Assessing the Uptake of Core Outcome Sets in Randomized Controlled Trials for Preterm Birth

Research output: Contribution to conferencePosterpeer-review

Abstract

Objective: Our study aims to analyze the uptake of COS within PTB clinical trials.

Background: PTB has high prevalence and substantial costs. Interventions are determined based on the results of randomized controlled trials (RCTs), which often have varying results. Core outcome sets (COS) were created across medical fields to standardize outcome reporting. Across major medical journals, COSs were not used in 98% of trials. Determining the adoption of outcomes of PTB COS will improve treatment decisions and research quality.

Methods: On June 26, 2023, we conducted a systematic search on phase III/IV trial registry entries regarding PTB interventions via ClinicalTrials.gov and International Clinical Trial Registry Platform (ICTRP). Inclusion criteria were the following: subjects were patients receiving an intervention for PTB, study enrollment began within five years prior to publication of PTB COS to June 26, 2023, and evaluated the effectiveness or efficacy of interventions. Authors screened and extracted data in masked, duplicate fashion. Qualifying trials were analyzed for the percentage of adopted outcomes from PTB COS.

Results: No trial in our sample reported the entirety of the PTB COS. The most commonly reported outcome was offspring mortality (54.3%, 50/92) and the least reported outcome was late neonatal neurodevelopment morbidity (3.3%, 3/92). Additionally, 22% of trials in the sample reported zero outcomes related to the PTB COS.

Conclusion: Our results demonstrated no significant change in outcome reporting before or after PTB COS publication. We recommend focusing on both the reporting of outcomes and the measurements that are used.
Original languageAmerican English
StatePublished - 21 Jul 2023
Event7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States
Duration: 21 Jul 202321 Jul 2023

Conference

Conference7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics
Abbreviated title7th Joint Annual Research Meeting
Country/TerritoryUnited States
CityTulsa
Period21/07/2321/07/23

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