Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, USA.
Orthop J Sports Med. 2016 Sep 12;4(9):2325967116665589. doi: 10.1177/2325967116665589. eCollection 2016 Sep.
There has been increased emphasis in orthopaedics on high-quality prospective research to provide evidence-based treatment guidelines, particularly in sports medicine/shoulder surgery. The external validity of these studies has not been established, and the generalizability of the results to clinical practice in the United States is unknown.
Comparison of patient demographics in major prospective studies of arthroscopic sports and shoulder surgeries to patients undergoing the same procedures in the National Surgical Quality Improvement Program (NSQIP) database will show substantial differences to question the generalizability and external validity of those studies.
Cross-sectional study; Level of evidence, 3.
This study utilized patients undergoing arthroscopic anterior cruciate ligament reconstruction (ACLR), meniscectomy (MX), rotator cuff repair (RCR), and shoulder stabilization (SS) from the NSQIP database (2005-2013). Two prospective studies (either randomized controlled trials or, in 1 case, a major cohort study) were identified for each of the 4 procedures for comparison. Demographic variables available for comparison in both the identified prospective studies and the NSQIP included age, sex, and body mass index (BMI).
From the NSQIP database, 5576 ACLR patients, 18,882 MX patients, 7282 RCR patients, and 993 SS patients were identified. The comparison clinical studies included cohort sizes as follows: ACLR, n = 121 and 2683; MX, n = 146 and 330; RCR, n = 90 and 103; SS, n = 88 and 196. Age differed significantly between the NSQIP and the patients in 6 of the 8 prospective clinical studies. Sex differed significantly between the NSQIP and the patients in 7 of the 8 prospective clinical studies. BMI differed significantly between the NSQIP and the patients of all 4 of the prospective clinical studies that reported this demographic variable.
Significant differences exist for patient age, sex, and BMI between patients included in major sports medicine/shoulder prospective studies and corresponding patients undergoing the same procedures in a nationwide database of academic and community centers in the United States. Future work is needed to understand whether major prospective clinical studies-frequently performed in high-volume, specialized practices-are truly indicative of the types of patients treated and expected results in the general orthopaedic practice. This study additionally argues for the importance of initiating a national registry dedicated to patients undergoing orthopaedic procedures in the United States.
矫形外科越来越强调高质量的前瞻性研究，以提供循证治疗指南，特别是在运动医学/肩部手术领域。这些研究的外部有效性尚未得到证实，其结果在美国临床实践中的普遍性尚不清楚。
将主要的关节镜运动和肩部手术前瞻性研究中的患者人口统计学数据与国家手术质量改进计划 (NSQIP) 数据库中接受相同手术的患者进行比较，将显示出实质性差异，从而质疑这些研究的普遍性和外部有效性。
横断面研究；证据水平，3 级。
本研究利用了 NSQIP 数据库（2005-2013 年）中接受关节镜前交叉韧带重建术 (ACLR)、半月板切除术 (MX)、肩袖修复术 (RCR) 和肩部稳定术 (SS) 的患者。为每个 4 种手术各确定了 2 项前瞻性研究（随机对照试验，或在 1 种情况下为大型队列研究）进行比较。在确定的前瞻性研究和 NSQIP 中，可用于比较的人口统计学变量包括年龄、性别和体重指数 (BMI)。
从 NSQIP 数据库中，确定了 5576 例 ACLR 患者、18882 例 MX 患者、7282 例 RCR 患者和 993 例 SS 患者。比较的临床研究包括以下队列大小：ACLR，n=121 和 2683；MX，n=146 和 330；RCR，n=90 和 103；SS，n=88 和 196。在 8 项前瞻性临床研究中有 6 项研究中，年龄在 NSQIP 和患者之间存在显著差异。在 8 项前瞻性临床研究中有 7 项研究中，性别在 NSQIP 和患者之间存在显著差异。在报告了该人口统计学变量的 4 项前瞻性临床研究中，BMI 在 NSQIP 和患者之间存在显著差异。
在参加主要运动医学/肩部前瞻性研究的患者与在美国学术和社区中心进行相同手术的患者之间，患者的年龄、性别和 BMI 存在显著差异。需要进一步研究以了解在高容量、专业化实践中经常进行的主要前瞻性临床研究是否真正反映了普通矫形实践中治疗的患者类型和预期结果。本研究还强调了启动专门针对美国接受矫形手术患者的全国性登记册的重要性。
