Title: Metadata analysis of time needed for completion of quality of life instruments in dermatology trials
Session: Friday Poster Session II
Date: October 20th, 2023
Time: 2:55 pm MT
Introduction: Electronically collected patient reported outcomes (ePROs), specifically quality of life (QOL), are increasingly important to support regulatory submissions for new drugs. Assessment of QOL in patients with skin diseases can: show disease stage, progression, and therapy need but also demonstrate treatment benefit in clinical trials space. Therefore, selection of instruments that will collect high-quality data is of a critical importance. Aim of this research was to perform an analysis of metadata, specifically time to complete the form, for quality of life instruments in dermatology trials.
Methods: The literature search was performed in the Web of Science platform using QOL and dermatology keywords. Fifty articles with the highest number of citations were selected. Three general QOL instruments and two dermatology specific QOL instruments were identified. Completion times corresponding to the general and dermatology specific instruments were identified and analyzed using a metadata of 948 instruments and 17 234 458 assessment submissions.
Results: Five QOL instruments relevant to dermatology trials were identified: EuroQoL 5-Dimension 3-Level (EQ-5D-3L), EuroQoL 5-Dimension 5-Level (EQ-5D-5L), EuroQol 5-Dimension – Youth version (EQ-5D-Y), Dermatology Life Quality Index (DLQI), Children’s Dermatology Life Quality Index (CDLQI). Median times of form completion in seconds (s) increased in the following order: EQ-5D-Y < EQ-5D-3L < EQ-5D-5L < CDLQI < DLQI and were equal to 49 s < 62 s < 73 s < 78 s < 90 s. Metadata analysis showed that participants spent just over a minute to complete EQ-5D-3L and EQ-5D-5L forms which was up to 87 % less than the estimated completion time of 480 s. The CDLQI and DLQI completion times were also lower than estimated: by 35% and 25%, respectively.
Conclusions: Appropriately selected QOL instruments facilitate evaluation of new drug’s treatment benefit. Ideally, a general or a dermatology specific QOL instrument should demonstrate the treatment’s success of improving participant’s QOL. Trial age group is one of the factors to consider while choosing the QOL instrument for the trial. Time for completion is another factor, as it relates to the participant’s burden.
Scientific Advisor at Clario
Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Dr. Marszewska earned her M.Sc. and Ph.D. degrees in the field of chemistry. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career.