(A-020) A cross-sectional analysis of Patient-Reported Outcomes collection in registries indexed in the Heads of Medicines Agencies-European Medicines Agency Catalogues of Real-World Data Sources and Studies

Background: The inclusion of patient-reported outcomes (PRO) in registries has been encouraged, as reflected in the European Medicines Agency (EMA) “Guideline on registry-based studies”.

Objectives: This study explores PRO collection in registries indexed in the Heads of Medicines Agencies - European Medicines Agency Catalogue of real-world data sources (HMA-EMA RWD Catalogues).

Methods: Registries were retrieved from the HMA-EMA RWD Catalogues, filtered by “Data source type” to include only registries. Categorical and numerical variables of interest were defined, and descriptive statistics were conducted in R, including significance tests such as Fisher's exact test, Pearson's Chi-squared test, and Wilcoxon rank sum test.

Results: Of the 102 registries analyzed, 50 (49%) reported collecting PRO. Most registries that collected PRO were disease-specific (38; 76%), privately funded (29; 60%), implemented in secondary care settings (26; 58%), not formally qualified as data sources (44; 88%) and had a median observation time of 5 (1-26) years. Significant differences (p < 0.05) were found between registries collecting and not collecting PRO: PRO-collecting registries were more often privately funded and had an average population size approximately seven times smaller than those not collecting PRO.

Conclusions: The study shows a growing recognition of PRO’s role in registries, with half of the examined registries collecting PRO. These data, reflecting patient experiences and outcomes in real-world settings, play a role for supporting patient-centered decision-making. Further research should address challenges such as registry qualification, data quality, and logistical issues to optimize PRO inclusion.