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

Abstract

Asking study participants for their views of treatment efficacy seems like a good idea in dermatological clinical trials, yet only about a quarter of the trials examined in this review did so. Even when such information was recorded, it was often poorly and incompletely reported and given low prominence within the trial report. Our study findings call for a more comprehensive uptake for including participant efficacy outcomes alongside other assessor outcomes in clinical trials and, when included, to report those outcomes in full.

Outcomes in Psoriasis Clinical Trials from January 2011 to March 2012

“…Despite this, in the 54 clinical trials analyzed in this review, only about one fourth included a patient-reported measure among the primary outcomes. These figures are quite similar to those of Townshend et al [10], who, in 2003, analyzed 125 dermatologic trials and found that only 32 of them (25.6 %) mentioned participant efficacy outcomes. Another study observed that, even when information on quality of life was available [11], methods and results were not adequately reported.…”

“…Comparability of PASI is most likely a myth, not only because of a lack of standardized comparative studies across institutions and countries but because of the vast diversity of times at which it is assessed as an outcome. In this review, even when only considering the primary outcomes, the change in PASI score was assessed in the different studies at weeks 4,6,8,10,12,14,16,20,25,52, and 160. In addition, one study used it at 35 sessions of phototherapy.…”

Which outcomes should we measure in vitiligo? Results of a systematic review and a survey among patients and clinicians on outcomes in vitiligo trials

“…However, patient-centred outcomes have rarely been included in vitiligo trials, despite previous recommendations for inclusion in studies on vitiligo 1,4 and other dermatological conditions. 9 Therefore, it is important to create consensus among researchers to ensure that the outcomes used in the trials for vitiligo treatment are reliable, clinically relevant and important to both clinicians and patients.…”

Clinical trials and statistical analyses: what should dermatologists look for in a report?

“…Multiple end points may be needed to fully describe a multifaceted disease, such as acne. In other cases, multiple end points may arise from the need to get both a clinician's and a patient's assessment of efficacy (4). For example, in more cosmetic indications such as hair growth or glabellar lines, both the clinician's and subject's assessments may be important end points.…”