The application of patient-reported outcomes in clinical trials of digestive tract tumors conducted in China: a cross-sectional study of registered clinical trial protocols

With the adoption of international health standards, patient-reported outcomes (PROs) are increasingly used in clinical trials, promoting the effective implementation of patient-centered healthcare. However, the characteristics of PRO use in digestive tract tumor trials in China remain poorly understood. The aim of this study was to evaluate PRO application and characteristics in randomized clinical trials of digestive tract tumors conducted in China.

In this cross-sectional study, we identified data from the ClinicalTrials.gov database and the Chinese Clinical Trial Registry and the dataset was restricted to randomized clinical trials of digestive tract tumors conducted in China between January 1, 2010, and June 30, 2025. Trials were classified into four groups: (1) those listing PROs as primary outcomes; (2) those listing PROs as secondary outcomes; (3) trials listing PROs as co-primary outcomes (both primary and secondary); and (4) trials without any PRO instrument.

Of 2292 trials, 928 (40.5%) incorporated PRO instruments as part of their results. Among these, 29.6% (275/928) listed PRO as primary outcomes, 54.2% (503/928) as secondary outcomes, and 16.2% (150/928) as co-primary outcomes. The most frequent conditions for the explicit use of specific PRO instruments included colorectal (405/928, 43.6%), stomach (229/928, 24.7%), and esophageal (166/928, 17.9%) tumors. Commonly used PRO instruments included the Visual Analog Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, and the Numeric Rating scale. Among relevant trials, only 4.8% (6/125) used the traditional Chinese medicine (TCM) Symptom Score.

Recently, PRO use has shown an increasing trend in randomized clinical trials on digestive tract tumors conducted in China. Nonetheless, the low proportion of clinical trials of digestive tract tumors using PROs remains noteworthy. Future efforts should develop TCM-specific PRO tools and integrate TCM syndrome scales with Western PROs in TCM-oncology trials.