FRI0655 Title: the consistency of outcomes reported in trials of systemic sclerosis. improving over time?
Authors: D. J. Sumpton, A. Bigot, B. Sautenet, J. C. Craig, G. Hassett, V. Thakkar, P. Tugwell, A. Tong
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background:</h3> Standardisation of outcome domains and measures in trials in rheumatology has generally improved the consistency and relevance of outcomes reported in rheumatic conditions over the last two decades. The Outcome Measures in Rheumatology (OMERACT) 'core response set' for trials in Systematic Sclerosis (SSc) was developed in 2008 and comprises 11 domains and 31 measures1. <h3>Objectives:</h3> We aimed to assess the scope, and consistency of outcomes reported in trials of SSc, and the uptake of this core response set. <h3>Methods:</h3> MEDLINE, Cochrane CENTRAL, Embase and clinicaltrials.gov were searched to identify randomised clinical trials published between 2000 and June 2016 in adults with SSc. Outcomes and measures were recorded for each trial and classified into domains. The scope and consistency of domains were compared between those trials published from 2000 to 2010 and 2011 to mid-2016 to determine whether has been uptake of the core domain and measurement set reported. A two-year lag between publication of the core set in 2008 and start of the second-time period was set to allow to allow for core reponse set uptake. <h3>Results:</h3> Overall 114 trials (4860 patients, median sample size of 33) were identified. The majority of trials were interventions for immunotherapeutic agents or vasodilators and included a total of 2736 measures (of 78 domains), with a mean of 24 measures per trial. The proportion of trials reporting any outcome from the each domain is listed: (% of 2000–2010 trials, % of 2011–2016 trials, change in %): health-related quality of life and function (42.6, 56.5, +13.9); skin (39.7, 47.8, +8.1); pulmonary (33.8, 43.5, +9.7); global health (14.7, 21.7, +7.0); gastrointestinal (4.4, 10.9, +6.5); ; cardiac (13.2, 15.2, +2); biomarkers of ESR/CRP (7.4, 8.7, +1.3%) musculoskeletal (5.9, 6.5, +0.6); Raynaud9s phenomenon (20.6, 19.6, -1.0) renal (14.7, 10.9, -3.8); digital ulcers (23.5, 19.6, -3.9%). Six measures had a greater than 5% increase in reporting frequency across trial periods: HAQ-DI (from 38.2% to 47.8%), SF-36 (from 17.6% to 28.3%), Modified Rodnan Skin Score (from 38.2 % to 47.8%), pulmonary function tests (from 30.9% to 43.5%), measures of dyspnoea (4.4% to 10.9%) and patient global disease (from 10.3% to 21.7%). <h3>Conclusions:</h3> There was a wide range of domains reported in trials in systemic sclerosis. The uptake of domains and measure as per the core response set is low in SSc trials compared to other rheumatic diseases with only modest improvement in reporting of 6 out of 31 measures. Improvements in reporting of specific measures align with the recent development of a composite response index in systemic sclerosis (CRISS)2. <h3>References</h3> 1. Khanna D, et al. Development of a provisional core set of response measures for clinical trials of systemic sclerosis, Ann Rheum Dis2008;67:703–9. 2. Khanna D, et al. The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis Res Ther2016;68:299–311. <h3>Disclosure of Interest:</h3> None declared