Responsiveness and Minimally Important Differences of the Traditional Chinese Version of PROMIS Paediatric-25 Profile in Chinese Children with Cancer

Background: Although the Patient-Reported Outcomes Measurement Information System Paediatric-25 Profile version 2.0 (PROMIS-25) has shown good reliability and validity in assessing HRQOL in Chinese children with cancer, its responsiveness (ie, the ability of the instrument to identify temporal changes in the construct to be measured) in detecting clinically meaningful changes in these children remains unclear. Objective: To evaluate the responsiveness and minimally important difference (MID) of the traditional Chinese PROMIS-25 for Chinese children with cancer. Design: Prospective study. Methods: The responsiveness of traditional Chinese PROMIS-25 domains before and after cancer treatment was evaluated by testing 24 a priori hypotheses of the correlations between changes in the domain scores and the corresponding changes in domain/total scores of the traditional Chinese Patient Health Questionnaire-9, traditional Chinese Paediatric Quality of Life Inventory 4.0, and 11-point numeric pain rating scale. The MID for each domain was determined by anchored-based method (MID-A), receiver operating characteristic curve analysis method, and distribution-based method (MID-D). Results: A total of 103 children with cancer (13.1 ± 1.8 years) were recruited. The traditional Chinese PROMIS-25 demonstrated moderate to high responsiveness. As all MID-As were higher than the MID-Ds, MID-As were recommended to determine domain changes. The MID-As were Physical Function = 12.3; Anxiety = 17.2; Depression = 15.4; Fatigue = 13.6; Peer Relationships = 6.5; and Pain Interference = 13.0. Limitations: This study excluded children with cognitive or visual impairments, as well as those requiring end-of-life care. Conclusions: The traditional Chinese PROMIS-25 is a responsive instrument to detect health-related quality of life changes among Chinese children with cancer. Our results provided important references for using PROMIS-25 in clinical practice and research.