背景:这项研究旨在确定最小的临床重要差异(MCID),和美国骨科足踝协会(AOFAS)量表的实质性临床获益(SCB),疼痛的视觉模拟量表(VAS),以及进行性塌陷性足畸形(PCFD)手术中的简短表格36健康调查(SF-36)。
方法:在这项回顾性队列研究中,纳入了2015年7月至2021年4月期间接受手术的84例PCFD患者(84英尺).该研究评估了患者的主观感知,以及他们的VAS,AOFAS,和至少两年随访的SF-36得分,并对这些数据进行统计分析。本研究利用Spearman相关分析来确定患者的主观感知与其VAS之间的相关程度。AOFAS,和SF-36得分。最小可检测变化(MDC),MCID,和用于VAS的SCB,AOFAS,和SF-36使用基于分布和锚定的方法计算。从基于分布和锚定的方法获得的分类结果使用Cohen的kappa进行评估。
结果:根据患者的主观感受,共有84个人被分为三组,无改善组7人,14在最低改善组中,在实质性改进组中有63人。Spearman的相关分析表明,患者的主观感知与VAS表现出中等到强的关联,AOFAS,SF-36PCS,和SF-36MCS,所有系数都超过0.4。VAS的MCID,AOFAS,SF-36PCS,和SF-36MCS在PCFD手术中使用基于分布的方法确定为0.93、5.84、4.15和4.10点,使用基于锚的方法确定为1.50、10.50、8.34和3.03点。VAS的SCB,AOFAS,SF-36PCS,SF-36MCS在PCFD手术中分别为2.50、18.50、11.88和6.34分,分别。此外,初步的内部验证工作证明了这些发现的实际应用和临床实用性.除了SF-36PCS的基于分发的MCID之外,这表明了公平的协议,所有其他措施都显示出中等到几乎完美的一致性。
结论:MDC,MCID,和SCB直观地增强了对VAS的解释,AOFAS,和SF-36在PCFD手术中,协助所有利益相关者更好地了解临床护理的治疗益处和局限性,从而做出更理性的决定。这些参数中的每一个都有自己的重点,并补充其他参数。建议使用这些参数来评估结果的临床相关性,他们的推广应该扩展到脚和脚踝手术的其他领域。
BACKGROUND: This study aimed to ascertain the minimal clinically important difference (MCID), and substantial clinical benefit (SCB) of the American Orthopedic Foot and Ankle Society (AOFAS) scale, visual analog scale (VAS) for pain, and Short Form-36 Health Survey (SF-36) in progressive collapsing foot deformity (PCFD) surgery.
METHODS: In this retrospective cohort study, a total of 84 patients with PCFD (84 feet) who underwent surgery between July 2015 and April 2021 were included. The study assessed the patients\' subjective perception, as well as their VAS, AOFAS, and SF-36 scores at a minimum two-year follow-up, and these data were subjected to statistical analysis. The study utilized Spearman correlation analysis to determine the degree of correlation between patients\' subjective perception and their VAS, AOFAS, and SF-36 scores. The minimal detectable change (MDC), MCID, and SCB for VAS, AOFAS, and SF-36 were calculated using both distribution- and anchor-based methods. The classification outcomes obtained from the distribution- and anchor-based methods were assessed using Cohen\'s kappa.
RESULTS: Based on the subjective perception of the patients, a total of 84 individuals were categorized into three groups, with 7 in the no improvement group, 14 in the minimum improvement group, and 63 in the substantial improvement group. Spearman\'s correlation analysis indicated that the patients\' subjective perception exhibited a moderate to strong association with VAS, AOFAS, SF-36 PCS, and SF-36 MCS, with all coefficients exceeding 0.4. The MCID of VAS, AOFAS, SF-36 PCS, and SF-36 MCS in PCFD surgery were determined to be 0.93, 5.84, 4.15, and 4.10 points using the distribution-based method and 1.50, 10.50, 8.34, and 3.03 points using the anchor-based method. The SCB of VAS, AOFAS, SF-36 PCS, and SF-36 MCS in PCFD surgery were 2.50, 18.50, 11.88, and 6.34 points, respectively. Moreover, the preliminary internal validation efforts have demonstrated the practical application and clinical utility of these findings. With the exception of the distribution-based MCID of SF-36 PCS, which showed fair agreement, all other measures demonstrated moderate to almost perfect agreement.
CONCLUSIONS: The MDC, MCID, and SCB intuitively enhance the interpretation of VAS, AOFAS, and SF-36 in PCFD surgery, assisting all stakeholders to better understand the therapeutic benefits and limitations of clinical care, and thus to make a more rational decision. Each of these parameters has its own emphasis and complements the others. These parameters are recommended for evaluating the clinical relevance of the results, and their promotion should extend to other areas of foot and ankle surgery.