Abstract
Introduction: Chronic kidney disease (CKD) is a progressive condition that affects millions of people worldwide. A standardized core outcome set (COS) was developed for CKD by the International Consortium for Health Outcomes and Measurements (ICHOM) in 2018. This study aims to evaluate the frequency of reporting for these outcomes before and after the publication of the core outcome set.
Methods: A literature search was done to gather the phase III/IV clinical trials evaluating chronic kidney disease through Clinicaltrials.gov. Data extraction of included studies was completed in a masked, duplicate fashion. The included studies were evaluated for characteristics such as survival, burden of disease, patient-reported health-related quality of life (HRQOL), and treatment modality-specific outcomes.
Results: We found that the majority of all COS domains were underreported in CKD clinical trials before and after publication of the COS. Of the included trials, 81.3% did not sufficiently report HRQOL. Kidney allograft function for transplant treatments showed to have the best reporting at 78.6% (11/14).
Conclusion: Our study highlights the importance of implementing the ICHOM COS in CKD clinical trials. We found that there is a notable deficiency in COS reporting before and after the COS publication date among all domains. We suggest efforts be made to improve the adoption of consistent outcome reporting that would benefit the prevalent population of patients affected by CKD.
Methods: A literature search was done to gather the phase III/IV clinical trials evaluating chronic kidney disease through Clinicaltrials.gov. Data extraction of included studies was completed in a masked, duplicate fashion. The included studies were evaluated for characteristics such as survival, burden of disease, patient-reported health-related quality of life (HRQOL), and treatment modality-specific outcomes.
Results: We found that the majority of all COS domains were underreported in CKD clinical trials before and after publication of the COS. Of the included trials, 81.3% did not sufficiently report HRQOL. Kidney allograft function for transplant treatments showed to have the best reporting at 78.6% (11/14).
Conclusion: Our study highlights the importance of implementing the ICHOM COS in CKD clinical trials. We found that there is a notable deficiency in COS reporting before and after the COS publication date among all domains. We suggest efforts be made to improve the adoption of consistent outcome reporting that would benefit the prevalent population of patients affected by CKD.
| 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 |