退行性半月板撕裂关节镜手术患者Lysholm评分、WOMET评分及疼痛的最小重要差异与患者可接受症状状态
简介
基于900例连续接受关节镜下半月板部分切除术（APM）的患者队列，以及146例经关节镜证实内侧半月板撕裂、随机接受APM或安慰剂手术的试验人群，该研究前瞻性收集Lysholm、WOMET及运动时疼痛数字评分（pain-NRS）数据，并采用患者整体变化印象锚点问题计算最小重要差异（MID），于术后12个月判定患者可接受症状状态（PASS）。各量表与锚点问题均呈…
英文摘要
BACKGROUND: To assess the clinical relevance of trials, facilitate comparisons across studies, and enable a priori power calculations for future trials, concepts coined 'minimal important difference' (MID) and 'patient acceptable symptom state' (PASS) have been advocated. In this study, we present MID and PASS values for three patient-reported knee outcomes: the Lysholm knee score, the Western Meniscal Evaluation Tool (WOMET), and knee pain after exercise measured on a numerical rating scale (pain-NRS), among patients who underwent arthroscopy for a degenerative meniscus tear of the knee. METHODS: The outcome scores were prospectively collected from two patient populations: a cohort of 900 consecutive patients undergoing arthroscopic partial meniscectomy (APM) and a trial involving 146 patients with an arthroscopically-verified tear of the medial meniscus who were randomised to either APM or placebo surgery. The anchor question for calculating MID was the Patients' Global Impression of Change, assessed using a 5-point Likert scale. Data on outcomes were collected at the time of knee arthroscopy (baseline) and at 2, 6, and 12 months postoperatively. PASS was determined at 12 months postoperatively. MID was determined using four methods: predictive, mean difference of change, mean change, and receiver operating characteristic (ROC) methods, by pooling data from all time points in the cohort and trial. PASS values were calculated using the ROC and the 75th percentile methods. RESULTS: All instruments demonstrated strong correlation with the anchor question (Spearman's rho from 0.55 to 0.63). Depending on the method used, MID values varied from 13.8 to 19.2 points for Lysholm, 12.8 to 22.2 points for WOMET, and 1.3 to 2.3 for pain-NRS. The calculated PASS thresholds ranged from 87.5 to 89 points for Lysholm, 89.9 to 91.1 points for WOMET, and 1 to 1.5 for pain-NRS. CONCLUSIONS: Our study offers credible MID and PASS estimates for Lysholm, WOMET, and pain-NRS scores in patients undergoing arthroscopy for a degenerative meniscus tear. These thresholds can assist in the design and interpretation of future research and in evaluating treatment outcomes in this patient population. TRIAL REGISTRATION: ClinicalTrials.gov NCT00549172 (first registered October 25, 2007).