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The following is a summary of “Evaluation of inclusion and exclusion criteria for pyoderma gangrenosum in clinical research: A systematic review,” published in the October 2024 issue of Dermatology by Li et al.
Pyoderma gangrenosum (PG), a rare inflammatory skin disease, had been challenging to diagnose due to its nonspecific histological characteristics.
Researchers conducted a retrospective study to characterize the inclusion and exclusion criteria for diagnosing the PG in clinical research studies and to evaluate its eligibility for clinical trials.
They identified PG inclusion and exclusion criteria in research studies and searched the USA and international clinical trials databases for eligibility criteria in PG trials.
The results showed a broad range in inclusion and exclusion criteria for diagnosing PG, among 8 categories defining inclusion criteria, the most common were diagnosis by a dermatologist (n = 25, 31.6%), absence of listed inclusion criteria (n = 21, 26.6%), and clinical and histopathologic features indicative of PG (n = 20, 25.3%). In current clinical trials, 6 categories were utilized to outline inclusion criteria, with the predominant categories being clinical and histopathologic features consistent with PG (n = 5, 31.3%), identification based on a PG diagnosis (n = 4, 25.0%), and clinical features indicative of PG (n = 3, 18.8%).
They concluded the need for consensus guidelines and a rigorous framework to enable high-quality future trials for PG due to the heterogeneity in diagnostic and eligibility criteria used in PG-directed clinical research and current clinical trials.
Source: karger.com/drm/article/240/1/26/868369/Evaluation-of-Inclusion-and-Exclusion-Criteria-for