Incorporating patient reported outcome measures in clinical practice: development and validation of a questionnaire for inflammatory arthritis.

Background Rheumatology is embarking on a fundamental redesign of rheumatic disease care. It has become mandatory not only to recognise disease activity core set data, but also the risks for other co-morbidities associated with inflammatory arthritis. Measurement of patient reported outcomes have become critical in both standard clinical practice and long term observational studies. Objectives To assess validity, reliability and responsiveness to change of a patient self-reported questionnaire which can assess construct outcome measures of patients with inflammatory arthritis. Methods Four hundred and sixty-two patients with inflammatory arthritis were included in this work. The questionnaire was developed by integrating information obtained from patients suffering from inflammatory arthritis based on the Rasch model for ordered response options. The questionnaire includes assessment for functional disability, quality of life, VAS for joint pain, global status, fatigue, duration of morning stiffness, review of the systems, falls and cardiovascular risks, self-helplessness, as well as self reported joint pain. Results The questionnaire was reliable as demonstrated by a high-standardised alpha (0.891-0.992). The questionnaire items correlated significantly (p<0.01 ) with clinical parameters of disease activity. RA patient reported tender joints correlated significantly with the physician's scores (0.842). Changes in functional disability, quality of life as well as self-helplessness scores showed significant (p<0.01) variation with disease activity status. The PROMs questionnaire also showed a high degree of comprehensibility.(9.4). Conclusion Integrating patient reported outcome measures into standard clinical practice is feasible and applicable. This version of a multidimensional questionnaire was found to be valid and reliable. It provides informative quantitative measures for the disease activity core set data, and in the mean time, facilitates assessing the patients' health related quality of life measure, cardiovascular and falls risks on an individual basis.