Original articleEvaluation of self-report questionnaires for assessing rheumatoid arthritis activity: A cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients
Introduction
The advances achieved over the last decade in the treatment of rheumatoid arthritis (RA) have radically changed the management of this disease, leading to more optimistic expectations regarding disease outcomes [1], [2]. Thus, the current treatment objective is a low disease activity state (LDAS) or remission obtained via tight control of disease activity. To achieve this objective, reliable evaluation tools are needed [3]. The recommended core set of variables for assessing RA activity in clinical trials is composed of the tender joint count (TJC), swollen joint count (SJC), pain and physical function scores determined by the patient, global assessment of disease activity by the patient and physician, and one acute-phase reactant [4], [5]. In practice, there is no reference standard for assessing the activity of RA. RA differs from other chronic diseases such as hypertension and diabetes in that no single parameter is available for assessing disease control [6], [7]. Composite indices have consequently been developed [3]. Among them, the Disease Activity Score 28 (DAS28) [8] is the most widely used and is considered the most specific measure of RA activity [9]. Nevertheless, use of the DAS28 is far from routine in clinical practice [10]. Other indices such as the Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) are less widely used than the DAS28 [11], [12].
A recent study done in France highlighted the major influence of patient opinions on treatment decisions [13]. Tools that collect patient-reported data play an important role in monitoring RA patients. These tools include questionnaires and scales that assess a broad spectrum of domains such as pain, overall disease status, fatigue, physical function, and quality of life [14]. The earliest self-report questionnaires measure function or quality of life. Their results correlate with activity parameters and indices and provide additional prognostic information [4], [15], [16]. However, these questionnaires take too long to complete to be of use for monitoring patients in everyday practice, as opposed to clinical trials. More recently, self-report questionnaires based on patient-reported outcomes (PROs) were developed. They are easier to complete. These self-report questionnaires provide scores based on three patient-reported variables, namely, physical function, pain intensity, and an overall assessment of the disease [17]. Thus, they allow a quantitative assessment of disease activity based on patient-reported data, without requiring routine joint counts [18], [19]. They are designed for monitoring patients in everyday clinical practice but cannot replace the clinical examination.
We used two self-report questionnaires on RA activity, the Routine Assessment of Patient Index Data (RAPID3) and the Rheumatoid Arthritis Disease Activity Index 5 (RADAI5). Both questionnaires are completed only by the patient, and neither requires joint counts. The RAPID3 and RADAI5 have been validated not only in clinical trials, but also in everyday practice in the US and in Austria [20], [21], [22], [23], [24]. The primary objective of this study was to confirm the validity of the RAPID3 and RADAI5 in a population of RA patients receiving follow-up at the rheumatology department of a teaching hospital in France. To achieve this objective, we compared the RAPID3 and RADAI5 scores to the values of widely used disease activity indices (DAS28, CDAI, and SDAI). Our secondary objective was to improve the definition of a disease flare. Current therapeutic objectives are not always achieved in everyday practice. Thus, the remission rate is 20% at best [25], [26]. A more realistic approach may consist in detecting activity peaks or flares, with the goal of rapidly adjusting the treatment. Although the OMERACT recently released a qualitative definition of the RA flare [27], there is currently no definition based on disease activity or its changes over time. The secondary objective of this study was to compare the opinions of the patients and physicians about the presence of a disease flare and to identify cutoffs for flare detection based on self-report questionnaire scores and disease activity indices.
Section snippets
Questionnaires and indices
RAPID3 is a PRO-based index that uses the three core set criteria evaluated by the patient, namely, physical function, pain, and the overall disease assessment [28]. Physical function is assessed for 10 activities, of which eight are the simplified activities in the modified Health Assessment Questionnaire (MHAQ) and two are complex activities. Each activity is scored from 0 to 3, and the sum of the scores (range, 0–30) is computed and divided by 10 to obtain a score that can range from 0 to
Patients
We studied 200 patients, of whom 151 (75.5%) were women. Mean age was 56.9 ± 11.5 years and mean disease duration was 12.8 ± 8.3 years. Rheumatoid factors were detected in 156 (78%) patients, ACPAs in 150 (75%) patients, and radiological erosions in 142 (71%) patients. Extraarticular manifestations of RA were noted in 50 (25%) patients. The treatment included a conventional disease-modifying antirheumatic drug (DMARD) in 154 (77%) patients, usually methotrexate (117 patients), and a biologic agent in
Discussion
Patient-reported parameters for assessing the activity of RA were first assessed by retrospective analyses of data from clinical trials. They were found to separate treated from placebo patients at least as well as physician-reported parameters, the DAS28, and the ACR response criteria [20], [30], [31], [32], [33]. Consequently, disease activity scores based on combinations of patient-reported parameters were developed, including the RAPID3 and RADAI5, which have been validated in everyday
Disclosure of interest
The authors declare that they have no conflicts of interest concerning this article.
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Cumulative patient-based disease activity monitoring in rheumatoid arthritis – predicts sustained remission, flare and treatment escalation
2020, Seminars in Arthritis and RheumatismCitation Excerpt :The definition of flare in this study was pragmatically taken as SDAI status shifting from remission or LDA to moderate or high activity, indicating there was a need to escalate DMARD to achieve treat-to-target. There were attempts to characterize RA flares from both patients’ and physicians’ perspectives, e.g. FLARE-RA self-administered tool to detect recent or current flare[28], two units of CDAI increment as minimal clinically important difference corresponding to worsening among RA patients who achieved low disease activity[29] and SDAI value at 16.7 (moderate activity range) derived from a cross-sectional study using RAPID3 questionnaire[30] (coincidentally in our study, the median SDAI of those patients whose rheumatologists decided to escalate DMARD was 16.6). Indeed, SDAI appeared to be better than DAS28(CRP) or DAS28(ESR) in discriminating the decision of modifying DMARD therapy in a prospective study[31]: DAS28(ESR) = 4.2 (sensitivity 87%, specificity 70%); DAS28(CRP) = 3.6 (sensitivity 86%, specificity 78%); and SDAI = 15 (sensitivity 90%, specificity 86%).
Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis
2018, Joint Bone SpineCitation Excerpt :Thus, cut-offs can enhance the usefulness of a tool born to allow a closer monitoring of RA and could represent a selection criteria for patient participation in research studies. A regular self-evaluation with RAID may also ensure prospective flare detection, although other approaches (questionnaire completed during physician visits) have been suggested to identify flares retrospectively [16,17]. Dougados et al. gave the following keys to understand this tool: a change of at least 3 points (absolute improvement) or 50% (relative improvement) from baseline value is able to define a minimum clinically important improvement (MCII), while a maximal value of 2 characterizes the patient acceptable symptom state (PASS) [18].
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2014, Revue du Rhumatisme (Edition Francaise)High pain catastrophizing scores in one-fourth of patients on biotherapy for spondylarthritis or rheumatoid arthritis
2014, Joint Bone SpineCitation Excerpt :Longitudinal studies would also be useful to determine whether catastrophizing is associated with a greater likelihood of biotherapy initiation in response to the greater intensity of the complaints and/or with decreased subjective effectiveness of biotherapies related to poor coping mechanisms. Thus, catastrophizing may contribute to the discrepancies seen in some patients between subjective disease-activity parameters (patient-reported outcome [PRO] tools such as RAPID3 [7] and/or Patient Acceptable Symptom State [8,9]) compared to the objective activity of the disease. An earlier study in RA showed that catastrophizing was among the three sources of patient-physician discordance in assessing treatment effectiveness (with lower effectiveness according to the patients), the other two sources being depression and persistent pain [1].