Abstract

Please cite this article in press as: Kirwa Rheumatology (2013), http://dx.doi.org/10 0973-3698/$ e see front matter Copyright a http://dx.doi.org/10.1016/j.injr.2013.11.019 Between 1983 and 1988 a series of papers demonstrated that Rheumatologists varied considerably in the way they use clinical measures to make judgements about the efficacy of treatment. Clinicians came tomarkedly different conclusions about individual patient response to treatment when managing rheumatoid arthritis (RA) in routine clinical practice. In clinical studies of RA it had been common to use a selection of traditional measures to define the endpoints of the trials. However, the measures chosen were often unique to a particular study, not comprehensive, insensitive to change, and measured overlapping concepts. In spite of conferences, reviews, and editorials no consensus emerged on the appropriate endpoints to include in RA clinical trials. In this context, an endpoint is any measure that is used in the evaluation of patients with RA. During these activities a methodological framework to select valid endpoints and indices was proposed, but the problems with existing measures were in their validity, their relation with individual patient outcomes, and in their multitude. It became recognised that some measures represent the patho-physiological occurrences that follow from the cause of RA, suchas inflammatoryactivity,whereasoutcomemeasures represent the suffering or loss of health experienced by an

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