Evaluating the Correlation and Responsiveness of Patient-Reported Pain With Function and Quality-of-Life Outcomes After Spine Surgery

Evaluating the Correlation and Responsiveness of Patient-Reported Pain With Function and Quality-of-Life Outcomes After Spine Surgery
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DOI:
10.1097/brs.0b013e31822ef6de
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发表时间:
2011-10-01
期刊:
影响因子:
3
通讯作者:
Andersson, Gunnar
Andersson, Gunnar
中科院分区:
医学2区
文献类型:
--
作者:
DeVine, John;Norvell, Daniel C.;Andersson, Gunnar

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研究设计。系统回顾。客观。确定脊柱手术后患者报告的疼痛与身体功能和健康相关生活质量 (HRQoL) 的相关性,并确定脊柱手术后疼痛、身体功能和 HRQoL 的反应性。背景数据摘要。有几种经过验证的结果工具可用于评估慢性腰痛治疗的成功与否。这些以患者为中心的工具包括基于数字量表的疼痛测量、经过验证的特定条件功能结果测量和 HRQoL 结果测量。目前尚不清楚这三种类型的患者报告的结果是否测量不同的结构,以及是否应在脊柱手术后测量所有这三种结果。此外,尚不清楚这些结果指标中哪一个对腰痛脊柱手术后的变化最敏感。方法。在 MEDLINE、EMBASE 和 Cochrane 协作图书馆中对截至 2010 年 12 月发表的文献进行了系统检索。使用 Spearman 等级相关系数对疼痛(视觉模拟量表,VAS)、身体功能(Oswestry 残疾指数,ODI)和 HRQoL(36 项简表健康调查 [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,我们通过将变化评分除以基线评分的 SD 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果测量的响应性,并将 0.2 至 0.3 的效应大小报告为“小”效应,0.5 左右为“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差异是否显着不同,当有足够的数据来执行测试时,我们在疼痛、功能和 HRQoL 评分的三个测量值之间进行了 Wilcoxon 符号秩检验。结果。使用斯皮尔曼等级相关系数,所有相关性均不超过 0.70,这表明这些结果测量的是不同的结构。最强的相关性是 VAS 背痛变化评分与 SF-36 身体综合评分变化评分 (rho = 0.67) 以及 VAS 背痛变化评分和 ODI 变化评分 (rho = 0.69) 之间的相关性。报告疼痛测量值和 ODI 的五项研究的汇总平均效应大小分别为 1.4 +/- 0.57 和 1.1 +/- 0.39。两者都被认为是“大”效应量。报告 SF-36 身体和心理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。两者都被认为是“中等”效应大小。报告 EQ-5D 和 SF-36 总分的单项研究的汇总平均效应大小分别为 0.78 +/- 0.12 和 0.34 +/- 0.21。它们分别是“中”和“小”。结论。我们观察到疼痛的变化与 HRQoL 结果测量的变化之间几乎没有相关性。 VAS 疼痛与 ODI 之间的相关性最强,但仍不被认为很强 (0.69)。这些发现表明,这三种结果(疼痛、功能和 HRQoL)正在测量不同的结构。就反应性而言,VAS 疼痛和 ODI 是唯一在腰椎手术后显示出巨大效果的结果指标。没有一种 HRQoL 工具对治疗如此敏感。 EQ-5D、SF 身体综合和 SF 心理综合结果表现出中等影响,而 SF-36 总分表现出较小影响。响应措施表明,结果工具越具体,响应就越敏感。临床建议。建议 1:当手术治疗 CLBP 时,我们建议在手术干预前后同时进行疼痛 VAS 和针对具体情况的身体测量(例如 ODI),因为这些结果是最具治疗特异性且对变化最敏感的结果。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。
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 coefcients, 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 (rho = 0.67) and VAS back pain change scores and ODI change scores (rho = 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.