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膝关节半月板手术患者的患者报告结局测量信息系统测试的临床显著改善应如何定义?

How Should We Define Clinically Significant Improvement on Patient-Reported Outcomes Measurement Information System Test for Patients Undergoing Knee Meniscal Surgery?

机构信息

Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.

Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A..

出版信息

Arthroscopy. 2020 Jan;36(1):241-250. doi: 10.1016/j.arthro.2019.07.036.

DOI:10.1016/j.arthro.2019.07.036
PMID:31864584
Abstract

PURPOSE

The purpose of the study was to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) thresholds for the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) computerized adaptive test (CAT) instrument in patients undergoing arthroscopic meniscal surgery.

METHODS

The PROMIS PF CAT was administered preoperatively and postoperatively to patients undergoing arthroscopic meniscal surgery. At 6 months postoperatively, patients graded their knee function based on a domain-specific anchor question. A satisfaction anchor question was used to indicate achievement of the PASS. Receiver operating characteristic analysis determined the relevant psychometric values. Cutoff analysis was performed to find preoperative patient-reported outcome scores predicting achievement of clinically significant outcomes (CSOs).

RESULTS

A total of 73 patients (41.1% female patients) were included, with a mean age of 44.9 ± 12.8.0 years and average follow-up period of 24.0 ± 1.2 weeks. The MCID on the PROMIS PF CAT was calculated to be 2.09 (area under the curve [AUC], 0.75; 95% CI, 0.57-0.94). Net score improvement equivalent to achievement of SCB was found to be 6.50 (AUC, 0.77; 95% CI, 0.55-0.99). The PASS was found to be 46.1 (AUC, 0.86; 95% CI, 0.76-0.96). A preoperative score below 37.6 on the PROMIS PF CAT predicted achievement of the MCID (AUC, 0.76; 95% CI, 0.62-0.87), whereas scores above 41.9 predicted achievement of the PASS (AUC, 0.77; 95% CI, 0.65-0.90). Higher baseline functional status and the absence of pre-existing arthritis were also found to be statistically significant predictors of achieving CSOs.

CONCLUSIONS

Our study defined the MCID, SCB, and PASS for the PROMIS PF CAT. We found that a preoperative score below 37.6 was predictive of achieving a meaningful clinical change with surgery whereas a preoperative score above 41.9 was predictive of patients who would attain an acceptable postoperative health state. In addition, exercising more days per week and the absence of arthritis increased the likelihood of achieving postoperative CSOs.

LEVEL OF EVIDENCE

Level III, retrospective cohort.

摘要

目的

本研究旨在确定接受关节镜半月板手术患者的患者报告结局测量信息系统(PROMIS)物理功能(PF)计算机自适应测试(CAT)的最小临床重要差异(MCID)、显著临床获益(SCB)和患者可接受的症状状态(PASS)阈值。

方法

对接受关节镜半月板手术的患者术前和术后进行 PROMIS PF CAT 评估。术后 6 个月,患者根据特定于域的锚定问题对其膝关节功能进行分级。满意度锚定问题用于表示达到 PASS。接受者操作特征分析确定相关心理测量值。进行截断分析以找到预测达到临床显著结果(CSO)的术前患者报告结局评分。

结果

共纳入 73 例患者(41.1%为女性),平均年龄 44.9±12.8 岁,平均随访时间为 24.0±1.2 周。PROMIS PF CAT 的 MCID 计算为 2.09(曲线下面积 [AUC],0.75;95%CI,0.57-0.94)。发现净评分改善相当于达到 SCB 的程度为 6.50(AUC,0.77;95%CI,0.55-0.99)。PASS 为 46.1(AUC,0.86;95%CI,0.76-0.96)。PROMIS PF CAT 术前评分低于 37.6 分预测达到 MCID(AUC,0.76;95%CI,0.62-0.87),而评分高于 41.9 分预测达到 PASS(AUC,0.77;95%CI,0.65-0.90)。较高的基线功能状态和无预先存在的关节炎也被发现是达到 CSO 的统计学显著预测因素。

结论

我们的研究确定了 PROMIS PF CAT 的 MCID、SCB 和 PASS。我们发现,术前评分低于 37.6 分预示着手术可实现有意义的临床改善,而术前评分高于 41.9 分预示着患者可达到可接受的术后健康状态。此外,每周运动天数增加和无关节炎增加了术后达到 CSO 的可能性。

证据水平

三级,回顾性队列。

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