Xu Chao, Wei Jie, Li Liang, Yao Shuxin, Chang Xiaofeng, Ma Jianbing, Shang Lei
Department of Health Statistics, Faculty of Preventive Medicine, The Fourth Military Medical University, No.169 W. Changle Rd, Xi'an, Shaanxi, China.
Department of Knee Joint Surgery, Honghui Hospital, Xi'an Jiaotong University, No. 555 E. Youyi Rd, Xi'an, Shaanxi, China.
Qual Life Res. 2025 Mar;34(3):763-775. doi: 10.1007/s11136-024-03850-6. Epub 2024 Dec 3.
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.
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.
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.
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.
患者报告结局测量指标（PROMs）在全膝关节置换术（TKA）中使用得越来越频繁。通过使用高质量的量表，外科医生可以更全面、准确地评估TKA手术的效果。目前，尚无广泛接受的TKA PROMs概念模型。本研究的目的是通过开发一个专门为中国大陆TKA患者设计的PROM概念模型和初步内容来填补这一空白。
研究设计包括三个阶段：（1）有针对性的文献综述，随后形成概念模型库；（2）收集涉及专家和患者的定性数据，从而开发初步的中文TKA PROM（CTP）；（3）专家使用德尔菲法对CTP进行评审，并对患者进行认知反馈访谈。
64名患者和28名专家参与了本研究。概念模型聚焦于六个关键概念：疼痛、症状、功能、生活质量、期望和满意度。为匹配该模型，作者共制定了35个条目。
在患者和多学科专家小组的大量参与下，开发了CTP的概念模型和初步内容。患者视角与临床视角的整合确保了对所有相关疾病体验的全面呈现以及临床实践的重点。通过心理测量测试进一步完善后，CTP有望为针对中国TKA患者的研究提供一种标准化、全面的测量方法。
