足踝手术中患者报告结果测量信息系统(PROMIS)的最小临床重要差异

PROMIS Minimal Clinically Important Differences Across Foot and Ankle Surgeries.

作者信息

Zona Nathaniel E, Hewitt Michael A, Keeter Carson, Buckley Sara E, Hunt Kenneth J

机构信息

Department of Orthopedic Surgery, University of Colorado School of Medicine, Aurora, CO, USA.

出版信息

Foot Ankle Orthop. 2025 May 2;10(2):24730114251334055. doi: 10.1177/24730114251334055. eCollection 2025 Apr.

Abstract

BACKGROUND

Minimal clinically important differences (MCIDs) increase patient-reported outcome measure (PROM) utility by defining benchmarks of meaningful improvement. The threshold for appreciable improvement may be unique to specific patient characteristics. To help establish benchmarks and improve evaluation of patient progress, this study investigates whether surgery type and demographic characteristics impact MCID.

METHODS

All foot and ankle patients within a single institution's PRO registry were screened. Patients without preoperative or ≥ 180-day follow-up in PROMIS physical function (PF) Computer Adaptive Test (CAT) (v2.0) and pain interference (PI) CAT (v1.1) were excluded. Foot and Ankle Single Assessment Numeric Evaluation (FA SANE) was used as an anchor for MCID calculations. MCID was compared across 11 foot and ankle surgical categories, reported sex, body mass index (BMI), and social deprivation index (SDI).

RESULTS

We included 1243 patients with an average follow-up of 456 ± 176 days. Patients significantly improved in PF by 8.2 ± 10.9 ( < .001) and PI by -8.1 ± 9.5 ( < .001). Global MCID estimates for PF and PI were 5.5 (95% CI 4.9, 6.0) and -5.8 (95% CI -5.3, -6.3), respectively, when anchored against FA SANE. The MCIDs using a ½ SD distribution-based method were 5.5 and -4.8, respectively. Surgery type greatly affected MCID, ranging from 2.3 and -3.8 for hardware removals to 15.7 and -9.8 for small soft tissue surgeries. MCID differences across reported sex, BMI, and SDI never exceeded 1.9 points.

CONCLUSION

A 6-month postoperative improvement of ≥ 5.5 and ≤ -4.8 in PROMIS PF and PI suggest meaningful clinical differences from baseline. However, MCID values for PROMIS scales vary across foot and ankle surgeries and patient characteristics, suggesting a global MCID for patient populations may not reflect the true threshold of meaningful change for each individual patient. Anchoring to FA SANE allows physicians to more objectively gauge appreciable change in patient-specific contexts.

LEVEL OF EVIDENCE

Level III, retrospective cohort study.

摘要

背景

最小临床重要差异(MCID)通过定义有意义改善的基准提高了患者报告结局测量(PROM)的效用。可察觉改善的阈值可能因特定患者特征而异。为了帮助建立基准并改善对患者进展的评估,本研究调查手术类型和人口统计学特征是否会影响MCID。

方法

对单个机构的PRO登记册中的所有足踝患者进行筛查。排除在PROMIS身体功能(PF)计算机自适应测试(CAT)(v2.0)和疼痛干扰(PI)CAT(v1.1)中没有术前或随访时间≥180天的患者。足踝单评估数字评分(FA SANE)用作MCID计算的锚定指标。比较了11种足踝手术类别、报告的性别、体重指数(BMI)和社会剥夺指数(SDI)的MCID。

结果

我们纳入了1243例患者,平均随访时间为456±176天。患者的PF显著改善了8.2±10.9(P<.001),PI显著改善了-8.1±9.5(P<.001)。以FA SANE为锚定指标时,PF和PI的总体MCID估计值分别为5.5(95%CI 4.9,6.0)和-5.8(95%CI -5.3,-6.3)。使用基于½标准差分布方法的MCID分别为5.5和-4.8。手术类型对MCID有很大影响,从硬件取出术的2.3和-3.8到小软组织手术的15.7和-9.8不等。报告的性别、BMI和SDI之间的MCID差异从未超过1.9分。

结论

PROMIS PF和PI术后6个月改善≥5.5和≤-4.8表明与基线存在有意义的临床差异。然而,PROMIS量表的MCID值因足踝手术和患者特征而异,这表明针对患者群体的总体MCID可能无法反映每个患者有意义变化的真实阈值。以FA SANE为锚定指标可使医生在特定患者背景下更客观地衡量可察觉的变化。

证据水平

III级,回顾性队列研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b2c/12049601/3942bfb74b25/10.1177_24730114251334055-img2.jpg

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