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

Abstract

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.

Keywords

• Lung cancer
• Core outcome sets
• Clinical trials
• Adherence
• Uptake