605 Uptake and reporting of the harmonising outcome measures for eczema (HOME) core outcome set in randomized clinical trials for systemic treatments for atopic dermatitis

M. Lam, P. Spuls, Y.A. Leshem,L.A. Gerbens,K. Thomas,B. Arents, T. Burton,C. Flohr,A. Drucker

Journal of Investigative Dermatology(2023)

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摘要
The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set for atopic dermatitis clinical trials to minimize research waste. In 2018, HOME published guidance for reporting results for continuous measures, specifying that baseline and follow-up mean and standard deviation should be reported. We investigated the proportion of randomized clinical trials (RCTs) of systemic treatment for atopic dermatitis that adhere to HOME reporting guidelines. We identified trials with publicly available results in or after 2018 included in a living systematic review and network meta-analysis (NMA) of RCTs of systemic treatments for atopic dermatitis. We assessed whether investigators reported results for four HOME recommended instruments (EASI, POEM, DLQI instruments, PP-NRS), if they reported according to HOME guidelines and/or with sufficient detail for inclusion in the NMA for each continuous outcome. We included 52 trials; EASI was reported in 49 (94%), POEM in 31 (60%), DLQI in 33 (63%) and PP-NRS in 32 (62%). Adherence to HOME reporting guidance was low for each of EASI (8%), POEM (6%), DLQI (3%), and PP-NRS (3%). The proportion of trials that could not be included in the NMA for EASI, POEM, DLQI, and PP-NRS due to reporting only dichotomous or inadequate continuous data were 27% , 6%, 3% and 3%, respectively. This research waste highlights the importance of standardized outcome reporting to facilitate evidence synthesis and better inform clinical practice guidelines.
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关键词
eczema,harmonising outcome measures,clinical trials,core outcome,systemic treatments
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