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Patient-Reported Outcome Measures in Clinical Trials: An Analysis of Trends From 2008 to 2023
Maja Kuharic1, Justin Yu2, Mrinmayee Joshi2
1Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Objectives:
To examine trends in patient-reported outcome (PRO) measure use in clinical trials (2008-2023) and analyze adoption patterns of common PRO measures across geographic regions, disease categories, and age groups.
Methods:
We identified PRO measures from PROQOLID and health technology assessment recommendations, including generic instruments (EuroQol 5-Dimension [EQ-5D], SF-36/12/8/6D, Patient-Reported Outcomes Measurement Information System [PROMIS]), condition-specific measures (EORTC QLQ-C30/QLU-C10D, Functional Assessment of Chronic Illness Therapy), and pediatric instruments (Pediatric Quality of Life Inventory [PedsQL], EQ-5D-Y, PROMIS Pediatric, Child Health Questionnaire, Child Health Utility 9D). Using a custom Python algorithm (96% sensitivity, 97% specificity), we searched ClinicalTrials.gov for interventional studies incorporating PRO measures.
Results:
Among 475 844 registered trials, PRO measure usage increased substantially. Adult trials incorporating PROs grew from 12.7% (n = 1783) in 2008 to 23.5% (n = 7808) in 2023; pediatric trials increased from 8.0% (n = 231) to 17.7% (n = 1118). EQ-5D surpassed SF measures as the most widely used generic instrument in 2017 (2023: EQ-5D n = 1023, SF n = 781), growing at a compound annual growth rate of 16.2%, whereas PROMIS demonstrated the most rapid expansion with a compound annual growth rate of 51.9%. PRO measures were most frequently implemented in trials studying pathological conditions, nervous system diseases, and neoplasms, with distinct regional preferences: EQ-5D predominated in Europe, whereas SF and PROMIS measures were more common in North America.
Conclusions:
By 2023, nearly one-quarter of adult trials included PRO measures, with growing pediatric implementation. PRO integration continues expanding, driven by regulatory and health technology assessment requirements. EQ-5D's emergence as the leading measure may reflect widespread health technology assessment endorsement. These findings inform PRO selection strategies and identify opportunities for greater pediatric implementation and regional adoption.
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