Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources
Abstract Background Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-w...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-10-01
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| Series: | BMC Ophthalmology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12886-019-1208-9 |
| _version_ | 1818145708626149376 |
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| author | Vincent Daien Bora M. Eldem James S. Talks Jean-Francois Korobelnik Paul Mitchell Robert P. Finger Taiji Sakamoto Tien Yin Wong Obaro Evuarherhe Gemma Carter Joao Carrasco |
| author_facet | Vincent Daien Bora M. Eldem James S. Talks Jean-Francois Korobelnik Paul Mitchell Robert P. Finger Taiji Sakamoto Tien Yin Wong Obaro Evuarherhe Gemma Carter Joao Carrasco |
| author_sort | Vincent Daien |
| collection | DOAJ |
| description | Abstract Background Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-world research. However, there is limited information for each data source on the design, consistency, data captured, limitations and usability for assessing research questions. Using a systematic approach, we identified RWD sources for patients with retinal diseases and assessed them for completeness of data relating to different outcomes. Methods A systematic literature review was carried out to identify RWD sources for patients with retinal disease. Potentially relevant articles published between 2006 and 2016 were screened following electronic searches in Embase and MEDLINE. Congress and supplementary searches were undertaken to identify RWD sources that may not be referenced in full publications. For each data source, availability and quantity of data on baseline status, clinical outcomes, treatment and management, safety, and patient-reported and economic burden were assessed using a bespoke completeness assessment tool based on International Consortium for Health Outcomes Measurement guidelines for macular degeneration. Completeness of data for each area of interest in each data source was assessed and rated using a ‘good–moderate–poor’ rating system based on availability and quantity of available data. Each data source was then given an overall score based on its score for each of the 7 areas of interest. Results A total of 128 RWD sources from 32 countries were identified. Of the identified sources, 64 sources from 16 countries of interest were analyzed. Most of these sources provided information on baseline status and clinical outcomes and treatment, but few collected data on economic and patient-reported burden. Of the RWD sources analyzed, 10 scored highly in the overall completeness assessment, collecting data on most or all of the areas of interest; these sources are considered to be robust data sources for performing ophthalmology real-world studies. Conclusions The study provides a comprehensive list of RWD sources for patients with retinal disease, many of which will be useful for conducting real-world studies in the field of ophthalmology. |
| first_indexed | 2024-12-11T12:07:45Z |
| format | Article |
| id | doaj.art-48ff1ba02ceb49afb884803c81dd7d53 |
| institution | Directory Open Access Journal |
| issn | 1471-2415 |
| language | English |
| last_indexed | 2024-12-11T12:07:45Z |
| publishDate | 2019-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Ophthalmology |
| spelling | doaj.art-48ff1ba02ceb49afb884803c81dd7d532022-12-22T01:07:53ZengBMCBMC Ophthalmology1471-24152019-10-0119111210.1186/s12886-019-1208-9Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sourcesVincent Daien0Bora M. Eldem1James S. Talks2Jean-Francois Korobelnik3Paul Mitchell4Robert P. Finger5Taiji Sakamoto6Tien Yin Wong7Obaro Evuarherhe8Gemma Carter9Joao Carrasco10Department of Ophthalmology, Gui De Chauliac HospitalFaculty of Medicine, Ophthalmology Department, Hacettepe UniversityDepartment of Ophthalmology, Royal Victoria InfirmaryService d’ophtalmologie, CHU Bordeaux, France - Univ. Bordeaux, InsermCentre for Vision Research, Westmead Institute for Medical Research, University of SydneyDepartment of Ophthalmology, University of BonnDepartment of Ophthalmology, Kagoshima University Graduate School of Medical and Dental SciencesSingapore Eye Research Institute, Singapore National Eye CentreOxford PharmaGenesisOxford PharmaGenesisBayer Consumer Care AGAbstract Background Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-world research. However, there is limited information for each data source on the design, consistency, data captured, limitations and usability for assessing research questions. Using a systematic approach, we identified RWD sources for patients with retinal diseases and assessed them for completeness of data relating to different outcomes. Methods A systematic literature review was carried out to identify RWD sources for patients with retinal disease. Potentially relevant articles published between 2006 and 2016 were screened following electronic searches in Embase and MEDLINE. Congress and supplementary searches were undertaken to identify RWD sources that may not be referenced in full publications. For each data source, availability and quantity of data on baseline status, clinical outcomes, treatment and management, safety, and patient-reported and economic burden were assessed using a bespoke completeness assessment tool based on International Consortium for Health Outcomes Measurement guidelines for macular degeneration. Completeness of data for each area of interest in each data source was assessed and rated using a ‘good–moderate–poor’ rating system based on availability and quantity of available data. Each data source was then given an overall score based on its score for each of the 7 areas of interest. Results A total of 128 RWD sources from 32 countries were identified. Of the identified sources, 64 sources from 16 countries of interest were analyzed. Most of these sources provided information on baseline status and clinical outcomes and treatment, but few collected data on economic and patient-reported burden. Of the RWD sources analyzed, 10 scored highly in the overall completeness assessment, collecting data on most or all of the areas of interest; these sources are considered to be robust data sources for performing ophthalmology real-world studies. Conclusions The study provides a comprehensive list of RWD sources for patients with retinal disease, many of which will be useful for conducting real-world studies in the field of ophthalmology.http://link.springer.com/article/10.1186/s12886-019-1208-9Retinal diseasesAge-related macular degenerationChoroidal neovascularizationDiabetic macular edemaRetinal vein occlusionAnti-VEGF |
| spellingShingle | Vincent Daien Bora M. Eldem James S. Talks Jean-Francois Korobelnik Paul Mitchell Robert P. Finger Taiji Sakamoto Tien Yin Wong Obaro Evuarherhe Gemma Carter Joao Carrasco Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources BMC Ophthalmology Retinal diseases Age-related macular degeneration Choroidal neovascularization Diabetic macular edema Retinal vein occlusion Anti-VEGF |
| title | Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources |
| title_full | Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources |
| title_fullStr | Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources |
| title_full_unstemmed | Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources |
| title_short | Real-world data in retinal diseases treated with anti-vascular endothelial growth factor (anti-VEGF) therapy – a systematic approach to identify and characterize data sources |
| title_sort | real world data in retinal diseases treated with anti vascular endothelial growth factor anti vegf therapy a systematic approach to identify and characterize data sources |
| topic | Retinal diseases Age-related macular degeneration Choroidal neovascularization Diabetic macular edema Retinal vein occlusion Anti-VEGF |
| url | http://link.springer.com/article/10.1186/s12886-019-1208-9 |
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