Taking a chance on outcome standardisation: A cross-sectional analysis assessing the uptake of the prevention of preterm birth core outcome set in randomised controlled trials

ObjectiveAnalyse uptake of the core outcome set (COS) within preterm birth (PTB) clinical trials.DesignOn 26 June 2023, we conducted a systematic search of phase III/IV trial registry entries regarding PTB interventions via ClinicalTrials.gov and the International Clinical Trial Registry Platform. These trials were analysed for the outcomes measured.SettingN/A.SampleAfter searching the two databases, 5257 randomised controlled trials (RCTs) were screened, resulting in 92 RCTs for analysis.MethodsInclusion criteria were the following: subjects were patients receiving an intervention for PTB, study enrolment began within 5 years prior to publication of PTB COS to 26 June 2023, and evaluated the efficacy of interventions. Authors screened and extracted data in masked, duplicate fashion, then performed an interrupted time series analysis, analysis of variance and correlation analysis.Main outcome measuresWe extracted outcomes measured by each clinical trial in our sample. Trials were analysed for the percentage of adopted outcomes from PTB COS.ResultsAfter COS publication, there was no significant change in percentage of COS outcomes measured. The most measured outcome was 'offspring mortality' (54.34%, 50/92) and the least measured outcome was 'late neonatal neurodevelopment morbidity' (3.26%, 3/92). Additionally, 22.83% (21/92) of trials measured zero outcomes related to the PTB COS.ConclusionOur results demonstrated no significant change in outcome measurement before or after PTB COS publication. We recommend focusing on both the measurement of outcomes and the assessments that are used.