Sahoo Sambit, Stojanovska Martina, Imrey Peter B, Jin Yuxuan, Bowles Richard J, Ho Jason C, Iannotti Joseph P, Ricchetti Eric T, Spindler Kurt P, Derwin Kathleen A, Entezari Vahid
Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Department of Orthopaedic Surgery, Orthopaedic & Rheumatologic Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Am J Sports Med. 2022 Jul;50(8):2304-2314. doi: 10.1177/03635465211023967. Epub 2021 Sep 2.
Most orthopaedic journals currently require reporting outcomes of surgical interventions for at least 2 postoperative years, but there have been no rigorous studies on this matter. Various patient-reported outcome (PRO) measures (PROMs) have been used to assess the status of the shoulder after rotator cuff repair (RCR).
We hypothesized that the mean shoulder-specific PROMs at 1 year improve substantially over baseline but that there is no clinically meaningful difference between the mean 1- and 2-year PROMs after RCR.
Meta-analysis; Level of evidence, 2.
We conducted a systematic review of published randomized controlled trials (RCTs) and prospective cohort studies (level of evidence 1 and 2) reporting the shoulder-specific American Shoulder and Elbow Surgeons (ASES), the Constant, or the Western Ontario Rotator Cuff (WORC) Index scores at baseline, 1 year, and 2 years after RCR. The methodologic quality of studies was assessed. Also, the random effects meta-analyses of changes in PROMs for each of the first and second postoperative years were conducted.
Fifteen studies (n = 11 RCTs; n = 4 cohort studies) with a total of 1371 patients were included. Studies were highly heterogeneous, but no visual evidence of major publication bias was observed. The weighted means of the baseline PROMs were 46.2 points for the ASES score, 46.4 points for the Constant score, and 38.8 points for the WORC Index. The first-year summary increments were 41.1 (95% CI, 36.0-46.2) points for the ASES score, 34.2 (95% CI, 28.8-39.6) points for the Constant score, and 42.9 (95% CI, 37.3-48.4) points for the WORC Index. In contrast, the second-year summary increments were 2.3 (95% CI, 1-3.6) points for the ASES score, 3.2 (95% CI, 1.9-4.4) points for the Constant score, and 2 (95% CI, -0.1 to 4) points for the WORC Index.
All PROMs improved considerably from baseline to 1 year, but only very small gains that were below the minimal clinically important differences were observed between 1 year and 2 years after RCR. This study did not find any evidence for requiring a minimum of 2 years of follow-up for publication of PROs after RCR. Our results suggest that focusing on 1-year PROMs after RCR would foster more timely reporting, better control of selection bias, and better allocation of research resources.
目前大多数骨科期刊要求报告手术干预至少2年的术后结果，但对此尚无严格研究。各种患者报告结局（PRO）指标（PROMs）已被用于评估肩袖修复术（RCR）后肩部的状况。
我们假设，术后1年时肩部特异性PROMs的均值较基线水平有显著改善，但RCR术后1年和2年的PROMs均值在临床上无显著差异。
荟萃分析；证据等级，2级。
我们对已发表的随机对照试验（RCTs）和前瞻性队列研究（证据等级1级和2级）进行了系统综述，这些研究报告了RCR术后基线、1年和2年时肩部特异性的美国肩肘外科医师学会（ASES）、Constant或西安大略肩袖（WORC）指数评分。评估了研究的方法学质量。此外，还对术后第一年和第二年PROMs变化进行了随机效应荟萃分析。
纳入了15项研究（n = 11项RCTs；n = 4项队列研究），共1371例患者。研究具有高度异质性，但未观察到明显的发表偏倚迹象。ASES评分的基线PROMs加权均值为46.2分，Constant评分为46.4分，WORC指数为38.8分。ASES评分的第一年汇总增量为41.1（95% CI，36.0 - 46.2）分，Constant评分为34.2（95% CI，28.8 - 39.6）分，WORC指数为42.9（95% CI，37.3 - 48.4）分。相比之下，ASES评分的第二年汇总增量为2.3（95% CI，1 - 3.6）分，Constant评分为3.2（95% CI，1.9 - 4.4）分，WORC指数为2（95% CI， - 0.1至4）分。
从基线到1年，所有PROMs均有显著改善，但RCR术后1年和2年之间仅观察到非常小的增益，低于最小临床重要差异。本研究未发现任何证据支持RCR术后报告PROs需要至少2年的随访。我们的结果表明，关注RCR术后1年的PROMs将促进更及时的报告、更好地控制选择偏倚以及更合理地分配研究资源。
