PURPOSE: Patient-reported outcome measures (PROMs) are being used more frequently in total knee arthroplasty (TKA). By utilizing high-quality scales, surgeons can achieve a more comprehensive and accurate evaluation of the effectiveness of TKA surgery. Currently, there is no widely accepted conceptual model for TKA PROMs. The objective of this study is to fill this gap by developing a conceptual model and preliminary content for a PROM that is specifically designed for TKA patients in mainland China. METHODS: The study design consisted of three stages: (1) a targeted literature review followed by the formation of a conceptual model pool
(2) qualitative data collection involving experts and patients, leading to the development of the preliminary Chinese TKA PROM (CTP)
and (3) review of the CTP by experts using the Delphi method, along with cognitive debriefing interviews with patients. RESULTS: 64 patients and 28 experts took part in this study. The conceptual model focused on six key concepts: pain, symptom, function, quality of life, expectation, and satisfaction. To match the model, the authors developed a total of 35 items. CONCLUSION: A conceptual model and preliminary content for CTP was developed with substantial participation from patients and a multidisciplinary group of experts. The integration of patient and clinical perspectives ensured a comprehensive representation of all relevant disease experiences and the focus of clinical practice. With further refinement through psychometric testing, the CTP is positioned to provide a standardized, comprehensive measure for research specific to Chinese TKA patients.