Carlini Anthony R, Agel Julie, Bosse Michael J, Frey Katherine P, Staguhn Elena D, Vallier Heather A, Obremskey William, Swiontkowski Marc F, Cannada Lisa K, Tornetta Paul, MacKenzie Ellen J, O'Toole Robert V, Reider Lisa, Allen Lauren E, Collins Susan C, Castillo Renan C
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Department of Orthopaedics and Sports Medicine, University of Washington Harborview Medical Center, Seattle, Washington.
J Bone Joint Surg Am. 2024 Oct 2;106(19):1767-1775. doi: 10.2106/JBJS.23.01201. Epub 2024 Jul 2.
The Short Musculoskeletal Function Assessment (SMFA) is a well validated, widely used patient-reported outcome (PRO) measure for orthopaedic patients. Despite its widespread use and acceptance, this measure does not have an agreed upon minimal clinically important difference (MCID). The purpose of the present study was to create distributional MCIDs with use of a large cohort of research participants with severe lower extremity fractures.
Three distributional approaches were used to calculate MCIDs for the Dysfunction and Bother Indices of the SMFA as well as all its domains: (1) half of the standard deviation (one-half SD), (2) twice the standard error of measurement (2SEM), and (3) minimal detectable change (MDC). In addition to evaluating by patient characteristics and the timing of assessment, we reviewed these calculations across several injury groups likely to affect functional outcomes.
A total of 4,298 SMFA assessments were collected from 3,185 patients who had undergone surgical treatment of traumatic injuries of the lower extremity at 60 Level-I trauma centers across 7 multicenter, prospective clinical studies. Depending on the statistical approach used, the MCID associated with the overall sample ranged from 7.7 to 10.7 for the SMFA Dysfunction Index and from 11.0 to 16.8 for the SMFA Bother Index. For the Dysfunction Index, the variability across the scores was small (<5%) within the sex and age subgroups but was modest (12% to 18%) across subgroups related to assessment timing.
A defensible MCID can be found between 7 and 11 points for the Dysfunction Index and between 11 and 17 points for the Bother Index. The precise choice of MCID may depend on the preferred statistical approach and the population under study. While differences exist between MCID values based on the calculation method, values were consistent across the categories of the various subgroups presented.
Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.
短肌肉骨骼功能评估（SMFA）是一种经过充分验证、广泛应用于骨科患者的患者报告结局（PRO）指标。尽管该指标被广泛使用和认可，但尚未有公认的最小临床重要差异（MCID）。本研究的目的是利用一大群患有严重下肢骨折的研究参与者来创建分布性MCID。
采用三种分布方法来计算SMFA功能障碍指数和困扰指数及其所有领域的MCID：（1）标准差的一半（1/2 SD），（2）测量标准误的两倍（2SEM），以及（3）最小可检测变化（MDC）。除了按患者特征和评估时间进行评估外，我们还在几个可能影响功能结局的损伤组中对这些计算结果进行了审查。
在7项多中心前瞻性临床研究中，从60个一级创伤中心接受下肢创伤手术治疗的3185例患者中总共收集到4298份SMFA评估结果。根据所使用的统计方法，与总体样本相关的SMFA功能障碍指数的MCID范围为7.7至10.7，SMFA困扰指数的MCID范围为11.0至16.8。对于功能障碍指数，性别和年龄亚组内评分的变异性较小（<5%），但与评估时间相关的亚组间变异性适中（12%至18%）。
功能障碍指数的MCID在7至11分之间，困扰指数的MCID在11至17分之间，这是合理的。MCID的精确选择可能取决于首选的统计方法和所研究的人群。虽然基于计算方法的MCID值存在差异，但在各亚组类别中数值是一致的。
预后III级。有关证据水平的完整描述，请参阅作者须知。
