Development of a joint set of database parameters for the EU-ROP and Fight Childhood Blindness! ROP Registries

Abstract

Background/aims: The incidence of retinopathy of prematurity (ROP) is increasing and treatment options are expanding, often without accompanying safety data. We aimed to define a minimal, patient-centred data set that is feasible to collect in clinical practice and can be used collaboratively to track and compare outcomes of ROP treatment with a view to improving patient outcomes.; Methods: A multinational group of clinicians and a patient representative with expertise in ROP and registry development collaborated to develop a data set that focused on real-world parameters and outcomes that were patient centred, minimal and feasible to collect in routine clinical practice.; Results: For babies receiving ROP treatment, we recommend patient demographics, systemic comorbidities, ROP status, treatment details, ophthalmic and systemic complications of treatment, ophthalmic and neurodevelopmental outcomes at initial treatment, any episodes of retreatment and follow-up examinations in the short and long-term to be collected for use in ROP studies, registries and routine clinical practice.; Conclusions: We recommend these parameters to be used in registries and future studies of ROP treatment, to reduce the variation seen in previous reports and allow meaningful assessments and comparisons. They form the basis of the EU-ROP and the Fight Childhood Blindness! ROP Registries.; Competing Interests: Competing interests: CC: previous Scientific Advisory Board membership—Novartis, Aspen. JMP: speaker—Novartis. DB: Novartis—past funding for research for the institution; Bayer—past funding for research, consultancy, paid to institution; Alcon—current, advisor, paid to author. TUK: recipient of lecture fees and consultant fees from Alimera Sciences and Roche; recipient of lecture fees from Allergan; recipient of lecture fees and consultant fees and financial support of research projects from Bayer and Novartis; recipient of lecture fees from Heidelberg Engineering. GAG, W-CW, SK, PZ, SD, JE, MH, JS, GK-F: none declared. AS: speaker: Bayer, Novartis; scientific advisory boards: Bayer, Novartis; research grants: Bayer and Novartis; clinical trials: Bayer and Novartis. The EU-ROP project is currently financed by extramural grants from the University Medicine Greifswald, solicited through the EU-ROP principal investigator from Novartis Pharma AG and Bayer Vital AG. Companies supporting the registry do not have any influence on the content or the design of the registry.The Fight Childhood Blindness! ROP Registry is a Save Sight Registry which receives funding from research and educational grants, and private donations, on a strictly non-binding basis. (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)