Ian A Rodrigues1, Sara M Sprinkhuizen2, Daniel Barthelmes3, Mark Blumenkranz4, Gemmy Cheung5, Julia Haller6, Robert Johnston7, Ramasamy Kim8, Caroline Klaver9, Martin McKibbin10, Nor Fariza Ngah11, Suzann Pershing12, Dato Shankar2, Hiroshi Tamura13, Adnan Tufail14, Christina Y Weng15, Inger Westborg16, Catherine Yelf17, Nagahisa Yoshimura18, Mark C Gillies19. 1. International Consortium for Health Outcomes Measurement, Boston, Massachusetts; Department of Ophthalmology, St Thomas' Hospital, London, United Kingdom. 2. International Consortium for Health Outcomes Measurement, Boston, Massachusetts. 3. Department of Ophthalmology, University Hospital Zurich, and the University of Zurich, Zurich, Switzerland; The Save Sight Institute, The University of Sydney, Sydney, Australia. 4. Byers Eye Institute, Stanford University, Palo Alto, California. 5. Singapore National Eye Center, Singapore. 6. Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania. 7. Gloucestershire Hospitals NHS Foundation Trust, Gloucester, United Kingdom. 8. Aravind Eye Hospital, Madurai, India. 9. Erasmus Medical Center, Rotterdam, Netherlands. 10. Royal College of Ophthalmologists, London, United Kingdom. 11. Hospital Selayang, Selangor, Malaysia. 12. Byers Eye Institute, Stanford University, Palo Alto, California; Veterans Affairs Palo Alto Health Care System, Livermore, California. 13. Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan; Division of Medical Information Technology & Administration Planning, Kyoto University Hospital, Kyoto, Japan. 14. Moorfields Eye Hospital, London, United Kingdom. 15. Baylor College of Medicine, Houston, Texas. 16. Umeå University, Registercenter Syd/EyeNet Sweden, Karlskrona, Sweden. 17. Macular Society, Andover, United Kingdom. 18. Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan. 19. The Save Sight Institute, The University of Sydney, Sydney, Australia. Electronic address: mark.gillies@sydney.edu.au.
Abstract
PURPOSE: To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses. Published by Elsevier Inc.
PURPOSE: To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses. Published by Elsevier Inc.
Authors: Ian J Saldanha; Kristina Lindsley; Diana V Do; Roy S Chuck; Catherine Meyerle; Leslie S Jones; Anne L Coleman; Henry D Jampel; Kay Dickersin; Gianni Virgili Journal: JAMA Ophthalmol Date: 2017-09-01 Impact factor: 7.389
Authors: Tiarnan D Keenan; Susan Vitale; Elvira Agrón; Amitha Domalpally; Andrew N Antoszyk; Michael J Elman; Traci E Clemons; Emily Y Chew Journal: Ophthalmol Retina Date: 2019-06-11
Authors: Kristina B Lindsley; Susan Hutfless; Barbara S Hawkins; Jill F Blim; Dan Roberts; Timothy W Olsen; Flora Lum; Kay Dickersin Journal: JAMA Ophthalmol Date: 2018-11-01 Impact factor: 7.389
Authors: Darren S Thomas; Alasdair Warwick; Abraham Olvera-Barrios; Catherine Egan; Roy Schwartz; Sudeshna Patra; Haralabos Eleftheriadis; Anthony Khawaja; Andrew Lotery; Philipp L Muller; Robin Hamilton; Ella Preston; Paul Taylor; Adnan Tufail Journal: BMJ Open Date: 2022-04-15 Impact factor: 2.692
Authors: Vuong Nguyen; Martin Puzo; Jorge Sanchez-Monroy; Pierre-Henry Gabrielle; Catherine C Garcher; Florian Baudin; Benjamin Wolff; Laurent Castelnovo; Guillaume Michel; Louise O'Toole; Daniel Barthelmes; Mark C Gillies Journal: Retina Date: 2021-07-01 Impact factor: 4.256
Authors: Mohammad O Tallouzi; Jonathan M Mathers; David J Moore; Philip I Murray; Nicholas Bucknall; Jane M Blazeby; Melanie Calvert; Alastair K Denniston Journal: Trials Date: 2017-12-01 Impact factor: 2.279