Assessing the Uptake of Core Outcome Sets in Randomized Controlled Trials for Type 1 Diabetes

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Abstract

Objective: This study aims to analyze the uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in their use in trials before and after COS development.

Background: T1D is a chronic illness that causes health and financial burdens throughout a lifetime. The use of COS has the potential to increase consistency and reliability of outcomes in T1D research. To better understand the uptake of COS in T1D, the usage of COS before and after its development in December 2017 must be investigated.

Methods: On June 26,2023, we searched through ClinicalTrials.gov to find randomized control trials for T1D. The COMET Initiative database was used to select a specific COS for uptake analysis, characterizing a set of eight trial endpoints. Studies were analyzed for COS uptake before and after their development. Screening and data collection took place in a masked, duplicate fashion. Data analysis was used to calculate the proportion of trials planning to measure the complete COS and to assess the most frequently reported COS outcomes.

Results: Of the 3,792 articles originally screened, 144 trials were included in our final sample. Following the publication of the Delphi study for T1D, the use of COS did not increase as the trends in its use remained mostly linear after the study's publication. In addition, we found that within the set of core outcomes, the most frequently implemented were HbA1c and severe hypoglycemia. The remainder of outcomes within the set rarely appeared as endpoints for investigation in T1D studies.

Conclusion: Our study revealed an evident decrease in the use of standard outcomes over time, despite the publication of the T1D COS. Inconsistency in COS implementation affects evidence-based practices and patient care. Educating researchers about COS and promoting its uptake is crucial. Enhanced COS adoption in T1D trials may also benefit other medical fields, improving clinical research.
Original languageAmerican English
StatePublished - 21 Jul 2023
Event7th Annual Joint Research Meeting - Oklahoma State University Center for Health Sciences, Tulsa, United States
Duration: 21 Jul 202321 Jul 2023

Conference

Conference7th Annual Joint Research Meeting
Country/TerritoryUnited States
CityTulsa
Period21/07/2321/07/23

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