Abstract
Background and purpose:
Patient-reported outcomes (PROs) are health condition assessments directly expressed by patients, providing a precise reflection of the patient's perspective. We aim to understand how PROs were being used to provide suggestions for conducting high-quality clinical studies of Traditional Chinese medicine (TCM) for cardiovascular diseases (CVD).
Methods:
We searched clinical studies of TCM for CVD from the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) registered between January 1, 2010, and December 31, 2023. Trial phases, study types, age, gender, TCM interventions, regions and countries, time trends, PROs as primary/secondary/co-primary outcomes, and PRO instruments explicitly specified or implicitly specified were analyzed. We classified the studies that explicitly specified PROs into 14 categories based on the International Classification of Diseases-11 (ICD-11) ,and compared their PRO instruments with the Core Outcome Measures in Effectiveness Trials (COMET).
Results:
487 TCM CVD studies were identified. 194 studies did not mention the use of PRO instruments. 250 studies explicitly specified the PRO tool, while 43 studies implicitly (studies registration mentioned the use of PROs, but PRO instruments were not specified). Out of the 293 studies that included PROs, 84 (17.2%) listed PROs as their primary outcomes, 144 (29.6%) as secondary outcomes and 65 (13.3%) as co-primary outcomes. Chronic coronary heart disease (26.96%), hypertension (15.70%), and heart failure (14.68%) were the most common diseases in that 250 studies. Furthermore, their PRO instruments partially complied with COMET's recommendations ,while other diseases did not. Frequently used PRO instruments included the SAQ (Seattle Angina Questionnaire), the TCMSS (TCM syndrome score), the SF-8/12/36 (Short-Form 8/12/36-item Health Survey), and the VAS (Vsual Analog Scale).
Conclusion:
Over the past decade, there has been a continued increase in the use of PROs as a measure in clinical investigations focused on TCM for CVD. Research and development of PROs core endpoints for different CVD could be improved. Given the current challenges surrounding the use of PROs in clinical studies of TCM, such as the inconsistent availability and absence of standardized PRO instruments for TCM, it is crucial to prioritize research on establishing standardized and normalized scales specifically designed for TCM.