According to researchers of a study published in Dermatology Online Journal, assessment of psoriasis severity in clinical trial enrollment screenings may be unintentionally overrated, leading to eligibility creep. The authors evaluated the potential role of psychosocial incentives on grading of psoriasis lesions and found that empathy incentives may drive elevated severity rankings at baseline screenings.
The survey study included 2 vignette-style questions with randomly allocated psychosocial incentive prompts. Respondents were asked to assign Psoriasis Area and Severity Index scores to selected psoriasis lesion images, with a score of 3 or more indicating eligibility for a fictional trial. The survey also asked whether or not patients deemed ineligible at initial screenings should be scheduled for re-evaluation.
The authors observed no significant difference in number of total lesions identified for study enrollment between the psychosocial subgroups (P=.3). Numerically, the professional uncertainty incentive subgroup selected the fewest lesion pictures for enrollment, and the empathy subgroup selected the most. In addition, the empathy subgroup respondents were significantly more likely to schedule re-evaluations for ineligible patients compared with the other subgroups (69.7% vs 59.1%; P=.046).
Overall, the authors suggested that empathetic situations may drive inflated psoriasis severity scoring at trial enrollments and that improvements in placebo arms in clinical trials may be due to eligibility creep.
Reference: Rakita U, Guraya A, Porter CL, Bray JK, Feldman- SR. Understanding eligibility creep in psoriasis assessments: a survey study. Dermatol Online J. 2022;28(3):10.5070/D328357780. doi:10.5070/D328357780
