Background: Current response criteria in rheumatoid arthritis (RA) usually assess only three patient-reported outcomes (PROs): pain, functional disability and patient global assessment. Other important PROs such as fatigue are not included.
Objective: To elaborate a patient-derived composite response index for use in clinical trials in RA, the RA Impact of Disease (RAID) score.
Methods: Ten patients identified 17 domains or areas of health relevant for inclusion in the score, then 96 patients (10 per country in 10 European countries) ranked these domains in order of decreasing importance. The seven most important domains were selected. Instruments were chosen for each domain after extensive literature research of psychometric properties and expert opinion. The relative weight of each of the domains was obtained from 505 patients who were asked to “distribute 100 points” among the seven domains. The average ranks of importance of these domains were then computed.
Results: The RAID score includes seven domains with the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%). Weights were similar across countries and across patient and disease characteristics. Proposed instruments include the Health Assessment Questionnaire and numerical ratings scales.
Conclusion: The preliminary RAID score is a patient-derived weighted score to assess the impact of RA. An ongoing study will allow the final choice of questionnaires and assessment of validity. This score can be used in clinical trials as a new composite index that captures information relevant to patients.
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Appendices 1 and 2 are published online only at http://ard.bmj.com/content/vol68/issue11
Funding EULAR grant CLI.013.
Competing interests None.
Ethics approval All applicable regulations were respected and the project was accepted by ethical committees in participating countries.
This project, supported financially by EULAR, was convened by TKK, facilitated by LG, and has as steering committee one other rheumatologist (MD), two patients with RA (SC and MdW), one epidemiologist (LC) and one allied health professional (TH). Ten countries were involved in the elaboration of the RAID: Estonia, France, Greece, Italy, the Netherlands, Norway, Spain, Romania, Turkey and United Kingdom. Germany and Finland have subsequently become part of the validation project.