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Analysis of core outcome set reporting in coronary intervention trials
Aaron Duncan1,2, Frances Shiely3
1University College Cork, Cork, Ireland 120227684@umail.ucc.ie.
Insights
The adoption of a core outcome set (COS) in percutaneous coronary intervention (PCI) trials remains low, indicating a need for greater awareness and consistent outcome reporting. This study highlights challenges in trial design and outcome variability.
Area of Science:
- Cardiology
- Clinical Trials Methodology
- Health Outcomes Research
Background:
- Standardized outcome reporting in percutaneous coronary intervention (PCI) trials is crucial for consistent data interpretation.
- A European Society of Cardiology core outcome set (COS) for PCI trials was published in 2018.
- The utilization and impact of this PCI COS on trial reporting practices require evaluation.
Purpose of the Study:
- To assess the adherence of PCI trials to the established COS.
- To evaluate changes in outcome reporting practices after the COS availability.
- To examine the impact of COS on outcome variability, consistency, and patient and public involvement (PPI).
Main Methods:
- Literature search for randomized controlled trials in PCI between 2014-2022.
- Inclusion of late-phase trials investigating coronary intervention.
- Primary outcome: proportion of trials reporting all COS-defined outcomes; secondary outcomes: number of primary outcomes, PPI use, outcome variability, and consistency.
Main Results:
- 55% of PCI trials utilized a COS post-availability versus 40% prior (p=0.121).
- Fewer primary outcomes were reported post-COS implementation (2 vs 2.3, p=0.014).
- No significant difference in PPI use; higher outcome variability noted before COS, similar consistency.
Conclusions:
- Core outcome set (COS) utilization in PCI trials is suboptimal, suggesting low awareness among trial designers.
- Inconsistency and heterogeneity in reporting clinical trial outcomes persist.
- There is a notable lack of patient and public involvement (PPI) in PCI trial design.
Background:
This paper will focus on outcome reporting within percutaneous coronary intervention (PCI) trials. A core outcome set (COS) is a standardised set of outcomes that are recommended to be reported in every clinical trial. Using a COS can help to ensure that all relevant outcomes are consistently reported across clinical trials. In 2018, the European Society of Cardiology outlined the only COS published for PCI trials.
Methods:
We searched the literature for all randomised controlled trials published between 2014 and 2022. PCI trials included were late-phase trials and must investigate coronary intervention. The primary outcome was the proportion of trials that reported all of the COS-defined outcomes within their publication as either a primary, secondary or safety endpoint. The secondary outcomes included; the number of primary outcomes reported per study, the proportion of studies which use patient and public involvement (PPI) during trial design, outcome variability and outcome consistency.
Results:
9580 trials were screened and 115 studies met inclusion/exclusion criteria. Our study demonstrated that 55% (34/62) of PCI trials used a COS when it was available, compared with 40% (21/53) before the availability of a PCI COS set, p=0.121. Fewer primary outcomes were reported after the implementation of the COS, 2 compared with 2.3, p=0.014. There was no difference in the use of PPI between either group. There was a higher level of variability in outcomes reported before the availability of the COS, while the consistency of outcome reporting remained similar.
Conclusion:
The use of a COS in PCI trials is low. This study provides evidence that there still is a lack of awareness of the COS among those who design clinical trials. We also presented the inconsistency and heterogenicity in reporting clinical trial outcomes. Finally, there was a clear lack of PPI utilisation in PCI trials.
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