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腰椎手术患者中患者报告结局指标的合理选择

Rational Selection of Patient-Reported Outcomes Measures in Lumbar Spine Surgery Patients.

作者信息

Boden Susanne H, Farley Kevin X, Campbell Collier, Boden Scott D, Gottschalk Michael B

机构信息

Oakland University William Beaumont School of Medicine, Rochester, Minnesota.

Emory University School of Medicine, Department of Orthopaedics, Atlanta, Georgia.

出版信息

Int J Spine Surg. 2020 Jun 30;14(3):347-354. doi: 10.14444/7046. eCollection 2020 Jun.

Abstract

BACKGROUND

The Short Form-12 (SF-12) was developed as a shorter version of the SF-36, yet there has been limited validation of its reliability at measuring postoperative changes. The purpose of this study was to determine if the SF-12 could safely substitute for the SF-36 in measuring postoperative change in lumbar spine surgery patients and if the condition specific (Oswestry Disability Index [ODI]) or pain (visual analog scale [VAS]) instruments, provided additional utility.

METHODS

A total of 972 patients from a single center who underwent lumbar spine surgery for a predominant symptom of radiating leg pain with (n = 237) or without (n = 735) fusion and prospectively completed both SF-36 and ODI instruments before and after surgery were included. The SF-12 score was calculated from the appropriate subset of SF-36 responses. The absolute sensitivity and the intraclass correlation coefficient were calculated. Reliability of each instrument to measure preoperative to postoperative change was calculated as the standardized response mean.

RESULTS

The SF-12 and SF-36 demonstrated a strong correlation with each other ([0.97, < .001] and [0.93, < .001], respectively) preoperatively and postoperatively. The SF-12 and SF-36 scores were moderately to strongly inversely correlated with the ODI. The ODI showed greater reliability at measuring change than the SF-12 for both fusion (0.94 versus 0.72) and nonfusion (0.81 versus 0.33) lumbar surgery patients.

CONCLUSIONS

The SF-12 was as effective as the SF-36 to measure general health status in lumbar spine surgery patients, and both were moderate to strong predictors of ODI preoperatively and postoperatively, but lack the reliability to detect change seen with the ODI or VAS after surgical intervention.

LEVEL OF EVIDENCE

CLINICAL RELEVANCE

These data suggest that the SF-12 is a valid substitute for the SF-36 to measure postoperative outcomes changes, but that the ODI should continue to be used to measure condition specific changes in function.

摘要

背景

简明健康状况调查量表12项版(SF - 12)是作为简明健康状况调查量表36项版(SF - 36)的简短版本开发的,但在测量术后变化方面其可靠性验证有限。本研究的目的是确定在测量腰椎手术患者术后变化时,SF - 12是否可以安全替代SF - 36,以及特定病情(奥斯威斯功能障碍指数[ODI])或疼痛(视觉模拟评分法[VAS])工具是否具有额外的效用。

方法

纳入来自单一中心的972例接受腰椎手术的患者,这些患者主要症状为放射性腿痛,其中有融合手术的患者237例,无融合手术的患者735例,患者术前和术后均前瞻性地完成了SF - 36和ODI工具的评估。SF - 12评分由SF - 36相应的子集中的数据计算得出。计算绝对敏感度和组内相关系数。每种工具测量术前至术后变化的可靠性以标准化反应均值计算。

结果

术前和术后,SF - 12与SF - 36相互之间均显示出强相关性(分别为[0.97,P <.001]和[0.93,P <.001])。SF - 12和SF - 36评分与ODI呈中度至强负相关。对于融合腰椎手术患者(0.94对0.72)和非融合腰椎手术患者(0.81对0.33),ODI在测量变化方面显示出比SF - 12更高的可靠性。

结论

在测量腰椎手术患者的总体健康状况方面,SF - 12与SF - 36同样有效,并且两者在术前和术后都是ODI的中度至强预测指标,但在检测手术干预后ODI或VAS所显示的变化方面缺乏可靠性。

证据级别

3级。

临床相关性

这些数据表明,SF - 12是测量术后结果变化的SF - 36的有效替代工具,但ODI应继续用于测量特定病情的功能变化。

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