Assessing the Uptake of the Lung Cancer Core Outcome Set: A Cross-Sectional Analysis

Introduction
A core outcome set (COS) helps standardize outcome measurements across clinical trials. Although lung cancer is the leading cause of cancer-related deaths, research exploring COS implementation across lung cancer trials remains limited. We aim to analyze the uptake of the lung cancer COS and identify potential gaps in COS adherence.
Methods
On June 26, 2023, we conducted a cross-sectional analysis of clinical trials that evaluated lung cancer interventions. Our sample consisted of studies registered on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform between September 2011 and June 2023. In a masked and duplicate fashion, investigators extracted data regarding trial characteristics and COS adoption. An interrupted time series analysis was conducted to evaluate the adherence of lung cancer COS before and after its publication.
Results
Of the 626 observed trials, we found no overall significant difference in lung cancer COS uptake pre- and post-publication (0.01%, 95% confidence interval: -0.16% to 0.19%, p=0.85). The most frequently measured outcomes were “overall survival” (91.69%%) and “treatment-related mortalities” (54.69%). Health-related quality of life questionnaires were typically used to evaluate outcomes in the “Degree of health” domain (49.20%). Outcomes related to “time from diagnosis to treatment” (0%), “place of death” (0.16%), and “duration of time spent in the hospital at the end of life” (1.60%) were rarely measured.
Conclusions
Despite the advantages of COS implementation, adherence across lung cancer clinical trials remains alarmingly low—which could compromise data reliability and patient care. Our findings showcase these inconsistencies and emphasize the need for proactive approaches to improve uptake.

Contributors

Andrew V. Tran, Brody Dennis, Matthew Rashid, Kyle Fitzgerald, Garrett Jones, Kimberly Magana, Jay Modi, Trevor Magee, Shaelyn Ward, Griffin Hughes, Alicia Ito Ford, Matt Vassar

Publication

Journal: JTO clinical and research reports
Volume: 5
Issue: 12
Pages: -
Year: 2024
DOI: 10.1016/j.jtocrr.2024.100713

Further Study Information

Current Stage: Completed
Date:
Funding source(s): Dr. Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the U.S.Office of Research Integrity, the Oklahoma Center for Advancement of Science and Technology, and internal grants from the Oklahoma State University Center for Health Sciences — all outside of the present work. Dr. Ford reports receipt of funding from the Center for Integrative Research on Childhood Adversity, the Oklahoma Shared Clinical and Translational Resources, and internal grants from Oklahoma State University and Oklahoma State University Center for Health Sciences — all outside of the present work. The remaining authors declare no conflict of interest.

Health Area

Disease Category: Cancer

Disease Name: Lung cancer

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- COS uptake study

Method(s)

- Systematic review

1) cross-sectional analysis of clinical trials that evaluated lung cancer interventions.
2) In a masked and duplicate fashion, investigators extracted data regarding trial characteristics and COS adoption.
3) An interrupted time series analysis was conducted to evaluate the adherence of lung cancer COS before and after its publication.

Linked Studies



Related Links

    No related links