AB1360 Range and consistency of outcome measures reported in randomised trials in dermatomyositis: a systematic review

Background Dermatomyositis – an idiopathic inflammatory myopathy- can be resistant and unresponsive to initial treatments and require chronic therapy. Symptoms including muscle weakness and skin rash can lead to severe complications and impair quality of life. There are a paucity of randomised trials in dermatomyositis, which may not consistently report outcomes that are important to patients and their clinicians. Objectives To assess the scope and consistency of outcomes reported in randomised trials in dermatomyositis. Methods MEDLINE, Embase, CINAHL, PsycINFO were searched to February 2017 for randomised trials in children and adults with dermatomyositis. The frequency and characteristics of the outcome domains and measures reported were then analysed. Similar outcomes were grouped into outcome domains and classified as surrogate, clinical or patient-reported outcomes. The frequency and characteristics of the outcome domains and measures reported were then analysed. Results We included 18 trials (n=844 participants), reporting 680 outcome measures. These were grouped into 27 different outcome domains; including 12 (44%) clinical outcomes, 9 (33%) surrogate/biochemical outcomes, and 6 (22%) patient-reported outcomes. The 5 most frequently reported outcome domains were: physical function (13 trials, 72%), muscle strength (12, 67%), muscle inflammation (12, 67%), biomarkers (11, 61%), and composite i.e. myositis disease activity (10, 56%). Conclusions The majority of outcomes reported in trials in dermatomyositis are clinical outcomes and few are patient-reported. Establishing a core set of patient-important outcomes may improve the consistency and relevance of outcomes reported in trials in dermatomyositis to inform decision-making. Disclosure of Interest None declared