{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:52:12Z","timestamp":1781513532615,"version":"3.54.1"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004337","name":"Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eye"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background\/Objectives<\/jats:title>\n                    <jats:p>Real-world data (RWD) is becoming increasingly important in ophthalmology, offering insights into clinical outcomes, therapeutic approaches, and healthcare practices. However, methodological variability limits comparability and generalisability across RWD studies. This Delphi consensus aimed to establish expert agreement on the need for standardised methodologies in ophthalmology RWD studies, identify the key clinical and patient-reported data elements that should be collected, and explore strategies for consistent implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A modified Delphi methodology was followed. A steering committee (SC) of three ophthalmologists developed 38 consensus statements across five key topics. These statements were developed into an online four-point Likert scale survey and distributed to healthcare professionals experienced in managing retinal diseases via members of The Ophthalmology Network. Consensus was defined a priori as \u226575% agreement. Results were shared with the SC and key recommendations were discussed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 244 responses were received, predominantly from retina specialists (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009232, 95%), with broad representation across six regions, the largest being Europe (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009116, 48%). Consensus was achieved for all 38 statements, with 36 (95%) reaching \u226590%. These statements covered key principles, including: variability of current standards, ideal clinical standards for RWD collection, RWD analysis methodology, ideal patient-reported standards, and implementing and reporting consistent standards\/frameworks. As the stopping criteria were met, no further Delphi rounds were conducted. Eight key recommendations were developed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The outputs from this consensus aim to guide future ophthalmology RWD studies towards improved consistency, reliability, and generalisability, ultimately strengthening the evidence base for clinical decision-making to improve patient outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1038\/s41433-026-04424-1","type":"journal-article","created":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T10:22:58Z","timestamp":1775125378000},"page":"1342-1350","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Defining a standards framework for ophthalmology real-world data methodologies through an expert-led Delphi consensus"],"prefix":"10.1038","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9688-4845","authenticated-orcid":false,"given":"Pierre-Henry","family":"Gabrielle","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3238-9682","authenticated-orcid":false,"given":"Francesco","family":"Bandello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aude","family":"Couturier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0815-4771","authenticated-orcid":false,"given":"Christiana","family":"Dinah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Downey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3400-1987","authenticated-orcid":false,"given":"Alessandro","family":"Invernizzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8928-5599","authenticated-orcid":false,"given":"Arshad M.","family":"Khanani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge C. 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Roche commissioned Triducive Partners Limited to facilitate the project and analyse the responses to the consensus statements in line with the Delphi methodology. The authors state the following conflicts of interest: All authors received honoraria from Roche while undertaking this study. Roche commissioned Triducive Partners Limited to facilitate the project and analyse the responses to the consensus statements in line with the Delphi methodology.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The conduct of the study adhered to the ethical principles outlined in the Declaration of Helsinki (2013). This study did not require an ethics committee approval, as it was a non-interventional opinion-based Delphi process involving HCPs, with no collection of sensitive or participant-identifiable data. A statement of consent was included at the start of each survey, and consent was implied by survey completion. Respondents received no incentives. Surveys were completed anonymously, and no personal identifiers or protected characteristics were collected.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}]}}