Abstract
Objective: The objective of this study is to examine the use and application of the Core Outcome Set (COS) for macular degeneration (MD) within clinical trials.
Background: A common issue for many systematic reviewers is finding comparability between studies so that they can accurately compile data to further add to our understanding of a given condition, disease, or treatment type. Core outcome sets were developed by groups, such as the COMET Initiative, to foster better comparability between trials. This study seeks to evaluate the adoption and implementation of the MD COS since its publication in 2016.
Methods: In this cross-sectional investigation, we screened ClinicalTrials.gov for clinical trials evaluating outcomes for patients with macular degeneration. We extracted seven domains from our COS for each included trial as follows: Distance visual acuity, mobility and independence, emotional well-being, reading and accessing information, number of treatments, complications of treatment, and presence of fluid, edema, or hemorrhage.
Results: Our search yielded 2,152 trials for initial consideration. After exclusions, we analyzed 159 clinical trials. The most commonly adhered to COS domain was distance visual acuity (139/159; 87.4 %). The least commonly adhered to COS domains were mobility and independence (30/159; 18.9%) and number of treatments (32/159; 20.1%). The most common treatment type was intravitreal anti-VEGF treatment (132/159; 83%), while the least common were retinal radiation therapy (1/159; 0.6%) and surgical treatment (1/159; 0.6%).
Conclusion: Our study found no recognizable patterns in COS usage rates for MD trials. We recommend more cooperation between federal regulatory agencies and COS initiatives in an effort to help with uptake of COSs. Additionally, we suggest further studies that analyze adherence to COSs consider regulatory recommendations.
Background: A common issue for many systematic reviewers is finding comparability between studies so that they can accurately compile data to further add to our understanding of a given condition, disease, or treatment type. Core outcome sets were developed by groups, such as the COMET Initiative, to foster better comparability between trials. This study seeks to evaluate the adoption and implementation of the MD COS since its publication in 2016.
Methods: In this cross-sectional investigation, we screened ClinicalTrials.gov for clinical trials evaluating outcomes for patients with macular degeneration. We extracted seven domains from our COS for each included trial as follows: Distance visual acuity, mobility and independence, emotional well-being, reading and accessing information, number of treatments, complications of treatment, and presence of fluid, edema, or hemorrhage.
Results: Our search yielded 2,152 trials for initial consideration. After exclusions, we analyzed 159 clinical trials. The most commonly adhered to COS domain was distance visual acuity (139/159; 87.4 %). The least commonly adhered to COS domains were mobility and independence (30/159; 18.9%) and number of treatments (32/159; 20.1%). The most common treatment type was intravitreal anti-VEGF treatment (132/159; 83%), while the least common were retinal radiation therapy (1/159; 0.6%) and surgical treatment (1/159; 0.6%).
Conclusion: Our study found no recognizable patterns in COS usage rates for MD trials. We recommend more cooperation between federal regulatory agencies and COS initiatives in an effort to help with uptake of COSs. Additionally, we suggest further studies that analyze adherence to COSs consider regulatory recommendations.
| Original language | American English |
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| State | Published - 21 Jul 2023 |
| Event | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States Duration: 21 Jul 2023 → 21 Jul 2023 |
Conference
| Conference | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics |
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| Abbreviated title | 7th Joint Annual Research Meeting |
| Country/Territory | United States |
| City | Tulsa |
| Period | 21/07/23 → 21/07/23 |