The Lancet regional health. Western Pacific · 2026
Quantitative refinement and multicentre psychometric validation of the Chinese total knee arthroplasty patient-reported outcome measure: a prospective cohort study with repeated measures.
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Xu Chao, Chang Xiaofeng, Ye Feng, Wu Haodong, Chen Guo, Zhang Rui, Yao Shuxin, Shang Lei, Ma Jianbing
Аннотация
BACKGROUND: Total knee arthroplasty (TKA) requires valid, culturally appropriate patient-reported outcome measures (PROMs). A 35-item preliminary Chinese Total Knee Arthroplasty Patient-reported Outcome Measurement (CTP) was previously developed by our group through qualitative research with Chinese patients and multidisciplinary experts, but it had not undergone quantitative refinement or prospective multicentre psychometric validation. The present study aimed to refine the instrument and evaluate the psychometric properties of its operated-knee core score.
METHODS: We conducted a prospective multicentre cohort psychometric study with repeated assessments at tertiary hospitals in Xi'an, Chengdu, and Lanzhou. Participants were recruited from June 2023 to June 2024, with 12-month follow-up continuing through June 2025. Three independent cohorts were used for quantitative item screening, final scale construction, and psychometric evaluation. We assessed internal consistency (Cronbach's α), test-retest reliability (ICC), structural validity, convergent validity (correlations with WOMAC), and responsiveness (effect size [ES]; standardised response mean [SRM]).
FINDINGS: The three analytic cohorts included 321, 529, and 898 participants, respectively (total n = 1748). Across the three cohorts, the mean age was 66·5 years (SD 7·2), and 1195 participants (68·4%) were female. Exploratory factor analysis supported a three-factor structure (Function, Symptoms, Quality of Life) explaining 72·2% of variance, with all item loadings ≥0·40. The final clinical questionnaire contained 22 items. The principal psychometric analyses evaluated a 16-item operated-knee core score, which showed high internal consistency (Cronbach's α = 0·864) and good test-retest reliability (ICC = 0·836). Convergent validity was supported by a strong correlation between CTP Function and WOMAC Function (r = 0·698; 95% CI 0·663-0·730; p < 0·001). At 12 months, the mean operated-knee core score decreased from 33·52 (SD 8·74) to 21·81 (SD 9·81), with an ES of 1·34 and an SRM of 1·66.
INTERPRETATION: The final CTP is a 22-item, target-population-informed clinical PROM. Its 16-item operated-knee core score showed satisfactory reliability and responsiveness, with partial support for the proposed three-factor structure and convergent validity for selected overlapping constructs.
FUNDING: National Natural Science Foundation of China, Key Research and Development Program of Shaanxi Province, Cultivation Project for General Project of Xi'an Health Commission, Xi'an Municipal Science and Technology Plan Project: General Medical Research Project, the Program for Innovation Team of Shaanxi Province.
METHODS: We conducted a prospective multicentre cohort psychometric study with repeated assessments at tertiary hospitals in Xi'an, Chengdu, and Lanzhou. Participants were recruited from June 2023 to June 2024, with 12-month follow-up continuing through June 2025. Three independent cohorts were used for quantitative item screening, final scale construction, and psychometric evaluation. We assessed internal consistency (Cronbach's α), test-retest reliability (ICC), structural validity, convergent validity (correlations with WOMAC), and responsiveness (effect size [ES]; standardised response mean [SRM]).
FINDINGS: The three analytic cohorts included 321, 529, and 898 participants, respectively (total n = 1748). Across the three cohorts, the mean age was 66·5 years (SD 7·2), and 1195 participants (68·4%) were female. Exploratory factor analysis supported a three-factor structure (Function, Symptoms, Quality of Life) explaining 72·2% of variance, with all item loadings ≥0·40. The final clinical questionnaire contained 22 items. The principal psychometric analyses evaluated a 16-item operated-knee core score, which showed high internal consistency (Cronbach's α = 0·864) and good test-retest reliability (ICC = 0·836). Convergent validity was supported by a strong correlation between CTP Function and WOMAC Function (r = 0·698; 95% CI 0·663-0·730; p < 0·001). At 12 months, the mean operated-knee core score decreased from 33·52 (SD 8·74) to 21·81 (SD 9·81), with an ES of 1·34 and an SRM of 1·66.
INTERPRETATION: The final CTP is a 22-item, target-population-informed clinical PROM. Its 16-item operated-knee core score showed satisfactory reliability and responsiveness, with partial support for the proposed three-factor structure and convergent validity for selected overlapping constructs.
FUNDING: National Natural Science Foundation of China, Key Research and Development Program of Shaanxi Province, Cultivation Project for General Project of Xi'an Health Commission, Xi'an Municipal Science and Technology Plan Project: General Medical Research Project, the Program for Innovation Team of Shaanxi Province.