比较随机试验参与者与筛选后的非参与者：对年轻半月板撕裂患者手术与运动疗法普适性的启示
简介
该研究通过比较丹麦DREAM随机对照试验（比较早期手术与运动疗法+患者教育，121例）与平行临床队列（182例18-40岁半月板撕裂患者，因各种原因未参与RCT），评估RCT结果的普适性。关键发现：两组患者在基线特征和症状严重程度上总体相似，仅症状持续时间、起病方式和KOOS症状子量表评分存在统计学差异；手术组（RCT 60例 vs 队列52例）和运动治疗组…
英文摘要
PURPOSE: To investigate the generalizability of the study population and treatment effects observed in a randomized controlled trial comparing a strategy of early surgery to a strategy of exercise therapy and patient education (with the option of later surgery) for young adults with meniscal tears, through comparison with a parallel clinical cohort. METHODS: We compared patient characteristics of patients (n = 121) from the Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) to patients (n = 182) aged 18-40 years with a meniscal tear participating in a parallel clinical cohort (i.e., those who were screened for the RCT, but not participating for various reasons), to assess the generalizability of the DREAM study population. In addition, we compared observed treatment effects between the trial and cohort (Knee injury and Osteoarthritis Outcome Score, mean of 4/5 subscales-KOOS4) of surgery (trial [n = 60] vs. cohort [n = 52]) and exercise (trial [n = 61] vs. cohort [n = 51]). RESULTS: Patients participating in the DREAM trial and the clinical cohort were, on average, similar in most patient characteristics and level of patient-reported symptoms at baseline, except for symptom duration, symptom onset and KOOS symptom subscale scores, where statistically significant differences were observed. Similar baseline to 12-month average KOOS4 trajectories were observed for trial and cohort patients following surgery (time × group p = 0.98; adjusted mean difference in change 0.7, 95% confidence interval [CI] -7.1 to 8.5) and exercise therapy (time × group p = 0.62; adjusted mean difference in change 3.2, 95% CI -4.3 to 10.7). CONCLUSIONS: Overall, both baseline characteristics and observed improvements of surgery and exercise therapy observed in the DREAM trial were largely comparable to those observed in the clinical cohort, suggesting that the DREAM trial results were generalizable to patients aged 18-40 years with meniscal tears observed in daily clinical practice. LEVEL OF EVIDENCE: Level II.