OBJECTIVES: Clinician reported outcomes (ClinRO’s) are often crucial primary endpoints in therapeutic areas where objective clinical assessments are unavailable or infeasible and are routinely used in dermatology clinical trials. Due to the nature and presentation of dermatological symptoms, there is a need for standardized training and assessment in an attempt to reduce variability of subjective ratings and increase data quality. This study assessed the impact of standardising clinician (rater) training on a dermatology outcome measure.

METHODS: Clinicians were to visually assess severity of dermatological conditions in human examples using a Clinician-Reported Severity Scale ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate) to 4 (Severe). Clinician ratings were obtained on example photographic images and on human models. Ratings were recorded for pre-training and post-training and compared to the consensus of an expert panel.

RESULTS: 94 clinicians’ scores were compared to those from an expert panel through weighted kappa analyses. Pre-training kappa coefficients ranged from 0.33 to 1.00 with a mean of 0.87 and standard deviation of 0.10. Post-training kappa coefficients ranged from 0.90 to 0.98 with a mean of 0.96 and standard deviation of 0.02. A paired t-test comparing pre- and post-training kappa coefficients found a significant increase: M_D = 0.09, 95% CI [0.07, 0.11]. t(93) = 8.54, p < .001.

CONCLUSIONS: Dermatology clinical trials often rely on subjective ClinRO’s as common endpoint measures. This research supports that standardization of rater training can help greatly improve data quality of ClinRO’s in dermatology clinical trials.