joint stiffness 76% 74% Burning sensations 78% 33% Tingling sensations 65% 43% Numbness 74% 30% Change in skin colour 87% 20% Muscle cramps 78% 28% Weakness or loss of strength 83% 54% Fatigue 87% 72% Emotional distress 83% 37% Concentration difficulties 83% 33% Sleep problems 83% 57% 1Retest analysis per item of duration of the complaint during the past month (0, 1–5, 6–15 or 16–30 days). 2Percentage of patients that had the complaint at least 1 day in the past month in the first questionnaire. Conclusions The SPARRA questionnaire seems to be a reliable scale for evaluating symptoms in persons at risk for RA. More follow-up and data from collaborating centers within Europe is necessary for assessment of the construct, criterion and external validity. References Stack, Rheumatology 2014; van Tuyl, Musculoskel Care 2015 Disclosure of Interest None declared