Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery
IntroductionThe aim of the study was to define a core outcome set (COS) to be measured following cataract surgery for the postoperative evaluation of monofocal intraocular lenses (IOLs). Compared to current COSs, the present work provides updates considering the advances in the technology due to the...
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Frontiers Media S.A.
2024-02-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1339793/full |
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| author | Rosanna Tarricone Rosanna Tarricone Carla Rognoni Anita Ciarlo Ilaria Giabbani Leonardo Novello Marco Balestrieri Giacomo Costa Eleonora Favuzza Rita Mencucci Leonardo Taroni Daniele Tognetto Rosa Giglio |
| author_facet | Rosanna Tarricone Rosanna Tarricone Carla Rognoni Anita Ciarlo Ilaria Giabbani Leonardo Novello Marco Balestrieri Giacomo Costa Eleonora Favuzza Rita Mencucci Leonardo Taroni Daniele Tognetto Rosa Giglio |
| author_sort | Rosanna Tarricone |
| collection | DOAJ |
| description | IntroductionThe aim of the study was to define a core outcome set (COS) to be measured following cataract surgery for the postoperative evaluation of monofocal intraocular lenses (IOLs). Compared to current COSs, the present work provides updates considering the advances in the technology due to the development of new generation monofocal IOLs, which are characterized by a safety profile comparable to standard monofocal IOLs but with an extended range of intermediate vision.MethodsHealthcare professionals (ophthalmologist surgeons) and patients were involved in the selection of outcomes to be included in the COS, starting from a list of indicators retrieved from a systematic literature search. The search considered observational studies with both a retrospective or prospective design, case studies and classic randomized controlled trials (RCTs). A mixed methodology integrating a Delphi-driven and an expert panel approach was adopted to reach an agreement among clinicians, while patients were involved in the completion of a questionnaire.ResultsThe final COS included 15 outcomes. Eleven outcomes, all clinical, were considered for inclusion after a joint discussion among ophthalmologists; seven outcomes were linked to visual acuity, while the remaining to contrast sensitivity, refractive errors, aberrations and adverse events. Measurement metrics, method of aggregation and measurement time point of these outcomes were specified. The most important aspects for the patients were (1) quality of life after cataract surgery, (2) the capacity to perform activities requiring good near vision (e.g., reading), (3) spectacle independence, and (4) safety of movements without fear of getting hurt or falling (intermediate vision).DiscussionIn a context with limited healthcare resources, it is important to optimize their use considering also the preferences of end-users, namely patients. The proposed COS, developed involving both ophthalmologists and patients, provides an instrument for the postoperative evaluation of different technologies in the context of monofocal IOLs, which can be used not only in clinical trials but also in clinical practice to increase the body of real-world evidence. |
| first_indexed | 2024-03-07T23:37:42Z |
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| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-07T23:37:42Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Medicine |
| spelling | doaj.art-9ec01f2f6b4f4cffb8b672cecb0225cb2024-02-20T05:12:04ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2024-02-011110.3389/fmed.2024.13397931339793Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgeryRosanna Tarricone0Rosanna Tarricone1Carla Rognoni2Anita Ciarlo3Ilaria Giabbani4Leonardo Novello5Marco Balestrieri6Giacomo Costa7Eleonora Favuzza8Rita Mencucci9Leonardo Taroni10Daniele Tognetto11Rosa Giglio12Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, ItalyDepartment of Social and Political Sciences, Bocconi University, Milan, ItalyCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, ItalyCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, ItalyCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, ItalyCentre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, ItalyOspedale Morgagni-Pierantoni, AUSL della Romagna, Forlì, ItalyOspedale Morgagni-Pierantoni, AUSL della Romagna, Forlì, ItalyEye Clinic, Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, ItalyEye Clinic, Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, ItalyOspedale Morgagni-Pierantoni, AUSL della Romagna, Forlì, ItalyUniversity Eye Clinic, Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, ItalyUniversity Eye Clinic, Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, ItalyIntroductionThe aim of the study was to define a core outcome set (COS) to be measured following cataract surgery for the postoperative evaluation of monofocal intraocular lenses (IOLs). Compared to current COSs, the present work provides updates considering the advances in the technology due to the development of new generation monofocal IOLs, which are characterized by a safety profile comparable to standard monofocal IOLs but with an extended range of intermediate vision.MethodsHealthcare professionals (ophthalmologist surgeons) and patients were involved in the selection of outcomes to be included in the COS, starting from a list of indicators retrieved from a systematic literature search. The search considered observational studies with both a retrospective or prospective design, case studies and classic randomized controlled trials (RCTs). A mixed methodology integrating a Delphi-driven and an expert panel approach was adopted to reach an agreement among clinicians, while patients were involved in the completion of a questionnaire.ResultsThe final COS included 15 outcomes. Eleven outcomes, all clinical, were considered for inclusion after a joint discussion among ophthalmologists; seven outcomes were linked to visual acuity, while the remaining to contrast sensitivity, refractive errors, aberrations and adverse events. Measurement metrics, method of aggregation and measurement time point of these outcomes were specified. The most important aspects for the patients were (1) quality of life after cataract surgery, (2) the capacity to perform activities requiring good near vision (e.g., reading), (3) spectacle independence, and (4) safety of movements without fear of getting hurt or falling (intermediate vision).DiscussionIn a context with limited healthcare resources, it is important to optimize their use considering also the preferences of end-users, namely patients. The proposed COS, developed involving both ophthalmologists and patients, provides an instrument for the postoperative evaluation of different technologies in the context of monofocal IOLs, which can be used not only in clinical trials but also in clinical practice to increase the body of real-world evidence.https://www.frontiersin.org/articles/10.3389/fmed.2024.1339793/fullcataractmonofocal IOLspatients’ preferencescore outcome setstakeholders |
| spellingShingle | Rosanna Tarricone Rosanna Tarricone Carla Rognoni Anita Ciarlo Ilaria Giabbani Leonardo Novello Marco Balestrieri Giacomo Costa Eleonora Favuzza Rita Mencucci Leonardo Taroni Daniele Tognetto Rosa Giglio Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery Frontiers in Medicine cataract monofocal IOLs patients’ preferences core outcome set stakeholders |
| title | Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery |
| title_full | Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery |
| title_fullStr | Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery |
| title_full_unstemmed | Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery |
| title_short | Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery |
| title_sort | systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery |
| topic | cataract monofocal IOLs patients’ preferences core outcome set stakeholders |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1339793/full |
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