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Assessing core outcome set uptake in randomized controlled trials for chronic kidney disease: Cross-sectional analysis.
Hagood, Alex; Corwin, Logan Patrick; Modi, Jay S; Jones, Garrett A; Fitzgerald, Kyle J; Magana, Kimberly J; Ward, Shaelyn A; Magee, Trevor R; Hughes, Griffin K; Ford, Alicia Ito; Vassar, Matt.
Afiliación
  • Hagood A; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Corwin LP; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Modi JS; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Jones GA; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Fitzgerald KJ; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Magana KJ; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Ward SA; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Magee TR; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Hughes GK; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Ford AI; Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
  • Vassar M; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Contemp Clin Trials Commun ; 41: 101347, 2024 Oct.
Article en En | MEDLINE | ID: mdl-39262904
ABSTRACT
Main

problem:

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 in 2019. This study aims to evaluate the frequency of measurement for these outcomes before and after the publication of the COS.

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, and treatment modality-specific outcomes.

Results:

Our results showed that the majority of all COS domains were inadequately measured in CKD clinical trials before and after publication of the COS. Despite the increase in COS measurements following publication, the average percent of COS outcomes measured was less than 40 % per year even after four years.

Conclusion:

There is a notable deficiency in the complete measurement of COS among all domains both before and after COS publication. We suggest efforts be made to improve the adoption of consistent outcome measures that would benefit the growing population of patients affected by CKD.
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Contemp Clin Trials Commun Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Contemp Clin Trials Commun Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos