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评估脊柱手术后患者报告的疼痛与功能和生活质量结局的相关性和反应性。

Evaluating the correlation and responsiveness of patient-reported pain with function and quality-of-life outcomes after spine surgery.

机构信息

Eisenhower Army Medical Center, Ft Gordon, GA 30905, USA.

出版信息

Spine (Phila Pa 1976). 2011 Oct 1;36(21 Suppl):S69-74. doi: 10.1097/BRS.0b013e31822ef6de.


DOI:10.1097/BRS.0b013e31822ef6de
PMID:21897347
Abstract

STUDY DESIGN: Systematic review. OBJECTIVE: To determine the correlation of patient-reported pain with physical function and health-related quality of life (HRQoL) after spine surgery and to determine the responsiveness of pain, physical function, and HRQoL after spine surgery. SUMMARY OF BACKGROUND DATA: Several validated outcome instruments are available to assess the success of treatment for chronic low back pain. These patient-centered tools include measurements for pain based on numeric scales, validated condition-specific functional outcomes measures, and HRQoL outcomes measures. It is unclear whether these three types of patient-reported outcomes are measuring different constructs and whether all three should be measured after spine surgery. In addition, it is unclear which of these outcomes measures is most sensitive to change after spine surgery for low back pain. METHODS: A systematic search was conducted in MEDLINE, EMBASE, and the Cochrane Collaboration Library for literature published through December 2010. The correlation between pain (visual analog scale, VAS), physical function (Oswestry Disability Index, ODI), and HRQoL (36-Item Short Form Health Survey [SF-36] and European Quality of Life [EQ-5D]) change scores was performed using the Spearman rank correlation coefficients. To compare the responsiveness of pain, function, and HRQoL scores after spine surgery, we calculated effect sizes by dividing change scores by the SD of the baseline scores. This standardized method allowed us to compare the responsiveness of each outcome measure directly and reported an effect size of 0.2 to 0.3 as a "small" effect, around 0.5 a "medium" effect and 0.8 to infinity, a "large" effect. To determine whether the differences in effect sizes measuring responsiveness were significantly different, we conducted a Wilcoxon signed-rank test between each of the three measurements of pain, function, and HRQoL scores when there was enough data to perform the test. RESULTS: None of the correlations exceeded 0.70 using the Spearman rank correlation coefficients, suggesting that these outcomes are measuring different constructs. The strongest correlations were between the VAS back pain change scores and the SF-36 physical composite score change scores (ρ = 0.67) and VAS back pain change scores and ODI change scores (ρ = 0.69). The pooled mean effect sizes for the five studies that reported a pain measure and the ODI were 1.4 ± 0.57 and 1.1 ± 0.39, respectively. Both are considered "large" effect sizes. The pooled mean effect sizes for the three studies reporting the SF-36 physical and mental composite scores were 0.66 ± 0.39 and 0.54 ± 0.36, respectively. Both are considered "medium" effect sizes. The pooled mean effect sizes for the single studies reporting the EQ-5D and SF-36 total score were 0.78 ± 0.12 and 0.34 ± 0.21. These were "medium" and "small," respectively. CONCLUSION: We observed little correlation between the change in pain and the change in HRQoL outcomes measures. The strongest correlation was between VAS pain and ODI but was still not considered strong (0.69). These findings suggest that these three outcomes (pain, function, and HRQoL) are measuring different constructs. With respect to responsiveness, VAS pain and ODI were the only outcomes measures that demonstrated a large effect after lumbar spine surgery. None of the HRQoL tools were as sensitive to the treatment. The EQ-5D, SF physical composite, and SF mental composite outcomes demonstrated a medium effect, while the SF-36 total score demonstrated a small effect. The responsive measure shows that the more specific the outcomes tool, the more sensitive the response. CLINICAL RECOMMENDATIONS: Recommendation 1: When surgically treating CLBP, we recommend administering both a VAS for pain and a condition-specific physical measure such as the ODI before and after surgical intervention as these outcomes are the most treatment specific and responsive to change. Strength of recommendation: Strong.Recommendation 2: When evaluating the surgical outcomes for CLBP in the clinical-research setting, we recommend selecting a shorter version for measuring general HRQoL (e.g., SF-12, EQ-5D) to minimize clinician and patient burden. Strength of recommendation: Strong.

摘要

研究设计:系统评价。

目的:确定患者报告的疼痛与脊柱手术后的身体功能和健康相关生活质量(HRQoL)之间的相关性,并确定脊柱手术后疼痛、身体功能和 HRQoL 的反应性。

背景资料总结:有几种经过验证的结局评估工具可用于评估慢性下腰痛治疗的成功。这些以患者为中心的工具包括基于数字量表的疼痛测量、经过验证的特定疾病的功能结局测量以及 HRQoL 结局测量。尚不清楚这三种类型的患者报告结果是否在测量不同的结构,以及脊柱手术后是否都应进行测量。此外,尚不清楚这些结果测量中的哪一种在脊柱手术后对下腰痛的变化最敏感。

方法:在 MEDLINE、EMBASE 和 Cochrane 合作图书馆中进行了系统搜索,以查找截至 2010 年 12 月发表的文献。使用 Spearman 秩相关系数对疼痛(视觉模拟量表,VAS)、身体功能(Oswestry 残疾指数,ODI)和 HRQoL(36 项简短健康调查 [SF-36] 和欧洲生活质量 [EQ-5D])变化评分之间的相关性进行了分析。为了比较脊柱手术后疼痛、功能和 HRQoL 评分的反应性,我们通过将基线评分的标准差除以变化评分来计算效应大小。这种标准化方法使我们能够直接比较每个结局测量的反应性,并报告效应大小为 0.2 至 0.3 为“小”效应,约 0.5 为“中”效应,0.8 至无穷大为“大”效应。为了确定测量反应性的效应大小之间的差异是否有显著差异,当有足够的数据进行检验时,我们对疼痛、功能和 HRQoL 评分的每三个测量值之间进行了 Wilcoxon 符号秩检验。

结果:使用 Spearman 秩相关系数,没有一个相关性超过 0.70,这表明这些结果是在测量不同的结构。最强的相关性是 VAS 腰痛变化评分与 SF-36 身体综合评分变化评分之间(ρ=0.67)和 VAS 腰痛变化评分与 ODI 变化评分之间(ρ=0.69)。五项报告疼痛测量和 ODI 的研究的汇总平均效应大小分别为 1.4±0.57 和 1.1±0.39,均为“大”效应大小。报告 SF-36 身体和精神综合评分的三项研究的汇总平均效应大小分别为 0.66±0.39 和 0.54±0.36,均为“中”效应大小。单项研究报告 EQ-5D 和 SF-36 总分的平均效应大小分别为 0.78±0.12 和 0.34±0.21,分别为“中”和“小”。

结论:我们观察到疼痛变化与 HRQoL 结局测量之间的相关性很小。最强的相关性是 VAS 疼痛与 ODI,但仍不是很强(0.69)。这些发现表明,这三个结局(疼痛、功能和 HRQoL)是在测量不同的结构。就反应性而言,VAS 疼痛和 ODI 是唯一在腰椎手术后表现出大效应的结局测量。没有任何 HRQoL 工具对治疗如此敏感。EQ-5D、SF 身体综合评分和 SF 心理综合评分表现出中等效应,而 SF-36 总分表现出小效应。反应性测量表明,结果工具越具体,反应越敏感。

临床建议:建议 1:在手术治疗 CLBP 时,我们建议在手术干预前后同时使用 VAS 进行疼痛评估和特定疾病的物理测量,如 ODI,因为这些结果是最具特异性和对变化最敏感的。推荐强度:强。建议 2:在临床研究环境中评估 CLBP 的手术结果时,我们建议选择较短的版本来测量一般 HRQoL(例如,SF-12,EQ-5D),以最大程度地减少临床医生和患者的负担。推荐强度:强。

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