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基于潜在类别分析的成人脊柱畸形健康相关生活质量量表的最小临床重要差异:是否可以对手术和非手术患者使用相同的数值?

Minimum clinically important difference of the health-related quality of life scales in adult spinal deformity calculated by latent class analysis: is it appropriate to use the same values for surgical and nonsurgical patients?

机构信息

Department of Biostatistics, Yildirim Beyazit University, Ankara, Turkey.

ARTES Spine Center, Ankara, Turkey; Vocational School of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.

出版信息

Spine J. 2019 Jan;19(1):71-78. doi: 10.1016/j.spinee.2018.07.005. Epub 2018 Aug 27.

Abstract

BACKGROUND CONTEXT

Health-related quality of life (HRQOL) parameters have been shown to be reliable and valid in patients with adult spinal deformity (ASD). Minimum clinically important difference (MCID) has become increasingly important to clinicians in evaluating patients with a threshold of improvement that is clinically relevant.

PURPOSE

To calculate MCID and minimum detectable change (MDC) values of total scores of the Core Outcome Measures Index (COMI), Oswestry Disability Index (ODI), Physical Component Summary (PCS), Mental Component Summary (MCS) of the Short Form 36 (SF-36), and Scoliosis Research Society 22R (SRS-22R) in surgically and nonsurgically treated ASD patients who have completed an anchor question at pretreatment and 1-year follow-up.

STUDY DESIGN/SETTING: Prospective cohort.

PATIENT SAMPLE

Surgical and nonsurgical patients from a multicenter ASD database.

OUTCOME MEASURES

Self-reported HRQOL measures (COMI, ODI, SF-36, SRS-22R, and anchor question).

METHODS

A total of 185 surgical and 86 nonsurgical patients from a multicenter ASD database who completed pretreatment and 1-year follow-up HRQOL scales and the anchor question at the first year follow-up were included. The anchor question was used to determine MCID for each HRQOL measure. MCIDs were calculated by an anchor-based method using latent class analysis (LCA) and MDCs by a distribution-based method.

RESULTS

All differences between means of baseline and first year postoperative total score measures for all scales demonstrated statistically significant improvements in the overall population as well as the surgically treated patients but not in the nonsurgical group. The calculated MDC and MCID values of HRQOL parameters in the entire study population were 1.34 and 2.62 for COMI, 10.65 and 14.31 for ODI, 6.09 and 7.33 for SF-36 PCS, 6.14 and 4.37 for SF-36 MCS, and 0.42 and 0.71 for SRS-22R. The calculated MCID values for surgical and non-surgical treatment groups were 2.76 versus 1.20 for COMI, 14.96 versus 2.45 for ODI, 7.83 versus 2.15 for SF-36 PCS, 5.14 versus 2.03 for SF-36 MCS, and 0.94 versus 0.11 for SRS-22R; the MDC values for surgical and nonsurgical treatment groups were 1.22 versus 1.51 for COMI, 10.27 versus 9.45 for ODI, 5.16 versus 6.77 for SF-36 PCS, 6.05 versus 5.67 for SF-36 MCS, and 0.38 versus 0.43 for SRS-22R.

CONCLUSIONS

This study has demonstrated that MCID calculations for the HRQOL scales in ASD using LCA yield values comparable to other studies that had used different methodologies. The most important finding was the significantly different MCIDs for COMI, ODI, SF-36 PCS and SRS-22 in the surgically and nonsurgically treated cohorts. This finding suggests that a universal MCID value, inherent to a specific HRQOL for an entire cohort of ASD may not exist. Use of different MCIDs for surgical and nonsurgical patients may be warranted.

摘要

背景

健康相关生活质量(HRQOL)参数已被证明在成人脊柱畸形(ASD)患者中是可靠和有效的。最小临床重要差异(MCID)对于评估具有临床相关改善阈值的患者的临床医生来说变得越来越重要。

目的

计算接受手术和非手术治疗的 ASD 患者在治疗前和 1 年随访时完成锚定问题后的总评分的核心结局测量指标(COMI)、Oswestry 残疾指数(ODI)、物理成分综合评分(PCS)、精神成分综合评分(MCS)的简短 36 项健康调查(SF-36)和脊柱侧凸研究协会 22R(SRS-22R)的 MCID 和最小可检测变化值(MDC)。

研究设计/设置:前瞻性队列研究。

患者样本

来自多中心 ASD 数据库的手术和非手术患者。

观察指标

自我报告的 HRQOL 措施(COMI、ODI、SF-36、SRS-22R 和锚定问题)。

方法

共有 185 名手术和 86 名非手术患者来自多中心 ASD 数据库,他们在第一年随访时完成了治疗前和 1 年随访的 HRQOL 量表和锚定问题。锚定问题用于确定每个 HRQOL 测量的 MCID。使用基于潜在类别分析(LCA)的锚定方法计算 MCID,使用基于分布的方法计算 MDC。

结果

所有基线和第一年术后总评分测量的均值差异表明,在整个人群以及手术治疗患者中,所有量表的总体表现均有统计学显著改善,但在非手术组中没有改善。在整个研究人群中,HRQOL 参数的计算 MDC 和 MCID 值为 COMI 为 1.34 和 2.62,ODI 为 10.65 和 14.31,SF-36 PCS 为 6.09 和 7.33,SF-36 MCS 为 6.14 和 4.37,SRS-22R 为 0.42 和 0.71。手术和非手术治疗组的计算 MCID 值分别为 COMI 为 2.76 与 1.20,ODI 为 14.96 与 2.45,SF-36 PCS 为 7.83 与 2.15,SF-36 MCS 为 5.14 与 2.03,SRS-22R 为 0.94 与 0.11;手术和非手术治疗组的 MDC 值分别为 COMI 为 1.22 与 1.51,ODI 为 10.27 与 9.45,SF-36 PCS 为 5.16 与 6.77,SF-36 MCS 为 6.05 与 5.67,SRS-22R 为 0.38 与 0.43。

结论

本研究表明,使用 LCA 对 ASD 的 HRQOL 量表进行 MCID 计算可得出与使用其他不同方法的其他研究相当的值。最重要的发现是手术和非手术治疗队列中 COMI、ODI、SF-36 PCS 和 SRS-22 的 MCID 存在显著差异。这一发现表明,对于整个 ASD 患者群体来说,可能不存在特定 HRQOL 固有的通用 MCID 值。可能需要为手术和非手术患者使用不同的 MCID 值。

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