How prominent are patient-reported outcomes in clinical trials of dermatological treatments?

The British Journal of Dermatology
A P TownshendH C Williams

Abstract

Assessment of symptoms or disease improvement by study participants is an important aspect of assessing new dermatological therapies in clinical trials, especially for chronic skin diseases that lack objective severity markers. We sought to determine the frequency and prominence of reporting of participants' subjective efficacy outcomes in dermatological clinical trials. Our secondary objective was to determine whether participant and physician outcomes agree in terms of direction and magnitude. Systematic review of 125 randomized controlled trials identified from the Archives of Dermatology, British Journal of Dermatology, Clinical & Experimental Dermatology, Journal of Dermatological Treatment and Journal of the American Academy of Dermatology published between 1994 and 2001 (25 from each). Studies were retrieved in hard copy from the Cochrane Skin Group specialized register of trials and data were abstracted and summarized. Participant efficacy outcomes were mentioned in some form in only 32 of 125 trials (25.6%, 95% exact confidence interval 18.2-34.2%). Of these 32 studies, participant outcomes were mentioned only in the methods section in two studies, in the methods and results section without further data in nine studies...Continue Reading

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Citations

Jan 31, 2012·Dermatologic Clinics·Seema P Kini, Laura K DeLong
Nov 4, 2011·The Journal of Investigative Dermatology·Hywel C Williams, Robert P Dellavalle

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